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'Gluten free' or 'very low gluten' claims
About 1% of people in the UK are intolerant to gluten – this condition is also known as coeliac disease. People with coeliac disease need to avoid foods that contain gluten to prevent potentially serious health effects. This means labelling claims about gluten in foods are very important. Foods that contain gluten include wheat, rye and barley.
The European Commission compositional and labelling standards (Commission Regulation (EC) No. 41/2009) establish levels of gluten for foods that makes a claim to be either 'gluten-free' or 'very low gluten'. These levels are:
- 'gluten-free' – 20 parts or less of gluten per million.
- 'very low gluten' – 100 parts or less of gluten per million. However, only foods with cereal ingredients that have been specially processed to remove the gluten may make a 'very low gluten' claim.
Manufacturers can only use the phrase 'gluten-free' if they can demonstrate that, when tested, their product is 20 parts or less of gluten per million. They will also be required to demonstrate that any products claiming to be 'very low gluten' comply to the legislation.
Manufacturers producing foods with no deliberate gluten containing ingredients, but due to the high risk of gluten cross-contamination, will be unable to label foods as 'gluten-free' or 'very low gluten'. However, if steps have been taken to control gluten cross-contamination, these manufacturers may be able to indicate which foods do not contain gluten-containing ingredients. This allows people with coeliac disease to make informed choices about the food they eat based on their individual levels of sensitivity
Source: FSA Allergy training
1.2.10: Non-Official Control Interventions
Officers undertaking non-official control interventions are not required to meet the qualification requirements set out in this Chapter, but they should, however, be appropriately authorised.
Any visits by appropriately authorised officers, must be confined to information collection and reporting back and appropriate advice and education. The overall management of non-official control interventions must remain in the hands of a food law enforcement officer qualified in accordance with this Chapter, and decisions to take other enforcement action and/or intervene further must also be made by such an officer.
1.2.9.2.2: Qualifications & Awarding Bodies - Food Standards
• The REHIS or EHRB Diploma in Environmental Health (or its antecedents), or Certificate of Registration of EHRB;
• The Higher Certificate in Food Standards Inspection issued by SFSORB;
• The Higher Certificate in Food Premises Inspection issued by EHORB or the IFST with an endorsement to include Food Standards Enforcement.
• Diploma in Trading Standards (DTS) or its antecedents;
• Diploma in Consumer Affairs (DCA) provided it includes the Food and Agriculture Paper of Part II, or its antecedents;
• a DCA Certificate of Competence in relation to Food and Agriculture (or its antecedents);
• One of the following Trading Standards Qualifications Framework Certificates with the Food Standards service delivery module (issued by TSI):
• Module Certificate;
• Diploma in Consumer Affairs and Trading Standards (DCATS);
• Certificate of Competence.
• Higher Diploma in Consumer Affairs and Trading Standards (HDCATS) (this certificate must be presented with one of the awards/certificates listed above).
All officers undertaking official controls are required to undertake a period of structured practical training as part of the preparation for the award of these qualifications.
852 General Provisions
Article I of regulation (EC) 852 exempts domestic food activities for personal consumption and very small scale supply of foods from the scope of food hygiene legislation.
Article 2 provides some key definitions such as:
"Food Hygiene- the measures and conditions necessary to control hazards and to ensure fitness for human consumption of a foodstuff taking into account its intended use"
A - Account
This term describes the stage in which the interviewee’s recollection of the events of interest is obtained. This stage is directed at obtaining the fullest possible account from the suspect. There are two accepted approaches of inducing recollection known as:
The cognitive approach;
Conversation management.
Different techniques for assisting recollection are associated with each method. With the cognitive method, the interviewee is asked to think back and mentally relive the event, initially with minimal interference from the interviewing officer. The officer does not interrupt, makes effective use of pauses and avoids leading questions. The interviewee is then encouraged to recall the event again using a different chronological order, or from a different perspective.
When the conversation management method is used, the interviewee is asked first to say what happened and the officer then subdivides the account into a number of individual parts which are enquired about in turn for further details.
The cognitive method provides the interviewee with greater control over the way the interview develops, whereas conversation management attributes more authority to the interviewer. This basic difference between the two approaches broadly defines when each is most appropriately used. For example, conversation management may be more appropriate for reluctant interviewees than the cognitive method.
A localised food hazard -
one in which food is not distributed beyond the boundaries of the Food Authority and is not deemed to be a serious localised food hazard;
A non-localised food hazard
One in which food is distributed beyond the boundaries of the Food Authority.
A serious localised food hazard
One in which food is not distributed beyond the boundaries of the Food Authority but which involves E. coli O157, other VTEC, C. botulinum, Salmonella typhii or Salmonella paratyphi or which the Food Authority considers significant because of, for example, the vulnerability of the population likely to be affected, the numbers involved or any deaths associated with the incident.
Accountable
HSE answers to ministers, Parliament and the public for any legislation it proposes, with appeals procedures for enforcement actions.
Acid coagulated fresh cheese
'Fresh cheese' normally refers to cheese produced by acid coagulation at 30 - 32°C with little or no added rennet.
Varieties: Cottage cheese and Quark
Coagulation: The distinguishing characteristic of these varieties is that coagulation of the milk is achieved by acidification to pH 4.6 - 4.8, with little or no coagulating enzyme. Acidification is normally by lactic acid producing cultures.
pH Control: After cutting at pH 4.6 - 4.8, the curd is cooked to 52 C which is sufficient to inactivate the culture and prevent further acid development. Acidity is also reduced by washing the curd before salting.
Moisture Control: Curd moisture is reduced by syneresis during cooking but remains high, 60 - 70%, in the finished cheese.
Fresh cheese as the name implies is consumed fresh and has a shelf life of only 2 - 3 weeks.
acid treatment
Acid based detergents are effective in the removal of milk protein from equipment and as such are an essential part of an effective dairy cleaning programme.
Acquisition and disclosure of communication data
Local authorities are permitted to request, via a single point of contact, certain communication data from communication service providers.
Action by food authority - food hazard
When a Food Authority becomes aware of a food hazard it should take action to protect public health and safety at the earliest opportunity, including detaining or seizing the food concerned if it is located within the Food Authority’s area (see Chapter 3.4).
Food Authorities should also consider the use of other powers under the Food Hygiene (Scotland) Regulations 2006 or the Food Safety Act 1990 as appropriate, relevant to the circumstances involved.
Localised food hazards should be dealt with locally by the Food Authority, in conjunction with other relevant agencies and need not be reported to the Agency. Serious localised food hazards and non-localised food hazards should be notified by the Food Authority to the Agency and other relevant agencies at the earliest opportunity and by the quickest available means and confirmed in writing on the incident report form located at
https://incidents.foodapps.co.uk/Incidentreportform/login.aspx or the hard copy at Annex 4. This form can be submitted directly to the Food Incidents Team via the website.
However, where a Food Authority becomes aware that a food business operator in their area has withdrawn food from the market in accordance with Article 19 of Regulation 178/2002 due to non-compliance of the food safety requirements of that Regulation, the Food Authority should confirm that the Agency is also aware. Responsibility for action at local level remains with the Food Authority unless the Agency notifies the Food Authority otherwise.
Action following prohibition of a person
The Food Authority should notify the Royal Environmental Health Institute of Scotland (REHIS) as soon as possible after a hygiene prohibition order is made against a person prohibited from running a food business, provided the order is not the subject of an appeal and the period allowed for appeal has expired, supplying the following information:
• Case number
• Court details
• Date of Hygiene Prohibition Order
• Date(s) of offence
• Nature of offence(s)
• Regulation number under which offence was made
• Penalties
• Name of food business operator or manager
• Name of the business
• Food Business establishment address including post code
• Business type/main activity (e.g. catering, retail etc)
• Details of assumed names.
Activities of HSE
HSE is required to submit to the Secretary of State such proposals as it considers appropriate for making regulations under any of the relevant statutory provisions, and to submit to the Secretary of State particulars of what it proposes to do for the purpose of performing its functions. HSE is also required to ensure that its activities are in accordance with proposals approved by the Secretary of State.
The Secretary of State has the power to direct HSE in particular matters (although they may not give directions with regard to the enforcement of the relevant statutory provisions in any particular case). In practice, almost all health and safety proposals since the 1974 Act have been put forward to ministers by HSE. In exercising their responsibilities for negotiating and implementing European health and safety law, ministers have always looked to HSE for help and advice.
Additional requirements for approved establishments
Approved establishments are required to comply with the general hygiene requirements set out in Regulation (EC) 852/2004, the requirements of general food law set out in Regulation (EC) 178/2002 together, where necessary, with the animal by-products arrangements set out in regulation (EC) 1774/2002.
Regulation (EC) 853/2004 sets out some additional management, structural and operational arrangements which certain approved establishments must also comply with.
These arrangements are set out in Annex III to the Regulations and are organised according to the nature of the food handled.
Additives
Additives are defined as
“..Any substance not normally consumed as a food by itself and not normally used as a typical ingredient of the food…the intentional addition of which to food for a technological... purpose in the manufacture…of such foods, results….in it or its by products becoming a component of or otherwise affecting the characteristics of such foods.”
Address of Sheriff
This address may be printed on the reverse of the notice or provided separately in a letter to the food business operator.
Adequacy of HACCP systems
Regulation (EC) 854/2004 requires that competent authorities verify that HACCP procedures are applied properly and continuously in approved establishments.
Officers should verify that these procedures guarantee as far as possible that products produced in an approved establishment comply with: microbiological criteria; legislation on residues, contaminants and prohibited substances and do not contain physical hazards.
It should be recognised, however, that guidance produced by LACORS states that food safety management standards should not be interpreted in a more strict way just because the business is approved.
Adequacy of such procedures
The purpose of product recall systems and procedures is to ensure that the public is protected from any food that may fail the food safety requirements. As such an effective product recall system will place the interests of the consumer at the heart of its operation.
A typical procedure might involve several different levels of response depending on the nature of the problem and the required intervention by the business.
Advanced disclosure
The Coroner should focus on information relevant to his/her inquiry and be mindful of any potential prejudice to ongoing investigations or future criminal proceedings. However, it may be necessary to remind the Coroner of such risks, particularly where evidence you have gathered is intended as advance rebuttal of any ‘defences’ and its disclosure could prejudice ongoing enquiries, such as future interviews of suspects.
Where potentially prejudicial material is identified and the Coroner decides not to disclose it to the interested persons (see below), s/he may nevertheless use that information to inform his/her inquiry. The material will, for example, assist the Coroner in identifying the scope of the inquest, matters each witness may be asked to address and the potential for witnesses to incriminate themselves.
Provided the approach in the MoU can be adopted, it is not anticipated that HSE should need to request a written undertaking from the Coroner not to disclose material from HSE’s investigation without its permission. You should contact Legal Adviser’s Office if you experience any difficulties with issues of disclosure connected with an inquest.
HSE will normally wish to assert privilege over any confidential communications made for the purpose of seeking, obtaining or giving legal advice. That privilege extends to communications with third parties made for the purposes of pending or contemplated litigation, and also to reports which were obtained for the purposes of that litigation. This may include expert reports or draft reports prepared for the purposes of supporting a prosecution, as well as HSE’s internal documents.
The above approach applies only to HSE material and not to documents that might be in the possession of others, including the police. You should remember that a Coroner is a judicial officer and treat him/her accordingly.
Adverse Micro Results
In accordance with regulation 9 of the Food Safety (Sampling and Qualifications) Regulations 1990, a copy of the certificate of examination must be supplied, on request, to the owner of the food which has been examined. If the alleged offence is thought to be related to the manufacturer, they should be informed at the earliest opportunity by the fastest possible means (e.g. fax or telephone, subsequently confirmed in writing), along with the relevant Food Authority.
The packer or, in the case of imported food, the importer, or their agent, may also be notified. However, where the Food Authority is undertaking an investigation the release of the certificate may be delayed if its early release might compromise the investigation.
Adverse sampling result (analysis)
In accordance with regulation 9 of the Food Safety (Sampling and Qualifications) Regulations 1990, a copy of the certificate of analysis must be supplied, on request, to the owner of the food which has been analysed. If the alleged offence is thought to be related to the manufacturer, they should be informed at the earliest opportunity by the fastest possible means (e.g. fax or telephone, subsequently confirmed in writing) along with the relevant Food Authority. The packer or, in the case of imported food, the importer, or their agent, may also be notified. However, where the Food Authority is undertaking an investigation the release of the certificate may be delayed if its early release might compromise the investigation.
Advisory Labelling
When communicating with allergic consumers through labelling, point of sale information, leaflets and websites, consumers should be advised always to refer to the ingredients list, and the labelling generally, for detailed information about the composition of the product and the presence of particular allergens.
Any advisory labelling should be in close proximity to the ingredients list. It is recommended that there is a clear distinction in the labelling information provided between ingredients that are deliberate components of the food (whatever the level of incorporation) and any possible allergen cross-contamination arising from production of the raw ingredients or during the manufacture or transport of the food. List of ingredients should include only ingredients deliberately added to the product.
The practice of including possible contaminants in the
ingredients list (so called ‘last ingredient listing’) is illegal under Section 15(1)(a) of The Food Safety Act 1990 (Article 14(1)(a) of The Food Safety (Northern Ireland) Order 1991) and possible allergen cross-contaminants should be declared separately.
However, information on deliberate ingredients and possible contaminants should be adjacent to each other and in the same field of vision as the ingredients list.
The presence of deliberately added allergenic ingredients, and/or advice on the possible presence of allergen cross-contamination, may additionally be indicated by means of an allergy information/advice panel. These panels are not a legal requirement but, where such information is given, it is best practice to associate it clearly with the ingredients list. If such devices are employed, all allergenic foods or ingredients as defined by law and used in the food should be listed in such a box, panel or statement.
If using a box headed, for example, ‘Allergy Advice’, make sure that there is a clear distinction between allergens that are deliberate ingredients and those that are possible cross-contaminants. An example of how this may be done is given below, but other formats for the box or statement may be used: Advisory labelling on possible cross-contamination with allergens should be justifiable only on the basis of a risk assessment applied to a responsibly managed operation. Warning labels should only be used where there is a demonstrable and significant risk of allergen crosscontamination, and they should not be used as a substitute for Good Manufacturing Practices.
The use of detailed explanations of the mechanisms by which contamination occurs (‘made on a line that also handles allergen X’ or ‘made in a factory that also handles allergen X’) may be confusing to consumers who do not have experience of food manufacturing conditions, separation techniques and cleaning procedures. Such consumers could therefore either ignore or incorrectly interpret such statements in terms of the risk of allergen cross-contamination that they represent. Consumer research conducted in 2002 demonstrated that most consumers wanted clear and consistent statements about what they could and could not eat, with the same phrases used by all manufacturers and retailers.
However, in a recent consultation on possible phrases to be used to convey allergen advisory information there was a significant proportion of respondents who did not like phrases such as ‘Not suitable for’ or ‘Not recommended for’ (http://www.food.gov.uk /multimedia/pdfs / maycontainconsummary.pdf). Such consumers preferred to be presented with the facts, which would allow them to make their own decision on whether or not to eat the food. Some manufacturers agreed with this, not wishing to make medical judgements for individuals, while others preferred to make a suitability statement, believing that it is difficult to communicate the risk-based approach behind using an allergen advisorystatement.
Either way, consumers need to be told about the potential risk in a simple, consistent way. It is suggested that a brief, factual phrase is used to communicate the risk and this will also be easily translatable into other languages. For example:
• may contain X
• not suitable for someone with X allergy
A number of illustrative examples of particular products and situations where advisory labelling is and is not appropriate are given in Appendix III.
Aetiology
Is the causative factor of an outbreak. In the UK the majority of outbreaks are caused by pathogenic bacteria or enteric viruses but the aetiology might be chemical in nature.
Ageing of ice cream
Ageing increases the viscosity of the product and allows emulsifiers time to act.This is shown in the diagram below, which shows ice cream sitting on a mesh screen at ambient temperature: You can see above the increased amount of shape retention and slowness of melt that comes from the added emulsifiers (picture 3), particularly polysorbate 80.
Ageing the milk
Ageing of the milk refers to the practice of giving the starter culture time to begin acid production in the milk before the rennet is added. This is done for two reasons:
1) To ensure the culture is active before the milk is renneted. It is impossible to inoculate after the milk is set. Normally, 45 - 60 min is sufficient to decrease pH by 0.01 units or increase the titratable acidity by 0.005 - 0.01%
2) Development of acidity aids the coagulation process, especially the secondary stage.
Ageing of the milk may be carried out in the cheese vat or in a separate tank.
Airborne Particles in Manufacturing Area
It is recommended that, wherever practically possible, consideration should be given to the implications of air movement. For example, where nut products and nut free products are produced in the same production area it may be possible to dedicate air conditioning/extraction fan systems to contain nut dust, or positive pressure may be used in nut free rooms to prevent nut traces entering the room on the air.
When scheduling production runs consideration should be given to scheduling those products not containing the allergenic ingredient first. Additionally, long runs of allergenic products should be undertaken wherever possible, to minimise changeovers and these should be followed by a major clean down.
Aircraft inspections
The large number of airlines and, in some cases, the size of their fleets, requires the following information to be obtained and made available prior to making a decision whether to undertake an inspection:
• named contact and contact details for an airline to deal with enquiries (this might be a food safety advisor employed by the airline);
• number of aircraft, their type and registration numbers, where appropriate;
• routes flown – long haul, short haul and countries of destination;
• airline food safety policy/procedure documents or manual;
• type of catering menus and the service of high-risk foods;
• food handler (cabin staff) knowledge – up-to-date guidance notes/explanatory sheets and/or training commensurate with the food handling activity covering personal hygiene; handling of food; cross contamination issues arising from other duties; pest awareness; food temperature control (as required by Annex II of Regulation 852/2004), if appropriate, and monitoring; own health status and exclusion from work policy;
• training records, standard of training, including retraining, when appropriate;
• flight caterers, and/or nominated companies assembling and/or transporting meals to the aircraft, used by each airline. In-flight menus should assist in the assessment of whether high-risk foods are handled and/or prepared on board.
The onus is on the airline to provide evidence that the food originates from a reputable source;
• specifications in place with the caterer for the supply of food to aircraft and the accepted temperature for delivery, including for high-risk foods;
• details of food and water safety arrangements when supplied to an aircraft in a foreign location;
• potable water supply – source, use of bowsers, cleaning/disinfection of storage tanks – frequency/effectiveness. To be checked prior to or after the inspection;
• flights or routes with return catering including multiple sector catering, and from which airports;
• pest control contract and monitoring;
• cleaning contractor, with details of contracts, e.g. cleaning schedules, and monitoring of the effectiveness of the cleaning regime;
• reports of analysis/examination of food and potable water on aircraft by the airline, which should relate to the Food Authority’s own sampling regime; and
• whether the airline undertakes self-audits and whether any reports are available.
The above information should assist an officer to assess the need to actually board a particular aircraft to carry out an inspection. In practice, taking account of Annex 5, and with the appropriate information obtained from the airline company and/or the relevant Home Authority, this might result in a visit to particular types of aircraft, providing high-risk meals.
Aircraft Inspections
It is the responsibility of the airline to provide to the authorised officer any evidence of reputable food suppliers.
The decision to board an aircraft should be based largely on any information provided by the airline; confirmation of the authenticity of the information, and the receipt of any food or food hygiene related complaints from passengers or crew. If such information (as outlined in Section 4.4.6.2) is satisfactory, there might be no need to board an aircraft, particularly if the information shows that specific types of aircraft and food safety practices meet requirements. It is, however, essential to verify on-board conditions and practices at regular intervals by inspection.
At least annual checks should be made on the information provided by the airline concerning food hygiene issues, either by the Home Authority, or in the absence of a Home Authority, by an authorised officer of the relevant enforcing Food Authority. Such checks should confirm, for example, that no changes have taken place to in-flight caterers, source of water supply, etc. Where arrangements are in place, Home Authorities should ensure that airlines are aware of their responsibilities in relation to providing information. Home Authorities should provide relevant information to other Food Authorities, when requested to do so and, where this relates to general airline policy and procedures, be afforded appropriate confidentiality.
Aircraft Inspections
In respect of aircraft, primary consideration should be given to the origin of the food on board, including water and other drinks, and the transport to, and loading of, the aircraft. The aim of the legislation will best be achieved by adopting a balanced approach of inspection and professional judgement.
Aircraft inspections - points to consider
• Flight caterers – confirmation of the information obtained, regarding source of meals, etc;
• Transport and loading of aircraft, including the means of temperature control of the food in the delivery vehicle;
• Food storage facilities on the aircraft, including the provision of insulated containers and/or ice-packs and the maximum stated time period until serving and/or re-heating, taking account of the type of aircraft, e.g. long or short haul, and the food served;
• Whether food is prepared on the aircraft and the facilities available for such operations, e.g. personal hygiene; avoidance of cross-contamination; provision of disposable gloves for certain duties and disinfectant wipes;
• Return flight meals taking account of the shelf-life of the food;
• Temperature control (as required by Annex II, of Regulation 852/2004) and monitoring during flights;
• Reheating/cooking;
• Pest control;
• Water supply – source and potability/cleanliness of tanks;
• Procedures for cleaning food handling areas, trolleys/carts;
• Food and water sampling.
Alkali treatment
Alkaline or caustic detergents have a pH of greater than 7 and are most effective in the removal of milk fat deposits from dairy equipment and less effective in protein removal.
It is common for small dairies to use only alkaline detergents as part of their cleaning regime in order to keep their costs down. However this might result, in time, in protein deposits appearing on the equipment and the formation of milk stone.
When high colony counts are obtained from microbiological samples taken from the dairy, it is prudent to check whether the dairy is using an alakaline detergent only regime. If so it may be useful to undertake an acid detergent wash of the equipment and then build in periodic acid cleans into the cleaning schedule in future.
Allergen free
An ‘allergen-free’ claim is an absolute claim, which may be interpreted by consumers to mean a complete absence, whereas the best that can be scientifically demonstrated at present, is that samples of the food were shown to be below the analytical limit of detection of a testing method on one or more occasions. However, when there is general agreement on the management action levels below which adverse reactions are unlikely to be triggered, appropriate limits for claiming that a product is free from a particular allergen can be set.
Allergenic foodstuff
Current legislation recognises 14 foods known to commonly produce severe adverse reactions across the EU (see Annex IIIa of Directive 2000/13/EC and Appendix I of this document), those foods listed in the Annex have to be labelled whenever they are intentionally used in a product. The 14 allergenic foods specified in the legislation were determined by the European Food Safety Authority (EFSA) Scientific Panel on Dietetic Products, Nutrition and Allergens, to be important allergens that required food labels because of the severity and prevalence of the allergy in Europe.
These food types present the greatest risk if present inadvertently and therefore should all be considered in the risk assessment process. Other allergenic foods, for example, kiwi fruit, may be added to Annex IIIa in future, dependent on the prevalence of adverse reactions in sensitive consumers and their inherent potency to trigger severe reactions.
Allergens guidance
This guidance sets out general principles that could be used to manage specific allergenic ingredients in differing situations. The focus of this guidance is the production of prepacked foods (for instance, food put into packaging before sale, normally at a site separate from that where the product is sold to the consumer), however, the general principles could also be applied to non-prepacked foods.
Allergy alerts
Allergy Alerts are used by the Agency to quickly communicate allergen risks directly to the consumer. Food Authorities receive copies of these Allergy Alerts for information purposes only.
alpha casein
There are two principle groups of alpha casein found in milk:
alpha(s1)-casein and alpha(s2)-casein. Both are hydrophobic and will easily be precipitated out of solution at low pH.
Alternative enforcement strategies
Low-Risk Activities (category E establishments)
“Low-risk” establishments must be subject to an alternative enforcement strategy or intervention, at least once during any 3-year period.
Food Authorities who decide to subject “low-risk” establishments to alternative enforcement strategies must set out their strategies for maintaining surveillance of such establishments in their Food Service Plan or Enforcement Policy.
It is not intended to preclude inspection, partial inspection or audit at such establishments where any of these are the Food Authority’s preferred surveillance option. In which case the minimum frequency of intervention is determined by the intervention rating
Amount of allergen
It should be borne in mind that different people can have different levels of sensitivity, and that sensitivity can vary in the same person under different circumstances. EFSA has reviewed the 14 allergenic foods currently listed in Annex IIIa of Directive 2003/89 /EC in terms of what is known about the amounts of allergen needed to trigger adverse reactions and also possible detection methods (see www.efsa.eu.int/science/nda/nda_opinions/catindex_en.html).
However, the scientific literature is not yet sufficient to draw firm conclusions regarding the highest dose that would not cause an adverse effect.
Analysis and interpretation
Once information has been gathered regarding the nature and scope of the suspected outbreak by means of descriptive epidemiological techniques, the data should be analysed to:
- Calculate attack rates;
- Confirm factors common to all or most cases;
- Categorise cases by "time, place or person" associations;
- Construct epidemic curve;
- Review all existing data;
- Review hypotheses;
- Collect further clinical and food specimens for laboratory tests;
- Carry out analytical epidemiological study;
- Ascertain source and mode of spread.
Anaphylaxis/Anaphylactic Shock
Acute form of allergy characterised by uticaria, swelling of the lips, shortness of breath, and rapid fall in blood pressure. Without immediate treatment which consists of intramuscular injection of adrenaline, anaphylaxis can be fatal.
Animal By-Products Regulations
The Animal By-Products Regulations 2005 (as amended) set out the enforcement arrangements of Regulation (EC) 1774/2002. The responsibility for the enforcement of these requirements falls to Defra in approved slaughterhouses, meat cutting plants and game handling establishments and to local authorities in other businesses.
Animal Health
Animal Health is an executive agency of Defra which is responsible for the regulation of farmed animals in England and Wales. It includes the departments previously known as the Dairy Hygiene Inspectorate and the State Veterinary Service.
In England and Wales, Animal Health Officers are responsible for the enforcement of food hygiene law in milk production units (on-farm milking parlours). In Scotland this responsibility rests with the local authorities.
Antibiotic failures and presumptive failures
Milk that is contaminated or presumed to be contaminated by antibiotic residues should be treated as a Category 2 Animal by-product and disposed of accordingly. The Food Standards Agency has produced some guidance on the interpretation of this requirement in a number of different scenarios and a copy of this guidance is available in the Library section (click on "further reading" at the end of this module).
Where a presumptive antibiotics test such as the "Snap" test identifies the presence of antibiotic residues, the milk should be treated as Category 2 waste until the contrary has been proved through appropriate sampling using a reference method.
Antibiotic residues in milk
Antibiotics are commonly administered to cows on the farm to treat a range of clinical infections including mastitis. However, when a cow is receiving such treatment, the food business operator is required to take positive steps to prevent milk contaminated with antibiotic residues from entering the food chain.
Most farmers are perfectly capable of ensuring that this requirement is met but there may be occasions when milk from antibiotic-treated cows is mixed with milk intended for human consumption. This may be due to cross-contamination of milking equipment or accidental milking of prohibited cows.
The presence of antibiotic residues in milk may be harmful to consumers with an antibiotic allergy and may also have adverse effects on the production of dairy products especially fermented ones such as cheese or yoghurts due to the inhibition of microbial growth caused by the presence of the antibiotic.
For these reasons, farmers and milk processors will normally undertake antibiotic residue tests of raw milk that is destined for human consumption often using rapid tests such as the Beta Star or "snap" test or dye reduction tests such as the Aschaffenburg & Mullen test.
Appeal
improvement notices are suspended pending the hearing of the appeal but a prohibition notice remains in force unless the tribunal directs otherwise;
Appeals
There is no appeal against a Hygiene Emergency Prohibition Notice. There is, however, an appeal against the Hygiene Emergency Prohibition Order which is to the Crown Court. The food business operator may also appeal should the authority refuse to issue a certificate lifting the Hygiene Emergency Prohibition Order to the Magistrates Court.
Appendix 1
It should be noted that Appendix I also includes information on ingredients derived from the listed allergenic foods that are exempt from the allergen labelling directive; these are not an allergen cross-contamination risk.
Applicant
The investigating officer is required to complete a written application which provides details of the necessity and proportionality of obtaining the communication data.
This application is then forwarded to a nominated “designated person”.
Click here to view a specimen application form
application for approval
Article 31(2)(a) Regulation 882/2004 obliges Competent authorities to establish procedures for food business operators to follow when applying for the approval of their establishments in accordance with Regulation 853/2004.
These procedures are set out in the Food Law Code of Practice and any deviations must be recorded and retained where possible and agreed by the Food Standards Agency beforehand
Application for approval
Applications for approval of establishments should only be accepted from food business operators that intend to engage in activities for which approval would be required in accordance with Regulation 853/2004.
Under no circumstances should approval be granted to an establishment which is not subject to approval under Regulation 853/2004. Food Authorities should ensure that the food business operator supplies all relevant information before an application for approval is determined.
This information may be obtained from the food business operator in documentation supplied with the application or during the subsequent on-site visit to the establishment as required by Article 31(2)(b) of Regulation 882/2004 (see Section 5.1.7). It is a matter for the Food Authority to decide at which stage of the application this information should be provided. In considering applications for approval Food Authorities should ensure that they fully consider any exemption that may be available to the applicant afforded by Article 1 of Regulation 853/2004.
Application of ID Mark
In the case of packaging containing cut meat or offal, the mark must be applied to a label fixed to the packaging, or printed on the packaging, in such a way that it is destroyed when the packaging is opened. This is not necessary, however, if the process of opening destroys the packaging.
When wrapping provides the same protection as packaging, the label may be affixed to the wrapping.
For products of animal origin that are placed in transport containers or large packages and are intended for further handling, processing, wrapping or packaging in another establishment, the mark may be applied to the external surface of the container or packaging.
Application to the court
This should be made personally and the officer must be prepared to give evidence on oath to the Magistrates.
The authorised officer should provide detailed evidence when the application is heard as to the reason the Notice was served in the first instance and that the imminent risk criteria is still fulfilled at the time of the hearing.
Applications for approval
Procedures for handling applications for approval are set out in Sections 5.1.6 et seq. Food Authorities should ensure that they, and food business operators, follow these procedures as appropriate.
Any deviations from these procedures should be recorded and retained by the Food Authority and should, where possible, be agreed with the Food Authority beforehand. An overview of the approval process is set out in a flow chart at Annex 3 of the Practice Guidance.
A series of template forms is also provided at Annex 11 of the Practice Guidance to assist Food Authorities in the administration of approvals. Whilst the content of these documents should be regarded as the minimum required, Food Authorities may adapt them as necessary to meet local requirements.
Approach to audit
An audit may include:
• audit of a complete food safety management system;
• audit of selected elements of a food safety management system, where the
system is complex;
• audit of part of a system in relation to a particular product; or
• audit of certain organisational arrangements, for example, temperature monitoring.
Approach to HACCP
The Food Law Code of Practice states (4.2.3.1)
Role of Local Authorities
Assess the hazards posed by the activities of the business, the food business operator’s understanding of those hazards, and the application of appropriate controls; having regard to the nature and size of the business
Assess and verify appropriate procedures based on HACCP principles appropriate to the nature and size of the business, confirming that controls are in place and operating effectively and that appropriate corrective action is taken when necessary;
Establish whether food is being handled and produced hygienically, is safe to eat, and that relevant temperature controls are being observed;
Approach to Health and Safety
This should include a clear statement of who is responsible for doing what. HSE strongly believes that everyone has a part to play in managing health and safety at work and places a strong emphasis both on leadership by management, and the meaningful involvement of workers in managing their own health and safety.
Approach to inspection
In general, an officer conducting a food hygiene inspection should:
• Assess the risk of the food business failing to meet food hygiene requirements;
• Assess the hazards posed by the activities of the business, the food business operator’s understanding of those hazards, and the application of appropriate controls; having regard to the nature and size of the business;
• Establish whether food is being handled and produced hygienically having regard to subsequent processing;
• Assess and verify appropriate procedures based on HACCP principles appropriate to the nature and size of the business, confirming that controls are in place and operating effectively and that appropriate corrective action is taken when necessary;
• Establish whether food is being handled and produced hygienically, is safe to eat, and that relevant temperature controls are being observed;
• Recommend good food hygiene practice in accordance with EU and UK Industry Guides, relevant sector specific code, and other relevant technical standards, and promote continued improvements in hygiene standards through the adoption of good practice;
• Check the source and any health or identification marking of raw materials, and the identification marking and destination of finished products. Where deficiencies in health or identification marking are identified, officers should refer to and implement any relevant provisions of Chapters 1.7 and 2.4 of this Code and the Home Authority Principle, and consider using their powers under Regulation 27 of the Food Hygiene (Scotland) Regulations 2006 (See also Regulation 23 in this regard) to remove affected products from the food chain; and
• In relation to retail and catering businesses that sell or use live bivalve molluscs, ensure that where parcels of live bivalve molluscs are split before sale to the ultimate consumer, that information on identification marks is retained for at least 60 days.
In addition to the general requirements detailed above, a food hygiene inspection should include if appropriate:
• A discussion with any staff responsible for monitoring and corrective action at critical control points to confirm that control is effective;
• A physical inspection to determine whether critical controls have been identified and whether the controls are in place and to assess compliance with relevant food law;
• An assessment of compliance with the traceability requirements of Article 18 of Regulation 178/2002;
• A discussion regarding any hazards that have been identified by the officer that have not been covered by the business’s systems;
• A discussion regarding any failure to implement or monitor any critical controls that have been identified by the business.
Published UK Guides to Good Practice may be particularly relevant to certain establishments subject to food law as will other published recommended industry codes of practice. Officers may draw these to the attention of food business operators in appropriate circumstances.
The full scope of the food hygiene inspection is detailed in the relevant inspection form for the business concerned.
Approach to inspection
In general, an officer conducting a food hygiene inspection should:
• assess the risk of the enterprise failing to meet food hygiene requirements;
• assess the hazards posed by the activities of the business, the food business operator’s understanding of those hazards, and the application of appropriate controls; having regard to the nature and size of the business;
• establish whether food is being handled and produced hygienically, having regard to subsequent processing;
• assess and verify appropriate procedures based on HACCP principles (where they are required by law) appropriate to the nature and size of the business, confirming that controls are in place and operating effectively, and that
appropriate corrective action is taken when necessary, other than in respect of primary production;
• in respect of primary production, establish that food business operators and their employees have an understanding of the hazards posed by the activities of the business, and assess and verify that preventative/corrective actions necessary to protect the safety of food entering the human food chain take place;
• establish whether food is being handled and produced hygienically, is safe to eat, and that relevant temperature controls are being observed;
• recommend good food hygiene practice in accordance with EU and UK Industry Guides, relevant sector specific codes, and other relevant technical standards, and promote continued improvements in hygiene standards through the adoption of good practice;
• check the source and any health or identification marking of raw materials, and the identification marking and destination of finished products.
Where deficiencies in health or identification marking are identified, officers should refer to and implement any relevant provisions of Chapters 1.7 and 2.4 of this Code and the Home Authority Principle, and consider using their powers under Regulation 27 of the Food Hygiene Regulations 2006 (see also Regulation 23 in this regard) to remove affected products from the food chain; and
• in relation to retail and catering businesses that sell or use live bivalve molluscs, ensure that where parcels of live bivalve molluscs are split before sale to the ultimate consumer, that information on identification marks is retained for at least 60 days.
In addition to the general requirements detailed above, a food hygiene inspection should include if appropriate:
• a discussion with any staff responsible for monitoring and corrective action at critical control points to confirm that control is effective;
• a physical inspection to determine whether critical controls have been identified and whether the controls are in place, and to assess compliance with relevant food law;
• an assessment of compliance with the traceability requirements of Article 18 of Regulation 178/2002;
• a discussion regarding any hazards that have been identified by the officer that have not been covered by the business’s systems; and
• a discussion regarding any failure to implement or monitor any critical controls that have been identified by the business.
Published UK Guides to Good Practice may be particularly relevant to certain establishments subject to food law as will other published recommended industry codes of practice. Officers may draw these to the attention of food business operators in appropriate circumstances.
The full scope of the food hygiene inspection is detailed in the relevant inspection form, where one has been developed, for the business concerned
Approach to inspection
This will be dependent on what approach the inspection takes:
• a full inspection, which is a check on compliance with legal requirements in accordance with elements set out in Section 4.2.2 of this Code. A full inspection will consider all aspects of a food business including structure, food safety management and management arrangements; or
• a partial inspection, which is an inspection that covers only certain elements of the inspection as laid down in Section 4.2.2 of this Code. It is not necessary to inspect every aspect of a food business at every inspection. Where the scope of an inspection is limited, however, the reasons for adopting this approach must be documented on the establishment file, and the scope of the partial inspection must be specified in the inspection report provided to the food business
operator.
Appropriate critical limits
Critical limits should be properly validated, that is to say based on sound scientific principles and measurable.
Appropriate prohibition
The prohibitions available to the Magistrates or Sheriff under the Food Hygiene Regulations are:
1) A prohibition of the use of any process or treatment for the purpose of the business.
This might be used to stop the preparation of a food where the court is satisfied that the method used presents a health risk.
2) A prohibition of the use of any premises or equipment for purposes of the business or any other business of same class or description.This prohibition would be appropriate where the construction or use of premises or equipment presents the health risk. For example, if the premises were in a poor state of repair or if equipment was found to be defective.
3) A prohibition of the use of any premises or equipment for the purposes of any food business.This would be appropriate where the state or condition of the premises presents the risk to health. For example a serious pest infestation or cross contamination issues.
Appropriate Prohibition HEPN
The prohibitions available to the authorised officer under the Food Hygiene Regulations are:
1) A prohibition of the use of any process or treatment for the purpose of the business.
This might be used to stop the preparation of a food where the officer is satisfied that the method used presents an imminent risk to health.
2) A prohibition of the use of any premises or equipment for purposes of the business or any other business of same class or description.This prohibition would be appropriate where the construction or use of premises or equipment presents the imminent risk. For example, if the premises were in a poor state of repair or if equipment was found to be defective.
3) A prohibition of the use of any premises or equipment for the purposes of any food business.This would be appropriate where the state or condition of the premises presents the imminent risk to health. For example a serious pest infestation or cross contamination issues.
Appropriate prohibition HEPN 1
For example:
If the prohibition is for a process or treatment, this section should read:
"You must not use it for the purposes of (this) (any)(this or any similar) food business"
If the prohibition is for the construction of premises or use of equipment, this section should read:
"You must not use it for the purposes of (this)(any) (this or any similar) food business"
If the prohibition is related to the state or condition of the premises, this section should read:
"You must not use it for the purposes of (this) (any) (this or any similar) food business"
Approval application
Applications for approval may only be made by the relevant Food Business Operator and a template application form is provided in the Food Law Practice Guidance for this purpose. It should be noted that this template application form may be edited or altered by the food authority to make it more relevant for the premises concerned.
Approval code
The approval code should be incorporated into an identification mark which approved establishments are required to apply to their products, as appropriate (see also Section 5.1.13). The requirements for the form of the identification mark are set out in Annex II, Section I B of Regulation 853/2004. A Food Authority should agree an identification mark with each establishment it approves which (a) incorporates the approval code it has allocated and (b) meets the requirements of Annex II, Section I B of Regulation 853/2004.
Food Authorities should be aware that the UK has opted to use the transitional derogation provided by Article 8 of Regulation 2073/2005 on microbiological criteria for foodstuffs concerning compliance with the value set in Annex I to that Regulation for Salmonella in minced meat, meat preparations and meat products intended to be eaten cooked placed on the national market of a Member State. The Regulation permits this transitional derogation to be used up to 31 December 2009, and the UK has opted to use it until this date. In accordance with Article 8 of Regulation 2073/2005 a ‘special mark’, which cannot be confused with the identification mark provided for in Annex II, Section I B of Regulation 853/2004, must be applied to products which the transitional derogation applies.
The 'special mark' to be used is an oval within an oblong. Within the oval there should be the letters UK, the license/approval number, and the letter N, to indicate that the product is for the national market. This combines the oval shape of the identification mark, and much of the information required by that mark whilst remaining distinct in itself, thereby meeting the requirement of the Regulation that the special mark ‘cannot be confused with the identification mark’.
Approval is required
These premises are entirely wholesale, ie not 'retail'.
Such premises will include manufacturing establishments, cold stores (eg for meat &/or fish), 'wholesale markets', etc.
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Approval is required
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Approval notification document
The approval notification document should specify:
i. Details of activities to which the approval relates;
ii. The approval numberof the establishment;
iii. Classification;
iv. Special hygiene direction(s);
v. Any derogations that have been granted;
vi. Any other conditions or limitations specified by the Food Authority;
vii. Any arrangements acceptable to the Food Authority;
Any relevant information and documentation relating to the above should be retained on file;
Approval of coldstores
Cold stores appear to fit within the definition of “retail” and so if they are only supplying the final consumer will not require approval. However the EC Commission have suggested that coldstores which operate on a wholesale basis:
“...must be approved insofar as they are used in relation with activities for which Annex III of Regulation 853/2004 lays down requirements.”
As such there is no blanket exception to approval for coldstores but being retail outlets they can rely on the "retail to retail" exemption where appropriate.
Fresh meat cold stores which supply on a wholesale basis may need approval but are no longer under veterinary control and as such are the responsibility of the relevant Local Authority.
Approval of establishments
District Council Authorities in two-tier Food Authority areas approving establishments subject to approval under Regulation 853/2004, either fully or conditionally, should inform the County Council Food Authority of a food business establishment’s approval or conditional approval within 28 days of the approval being granted.
Food Authorities should pass information they receive which indicates a change in the operations within a food business establishment, and information on any withdrawal, suspension or reinstatement of an establishment’s approval, to other relevant Food Authorities within 28 days.
It should be noted, however, that establishments at the level of primary production that have been registered with the Rural Payments Agency (RPA) prior to 1 December 2006 are considered registered for the purposes of Article 6(2) of Regulation 852/2004.
Approval on site visit
This should take the form of a inspection of the establishment (see Section 4.1.3), to verify that, where necessary, all systems, procedures and documentation meet the relevant requirements of Regulation 852/2004 and Regulation 853/2004.
The inspection should be conducted in accordance with, and cover, all aspects of the relevant inspection form for the business concerned, and consider all issues identified by Regulation 853/2004, as requiring Food Authority consent. As per Article 31(2) of Regulation 882/2004 all the requirements of food law relevant to that business must be met.
Approval planned programme of works
Where an authorised officer carries out an initial assessment of an establishment as part of an approval application, he/she should identify any non-compliances with relevant food law and set out in writing those matters which the business must attend to before approval is granted.
A copy of this programme of works should be retained on file by the food authority.
Approval procedures
Procedures for handling applications for approval are set out in Sections 5.1.6 et seq. below. Food Authorities should ensure that they, and food business operators, follow these procedures as appropriate.
Any deviations from these procedures should be recorded and retained by the Food Authority and should, where possible, be agreed with the Food Authority beforehand. An overview of the approval process is set out in a flow chart at Annex 4 of the Practice Guidance.
A series of template forms is also provided at Annex 11 of the Practice Guidance to assist Food Authorities in the administration of approvals. Whilst the content of these documents should be regarded as the minimum required, Food Authorities may adapt them as necessary to meet local requirements.
approval relevant documents
Other relevant documents include:
i. HACCP documentation;
ii. supplier information;
iii. product list;
iv. raw material, product and water test results;
v. process records;
vi. management and key contact names and contact details;
vii. photographs and digital images;
viii. product recall procedures;
Approved codes of practice (ACOPs)
Approved codes of practice (ACOPs) are approved by HSE with the consent of the appropriate Secretary of State – they do not require agreement from Parliament. ACOPs have a special status in law.
Failure to comply with the provisions of an ACOP may be taken by a court in criminal proceedings as evidence of a failure to comply with the requirements of the Act or of regulations to which the ACOP relates, unless it can be shown that those requirements were complied with in some other equally effective way. ACOPs (which can be updated more easily) provide flexibility to cope with innovation and technological change without a lowering of standards.
Approved establishment hygiene training
There used to be a requirement in product specific legislation prior to 2006 for the food authority to be involved in the planning and implementation of approved establishment's training programmes. This requirement is no longer present in Regulation (EC) 853/2004, however where there has been such involvement, this should be clearly stated on the file.
In addition it is recommended that an assessment of the establishment's arrangements for hygiene training is retained on file.
Approved establishment notices
Copies of any warning letters or notices including Remedial Action Notices issued with respect to the business should be retained on file.
Approved establishment plans
Plans obtained from the FBO of an approved establishment and retained by the food authority should specify:
i. The layout of the establishment;
ii. The location of equipment;
iii. Work flows for each product line;
iv. Water distribution system within the establishment including all outlets and sampling points;
v. Drainage layout;
vi. Pest control - baiting and/or trapping points within the establishment and external areas;
Approved establishment product withdrawal
In accordance with Regulation (EC) 178/2002, Article 18, Food Business Operators of approved establishments must ensure that there are suitable systems and procedures in place to demonstrate the traceability of all foods supplied to them and by them to wholesale customers.
The manner in which this obligation is achieved will vary from business to business and, depending on the size of the business, there may not be a need for a formal documented system. However, full details of how traceability is achieved should be recorded in the approved establishment approval file.
In addition, details of how the business would comply with the requirements of Article 19 of Regulation (EC) 178/2002 should be recorded in the file. There is no absolute requirement for the business to have a documented product withdrawal/recall plan but it is recommended that businesses seeking approval are encouraged to produce one which should then be tested out periodically to ensure that it works properly.
The approved establishment file should set out how the business would respond to a product withdrawal/recall and contain names and contact details of key personnel at both the establishment and food authority. These details should be reviewed regularly.
Approved establishment synopsis
The synopsis of the establishment should briefly describe what type of establishment it is, products produced, volume of product, type of trade, number of employees, approval number and what it is approved for. This synopsis should be no more than one side of an A4 sheet.
The purpose of the synopsis is to provide officers, including members of the food authority management team, with a brief summary of the key details of the establishment.
Approved establishments
There will be establishments where two or more products of animal origin subject to requirements of Regulation 853/2004 are applicable, e.g. an establishment producing both meat products and fishery products. In such cases the relevant provisions will apply to areas of the establishment where each type of product is produced. All relevant provisions of the Regulation will apply to those areas of the establishment where facilities are shared.
Approved establishments - FSA Responsibilities
Such establishments are slaughterhouses, game handling establishments, and cutting plants placing fresh meat on the market. The MHS is also responsible for establishments co-located with these establishments in which minced meat, meat preparations, mechanically separated meat, meat products, rendered animal fats and greaves, treated stomachs, bladders and intestines, gelatine and/or collagen are also produced.
The Agency is also responsible for enforcement in relation to the matters regulated by Schedule 6 of the Food Hygiene Regulations 2006, in so far as it applies in relation to raw cows’ milk intended for direct human consumption.
Approved establishments - LA Responsibilities
These “product-specific” establishments will be producing any, or any combination, of the following: minced meat; meat preparations; mechanically separated meat; meat products; live bivalve molluscs; fishery products; raw milk (other than raw cows’ milk); dairy products; eggs (not primary production) and egg products; frogs legs and snails; rendered animal fats and greaves; treated stomachs; bladders and intestines; gelatine and collagen; and will include certain cold stores and certain wholesale markets. Food Authorities are also responsible for enforcement in respect of collection centres and tanneries supplying raw material for the production of gelatine or collagen intended for human consumption.
Approved establishments Inspection Reports
It is recommended that the aide memoires produced by LACORS are used for the assessment of approved establishments with relevant food law and that copies are retained on file.
Approved establishments labels
As part of an approval exercise it is important for the food authority to consider the appropriate use of the Identification Mark by the food business and as such it is recommended that copies of product labels which bear the ID mark are taken and retained on file.
Where the business is involved in the bulk supply of dairy or fishery products, copies of the Commercial Document should be retained on file.
Approved establishments offsite facilities
These might include laboratories, waste disposal facilities, food storage units such as coldstores, transport operations and training centres.
Approved establishments responsibility for enforcement
The Meat Hygiene Service are responsible for the enforcement of food hygiene law in approved slaughterhouses; approved meat cutting plants and approved game handling establishments. They are also responsible for co-located premises which handle minced meat, meat preparations, mechanically separated meat and meat products.
Local authorities are responsible for the enforcement of this legislation in non-approved slaughterhouses, cutting plants and game handling establishments. They also have the responsibility for the enforcement in establishments which handle:
Meat products, meat preparations, minced meat and mechanically separated meat (if not co-located with approved slaughterhouses, cutting plants or game handling establishments).
Fishery products, live bivalve molluscs, raw milk (other than raw cows milk) dairy products, egg products, eggs (other than at primary production) and coldstores
Approved establishments sampling results
Both chemical and microbiological sampling should be undertaken in approved establishments in accordance with the food authority's Sampling Policy and Programme. Where the establishment falls within a two-tier authority, it would be prudent for the District Council to request copies of any results of chemical sampling from their County Council colleagues and for these to be retained on file.
Where adverse results are received, the food authority should retain details of the result, the subsequent communication with the business and details of any investigation.
Aresenic in Food
Arsenic in Food (Scotland) Regulations 1959 (SI No. 928)
Scope- These regulations provide that, subject to certain exceptions, it will be an offence to sell, consign or deliver any food which contains more than one part per million (1mg/Kg) of arsenic.
Lower limits are specified for beverages, some soft fruit concentrates and ice cream. Higher limits are specified for some products which are either food essences or ancillary foods.
The primary regulations were amended in 1973 by the Arsenic in Food (Scotland) Amendment Regulations 1973 SI No. 1039 which allow for a maximum permitted arsenic content in food to be prescribed by other regulations.
Arsenic is present in food in various chemical forms, with inorganic forms being the most toxic. In the UK, fish is the main contributor of arsenic in the diet.
Ingredients/Products
The regulation applies to any food or ingredient intended for use in food.
Labelling Requirements
None.
Public Analyst Observation
Can be found in American rice, Bangladesh Rice and is naturally occurring.
No issues in shellfish/fish.
Associated Regulations
Arsenic in Food (Scotland) Amendment Regulations 1973 (SI No. 1039)
Further Information
Survey work: - The FSA completed a survey of total and inorganic Arsenic in fish in
2005.
The survey concluded that shellfish tended to accumulate higher levels of the more toxic inorganic form of arsenic than the composite fish samples, but the levels of inorganic arsenic were low. The maximum intake of inorganic arsenic was below 5 per cent of the safety guideline set previously by the World Health Organisation.
The data indicated that exposure is as low as is reasonably practicable.
Arsenic in fish and shellfish 2005
Total diet study 2000
Arranging to see the witness
The circumstances of the investigation will dictate whether or not it is appropriate to see witnesses with the knowledge of their employer (or another person). In determining the arrangements for interviews, you will need to use your discretion in this respect so as to ensure that the witness feels most able to assist the investigation, free of any risk of intimidation (intended or otherwise).
In many cases, dutyholders will voluntarily assist you with making suitable arrangements to interview witnesses. However, should this not prove to be the case, you have a number of powers to require this under section 20 HSWA, including the power to require any person to afford you such facilities and assistance as are necessary to enable you to exercise your powers (section 20(2)(l)). This can include facilities to see witnesses in private (subject to a person’s right to have another person present if you are requiring information under section 20(2)(j)). You do not have to make appointments to see employees via their employer. However, you should arrange to see potential witnesses at an appropriate time.
Witness statements should normally be taken as soon as possible to ensure that:
- the events are still fresh in the mind of the witness;
- the evidence is recorded before the witness is tempted/has opportunity to discuss their evidence with others.
This approach will give you the best evidence from the witness and make it more difficult for the defence to challenge the witness's evidence.
In some cases it may be more appropriate to obtain the home contact details of the potential witness and contact them there. (Ensure you follow HSE’s personal safety advice in the section Your Health & Safety on the Intranet.)
Art 14 178/2002
Paragraphs (3) and (4) of this article are particularly relevant:
“3. In determining whether any food is unsafe, regard shall be had:
a) to the normal conditions of use of the food by the consumer and at each stage of production, processing and distribution, and
b) to the information provided to the consumer, including information on the label, or other information generally available to the consumer concerning the avoidance of specific adverse health effects from a particular food or category of foods.”
“4. In determining whether any food is injurious to health, regard shall be had:
a) not only to the probable immediate and/or short-term and/or long-term effects of that food on the health of a person consuming it, but also on subsequent generations;
b) to the probable cumulative toxic effects;
c) to the particular health sensitivities of a specific category of consumers where the food is intended for that category of consumers.”
Various criteria, have to be considered, including information provided to the consumer concerning the avoidance of specific adverse health effects from a particular food or category of foods (see Article 14(3)(b)); and also the particular health sensitivities of a specific category of consumers where the food is specifically intended for that category of persons (see Article 14(4)(c)). In the allergy context, this refers particularly to foods sold as ‘free from’ certain allergens or ‘suitable for’ people with particular health needs (for example, those people who have coeliac disease). (See section 2).
Article 14
As such, regard must be had to the following:
- The nature of the contamination
- The risk to health
- The evidence available
- The quantity of food involved in relation to any sampling which has been undertaken.
The authorised officer must take into account any treatment or processing that the food is likely to be subjected to prior to consumption when making judgements with respect to their detention and seizure powers.
The following aspects should be considered when making a judgement in relation to detention and seizure powers. Regard should be had to the precautionary principle as set out in Regulation (EC) 178/2002. In any case the authorised officer should always opt for the highest level of consumer protection if there is any doubt as to whether the food will be used for human consumption.
Article 14 178/2002
Regulation 178/2002 SECTION 4 GENERAL REQUIREMENTS OF FOOD LAW
Article 14 : Food safety requirements
1. Food shall not be placed on the market if it is unsafe.
2. Food shall be deemed to be unsafe if it is considered to be:
(a) injurious to health;
(b) unfit for human consumption.
3. In determining whether any food is unsafe, regard shall be had:
(a) to the normal conditions of use of the food by the consumer and at each stage of production, processing and distribution, and
(b) to the information provided to the consumer, including information on the label, or other information generally available to the consumer concerning the avoidance of specific adverse health effects from a particular food or category of foods.
4. In determining whether any food is injurious to health, regard shall be had:
(a) not only to the probable immediate and/or short-term and/or long-term effects of that food on the health of a person consuming it, but also on subsequent generations;
(b) to the probable cumulative toxic effects;
(c) to the particular health sensitivities of a specific category of consumers where the food is intended for that category of consumers.
5. In determining whether any food is unfit for human consumption, regard shall be had to whether the food is unacceptable for human consumption according to its intended use,
for reasons of contamination, whether by extraneous matter or otherwise, or through putrefaction, deterioration or decay.
6. Where any food which is unsafe is part of a batch, lot or consignment of food of the same class or description, it shall be presumed that all the food in that batch, lot or consignment is also unsafe, unless following a detailed assessment there is no evidence that the rest of the batch, lot or consignment is unsafe.
7. Food that complies with specific Community provisions governing food safety shall be deemed to be safe insofar as the aspects covered by the specific Community provisions are concerned.
8. Conformity of a food with specific provisions applicable to that food shall not bar the competent authorities from taking appropriate measures to impose restrictions on it being
placed on the market or to require its withdrawal from the market where there are reasons to suspect that, despite such conformity, the food is unsafe.
9. Where there are no specific Community provisions, food shall be deemed to be safe when it conforms to the specific provisions of national food law of the Member State in whose territory the food is marketed, such provisions being drawn up and applied without prejudice to the Treaty, in particular Articles 28 and 30 thereof.
Article 16 - Regulation 178/2002
Presentation
"Without prejudice to more specific provisions of food law, the labelling, advertising and presentation of food or feed, including their shape, appearance or packaging, the packaging materials used, the manner in which they are arranged and the setting in which they are displayed, and the information which is made available about them through whatever medium, shall not mislead consumers."
Article 18 178/2002
Regulation 178/2002
SECTION 4 GENERAL REQUIREMENTS OF FOOD LAW
Article 18
Traceability
1. The traceability of food, feed, food-producing animals, and any other substance intended to be, or expected to be, incorporated into a food or feed shall be established at all stages of production, processing and distribution.
2. Food and feed business operators shall be able to identify any person from whom they have been supplied with a food, a feed, a food-producing animal, or any substance intended to be, or expected to be, incorporated into a food or feed. To this end, such operators shall have in place systems and procedures which allow for this information to be made available
to the competent authorities on demand.
3. Food and feed business operators shall have in place systems and procedures to identify the other businesses to which their products have been supplied. This information shall be made available to the competent authorities on demand.
4. Food or feed which is placed on the market or is likely to be placed on the market in the Community shall be adequately labelled or identified to facilitate its traceability, through relevant documentation or information in accordance with the relevant requirements of more specific provisions.
5. Provisions for the purpose of applying the requirements of this Article in respect of specific sectors may be adopted in accordance with the procedure laid down in Article 58(2).
Article 19 178/2002
Regulation 178/2002
SECTION 4 GENERAL REQUIREMENTS OF FOOD LAW
Article 19
Responsibilities for food: food business operators
1. If a food business operator considers or has reason to believe that a food which it has imported, produced, processed, manufactured or distributed is not in compliance with the food safety requirements, it shall immediately initiate procedures to withdraw the food in question from the market where the food has left the immediate control of that initial food business operator and inform the competent authorities thereof. Where the product may have reached the consumer, the operator shall effectively and accurately inform the consumers of the reason for its withdrawal, and if necessary, recall from consumers products already supplied to them when other measures are not sufficient to achieve a high level of health protection.
2. A food business operator responsible for retail or distribution activities which do not affect the packaging, labelling, safety or integrity of the food shall, within the limits of its respective activities, initiate procedures to withdraw from the market products not in compliance with the food-safety requirements and shall participate in contributing to the safety of the food by passing on relevant information necessary to trace a food, cooperating in the action taken by producers, processors, manufacturers and/or the competent authorities.
3. A food business operator shall immediately inform the competent authorities if it considers or has reason to believe that a food which it has placed on the market may be injurious to human health. Operators shall inform the competent authorities of the action taken to prevent risks to the final consumer and shall not prevent or discourage any person from cooperating, in accordance with national law and legal practice, with the competent authorities, where this may prevent, reduce or eliminate a risk arising from a food.
4. Food business operators shall collaborate with the competent authorities on action taken to avoid or reduce risks posed by a food which they supply or have supplied.
feed of the reason for its withdrawal, and if necessary, recall from them products already supplied when other measures are not sufficient to achieve a high level of health protection.
Article 2 Inquests
An example might be a death in custody, either in prison or under police detention.
See: R (on the application of Takoushis) v HM Coroner for Inner North London & Others [2005] EWCA Civ 1440.
Article 2 Inquests
The House of Lords has ruled that, while a criminal investigation and prosecution may not discharge this obligation, an inquest is likely to do so. The inquest must, however, determine not only the identity of the deceased and when, where and how the death occurred, but also in what circumstances1. The limited ambit of a ‘standard’ inquest will not satisfy the obligation on the state.
Whether the enhanced form of inquest will be required will depend on the precise circumstances of the particular case2. Only those inquests that are concerned with a possible breach of Article 2 by an agent of the state have this wider scope; other types of inquest can be more limited. The Coroner’s decision will determine the questions s/he will need to address during the inquest and will have an impact on the assistance that you provide to the Coroner.
1 See: R v HM Coroner for the Western District of Somerset & Another, ex parte Middleton (FC) [2004] UKHL 10. An inquest, being the means by which the state ordinarily discharged its procedural obligation to investigate under Article 2 of the Convention, ought ordinarily to culminate in an expression, however brief, of the jury’s conclusion on the disputed factual issues at the heart of the case. The only change needed to the current regime was to interpret the word ‘how’ in the rules (‘how … the deceased came by his death’) as meaning not simply ‘by what means’ but ‘by what means and in what circumstances’. That could be done by inviting an expanded form of verdict, by inviting a narrative form of verdict in which the jury’s factual conclusions were briefly summarised, or by inviting the jury’s answers to factual questions put by the Coroner. If the Coroner invited a narrative verdict or answers to questions, he might find it helpful to direct the jury with reference to some of the following matters: where and when the death took place; the cause or causes of such death; the defects in the system which contributed to the death; and any other factors relevant to the circumstances of the death.
2 See: R (on the application of Takoushis) v HM Coroner for Inner North London & Others [2005] EWCA Civ 1440. In cases where a death may have been caused by medical negligence in an NHS hospital, the ‘standard’ form of inquest will, together with the possibility of criminal, civil and disciplinary proceedings, satisfy the obligation on the state to carry out a public investigation of the facts that will be practical and effective. The Court was concerned that Article 2 might be engaged in every case.
Article 5 - Enforcement
The Food Law Practice Guidance states:
“Food premises that present a clear and imminent danger to public health should have formal enforcement action taken against them to secure improvement.”
“For food premises that do not present a clear and imminent danger to public health, the focus of enforcement visits should be to help the business improve its standards of food safety.”
Article 8 Food Safety Order
Article 8 of the Food Safety Order 1991 permits an authorised officer to detain a named food for a maximum period of 21 days at either the place where the food was discovered or a place specified in the notice if he/she suspects the the food fails food safety requirements.
Article 8 Food Safety Order
Article 8 of the Food Safety Order (NI) 1991 permits an authorised officer to seize food in circumstances where he/she is satisfied that the food fails food safety requirements.
Once the food has been seized, the officer is required to seek a condemnation order from a Justice of the Peace, normally within 2 days.
Where an officer seizes food but the Magistrate fails to condemn it, compensation is payable to the owner of the food.
Articles 18 and 19 178/2002
Article 18 requires that all food businesses shall have in place "systems and procedures" to ensure the traceability of foods. Article 19 requires that those responsible for the production, manufacture or import of unsafe foods must notify the competent authority and take steps to withdraw such food from the market if it has left its initial control. Further duties are placed on businesses throughout the foodchain to participate in product withdrawals and recalls where necessary.
Articles 18 and 19 are enforced by the General Food Regulations 2004 (as amended).
It is important to obtain detailed information about the preparation and handling of suspect food. Officers should examine documents, seize if necessary and look for evidence of:
• Suppliers used
• Premises supplied
Assist in the decision as to further action to take.
Once statements have been taken from all of the relevant witnesses, an assessment can be made of the adequacy of the evidence available. This can be achieved by applying the evidential test
Assist in the examination of the witness in court.
Both defence and prosecution lawyers are provided with copies of statements made by witnesses. Witness statements can therefore assist the lawyers to put relevant questions to the witnesses. One of the key functions of a criminal trial is to establish whether the witnesses “Come up to Proof”. That is to say, whether the oral evidence that they give in court concurs with any previous statements that they have made in relation to the matter. Witness statements are an essential element in this process
Assisting the Coroner
You should, however, bear in mind that such assistance is incidental to, and not a part of, your function as an HSE inspector. The Coroners’ Society is aware that HSE has limited resources to meet its own responsibilities. The statutory responsibility for ascertaining the identity of the deceased and when, where and how they came by their death, remains with the Coroner.
ATPase Test
A quick, simple test used to check the effectiveness of wet cleaning procedures. ATPase is an enzyme involved in cell metabolism in plants, animals and microbes and so, if it is detected, it shows that some organic matter is present, although it cannot be used to distinguish whether the ATPase comes from food residues or microbes.
Attack rates
Attack rates can be defined as the incidence of disease in a selected group of people. It is the number of people in that group who developed a disease divided by the total number of people in the group.
A cohort study involves a comparison of the attack rates among a group exposed to a factor against the attack rate of those not exposed. Attack rates can be calculated as follows:
Attack rate (exposed) = Number of people exposed to a factor who became ill
Total number of people exposed to a factor
Attack rate (not exposed) = Number of people not exposed to a factor who became ill
Total number of people not exposed to a factor
In order to determine whether there is a degree of association between consuming a food and illness, the relative risk can be calculated:
Relative risk = Attack rate among people exposed to a factor
Attack rate among people not exposed to a factor
If the relative risk is greater than 1.0, then there is a possible link between being exposed to the factor in question and illness. The greater the relative risk, the greater the association between the factor and illness.
For example, if the following information were obtained during an outbreak investigation:
What are the attack rates and relative risks for the consumption of eggs?
Attack rate (exposed) = No. of people exposed to a factor who became ill
Total number of people exposed to a factor
= 43 = 80%
54
Attack rate (not exposed) = No. of people not exposed to a factor who became ill
Total number of people not exposed to a factor
= 3 = 14%
21
Relative risk = Attack rate among people exposed to a factor
Attack rate among people not exposed to a factor
= 80 = 5.7
14
A relative risk of 5.7 indicates a clear association between consumption of the eggs and illness.
It should be noted that this is "back of fag packet" epidemiology. It is intended to give the investigator a clue about foods likely to be associated with the outbreak. It is recommended that detailed statistical tests are also carried out to provide more reliable information.
Attendance at Coroner's Court
Should the Coroner invite you to sit on the bench with him/her as an assessor, you should decline. While HSE appreciates the wish for a technical assessor, this practice could raise questions regarding the role of the inspector, especially if there were subsequent criminal proceedings. In general, where an inspector has first hand knowledge of, or expertise in, the matter under consideration, s/he is likely to be of equal assistance if called as a witness.
Audit
The term ‘audit’ is defined in Regulation (EC) 882/2004 as:
“a systematic and independent examination to determine whether activities and related results comply with planned arrangements and whether these arrangements are implemented effectively and are suitable to achieve objectives”
Audit of approved establishments
Audits of approved establishments
Article 4: 854/2004 states that audits of good hygiene practices shall verify that food business operators apply procedures continuously and properly concerning at least:
(a) checks on food-chain information;
(b) the design and maintenance of premises and equipment;
(c) pre-operational, operational and post-operational hygiene;
(d) personal hygiene;
(e) training in hygiene and in work procedures;
(f) pest control;
(g) water quality;
(h) temperature control; and
(i) controls on food entering and leaving the establishment and
any accompanying documentation.
Authorisation for service of RANs
The Food Law Code of Practice states:
Remedial Action Notices or Detention Notices under regulation 9 of the Food Hygiene Regulations (NI) 2006 should be signed only by Environmental Health Officers (see Section 1.2.9.1.4) who:
• have two years’ post qualification experience in food safety matters;
• are currently involved in food law enforcement;
• who are properly trained, competent and duly authorised.
Authorisation for suspension of approval
Regulation 3 (3) and Schedule 5 of the Official Feed and Food Controls (England) Regulations 2009 identifies food authorities as bodies which are able to suspend approval in accordance with Article 31(2)(e) of Regulation (EC) 882/2004.
Authorisation of officers
The Food Safety Act 1990 allows for the authorisation of officers, in writing, either generally or specially to act in matters arising under the Act or Regulations made under the Act.
However, Officers performing duties under the Food Hygiene (Scotland) Regulations 2006 and the Official Feed and Food Controls (Scotland) Regulations 2007, need to be separately authorised in writing to deal with matters arising under these implementing
Regulations, e.g. issues under the “specified community provisions”.
With regard to other specific food Regulations made under the European Communities Act 1972, where appropriate, relevant officers should be specially authorised for each of those Regulations.
Food Authorities should ensure that officers they authorise in accordance with their documented procedure to carry out enforcement under the food law are:
• Suitably qualified;
• Experienced; and
• Competent to carry out the range of tasks and duties they are required to perform.
This applies equally to those who are directly employed, to temporary staff, and to those employed by or as contractors.
There may be other qualifications that are equivalent to those specifically set out in this Code. The Agency should be approached to consider such cases. Existing or prospective Food Authority officers may also have a range of qualifications, additional training and experience that together indicate their competence to undertake specific enforcement activities identified in this Code. In such cases the relevant professional and awarding bodies should be approached directly by either the existing Food Authority employer or prospective employer for an assessment of equivalence.
Nationals from countries in the European Economic Area have a right under Community law to the recognition of qualifications and experience gained outside the UK. This situation may arise if an individual seeks employment in Great Britain as a Public Analyst, Food Examiner or food law enforcement officer, having acquired relevant qualifications and work experience in their home country. Food Authorities should accept suitable non-UK qualifications and experience in order to give effect to these Community rights. The equivalence of non-UK qualifications will be determined by organisations recognised by the Department of Business Enterprise and Regulatory Reform for the purposes of Directive 89/48/EEC18 (The Mutual Recognition of Professional Qualifications). Food Authorities should make enquiries with the relevant professional and awarding bodies if they have any doubts in this area before confirming an appointment.
Authorisation of officers
Relevant food hygiene and safety legislation;Requirements in Regulation 882/2004 on official controls for competent authorities with responsibility for enforcement of food law;This Code of Practice;The Practice Guidance accompanying this Code;The Food Authority’s Enforcement Policy; UK and EU Guides to Good Practice;Relevant guidance issued by the Agency and by LACORS or SFELC;Relevant industry codes of practice.All establishments which attract a minimum intervention frequency of 12 months or less under the intervention rating scheme at Annex 5.All premises that, under the inspection rating scheme at Annex 5, score 15 points in the Consumers at Risk section (A.5.3.1.3).
The following establishments should be inspected only by environmental health officers or officers holding the Higher Certificate in Food Premises Inspection:
Those who do not hold the required qualifications may assist qualified officers to carry out inspections.
The nature and types of food businesses in their area and the technology utilised by the businesses that the officer is required to inspect;
Officers authorised to undertake food hygiene and safety controls of food business establishments should have a detailed knowledge of the following:
Authorisation of officers
The Food Safety Act 1990 allows for the authorisation of officers, in writing, either generally or specially to act in matters arising under the Act or Regulations made under the Act. However, officers performing duties under the Food Hygiene (England) Regulations 2006 and the Official Feed and Food Controls (England) Regulations 2007, need to be separately authorised in writing to deal with matters arising under these implementing Regulations, e.g. issues under the “specified Community provisions”.
With regard to other specific food Regulations made under the European Communities Act 1972, where appropriate, relevant officers should be specially authorised for each of those Regulations. Food Authorities should ensure that officers they authorise in accordance with their documented procedure to carry out enforcement under food law are:
• suitably qualified;
• experienced; and
• competent to carry out the range of tasks and duties they are required to perform.
This applies equally to those who are directly employed, to temporary staff, and to those employed by or as contractors. There may be other qualifications that are equivalent to those specifically set out in this Code.
The Agency should be approached to consider such cases. Existing or prospective Food Authority officers may also have a range of qualifications, additional training and experience that together indicate their competence to undertake specific enforcement activities identified in this Code. In such cases the relevant professional and awarding bodies should be approached directly by either the existing Food Authority employer or prospective officer for an assessment of equivalence.
Nationals from other countries in the European Economic Area have a right under Community law to the recognition of qualifications and experience gained outside the UK. This situation may arise if an individual seeks employment in Great Britain as a Public Analyst, Food Examiner or food law enforcement officer, having acquired relevant qualifications and work experience in their home country. Food Authorities should accept suitable non-UK qualifications and experience in order to give effect to these Community rights.
The equivalence of non-UK qualifications will be determined by organisations recognised by the Department for Business Enterprise and Regulatory Reform (BERR) for the purposes of Directive 89/48/EEC (the Mutual Recognition of Professional Qualifications).16 Food Authorities should make enquiries with the relevant professional and awarding bodies if they have any doubts in this area before confirming an appointment.
Authorisation of officers
The Food Safety Act 1990 allows for the authorisation of officers, in writing, either generally or specially to act in matters arising under the Act or Regulations made under the Act. However, officers performing duties under the Food Hygiene (Wales) Regulations 2006 and the Official Feed and Food Controls (Wales) Regulations 2007, need to be separately authorised in writing to deal with matters arising under these implementing Regulations, e.g. issues under the “specified Community provisions”.
With regard to other specific food Regulations made under the European Communities Act 1972, where appropriate, relevant officers should be specially authorised for each of those Regulations. Food Authorities should ensure that officers they authorise in accordance with their documented procedure to carry out enforcement under food law are:
• suitably qualified;
• experienced; and
• competent to carry out the range of tasks and duties they are required to perform.
This applies equally to those who are directly employed, to temporary staff, and to those employed by or as contractors. There may be other qualifications that are equivalent to those specifically set out in this Code.
The Agency should be approached to consider such cases. Existing or prospective Food Authority officers may also have a range of qualifications, additional training and experience that together indicate their competence to undertake specific enforcement activities identified in this Code. In such cases the relevant professional and awarding bodies should be approached directly by either the existing Food Authority employer or prospective officer for an assessment of equivalence.
Nationals from other countries in the European Economic Area have a right under Community law to the recognition of qualifications and experience gained outside the UK. This situation may arise if an individual seeks employment in Great Britain as a Public Analyst, Food Examiner or food law enforcement officer, having acquired relevant qualifications and work experience in their home country.
Food Authorities should accept suitable non-UK qualifications and experience in order to give effect to these Community rights. The equivalence of non-UK qualifications will be determined by organisations recognised by the Department for Business Enterprise and Regulatory Reform (BERR) for the purposes of Directive 89/48/EEC (the Mutual Recognition of Professional Qualifications).16 Food Authorities should make enquiries with the relevant professional and awarding bodies if they have any doubts in this area before confirming an appointment.
Authorisation to suspend
Regulation 3 (3) and Schedule 5 of the Official Feed and Food Controls Regulations (NI)2009 identifies district councils as bodies which are able to suspend approval in accordance with Article 31(2)(e) of Regulation (EC) 882/2004
Authorised officer
An officer authorised by the authority in writing for the purpose of serving Hygiene Emergency Prohibition Notices under the Food Hygiene (England) Regulations 2006.
Authorised officer
An officer authorised by the authority in writing for the purpose of serving Detention and seizure Notices under the Food Hygiene (England) Regulations 2006 and Food Safety Act 1990.
Authorised officer - HIN
An officer authorised either generally or specifically under the Food Hygiene Regulations 2006 by the food authority to exercise functions under Regulation 6.
The qualifications and experience of officers eligible for the issue of Hygiene Improvement Notices are specified in the Food Law Code of Practice. In summary, qualified Environmental Health Officers (EHOs) and holders of the Higher Certificate in food premises inspection may draft and serve Hygiene Improvement Notices in any food business.
Holders of the Ordinary Certificate in Food Premises Inspection will only be able to issue Hygiene Improvement Notices in lower risk premises (Category C or below).
authorised officer detention and seizure
Section 1.2.9.3.1 of the Food Law Code of Practice identifies the following permitted officers for the purposes of section 9 of the Food Safety Act 1990:
• authorised Environmental Health Officers and, where relevant;
• authorised Official Veterinarians;
• appropriately authorised Trading Standards Officers (see Section 3.4.3); and
• in respect of fresh meat only, officers qualified in accordance with the Authorised
Officers (Meat Inspection) Regulations 1987
In addition, successful holders of the Higher Certificate in Food Control may be authorised to detain and seize food. Click here for an explanatory letter from the FSA on this topic.
Authorised officer HEPN
Hygiene Emergency Prohibition Notices should be signed only by Environmental Health Officers who have two years' post qualification experience in food safety matters; are currently involved in food law enforcement and; are properly trained, competent and duly authorised.
Food law Code of Practice 1.2.9.1.6:
Authorised officers
Officers authorised to undertake food hygiene and safety official controls of food business establishments should have a detailed knowledge of the following:
• the nature and types of food businesses in their area and the technology utilised
by the businesses that is subject to official control by the officer;
• relevant food hygiene and safety legislation;
• requirements in Regulation 882/2004 on official controls for competent authorities with responsibility for enforcement of food law;
• this Code of Practice;
• the Practice Guidance accompanying this Code;
• the Food Authority’s Enforcement Policy;
• UK and EU Guides to Good Practice;
• relevant guidance issued by the Agency and by LACORS; and
• relevant industry codes of practice.
The following establishments should be inspected only by Environmental Health Officers or officers holding the Higher Certificate in Food Premises Inspection:
• all establishments which attract a minimum intervention frequency of 12 months or less under the intervention rating scheme at Annex 5; and
• all establishments that, under the intervention rating scheme at Annex 5, are in the “substantial” category of the Consumers at Risk section (A5.3, Part 1C).
Those who do not hold the required qualifications may assist qualified officers to
carry out inspections.
Authorised Officers for service of RANS and Detention Notices
The Food Law Code of Practice states:
"1.2.9.1.8 Service of Remedial Action Notices/Detention Notices Remedial Action Notices or Detention Notices served under regulation 9 of the Food Hygiene (England)Regulations 2006 should be signed only by Environmental Health Officers who:
• have two years’ post qualification experience in food safety matters;
• are currently involved in food law enforcement;
• who are properly trained, competent and duly authorised."
Automated milking systems
Modern production holdings will use automated milking systems to ensure that the large numbers of the modern dairy herd are adequately and hygienically catered for.
Cows are introduced into individual stalls within the milking parlour and after initial cleaning/sanitisation procedures are hooked up to the automatic milking system. This works by placing a vacuum cup onto each teat which simulates the action of the suckling calf and hence stimulates milk secretion.
Once a cow has been successfully milked, the system will run through an automated cleaning and disinfection programme to prevent any cross contamination to the next cow.
Awareness of staff of these procedures
The assessment of the product withdrawal and recall systems should not be confined to discussions with members of the dairy management team but should also include interviews with relevant staff such as:Vehicle drivers and Administration staff.
Balance tank
The main function of the balance tank is to provide a constant supply of milk to the pasteuriser. It consists of a cylindrical tank containing a ball and float mechanism similar to that found in a wc cistern.
Balance tank
The balance tank also helps to ensure that a higher pressure is maintained on pasteurised side of heat exchanger, it prevents air intake into the system and it receives “recirculated” milk following a diversion of the pasteuriser.
It is also often used as a header tank for the addition of detergents and sterilents during CIP.
Barrel freezer
Continuous barrel freezer
Here, ice cream mix is fed through the centre of a jacketed pipe. The jacket contains a coolant that causes the mix to freeze on contact. A stirrer inside the pipe continuously scrapes the frozen mix from the inside of the pipe and whips air into the freezing mixture.
Batch pasteuriser
Involves the heat treatment of a fixed volume of milk in a vat or tank. This is normally achieved by using a jacketed tank where hot water is passed around the outside of the tank and gently heats the milk within, which is continuously stirred using an agitator.
Batch pasteurisation is commonly used for dairy products such as ice cream mixes. The photograph below shows a batch pasteuriser used on an on-farm dairy for the heat treatment of cream.
The usual heat-treatment for batch pasteurised milk is 63°C for 30 minutes. However, equivalents may be used for drinking milk and much higher temperatures are commonly used for cheese and yoghurt manufacture.
Inside the tank there is a rotating agitator which prevents the milk from burning onto the inside of the tank and ensures an even distribution of heat. As a consequence of this agitation, a layer of froth commonly develops in the airspace at the top of the tank. This froth is well insulated by air and so requires a more thorough heat treatment to ensure that all pathogens have been destroyed. As such, it is a general rule of thumb that the airspace temperature, that between the top of the product and the inside top of the tank, should receive a heat treatment of at least 3°C above the desired pasteurisation temperature.
For this reason many dairies will ensure that batch pasteurised milk is subjected to a temperature of 66°C for 30 minutes. Additionally, it is common practice to record both the temperature of the milk and that of the airspace on a thermograph chart.
Batches of food
When considering whether to seize or detain a batch, lot or consignment the authorised officer should take into account the following:
- The evidence available,
- The nature of contamination
- The nature and condition of any container holding the food.
- The risk to health
- The quantity of food involved in relation to any sampling that has been undertaken.
The authorised officer should use professional judgement to decide whether to detain or seize the whole batch, lot or consignment. It may be appropriate to seek expert advice if necessary.
If a whole batch, lot or consignment is detained and it subsequently becomes clear that only part of the detained food is affected and needs to be seized, the remainder of the batch may be released. The compensation provisions under section 9 of the Food Safety Act should always be considered if this course of action is taken.
Benefits
The Industrial Injuries Scheme provides preferential social security benefits for disablement caused by an accident or a prescribed occupational disease arising out of or in the course of employment. It is not necessary to have paid National Insurance contributions to be eligible for these benefits. Benefit is paid irrespective of fault on the part of the employer; it can be paid even if the employee was at fault.
Bereaved family liaison
Where the police are taking the initial lead in an investigation, a Family Liaison Officer may have been appointed to liaise with the family. In these circumstances, you should still contact the family in order to advise them of HSE’s involvement and role in the investigation. You should liaise with the police accordingly.
Beta Star Antibiotics test
This is a commonly used rapid test for ß-lactam antibiotics (e.g. penicillin, ampicillin etc.) in milk.
A measured sample of milk is added to a pre-prepared beta star vial and incubated for a few minutes. A test paper is introduced into the sample and the result is compared to a standard chart. Alternatively, the test paper can be inserted into a reader which will interprete and display the result of the test.
Border Inspection Post
Border Inspection Posts or BIPs are seaports or airports within EU Member States that have been approved by the European Commission to undertake the appropriate checks on products of animal origin imported from third countries.
Bottle scanners
There are two types of bottle scanners, although they may be incorporated into one machine: Base scanners and Side wall scanners.
Base scanners: Operate by passing a light beam up through the base of the empty bottle prior to filling onto a photo-electric cell above. Any opaque foreign material on the base of the bottle will interrupt the light beam and cause the bottle rejection mechanism to operate. This normally consists of a rotating wheel of vacuum suckers which when activated, pulls the relevant bottle off from the conveyor into a rejects tray.
Side wall scanners operate by taking a digital image of the profile of an empty bottle and then comparing that image with a control one. If there is a substantial difference between the images due to the presence of foreign material, the bottle is rejected using the same mechanism as the base scanner.
The video below shows a base bottle scanner in operation.
Bottle washing
The most common type of automatic bottle washer used in the dairy industry is the hydrojet system where bottles pass through a number of soak tanks and are then inverted over a series of high pressure detergent jets which blast the inside of the empty bottle thus removing any residual deposits.
The main stages of bottle washing are:
1. Empty dirty bottles are fed into the rear of the washer and then fall into inverted cups which carry them through the washing process. The cups hold the bottles around the shoulder exposing the bottle neck.
2. The bottles are carried on a conveyor chain through a series of water baths starting with a water rinse bath and then moving through different baths each containing caustic based detergent. The temperature of the baths increases as the bottles move along until temperatures of at least 83°C are reached. Gauges on the front of the washer display these temperatures and it is important that a steady temperature gradient is maintained to prevent thermal shock and hence cracking of the bottles.
3. The bottles are then inverted and pass over a series of hydrojet bars where hot caustic detergent is jetted directly into the bottles. It is important that these jet bars are inserted and maintained correctly otherwise misaligned bars can result in the detergent jets missing the bottles and even damaging them (causing a characteristic crescent shaped chip on the bottle rim).
4. Finally the bottles pass through a final rinse jetting process where the temperature of the clean bottles is reduced prior to filling.
Breach of the Notice or Order
If there is a breach of the Notice/Order the authorised officer must start proceedings immediately in conjunction with the legal department.
If the authorised officer believes that the food business operator is unlikely to reply to a summons then application for a warrant must be made. The court will decide whether this is the course of action to take and the question of bail may arise.
Any relevant Primary/home/originating authorities should be advised of any Hygiene Emergency action and officers must have regard to LGR guidance on the home authority principle.
Breaches of temperature requirements
If the food itself is at a higher temperature than the prescribed chill holding temperature, or a lower temperature than the prescribed hot holding temperature, and the authorised officer is of the opinion that the food has not been produced, processed, or distributed, in accordance with the Food Hygiene (England) Regulations 2006, the officer should normally deal with the food under regulation 27 of the Regulations (see also regulation 23 in this regard).
Voluntary Procedures to remove food from the food chain may, however, be used in appropriate circumstances (see Section 3.4.9). If food is at a higher temperature than 8ºC (chill holding) or below 63ºC (hot holding), but does not fail food safety requirements, the authorised officer should use professional judgement to determine the most appropriate action in the circumstances. The food may still be fit for consumption, even if it has been maintained at temperatures higher than those specified in the Regulations beyond the time limits allowed.
Authorised officers should enquire into the history of the food, in particular to ascertain whether it could previously have been exposed to temperatures above 8ºC. Enforcement decisions should take account of the history of the food and whether it is consistent with food safety. Authorised officers may adopt an educative approach as the first step towards securing compliance, and discuss the requirements of the legislation with the food business operator to ensure they understand the controls, why they are needed, and how they can be achieved.
Breaches of temperature requirements
If the food itself is at a higher temperature than the prescribed chill holding temperature, or a lower temperature than the prescribed hot holding temperature, and the authorised officer is of the opinion that the food has not been produced, processed, or distributed, in accordance with the Food Hygiene (Wales) Regulations 2006, the officer should normally deal with the food under regulation 27 of the Regulations (see also regulation 23 in this regard).
Voluntary Procedures to remove food from the food chain may, however, be used in appropriate circumstances (see Section 3.4.9). If food is at a higher temperature than 8ºC (chill holding) or below 63ºC (hot holding), but does not fail food safety requirements, the authorised officer should use professional judgement to determine the most appropriate action in the circumstances. The food may still be fit for consumption, even if it has been maintained at temperatures higher than those specified in the Regulations beyond the time limits allowed.
Authorised officers should enquire into the history of the food, in particular to ascertain whether it could previously have been exposed to temperatures above 8ºC. Enforcement decisions should take account of the history of the food and whether it is consistent with food safety. Authorised officers may adopt an educative approach as the first step towards securing compliance, and discuss the requirements of the legislation with the food business operator to ensure they understand the controls, why they are needed, and how they can be achieved.
Bread and Flour Regulations 1998
Scope
The key provisions of the regulations deal with laying down rules on the composition and labelling of wheat flour, and bread.
Ingredients/Products
1. Bread: This includes any size, shape and form which is usually known as bread and consists of dough made from flour and water, with or without other ingredients, which has been fermented by yeast or otherwise leavened and subsequently baked or partly baked. It excludes buns, bunloaves, chapattis, pitta bread, potato bread or bread specially prepared for coeliac sufferers.
2. Flour: The product which is derived from, or separated during, the milling or grinding of cleaned cereal whether or not the cereal has been malted or subjected to any other process, and includes meal, but does not include other cereal products, such as separated cereal bran, separated cereal germ, semolina or grits.
3. Flour bleaching agent: Any food additive primarily used to remove colour from flour.
4. Flour treatment agent: Any food additive other than an enzyme preparation which is added to flour or dough to improve its baking quality.
Fortification of Wheat Flour
The regulations specify in Schedule 1 the amount of essential ingredients to be added to flour derived from wheat. There are exceptions in the case of wholemeal flour, self raising flour which has a calcium content of not less than 0.2per cent, and wheat malt flour. The permitted ingredients are:-
• Calcium carbonate
• Iron (Specifications for iron are set out in Schedule 2)
• Thiamin (Vitamin B1)
• Nicotinic acid or nicotinamide
Added Ingredients
The regulations were amended by the Miscellaneous Food Additives (Amendment) (Scotland) Regulations 1999 which require that no person can use any flour
bleaching agent in the preparation of any flour or bread. Schedule 3 in the Bread and Flour Regulations was also deleted. The Miscellaneous Food Additives Regulations also control the addition of additives to bread and flour.
Labelling Requirements
The food must be labelled with its name.
Bread may be described as
(a) ‘Wholemeal’ only if:-
All the flour used as an ingredient in the preparation of the bread is wholemeal; or
(b) ‘Wheatgerm’: Where the bread has an added processed wheatgerm content of not less than 10%. This percentage being calculated on the dry matter of the bread.
If none of the aforementioned names apply, the name of the bread may be one that is customary in the area where it is sold, or a name which is sufficiently precise to describe the food. (Food Labelling Regulations 1996 as amended). For example
‘White’, ‘Brown’ or ‘Soda bread’.
Bread which has been 'aerated' or 'partially baked' must include this in the name of the food.
Trade names e.g. Hovis or Granary cannot be used on their own, but may be included with other words in the name.
Bread on Display
Bread, which contains any of the following types of additives:- antioxidant, artificial sweeteners, colour, flour improvers, flavour enhancer, flavouring, preservative, must have a notice in close proximity to it, which clearly tells customers which of these additives are present in that bread.
Public Analyst Observation
Sampling provisions are contained in the Regulations.
Flour mills need to be checked in relation to descriptions of flour products
(wholemeal and brown).
Associated Regulations
Bread and Flour Regulations 1998 SI No. 141 (as amended)
Food Labelling Regulations 1996 SI No. 1499 (as amended)
Further Information
Bakers Federation web page
FSA Bread and Flour Guidance Notes
Broadly compliant
For the purpose of this section “broadly compliant”, in respect of food hygiene, is defined as an establishment that has an intervention rating score of not more than 10 points under each of the following three parts of Annex 5, A5.2: Part 2: Level of (Current) Compliance - Hygiene and Level of (Current) Compliance – Structure; and Part 3: Confidence in Management.
For the purposes of this section, “broadly compliant”, in respect of food standards, is defined as an establishment that has an intervention rating score of not more than ten points under each of the following parts of Annex 5, A5.4: Part 2: Level of (Current) Compliance; and Part 3, Confidence in Management/Control Systems.
Where a Food Authority is using the Office of Fair Trading (OFT) risk-rating system for food standards (formerly the LACORS system), “broadly compliant” is defined as an establishment that has a score of not more than 10 points for Confidence in Business’ Control System (the Local Element).
Brucellosis
Brucellosis is a zoonotic infection of cows caused by Brucella abortus which, if present in milk, is easily destroyed by pasteurisation temperatures.
BSI
The British Standards Institution (BSI) is the national body responsible for the development of British Standards. The vast majority of these are transposed European or international standards.
BSI is the gateway to UK participation in the Comité Européen de Normalisation (CEN) and International Organization for Standardization (ISO) and, through the British Electrotechnical Committees, in the Comité Européen de Normalisation Electrotechnique (CENELEC) and the International Electrotechnical Commission (IEC). HSE is a major contributor – often on behalf of BSI – to the development of many of the standards which have health and/or safety aspects.
Businesses outside area
When exercising these powers, authorised officers should liaise with the relevant Food Authority for the area they are visiting, in advance wherever possible. This applies whether or not the business being visited is a food business. If it is not possible to give prior notice to the Food Authority in which the business is located, for example in an emergency or out of hours, the Food Authority should be notified as soon as practicable thereafter.
Authorised officers exercising these powers should not give advice or recommend changes to a company’s systems or procedures. Such matters should be passed to the Food Authority for the area for appropriate action. Authorised officers exercising powers of entry in food businesses outside their own area must not exercise any enforcement powers other than those associated with their powers of entry, which include the taking of samples in connection with the investigation of suspected offences within their own area. Other enforcement powers, which include the seizure or detention of food, must only be exercised by authorised officers of the Food Authority in which the business is located.
Butter
Butter is made from churning cream and usually has a fat content of >80%. It is normal to make butter from pasteurised cream which has been achieved at >85°C for 15 seconds. The higher temperatures allow for the breakdown of fat globules to occur.
Continuous churning machines are often used in industry.
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Source: Dairy Processing Handbook. Published by Tetra Pak Processing Systems AB, S-221 86 Lund, Sweden..
Butterfat determination
There are two main methods by which the percentage buterfat may be determined in
liquid dairy products such as milk and cream:
The Gerber method of butterfat determination involves the addition of sulphuric acid and amyl alcohol to the milk or cream sample which is then centrifuged in a specially calibrated butyrometer. After centrifugation, the butyrometer is inverted in a water bath and the fat percentage can be read off from the graduated scale on its stem.
Automatic butterfat analysis machines are commonly found in modern processing dairies and whilst they may need to be calibrated against results obtained by the Gerber method, they can produce accurate butterfat determinations within seconds.
The lactoscope pictured above will also provide accurate protein, lactose and solids non fat results.
C - Closure
To avoid immediate or future problems with the relationship formed between the interviewer and interviewee, officers should ensure that, at the end of an interview:
interviewees are thanked before leaving;
every one understands what has happened during the interview;
every one understands what will happen in the future.
Closure should also include elements such as giving the interviewee the opportunity to ask any questions. It is crucial that the officer responsible always ensures that there is a planned closure, rather than an impromptu end, to the interview.
Calibration of thermometers
A certificate of such calibration should be obtained. Food Authorities should also check devices for accuracy at regular intervals between each calibration (e.g. against a reference thermometer used only for that purpose) to ensure they remain within relevant tolerances. Details of such checks should be recorded and these records retained. Food Authorities should ensure that temperature measurements that are to be used in evidence should be taken with a thermometer or other measuring device that has a current certificate of calibration.
Cancellations
RIPA authorisations must be cancelled as soon as the authorising criteria are no longer met.
Cardboard cartons
There are two main types of cardboard carton used in the dairy i
ndustry:
Tetrapacks (and similar) are used for fresh milk packaging. The flattened cartons are delivered to the dairy and then reformed on the filling machine just prior to use.
Variations to this type of carton include the Tetra Top which incorporates a plastic pouring spout on the top of the carton sealed by a plastic cap.
The Tetra Brik is the type of carton used for UHT milks and is supplied to the dairy on large rolls. The cartons are formed within the aseptic filling machines.
Casein
Is often defined as a protein that precipitates from milk at pH 4.6. It exists in milk in complicated “micelles” in association with colloidal calcium phosphate (CCP) and Calcium monophosphate (CMP)
There are a variety of forms of casein. Alpha and Beta casein will easily precipitate out of milk in the presence of Calcium ions. They are held in colloidal solution in milk by a layer of Kappa casein which “protects” the alpha and beta casein.
Kappa casein is readily attacked and denatured by chymosin (rennet) which exposes the alpha and beta casein and leads to their precipitation and curd formation. This is the basic principle in the manufacture of cheese.
The casein micelle is relatively unstable and precipitation of alpha and beta casein will also occur during heat treatment, homogenisation and in acid conditions.
Caseins and Caseinates Regulations 1985
Scope
These regulations implement Commission Directive 83/417/EEC relating to certain lacto proteins (casein and caseinate) intended for human consumption.
Regulations
• Prescribe reserved descriptions, composition and manufacturing characteristics for casein products.
• Impose labelling and advertising provisions.
• Impose additional labelling requirements.
• Require heat treatment of casein before sale of casein products. The heat treatment must be at least equivalent to pasteurisation unless the casein product is itself subjected to such heat treatment during its preparation.
Ingredients/Products
Casein is defined as the principal milk constituent, washed and dried, insoluble in water and obtained from skimmed milk by precipitation by the addition of acid, by micro-biological acidification, by using rennet or by using other milk coagulating enzymes, without prejudice to the possibility of prior use of ion exchange processes and concentration processes.
Caseinate means a product obtained by drying casein treated with neutralising agents.
Caseinate product means edible acid casein, edible rennet casein or any edible caseinate.
What are Caseinates?
Since casein itself will not dissolve in water it will more likely be seen as caseinates, which are the salts of casein, on ingredients labels. They are made by dissolving acid casein in a suitable hydroxide and drying it to make a water soluble product.
• Ammonium caseinate is used mainly in bakery products.
• Calcium caseinate is used as a nutrient supplement. It is used in creamed cottage cheese, powdered diet supplements, nutritional beverages, processed cheese, and frozen desserts because it has a milky appearance and smooth feel in the mouth.
• Potassium caseinate is used in frozen custard, ice cream, ice milk, and fruit sherbets.
• Sodium caseinate is highly soluble and is used as an emulsifier in coffee whiteners, cottage cheese, cream liqueurs, yogurt, processed cheeses, and some meat products. It is also used to improve the whipping properties of dessert whips.
Labelling Requirements
The additional labelling provisions include:
• The Reserved descriptions specified for that product, in the case of caseinates an indication of the cation or cations.
• Use of the term ‘mixture of’ as appropriate followed by the reserved descriptions in descending order in weight as well as protein content calculated on dried extract expressed as a percentage of total weight of product sold.
• Name and Address of the packer, manufacturer or seller within the EEC.
• ‘Country of Origin’ if the product originates from a third country.
• Date of manufacture or some marking to identify the batch.
Schedule 1 part 1 deals with the casein products and their reserved descriptions whilst part 2 deals with technological adjuvants and bacterial cultures. Part 3 deals with standards.
The primary regulations were amended by Caseins and Caseinates (Scotland) Amendment Regulations 1989 SI No. 2321 and again by The Caseins and Caseinates (Scotland) Amendment Regulations 1990 SI No. 1 which implement provisions relating to:
• Analysis of Casein Products Commission Directive 85/503/EEC.
• Method of Sampling Commission Directive 86/424/EEC.
The amendment also reinstates caseinates as the generic name for use in ingredient lists.
Public Analyst Observation
These substances may be found in meat products as additional sources of protein.
Associated Regulations
Caseins and Caseinates (Scotland) Regulations 1986 (SI No. 2026)
Caseins and Caseinates (Scotland) Amendment Regulations 1989 (SI No. 2321) Caseins and Caseinates (Amendment) (Scotland) Regulations 1990 (SI No. 37) The Food Enzymes (Scotland) amendment Regulations 2010 (SSI No. 26) Commission Directive 83/417/EECrelating to certain lacto proteins (casein and
caseinate) intended for human consumption.
Commission Directive 85/503/EEC on methods of analysis for edible caseins and caseinates.
Commission Directive 86/424/EEC methods of sampling for chemical analysis of edible caseins and caseinates
Further Information
Health Issues: Milk allergy and intolerance
Catering establishment
means a restaurant, canteen, club, public house, school, hospital or similar establishment (including a vehicle or a fixed or mobile stall) where, in the course of a business, food is prepared for delivery to the ultimate consumer and is ready for consumption without further preparation
CEFAS
Centre for Environment, Fisheries and Aquaculture Science (CEFAS) is an executive agency of Defra which undertakes official controls in relation to fish and shellfish.
Local authority officers will liaise with CEFAS with respect to the approval of shellfish depuration centres.
Centralised CIP Syatems
This is a system where the detergents and sterilants are held in large tanks in a “tank farm”. Cleaning of equipment is controlled from a central computer.
Centrifugal pump
Centrifugal pumps are used throughout the dairy industry to pump liquids (raw milk, pasteurised milk, detergents, water etc) around the system in a non-calibrated fashion.
They are easily distinguishable by their characteristic "snail shell" shape. There should always be an additional flow control valve in place whenever a centrifugal pump is used to pump milk through a pasteuriser.
Changeover
When a production line is being used to produce more than one end product, the switch between products, which normally involves a thorough cleaning procedure, is known as a changeover.
Chapter 1 853
Article 1 of Regulation (EC) 853/2004 when read with Article 4, identifies the activities that fall within the scope of the regulation and hence the establishments that require approval.
It states: "Unless expressly indicated to the contrary, this Regulation shall not apply to food containing both products of plant origin and processed products of animal origin. However, processed products of animal origin used to prepare such food shall be obtained and handled in accordance with the requirements of this Regulation".
As such, a business that makes a food by mixing ready processed products of animal origin with plant material will fall outside of the scope of the regulations and therefore will not require approval.
Article 1 continues to list operations which would not require approval and states that, unless expressly indicated to the contrary, the regulation does not apply at the point of retail.
It should be noted that certain requirements of 853/2004 relating to the handling and storage of fishery products and bivalve molluscs do apply to retail establishments.
Chapter II 853/2004
Chapter II of Regulation (EC) 853/2004 places specific obligations on the FBO of an establishment which handles products of animal origin. In particular:
Article 3: Requires compliance with Annex II (Identification Marking) and Annex III (specific operational requirements).
Article 4: Requires establishments which place products of animal origin on the market to be approved with the exception of establishments carrying out only:
(a) primary production;
(b) transport operations;
(c) the storage of products not requiring temperature-controlled storage conditions; or
(d) certain retail operations
Article 5: Requires that foods placed on the market by an approved establishment must bear a Health Mark (Fresh meat carcasses or primal cuts) or an Identification Mark and that these marks may only be applied where the establishment complies with the relevant food law.
Chapter III 853/2004
Chapter III of Regulation (EC) 853/2004 states that any documents required under Annex II (Identification Marking) or Annex III (operational requirements) of the regulations are provided by the FBO. It also sets out the Salmonella free status of minced meat etc intended for export to Sweden and Finland.
Cheddar cheese manufacture
The main steps in cheddar cheese manufacture are:
1. Cheddaring, which is the cutting of the curd into large strips
2. Milling, which is formation of small strips of curd
3. Salting
4. Hooping
Cheese recovery
‘Cheese recovery’ refers to the handling of the following types of cheese and their preparation and/or processing for human consumption:
• line recovery
• fines
• mis-shapes
• off-cuts
• downgrade and quality rejects
• returns
• cheese contaminated with visible mould which is not present as part of
the production process or integral to the final product.
Guidance has been issued by the Food Standards Agency with respect to cheese recovery operations and this is available in the library section of this website.
Cheese ripening
The ripening of cheese involves the breakdown of proteins, lipids and carbohydrates in order to obtain a desired texture and flavour. It is achieved by storing the cheese for a desired period of time at specified temperatures and humidity.
Fresh cheeses are those which have not undergone the ripening process whereas mature cheeses may have been ripened for several years.
There are two main types of ripened cheese: surface ripened such as Brie where a mould is smeared on the outside of the cheese and encouraged to grow and; internal ripened cheese such as mature cheddar where the maturation process affects the internal properties of the cheese.
Chemical contaminants
However, in situations where the presence of chemical contaminants may pose an imminent risk to public health, the District Council Food Authority should investigate and take enforcement action, but should liaise closely with the County Council Food Authority. The exception to this is where chemical contamination is found during an inspection of establishments at the level of primary production, in which case Section 1.1.2 should apply as appropriate.
In cases where a clearly identified risk to health has been notified by means of a Food Alert issued by the Agency, either the District Council Food Authority, the County Council Food Authority or both may be required to investigate and take enforcement action - such responsibility will be defined in the Food Alert. The County Council Food Authority may also be required to investigate and take enforcement action when a clearly identified risk to health has been notified by a Public Analyst as a result of sampling.
Medical and other expert advice, including advice from the Public Analyst or Food Examiner, should be sought in order to establish whether contamination by chemicals is likely to pose an imminent risk to health.
County Council Food Authorities should investigate and take enforcement action in cases that involve the adulteration, composition, advertisement, presentation and labelling of food, apart from:
• the identification marking requirements at Annex II of Regulation 853/2004 which
are enforced by District Council Food Authorities; and
• the provisions of the Food Labelling Regulations 1996 relating to the sale of food
after the “use by” date, and the removal or alteration of “best before” or “use by”
dates which are enforced jointly by County and District Council Food Authorities.
CHIS duration of authorisations
Written authorisation for the use of CHIS can last for a maximum period of 12 months and can be renewed during this period.
Oral authorisations for the use of CHIS last for a maximum period of 72 hours unless renewed.
Chloroform in Food (Scotland) Regulations 1980
Scope
These regulations prohibit the sale and export of food containing chloroform in or on that food.
Ingredients/Products
Chloroform: This substance is colourless, volatile, non-flammable, and only slightly water-soluble. It is a pungent and sweet-tasting liquid. It is usually derived from acetone, acetaldehyde, or ethyl alcohol by the reaction of chloride of lime: used chiefly in medicine as a solvent and formerly as an anaesthetic.
Chloroform is one of the trihalomethanes and is a known carcinogenic substance. For the purposes of the regulations food found to contain chloroform may be treated
as failing the food safety requirement of the EC Regulation 178/2002 as enacted by
the General Food Regulations 2004.
Public Analyst Observation
Chloroform is not currently found in foods.
Associated Regulations
General Food (Scotland) Regulations 2004
EC Regulation 178/2002
chopping boards and utensils
Separate chopping boards and utensils must be used for raw and ready-to-eat foods unless all such equipment is cleaned and disinfected by heat in a commercial dishwasher meeting the standard set out in this guidance, and there is a system in place to ensure that disinfected equipment is not subject to recontamination from raw foods
Ciminal prosecution
In England and Wales most cases are heard by magistrates who may, for serious offences, impose a maximum fine of £20 000. Some cases are referred to the Crown Court where there is no limit on the fine that may be imposed.
In Scotland cases are taken in the sheriff courts either on summary procedure or on indictment
procedure before a jury.
Certain very serious offences by individuals may attract a prison sentence. A prosecution may be brought against individuals and corporate bodies; in the case of a death resulting from a work activity, the need for a manslaughter investigation is always considered. Such manslaughter (in Scotland, culpable homicide), including corporate manslaughter (or in Scotland, corporate homicide), investigations are conducted by the police, with assistance from HSE or the local authority as appropriate
Circulating detergents for too long
It is very likely that operators will have other jobs to attend to whilst the mobile cleaning unit is in use and so there is a potential for the cleaning circulation period to extend beyond that recommended by the detergent companies.
Short variations may have no undesirable effects but if a detergent is circulated for hours rather than minutes, especially at high temperatures, it may denature and leave deposits in the dairy equipment.
Officers should examine cleaning procedures and then discuss with staff how these procedures are implemented in practice. It may be good time management to have a lunch break at the same time that a cleaning cycle is in progress but this may have a detrimental effect on the effectiveness of the CIP system.
Clarifier
A clarifier is a centrifuge used to remove debris and somatic cells from raw milk. Unlike a separator, it operates at slow speeds to ensure that any extraneous matter is removed from the milk prior to processing.
Clarifiers are not always used and smaller dairies will simply employ in-line filters to remove extraneous material from the raw milk.
Cleaning
Every food business should have an effective cleaning and, where necessary, disinfection programme in place. There is no legal requirement for a business to devise and implement a written cleaning schedule but such a procedure will help to plan and monitor cleaning processes.
Cleaning and disinfection
It is essential that officers identify any steps in the food operation where effective cleaning and disinfection is critical to food safety and verify that the equipment, chemicals and procedures are adequate to reliably achieve the required standard.
Such verification procedures might include:
Observation of cleaning and disinfection procedures in practice;
Discussions with staff to determine their understanding of the procedures;
Sampling of relevant sanitisers or disinfectants to verify their suitability at the concentrations and contact times specified to kill any specified pathogens.
Cleaning and disinfection
It is important that steps are taken to reduce the contamination of milk entering the food chain and to eliminate the possibility of cross contamination between cows. This will be discussed in more detail in module 4 of this course.
Cleaning and disinfection
Where appropriate, such as in institutional outbreaks, cleaning and disinfection regimes should be identified, agreed by the OCT and then implimented. Officers should take steps to verify that such cleaning/disinfection procedures are understood by staff and are put into place.
Cleaning materials
Separate cleaning materials including cloths, sponges and mops should be provided, and materials for use in clean areas should be stored in designated clean areas accessible by staff in a way that ensures that their clothing and hands are not contaminated when storing or removing materials
Cleaning of teat
Prior to the application of the milking cups, the food business operator should ensure that the teats are free from visible dirt and that a food grade sanitiser has been applied to reduce the level of surface bacteria.
Officers in Scotland, who are responsible for the enforcement of hygiene law in production holdings, should ensure that there are adequate teat cleaning procedures in place, suitable supplies of sanitiser and that the relevant staff are aware of these procedures.
Clinical Samples
The submission of faecal and other clinical samples should be a high priority in the early stages of an outbreak as some pathogens and most bacterial toxins are only found soon after the onset of illness.
In addition, identification of the agent responsible may direct the sampling of food or environmental specimens. All specimens taken as part of an outbreak investigation must be identified with a reference number or outbreak code to distinguish them from other specimens and to facilitate the retrieval of computer data.
Other clinical samples for non-culture techniques may be helpful in the later stages if cultural techniques have failed to yield an organism (eg E. coli O157 infection).
Closing meeting
The dairy management team should be provided with a brief verbal report on the strengths and weaknesses of their food safety management system and in their compliance with the relevant food law.
Clotted cream
Clotted cream is made by firstly gently heating double cream and then scalding it in shallow pans at 70-80°C to form the desired clots.
Co-ordination of Advice, Enforcement and the Home Authority Principle
The Agency endorses the Local Authorities Co-ordinators of Regulatory Services (LACORS) Home Authority Principle and Food Authorities should where possible adopt and implement its provisions.
A Food Authority that is unable to adopt, implement, or adhere to the Home Authority Principle must firstly discuss the matter with LACORS and, if the matter cannot be
resolved, with the Agency.
The co-ordination of Food Authority advice and enforcement is essential to ensure uniformity of treatment and consistency in dealing with food businesses, especially those that have more than one branch or unit situated in different Food Authority
areas. Food Authorities considering giving advice or taking enforcement action in relation to food businesses which have a Home Authority should consider whether they need to contact the Home Authority before doing so. This would normally be necessary, for example, where the advice or enforcement action relates to centrally agreed policies or procedures of a food business. It might not be necessary, however, where such action relates to matters of an exclusively local nature.
From April 2009, Food Authorities in England may become the Primary Authority for a food business operator that has establishments in more than one Local Authority area. Scottish Food Authorities should treat a Primary Authority as if they were the ‘Home Authority’.
Cocoa and Chocolate Products (Scotland) Regulations 2003
Scope
The regulations implement the European Directive 2000/36/EC relating to cocoa and chocolate products intended for human consumption.
The regulations do not apply to composite foods containing such a product as an ingredient. However where a cocoa or chocolate product (designated product) is used as an ingredient in another food, it must meet the compositional requirements.
The compositional requirements are contained in Schedule 1 and a QUID declaration of the amount of the designated product will be required when contained in a composite product such as a pre-packed chocolate chip cookie (normal QUID rules apply to designated products).
Ingredients/Products
The products covered by the regulations include
• Cocoa butter
• Cocoa and powdered chocolate (including reduced fat and non fat)
• Chocolate, milk chocolate, (including family milk chocolate, white chocolate, filled chocolate, 'Chocolate a la taza' and chocolates or pralines
The central requirement of the Regulations is to provide ‘reserved descriptions’ for
‘designated products’. Schedule 1 of the Regulations states the reserved descriptions with the minimum compositional requirements for each. A reserved description cannot be used to describe a product unless it meets the relevant compositional requirements. Where the compositional requirements are met, the reserved description must be used in the name of the food.
Schedule 1 is provided in the annex to this document.
Schedule 1 permits additional ingredients to be added to designated products (other than cocoa butter and powdered cocoa products) but must not exceed 40% of the weight of the finished products e.g. nuts, fruit, honeycomb. The regulations prohibit the addition of:
• animal fats and their preparations not derived solely from milk
• flour, granular and powdered starch (other than in chocolate a la taza and chocolate familiar a la taza : see Schedule 1 of the regulations). Flour includes all types of flour i.e. cereal flours as well as ingredients such as soya flour.
Flavour
Flavouring may also be added to a designated product except cocoa butter provided the flavouring does not mimic the taste of chocolate or milk fat. However, flavourings that significantly characterise the food product will have to indicate this in the name
of the food e.g. orange flavoured milk chocolate.
The Food Labelling Regulations provide controls for the use of the word ‘chocolate’ to foods that are not designated products, but have a chocolate flavour. Schedule 8 of the Food Labelling Regulations 1996 as amended requires that a food is not described as having a chocolate flavour unless that flavour is derived wholly or mainly from either chocolate or (where the purchaser would not be misled by the description) from non-fat solids. Therefore the use of the word ‘flavour’ e.g.
‘chocolate flavour sauce’ may be used provided the purchaser is not misled by the description,
The Regulations require that a food cannot include any reserved description set out in Schedule 1 unless:
a) the food is the designated product to which the reserved description relates.
b) the description is used to indicate explicitly that the substance to which it relates is only an ingredient of that food.
c) the description is used to indicate explicitly that the food in question is not and does not contain a designated product.
Use of Vegetable Fats other than Cocoa Butter
Regulation 3 permits the addition of authorised vegetable fats other than cocoa butter to specific designated products - i.e. in column 2 of Schedule 1 items 3, 4, 5,
6, 8 and 9. The addition of these fats must not exceed 5% of the finished product, after the deduction of the total weight of any other edible substance permitted, without reducing the minimum content of cocoa butter or total dry cocoa solids. The authorised vegetable fats are listed in Schedule 2 of the Regulations.
Chocolate Products
Schedule 1 of the Regulations describes the various chocolate products as being obtained from cocoa products and sugars i.e. the products must contain added sugars.
Use of Sweeteners
Artificial sweeteners may be used in accordance with the rules in the Sweeteners in Food Regulations5. These provide restrictions on the specific sweeteners that may be used and the Food Labelling Regulations 1996 require additional labelling to indicate their presence.
5 EC Regulation 1333/2008
FSA advice on the use of sweeteners and amount of added sugars is summarised as follows:
a) ‘Chocolate’ including some added sugars with sweeteners used to replace part of the sugar is a chocolate product and must comply with Cocoa and Chocolate Products Regulations.
b) ‘Chocolate’ with no added sugars and no added sweeteners is not a chocolate product and does not have to comply with the Cocoa and Chocolate Products Regulations labelling requirements. The term ‘chocolate’ or any of the reserved descriptions in their labelling may be used provided that the term is used with sufficient context to indicate clearly that the food is not and does not contain chocolate. The name of the food and the use of the word ‘chocolate’ on the labelling must therefore be put into appropriate context.
c) ‘Chocolate’ where there are no added sugars but with added sweeteners. This is not a chocolate product and is not required to carry Cocoa and Chocolate Products Regulations labelling requirements. The product has to comply with the Sweeteners in Food Regulations and additional labelling requirements in the Food Labelling Regulations 1996, as amended. FSA guidance recommends that the use of the word ‘chocolate’ on the labelling of such products must be put into context so as not to confuse the consumer e.g. ‘no added sugar chocolate with sweetener(s)’.
Labelling Requirements
Regulation 6 specifies requirements with regard to labelling and marking of designated products.
Where a product contains vegetable fats other than cocoa butter, the products labelling must include the words ‘contains vegetable fats in addition to cocoa butter’. The declaration must be in the same field of vision as the list of ingredients, in bold lettering at least as large as that of the list of ingredients and located near to the reserved description in at least one place on the packaging, but not necessarily each time the reserved description appears. It should be noted that this statement is required in addition to the listing of the vegetable fats in the product list of
ingredients.
Milk Solids Declaration
Milk chocolate made from either 14/25 recipe or the 20/20 recipe must give an indication of the milk solids content in the form ‘milk solids x % minimum’.
Cocoa Solids Declaration
Designated products (except cocoa butter, white chocolate, filled chocolate, chocolates and pralines) must be labelled with a declaration of the cocoa solids content as ‘cocoa solids x % minimum’. For those products containing additional ingredients such as nuts or honeycomb it should be clear that the declared percentage relates to the weight of the chocolate part and not the whole product.
Regulation 6 (4) states how the percentage of cocoa solids in the product must be calculated. An example can be found in the FSA guidance:
The designated products require that ‘fat-reduced cocoa powder’ and ‘fat -reduced drinking chocolate’ as well as products described using any of the permitted reserved descriptions for these products are required to be labelled with an indication of the cocoa butter content.
No specific wording is stipulated for the declaration. The FSA guidance recommends the words ‘contains cocoa butter x % minimum’ be used.
Calculation of cocoa solids
Sugar 48
Cocoa solids content
Cocoa solids declared
Milk solids 820g/80g =25%
Is calculated on Cocoa solids 2020g/98g=20% Vegetable fats 4
Hazelnut 18
Lecitin 1
Vanillin 1
Total 100g
Assortments
Where the designated products are sold in assortment, the reserved description may be replaced by ‘assorted chocolates’, ‘assorted filled chocolates’ or similar
statement. The list of ingredients may cover all the products in the assortment, instead of a separate list of ingredients for each product.
Manufacturers may choose to supplement the reserved descriptions ‘chocolate’,
‘milk chocolate’ and ‘couverture chocolate’ with further descriptions that emphasise the quality of the chocolate e.g. extra fine milk chocolate. Where such descriptions are used, the product must meet the following additional requirements:
- Chocolate - not less than 43% dry cocoa solids, including not less than 26%
cocoa butter
- Milk chocolate - not less than 30% dry cocoa and not less than 18% dry milk solids
- Couverture chocolate -not less than 16% dry non-fat cocoa solids.
Seasonal Selection Packs
If designated products are sold in a seasonal selection pack, the outer packaging is not required to carry any labelling information provided each item in the pack is properly labelled.
Minimum Durability
All chocolate food products sold pre-packed are subject to the indication of minimum durability requirements of the Food Labelling Regulations.
Public Analyst Observation
Inadvertent allergen ingredients can occasionally turn up in Chocolate products e.g. traces of nuts.
No other issues as there are few manufacturers in the United Kingdom.
Authorised officers should be aware of chocolate flavour coatings being described as chocolate.
Associated Regulations
Cocoa and Chocolate Products (Scotland) Regulations 2003 (SSI No. 291)
EC Directive 2000/36/EC relating to cocoa and chocolate products intended for human consumption relating to cocoa and chocolate products intended for human consumption
Further Information
The FSA guidance notes (Revised May 2006) on The Cocoa and Chocolate
Products Regulations 2003 should be consulted for further guidance
Quick Guide to Chocolate
Code of Practice - Use of HINs
The Food Law Code of Practice states:
Chapter 3.2 - Hygiene Improvement Notices/Improvement Notices
3.2.1 Introduction
This Chapter deals with the use of Hygiene Improvement Notices under regulation 6 of the Food Hygiene (England) Regulations 2006. It then deals with the use of Improvement Notices under section 10 the Food Safety Act 1990.31 A model form for use in connection with regulation 6 of the Food Hygiene (England) Regulations 2006 can be found at Annex 7. Food Authorities must continue to use the prescribed forms set out in the Food Safety (Improvement and Prohibition - Prescribed Forms) Regulations when using powers under section 10 of the Food Safety Act 1990.
3.2.2 Hygiene Improvement Notices (Food Hygiene (England) Regulations 2006, regulation 6) (See also Section 1.2.9.1.5)
3.2.2.1 When to use Hygiene Improvement Notices
Hygiene Improvement Notices may be appropriate in any of the following circumstances or a combination thereof:
• formal action is proportionate to the risk to public health;
• there is a record of non-compliance with breaches of the food hygiene regulations; and
• the authorised officer has reason to believe that an informal approach will not be
successful.
3.2.2.2 When Hygiene Improvement Notices are inappropriate
The Hygiene Improvement Notice procedure would be inappropriate in the following
circumstances:
• where the contravention might be continuing, for example, personal cleanliness of staff, and a notice would only secure an improvement at one point in time;
• in transient situations, and it is considered that swift enforcement action is needed, for example, a one day festival or sporting event (a Hygiene Emergency Prohibition Notice would be the only formal remedy which would have immediate effect); and
• where there is a breach of good hygiene practice but no failure to comply with an
appropriate regulation.
3.2.3 Improvement Notices (Food Safety Act 1990, section 10) (See also Section 1.2.9.1.6)
3.2.3.1 When to use Improvement Notices
Food Authorities should deal with breaches of the Food Hygiene (England)
Regulations 2006 by using the enforcement powers provided by those Regulations (such as Hygiene Improvement Notices under regulation 6). However, where legislation such as the Animal By-products (Identification) Regulations 1995 is involved, they should issue an Improvement Notice under section 10 of the Food Safety Act 1990.
3.2.3.2 When Improvement Notices are not appropriate
The improvement notice procedure would be inappropriate where breaches exist in
respect of food standards which pose a potential and imminent risk of injury to health and it is considered that swift enforcement action is needed. An Emergency Prohibition Notice would be the only formal remedy which would have immediate effect.
Code of Practice/Practice Guidance
These documents provide detailed guidance to officers on issues such as:-
• Qualifications and experience
• General Enforcement including Powers of entry
• Seizure and detention
• Application of laws to Crown premises etc
• The scope of a food standards inspection
Codex alimentarius commission
The Codex Alimentarius Commission (CAC) was established by the Food and Agricultural Organization of the United Nations (FAO) and the World Health Organization (WHO) to protect the health of consumers and ensure fair practices in food trade. The Commission first met in 1963. Codex is funded by FAO and the WHO and has 180 member governments, including the European Community as a member organisation.
The Codex Alimentarius (Latin for "food code") is the result of the work of the Commission and its around 20 technical committees: a collection of internationally adopted food standards, guidelines and codes of practice.
Codex standards are adopted in most cases by consensus and are based on the best scientific and technical knowledge. Codex is the only international forum bringing together scientists, technical experts, government regulators, as well as international consumer and industry organizations.
Coeliac Disease
A life-long autoimmune condition characterised by damage to the small intestinal wall due to intolerance to gluten protein present in wheat, rye,barley, oats, spelt, kamut or their hybridised strains.
Coeliac disease
Villi (tiny, finger-like projections that line the gut) become inflamed and then flattened, leading to a decreased surface area for absorption of nutrients from food. People with coeliac disease can, as a result, have a wide range of
digestive symptoms and can suffer from nutritional deficiencies.
However, other people who do not have coeliac disease can be allergic to cereals, such as wheat.
Coffee Extracts and Chicory Extracts (Scotland) Regulations
Scope
The Regulations implement Directive 1999/4/EC and apply to coffee and chicory extracts which are ready for delivery to the ultimate consumer or to a catering establishment. The Regulations do not apply to the product known as café torrefacto soluble. The Regulations prescribe definitions and reserved descriptions for coffee extracts and chicory extracts and restrict the sale of such foods which must be
labelled with a reserved description.
Ingredients/Products
The regulations apply to coffee and chicory extracts which are defined as follows:-
Coffee extract: The concentrated product obtained by extraction from roasted coffee beans using water as the only means of extraction (excluding any process of hydrolysis involving the addition of a acid or base) and which contains only the soluble and aromatic constituents of coffee apart from the insoluble substances which it is impossible to remove and insoluble solids derived from coffee.
Chicory extract: The concentrated product obtained by extraction from roasted chicory using only water as the method of extraction (excluding any process of hydrolysis involving the addition of an acid or base).
The use of the reserved descriptions is restricted in the labelling of foodstuffs unless:
a) The food is the designated product to which the reserved description relates b) The description is used in such a context as to indicate explicitly or by clear
implication that the substance to which it relates is only an ingredient of that food
c) The description is used in such a context as to indicate explicitly or by clear implication that such food is not and does not contain a designated product.
Annex 1 of the Regulations states the reserved descriptions and designated products of both coffee extracts and chicory extracts. (See attached Schedule)
Labelling Requirements
There are specific labelling requirements for the designated products in addition to the general requirements of the Food Labelling Regulations 1996 as amended. These are:
• A reserved description of the product
• The word 'decaffeinated' for coffee extracts which have been subjected to a decaffeination process and in which the residual anhydrous caffeine content does not exceed 0.30% of its coffee-based dry matter content
• In the case of coffee and chicory extracts in liquid form in which sugar has been used, the words ‘with x’, ‘preserved with x’, ‘with added x’ or ‘roasted with x’ as
appropriate, x being the name of the sugar product used. The name of the sugar product used must be the reserved description from Specified Sugar Products (Scotland) Regulations 2003 or if no reserved description the name of the product as if it were itself being sold as a food
• In the case of coffee/ chicory extracts in paste or liquid form a declaration of the minimum coffee/ chicory based dry matter content expressed as a percentage
• In the case of coffee extracts in liquid form containing more than 25% coffee based dry matter and for chicory extracts in liquid form containing more than
45% chicory based dry matter the word ‘concentrated’ may be added to the reserved description
• The information required by these regulations must be in a conspicuous place so as to be clearly visible, clearly legible and indelible and easy to understand.
Public Analyst Observation
There tend to be very few issues regarding composition and labelling of these products.
Associated Regulations
Coffee Extracts and Chicory Extracts (Scotland) Regulations 2001 (SSI No. 38)
Directive 1999/4/EC relating to coffee extracts and chicory extracts.
Collateral Intrusion
"HMRC seeks to conduct directed surveillance against T on the grounds that this is necessary and proportionate for the collection of a tax. It is assessed that such surveillance will unavoidably result in the obtaining of some information about members of T’s family, who are not the intended subjects of the surveillance. The authorising officer should consider the proportionality of this collateral intrusion, and whether sufficient measures are to be taken
to limit it, when granting the authorisation. This may include not recording or retaining any material obtained through such collateral intrusion."
RIPA Code of Practice
Collect faecal specimens
The CPHM would be responsible for liaising with GPs and other members of the medical team.
In terms of faecal specimens, early efforts should be made to obtain stool samples from any patients complaining of diarrhoea. However, it is important not to collect too many samples as this might tie up valuable Environmental Health staff and place an undue burden on the laboratory.
It may be appropriate to be selective. For example it would be better to obtain stool samples from patients who have recently started symptoms rather than those who have been ill for some time. There is a much better chance of recovering pathogens at an early stage of infection, especially if the cause of the infection is an enteric virus.
Collect faecal specimens
The CCDC would be responsible for liaising with GPs and other members of the medical team.
In terms of faecal specimens, early efforts should be made to obtain stool samples from any patients complaining of diarrhoea. However, it is important not to collect too many samples as this might tie up valuable Environmental Health staff and place an undue burden on the laboratory.
It may be appropriate to be selective. For example it would be better to obtain stool samples from patients who have recently started symptoms rather than those who have been ill for some time. There is a much better chance of recovering pathogens at an early stage of infection, especially if the cause of the infection is an enteric virus.
Colloid
A colloid is a jelly like substance. Proteins often form colloidal solutions, for example egg white, rather than true solutions.
colostrum
Colostrum is the first milk produced by a newly lactating cow which is particularly rich in nutrients and immunoglobulins.
Commission Decision
A Commission Decision is a piece of legislation which may be produced quickly, often in response to an emerging food safety concern, and may apply to a specific Member State or relate to a specific issue.
Common problems
• Bottled water/spring water/mineral water not in compliance with the Natural Mineral Water, Spring Water and Bottled Drinking Water Regulations 1999, as amended, e.g. Zam Zam water for human consumption.
• Carbonated soft drinks with excess preservative and colours.
• Pickled vegetables with excess preservative.
• Labelling issues in general.
• Mustard Seed Oil containing erucic acid in excess of permitted levels.
• Bacillus cereus contamination of ‘wet’ preserved bean curd usually presented in glass jars.
• Mycotoxins in a wide range of products including nuts, dried fruit, cereals and spices.
• Nuts or dried fruit subject to specific import controls that have not been imported via a designated port point of entry.
• Salmonella spp. in untreated (unroasted) curry powder and other spices.
• Presence of non-permitted additives (preservatives, colours, flavours, enhancers, etc.).
• Excess colours in confectionery and coated fennel seed above permitted levels.
• Fish – mis-descriptions, authenticity
Common Veterinary Entry Document
The Common Veterinary Entry Document (CVED) is provided for by European Law to facilitate the lawful importation of Animals and Products of Animal Origin into the EU from third countries. It consists of two parts (see below).
Part 1 provides details of the exporter, importer and the consignment including references to health certificates and seal numbers. This part is completed by the person responsible for the consignment and presented to the Border Inspection Post prior to the arrival of the food.
Part 2 is completed by the authorised officer at the Border Inspection Post and provides for details of the results of veterinary checks (Identity, documentary and physical checks) to be recorded. Once the relevant parts of the CVED have been completed, the form is signed by the OV or OFI and the official stamp of the BIP is applied.
All consignments of POAO from third countries must be presented to a BIP, be subjected to veterinary checks and hence be accompanied by a CVED on their onward journeys inland. The CVED is only required to be retained by the first destination inland which may be a warehouse, factory, restaurant or indeed any type of establishment.
Failure to produce a valid CVED on demand by an authorised officer at a first destination inland may render the consignment of POAO eligible for seizure.
Common Veterinary Entry Document
The Common Veterinary Entry Document (CVED) is provided for by European Law to facilitate the lawful importation of Animals and Products of Animal Origin into the EU from third countries. It consists of two parts:
Part 1 provides details of the exporter, importer and the consignment including references to health certificates and seal numbers. This part is completed by the person responsible for the consignment and presented to the Border Inspection Post prior to the arrival of the food.
Part 2 is completed by the authorised officer at the Border Inspection Post and provides for details of the results of veterinary checks (Identity, documentary and physical checks) to be recorded. Once the relevant parts of the CVED have been completed, the form is signed by the authorised officer and the official stamp of the BIP is applied.
All consignments of POAO from third countries must be presented to a BIP, be subjected to veterinary checks and hence be accompanied by a CVED on their onward journeys inland. The CVED is only required to be retained by the first destination inland which may be a warehouse, factory, restaurant or indeed any type of establishment.
Failure to produce a valid CVED on demand by an authorised officer at a first destination inland may render the consignment of POAO eligible for seizure.
Communication
The important issues to consider here are:
- the best routes of communication with colleagues, patients and the public;
- Accuracy and timeliness of communications;
- Inclusion of all those who need to know;
- Preparation of written reports for local use and for FSA.
Communication between Investigators and the OCT
Communication between investigators and the OCT is an essential component of an effective outbreak investigation process and details of how this is to be achieved in practice should be specified in the Outbreak Control Plan.
Where investigators discover relevant information they must ensure that it is relayed quickly and accurately to the OCT. Where the accuracy of information cannot be guaranteed, the OCT should be informed of this but information should not be witheld pending verification.
Similarly, investigators must be kept up to date regarding the progress of the investigation and their role within it.
With larger outbreak investigations, it may be appropriate to hold OCT meetings in Council Chambers or similar and invite as many of the investigation team to be present so that they may hear for themselves the issues being discussed by the OCT.
Communication data
"The term ‘communications data’ embraces the ‘who’, ‘when’ and ‘where’ of a communication but not the content, not what was said or written. It includes the manner in which, and by what method, a person or machine communicates with another person or machine. It excludes what they say or what data they pass on within a communication including text, audio and video."
RIPA Code of Practice
Communication with food examiners/analysts
Investigating officers should ensure that they liaise closely with food examiners and, where necessary, public analysts so that any food and/or faecal samples that they collect are relevant to the investigation and that any necessary supplementary information is also provided so that the results may be interpreted.
In particular, officers should take steps to avoid overloading laboratories with inappropriate samples.
Communication with FSA
The Outbreak Control Team (OCT) should at an early stage of an outbreak investigation consider whether it is appropriate to contact the Food Standards Agency and if so, whether it would be useful to invite a representative of the FSA to attend future meetings.
The responsibility for the management of the outbreak rests with the OCT but there may be regional and/or national considerations which the FSA may need to co-ordinate. The FSA may also be able to provide additional resources.
Communication with FSA - addresses
2.4.8 Electronic mail addresses
Food Authorities must notify the Agency of their electronic mail address and notify any changes to these details (see Section 2.2.3).
Communication with FSA - Approvals
2.4.3 Matters relating to product-specific establishments subject to approval under Regulation 853/2004
Food Authorities must notify the Agency:
• when an establishment has been approved or conditionally approved;
• where an approved establishment ceases activities that are the subject of the approval or conditional approval;
• where an approval or conditional approval has been withdrawn or suspended;
• where a live bivalve mollusc purification centre or modification to an existing centre is proposed (see Section 5.1.10);
• where they have designated a live bivalve mollusc relaying area (see Section 5.1.11) - the notification should include the relevant details of the area and any specified operating conditions; or
• where consideration is being given to the issue of a Closure Notice to restrict the
harvesting of live bivalve molluscs (see Section 5.3.6).
2.4.4 Quality of live bivalve mollusc production and relaying areas
Food Authorities responsible for live bivalve mollusc production or relaying areas
must notify the Agency where sample results suggest a significant variation in the quality of such areas (see Section 4.3.3.2).
2.4.5 Matters relating to the delegation of tasks related to official controls
Food Authorities responsible for the delegation of specific tasks to independent third parties (control bodies)27 must provide the Agency with details of the control body and the tasks delegated to it.
Communication with FSA - EU
2.4.6 Matters relating to liaison arrangements with other Member States
Food Authorities must notify the Agency whenever they become aware of a transborder matter that should be referred directly to the Agency (see Section 2.5.2.1).
Communication with FSA - food hazards
2.4.2 Matters relating to food hazards
Food Authorities must notify the Agency as soon as they become aware of a:
• serious localised food hazard;
• non-localised food hazard;
• serious localised outbreak of food-borne illness; and
• withdrawal or recall of food by a food business operator due to non-compliance
with the food safety requirements of Regulation 178/2002 (Article 19).
Communication with FSA - Lead Officers
2.4.7 Lead officers
Food Authorities must notify the Agency of the name of their appointed lead officer who has operational and management responsibility for food hygiene and safety matters and/or for food standards matters, and notify any changes to these details (see Section 1.2.8).
Communication with the media
The Outbreak Control Team (OCT) must speak with one voice to the media and there must be effective plans in place to ensure that conflicting information is not provided. The OCT should recognise that the various types of media (newspapers, radio, TV) will have different requirements in terms of deadlines and target audiences and so it is normal for the OCT to appoint a media relations officer to ensure that these requirements are, as far as possible, accommodated.
It should be recognised that in the absence of appropriate media relations management, the media may choose to publish inaccurate or conflicting information.
For larger outbreaks, regular media briefing sessions should be arranged with the chair of the OCT.
Community Hygiene Regulations
The Community Hygiene Regulations include: Regulation (EC) 178/2002, Regulation (EC) 852/2004, Regulation (EC) 853/2004 and Regulation (EC) 2073/2005 as well as a number of other amending and supplementary regulations.
Companies and compelled statements taken from directors
40. Although a compelled statement taken under section 20(2)(j) is not admissible in evidence against its maker, there may be situations where it will be necessary to rely on the evidence of a director who has been compelled to make such a statement, against the company.
41. It may be argued later that the director should be regarded as "the company" and therefore cannot be compelled to give evidence against the company as this would infringe the company's right against self-incrimination.
42. However, the courts have held that, although the general privilege against self-incrimination, which allows a person to refuse to answer a question that could expose them to a risk of prosecution, can be claimed by a company or any other body with legal personality6, it is limited to the person who makes the statement. This means that a director cannot claim the privilege against self-incrimination to avoid incriminating the company or to prevent the company disclosing information that would incriminate the director7.
Compelled statements taken under section 20(2)(j) HSWA
Section 20(2)(j) of the Health & Safety at Work Act (HSWA) gives the authorised officer the power to require any person whom they have reasonable cause to believe will be able to provide information relevant to their examination or investigation, to answer such questions as the officer thinks fit to ask and to sign a declaration of the truth of the answers.
Information obtained using this power should be recorded in the form of a statement using form LP7 and, if required, the continuation form LP8. The witness must sign the declaration of truth. You should only record the information provided to you by the witness, i.e. the answers given. It is essential that you make it clear to the witness that you are using your compulsory powers before asking any questions.
Answers given by a person compelled to answer your questions are not admissible against that person or their spouse or civil partner (section 20(7) HSWA, as amended).
Compensation
When the Court is not satisfied of the imminent risk to health, or the Local Authority does not apply to the Court within three days, the Authority is liable for compensation for losses resulting from the action it has taken.
Compensation for HEPN
"Where a hygiene emergency prohibition notice is served on a food business operator, the enforcement authority shall compensate him in respect of any loss suffered by reason of his complying with the notice unless -
(a) an application for a hygiene emergency prohibition order is made within the period of three days beginning with the service of the notice; and
(b) the court declares itself satisfied, on the hearing of the application, that the health risk condition was fulfilled with respect to the food business at the time when the notice was served, and any disputed question as to the right to or the amount of any compensation payable under this paragraph shall be determined by arbitration."
Regulation 8(10)
Competent Authority
The responsibility for the effective implementation of food law in Northern Ireland is shared between central bodies such as the Food Standards Agency (FSA) and the Department of Agriculture and Rural Development (DARD) and District Councils.
For the purposes of food hygiene law, the Food Hygiene Regulations (NI) 2006 allocates enforcement responsibility to the FSA with respect to activities in approved slaughterhouses, meat cutting plants and game handling establishments. However, in practice, DARD undertake these functions on behalf of the FSA.
District Councils are the "competent authorities" in terms of food hygiene law in other establishments.
Competent authority
The responsibility for the effective implementation of food law in the UK is shared between central bodies such as the Food Standards Agency (FSA) and the Department for Food and Rural Affairs (Defra) and Local Authorities, including Port Health Authorities.
For the purposes of food hygiene law, the Food Hygiene (England) Regulations 2006 allocates enforcement responsibility to the FSA with respect to activities in approved slaughterhouses, meat cutting plants and game handling establishments. Local Authorities are the "competent authorities" in terms of food hygiene law in other establishments.
Competent Authority
The responsibility for the effective implementation of food law in the UK is shared between central bodies such as the Food Standards Agency (FSA) and the Department for Food and Rural Affairs (Defra) and Local Authorities, including Port Health Authorities.
For the purposes of food hygiene law, the Food Hygiene (Wales) Regulations 2006 allocates enforcement responsibility to the FSA with respect to activities in approved slaughterhouses, meat cutting plants and game handling establishments. Local Authorities are the "competent authorities" in terms of food hygiene law in other establishments.
Competent Authority
The responsibility for the effective implementation of food law in the UK is shared between central bodies such as the Food Standards Agency (FSA) and the Department for Food and Rural Affairs (Defra), the Scottish Government and Local Authorities, including Port Health Authorities (in England).
For the purposes of food hygiene law, the Food Hygiene (Scotland) Regulations 2006 allocates enforcement responsibility to the FSA with respect to activities in approved slaughterhouses, meat cutting plants and game handling establishments. Local Authorities are the "competent authorities" in terms of food hygiene law in other establishments.
Competent Person
A competent person is someone who has sufficient training and experience or knowledge and other qualities that allow them to assist the employer properly. The level of competence required will depend on the complexity of the situation and the particular help the employer needs.
When appointing people, it is advisable for employers to give preference to those in their own workforce who have the appropriate level of competence. In some circumstances, a combination of internal and external competence might be appropriate. For example, employers may need outside help in devising and applying measures identified in risk assessments that are needed to protect workers’ health and safety. Employers may also need help from experts such as health professionals to advise on the health effects of particular work activities or to carry out procedures such as health surveillance.
Complex equipment
Under no circumstances should it be considered safe to use the same complex equipment, such as vacuum packing machines, slicers, mincers, etc, for both raw and ready-to-eat foods.
Where, for example vacuum packing of ready-to-eat foods is carried out, the vacuum packing machine for this purpose should be located in a designated clean area where there is no risk from cross-contamination via splashes, hands, clothing, packaging or other equipment and should never be used for packing raw foods.
Dual use of complex equipment for raw and ready-to-eat foods should NEVER be regarded as a safe practice
Compound ingredients
The 25% rule relating to compound ingredients has been removed by the Food Labelling (Amendment) No 2 Regulations 2004. All ingredients (with a small number of exceptions) will have to be identified on a label from November 2005.
Conclusion of OCT
Once the outbreak investigation has been completed it is important to produce a final report so that lessons may be learned regarding both the positive and negative elements of the investigation.
Conditional approval
Food Authorities should bear in mind that a food business operator can only make an application for the approval of establishments under their control, the decision whether or not to grant conditional approval to an establishment which does not fully comply rests with the Food Authority.
Professional judgement should be used in deciding whether it would be appropriate to grant conditional approval, on a case by case basis. If conditional approval is granted, a further visit must be carried out within three months of the conditional approval being granted in accordance with Article 31(2)(d) of Regulation 882/2004. This visit should be an inspection (see Section 4.1.3).
In appropriate circumstances as set out in Article 31(2)(d) of Regulation 882/2004, conditional approval may be extended, but this is restricted to a maximum of six months from the date of the initial granting of conditional approval. Professional judgement should used in deciding whether it would be appropriate to extend conditional approval, on a case by case basis.
Conditioning
‘Conditioning’ is defined in Regulation (EC) 853/2004 as:
"the storage of live bivalve molluscs coming from class A production areas, purification centres or dispatch centres in tanks or any other installation containing clean seawater, or in natural sites, to remove sand, mud or slime, to preserve or to improve organoleptic qualities and to ensure that they are in a good state of vitality before
wrapping or packaging."
Conditions Where the Prohibition of Equipment may be Appropriate
• Use of defective equipment, e.g. a pasteuriser incapable of achieving the required pasteurisation temperature;
• Use of equipment for the processing of high-risk foods that has been inadequately cleaned or disinfected or which is grossly contaminated and can no longer be properly cleaned.
Conduct interviews with cases
It is important to obtain basic information at an early stage but it would not be necessary to undertake detailed interviews at this point.
The basic initial information that should be gathered from patients could include:
• Name
• Address
• Date of Birth
• Sex
• Occupation (to determine whether patient is likely to spread the infection ie food handler)
• Details of symptoms
• Date of onset of symptoms
• Duration of symptoms
• Details of any commercial premises visited recently (Restaurants etc)
• Details of any events attended recently (ie wedding, parties etc)
• Details of any suspect foods
• Details of anyone else that they consider may have been or could be affected
Conduct site investigation
The main tasks of an Environmental Health inspection of premises implicated in an outbreak of infectious disease are:
a) To stop any hazardous operations
b) Trace any implicated foods
c) Determine the likely cause of problem
d) Communicate all of the above to the Outbreak Control Team
• Quickly
• Concisely
• Accurately
Confirm the aetiology
There may be strong epidemiological and environmental evidence to suggest that the outbreak has been caused by a particular organism but it may be necessary to undertake further analytical studies to confirm that this is the case.
In particular, investigators should be alert to the possibility of more than one causative organism in an outbreak each of which may require quite separate control measures.
Conflicts of interest
Officers should not provide their own services, e.g. training, in their own time within their Food Authority area.
Food Authorities should ensure that potential or actual conflicts of interest do not arise as a result of Home or Originating Authority responsibilities and contracting in services for enforcement purposes. Food Authorities and their officers should avoid promoting the Food Authority’s services exclusively if other providers of those services exist in the area or the services offered by a particular organisation. Pest control and food hygiene training are examples of local Food Authority services that may be provided in competition with those supplied by other organisations. Where a Food Authority delegates enforcement to an independent third party (control body),then that Authority must obtain proof that the control body is impartial and free from any conflict of interest as regard the tasks delegated to it.
Consider continuing risk
This is an important issue as it will clearly influence the degree of urgency that is required with respect to the investigation. One way of determining whether the outbreak is an on-going or continuous one is by constructing an epidemic curve.
Consider the nature of the business
Officers should Identify the nature of the HACCP system required relative to the size and activity of the food business.
Consider whether or not the cases have the same illness and establish a diagnosis;
This task is for the medical staff of the outbreak team to determine.
Consistent
new legislation is consistent with existing regulations – in health and safety and other subjects – and compatible with international law and standards.
Consultation
Before it puts forward proposals for new legislation or codes of practice to ministers, HSE issues formal consultation documents which are made publicly available and which have a very wide circulation. This ensures that HSE, in finalising its proposals, is aware of the views of a range of people and institutions that may be affected by new health and safety provisions.
The same procedure is followed whether the proposed law on standards originated domestically or from the European Union (EU). Though the consultation process in the latter case is necessarily constrained by the terms of the EU legislation, questions will normally arise about application and interpretation, about the chosen method of implementing a directive, and about any options or consequences for the reform of related British law. In every case it is HSE’s objective to ensure, both in the negotiation of European proposals and in their implementation, that established British standards are maintained or improved.
Consultation with other bodies
HSE has links with other bodies, notably universities, engineering institutions and the Health Protection Agency, which has a national function in relation to ionising and other radiations, infectious diseases and chemical incidents. Close contact is also maintained with professional and scientific societies, for example, the Royal Society, the British Occupational Hygiene Society, the Institution of Occupational Safety and Health and the Royal Society of Chemistry, which make a major input into the development of the scientific and technical base
of occupational health and safety in the UK.
Contact with bereaved
In investigations where a member of the bereaved family may be involved as a potential defendant, then all contact should be carefully planned and agreed with line managers. If necessary, you should contact Legal Adviser’s Office for further advice.
HSE acknowledges that understanding diversity plays an important part in liaising with bereaved relatives. Inspectors should be sensitive to the potential diversity of bereaved families, and all those with a direct and close relationship with the deceased should be treated fairly, with decency, dignity and respect.
Contacting the Coroner
In the majority of cases, it should be possible to contact and, if necessary, arrange to meet the Coroner (or his/her officials) within three weeks of the date of the death. You should also keep the Coroner informed as to the progress of HSE’s investigation. How frequently you will need to contact the Coroner’s office will vary from case to case, but contact at least every two months will often be appropriate.
The Coroner may wish to visit the scene of the accident. Where you are aware of this, you should consider whether to accompany him/her on this visit.
Where HSE is involved in the investigation, it may be necessary to remind the Coroner that HSE should be informed when the inquest is to be held. Rules 19(b)(ii) and 20(2)(f) of the Coroners Rules require the Coroner, if requested by an HSE inspector, to notify the him/her of the date, hour and place of the inquest.
Contamination of foodstuffs by infected individuals
Food handlers infected by E. coli O157 will be a source of the bacteria and can contaminate the food or surfaces the food may come into contact with. No one suffering from or carrying an infection that could be transmitted through food should be allowed to handle food or enter the food-handling area if there is a risk of contaminating food. Staff handling food or working in a food handling area must report an infection or symptoms to management immediately. Further guidance is set out in the Agency’s publication Food Handlers: Fitness to Work.
contamination of ready-to-eat food with E. coli O157
E. coli O157 is a particularly dangerous type of bacteria because it can cause serious, untreatable, illness and even death from very low-levels of contamination of ready-to-eat food. Because E. coli O157 survives at freezer, chill and ambient temperatures, measures to control cross-contamination apply to all of these environments.
Although E. coli O157 is the key focus of this guidance, the measures outlined will also help in the control of other food poisoning bacteria, such as campylobacter and salmonella.
Contamination through clothing, aprons and gloves
Cross-contamination can occur if food handlers handle both raw foods and ready-to-eat foods without adequate washing of hands and/or changing of clothes/aprons/gloves in between
Contract and temp staff
Food Authorities should also be satisfied that such staff are competent to undertake the duties required and are familiar with the Food Authority’s enforcement and other policies and procedures. Food Authorities must ensure that persons employed by contractors to undertake inspection or other enforcement activities on behalf of the Food Authority are duly authorised to do so by the Food Authority in writing.
Control measures
Supervision must ensure that critical cross-contamination controls are implemented at all times. If a breakdown in procedure is detected, it must be considered a serious incident and the food business operator must take immediate steps to ensure that no food placed at risk from E. coli O157 cross-contamination is supplied for consumption. Effective action must also be taken in respect of any product that has already been placed on the market.
Control measures
The purpose of control measures are to:
- Control the source of infection;
- Control the mode of spread of the infection;
- Protect persons who may be at risk from infection;
Controlling factors
Are factors which have a negative influence on the outgrowth of pathogens and will include pH, the salt or sugar content of food, water activity and presence of certain microbial inhibitors such as nitrite.
Cook Safe
Cook Safe has been developed by the Food Standards Agency in Scotland to help small businesses to comply with the requirement for systems based on HACCP principles.
Cooking the curd
The combination of heat and the developing acidity (decreasing pH) causes syneresis with resulting expulsion of moisture, lactose, acid, soluble minerals and salts, and whey proteins. Cooking too quickly causes the curd to shatter more easily and forms a tough exterior on the curd particles which prevents moisture release and hinders development of a smooth texture during pressing.
Cooler exit
This is the point at which the chilled pasteurised milk leaves the pasteuriser. The temperature of the milk should not exceed 6°C and must pass the phosphatase test.
CoP
The exception to this is where such contamination is found during an inspection of establishments at the level of primary production in which case Section 1.1.2 should apply as appropriate.
CoP
However, as District Council Food Authorities enforce other temperature control requirements, they should also enforce relevant parts of the Regulations including the verification of temperatures in stores, vehicles and at the point of sale (see Chapter 3.7).
Core functions
The core functions of a public authority will include those activities which form part of its normal business. For example, core functions of a local authority will include: inspections and audits; complaint investigations; site visits etc.
Where a public authority breaches the right to privacy of a person whilst exercising its core function, RIPA will apply. In some circumstances, RIPA will prohibit specific activities carried out by public authorities and in other RIPA will set out an authorisation process to enable such core functions to be performed.
Coroner's Inquest
Section 8(1) of the Coroners Act 1988 requires a Coroner to hold an inquest as soon as practicable following a death, and s/he is not permitted by the Rules to adjourn an inquest for the sole reason that criminal proceedings arising from the death have commenced.
However, the Coroner must adjourn where certain proceedings, including those relating to manslaughter and corporate manslaughter, are ongoing. Therefore, where the police investigate a work-related death and this leads to a file being submitted to the CPS, the inquest will be formally opened and adjourned pending the outcome of the police investigation and the CPS prosecution (if any).
Coroner's notes
As with obtaining a court transcript, Coroners will charge for copies of their notes. It may be that the Coroner’s notes are admissible as proof of the fact that words contained in the notes were said by the witness at the inquest, but not as evidence of the truth of what was said. Should you consider it necessary to your case to use the Coroner’s notes in this way, you should contact Legal Adviser’s Office for further advice.
Coroners Court
Where HSE is involved in the investigation, you should remind the Coroner that HSE should be informed when the inquest is to be held. Whilst HSE may be investigating a work-related death, the Coroner remains responsible for performing his/her statutory functions, including investigating the cause of death and conducting the inquest. It is important that HSE and the Coroner benefit from an effective working relationship, which is now underpinned by the Memorandum of Understanding between HSE and the Coroners’ Society.
Coroners Court
You should enquire as to the cause of death recorded for the deceased as this may be relevant to your investigation, and maintain regular contact with the Coroner’s office throughout the investigation.
Corporate manslaughter
In England and Wales, the offence is known as ‘corporate manslaughter’ and replaces the common law offence of manslaughter by gross negligence in respect of all organisations covered by the Act. The offence is investigated by the police and prosecuted by the CPS.
Correspondence
All correspondence should identify each contravention and the measures which, in the opinion of the officer, could be taken in order to secure compliance.
Correspondence should contain an indication of the time scale suggested for achieving compliance to allow steps to remedy non-compliance to be planned and prioritised. The indication of this timescale for compliance does not require the Food Authority to revisit to monitor compliance. Revisits should be conducted in accordance with Chapter 4.2.5.
Standard documents, circulars, booklets and other publications issued by the Food Authority should be accurate and reflect current practice. Food Authorities should be prepared to discuss letters, circulars etc with any food business operator to whom they have been sent.
Correspondence
All correspondence should identify each contravention and the measures which, in the opinion of the officer, could be taken in order to secure compliance. Correspondence should contain an indication of the time scale suggested for achieving compliance. Standard documents, circulars, booklets, and other publications issued by the Food Authority should be accurate and reflect current practice. Food Authorities should be prepared to discuss letters, circulars, etc. with any food business operator to whom they have been sent.
Courses available to complete online
Food Refresher (1 module)
Approved Establishments (3 modules)
Audit of HACCP Systems (2 Modules)
Food Law Code of Practice (7 Modules)*
Food Enforcement (3 Modules)
Investigation of Food Poisoning Outbreaks (2 Modules)
Interviewing Suspects (1 Module)**
Intervention Risk Rating (1 Module)
Dairy Products (5 Modules)
Regulation of Investigatory Powers (1 Module)*
Witness Statements (1 Module)**
Food Allergen Management (1 Module)
Guide to Health and Safety Regulation (1 Module)*
Work related deaths and inquests** (1 module)
Each module provides approximately 2 hours CPD
*England, Scotland and Wales only. **England and Wales only
Covert surveillance
Covert surveillance involves the monitoring of a person's activities where the target of these observations has no knowledge of them.
Covert surveillance
Following a complaint from local residents regarding noisy equipment at a printing works, a letter is sent to the owner of the business making him aware of the complaints, requesting him to take steps to remedy the situation and warning him that the Council will be monitoring the premises.
Shortly after this letter has been sent out, an officer from the Council visits local residents to determine whether the noise constitutes a statutory nuisance. The business was warned that observations were intended and so this is an overt rather than covert activity and so no authorisation for directed surveillance is required.
Criminal conduct
A police investigation into whether an individual has committed the offence of ‘unlawful act’ manslaughter is also possible, although much less likely in cases involving HSE.
See: R v Adomako [1995] 1 A.C. 171; R v Misra and Srivastava [2005] 1 Cr App R 21.
Criteria to be met with respect to analytical evidence
There must be no evidence of bias in the choice of cases or non-cases, or as the result of a poor response rate;
The time relationship between the consumption of the suspect food and the onset of illness must be consistent with the incubation period of the disease
The association must be strong enough for mere coincidence to be reasonably excluded. By convention, if an epidemiological study seeks to establish a link with a single food, then if the association is so strong that it would only occur 5 times or fewer in a hundred (p=0.05) then the association is deemed to be real, rather than coincidence. If more than one food is suspect, the p-value must be lower for coincidence to be safely ruled out.
Critical control point
A step at which control can be applied and is essential to prevent or eliminate a food safety hazard or reduce it to an acceptable level.
Crown Premises
The Food Hygiene (Scotland) Regulations 2006 do not contain the specific
exemptions for certain members of the Royal Family or certain Royal residences as
afforded by the Food Safety Act 1990 (see Paragraph 1.6.3 below), Food Authorities
should use discretion when exercising their powers in respect of Crown premises.
In practice, Food Authorities should adopt the same approach to the enforcement of
the Food Hygiene (Scotland) Regulations 2006 in respect of Crown premises as they
do in respect of the Food Safety Act 1990.
Crown premises
The Food Hygiene (Wales) Regulations 2006 do not contain the specific exemptions for certain members of the Royal Family or certain Royal residences afforded by the Food Safety Act 1990 (see Section 1.6.3 below). Food Authorities should use discretion when exercising their powers in respect of Crown premises. In practice, Food Authorities should adopt the same approach to the enforcement of the Food Hygiene (Wales) Regulations 2006 in respect of Crown premises as they do in respect of the Food Safety Act 1990.
Crown Premises
The Food Hygiene (England) Regulations 2006 do not contain the specific exemptions for certain members of the Royal Family or certain Royal residences afforded by the Food Safety Act 1990 (see Section 1.6.3 below). Food Authorities should use discretion when exercising their powers in respect of Crown premises. In practice, Food Authorities should adopt the same approach to the enforcement of the Food Hygiene (England) Regulations 2006 in respect of Crown premises as they do in respect of the Food Safety Act 1990.
Crown premises - Group 1
Group 1 - includes premises situated on Crown land where there are normally no security implications, e.g. restaurants in museums or Royal Parks. These premises should be treated like any other food business.
Group 1 premises should normally be visited without prior arrangement.
Crown Premises Group 2
Group 2 - includes premises with controlled entry but normally minimal security implications. Most government and police premises fall within this category. They are similar to many private businesses with security systems. First visits to Group 2 premises should be by prior arrangement. Future visits may be unannounced, but arrangements for subsequent visits should be agreed at the first inspection and confirmed in writing.
Crown Premises Group 3
Group 3 - includes premises where unannounced entry is not possible because of security implications and/or for the personal safety of the authorised officer, e.g. HM Forces, defence and national security establishments, prisons and remand centres, and parts of police premises that accommodate prisoners.
Group 3 premises should always be visited by prior arrangement with the appropriate contact at the establishment concerned, e.g. the defence establishment security officer, the commanding officer or nominated representative of an HM Forces establishment, the Governor of a prison service establishment, or the officer in charge of police premises. This will enable the authorised officer to obtain entry without undue delay. The contact may be reminded of the power of entry if an authorised officer considers that the suggested appointment is too far in advance. Authorised officers who have not been security cleared will be subject to visitor control procedures and escorted at all times. Officers should carry an identity card that incorporates their photograph.
Authorised officers should bear in mind that there may be times when it will not be possible for an inspection to take place or continue in Group 3 premises. Any such
reasonable restriction should not be regarded as obstruction. The authorised officer’s name, date of birth, card or pass number (if any), and the registration number of the officer’s motor vehicle should be given in advance of a visit to Group 3 premises, if required.
Crustaceans
The rules do not name any species of crustaceans. However, ‘crustaceans’ includes all species of crustaceans (for example lobster, crab, prawns and langoustine). Although molluscs are known to cause allergic reactions in those who are susceptible, they are not currently included in the list of specified allergens. The Commission has indicated that they will be asking EFSA’s opinion on this in the near future.
Curd handling
Most brine or surface salted varieties are dipped directly into the forms or pressed under the whey. In the absence of salt, the curd is fused to form a smooth, plastic mass. The hoops are turned at regular intervals to promote uniform drainage, symmetrical shape, and a smooth finish.
Some varieties such as Gouda are pressed under the whey before draining. This encourages formation of smooth texture and prevents incorporation of mechanical openings in the cheese due to trapped air or pockets of whey.
For Cheddar the curd is kept warm in the vat or drain table and allowed to ferment to pH 5.2 -5.4 and is then salted in the vat.
Customary Names
A name which is customary in a particular area, i.e. Barm cake, might not be understood on its own if it is used for the same food when it is sold outside that area. In such cases supplementary information describing what the food is should be given.
Cutting the curd
This may be carried out automatically or manually but is essential to ensure that the quality of the cheese is maintained. Cutting of the curd should take place when the curd is firm enough to do so but before it becomes brittle as this will cause the formation of "fines" which are small particles of curd which are lost during the cutting process and if produced in significant quantities can reduce the protein and fat content of the resultant cheese.
D Values
The D value or decimal reduction time is a measure, in minutes, of the heat resistance of a microorganism quoted at a particular temperature ie “D121”. It is the time in minutes at a given temperature required to destroy 90% of the target microorganism and as such a higher “D” Value indicates higher heat resistance by the microorganism.
For example, a D value at 72°C of 1 minute means that for each minute of processing at 72°C the bacteria population of the target microorganism will be reduced by 90%.
In the diagram below, the D value at 72°C is 14 minutes (40-26).
It is important to recognise that the more microorganisms present in the raw material, the longer it will take to get to desired level using a standard heat treatment.
D values can be expressed as 5D, 8D or 12 D: An 8D process will reduce microbial numbers by 100,000,000. 5D and 8D treatments are commonly used in the food industry and 12D used for low acid canning.
D values can be used to produce thermal death time curve for different species which can assist the processor to select an appropriate time/temperature combination
Dairy fitness to work
There is no requirement for staff at approved dairies to obtain medical certification prior to working at a dairy but there is a legal requirement that:
"No person suffering from, or being a carrier of a disease likely to be transmitted through food or afflicted, for example, with infected wounds, skin infections, sores or diarrhoea is to be permitted to handle food or enter any food-handling area in any capacity if there is any likelihood of direct or indirect contamination. Any person so affected and employed in a food business and who is likely to come into contact with food is to report immediately the illness or symptoms, and if possible their causes, to the food business operator." Regulation (EC) 852/2004 Annex II Chapter VIII
Officers should take steps during an audit of a dairy to verify that adequate procedures are in place with respect to this by:
- Looking at written procedures and associated records such as health questionnaires and absence reports.
- Speaking with supervisory staff regarding their understanding of the practical application of the fitness to work policy ie what would they do if a member of staff reported to them that they had been sick?
- Speaking to members of staff, particularly those with direct product contact such as filler operators and engineers, regarding their understanding of the procedure.
Dairy layout
Ideally there should be a clear separation between raw milk handling areas and finished product areas but in many dairies which have evolved and developed over time this may not be apparent.
Where a new dairy is being built, there should be a direct product flow from the raw milk intake to the finished product despatch area.
Where there is an existing dairy, the officer should obtain a detailed plan of the establishment and then walk through the process to ensure that adequate separation between raw and processed exists in practice. The introduction of "zones" which restrict the movement of staff and equipment may be helpful in older dairy buildings to ensure adequate separation.
Dairy Maintenance
When assessing the adequacy of a dairy's maintenance programme, it would be prudent to select a key piece of equipment, such as a heat exchanger, and undertake the following tasks:
- Review any documented procedures for the maintenance of the equipment in question. This might include contract documents for third party maintenance programmes.
- Review documented records which demonstrate that the planned maintenance procedures have been carried out.
- Discuss with relevant staff how the procedures are carried out in practice.
- Look at the equipment in question for signs that the maintenance has been undertaken in accordance with the records. This might be indicated by the presence of stickers on the equipment or other obvious signs of maintenance.
- Cross refer the maintenance records with relevant production records. For example if maintenance records suggest that maintenance on a pasteuriser was carried out on a specified date, check to see if the production records for that date confirm that the pasteuriser was out of service.
Dairy personal hygiene arrangements
There should be an adequate number of hand washing facilities located at appropriate points around the dairy and staff should be encouraged to wash their hands prior to entering any processing or filling areas.
There are certain members of staff whose personal hygiene arrangements are of greater significance for example filler operators and engineers who may both be handling product contact surfaces during a production run. As such officers should:
- Discuss knowledge of hand washing procedures with these staff
- Verify that adequate hand washing facilities are provided for these staff to use
- Verify by observation that hand washing procedures are followed.
The most effective time to verify this arrangements are at the start-up of a dairy first thing in the morning where both operators and engineers will be routinely handling product contact components.
Dairy pest control
Common pest control issues at dairy establishments include:
- Flies in areas where plastic polybottles are stored and in particular unwrapped.
- Cockroaches in and around glass bottle washers
- Rodents in dry goods and carton stores
Dairy products
Dairy products must carry identification marks as described in Section I of Annex II of Regulation (EC) No 853/2004. Under this, the mark is only required to be oval in shape when it is applied in an establishment in the EU. The name of the third country can be given either in full or as a two letter code (in accordance with the ISO standard country code).
Dairy products process
Below is a diagram (supplied by HRS Ltd) which depicts the pasteurisation process for a dairy product, in this case rice pudding. Here, milk is pre-heated, homogenised and then mixed with rice in a balance tank. The rice pudding is then fed through a tubular pasteuriser which consists of a heated section, holding tube and cooling section and then filled into containers.
De-crating of empty bottles
Empty milk bottles are normally removed from milk crates automatically by de-crating machines. This is an excellent vantage point for members of staff to act as "spotters", looking out for and removing grossly soiled bottles before they re-enter the system.
Deaerator
This piece of dairy equipment is rarely seen in the UK and as the name suggests its function is to remove air from the raw milk prior to pasteurisation.
Deaf witnesses and people with speech difficulties
In such cases you should also arrange for an interpreter to be present, unless the witness agrees in writing to be interviewed without an interpreter present26. The interpreter should read the written record and certify its accuracy27.
Dealing with the witness
All witnesses should be treated with courtesy and every attempt should be made to put witnesses at their ease. It is preferable to speak to witnesses in a private room so that there is a more relaxed environment. At the outset, you should explain to the witness that the primary aim of taking a statement from them is to find out what happened.
It is common practice within HSE to use the term witness “interview” when taking or proposing to take a witness statement. Elsewhere in the criminal justice system the term “interview” is used to refer to the questioning of a suspect. It is important therefore to clearly explain to a potential witness that they are not a suspect and you propose to take a statement from them.
Any statement should be written and signed in ink. Witness statements should be drafted so that they are concise and to the point. They should only deal with matters within the direct knowledge of the witness. As far as is possible, you should try to record the witness's own words.
You may find it helpful to take notes before beginning to write the statement. Once the statement has been completed, you should read it over to the witness before it is signed. If there are any alterations on the statement, these should be initialled by the witness.
When questioning the witness, you should ask all relevant questions so as to satisfy your duty under the Criminal Procedure and Investigations Act 1996 to pursue all reasonable lines of inquiry, whether these point towards or away from the suspect (see ‘Key requirements’ in the relevant section on disclosure of unused material in the Pre-trial Stage).
You will be concerned with obtaining the best evidence possible and therefore you will want to know from the witness whether they have discussed their evidence with anyone else (including the solicitor representing any suspect e.g. a company/employer or another person). If there is any information relevant to the weight to be attached to a witness's evidence, this should be recorded in your notebook.
It is essential that you record each witness’s home address, telephone numbers (including their home) and dates to avoid (if known) on the form attached to the statement, so that you can contact the witnesses at any time, if necessary. It is also essential that you record the witness’s date of birth on the back of the statement where indicated. This is a legal requirement if the witness is under 18. However, it is also necessary in other circumstances, in order to properly identify the witness and, if required, perform a check for any previous convictions (see the related section in Attendance of witnesses[16] ). You should also ask whether or not the witness will consent to the disclosure of their witness statement for the purposes of any subsequent civil proceedings that may be commenced. You should make a written record of their reply on the back of their statement. If a request for disclosure is received for any other purpose then you must seek consent for this and again make a written record of the reply.
Decide whether to convene a formal outbreak control group;
As a guide, the Outbreak Control Team should be called when:
• A disease poses an imminent health risk.
• There are a significant number of cases.
• The outbreak involves a significant disease ie severity/low infective dose.
• Cases have occurred in several Local Authorities.
• High Risk establishment involved.
Decision to withdraw detention
The decision to issue a Withdrawal of Detention of Food Notice should be taken either by the officer who originally issued the notice or initiated the action or by another officer with the relevant experience. A Withdrawal of Detention of Food Notice should be served as soon as possible to prevent possible deterioration of the food. The notice need not be served by the officer who made the decision, but may be served by any authorised officer.
Decision trees
Decision trees can be used to obtain a logical approach to the identification of critical control points. There are a number of decision trees available, each ask a series of questions regarding the nature of the control applied to a particular step in the food process.
Click here to view the Codex alimentarius ccp decision tree.
Decontamination of cloths and mops used for cleaning:
Cleaning materials that were previously used for surfaces, equipment or utensils designated for preparation of raw foods should not subsequently be used for the cleaning of surfaces, equipment or utensils that are used for ready-to-eat foods, or in any designated clean area.
Separate cloths must be designated for use only in clean environments (i.e. for cleaning surfaces and equipment used with ready-to-eat foods). In situations where cloths etc are to be re-used in clean areas, the laundering process should be regarded as critical to food safety. Laundering should be carried out at a suitably high temperature. A wash cycle that achieves 82°C or higher, can be considered acceptable.
This may be achieved through a standard hot cycle, which typically operates at 90°C. Procedures, including contractual arrangements, must ensure that cycles employed for the washing of cleaning cloths are not changed to lower temperatures as a result of energy efficiency reviews.
Decontamination of foods
The decontamination of foods that may already contain E. coli O157 or other microbiological pathogens is not covered in this document. Such controls through cooking or other processing steps are covered in existing guidance published by the Food Standards Agency.
Decontamination of utensils and small equipment:
Properly maintained commercial grade dishwashers in which water reservoirs are maintained at a temperature of more than 80°C providing contact times of at least 15 seconds offer adequate disinfection control. The manufacturer’s cleaning and maintenance instructions must be followed and instructions typically include the removal of food debris, plastic wrapping and limescale from the water jets, filters and drains, as well as carrying out regular cleaning.
Defective product
A defective product is defined as one where the safety of the product is not such as persons generally are entitled to expect. Criteria include any instructions or warnings given with the product and what might reasonably be expected to be done with it.
Deferred Interventions
Such situations may include those where there is evidence that:
• an unsafe practice is occurring or has occurred which represents a significant hazard to public health;
• a particular food handling or food preparation practice is found to entail a previously unsuspected hazard to public health;
• a foodstuff previously thought to be safe is found to be hazardous to public health;
• a food with widespread distribution is found to be contaminated and thereby presents a significant hazard to public health;
• a food with widespread distribution is the subject of fraud in labelling or presentation; and
• in the case of primary production, an occurrence on-farm of a contagious animal disease (such as Blue Tongue) or a natural disaster (such as severe flooding) makes on-farm inspection impractical. Where such a situation arises the Agency may (by means of a communication issued in accordance with Section 2.2.2) require Food Authorities to take specific action. Food Authorities are required to have regard to and to act on, any such communication. Discussions will normally take place with LACORS before Food Authorities are asked to defer their interventions. In all cases, the Agency will, before taking action under this paragraph, consider whether urgent action by Food Authorities is necessary to protect public health or the interests of consumers. Food Authorities may be asked to provide information to the Agency about the action that they have taken, in response to requests under this paragraph and any action taken should be documented.
Density of milk
Density can be defined as the mass of a substance per unit volume:
ρ = m
V
where ρ = density, m = mass and v = volume. The units of density are expressed as mass per volume: 1000 kg/m-3 = 1000 g/l = 1 g/cm-3
The specific gravity of milk is the ratio between the density of milk and the density of pure water
The common density of whole milk is 1030 kg/m-3 and this changes with temperature.
For example, the denisty of milk = 1030 - 0.179t - 0.368F + 3.74N,
where t = temperature in degrees C; F = percent fat; and N = percent nonfat solids
Description of food, distribution etc
Records should be made of any relevant characteristics of the food including the results of any tests carried out to determine such characteristics. For example, where relevant:
- The pH of the food
- The water activity of the food at key stages of production.
- The intended packaging
- The desired shelf life of the food
- The intended customer base
- The intended use of the food eg: ready to eat.
- The intended distribution of the food
Descriptive Epidemiology
The purpose of descriptive epidemiology is to best describe the nature and scope of the suspected outbreak and the main stages involve:
-The drawing up of lists of those at risk from infection;
- Identification of persons posing a risk of further spread of the infection;
- Establishment of a case definition;
- Identification of as many "cases" as possible;
- Collection of data from affected persons by means of a standardised questionnaire.
Designated clean area
A designated clean area is an area within a food establishment that is specifically managed to ensure that harmful bacteria, including E. coli O157, have been effectively excluded from all surfaces (including hands) that will come into contact with ready-to-eat foods.
All surfaces, hands, clothing etc in a designated clean area must remain free from any source of contamination so that food handlers can ensure there is no risk of E. coli O157 contamination being spread within the designated clean area.
As soon as the critical control represented by a designated clean area is breached, there will be potential for contamination to spread from successive contacts between clean and contaminated surfaces.
A clean area that has been compromised by possible E. coli O157 contamination presents an imminent risk. In these circumstances, operations must cease until all surfaces, equipment etc in the area have been decontaminated or replaced to ensure the risk of cross-contamination has been removed.
Designated person
For Local Authorities this person should be an Assistant Chief Officer, Assistant Head of Service, Service Manager or equivalent and should not be directly involved in the investigation
unless unavoidable.
The designated person grants authorisation if satisfied that the application is: Necessary and
Proportionate.
Destruction of food
If possible and if there is likely to be some delay before destruction, the food should be disfigured so as to prevent any possibility of it being returned to the food chain. The Food Authority should ensure the total destruction of the food by incineration or some other appropriate method, or if total destruction is not possible, such a degree of disfigurement that the food could never re-enter the food chain, e.g. by flattening tin cans for disposal in a suitably licensed landfill site, having regard to the requirements of relevant waste disposal legislation. A copy of the waste transfer note must be obtained and kept on file for any food that has been disposed of by a licensed waste disposal contractor under these arrangements.
Detention
The authorised officer may also act on information received, for example, a food alert from the Food Standards Agency and detain the food without actually physically inspecting the food personally.
An authorised officer may also detain food in an establishment subject to approval under Regulation (EC) 853/2004, in accordance with regulation 9 of the Food Hygiene (England) Regulations 2006. Detention Notices served under Regulation 9 of the Food Hygiene (England) Regulations 2006 do not provide any provision for compensation to be payable.
Detention different batches
If a quantity of food of different types or batches is being detained, the authorised officer should issue a separate Detention of Food Notice in respect of each type or batch. When considering whether to seize or detain a batch, lot or consignment, the authorised officer should take into account the following:
• the evidence available;
• the nature of the contamination;
• the nature and condition of any container holding the food;
• the risk to health; and
• the quantity of food involved in relation to any sampling which has been undertaken.
Detention Notice
This is provided under Regulation 9 of the Food Hygiene (Scotland) Regulations 2006:
“(5) An authorised officer of an enforcement authority may, at an establishment subject to approval under Article 4(2) of Regulation 853/2004, by a notice served on the relevant food business operator or his duly authorised representative (in this regulation referred to as a "detention notice") require the detention of any animal or food for the purposes of examination (including the taking of samples).”
This Regulation 9 Detention Notice is different to that provided by section 9 of the Food Safety Act 1990 in that the detention is not subject to the term “failing food safety requirements”; there is no time limit imposed on the detention and once served, there is no appeal against notice.
Detention Notice
This is provided under Regulation 9 of the Food Hygiene (England) Regulations 2006:
“(5) An authorised officer of an enforcement authority may, at an establishment subject to approval under Article 4(2) of Regulation 853/2004, by a notice served on the relevant food business operator or his duly authorised representative (in this regulation referred to as a "detention notice") require the detention of any animal or food for the purposes of examination (including the taking of samples).”
This Regulation 9 Detention Notice is different to that provided by section 9 of the Food Safety Act 1990 in that the detention is not subject to the term “failing food safety requirements”; there is no time limit imposed on the detention and once served, there is no appeal against notice.
Detention Notice
This is provided under Regulation 9 of the Food Hygiene Regulations (NI) 2006:
“(5) An authorised officer of an enforcement authority may, at an establishment subject to approval under Article 4(2) of Regulation 853/2004, by a notice served on the relevant food business operator or his duly authorised representative (in this regulation referred to as a "detention notice") require the detention of any animal or food for the purposes of examination (including the taking of samples).”
This Regulation 9 Detention Notice is different to that provided by Article 8 of the Food Safety Order 1991 in that the detention is not subject to the term “failing food safety requirements”; there is no time limit imposed on the detention and once served, there is no appeal against notice.
Detention Notices
This is provided under Regulation 9 of the Food Hygiene (England)* Regulations 2006:
“(5) An authorised officer of an enforcement authority may, at an establishment subject to approval under Article 4(2) of Regulation 853/2004, by a notice served on the relevant food business operator or his duly authorised representative (in this regulation referred to as a "detention notice") require the detention of any animal or food for the purposes of examination (including the taking of samples).”
This notice could be used, in establishments subject to approval, to detain any food that has been produced in circumstances where the officer suspects that the food safety management system has not been implemented effectively.
*Similar wording is found in the Wales, Scotland and Northern Ireland Regulations
Detention of food
The officer must specify the transport and the place where the food must be stored and this may be in another local authority’s area in which case arrangements must be made to check the food while it is being detained.
In all cases but particularly with highly perishable foods the authorised officer should act quickly at every stage and provide full information to any person carrying out analysis or examination of any food samples that have been taken as a result of the detention.
If food is to be detained where it is found the authorised officer must be satisfied that there are adequate arrangements in place to ensure its security and to prevent tampering or removal of the food.
The officer must organise periodic monitoring of the food throughout the period of the detention.
Before making any arrangements regard must be had to the nature of the food, the quantity any health hazard that it presents and the ownership of the establishment where it is located.
The authorised officer should generally try to avoid leaving it in charge or in the establishment owned by any person who may be prosecuted for an offence under Food Law as a result of the detention.
If food is to be detained where it is found, the officer must be satisfied that adequate arrangements are in place to ensure its security and prevent tampering. This could be by:
- Locking the food in a room or enclosure
- Sealing or marking so that removal of part is obvious
- Requiring the continuous presence of security personnel
Detention of food
Where the authorised officer has served a Detention of Food Notice, professional judgement should be used to determine whether food should be detained where it is, or moved elsewhere. If the officer has any doubts about the security or physical care of the food, the detention notice should specify a place to which the food is to be moved.
If food is to be removed to another Food Authority’s area the officer should notify that Food Authority and make any necessary arrangements for the food to be checked while it is being detained. In all cases, but especially with highly perishable food, the officer should act expeditiously at every stage and provide full information to those required to carry out analysis or examination of samples of the food. If food is to be detained where it is found, the authorised officer should be satisfied that adequate arrangements can be made to ensure its security and prevent tampering.
The officer should organise periodic monitoring of the food throughout the period of detention. Before making such arrangements, regard should be had to the nature of the food, the quantity, any health hazard that it represents, and the ownership of the establishment where it is located. The officer should generally avoid leaving it in the charge of, or in an establishment owned by, any person who may be prosecuted for an offence under food law.
Detention or seizure of food
Where an authorised officer suspects that food may fail food safety requirements, he may detain the food for a maximum period of 21 days using an Article 8 Food Safety Order 1991 Detention Notice.
Should the authorised officer become satisfied that the food in question fails food safety requirements, he may seize the food by taking possession of it and presenting it to a Justice of the Peace normally within 2 days, for condemnation.
If the detained food is subsequently found to be compliant with food law and/or the JP fails to condemn the seized food, compensation is payable by the food authority to the owner of the food.
Detention or seizure of food
Where an authorised officer suspects that food may fail food safety requirements, he may detain the food for a maximum period of 21 days using a Section 9 Food Safety Act 1990 Detention Notice.
Should the authorised officer become satisfied that the food in question fails food safety requirements, he may seize the food by taking possession of it and presenting it to a Magistrate (Sheriff in Scotland), normally within 2 days, for condemnation.
If the detained food is subsequently found to be compliant with food law and/or the Magistrate/Sheriff fails to condemn the seized food, compensation is payable by the food authority to the owner of the food.
Detergents being used at too high a dose
The detergent chamber of a mobile CIP unit is usually relatively small, perhaps 50 litre capacity, but this is sufficient to clean fairly large pieces of equipment such as filling bowls and small tanks. As such, the volume of detergent to be added to the tank is often a few hundred millilitres which may appear to the operator to be insufficient. There is a tendency therefore for operators of this equipment to judge the volume of detergent required "by eye" which may lead to over-dosing of chemicals.
Over-dosing may cause physical damage to rubber gaskets etc but will more commonly lead to detergent residues forming inside the equipment.
Determination of outbreak
This judgement should be made in consultation with the CPHM. An outbreak can be defined as:
"Two or more associated cases" or:
"A greater than expected rate of infection compared with usual background".
It is recommended that the precautionary principle is used whenever possible and as such where two or more cases of a disease are identified, there should be an assumption that there is an outbreak. This however may prove not to be the case after an initial investigation.
Determination of outbreak
This judgement should be made in consultation with the CCDC. An outbreak can be defined as:
"Two or more associated cases" or:
"A greater than expected rate of infection compared with usual background".
It is recommended that the precautionary principle is used whenever possible and as such where two or more cases of a disease are identified, there should be an assumption that there is an outbreak. This however may prove not to be the case after an initial investigation.
Direct contact between raw foods and ready-to-eat foods
Incorrect storage or handling of potentially contaminated raw foods may result in transfer of E. coli O157 by direct contact with the raw food and ready-to-eat food items. Direct contact between foods can occur in a fridge, freezer or on a surface. There is a risk of E. coli O157 contamination if raw and ready-to-eat foods are not adequately separated, wrapped or stored in the correct place. For example, if raw meat is stored above ready-to-eat food in a fridge there is a risk of juice dripping from the raw meat onto food below.
Directive 2003/89/EC
Directive 2003/89/EC and implementing Regulations in the UK required that from 25 November 2005 products not complying with this legislation were prohibited (but products that were labelled before that date could continue to be sold whilst stocks lasted).
Directors and managers
It is important to bear in mind that, where an offence has been committed by a body corporate, directors, managers, company secretaries or other similar officers of a corporate body may also be guilty of an offence under HSWA section 37.
These are people in positions of authority within the corporate body who have both the power and responsibility to decide corporate policy and strategy3. Whether such a person is a suspect in your investigation will depend on the evidence that you have collected.
You are under a duty to follow all reasonable lines of inquiry. This may include investigating the involvement of individuals in any suspected breach4. However, the Enforcement Policy Statement recognises that it may be necessary to target your investigation (e.g. towards the person best placed to control the risk).
Usually, you will only be in a position to decide whether an individual should be interviewed under caution once those lines of inquiry are completed. If, at that stage, you are satisfied that a person in a senior position is not a suspect, then you can, if necessary, request a statement from that person.
Disclosure of Information
However, care must be taken to ensure that information provided to the Coroner for the purpose of the inquest is not further disclosed indiscriminately without consideration of potential prejudice to the investigation or subsequent criminal proceedings.
In addition, the unauthorised disclosure of material to third parties could circumvent the rules governing pre-action discovery by parties to potential civil litigation. It could also by-pass HSE procedures on voluntary disclosure to interested parties and those relating to the consideration and application of the statutory exemptions under FOI.
At the meeting in 2001 between HSE, the Home Office and the Coroners’ Society (see above), the issue of disclosure of investigatory material to third parties was discussed. The subsequent Home Office Newsletter to Coroners advised that they should not disclose to third parties information passed to them by HSE without first obtaining HSE’s agreement. The need for care when disclosing material to third parties is a key element in the approach set out in the MoU.
While Coroners cannot require investigatory material in HSE’s possession to be provided to them, the courts have indicated that it is in the public interest for investigators to offer assistance so as to avoid unnecessary duplication. HSE also recognises that disclosure can help to answer questions that the bereaved family might have and may assist the Coroner in setting the ambit of the inquest.
You should therefore discuss with the Coroner the arrangements for sharing information obtained in the course of your investigation. It may be possible to identify contentious issues or areas of potential concern at this stage, but you may be unable to come to a final judgment until the Coroner has explained the scope of his/her inquiry and how s/he intends to conduct proceedings. Your initial letter to the Coroner should draw his/her attention to the MoU and the approach you will take.
In line with the MoU, contact with the Coroner should lead to agreement between you as to what information can be disclosed to third parties, and in what form. If agreement cannot be reached, the matter should be referred to Legal Adviser’s Office.
Disclosure of information by the Coroner
The Coroner does, however, have a discretion to make advance disclosure and may wish to make material available to interested persons, including the bereaved. There is an obligation on the Coroner to conduct the inquest in a fair manner and the requirements of fairness will vary from case to case. In some cases, there is less need for advance disclosure; the courts have accepted that they cannot be prescriptive as to what is necessary for the purposes of an inquest.
The courts have approved of the practice of Coroners providing a list of witnesses whose evidence will be heard in advance of the inquest. You are therefore entitled to ask the Coroner which witnesses s/he intends to call.
The Coroner may also wish to make use of Rule 37 of the Coroners Rules 1984, which allows statements to be admitted as evidence by having them read aloud at the inquest, rather than calling the witnesses to give oral evidence. Rule 37 may only be used where the contents of the statement are not likely to be disputed and the courts have disapproved of attempts by Coroners to admit witness evidence in this way without giving interested persons a proper opportunity to object following advance disclosure. An objection would mean that the witness would have to be called.
The approach under the MoU allows disclosure to the Coroner, who can determine what is strictly relevant for the purposes of the inquest (see above) and revert to you to discuss what advance disclosure may be required and the form it may take. The MoU envisages discussions between the Coroner (or the Coroner’s officer) and the HSE inspector to identify whether disclosure of material may be prejudicial to the criminal investigation. Where the Coroner considers it necessary to disclose a document which contains material that you consider to be potentially prejudicial, it may be possible to focus the advance disclosure by providing only part of the document to interested persons, omitting (generally by redaction) the material that you identified as causing concern. As stated above, the Coroner may nevertheless use all the information HSE provides, whether disclosed to interested persons or not, to inform his/her inquiry.
The MoU also explains that some of HSE’s investigatory material, while relevant to a potential prosecution, will have no part or use within inquest proceedings. If documentary evidence from the HSE investigation is being considered for disclosure pursuant to Rule 37, the Coroner must also decide whether the contents of the documents in question may be controversial.
Disinfection
Disinfection by heat using appropriate time/temperature combinations can be effective at destroying E. coli O157. The temperatures required are generally achieved in commercial dishwashers and in standard hot wash laundry cycles.
Disinfection using chemical disinfectants or sanitisers should not be substituted for physical separation as a critical control for E. coli O157 cross-contamination. However, in the limited cases set out in the guidance (sinks for cleaning and disinfecting food equipment and non-food-contact surfaces such as worktops and walls), it may be the only practicable control measure. In such cases, the use of disinfectants or sanitisers that meet BS EN 1276:1997 or BS EN 13697:2001 can be considered appropriate. This is provided that they are applied to visibly clean surfaces, and are used strictly in accordance with the manufacturer’s instructions relating to proper dilution of the chemical, the effective temperature range and the necessary contact time. Since effective chemical disinfection can only be achieved on visibly clean surfaces, a cleaning stage is required first.
Effective chemical disinfection is an essential prerequisite hygiene measure throughout the food industry and the guidance in this document can be used more generally for the selection and use of disinfectants.
Disinfection
Disinfectants that have been proven capable of destroying disease-causing bacteria should be applied after general cleaning to reduce microbial contamination to an acceptable level. Disinfection can only be successfully carried out on surfaces that have been thoroughly cleaned to remove grease and other dirt, as the effectiveness of disinfection is reduced in the presence of food matter.
Different types of disinfectants require different dilutions and contact times. These are specified and validated by the manufacturer and the FBO must follow the manufacturer’s instructions for dilution and contact time to ensure the product is effective. Disinfection should be followed by a final rinse of the surface or equipment with potable water to remove any remaining chemical, unless it is formulated for use without a final rinse.
Dispatch centre
‘Dispatch centre’ is defined in Regulation (EC) 853/2004 as:
"any on-shore or off-shore establishment for the reception, conditioning, washing, cleaning, grading, wrapping and packaging of live bivalve molluscs fit for human consumption."
Divert valve
The divert valve (diversion valve) is a protection mechanism that is situated at the terminal end of the holding tube after a calibrated recording thermometer. It consists of an air-activated valve that when in normal or “forward flow” operation allows the milk to pass from the holding tube into the regeneration section of the pasteuriser.
If the heated milk temperature drops below a pre-determined set point, for example 72ºC, the valve operates which diverts the milk back to the balance bowl.
As such, it prevents any under treated milk from passing through the system.
For liquid drinking milk plants, the diversion valve must be fitted, maintained and functional. One would normally expect that the operation of the divert valve is checked prior to the start up of the pasteuriser.
Documentary checks
Documentary Checks are carried out on 100% of consignments of POAO from third countries. A documentary check includes verification that the details on the health certificate and commercial documentation are correct.
Documented procedures
Robust documented procedures are essential for ensuring that measures for controlling E. coli O157 cross-contamination are being adhered to. Measures that are critical for control of E. coli O157 must be valid and this document provides advice that can be used to draw up valid procedures.
These procedures will need to be supported by training of all relevant staff. Training will need to ensure that staff fully understand and implement arrangements for separation and the maintenance of clean areas. Training will also need to ensure that staff are able to carry out proper handwashing technique and fully understand when handwashing is critical to protect ready-to-eat foods and the integrity of designated clean areas. Similarly, training in the correct use of disinfectants and sanitisers is critical to their effectiveness.
Documented procedures
Documented procedures should be based on sound evidence that the procedures are capable of controlling cross-contamination. This guidance document can be used to assist in determining types of control that should be effective if properly implemented. However, following the guidance will still require FBOs to ensure that disinfectants or sanitisers meet the specification recommended in this guidance and that machinery has been hygienically designed for its intended purpose and is being maintained, cleaned and disinfected according to manufacturers’ instructions.
Documents and self-incrimination
Under s 20 HSWA, you have the power to take a copy of documents required to be kept under any of the relevant statutory provisions or that are necessary for you to see for the purposes of your investigation. You should be aware that the defence may argue that, if such documents are relied upon in a prosecution, this infringes their right against self-incrimination. The basis of this argument is that, since the defendant was compelled to provide the copies, they have been compelled to incriminate themselves8.
The Court of Appeal has stated9 that there is a distinction to be drawn between the compulsory production of documents or other material which had an existence independent of the will of the suspect or accused person and statements that they have had to make under compulsion.
In other words, it is important to determine whether the material in question is evidence that a defendant has been compelled to create (e.g. a compelled statement) or evidence that was already in existence, where the effect of the compulsory power is to bring such evidence to the attention of the court (e.g. a company's documents).
As the law currently stands, material that a defendant has been compelled to create may be protected from subsequent prosecution use by the right not to incriminate oneself. Material that was already in existence, but which the defendant was required to produce, does not have this protection and may be used as part of the prosecution case.
Does the establishment handle relevant POAO?
Does the establishment handle products of animal origin that fall within the scope of 853/2004? Approval will not be required where a business makes a food from already processed products of animal origin when these are combined with plant ingredients unless the plant ingredients are characteristic of the food in question.
This exemption for certain food establishments is provided for by Article 1, paragraph 2 of Regulation (EC) 853/2004:
"Unless expressly indicated to the contrary, this Regulation shall not apply to food containing both products of plant origin and processed products of animal origin. However, processed products of animal origin used to prepare such food shall be obtained and handled in accordance with the requirements of this Regulation."
When read in conjunction with Article 2, Paragraph 1(n) of Regulation (EC) 852/2004:
"Processed products" means foodstuffs resulting from the processing of unprocessed products. These products may contain ingredients that are necessary for their manufacture or to give them specific characteristics."
For example if a FBO buys in ready cooked ham and makes ham salad sandwiches, approval will not be required because the final food (sandwich) was made from ready processed POAO (Ham) and plant ingredients (bread & salad). If, however, the FBO bought in raw meat and cooked the ham for his sandwiches on site, approval would be required (subject to other exemptions such as the nature of his client base).
If a dairy products manufacturer produces yoghurt for wholesale distribution, it will require approval. If the milk used for yoghurt production is received into the dairy ready processed, approval will still be required because the final product comprises merely of POAO. If the dairy produces strawberry yoghurt from pre-pasteurised milk, approval will still be required because the strawberries may be considered as a characteristic ingredient of the processed product rather than as a plant ingredient in its own right.
Domestic food law
Responsibility for Food law in the United Kingdom is a matter for the devolved administrations of the Welsh Assembly, Scottish Government and Northern Ireland Assembly. As such, regulations to implement, interpret (where permitted) and provide the enforcement arrangements for European legislation are produced separately by each of these administrations.
Double compartment roadtankers
These tankers have a capacity of approximately 20,000 litres and are used for the transfer of milk from collection centres to processing dairies. They normally comprise two separate 10,000 litre tanks.
Draining of whey
Most cheese is drained in the range of whey pH 6.1-6.4 (curd pH 6.0 - 6.3). Draining time should be uniform at about 20 min to prevent variation from vat to vat. Cheddar types may be stirred out 1 to 3 times as required to obtain required curd moisture.
Drawing of foremilk
The foremilk is the first milk produced in a milking session. This should normally be drawn off manually prior to placing the animal onto the milking system and the food business operator should examine the foremilk for any abnormalities particularly clots, blood or clear liquid which may be indicators of sub clinical mastitic infections.
Milk paddles (see above) are often used to examine the foremilk for abnormalities.
Drinking Milk (Scotland) Regulations 2008
Scope
These Regulations made provisions for the enforcement of Article 114(2) of, and Annex XIII to, Council Regulation (EC) No 1234/2007 establishing a common organisation of agricultural markets and on specific provisions for certain agricultural products.
Ingredients/Products
Milk is defined in the directive as the produce of milking one or more cows and as such the standards would not apply to milk from any other source.
Labelling Requirements
If a food business operator sells milk for drinking, or imports milk into the European Union, they must describe it using one of the following terms, and it must meet the standard for the fat content:
• Raw milk, which must not have been heated above 40°C or equivalent treatment
• Whole milk, heat treated and with a fat content of at least 3.5 per cent
• Non-standardised whole milk, heat treated and with a fat content less than 3.5 per cent
• Semi-skimmed milk, heat treated and with a fat content reduced to between 1.5 and 1.8 per cent
• Skimmed milk, heat treated and with a fat content reduced to 0.5 per cent or below
If a food business operator sells milk for drinking, it must not have been modified, except in the following ways:
• By the addition or removal of cream, whole milk, or semi-skimmed milk, in order to meet the fat content standards
• By enrichment with milk proteins, minerals or vitamins, as long as it is clearly labelled.
• By having the lactose reduced by conversion to glucose and galactose, as long as it is clearly labelled.
In addition, all milk must meet specific technical criteria for:
• Freezing point
• Mass per litre
• Protein content
Public Analyst Observation
Dairies do sometimes have difficulty regulating the fat content of semi-skimmed milk
Associated Regulations
Council Regulation (EC) No. 2597/97
Drinking Milk (Scotland) Regulations 2011 SSI No. 84
Dual use of equipment and machinery
There is a major risk of cross-contamination where the same item of equipment, such as vacuum packers, slicing machines and mincers, are used to process raw food and ready-to-eat food. E. coli O157 may contaminate the surfaces of such equipment after use with raw foods.
This contamination may not be adequately removed during the cleaning and disinfection process and this can result in any ready-to-eat foods, subsequently processed with the equipment, becoming contaminated.
Due diligence
The purpose of the due diligence defence, which had previously been available under Consumer Protection legislation, was to protect businesses who were conducting their activities in an appropriate and responsible way from prosecution simply because an offence had occurred. If, however, the business had acted recklessly or had been negligent, the defence would not be available to them.
Duration of authorisations
Written RIPA authorisations for directed surveillance may remain in place for a maximum period of three months unless they have been renewed during this period.
Oral authorisations for directed surveillance may remain in place for 72 hours unless they have been renewed.
E - Engage & Explain
These two terms also known as ‘Interview Preamble’ refers to early phases within the actual interview and is defined as follows:
The essential element of engagement is an introduction appropriate to the circumstances of the interview. It is desirable that a proper relationship is formed between the interviewer and interviewee. This requires, for example, that the officer develops an awareness of, and is able to respond to, the welfare needs of the interviewee and any particular fears and expectations.
The engage phase is followed by the explanation phase in which the officer should outline the reasons for the interview and explain what kinds of action will be followed during the interview, particularly the routines.
E - Evaluate
After each interview is completed, the event and the material that came from it should be evaluated fully.
The first consideration is whether the objectives of the interview were achieved. Decisions must then be made about whether any further interview is required or whether other inquiries need to be made (as corroboration, confirmation or as preparation for further investigation). An important element of the evaluation is to put the interview in the context of the whole investigation and to review the information obtained along with that already available. Consideration should be given to the following:
The points to prove of any offence;
Evidence of a defence to the offence;
What other areas need to be addressed during the investigation.
Evaluation can also help officers to improve their interviewing skills. To this end, they should take the opportunity to reflect on their personal performance and identify areas for future development or improvement.
Echinoderms
Echinoderms are marine animals including starfish, brittle fish, sea cucumbers and sea urchins.
Editing statements
This merely indicates that the prosecution will not seek to adduce the evidence so marked. The original signed statement to be tendered to the court is not marked in any way. The marking on the copy statement is done by lightly striking out the passages to be edited so that what appears beneath can still be read, or by bracketing, or by a combination of both.
It is not permissible to produce a photocopy with the deleted material obliterated, since this would be contrary to the requirement that the defence and the court should be served with copies of the signed original statement.
Whenever the striking out/bracketing method is used, it will assist if the following words appear at the foot of the frontispiece or index to any bundle of copy statements to be tendered:
‘The prosecution does not propose to adduce evidence of those passages of the attached copy statements which have been struck out and/or bracketed (nor will it seek to do so at the trial unless a notice of further evidence is served).’
Editing statements
Such statements must comply with the general requirements of sections 5A and 5B of the Magistrates Court Act 1980.
Effective handwashing
Effective handwashing is always required prior to handling ready-to-eat foods in order to control cross-contamination. It must also occur after:
• going to the toilet
• handling any food that may be a potential source of E. coli O157
• hand contact with shared cash registers, door handles, light switches, aprons or other surfaces that could come into contact with staff handling raw foods
• handling food and cleaning waste
• eating
• cleaning
Effective Labelling Messages
In the past advisory labels have tended to use the word ‘nuts’ without specifying the particular type of nut involved. Whilst this may be justifiable in certain situations where mixed or multiple nut ingredients re used or are supplied by the same suppliers, this may not always be he case. It is known that some people are only allergic to peanuts and thers are only allergic to tree nuts, and sometimes only to specific tree uts.
Consideration should therefore be given to whether it is possible on the label to indicate the species of nut involved. Similarly, where a product contains peanuts but may be cross-contaminated with tree nuts, it may be appropriate to use a phrase such as ‘May Contain Other Nuts’. If an allergenic food, or a derived ingredient, is listed in the ingredients list it is not necessary to additionally provide allergen advisory labelling for possible cross-contamination with the same source allergenic food.
For example, if an Indian-style ready meal contained peanuts, it would not be necessary to use warning labelling that some of the ingredients used in the sauce may contain peanuts.
Advisory statements need to be easily visible and clearly legible. Fonts should be simple. See the FSA Clear Labelling Guidance (http://www.food.gov.uk/multimedia/pdfs/clearlabelling.pdf) for general advice.
Effectiveness of control measures
Control measures should be implemented as soon as an outbreak is suspected and their effectiveness must be continually reviewed.
For example, such reviews might involve the collection of environmental swabs to verify that cleaning and disinfection regimes are being implemented.
EFSA
The European Food Safety Authority has a role in the regulation of Genetically Modified food and the use of health and nutritional claims with respect to foods.
Egg products ID marking
Identification marks do not have to be applied to eggs if they have been marked in accordance with Regulation (EC) 1234/2007 which sets out marketing standards for certain types of food.
Elicit all relevant information from a witness as soon after the event as is practicable.
A witness statement can be used to obtain relevant information from a witness in a logical and systematic fashion.
ELISA
Enzyme Linked ImmunoSorbent Assay: a sensitive technique for the detection and measurement of compounds, including proteins such as food allergens.
Emergency prohibition
If Authorised Officer is satisfied that an Imminent Risk of injury to health exists in respect of a food premises, piece of equipment or food process he may serve an Hygiene Emergency Prohibition Notice (HEPN) on the food business operator.
The service of an HEPN will ensure the immediate closure of the premises or the prohibition of the relevant equipment or process.
Within three days from the service of an HEPN in England, Wales and Northern Ireland, an application must be made to the Magistrates Court for a Hygiene Emergency Prohibition Order (HEPO). In Scotland an application for the Order must be made to the Sheriff within 5 days.
Once issued, this Order supersedes the HEPN and once issued may only be lifted, in writing, by the enforcement authority.
Emergency Prohibition
The following are examples of circumstances that may involve an imminent risk of injury to health and in which an authorised officer may therefore consider the use of prohibition powers. These examples are in no way prescriptive or exhaustive and are for illustrative purposes only.
• A process or treatment that introduces a teratogenic chemical (one that damages a developing foetus in the womb) into food, which may cause injury to the developing foetus, but the damage will not be apparent until the baby is born.
• A process or treatment that introduces a genotoxic chemical (one that damages genes or chromosomes) into food the effects of which may not manifest themselves until the effected child develops or a malignant tumour occur at some time in the future.
Enable an account to be drawn up of how a situation arose.
One of the duties of the investigating officer is to find out what has happened or what the circumstances that led up to the event under investigation were. This may be because the investigator has a public protection role and hence needs to establish the facts to prevent the event from recurring. Witness statements can be very useful investigative tools in this respect.
Enforcement
The role of enforcing authorities is to protect consumers where a food business operator has not implemented adequate controls or appropriate corrective actions.
Where an enforcing authority identifies that critical cross-contamination controls are inadequate or corrective actions have not been properly implemented, it must intervene and take all appropriate action to protect public health.
Enforcing authorities must always consider the use of Hygiene Emergency Prohibition Notices where inadequate control presents a risk of cross-contamination of ready-to-eat foods by E. coli O157. Enforcing authorities should take possession of food intended for use as a ready-to-eat product for the purposes of destruction if it has not been produced, processed or distributed in accordance with statutory hygiene requirements and it has been exposed to the risk of E. coli O157 cross-contamination.
Enforcement action
Enforcing authorities must always consider the use of Hygiene Emergency Prohibition Notices where inadequate control presents a risk of direct or indirect contamination of ready-to-eat foods by E. coli O157.
Enforcing authorities should take possession of food intended for use as a ready-to-eat product for the purposes of destruction if it has not been produced, processed or distributed in accordance with statutory hygiene requirements and it has been exposed to the risk of E. coli O157 contamination.
Enforcement in premises exempt from Hygiene law.
An example would be enforcement action taken under the General Food Regulations (made under the Food Safety Act 1990) in respect of a one-off event, such as a wedding reception that resulted in an outbreak of food poisoning i.e. the sale or supply of unsafe food in contravention of Article 1 (1) of Regulation 178/2002.
Enforcement of quick frozen Regulations
Authorised officers should, where relevant, examine all relevant documents permitting verification that the measuring instruments conform to the relevant EN standard, although not normally during every inspection.
Temperature monitoring of quick-frozen foodstuffs in cold stores and display cabinets should be carried out as part of inspection, although not normally during every inspection. The prime responsibility for monitoring delivery vehicles for compliance with the requirements of regulations 6, 8 and 9(3) (as read with Schedule 3, paragraphs 1, 2, 3(a, e, f and g)) rests with the Food Authority in whose area the vehicle operator is based. In the event of a problem being identified elsewhere, the inspecting Food Authority should liaise with the Food Authority that has prime responsibility.
Detailed examination and sampling of a load should only be undertaken where there is evidence that the temperature of food may have exceeded the maximum level set down in the Regulations. Transport vehicles should not be stopped en-route purely to enforce the Regulations. Inspection should normally take place only during the loading or unloading of a vehicle.
Enforcement Policy
Article 54 of Regulation 882/2004 provides for appropriate enforcement measures. Food Authorities should have regard to any advice issued by the Agency, LACORS and SFELC when drafting their food law Enforcement Policies.
A Food Authority’s Food Law Enforcement Policy may be part of a generic policy, or combined with other enforcement policies, e.g. feedingstuffs, providing the applicability of the Policy to the enforcement of food law is clear. Authorised officers should implement their Food Authority’s Food Law Enforcement Policy, which should reflect all the factors set out in Paragraph 3.1.3.
Departures from the Policy should be exceptional and the reasons for any departure should be recorded.
In deciding the type of enforcement action to take, an authorised officer should have regard to the nature of the breach and the history of compliance of the food business operator or, in the case of new businesses, an assessment of the food business operator’s willingness to undertake the work identified by the officer.
It is important that the full range of enforcement options remains open to an authorised officer. A Food Authority should not adopt policies where the number of hygiene improvement notices served or the number of reports to the Procurator Fiscal is an indicator of performance.
Enforcement policy
Food Authorities should have regard to any advice issued by the Agency and by LACORS when drafting their Food Law Enforcement Policies. A Food Authority’s Food Law Enforcement Policy may be part of a generic policy, or combined with other enforcement policies, e.g. feeding stuffs, providing the applicability of the policy to the enforcement of food law is clear. Authorised officers should implement their Food Authority’s Food Law Enforcement Policy, which should reflect all the factors set out in Section 3.1.3. Departures from the Policy should be exceptional and the reasons for any departure should be recorded. In deciding the type of enforcement action to take, an authorised officer should have regard to:
• the nature of the breach and the history of compliance of the food business operator; or
• in the case of new businesses, an assessment of the food business operator’s willingness to undertake the work identified by the officer. It is important that the full range of enforcement options remains open to an authorised officer. A Food Authority should not adopt policies where the number of (hygiene) improvement notices served or the number of other legal processes, such as prosecution or formal caution, is an indicator of performance.
Enforcement regarding non-registered food businesses
Officers are directed to Section 3 for general guidance on enforcement.
Officers should be careful to ensure that:
• Such establishments are subject to Regulation 852/2004;
• Such establishments are not subject to approval under Regulation 853/2004 (see Section 5).
Enhanced traceability
Food Business Operators (FBOs) are required, by Article 18 of Regulation (EC) 178/2002 to have sufficient "Systems and procedures" in place to assure the traceability of foods and ingredients which they purchase and those which they supply to other businesses.
In addition to this requirement, foods which are supplied from approved establishments must be marked with either a Health Mark (for fresh meat carcasses and wholesale cuts of meat)or identification mark (for other Products of animal origin) which identifies the source premises and the relevant food authority.
Enterobacteriacae
Many liquid processing dairies will carry out basic microbiological examination of their products on site and the most common test undertaken is for the indicator organisms of the family Enterobacteriacae.
Presence of Enterobacteriacae in post pasteurised product is indicative of poor handling, cleaning or possibly processing.
Environmental hazards in the HACCP process
Such environmental hazards might include matters which cannot be easily resolved by the implementation of pre-requisite programmes but which might present the potential to cause harm to the consumer through, for example, contamination of food.
An example of such environmental hazards might include the proximity of other premises or processes to the food manufacturer. For example an establishment handling ready to eat foods may have to consider the potential impact arising from a raw meat cutting plant situated next door. The pre-requisites of cleaning and disinfection in themselves may be insufficient to remove or reduce the risk of transfer of contamination from the raw meat premises to the ready to eat food to an acceptable level. As such the HACCP team in the ready to eat food manufacturer should be requested to consider the likelihood and severity of the potential hazards and if they are considered to be significant, introduce adequate controls.
Environmental Health Officer
For the purposes of this Code an Environmental Health Officer is a person holding the Diploma in Environmental Health (or its antecedents) awarded by the Royal Environmental Health Institute of Scotland (REHIS) or a Certificate of Registration of the Environmental Health Registration Board (EHRB) (or its antecedents).
The Higher or Ordinary Certificate in Food Premises Inspection may be awarded by any one of the following:
• The Scottish Food Safety Officers’ Registration Board (SFSORB);
• EHRB;
• The Institute of Food Science and Technology (IFST)
All officers undertaking inspections are required to undertake a period of structured practical training with a food enforcement authority as part of the preparation for the award of these qualifications.
Environmental Health Officer
For the purposes of this Code an “Environmental Health Officer” is a person holding a:
• Certificate of Registration of the Environmental Health Registration Board (EHRB); or
• Diploma in Environmental Health (or its antecedents) awarded by EHRB or the Royal Environmental Health Institute of Scotland (REHIS). The Higher or Ordinary Certificate in Food Premises Inspection may be awarded by any one of the following:
• EHRB;
• the Scottish Food Safety Officers’ Registration Board (SFSORB); or
• the Institute of Food Science and Technology (IFST).
All officers undertaking inspections are required to undertake a period of structured practical training as part of the preparation for the award of these qualifications.
Environmental samples
This may include swabs of surfaces, equipment, drains and sewers and should always be carried out before any cleaning or disinfection procedures are implemented by the food business operator.
Where possible, advice should be obtained from the clinical microbiologist and food examiner.
Epidemic curve
Epidemic Curve
An epidemic curve is a graphical display of the size and development of an outbreak over time. It can be easily constructed using the number of cases observed along the y-axis and the date of onset along the x-axis. The shape of the Epidemic curve can provide useful information about the way that the outbreak is progressing. For example:
Insert graph
When the curve shows a gradual rise or plateau (as in the graph above), it is likely that the outbreak is a Continuous Common Source outbreak. That is to say that whatever has caused the outbreak is still causing further illness.
If the epidemic curve shows a sudden increase of cases that subsequently fall off, with most cases occurring within one incubation period for the causative organism, this is likely to be a Point Source outbreak. This is likely to be the shape of the curve when patients have all been exposed to a common factor at the same time, for example guests at a wedding.
Propagated outbreaks are ones where secondary and even tertiary infections are observed. Here, person to person spread is often a major factor and this shape of curve, with several peaks occurring one incubation period apart, is often seen with enteric viral outbreaks.
Epidemic Curve
An epidemic curve is a graphical display of the size and development of an outbreak over time. It can be easily constructed using the number of cases observed along the y-axis and the date of onset along the x-axis. The shape of the Epidemic curve can provide useful information about the way that the outbreak is progressing. For example:
When the curve shows a gradual rise or plateau (as in the graph above), it is likely that the outbreak is a Continuous Common Source outbreak. That is to say that whatever has caused the outbreak is still causing further illness.
If the epidemic curve shows a sudden increase of cases that subsequently fall off, with most cases occurring within one incubation period for the causative organism, this is likely to be a Point Source outbreak. This is likely to be the shape of the curve when patients have all been exposed to a common factor at the same time, for example guests at a wedding.
Propagated outbreaks are ones where secondary and even tertiary infections are observed. Here, person to person spread is often a major factor and this shape of curve, with several peaks occurring one incubation period apart, is often seen with enteric viral outbreaks.
Equilibrium MAP
Equilibrium MAP
Here, the modified atmosphere is generated within the pack itself without the need to extract or replace the air.
The technique makes use of permeable and semi-permeable materials which allow the selective diffusion of gases through them leaving the desired atmosphere within the package.
This is commonly used for packaging fruit and vegetables.
Equipment
The pre-requisite programme should ensure the suitability, cleanliness and maintenance of equipment used within the food business. Regard should be had to the requirements of Materials and Articles in Contact with Foods and associated relevant legislation in terms of the composition of food contact surfaces and equipment not just on its physical structure.
Equipment maintenance
It is important that officers identify any equipment that is essential to produce safe food and consider in detail how the effective operation of that equipment will be maintained by the FBO.
Erucic Acid in Food (Scotland) Regulations 1977
Scope
These regulations implement European Directive 76/621/EEC which sets the maximum levels of erucic acid in oils and fats intended for human consumption and in foods containing added oil and fat.
Ingredients/Products
Erucic acid is a substance naturally found in some oils derived from plants, primarily in some varieties of mustard seed oil and rapeseed oil. Although there have been no confirmed cases of erucic acid toxicity in humans, high levels of erucic acid have been linked to the formation of fatty deposits in heart muscle in animals.
Erucic acid is defined in the regulations as cis-docos-13-enoic acid.
Prior to 1st July 1979 the limit was set at 10% calculated on fatty acid content of the oil or fat component. In respect of any oil or fat or food made thereafter the limit was set at 5% calculated by weight.
Exemptions
The regulations do not apply to:
• Food containing not more than 5% oil or fat unless it is described as specially prepared for infants or young children.
• Food intended for manufacturing or catering purposes.
A breach of the Erucic Acid in Food (Scotland) Regulations 1977 may occur when:
(a) Erucic acid is more than 5% of the fatty acid content of any oil or fat or mixture of the two.
(b) For foods with more than 5% total fat content, the erucic acid comprises more than 5% of the fatty acid content of all the oil or fat in the case of a food to which oil and/or fat has been added.
(c) Where a product to which oil and/or fat have been added is aimed explicitly or implicitly at young children and infants, the same conditions in (b) apply except there is no minimum fat level, all such foods must comply irrespective of total fat content.
The regulations were amended in 1982 by Erucic Acid in Food (Amendment) (Scotland) Regulations 1982 (SSI No. 18) implementing Commission Directive
80/891/EEC laying down the method of analysis for determining the erucic acid content of oils and fats and foods intended for human consumption.
Public Analyst Observation
Can be found in oily foods from Far East, Asia subcontinent and China.
There may be imported food issues regarding rape seed oils.
Associated Regulations
Erucic Acid in Food (Scotland) Regulations 1977 (SSI No 1028)
Erucic Acid in Food (Amendment) (Scotland) Regulations 1982 (SI No. 184) European Directive 76/621/EEC which sets the maximum levels of erucic acid in oils
and fats
Commission Directive 80/891/EEC laying down the method of analysis for determining the erucic acid content of oils and fats
Further Information
In 2004 the Food Standards Agency advised people not to eat particular pickles, sauces and preserved vegetables imported from Bangladesh, China, Pakistan and India, following a survey that showed that some products contained illegally high levels of erucic acid.
Eight out of 71 samples of pickles, sauces and preserved vegetables were found to contain levels of erucic acid exceeding the UK legal limit.
Erucic acid in food preserved in oil
FSA alerts
European Directive 76/621/EEC relating to the fixing of the maximum level of erucic acid in oils and fats intended as such for human consumption and in foodstuffs containing added oils and fats.
European Directive 80/891/EEC laying down the method of analysis for determining the erucic acid content of oils and fats and foods intended for human consumption
Establish a case definition
A simple definition of a "case" for the purpose of the outbreak should be formulated. For example a case could be defined as:
"any person with diarrhoea who ate food produced by Fulchester Deli between 1st and 16th September."
This initial case definition should be designed to include all those who could reasonably be part of the outbreak. It needs to define geographical, clinical and temporal parameters. This definition may have to be modified later.
Cases can be subdivided into 'confirmed' (on appropriate microbiological criteria) and 'unconfirmed'. When an outbreak involves more than one Local Authority, it is important to ensure consistency in the case definition that is adopted for the investigation and management of the outbreak.
It may be appropriate to classify cases as:
Confirmed: Those that meet the case definition and have been confirmed by microbiological means.
Probable: Those that meet the case definition but have not been confirmed by microbiological tests.
Possible: Those that loosely meet the case definition but may need further investigation in order to link with the outbreak.
Establishment
The term "establishment" is defined in Regulation (EC) 852/2004, Article 2 as "any unit of a food business"
In the case of Allan Rich Seafoods v Lincoln Magistrates' CourtQueen's Bench Division (Administrative Court)
21 December 2009 [2009] EWHC 3391 (Admin) the term "establishment" was explored for the purposes of approval under Regulation (EC) 853/2004:
"The definition of 'establishment' was clear: it was a unit of a food business. An assessment merely of the suitability of the premises would not fulfil the food safety purpose of the European Regulations. 'Establishment' denoted both premises and the manner in which those premises were used by the food business operator. Thus, approval was required for a food business or a unit of a food business, and not merely for the premises from which the business was conducted."
Establishment subject to approval
The phrase "subject to approval" appears to include both establishments which have been approved as well as those which fall within the scope of approval but have not been approved by the relevant food authority.
Establishments subject to alternative enforcement strategies
Food Authorities must ensure that these establishments continue to be subject to official controls to investigate complaints. These establishments must, as a minimum, be subject to an intervention by the Food Authority, which may take the form of an Alternative Enforcement Strategy, not less than once every three years for food hygiene, and once every five years for food standards. It is not intended that the flexibility offered to implement Alternative Enforcement Strategies should preclude full inspection, partial inspection or audit of such establishments, where any of these are the Food Authority’s preferred intervention option.
EU Commission Guidance
Guidance published by the EU Commission is non-statutory in nature and is issued periodically to assist businesses and competent authorities in Member States to adopt a uniform approach in the implementation and enforcement of food law.
EU Commisson Guidance has been issued on topics such as: approved establishments; the implementation of HACCP systems and; imported food control and copies may be obtained from the library section.
EU Commission Guidance on HACCP
‘The seven HACCP principles are a practical model for identifying and controlling significant hazards on a permanent basis.
This implies that where that objective can be achieved by equivalent means that substitute in a simplified but effective way the seven principles, it must be considered that the obligation laid down in Article 5, paragraph 1 of Regulation (EC) No 852/2004 is fulfilled.’
‘In certain cases, in particular in food businesses where there is no preparation, manufacturing or processing of food, it may seem that all hazards can be controlled through the implementation of the prerequisite requirements.
“In these cases it can be considered that the first step of the HACCP procedure (hazard analysis) has been performed and that there is no further need to develop and implement the other HACCP principles.’
Therefore there is no obligation for low risk businesses such as grocers or market stalls which only handle packaged goods to develop and implement systems based on HACCP principles.
European Directives
Are defined in Article 249 of the EC Treaty as follows:
"A directive shall be binding, as to the result to be achieved, upon each Member State to which it is addressed, but shall leave to the national authorities the choice of form and methods."
As such, there is a degree of flexibility to allow Member States to produce national legislation to interpret and bring the requirements of EU directives into force in their own countries.
European Law
A key element is the health and safety Framework Directive (89/391/EEC), primarily implemented in Britain by the Management of Health and Safety at Work Regulations, which established broadly based obligations for employers to evaluate, avoid and reduce workplace risks.
A range of related and other directives, implemented through national regulations, cover: the management of specific workplace risks (such as musculoskeletal disorders, noise, work at height or machinery); the protection of specific groups of workers (such as new or expectant mothers, young people and temporary workers); measures to complete and maintain the single market in the EU; and the protection of the environment.
European Regulations
European Regulations
Are defined in Article 249 of the EC Treaty as:
“A regulation shall have general application. It shall be binding in its entirety and directly applicable in all Member States.”
In other words, European Regulations apply directly to members of the EU and do not require domestic legislation to bring them into force. The requirements of such regulations may not be interpreted by member states unless the regulations specifically permit the use of “national rules”.
Evaluate
The officer should not just establish the nature of the systems and prcedures that the business is using but should constantly challenge the validity of the methods and the extent of their implementation.
Evaporated milk
Evaporated milk is a concentrated, sterilised milk product. The process of producing evaporated milk involves standardising, heat treating and evaporating the milk under reduced pressure, at temperatures between 60ºC and 65ºC.
The evaporated milk is then homogenised to prevent it separating under storage and then it is cooled and placed into cans, which are then sealed. At this point the cans are moved to a steriliser where they are heated to 121°C for 10 minutes. A cooling stage follows and the cans are then labelled and packed.
Evidence
Officer’s should note that the Magistrates Court hearing with regard to the confirmation of a Hygiene Emergency Prohibition Order is a civil matter and as such any evidence gathered to produce at this hearing does not have to comply with the provisions of the Police and Criminal Evidence Act 1984. However, if the evidence is to be used in a subsequent criminal trial, PACE will apply. Questions put to the Food Business Operator for the Hygiene Emergency Prohibition Order hearing need not be under caution. However, if these questions are to be used as evidence in a criminal court then the caution must be administered.
Evidence
"Evidence" is any material relevant to proving or disproving the offence(s) that you are investigating. It will commonly consist of:
- witness statements;
- transcripts of interviews under caution (often known in HSE as "PACE interviews");
- documents;
- physical evidence (also known as `real' evidence);
- evidence of a suspect's previous character.
Evidence at Inquest
If you are called to give formal evidence, you will stand in the witness box and the Coroner will ask you to explain your professional role. You will then be expected to answer questions put to you by the Coroner regarding the issues to be determined by the inquest. The extent to which you can provide factual evidence will depend on the time when you attended the scene. You should be careful about offering opinion evidence that is outside your individual expertise.
After giving formal evidence, the Coroner will invite the legal representatives present in the court (which may include the representatives of potential defendants in any future health and safety prosecution) to put any relevant questions to you. The family and the jury will then be given an opportunity to ask questions. These are likely to be by way of clarification of the circumstances or technical issues.
Evidence of real or simulated withdrawals/recalls.
There is no legal requirement for dairy FBOs to carry out product recall simulations but it is recommended that these are undertaken periodically to ensure that the system works in practice.
This could be initiated by an officer during a routine audit of the dairy by purchasing a relevant product prior to the audit and then requesting that a "mock" recall be carried out by the business with respect to that product. In particular the officer could ask that the FBO identify:
- Where the food was purchased from
- When the food was produced
- Date of despatch
Example 1
An individual is suspected of carrying out a series of criminal damage offences at a local shop, after a dispute with the owner. It is suggested that a period of directed surveillance should be conducted against him to record his movements and activities for the purposes of preventing or detecting crime.
Although these are legitimate grounds on which directed surveillance may be
conducted, it is unlikely that the resulting interference with privacy will be proportionate in the circumstances of the particular case. In particular, the obtaining of private information on the individual’s daily routine is unlikely to be necessary or proportionate in order to
investigate the activity of concern.
Instead, other less intrusive means are likely to be available, such as overt observation of the location in question until such time as a crime may be committed.
Example 2
An individual is suspected of claiming a false address in order to abuse a school admission system operated by his local education authority.
The local authority considers it necessary to investigate the individual for the purpose of preventing or detecting crime. Although these could be legitimate grounds for seeking a directed surveillance authorisation, if the individual’s actions were capable of constituting a crime, such surveillance is unlikely to be necessary or proportionate to investigate the activity.
Instead, it is likely that other less intrusive, and overt, means (such as unscheduled visits to the address in question) could be explored to obtain the required information.
Example 3
An individual is suspected of a relatively minor offence, such as littering, leaving waste out for collection a day early, or permitting dog-fouling in a public place without clearing up afterwards.
It is suggested that covert surveillance should be conducted against her to record her movements and activities for the purposes of preventing or detecting crime, or preventing disorder. Although these could be legitimate grounds for seeking a directed surveillance authorisation, if the individual’s actions were capable of constituting an offence or disorder, strong consideration should be given to the question of proportionality in the circumstances
of this particular case and the nature of the surveillance to be conducted.
In particular, the obtaining of private information on the individual’s daily routine is unlikely to be necessary or proportionate in order to investigate the activity of concern. Instead, other less intrusive means are likely to be available, such as general observation of the location in question until such time as a crime may be committed. In addition, it is likely that such offences can be tackled using overt techniques.
Exclusion of persons
The degree of risk of spreading infection posed by infected individuals is influenced by their clinical state and their standards of hygiene. Persons with diarrhoea present a far greater risk of spreading infection than do known symptom-free excreters but even symptom-free excreters with poor or doubtful standards of personal hygiene pose a potential risk. Clinically well excreters with normal formed stools and good personal hygiene standards pose minimal risk.
All persons with diarrhoea should be advised to remain off work or school until 48 hours after clinical recovery.
Particular persons have, however, been identified who pose a special risk of spreading infection and these persons may in some circumstances be excluded from attending work or school until they clear the infecting organism.
These groups are:-
Group A: Any person of doubtful personal hygiene or with unsatisfactory toilet, hand-washing or hand drying facilities at home, work or school.
Group B: Children, who attend pre-school groups or nursery.
Group C: People whose work involves preparing or serving unwrapped foods not subjected to further heating.
Group D: Clinical and social care staff in high risk care facilities who have direct contact with highly susceptible patients or persons in whom a gastrointestinal infection would have particularly serious consequences.
Each case should be considered individually taking into account:-
- the infecting organism and its infectivity.
- the age, intellectual acumen and hygiene standard of the excreter.
- the exact nature of the work.
In England, The Public Health (Infectious Disease) Regulations 1998, which are revoked by the Health and Social Care Act 2008, allowed LAs to exclude such individuals from working with food. Under the new Health Protection (Local Authority Powers) Regulations 2010 an Authorised Officer (AO) no longer has specific powers to require the handler to discontinue or refrain from any occupation connected with food.
An AO may, instead, (under Regulation 8 of the Regulations) serve notice to request the food handler to take action (or to refrain from action) to protect public health, such as formally requesting that the handler stays off work or provide the necessary stool samples for microbiological testing.
Where an AO believes a food handler presents or could present significant harm to human health, and believes that a request is not sufficient to protect human health, Section 45G of the Public Health (Control of Disease) Act 1984 as read with the Health Protection (Part 2A Orders) Regulations 2010 provide Justice of the Peace (JP) order-making powers, so that AOs may apply for an Order to require an infected food handler to stay off work.
Exempt from approval
These Premises are exempt from approval because they are an:
Establishment (eg on a farm) handling farmed birds or rabbits or wild game, and supplying 'small quantities' of meat from them directly to either:
- 'local retail establishments' (including market stalls) or;
- to the 'final consumer'.
Exempt from approval
These premises are exempt from approval because Regulation (EC) 853/2004 does not apply to:
'Food containing both products of plant origin and processed products of animal origin',
(eg cheese sandwiches), made from a processed PoAO which enters the establishment in that processed state, (ie cheese).
Exempt from approval
These premises are exempt from approval because they are a retailer mainly supplying PoAO to the public, and supplies to other retail establishments are on a marginal and localised and restricted basis.
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Exemptions
Such exemptions include:
• Personal imports of certain POAO from specified countries (excluding Meat or Dairy products) or:
• Trade samples that have received written approval from the Secretary of State as per regulation.
Exemptions from hygiene law
‘Small quantities’ is not defined in EU legislation and it is not, therefore, possible to include a definition in our implementing regulations. Interpretation of the term is, therefore, a matter for guidance. For the purposes of considering the extent to which the provisions of Regulations 852/2004 and 853/2004 apply to raw drinking milk, the Agency suggests a small quantity should be considered to be of the order of a crate a day in total (24 pints, approximately 14 litres).
Exemptions from hygiene law
‘Small quantities’ is not defined in EU legislation and it is not, therefore, possible to include a definition in our implementing regulations. Interpretation of the term is, therefore, a matter for guidance. For the purposes of considering the extent to which the provisions of Regulations 852/2004 and 853/2004 apply to raw drinking milk, the Agency suggests a small quantity should be considered to be of the order of a crate a day in total (24 pints, approximately 14 litres).
Existence of procedures for the withdrawal/recall of products
There is no legal obligation for a dairy FBO to have a documented product recall system in place. However, Article 19 of Regulation (EC) 178/2002 does place a duty on FBOs to withdraw and/or recall products from the market and notify the competent authority where food which fails food safety requirements has left their initial control.
The objective of a food audit is to determine, as far as possible, the ability of the FBO to respond to a food safety incident in a way that satisfies the legal obligation. To this end the officer should consider:
1) Through questioning of the FBO, their understanding of the type of incident which would trigger a response in accordance with Article 19.
2) The ability of the FBO to contact the competent authority under such circumstances: does the FBO know who the competent authorities are and how to contact them?
3) The definition of "initial control" in the context of the business - consideration should be given to the nature and extent of the distribution chain. For example is a product which has been despatched to a cold store pending delivery to a customer considered by the FBO to be still within their initial control?
Experts
If a Food Authority needs to engage expertise in an area listed in Chapter I of Annex II to Regulation 882/2004, it should ensure that any expert it engages has a recognised qualification and experience in the area for which the expertise is required.
Extending Brands
If it is decided to extend a brand name into a different product sector (forexample, an established confectionery product giving its name to a dessert product or ice cream), care should be taken that the presence of any allergen not associated with the original product is clearly indicated. The approach to allergen labelling across a brand should be as consistent as possible.
Extraction Solvents in Food (Scotland) Regulations 1993
Scope
These Regulations which implement the provisions of EC Directive prohibit the sale or importation into Scotland from outside the EC of extraction solvents (other than permitted extraction solvents which are listed in Schedule I of the Regulations), or any food having in or on it any extraction solvent other than a permitted extraction solvent.
Ingredients/Products
An extraction solvent is defined as any solvent which is used or intended to be used in an extraction procedure. Examples of extraction solvents include propane, butane, ethanol, and methanol. A full list is reproduced in Schedule 1 of the regulations. The Regulations also require that certain information be given with permitted extraction solvents on sale or imported into Scotland from outside the EC.
Labelling Requirements
The labelling information required includes:
• prescribing the name of the permitted extraction solvent;
• a clear statement that the solvent is of suitable quality;
• a batch or lot number for identification purposes;
• name and address of manufacturer or packer;
• net quantity by volume;
• any special storage conditions or conditions for use.
Schedule 2 of the Regulations defines foods in which only certain extraction solvents may be used and the certain purposes for which they can be used.
Schedule 3 gives maximum permissible residue levels for named extraction solvents. The primary regulations were amended in 1993 by Extraction Solvents in Food
(Scotland) Regulations 1993 (SI No. 330).
Public Analyst Observation
Extraction solvents tend not to present many issues regarding food composition.
The solvents can be used to take caffeine out of decaffeinated coffee. Today it is more likely that high pressure carbon dioxide would be used to remove caffeine and in consequence there tends to be no residue issues.
Associated Regulations
Extraction Solvents in Food (Scotland) Regulations 1993 (SI No. 330)
Extraction Solvents in Food (Amendment) (Scotland) Regulations 1995 (SI No. 263)
Extraction Solvents in Food (Amendment ) Regulations 1998 (SI No. 2257)
EC Directive 88/344 on extraction solvents used in the production of food and food ingredients
EC Directive 97/60 on extraction solvents used in the production of food and food ingredients
Factors contributing to salmonella food-poisoning outbreaks
The following factors were found to be relevant in (%) outbreaks of Salmonella food poisoning:
Prep. too far in advance 44%
Storage: ambient temp 29%
Contaminated food 27%
Undercooking 23%
Inadequate cooling 18%
Cross-contamination 14%
Inadequate re-heating 12%
Inadequate thawing 11%
Raw food consumed 9%
Use of leftovers 5%
Extra large quantities prepared 3%
Improper warm holding 2%
Infected food handlers 2%
Contaminated canned food <1%
Factory Trials and Consumer Testing
If conducting factory trials of allergen-containing products, measures should be taken to avoid allergen cross-contamination with existing products. Information on the presence, or potential presence, of allergens should be made available to those involved in factory trials and in taste testing and that information should be clearly conveyed with products presented for wider test and marketing purposes. However clearly they are labelled, care should be taken if sample products containing the major food allergens are distributed or offered where they can be taken by unsupervised children (for example through letterboxes, in stores or other public places).
Factual report for Coroner
The report should include a list of the witnesses who might be able to give factual evidence directly relevant to the death and a summary of the significant points of the witness statements you have taken. This will assist the Coroner in deciding the ambit of his/her inquiry and which witnesses to call.
In some cases, the factual report might be sufficient for the Coroner. However, the Coroner might prefer to see copies of some or all of the investigatory material so as to determine what is relevant for the purposes of the inquest. Where there is a substantial amount of material, it may not be cost effective to provide copies. It has been explained to the Coroners’ Society that, in such cases, the Coroner and/or the Coroner’s Officer will be invited to attend HSE’s premises to view the material. The Coroner should already be aware from the MoU and/or your communications with him/her that your investigation will be ongoing and will not be concluded until after the inquest. HSE will generally provide copies of statements rather than the originals.
Fail food safety requirements
Food is deemed to fail the food safety requirements if it is unsafe within the meaning of article 14 of Regulation (EC) 178/2002. The offence for placing unsafe food on the market is created by regulation 4(b) of the General Food Regulations 2004 (as amended).
Fairness
Article 76(1) of the PACE (NI) Order 1989 states:
"In any proceedings a court may refuse to allow evidence on which the prosecution proposes to rely if it appears to the court that, having regard to all the circumstances, including the circumstances in which the evidence was obtained, the admission of the evidence would have such an adverse effect on the proceedings that the court ought not to admit it."
Familiarisation tour
It is a good idea to undertake a quick walk through the process at an early stage of an audit preferably using the dairy's HACCP process flow diagram as a guide. The aims of this familiarisation tour are to:
- Verify the accuracy of the process flow diagram
- Help define the scope of the audit. The tour might identify new pieces of equipment or poor handling practices which may warrant further investigation.
- Verify the accuracy of the approval documentation and any plans provided by the dairy.
This should be a relatively quick stroll around the dairy facilities and it is recommended that photographs are taken of key pieces of equipment etc. These should be retained on the file an referred to during the familiarisation tours of subsequent audits.
FBO Obligations 852
Chapter II of Regulation (EC) 852/2004 places some key obligations on Food Business Operators. In summary these are:
Article 3: Food business operators shall ensure that all stages of production, processing and distribution of food under their control satisfy the relevant hygiene requirements laid down in this Regulation.
Article 4: Food business operators who are involved in primary production (hunting, farming, fishing etc) should comply with the rules of hygiene in Annex 1 to the Regulations and any additional requirements as specified in Regulation (EC) 853/2004. Other FBOs should comply with Annex II and any additional requirements specified in 853.
Food business operators are also required to, as appropriate, adopt the following
specific hygiene measures:
(a) compliance with microbiological criteria for foodstuffs;
(b) procedures necessary to meet targets set to achieve the objectives of this Regulation;
(c) compliance with temperature control requirements for foodstuffs;
(d) maintenance of the cold chain;
(e) sampling and analysis.
Article 5: Food business operators shall put in place, implement and maintain a permanent procedure or procedures based on the HACCP principles.
Article 6: Requires that food businesses are registered or approved with the competent authority.
Files
Copies of the following documents should be retained by the food authority with respect to dairy establishments:
The approval application form
Plans of the establishment
Synopsis
Pre-approval inspection report;
Planned programme of works to achieve approval;
Approval notification document
Copies of labels
letter indicating the Food Authority’s involvement in the planning and implementation of the establishment’s hygiene training of staff;
Inspection reports on premises and correspondence with establishment in chronological order;
Copies of notices or other formal action taken in chronological order;
Copy of company’s emergency withdrawal plan
Copy of any other documents
Results of all samples taken by the Food Authority;
Location of any off-site facilities
Further details are available in our Approved Establishments online course
Final consumer
‘final consumer’ means the ultimate consumer of a foodstuff who will not use the food as part of any food business operation or activity.
This definition will include persons who buy food on behalf of their friends and family.
Final rinse
The use of final rinses in a CIP cycle are not always necessary depending on the nature of the detergents used to clean the equipment.
Where final rinses are used they may comprise:
- Fresh potable water. Checks should be carried out to ensure that the water is indeed potable and adequate steps are taken to prevent contamination. For example officers should verify the source of such water in case it has been extracted from boreholes, stored or reclaimed. If this is the case, the officer should check the management arrangements to ensure the potability of the water.
- chlorinated water. Officers should check that the chlorine levels in the water have been appropriately calculated and are regularly monitored at the point of use to ensure that the desired chlorine contentrations are maintained.
- Terminal sterilant. The use of terminal sterilants such as peracid are common practice in the dairy industry and can be a very effective method of achieving adequate equipment sanitation. Peracid (peracetic acid) has a strong "vinegar" odour when first used but denatures to water over time. Terminal sterilants are applied at the end of the cleaning cycle and left in the equipment until it is ready for use.
First destination
These may include establishments used for storage, processing, and/or handling, buying or selling POAO or FNAO. Where the establishment is receiving POAO directly from a port, Common Veterinary Entry Documents (CVEDs) should be available for each consignment.
Where FNAO which are subject to the “High Risk” import controls as specified in Regulation (EC) No 669/2009 and Regulation (EC) No 1152/2009 are found at a first destination inland a Common Entry Document (CED) should be present.
Fishery products
Fishery Products
The definition of fishery products in Annex 1, Regulation (EC) 853/2002 includes all seawater or freshwater animals whether wild or farmed and including all edible parts of such animals, but does not include live shellfish, reptiles frogs and aquatic mammals.
Fishery products
Under Regulation (EC) No 853/2004 on hygiene rules for food of animal origin and, where applicable, EU Decisions that apply for specific third countries, fishery products/bivalve molluscs must have:
• Country of origin marked on the packaging.
• Establishment EU Approval Number. The establishment number is usually a simple printed number generally with an ‘EU Est.’ prefix, but this may not be present. The establishment number can sometimes be found embossed on canned goods, ink printed on glass or just incorporated on the label. Some goods carry two sets of establishment numbers, the second one pertaining to domestic rules in the third country and should be ignored.
If the number is not immediately apparent have a close look. The Agency website contains information on the appropriate marking of fishery products, under the section titled ‘Imports from other EU Member States at: (http://www.food.gov.uk/foodindustry/imports/want_to_import/fisheryproducts/)
Further guidance regarding the marking of fishery products has been produced by APHA and may be accessed via the library section of the imported food training website http://www.importedfood.co.uk/library/enforcement-guidance/ (Under ‘POAO’ section)
Fishery Products Chapter I and II
Chapter I sets out the Structural, equipment and hygienic conditions for fishing vessels including freezer vessels and factory vessels.
Chapter II lays down rules for handling fishery products during and after landing. These include:
1. Food business operators responsible for the unloading and landing of fishery products must:
(a) ensure that unloading and landing equipment that comes into contact with fishery products is constructed of material that is easy to clean and disinfect and maintained in a good state of repair and cleanliness; and
(b) avoid contamination of fishery products during unloading and landing, in particular by:
(i) carrying out unloading and landing operations rapidly;
(ii) placing fishery products without delay in a protected environment at the temperature specified in Chapter VII; and
(iii) not using equipment and practices that cause unnecessary damage to the edible parts of the fishery products.
2. Food business operators responsible for auction and wholesale markets or parts thereof where fishery products are displayed for sale must ensure compliance with the following requirements.
(a) (i) There must be lockable facilities for the refrigerated storage of detained fishery products and separate lockable facilities for the storage of fishery products declared unfit for human consumption.
(ii) If the competent authority so requires, there must be an adequately equipped lockable facility or, where needed, room for the exclusive use of the competent authority.
(b) At the time of display or storage of fishery products:
(i) the premises must not be used for other purposes;
(ii) vehicles emitting exhaust fumes likely to impair the quality of fishery products must not have access to the premises;
(iii) persons having access to the premises must not introduce other animals; and
(iv) the premises must be well lit to facilitate official controls.
3. When chilling was not possible on board the vessel, fresh fishery products, other than those kept alive, must undergo chilling as soon as possible after landing and be stored at a temperature approaching that of melting ice.
4. Food business operators must cooperate with relevant competent authorities so as to permit them to carry out official controls in accordance with Regulation (EC) No 854/2004, in particular as regards any notification procedures for the landing of fishery products that the competent authority of the Member State the flag of which the vessel is flying or the competent authority of the Member State where the fishery products are landed might consider necessary.
Fitness to work
There used to be a requirement for staff working in approved establishments to obtain medical certification to demonstrate their suitability to handle food. This requirement was removed in 2006 and as such the general requirement specified in Regulation (EC) 852/2004, Annex II, Chapter VIII will apply:
"No person suffering from, or being a carrier of a disease likely to be transmitted through food or afflicted, for example, with infected wounds, skin infections, sores or diarrhoea is to be permitted to handle food or enter any food-handling area in any capacity if there is any likelihood of direct or indirect contamination. Any person so affected and employed in a food business and who is likely to come into contact with food is to report immediately the illness or symptoms, and if possible their causes, to the food business operator."
Fixing the order on the premises
The officer should remove the Hygiene Emergency Prohibition Notice displayed at the premises and replace it with the Hygiene Emergency Prohibition Order in such a position that it can be seen and read by members of the public. Periodic checks must be made to ensure that the document is in place and has not been removed or defaced.
Flavouring
‘Flavouring’ means an additive consisting of a material used or intended for use in or on food to impart odour, taste or both, provided that such material does not consist entirely of:
(a) any edible substance (including herbs and spices) or product, intended for human consumption as such, with or without reconstitution, or
(b) any substance which has exclusively a sweet, sour or salt taste, and the components of which include at least one of the following—
(i) a flavouring substance,
(ii) a flavouring preparation,
(iii) a process flavouring,
(iv) a smoke flavouring;
‘Flavouring preparation’ means a product (other than a flavouring substance), whether concentrated or not, with flavouring properties, which is obtained by physical, enzymatic or microbiological processes from appropriate material of vegetable or animal origin;
‘flavouring substance’ means a chemical substance with flavouring properties the chemical structure of which has been established by methods normally used among scientists and which is—
(a) obtained by physical, enzymatic or microbiological processes from appropriate material of vegetable or animal origin,
(b) either obtained by chemical synthesis or isolated by chemical processes and which is chemically identical to a substance naturally present in appropriate material of vegetable or animal origin, or
(c) obtained by chemical synthesis but not included under sub-paragraph (b) of this definition,
and for the purposes of this definition and the definition of ‘flavouring preparation’—
(i) distillation and solvent extraction shall be regarded as included among types of physical process;
(ii) material of vegetable or animal origin is appropriate material of vegetable or animal origin if it either is raw or has been subjected to a process normally used in preparing food for human consumption and to no process other than one normally so used; and
(iii) drying, torrefaction and fermentation shall be treated as included among the types of process normally so used to which sub-paragraph (ii) above refers
Flavourings in Food (Scotland) Regulations 2010
Scope
These regulations implement EC Regulation 1334/2008 of the European Parliament and of the Council on flavourings and certain food ingredients with flavouring properties for use in and on foods and amending Council Regulation EEC 1601/91, Regulations EC 2232/96, EC 110/2008 and Directive 2000/13/EC(1)
Ingredients/Products
Flavouring is defined in the EU Regulation as ‘material used or intended for use in or on food to impart odour, taste or both’. The regulations also define ‘relevant flavourings’ which include flavouring substances, flavouring preparations, process flavouring, thermal process flavourings, flavour precursors and smoke flavouring.
Only permitted flavourings may be used in food. To be regarded as a permitted flavouring the relevant flavouring must comply with the specified purity criteria (Schedule 1): In general permitted flavouring should contain
• No element in a toxicologically dangerous quantity.
• No more than 3mg/kg of arsenic.
• No more than 10mg/kg of lead.
• No more than 1mg/kg of cadmium.
• No more than 1 mg/kg of mercury.
The Regulations prohibit the sale of food containing relevant flavourings resulting in certain substances in the food exceeding specified limits. These substances and the limits are listed in Schedule 2.
Regulation 3 prohibits the sale and advertisement for sale, for use as an ingredient in the preparation of food, of any relevant flavouring other than a permitted one. In addition the word ‘natural’ and similar expressions must not be used in a business sale to describe a relevant flavouring unless the relevant flavouring meets specific requirements.
Labelling Requirements
Regulation 4 and Schedule 3 prescribe labelling requirements for Business sales and Consumer sales. The requirements are as follows:
Business sale (Sale other than to the ultimate consumer)
• The name and address of the manufacturer, packer or seller within the EC.
• The word ‘Flavouring’ or more specific name or description.
• Either the words ‘for foodstuffs’’ or a more specific reference to the intended food.
Trade documents to contain the following information:
• A list in descending order of weight of the ingredient components using the following classifications:
- Natural flavouring substance.
- Flavouring substance identical to natural substances.
- Artificial flavouring substances.
- Flavouring preparations.
- Process flavourings.
- Smoke flavourings.
• Name and or E number of other substances where appropriate
Consumer sale (Sale to the ultimate consumer)
• The name and address of the manufacturer, packer or seller within the EC.
• The word ‘Flavouring’ or more specific names or descriptions.
• Indication of minimum durability.
• Special storage conditions or conditions of use.
• Instructions for use if omission would prevent appropriate use of the flavouring.
• A list setting out in descending order of weight components of the flavouring and where appropriate its E number.
Flow control
The flow control valve regulates the flow of the raw milk into the pasteuriser. If a centrifugal pump is fitted, the flow control unit is essential to ensure that the required duration of heat treatment is met.
Food Additives (Scotland) Regulations 2009
Scope
These regulations give effect to Regulation (EC) No. 1333 / 2008 on food additives, which replaces previous directives and decisions concerning food additives permitted for use in food. The regulation ensures efficient functioning of the internal market and a high level of protection of human health including protection of consumer interests.
The regulation continues to harmonise the use of food additives in foods in the community, including the use of additives in PARNUTS and the use of certain food colours for the health marking of meat and the decoration and stamping of eggs. The rules also cover the use of additives in food additives and food enzymes and carriers in nutrients. The regulations also deals with the purity of additives used in food. The purity criteria set out in Commission Directives 2008/60/EC (sweeteners),
2008/84/EC (miscellaneous additives) and 2008/128/EC (colours) will continue to apply.
Regulation 1333/2008 will be required, from 20 July 2010, the labelling of the six “Southampton” colours with a warning that they may have an adverse effect on activity and attention in children.
The Food Additives (Scotland) Regulations 2009 also re-enact, on a temporary basis, the Annexes to Directives 95/2/EC, 94/35 and 94/36. The provisions in these Annexes will continue to apply until they are transferred, in the form of a consolidated list of foods in which additives can be used, into Annex II of Regulation
1333/2008. This process must be completed by June 2011.
Ingredients / Products
The regulations apply to all food additives but do not apply to the following substances processing aids
• Substances used for the protection of plant and plant products
• Substances added to foods as nutrients
• Substances used for the treatment of water for human consumption
• Flavouring coming under Regulation(EC) No. 1334/2008
• Food enzymes coming under Regulation (EC) No. 1332/2008
A food additive is defined as
“...any substance, whether or not it has nutritive value, that is not normally consumed as a food in itself or used as a characteristic ingredient of food, and which, if added intentionally for a technological purpose to food in its manufacture, processing, preparation, treatment, packaging, transport or storage, results or may reasonably
be expected to result, in the substance or its by-products becoming directly a component of the food concerned...”
The definition does not include:
• Substances used for the treatment of drinking water
• Products containing pectin from dried apple pomace or citrus peel or a mixture of both, treated with dilute acid and part neutralised with sodium or potassium salt
• Chewing gum bases
• White or yellow dextrin, roasted or dextrinated starch, starch modified by acid or alcohol, bleached starch, physically modified starch and starch treated by amylolytic enzymes.
• Ammonium chloride
• Blood plasma, edible gelatine, protein hydrolysates and their salts, milk protein and gluten.
• Amino acids and their salts other than glumatic acid,glyciene, cysteine and cystine and their salts and having no additive function.
• Caseinates and casein and
• Inulin
The regulations also include colour which is defined in EC Directive 94 / 36, an additive whose primary purpose is adding or restoring colour in a food. This includes:
a) Any natural constituent of food and any natural source not normally consumed as food and not normally used as a characteristic ingredient of food and
b) Any preparation of pigment that has been selectively extracted from food or other natural sources
Colours may only be used to:
• Restore the original appearance of food where colour has been affected by processing, storage etc
• Giving colour to food otherwise colourless
• Making food more visually appealing
Sweeteners are also covered by the regulations and are defined as any food additive which is used or intended to be used to
• Impart a sweet taste to food or in a table-top sweetener
The Food Additive (Scotland) Regulations 2009 are enforced by Local Authorites. The regulations implement the EC Regulation and also introduce powers to enforce the rules including provisions relating to seizure and condemnation. The principal provisions are
• Use of Colours in or on food (Regulation. 3)
• Health marking of meat and meat products (Regulation 4)
• Use of colour on eggshells (Regulation 5)
• Sale of colour and food containing colours (Regulation 6)
• Use of miscellaneous additives (Regulation 8)
• Sale of food additives and food containing miscellaneous additives (Regulation
9)
• Placing on the market and the use of sweeteners (Regulation 11)
• Sale of food containing sweeteners (Regulation 12)
• Condemnation of food (Regulation 17)
Use of colours in or on food (Regulation 3)
Only a permitted colour may be used in or on food. Permitted colours are listed in Annex II to Directive 94/36. Foods to which colours may be added are specified in Annex III directive 94/36 (Foodstuffs to which only certain permitted colours may be added) along with the maxim permitted levels.
Annex IV dealing with colours permitted for certain uses only indicates the maximum levels of particular colours in food.
There are 18 permitted colours that can be used to a maximum level as specified for specific food categories. These are identified in the table in Part 2 of Annex V colours in permitted foodstuffs other than those mentioned in Annex II or III.
Health Marking of certain meat and meat products. (Regulation 4)
The regulation requires that only the following colours may be used for health marking:
(a) E155 Brown HT
(b) E133 Brilliant Blue FCF (c) E129 Allura Red AC or
An appropriate mixture of (b) and (c) above.
Use of colours on Egg Shells (Regulation 5)
Only permitted colours can be used for decorative colouring of egg shells or marking of egg shells (as stipulated in Regulation (EC) No. 1234 / 2007)
Sale of colours and food containing colours (Regulation 6)
Only permitted colours may be sold or used in or on food.
Only specified permitted colours may be sold directly to a consumer: Specified permitted colours are any permitted colours except:
• E123 Amaranth
• E127 Erythrosine
• E128 Red 2G6
• E154 Brown FK
• E160b Annatto, Bixin, Norbixin
• E161g Canthaxanthin
• E173 Aluminium and
• E180 Litholrubine BK
Use of miscellaneous additives (Regulation 8)
Only permitted miscellaneous additives can be used in or on food; and these are set out in Annex 1 of Directive 95/2. Foodstuffs in which a limited number of additives may be used are set out in Annex II
Foods which should not contain a miscellaneous additive as specified in Article 2a of
Directive 95/2 include:
• Unprocessed foodstuffs
• Honey (See EC Directive 2001/110)
• Non-emulsified oils and fats of animal or vegetable origin
• Butter
• Pasteurised and sterilized (including UHT) milk (including plain, skimmed and semi-skimmed) and plain pasteurised cream
• Unflavoured, live fermented milk products
6 Commission Regulations (EC) No. 884/2007 suspended the marketing and import of food containing E128 (Red 2G) in July 2007, this was subsequently enforced by all EU member States including the UK. Although 94/36/EC was not amended to remove E128 from the list of permitted colours, Commission
• Natural mineral water and spring water
• Coffee(excluding flavoured instant coffee) and coffee extracts
• Unflavoured leaf tea
• Sugars
• Dry pasta, excluding gluten free and/or pasta intended for hypoproteic diets.
• Natural unflavoured buttermilk (excluding sterilized buttermilk)
Where there is no limit indicated in the Annex to the Directive 95/2 the term “Quantum satis” is used, meaning that the additive must be used in accordance with good manufacturing practice at a level that is not higher than is necessary to achieve the intended purpose and provided that such use does not mislead the consumer.
Conditionally permitted preservatives and antioxidants are listed in Annex III and other permitted additives as set out in Annex IV.
Annex V lists the permitted carriers and carrier solvents, their E-Number and restrictions on use.
Annex VI lists the additives permitted in foods for infants and young children.
Sale of food additives and foods containing miscellaneous additives
(Regulation 9)
A person cannot sell any miscellaneous additive for use in or on food unless it is a permitted miscellaneous additive, nor is it permissible to sell any miscellaneous additive for use primarily as a carrier or carrier solvent earlier listed in Annex V to Directive 95/2.
A person cannot test sell direct to a consumer any miscellaneous additive that is not permitted.
A person cannot sell any food having in or on it any miscellaneous additive unless it is permitted, nor sell any relevant food additive in combination with a miscellaneous additive which has been used primarily as a carrier or carrier solvent.
Placing on the market and use of sweeteners (Regulation 11)
Only permitted sweeteners may be placed on the market for sale to the ultimate consumer or for use in or on food. (A list of permitted sweeteners, the foods they are permitted in, and maximum usable doses are listed in the Annex to EC Directive
94/35.
Sale of Food containing sweeteners (Regulation 12)
A person must not sell any food having in or on it any sweetener other than a permitted sweetener.
Condemnation of Food (Regulation 17)
Where the Public Analyst certifies food as contravening these regulations that food may be treated for the purposes of Article 8 of the Food Safety (Scotland) Act 1990 (under which the food may be seized and destroyed under an order of the justice of the peace) as failing to comply with the food safety requirement.
Public Analyst Observations.
1. Sweeteners: In general limits are being complied with but labelling issues can arise where food business operators fail to indicate it in the name of the food when being used as an ingredient. Officers who are inspecting premises that utilise sweeteners should take this into account when undertaking inspections. Officers need to consider use of sweeteners in foods which also contain sugars e.g. soft drinks.
2. Miscellaneous Additives: Issues can include
a) Carry-over of ascorbic acid preservative in bakery products not declared b) 100% steak burgers containing sulphur dioxide
c) Revised (lower) limits for nitrate/nitrite preservative in cured meat and meat products were introduced prior to these Regulations coming into force. Higher maximum limits are still applicable if certain defined “traditional” curing processes have been used. For this reason it is important for sampling
officers to record and transmit to the lab details of the process used whenever possible (i.e. sampling in factory, this would likely be impossible when sampling from retail premises).
3. Colours: Note that Annex V to 1333/2008 introduces the additional labelling provisions which will become applicable to foods containing the colours identified in the “Southampton” study and which are listed in that Annex.
There can be labelling issues for trade sales and trade documents. Officers may wish to pay particular attention to delivery ingredients held in the dry goods stores of food premises such as bakeries, butchers and other food processing factories.
Associated Regulations
Food Additives (Scotland) Regulations 2009 SSI No. 436
Regulation EC 1333/2008
Regulation EC 1234/2007
Regulation EC 884/2007
EC Directive 94/36
EC Directive 95/2
EC Directive 94/35
Directive 74/409/EEC
Food adulteration
An interesting insight into the occurrence of food adulteration in the 1800s is provided by Monier-Williams (1951) in his account of the work of Dr Hassall, the Director of the newly created Analytical Commission in 1851. He was the first to use microscopy techniques to determine the adulteration of coffee with chicory which subsequently led to the first regulatory standards being set.
Food alert documented procedure
This documented procedure should be developed in consultation with:
• Members of the relevant Food Liaison Group;
• HPS;
• Public Analyst;
• CPHM (EH/CD);
• Relevant officers of the Food Authority, e.g. Emergency Planning Officer.
The documented procedure must include, as a minimum, the following:
• Details, including contact details, of the Lead Officer for such matters;
• Any arrangements for the reception of and response to Alerts received outside office hours;
• Arrangements to ensure that Food Alerts and updates are brought to the attention of an officer with authority to initiate appropriate action without undue delay;
• Arrangements for the liaison with other relevant bodies, including neighbouring Food Authorities, both within and outside normal office hours;
• Arrangements to provide adequate staff resources to allow effective response to
alerts; and
• Arrangements to provide adequate equipment, including access to Council Offices out of hours, to allow an effective response to be made.
Food alerts procedure
This documented procedure should be developed in consultation with:
• Members of the relevant Food Liaison Group;
• HPA;
• Public Analyst;
• CCDC; and
• relevant officers of the Food Authority, e.g. Emergency Planning Officer.
The documented procedure must include, as a minimum, the following:
• details, including contact details, of the Lead Officer for such matters;
• liaison arrangements between County Council and District Council officers in two tier
Food Authority areas;
• any arrangements for the reception of and response to Alerts received outside
office hours;
• arrangements to ensure that Food Alerts and updates are brought to the attention
of an officer with authority to initiate appropriate action without undue delay;
• arrangements for the liaison with other relevant bodies, including neighbouring
Food Authorities, both within and outside normal office hours;
• arrangements to provide adequate staff resources to allow effective response to
alerts; and
• arrangements to provide adequate equipment, including access to Council
Offices out of hours, to allow an effective response to be made.
Food Allergens
The food allergens specified in law are:
1. Cereals containing gluten (i.e. wheat, rye, barley, oats, spelt, kamut or their hybridised strains), except:
(a) wheat-based glucose syrups including dextrose
(b) wheat-based maltodextrins
(c) glucose syrups based on barley
(d) cereals used for making distillates or ethyl alcohol of agricultural origin for spirit drinks and other alcoholic beverages.
2. Crustaceans.
3. Eggs.*
4. Fish, except:
(a) fish gelatine used as a carrier for vitamin or carotenoid preparations
(b) fish gelatine or isinglass used as a fining agent in beer and wine.
5. Peanuts.
6. Soybeans, except:
(a) fully refined soybean oil and fat
(b) natural mixed tocopherols (E306), natural D-alpha tocopherol, natural D-alpha tocopherol acetate, natural D-alpha tocopherol succinate from soybean sources
(c) vegetable oils derived from phytosterols and phytosterol esters from soybean sources
(d) plant stanol ester produced from vegetable oil sterols from soybean sources.
7. Milk* (including lactose), except:
(a) whey used for making distillates or ethyl alcohol of agricultural origin for spirit drinks and other alcoholic beverages
(b) lactitol.
8. Nuts, i.e. almonds (Amygdalus communis L.), hazelnuts (Corylus avellana), walnuts (Juglans regia), cashews (Anacardium occidentale), pecan nuts (Carya illinoiesis (Wangenh.) K.Koch), Brazil nuts (Bertholletia excelsa), pistachio nuts (Pistacia vera), macadamia nuts and Queensland nuts (Macadamia ternifolia), except:
nuts used for making distillates or ethyl alcohol of agricultural origin for spirit drinks and other alcoholic beverages.
9. Celery.
10. Mustard.
11. Sesame seeds.
12. Sulphur dioxide and sulphites at concentrations of more than 10 mg/kg or 10 mg/litre expressed as SO2.
13. Lupin.
14. Molluscs.
* There is a temporary exemption from labelling egg-derived lysozyme and for albumin (produced from egg) or milk (casein) products when used as fining agents in wine, in respect of wines that are marked, labelled or sold before 31 December 2010.
Food Authority
The food authority is the body responsible for the enforcement of food law within its area.
In Northern Ireland this responsibility falls, in most cases, to district councils but in the case of approved slaughterhouses, meat cutting plants and game handling establishments the Food Standards Agency is the relevant enforcement authority but the work is carried out on thier behalf by DARD.
Food authority
The food authority is the body responsible for the enforcement of food law within its area.
This responsibility falls, in most cases, to Local Authorities but in the case of approved slaughterhouses, meat cutting plants and game handling establishments the Food Standards Agency is the relevant enforcement authority.
Food Business Operator
The term "Food Business Operator" is defined in Article 2 of EU Regulation 178/2002 as:
“the natural or legal persons responsible for ensuring that the requirements of food law are met within the food business under their control”
Food contaminants
Using this provision Dr Hassall undertook a study of some 3000 samples which found that approximately 65% of foods were contaminated in some way and that food contaminants could be placed into three main classes: Contaminants which were not harmful but their addition to food was deceptive in nature, for example, chicory in coffee and water in milk; contaminants that were undesirable and foreign in nature such as bone fragments, straw and fibres and; dangerous contaminants such as lead, arsenic and mercury.
This work led to calls from analytical scientists for the law to be strengthened together with a growing realisation from the food industry that adulteration was having a negative effect on consumer perception of food and hence trade. There were also concerns that the lack of appropriate quality and purity standards would encourage unfair trading and competition practices. As such, in 1872 the Adulteration of Food & Drugs Act was passed.
Food Establishment Database
The database should include a comprehensive record of:
• food business establishments registered with the authority;
• food business establishments that are the decision-making base of businesses for which the Food Authority acts as Home Authority for food matters; and
• food business establishments which have been approved by the Food Authority.
Food failing food safety requirements
Food shall be deemed to be unsafe if it is considered to be:
- Injurious to health
- Unfit for human consumption
In determining whether food is unfit for human consumption the officer shall have regard to whether the food is unacceptable in accordance to its intended use, for reasons of contamination whether by extraneous matter or otherwise or through putrification deterioration or decay.
In determining whether food is injurious to health the authorised officer shall have regard to the probable immediate and/or long term and/or short term effects.
- Probable cumulative toxic affects
- Particular health sensitivity of specific categories of consumers where food is intended for that category of consumers.
In determining whether any food is unsafe the authorised officer must have regard to:
- The normal conditions of use of the food by the consumer and at each stage of production, processing and distribution.
- The information provided to the consumer including information on the label or any other information that is generally available to the consumer concerning the avoidance of adverse health affects from a particular food or category of food.
Food failing to meet food safety requirements
If officers are satisfied that the product fails to meet food safety requirements i.e. is unsafe (as described in Article 14 of Regulation (EC) No. 178/2002), the product may be seized under Section 9 of the Food Safety Act 1990, as amended by the General Food Regulations 2004 and dealt with accordingly.
Food fails food safety requirements
Food fails food safety requirements if:
It is considered to be "unsafe" in accordance with the definition in Article 14 of Regulation (EC) 178/2002 or;
An authorised officer has certified that the food fails food safety requirements by means of Regulation 27 of the Food hygiene (England) Regulations 2006 or:
The food fails a specific requirement, for example it contains a non-permitted colour or a specified contaminant and a Public Analyst has certified that the food fails food safety requirements as a consequence.
Food for Particular Nutritional Uses (Addition of Substances for
Scope
These regulations implement Commission Regulation (EC) No. 953/2009, which consolidate and repeal Commission Directive 2001/15/EC on substances that may be added for specific nutritional purposes in food for particular nutritional uses.
A number of nutritional substances such as vitamins, minerals, amino acids and others may be added to foods for particular nutritional uses in order to ensure that the particular nutritional requirements of the persons for whom they are intended are fulfilled and also conform to requirements of EC Directive 2009/39/EC.
New substances have been evaluated by EFSA and as such the list has been updated. In addition specifications are introduced for some vitamins and minerals for their identification.
A food for a particular nutritional use (a 'parnuts') is a food which, owing to its special composition or process of manufacture, is clearly distinguishable from food intended for normal consumption, and is sold in such a way as to indicate its suitability for its claimed nutritional purpose.
A particular nutritional use means the fulfilment of the particular nutritional requirements of certain categories of persons
a) whose digestive processes or metabolism are disturbed or
b) whose physiological condition renders them able to obtain special benefit from controlled consumption of certain substances in foodstuffs or
c) of infants or children in good health.
The regulations do not apply to infant formula, follow on formula, processed cereal based foods and baby foods for infants and young children as nutritional aspects for these foods are covered by Commission Directive 2006/141/EC, Directive
1999/21/EC and Commission Directive 2006/125/EC.
Ingredients/Products
The range of foods for particular nutritional uses is very wide and diversified. The widest possible choice of substances that can be safely used in the manufacture of foods for particular nutritional uses should be available for the categories of nutritional substance listed.
Offences: Regulation 3
It is an offence for a person to fail to comply with the specified provisions which are detailed in the Schedule to the regulation.
Specified provisions
1. Article 2(1) Eligible substances: Only the substances listed in the Annex to the Commission Regulation (EC) No. 953/2009 complying with the relevant specifications as necessary may be added for specific nutritional purposes for Parnuts as covered by Directive 2009/39.
2. Article 3(1) General Requirements: The use of substances added for specific nutritional purposes must result in safe food that fulfil the particular nutritional requirements as established by generally accepted scientific data.
3. Article 3(2): General Requirements: Upon request by the competent authority FSA Scotland a manufacturer or as appropriate an importer must produce the scientific work and the data establishing that the use of the substances complies with Article 3(1) of Commission Regulation (EC) No. 953/2009. (The information may be readily available through a publication in which case a reference to the publication will suffice.
4. Article 4(2): Specific requirements for substances listed in the Annex to Commission Regulation (EC) No. 953/2009: Purity criteria which apply to the substances listed when they are used in the manufacture of foodstuffs for purposes other than those covered by the Commission Regulation shall also apply to those substances
5. Article 4(3) Specific requirements for substances listed in the Annex to Commission Regulation (EC) No. 953/2009: In respect of substances listed for which there is no established purity criteria generally accepted purity criteria recommended by international bodies must apply.
Public Analyst Observations
There are no major issues identified with these regulations. Officers may want to check that the label correctly reflects the nutritional criteria. Special precautions may be required if samples are taken and submitted for checks on vitamin(s) content; please seek advice before sampling.
Associated Regulations
Food for Particular Nutritional Uses (Addition of Substances for Specific Nutritional
Purposes) (Scotland) Regulations 2009 SSI No. 427
Further Information
Commission Directive 2006/141/EC
Directive 1999/21/EC
Commission Directive 2006/125/EC
EC Directive 2009/39/EC
Commission Directive 2001/15/EC
Food hazard assessment
The assessment should include the following:
• the nature of the hazard;
• the toxicity of the contaminant, the allergenicity of an undeclared ingredient/constituent, or the virulence and pathogenicity of the organism;
• the type of injury which might be caused by a physical contaminant;
• the population likely to be affected and its vulnerability;
• the likely quantity and distribution of the food in the food chain up to the point of consumption;
• the ability and willingness of the producer or distributor to implement an effective withdrawal of the product;
• the ability to identify accurately the affected batch(es) or lot(s);
• the accuracy and extent of records held by the producer or distributor;
• the likely effectiveness of any trade withdrawal at all stages of the food chain;
• the stage(s) at which the fault is likely to have occurred (for example in processing, packaging, handling, storage or distribution) and its likely significance to the problem;
• whether other products produced in the same establishment may have been affected;
• whether the food has been imported;
• whether any of the food has been exported;
• whether there are wider implications for others in the same industry or for establishments using similar processes in other food industries; and
• the possibility that the complaint or problem has been caused by a malicious act (see Section 1.7.5).
When a Food Authority becomes aware of a food hazard it should take action to protect public health and safety at the earliest opportunity, including, if necessary, detaining or seizing the food concerned if it is located within the Food Authority’s
area (see Chapter 3.4). Food Authorities should also consider the use of other powers under the Food
Hygiene (England) Regulations 2006 or the Food Safety Act 1990 as appropriate, relevant to the circumstances involved.
Food hazard assessment
The assessment should include the following:
• the nature of the hazard;
• the toxicity of the contaminant, the allergenicity of an undeclared ingredient/constituent, or the virulence and pathogenicity of the organism;
• the type of injury which might be caused by a physical contaminant;
• the population likely to be affected and its vulnerability;
• the likely quantity and distribution of the food in the food chain up to the point of consumption;
• the ability and willingness of the producer or distributor to implement an effective withdrawal of the product;
• the ability to identify accurately the affected batch(es) or lot(s);
• the accuracy and extent of records held by the producer or distributor;
• the likely effectiveness of any trade withdrawal at all stages of the food chain;
• the stage(s) at which the fault is likely to have occurred (for example in processing, packaging, handling, storage or distribution) and its likely significance to the problem;
• whether other products produced in the same establishment may have been affected;
• whether the food has been imported;
• whether any of the food has been exported;
• whether there are wider implications for others in the same industry or for establishments using similar processes in other food industries; and
• the possibility that the complaint or problem has been caused by a malicious act (see Section 1.7.5).
When a Food Authority becomes aware of a food hazard it should take action to protect public health and safety at the earliest opportunity, including, if necessary, detaining or seizing the food concerned if it is located within the Food Authority’s area (see Chapter 3.4). Food Authorities should also consider the use of other powers under the Food Hygiene (Wales) Regulations 2006 or the Food Safety Act 1990 as appropriate, relevant to the circumstances involved.
Food hygiene
Regulation (EC) 852/2004, Article 2 defines "food hygiene" as:
"the measures and conditions necessary to control hazards and to ensure fitness for human consumption of a foodstuff taking into account its intended use"
Food Hygiene (England) Regulations 2006
The Food Hygiene (England) Regulations 2006 (as amended) provide the enforcement arrangements for the obligations placed on FBOs by the Community Hygiene Regulations: Regulation (EC) 852/2004; Regulation (EC) 853/2004 and Regulation (EC) 2073/2005.
The Regulations were also amended to permit the use of hygiene enforcement sanctions to remedy breaches of general food law contained in Regulation (EC) 178/2002.
The Food Hygiene (England) Regulations allocate the responsibility for the enforcement of hygiene law in approved slaughterhouses, meat cutting plants and game handling establishments to the Food Standards Agency and delegates responsibility for this task in other food businesses to local authorities.
Where an authorised officer identifies breaches of Community Hygiene regulations, he may use the enforcement sanctions contained in the Food Hygiene (England) Regulations to remedy those breaches. These sanctions include: Hygiene Improvement Notices; Hygiene emergency Prohibition Notices, Remedial Action Notices and prosecution.
Food Hygiene (Scotland) Regulations 2006
The Food Hygiene (Scotland) Regulations 2006 (as amended) provide the enforcement arrangements for the obligations placed on FBOs by the Community Hygiene Regulations: Regulation (EC) 852/2004; Regulation (EC) 853/2004 and Regulation (EC) 2073/2005.
The Regulations were also amended to permit the use of hygiene enforcement sanctions to remedy breaches of general food law contained in Regulation (EC) 178/2002.
The Food Hygiene (Scotland) Regulations allocate the responsibility for the enforcement of hygiene law in approved slaughterhouses, meat cutting plants and game handling establishments to the Food Standards Agency and delegates responsibility for this task in other food businesses to local authorities.
Where an authorised officer identifies breaches of Community Hygiene regulations, he may use the enforcement sanctions contained in the Food Hygiene (Scotland) Regulations to remedy those breaches. These sanctions include: Hygiene Improvement Notices; Hygiene emergency Prohibition Notices, Remedial Action Notices and prosecution.
Food Hygiene (Wales) Regulations
The Food Hygiene (Wales) Regulations 2006 (as amended) provide the enforcement arrangements for the obligations placed on FBOs by the Community Hygiene Regulations: Regulation (EC) 852/2004; Regulation (EC) 853/2004 and Regulation (EC) 2073/2005.
The Regulations were also amended to permit the use of hygiene enforcement sanctions to remedy breaches of general food law contained in Regulation (EC) 178/2002.
The Food Hygiene (Wales) Regulations allocate the responsibility for the enforcement of hygiene law in approved slaughterhouses, meat cutting plants and game handling establishments to the Food Standards Agency and delegates responsibility for this task in other food businesses to local authorities.
Where an authorised officer identifies breaches of Community Hygiene regulations, he may use the enforcement sanctions contained in the Food Hygiene (Wales) Regulations to remedy those breaches. These sanctions include: Hygiene Improvement Notices; Hygiene emergency Prohibition Notices, Remedial Action Notices and prosecution.
Food Hygiene Law
The requirements of food hygiene law are set out in Regulations (EC) 852/2004 (the general hygiene regulations); 853/2004 (additional requirements for establishments handling products of animal origin) and 2073/2005 (the microbiological criteria of foodstuffs regulation).
Enforcement of these requirements is provided for by the Food Hygiene (Scotland) Regulations 2006 which are made under the European Communities Act 1972 (ECA 72).
Food Hygiene Law
The requirements of food hygiene law are set out in Regulations (EC) 852/2004 (the general hygiene regulations); 853/2004 (additional requirements for establishments handling products of animal origin) and 2073/2005 (the microbiological criteria of foodstuffs regulation).
Enforcement of these requirements is provided for by the Food Hygiene (England) Regulations 2006 which are made under the European Communities Act 1972 (ECA 72).
Food Hygiene Law
The requirements of food hygiene law are set out in Regulations (EC) 852/2004 (the general hygiene regulations); 853/2004 (additional requirements for establishments handling products of animal origin) and 2073/2005 (the microbiological criteria of foodstuffs regulation).
Enforcement of these requirements is provided for by the Food Hygiene Regulations (NI) 2006 which are made under the European Communities Act 1972 (ECA 72).
Food Hygiene Law
The requirements of food hygiene law are set out in Regulations (EC) 852/2004 (the general hygiene regulations); 853/2004 (additional requirements for establishments handling products of animal origin) and 2073/2005 (the microbiological criteria of foodstuffs regulation).
Enforcement of these requirements is provided for by the Food Hygiene (Wales) Regulations 2006 which are made under the European Communities Act 1972 (ECA 72).
Food Hygiene Regulations Appeals
Right of appeal
20.-
(1) Any person who is aggrieved by -
(a) a decision of an authorised officer of an enforcement authority to serve a hygiene improvement notice;
(b) a decision of an enforcement authority to refuse to issue a certificate under paragraph (6) of regulation 7 or paragraph (8) of regulation 8; or
(c) a decision of an authorised officer of an enforcement authority to serve a remedial action notice,
may appeal to a magistrates' court.
(2) The procedure on an appeal to a magistrates' court under paragraph (1) shall be by way of complaint for an order, and the Magistrates' Courts Act 1980(a) shall apply to the proceedings.
(3) The period within which an appeal under paragraph (1) may be brought shall be -
(a) one month from the date on which notice of the decision was served on the person desiring to appeal; or
(b) in the case of an appeal against a decision to issue a hygiene improvement notice, the period specified in sub-paragraph (a) or, if it is shorter, the period specified in the notice pursuant to sub-paragraph (d) of paragraph (1) of regulation 6, and the making of a complaint for an order shall be deemed for the purposes of this paragraph to be the bringing of the appeal.
Food Incidents
Food Authorities should set up and implement a documented procedure for dealing with food incidents that are identified within their area.
Food Intended for Use in Energy Restricted Diets for Weight
Scope
These Regulations implement Commission Directive 96/8/EC dealing with composition and labelling requirements on food intended for use in energy-restricted diets for weight reduction.
Ingredients/Products
The legislation essentially deals with foods for use in energy-restricted diets for weight reduction that are specially formulated foods which, when used as instructed by the manufacturer, replace the whole or part of the total daily diet. They are divided in two categories collectively referred to as relevant food in the regulations:
(a) products presented as a replacement for the whole of the daily diet;
(b) products presented as a replacement for one or more meals of the daily diet.
Composition
The relevant foods must meet certain compositional requirements and be described only as
(a) ‘Total diet replacement for weight control’ or
(b) ‘Meal replacement for weight control’
Labelling Requirements
The labelling requirements for the relevant food can be generally summarised as set out in the following table
General provisions on labelling, advertising and presentation
The labelling, advertising or presentation of relevant foods must not refer to the rate or amount of weight loss that may result from its use.
The regulations also prohibit sale of relevant food intended as a replacement for the whole of the daily diet unless all the components are contained in the same package.
Public Analyst observations and comments
There tend to be few analytical problems; however, checks should be made for compliance with labelling requirements.
Associated Regulations
Food Intended for Use in Energy Restricted Diets for Weight Reduction (Scotland) Regulations 1997 SSI No. 2182
The Food for Particular Nutritional Uses (Miscellaneous Amendments) (Scotland) Regulations 2007 SI No. 408
Further Information
Commission Directive 96/8/EC
The Advertising Standards Authority have references to the above legislation in their
CAP Code.
Food Interventions
Where new information arises, in the case of a justified complaint or unsatisfactory sampling result, the Food Authority should consider whether it is appropriate to conduct an inspection, partial inspection or audit to investigate the matter.
An explanation for the choice of intervention should be documented in the establishment file in every case. If when conducting a planned intervention, other than an inspection, partial inspection or audit, an officer establishes that the nature of a food business has changed substantially, or the level of compliance has deteriorated, the intervention should be changed to an inspection or partial inspection, and the intervention rating revised as necessary. Equally, where new information arises, in the case for example of a justified complaint or poor sampling result, the Food Authority should reconsider both the intervention rating and appropriateness of the next planned intervention for that establishment.
Food Labelling (Amendment) (England) (No. 2) Regulations 2004
Implement Directive 2003/89/EC of the European Parliament and the Council of 10 November 2003, which amends Directive 2000/13/EC as regards indication of ingredients present in foodstuffs.
The Regulations for England and the equivalent Regulations in Scotland and Wales, amend the Food Labelling Regulations 1996, (as amended).
Sale of products that did not comply with the new rules were prohibited from 25 November 2005, but products that were labelled before that date could be sold while stocks lasted. The provisions in this legislation do not relate to foods sold loose or non-prepacked or those prepacked for direct sales (see guidance notes at www.food.gov.uk/multimedia/pdfs / labelamendguid25nov05.pdf).
Food Labelling (Amendment) (England) (No. 2) Regulations 2005
Implements Directives 2005/26/EC and 2005/63/EC14, exempts various ingredients derived from the listed allergenic foods from the labelling requirements of Directive 2003/89/EC.
Separate but parallellegislation applies in respect of Scotland and Northern Ireland and Wales, as indicated below. (See guidance notes at http://www.food.gov.uk/mulimedia/pdfs/labelguidederived.pdf and on the N. Ireland web page http://www.food.gov.uk /northernireland / niregulation/niguidancenotes/foodlabel).
Food Labelling (Declaration of Allergens) (England) Regulations 2007
These Regulations added Molluscs and Lupins to the original list of 12 named allergens which require labelling on pre-packed foods.
Food Labelling (Declaration of Allergens) Regulations 2008
The Food Labelling (Declaration of Allergens) Regulations 2008 came into force on 31 May 2008. This statutory instrument (SI) implemented Commission Directive 2007/68/EC amending Annex IIIa to Directive 2000/13/EC by replacing the list of allergens in Schedule AA1 of the Food Labelling Regulations 1996 with a revised list, which includes those ingredients that are permanently exempt from allergen labelling.
This SI also revoked the following:
- Regulation 34B(3) of, and Schedule 2A to, the Food Labelling Regulations 1996
- The Schedule to the Food Labelling (Amendment) (No.2) Regulations 2004
- The Food Labelling (Amendment) (No.2) Regulations 2005
- The Food Labelling (Amendment) (No.2) (Amendment) Regulations 2005
- The Food Labelling (Declaration of Allergens) Regulations 2007
Food Law Code of Practice
The Food Law Code of Practice contains statutory guidance which food authorities must have regard to when making arrangements for the delivery of a food official controls service.
The Code is issued by the Minister and provides detailed information on topics such as the qualification and experience of enforcement officers, the approach to food enforcement, the response to food incidents and the delivery of a food interventions programme.
Food Law Code of Practice
The following matters should be taken into account:
- The toxicity of the contaminant
- The virulence, pathogenicity of the contaminant organism
- The allergenicity of any ingredient or undeclared constituent
- The sensitivity of the population that is likely to be affected and its vulnerability.
- The quantity and distribution of the food.
- The ability of the food business operator to affectively remove food from sale in accordance with article 19 of 178/2002.
- The ability to accurately identify affected batches or lots.
- The accuracy and extent of records held by the business.
- The stage at which the problem or fault is likely to have occurred.
- Whether any products on the premises may have also been affected.
- Whether there are any wider or non localised implications.
- The possibility that the problem may have been caused by malicious tampering or a malicious act.
Food Law Code of Practice
The Food Law Code of Practice contains statutory guidance which food authorities must have regard to when making arrangements for the delivery of a food official controls service.
The Code is issued by the Welsh Assembly and provides detailed information on topics such as the qualification and experience of enforcement officers, the approach to food enforcement, the response to food incidents and the delivery of a food interventions programme.
Food Law Code of Practice
The Food Law Code of Practice contains statutory guidance which food authorities must have regard to when making arrangements for the delivery of a food official controls service.
The Code is issued by the Scottish Government and provides detailed information on topics such as the qualification and experience of enforcement officers, the approach to food enforcement, the response to food incidents and the delivery of a food interventions programme.
Food Law Practice Guidance
This non-statutory guidance is issued by the Food Standards Agency to assist food authorities with the delivery of their food official controls services.
The Practice Guide provides some procedural information, for example on the approval of food establishments, together with some standard forms to be used by food authorities.
Food machinery
Additional requirements for some particular types of food machinery and packaging machinery are set out in more specific standards. Lists of type-specific standards for machinery can be found at:
http://www.hse.gov.uk/food/standards.htm for food machinery
http://www.hse.gov.uk/food/cen.htm for packaging machinery
Food poisoning
Food poisoning is not defined in the legislation. The World Health Organisation (WHO) definition, was, on the advice of the Advisory Committee on the Microbiological Safety of Food, adopted for use throughout the UK in 1992 -
“Any disease of an infectious or toxic nature caused by or thought to be caused by the consumption of food or water”.
Although the words “food poisoning” are used in legislation the terms now more generally used are “foodborne disease” or “foodborne illness”.
Food Refresher Training
Officers whose knowledge or practical experience of food law enforcement is out of
date should receive structured refresher/update training and be monitored by the
lead officer or another experienced food law enforcement officer during the period of
training.
The extent of the revision training will vary according to the previous experience of
the officer and the period that the officer has not been undertaking food law enforcement duties. The minimum revision training should be 15 hours based on the principles of continuing professional development.
Officers that are newly qualified or are returning to food law enforcement duties after
an absence of more than 3 years should be monitored for at least three months or for
the duration of their revision training period, whichever is longer.
Food Refresher Training
Officers whose knowledge or practical experience of food law enforcement is out of date should receive structured revision training and be monitored by the lead officer or another experienced food law enforcement officer during the period of training. The extent of the revision training will vary according to the previous experience of the officer and the period that the officer has not been undertaking food law enforcement duties.
The minimum revision training should be 15 hours based on the principles of continuing professional development. Officers that are newly qualified or are returning to food law enforcement duties after an absence of more than three years should be monitored for at least three months or for the duration of their revision training period, whichever is longer, unless food law enforcement duties are at the level of primary production only and are in addition to current on-farm experience in relation to animal welfare or feed hygiene legislation.
Food registration
Regulation 882/2004 states in Article 31(1)(b) that ‘where such a list already exists for other purposes, it may also be used for the purposes of this Regulation’. The option to use existing lists is also detailed in the Commission’s guidance document on the implementation of Regulation 852/2004 where specific examples of suitable alternative registration information sources are made e.g. environmental or animal health data. A list of primary production establishments registered with the RPA has been made available to local authorities. A new dedicated food hygiene registration system at primary production level is not therefore required. Officers are directed to Section 3 for general guidance on enforcement.
Officers should be careful to ensure that:
• such establishments are subject to Regulation 852/2004; and
• such establishments are not subject to approval under Regulation 853/2004 (see Section 5).
Food registration
Food Authorities should enter relevant information from the registration form on to the database (see Chapter 1.4) and lists (see Section 1.5.4) of registered food business establishments. The registration form should then be placed on a file prepared in respect of that food business establishment. Food Authorities should keep application forms relating to businesses in a format that maintains their admissibility as evidence if required. If any information is omitted from a registration form submitted by a food business operator, the Food Authority should either make contact with the food business operator to obtain the missing information or, if a substantial amount of information is missing, return the form to the food business operator for full completion. On receipt of a completed application form, Food Authorities should also give consideration to carrying out an inspection of the establishment in accordance with Annex 5.
Food registration
The register of food business establishments held by each Food Authority in accordance with the now revoked Food Premises (Registration) Regulations 1991, as amended, in the Authority’s database (see Chapter 1.4) satisfies this requirement and may be carried forward. Food business operators will not, therefore, need to reregister food business establishments under their control which have already been registered with a Food Authority. Food Authorities must maintain their lists in accordance with the requirements of Article 31(1)(b) of Regulation 882/2004. In relation to primary production, establishments included in the RPA list (see Section 1.5.3.1) or other databases already held by the Food Authority, are considered registered under Article 31 (1)(b) of Regulation 882/2004.
Food Registration
The list should contain the following information about each food business and should be consistent with the information held in the Food Authority’s database:
• name of the food business;
• address of the food business establishment; and
• particulars and nature of the food business.
These authorities may give or send a copy of their list or any entry on it to any person who makes a request for such information. County Council Food Authorities should refer requests from the general public for information on registered food business establishments in their area to the relevant District Council Food Authority.
Food registration changes
Any changes to the details previously supplied e.g. a change of food business operator, a change to the activities carried out in relation to food, the closure of an establishment etc. should be notified by the food business operator to the relevant Food Authority. Notification of a change to the operator of a food business
establishment should be made by the new food business operator. On receipt of a notification of a change of activities Food Authorities should update the list of registered food business establishments as appropriate, and place or record the details on the file relating to that food business establishment.
Food registration forms
Food Authorities should enter relevant information from the registration form on to the
database (see Chapter 1.4) and lists (see Paragraph 1.5.4) of registered food business establishments. The registration form should then be placed on a file prepared in respect of that food business establishment.
Food Authorities should keep application forms relating to current businesses in a format that maintains their admissibility as evidence if required. If any information is omitted from a registration form submitted by a food business operator, the Food Authority should either make contact with the food business operator to obtain the missing information or, if a substantial amount of information is missing, return the form to the food business operator for full completion.
On receipt of a completed application form, Food Authorities should also give consideration to carrying out an inspection of the establishment in accordance with Paragraph 4.1.3.2.
Food registration lists
The register of food business establishments held by each Food Authority in accordance with the now revoked Food Premises (Registration) Regulations 1991, as amended, in the authority’s database (see Chapter 1.4) will satisfy this requirement and may be carried forward. Food business operators will not, therefore, need to re-register food business establishments under their control which have already been registered with a Food Authority. Food Authorities must maintain their lists in accordance with the requirements of Article 31(1)(b) of Regulation 882/2004.
Food registration lists
Food Authorities should also ensure that a separate, up-to-date, list of food business
establishments registered with them is available for inspection by the general public
at all reasonable times.
The list should contain the following information about each food business and should be consistent with the information held in the Food Authority’s database:
1. Name of the food business
2. Address of the food business establishment
3. Particulars and nature of the food business
Food Authorities may give or send a copy of their list or any entry on it to any person who makes a request for such information. However, requests for information on food business establishments which are not included in the list should be handled with due regard to Freedom of Information and Data Protection legislation (see also Chapter 1.3 of the Practice Guidance).
Food Safety Act
Responsibility for enforcement of the majority of the food standards, composition and
labelling regulations under the Food Safety Act 1990 rests with Local Authorities
(Section 26).
In Scotland Local Authorities appoint authorised officers specifically in writing to enforce the legislation on their behalf. Food Authorities should be aware that law relating to food is not necessarily made under the Food Safety Act 1990 and that separate authorisation is required.
Law that applies to food is also contained in and/or made under the Animal Health Act 1981, the European Communities Act 1972, the Consumer Protection Act 1987, the Consumer Protection from Unfair Trading Regulations 2008, the Weights and Measures Act 1985, the Medicines Act 1968 and directly under EC Regulations.
Food Safety Act
Responsibility for enforcement of the majority of the food standards, composition and
labelling regulations under the Food Safety Act 1990 rests with Local Authorities
(Section 26).
In Scotland Local Authorities appoint authorised officers specifically in writing to enforce the legislation on their behalf. Food Authorities should be aware that law relating to food is not necessarily made under the Food Safety Act 1990 and that separate authorisation is required.
Law that applies to food is also contained in and/or made under the Animal Health Act 1981, the European Communities Act 1972, the Consumer Protection Act 1987, the Consumer Protection from Unfair Trading Regulations 2008, the Weights and Measures Act 1985, the Medicines Act 1968 and directly under EC Regulations.
Food Safety Act 1990 - Section 14
Section 14(1) provides that it is an offence for a person to sell, to the purchaser’s prejudice , food which is not of the nature, substance or quality demanded by the purchaser .
Generally speaking, food is not of the nature demanded if it is not of the variety ordered
Food is not of the substance demanded if it contains a foreign object or material, to the presence of which the purchaser may reasonably object.
Quality is not the same as nature, so that if the customer gets the type of food he asks for he may still complain that it is sub-standard in quality
Food Safety Officer
An officer authorised by the authority in writing for the purpose of serving hygiene improvement notices under the Food Hygiene (England) Regulations 2006.
Food Samples
The statutory requirements applicable to food sampling and analysis and the provisions of the Food Law Code of Practice should be followed with respect to food sampling in connection with an outbreak of foodborne disease. LACORS guidance on food sampling provides useful advice.
Food scares
In the UK, the government responded to the Salmonella in eggs and Listeria “hysteria” scares by the commissioning of the Richmond report and the introduction of the Food Safety Act 1990. The emerging BSE crisis throughout Europe in the 1980’s and 1990’s and dioxin contamination of foods in Belgium were cited by the European Commission as driving forces in the creation of new EU law.
Food Standards Agency
The Food Standards Agency (FSA) is the Central Competent Authority for food law in the UK. It was established by the Food Standards Act 1999 and some of it's key functions include:
- Representing the UK at EU level on feed and food matters
- Monitoring the delivery of official controls by food authorities.
- Approval of fresh meat slaughterhouses, cutting plants and game handling establishments and performance of official controls in these establishments.
- Enforcement of wine standards law
- Commissioning research on food related matters
- Provision of guidance and advice to consumers, the food trade and enforcement officers.
FOOD STANDARDS AGENCY/SCOTTISH EXECUTIVE HEALTH DEPARTMENT
GUIDANCE ON THE INVESTIGATION AND CONTROL OF OUTBREAKS OF FOODBORNE DISEASE IN SCOTLAND
FSA GUIDANCE 2002 - Amendment No.8 – May 2006
Food Standards Law
Food standards legislation provides rules for the marketing, advertising, labelling and presentation of food. It also sets compositional and purity standards for foods and legal standards for materials and articles which come into contact with foods.
Foods not of animal origin
Foods not of animal origin will include fruit, vegetables, herbs, spices, nuts, soft drinks, alcoholic drinks, rice, grains, and confectionary.
Foreword
The standard and quality of food is important to all consumers and food businesses across Scotland. Consumers must have confidence that food they buy and eat will be what they expect, will not be harmful and that they are protected from fraud. This manual provides information to authorised officers on these areas. The Food Standards Agency in Scotland has worked closely with the Scottish Government to ensure that the reputation of Scottish food and drink is upheld as part of Scotland’s National Food and Drink Policy.
The Food Standards Training manual was first issued by the Food Standards
Agency Northern Ireland in order to assist authorised officers with the challenging area of food standards. In 2007, the Agency’s sector-specific simplification project considered the potential for expanding the use of this manual. In Northern Ireland the manual is now in its third successful year, and evaluation of the manual has further determined the need for this type of resource.
Work began in Scotland to produce a Scottish version of the manual in partnership with local authority authorised officers, based on the positive feedback received on the Northern Ireland manual from District Councils and to address issues raised by audits undertaken in Scotland.
Partnership is key in the development of Agency projects and a working group was established to take this project forward with members of the Scottish Food Enforcement Liaison Committee Food Standards Sub Committee. The group offered invaluable expertise and experience in producing the Scottish edition of this training manual, and kept the main objective in focus, to provide a practical training and reference tool for authorised officers. In addition to input from local authority colleagues, Scottish Public Analysts were also consulted on this document.
The aim of this manual is to provide a reference document for the wide range of food
standards legislation in force in Scotland and the associated codes of practice and
relevant guidance notes. It is not the intention that the manual will provide a detailed
account of each piece of legislation but it is hoped that it will go some way to assisting authorised officers to become more familiar with food standards legislation and associated guidance. It is also intended to give authorised officers an insight into some of the practical applications of food standards enforcement and to identify other sources of useful information.
Food legislation and guidance is ongoing and changes constantly. It is our aim to produce the most accessible and up to date training information. Given the ever evolving nature of food legislation it will be necessary to update the manual. Updates will be issued on a regular basis, and we would welcome comments and
suggestions.
Charles Milne
Food Standards Agency
Form preliminary hypothesis
It is important early in the investigation to produce an initial hypothesis of what is happening. This will be reviewed throughout the investigation as information comes to light.
For example the hypothesis may be broad initially:
"There is an outbreak of food poisoning in the Fulchester area caused by the consumption of food from the Fulchester Deli".
It may then become refined as microbiological evidence comes to light:
"There is an outbreak of Salmonellosis caused by the consumption of food from Fulchester Deli".
And then more detailed following epidemiological investigations:
"There is an outbreak of Salmonellosis caused by the consumption of chopped liver contaminated with Salmonella enteriditis PT 4 purchased from Fulchester Deli".
Formal Micro Sample
In accordance with regulation 13(10) of the Food Hygiene (England) Regulations 2006, the Food Safety (Sampling and Qualifications) Regulations 1990 apply in relation to a sample procured by an authorised officer of a Food Authority under regulation 12 of the Food Hygiene (England) Regulations 2006, as if it were a sample procured by an authorised officer under section 29 of the Food Safety Act 1990.
Formal micro sample
In accordance with regulation 13(10) of the Food Hygiene (Wales) Regulations 2006, the Food Safety (Sampling and Qualifications) Regulations 1990 apply in relation to a sample procured by an authorised officer of a Food Authority under regulation 12 of the Food Hygiene (Wales) Regulations 2006, as if it were a sample procured by an authorised officer under section 29 of the Food Safety Act 1990.
Formal microbiological samples
In accordance with Regulation 13(10) of the Food Hygiene (Scotland) Regulations 2006, the Food Safety (Sampling and Qualifications) Regulations 1990 apply in relation to a sample procured by an authorised officer of a food authority under Regulation 12 of the Food Hygiene (Scotland) Regulations 2006 as if it were a sample procured by an authorised officer under Section 29 of the Food Safety Act 1990.
formal or informal enforcement
A key issue to consider here is the need to remove any food that might be suspected to be contaminated from the food chain and to stop any activities which might be implicated in the outbreak.
These objectives may be achieved either formally through the use of appropriate notices or informally. If an informal approach is adopted, full written records of any actions must be made.
Formal sampling for analysis
Subject to regulation 6.4, regulation 6(1) of the Food Safety (Sampling and Qualifications) Regulations 1990, requires that the sample should be divided into 3 representative parts. The resultant parts of the sample are referred to in this Code as final parts. Where practicable, the division should be carried out in the establishment of the food business operator, who, if present, should be given the opportunity to observe the sampling and division before being invited to choose one of the parts for retention. The sampling of imported foods at the port of entry may pose particular difficulties. In the special circumstances found by Port Health Authorities, a sample need not be divided on the premises or in the presence of any representative of the seller/owner or importer, unless the legislation under which the sample is taken specifically requires otherwise.
Format of documentation
Documentation should be viewed as an essential component of a HACCP system rather than a bureaucratic necessity and there should be evidence available to demonstrate that documents are relevant and actively completed.
Formation of curd
The liquid whey is drained and used for animal feed, whey cheese production or fed into a reverse osmosis plant for the whey proteins to be recovered. The solid curd is left in the vat.
Free report/free narrative
This first stage in the interview of witnesses aims to put the witness at ease and obtain an overview of the evidence that they can provide. The officer should not ask detailed questions at this stage but should encourage the witness to describe, in their own words, their account of the events.
The officer might like to make bullet point notes of the comments made by the witness.
freezing point determination
Freezing point determination
The freezing point determination (FPD) of milk is achieved using a cryoscope.
The FPD is obtained by placing a small sample of milk into a cuvette and inserting this into a well in the machine. A thermistor is lowered into the milk which is rapidly frozen by a coolant bath and allowed to gently thaw. The thermistor detects the temperature that the milk thaws and displays the result in m°C.
The FPD value for whole milk is typically 509m°C which indicates a freezing point of around -0.5°C.
The presence of water will be indicated by a lower FPD for example 470m°C. The presence of milk powder, coolant or detergents will raise the FPD.
Frequency of inspection
Appropriate risk rating could be assessed by the use of Annex 5. In general, cruise ships and passenger ferries should be inspected at least once every 12 months and, subject to the above, general cargo and merchant ships every 18 months to 2 years, unless there are clear grounds to justify further investigations, e.g. the ship visiting a UK port for the first time or after an absence of 12 months or more.
Visits to other vessels, such as training yachts, based at specific ports should be decided on a basis of number of vessels, local conditions and knowledge gained through previous inspections.
Frequency of Intervention
Where a HEPO has been issued, the inspection frequency of the premises should be reviewed and the premises scheduled for an official control within six months.
Frequency of interventions
Annex 5 of the Food Law Code of Practice states:
"Food Authorities that are responsible for enforcing food hygiene law should determine the food hygiene intervention frequencies of food establishments within their area using the risk assessment criteria in this Annex, in order to determine their planned food hygiene intervention programmes."
Fresh meat
‘Fresh meat’ is defined in Regulation (EC) 853/2004 as
"meat that has not undergone any preserving process other than chilling, freezing or quick-freezing, including meat that is vacuum-wrapped or wrapped in a controlled atmosphere."
Fresh produce
Vegetables and fruits that have been supplied to food businesses as ready-to-eat, should already have been subjected to validated procedures to ensure bacterial load is reduced to levels that do not present a risk to health. The FSA recommends that bagged ready-to-eat fresh produce does not need to be rewashed. In environments where potential sources of E. coli O157 are being handled, the rewashing of products supplied as ready-to-eat could introduce an additional cross-contamination risk.
Leafy and root vegetables that have not been supplied as ready-to-eat will not have been subject to controlled washing procedures and should be classed as a potential hazard in terms of cross-contamination of E. coli O157, particularly if soil or manure is visible.
Further studies
It may be necessary to conduct further analytical or microbiological studies to confirm the nature and progress of the outbreak.
Fusion of curd grains
Fusion of the curd grains occurs naturally through syneresis but is commonly assisted through the use of presses and moulds.
Gas flushing MAP
Gas Flushing MAP
Here the atmosphere around the food is controlled at the point of packaging. Typically, the product is placed into a container; the air is drawn out forming a vacuum and is replaced by a selected combination of gases.
Gatherer
‘Gatherer’ is defined in Regulation (EC) 853/2004 as:
"any natural or legal person who collects live bivalve molluscs by any means from a harvesting area for the purpose of handling and placing on the market."
General Food Law
General food law requirements are set out in Regulation (EC) 178/2002 and the most important obligations placed on Food Business Operators include:
a) A prohibition from placing unsafe food on the market.
b) A requirement for FBOs to have "systems and procedures" in place to demonstrate the traceability of their food.
c) A requirement for certain FBOs to take steps to withdraw or recall food and notify the competent authority should they become aware that food that they have supplied fails food safety requirements.
The enforcement arrangements for these requirements are provided in Great Britain by the General Food Regulations 2004 which are made under the Food Safety Act 1990 and in Northern Ireland by the General Food Regulations (NI) 2004.
General Food Regulations
The General Food Regulations 2004 (as amended) provide the enforcement arrangements, in terms of food, for the obligations placed on Food Business Operators by Regulation (EC) 178/2002. In particular, Regulation 4 creates offences for FBOs who fail to comply with Articles 14 (unsafe food), 16 (labelling and presentation), 18 (traceability) and 19 (product withdrawal and recall) of 178/2002.
The General Food Regulations 2004 apply throughout Great Britain, in Northern Ireland the General Food Regulations (Northern Ireland) 2004 apply.
General Observations
"Local authority officers attend a car boot sale where it is suspected that counterfeit goods are being sold, but they are not carrying out surveillance of particular individuals and their intention is, through reactive policing, to identify and tackle offenders. This is part of the general duties of public authorities and the obtaining of private information is unlikely. A directed surveillance authorisation need not be sought."
RIPA Code of Practice
Generic names
Certain generic terms (e.g. vegetable oil, cheese, sugar and fish) may be used instead of more specific names for the purposes of listing ingredients of foods only. Their use is subject to certain conditions which are set out in Schedule 3 to the Regulations.
Although the generic terms vegetable oil, vegetable fat, animal oil, and animal fat all appear as separate entries, this does not prevent the use of indications which combine these terms in a way which makes their intention clear to the consumer, e.g. vegetable and animal oils, vegetable oils and fats, or vegetable and animal oils in varying proportions. Generic names “Vegetables” and “Crystallised fruit” have been deleted from Schedule 3 by the Food Labelling (Amendment) No2 Regulations 2004
Glass Milk bottle fillers
The most common form of glass milk bottle filler is the Dawson Carousel filler which operates by dispensing the milk from a rotating drum into glass bottles via a series of filling valves.
The photograph above shows the carousel filler in which the glass bottles are raised up to the red filler rubbers by cam operated platforms. Within each filler rubber there is two tubes, one draws air out of the bottle, the other feeds milk into the bottle. These carousel fillers are capable of filling bottles at very high speeds.
GMP
Existing GMP controls will assist with allergen management, for example avoiding cross-contamination by segregation, cleaning, using separate utensils etc. However, it should be noted that unlike microbiological risks, heating does not necessarily destroy food allergens and may actually increase their potency, for example roasting peanuts.The introduction of allergen management into a food business can be seen as an extension of existing food safety management rather than a completely new system.
Graham Cox QC
Graham Cox Q.C. was the Sheriff Principal of South Strathclyde, Dumfries and Galloway who presided over the fatal accident enquiry into the deaths of 21 people following an outbreak of E.coli o157 in 1996.
Grant of approval
When full approval is granted following conditional approval, the Food Authority should notify the food business operator in writing.52 Such a notification should also include details of the nature and scope of the approval any conditions or limitations that apply, and confirmation that the approval code allocated to the establishment may continue to be used. The Food Authority should retain a copy of the above notifications on the relevant establishment file and ensure that the Agency is notified of the approval in accordance with Section 2.4.3.
Gross breach of duty
In deciding whether there was a gross breach of duty, a jury in a corporate manslaughter trial must consider whether the organisation failed to comply with any relevant health and safety legislation, and may also have regard to any guidance relating to the alleged breach issued by a health and safety enforcing authority (which will include relevant Approved Codes of Practice and HSE guidance).
See Section 8 CMCHA 2007
Guides to good practice
Chapter III of Regulation (EC) 852/2004 provides for the production of guides to good practice to help Food Business Operators to comply with the requirements of food law. These guides may be produced either nationally or at a European Community level and contain non-statutory information on food law compliance.
HACCP
A food safety management system which identifies, evaluates, and controls hazards which are significant for food safety.
HACCP - Advantages of checklists
Function as an aide-memoire;
Help maintain the focus and objectivity of the assessment;
Act as a record of the assessment itself;
Help ensure the completeness of the assessment;
Useful tool in ensuring consistency of approach between different assessors;
Ensure transparency of the assessment process; and engender confidence in the assessment process by all concerned.
Source: World Health Organisation
HACCP - Assess development of HACCP plan
Assessing the basis for the development of the HACCP plan will include an evaluation of the accuracy of the product and process description, including information and consideration of the intended use of the product.
A flow diagram of the process under assessment should also be provided and consideration should be given to its accuracy, and when, how and by whom it was confirmed.
The assessor should consider the expertise used and how this has been utilized in the development of the HACCP plan. In evaluating the basis for the development of the HACCP plan, consideration should also be given to the adequacy of the prerequisites for HACCP.
HACCP - Assessing HACCP Management
Confidence in the management’s ability to implement and maintain HACCP may not always be easy to measure. However, the following elements may give an indication of the level of commitment of the management to ensuring food safety and compliance with HACCP:
_ the compliance history of the business;
_ the level of food hygiene training and its application;
_ the technical knowledge within or available to the company; and
_ the existence of satisfactory documented procedures and food safety management systems.
HACCP - Assessing the hazard analysis
The assessor should consider the adequacy of the hazard analysis, in particular whether all significant hazards have been identified, ensuring that this has been undertaken for all products and processes to which the assessment is directed.
In assessing the analysis of hazards, assessors may require access to supporting evidence in the form of, for example, records of validation, sample results, history of the safety of the product, generic plans, relevant and appropriate predictive models.
HACCP - Assessment of Codex requirements
An audit against the Codex requirements is useful to:
Gain confidence in the system
Assess likelihood of successful implementation.
To identify possible improvements.
Where “technical” deficiencies in system identified: recommendations made to business.
HACCP - assessment of control measures
The assessor should consider whether control measures eliminate or reduce identified significant hazards to acceptable levels. The assessor should ensure that all Critical Control Points (CCPs) have been identified, that appropriate critical limits have been determined and that, where relevant, these are at least operating within applicable legislative parameters. An assessment should be made of the critical limits in relation to how realistic these are, their measurability and their relevance. Evidence should be obtained as to how these were determined including the expertise used, and any supporting documentation to validate these.
Evidence should be obtained that the monitoring of critical limits indicates adequate control of the hazards. The adequacy of training in relation to personnel working at CCPs and engaged in monitoring should also be considered, as should whether suitable instructions have been given to such personnel, and their role in relation to appropriate and timely actions.
An assessment should also be made as to whether the corrective actions would adequately restore control and are adequate to prevent an unsafe product from reaching the consumer.
HACCP - Assessment of documentation
The following documents should be assessed:
_ the description of the product and its intended use;
_ the process flow diagram with the location of CCP and related parameters;
_ the HACCP worksheet on which are mentioned the hazards, the control measures, the CCPs, the critical limits, the monitoring procedures and the corrective actions;
_ the list of verification activities;
_ the results of monitoring and verification according to the HACCP plan; and
_ appropriate records necessary to assure the adequacy of prerequisites for HACCP.
HACCP - Assessment of implementation
The assessors should assess the adequacy of the implementation, i.e. whether the HACCP plan and the prerequisites for HACCP have actually been implemented in the food business, maintained and are functioning correctly. Assessors should consider whether records were in order, i.e. whether recordings of monitoring and verification results were as described in the HACCP plan.
HACCP - Assessment of legal requirements
Assessment of legal compliance should include reference to Article 5(2) 852/2004:
Have all hazards that must be prevented, eliminated or reduced to acceptable levels been identified?
Have all critical control points at the step(s) at which control is essential to prevent or eliminate a hazard or to reduce it to acceptable levels been identified?
Have critical limits been established at critical control points?
Audit of Codex HACCP Systems Assessment of legal compliance
Have monitoring procedures been established at critical points? Are these effective?
Have corrective actions been established where monitoring indicates that a critical control point is not under control?
Are there procedures to verify that the above measures are working effectively? Have these been carried out regularly?
Are there documents and records commensurate with the nature and size of the food business to demonstrate the effective application of the above measures?
Officers should remember that such assessments should:
Have a logical & systematic approach
Evidence based
Include discussions with staff
Full records should be made of such assessments and officers should only rely on verified information
HACCP - Audit based inspections
An audit approach to the assessment of HACCP systems by an enforcement officer should involve a logical and sequential assessment of the identification and control of significant hazards by the food business operator.
HACCP - audit report
Audit reports must differentiate between legal requirements and recommendations
and should wherever possible prioritise any remedial work.
HACCP - Closing meeting
The closing meeting should include a clear identification of and distinction between:
contraventions of Article 5 and technical breaches of the Codex system.
Where any identified non-conformaties are identified, they must be brought to the attention of the FBO at the earliest moment.
HACCP - Correct identification of CCPs
It is essential that critical control points have been properly identified. The use of a decision tree is recommended for this purpose but cannot be required in law.
HACCP - Description of food
It is important that the HACCP team fully understand the physio-chemical properties of the food that is the subject of the HACCP and the potential effects that these properties may have, in particular, on the growth or inhibition of microorganisms in the food.
The description of food should include a consideration of extrinsic factors such as the processes and treatments that the food will be subjected to and; intrinsic properties such as the salt content, pH or water activity.
The intended shelf life and method of distribution should also be considered here.
The purpose of this stage is to ensure that the HACCP team fully appreciate the vulnerabilities within their intended processes so that they may properly identify significant hazards which will require control and hence implement relevant controls in an effective way.
HACCP - Disadvantages of checklists
Improper design may include unnecessary or irrelevant items, or may omit critical items;
May restrict the initiative and judgment of the assessor and discourage critical evaluation;
Important that the use of a checklist does not evolve into a simple “tick-box” approach
ie: no critical evaluation.
Source World Health Organisation
HACCP - Discussion with staff
Every assessment of a HACCP system should include a discussion with key staff so as to assess their awareness and understanding of procedures and practices which are essential to food safety.
HACCP - Evidence based decisions
There are a number of factors which will influence an officers judgement in terms of the adequacy and effective implementation of HACCP systems including:
Discussions with the food business operator
Discussions with members of staff
Examination of documentation including plans and records.
However, an officer should always place more weight on evidence that he/she personally witnesses whether that be by observation or measurement.
For example, an officer may be told by a food business operator that a piece of equipment is cleaned and disinfected and indeed there may be written procedures and records to confirm this. However if the equipment is visibly dirty or there is evidence in the premises of poor hygiene practices, the officer should disregard these verbal and documentary assurances.
HACCP - feedback of audit findings
Officers should ensure that the key points identified in the audit are fed back to the food business operator at the end of the audit in a clear manner.
Steps should be taken to clarify any relevant matters.
HACCP - Intended use
The HACCP team should consider whether the food product will be supplied as a "ready to eat" product or whether there is an expectation that the consumer or a third party will subject the food to further processing. If this is the case the team should review the appropriate instructions that will be provided to ensure that the food is safe.
In addition, the HACCP team should consider whether the food is intended for supply to vulnerable groups for example to "meals on wheels". residential home, hospitals or for persons with specific dietary needs. If this is the case, the team may need to take this into account during the hazard analysis and in particular the hazard evaluation stage of the HACCP process.
HACCP - Introduction to audit
Officers should always undertake a quick “look see” of the establishment in order to identify the relevant processes, activities and any obvious failings. This should be an initial assessment of the risk that the establishment might pose and will include a verification of the existance and nature of any HACCP system.
This preliminary assessment should involve the production of sketch plans of the establishment to show product and staff flow and hence identify possible "hot spots" of cross contamination
Food business operators should be encouraged to do the same as Graham Cox QC, who chaired the fatal accident inquiry following the E.coli o157 outbreak in Lanarkshire commented:
“Where in a butcher’s premises ready to eat cooked meats are produced ..it is essential that the processes involved are separated from the raw meat processes so that cross-contamination between cooked and raw cannot happen. Barrs had never had a diagram showing these. If they had drawn one it would have been obvious straightaway that there was a risk of cross-contamination”
HACCP - methodology
This will include an assessment of the qualification and experience of the HACCP team, the manner in which hazard analysis has been undertaken and the approach used to identify critical control points.
HACCP - onsite documentation
Officers should focus on significant documentation to verify implementation of HACCP:
Supplier records and audit reports
Procedures and work instructions
Training records
Cleaning and disinfection records
Production and process control records
Laboratory results
Corrective action records
Despatch records
HACCP - opening meeting
Explain nature and purpose of assessment
Legal compliance
Technical compliance
Clarify matters from pre-visit assessment
Identify any significant failings.
HACCP - Preparation for audit
Officers should consider:
Previous inspection reports
Previous versions of HACCP plans
Complaints received regarding this or associated businesses
Sampling results and in particular any adverse results which might suggest that the system is not implemented effectively.
Any previous enforcement action which might have been proposed or taken by the food authority.
With respect to national companies, any advice or guidance provided by the Primary Authority or Home Authority.
Officers should also have regard to any general information and relevant industry guides and/or Codes of Practice.
HACCP - Process flow diagram
A process flow diagram (PFD) should be developed which identifies all key stages of the food activity from the purchase and receipt of raw materials to the supply of the finished food. The HACCP team should specify the start and end point of the HACCP on this diagram.
The PFD should be detailed enough to identify the key stages of the food production but for the purposes of clarity should not be over complicated.
In addition to the PFD, the HACCP team should develop plans of the establishment which set out product and personnel movements to identify any potential areas of cross contamination between raw and processed foods.
Should these plans reveal areas of potential cross contamination, the team should take steps to "design them out" before undertaking the hazard analysis.
The PFD should also be used to help with the ongoing review of the HACCP system by the food business operator and by enforcement officers as they carry out official controls.
HACCP - record of assessment
A written record should be made of any verbal feedback provided to the food business operator and any verbal responses made.
It is important that any report placed on the office file records matters that were discussed during the audit in terms of whether they were personally verified by the officer or whether the officer merely relied on unverified information provided by the food business operator.
In this respect “verified” will only include matters which were personally observed by the officer during the audit.
“unverified” refers to observation of documents and discussions with staff.
It is important that officers ensure that pro-formas are fully completed with additional notes prepared as required.
HACCP - Red Flagging of concerns
The food authority should adopt a strategic approach to the assessment of HACCP systems and as such any significant concerns relating to the adequacy or integrity of HACCP systems discovered by officers should be "red flagged" to members of the authority's management team.
HACCP - reports
All reports following the assessment of a HACCP system should be in writing and include:
Details of any identified contraventions and matters required to rectify them;
Details of technical breaches and recommendations for putting them right;
Priorities for the fbo to attend to.
Clear time limits for the identified works to completed.
HACCP - Retention of HACCP plan
It is important that the food authority carries out an ongoing assessment of the validity, adequacy, scope and effective implementaion of HACCP systems by food business operators. As such it is important that copies of the HACCP plan are retained on file so that progress may be monitored with reference to documents produced by the food business at an earlier stage.
HACCP - scope
It is important that the HACCP identifies significant hazards and appropriate controls for all food activities undertaken by the business.
HACCP - verification of arrangements
There should be a systematic verification of the management arrangements for food safety which depends on the nature of the HACCP system employed.
HACCP - Verification of the process flow diagram
Officers should "walk through" the process for selected product(s) and verify that the process flow diagram that the fbo has based his HACCP on is accurate. Officers should identify each process step and look for evidence of such steps that have not been identified in the PFD.
HACCP - verify PFD
The Process Flow Diagram (PFD) and any other plans of the establishment will play an essential role in the identification of significant hazards and associated controls. It is therefore vital that these are accurate and to this end the HACCP team should take steps to verify their accuracy.
This should be achieved by the HACCP team literally "walking through" the process, checking each process step against that identified on the PFD.
HACCP -assessment of verification procedures
The assessor should consider what, how, when and by whom the verification procedures have been undertaken, and whether these are adequate and effective. This may be indicated by an assessment of the validation data, sampling results, internal and external audit documentation as well as the frequency and thoroughness of all verification activities.
The assessor should also consider whether changes, deficiencies in the HACCP plan, new emerging hazards, etc., are adequately provided for. Assessors should consider what actions are taken as a result of inadequacies in the HACCP plan or its prerequisites, or any other non-conformities.
HACCP plan diagram
A typical HACCP plan diagram will identify:
- the relevant process step;
- the likely hazard at this step;
- the appropriate control for this hazard;
- whether this control is critical to food safety;
- if so, the critical limits to be applied;
- the monitoring required at the critical point;
- the corrective actions should the monitoring identify a failure at the critical limits and;
- reference to any records.
HACCP Principle 1
Conduct a hazard analysis
Hazard analysis involves the listing of all of the hazards that may be reasonably expected to occur at each step of food production from primary production, processing,
manufacture, and distribution until the point of consumption. Followed by the identification of hazards which are of such a nature that their elimination or reduction to acceptable levels is essential to the production of a safe food.
In conducting the hazard analysis, wherever possible the following should be included:
• the likely occurrence of hazards and severity of their adverse health effects;
• the qualitative and/or quantitative evaluation of the presence of hazards;
• survival or multiplication of micro-organisms of concern;
• production or persistence in foods of toxins, chemicals or physical agents; and,
• conditions leading to the above.
Consideration should be given to what control measures, if any exist, can be applied to each hazard.
More than one control measure may be required to control a specific hazard(s) and more than one hazard may be controlled by a specified control measure.
HACCP principle 2
The determination of CCPs should be undertaken in a logical way and can be achieved by using a decision tree. Click here to view an example of a decision tree.
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