In a separate file - Flow Diagram to determine if approval is required (Simplified). 2 pages.

Training on the Approval of food establishments - an introduction to Approvals, and some issues for enforcement officers For the London Region Food Study Group seminar on 20 June 2008. This presentation is a shorter version of my four hour training course for food officers in Hackney. Nigel Whiteley, Chartered Environmental Health Practitioner, L B Hackney. E-mail: nigel.whiteley@hackney.gov.uk. Tel: 020 8356 4917 Joint Co-ordinator, London Food Co-ordinating Group's Approvals Sub Group. http://www.london.ciehnet.org/ (See 'The Region', then scroll down to the link to our webpage). Contents 1 - Reminder 2 - What further guidance on approvals will the EC and the FSA provide? 3 - How do you determine if Approval is required? 4 - What Approved establishments are there in Hackney? 5 - What difference do the requirements for Approval make to a business? 6 - The procedure for approving an establishment 7 - What standards are required for Conditional Approval? 8 - What is the purpose of Approvals? 9 - What foods have officers found coming from establishments operating without approval, which involved Hackney? 10 - Procedures on discovering an establishment operating without Approval - suggestions. Appendices 1 - Map showing the 'local' area for an establishment in London 2 - Checklist of the relevant requirements of food law... for Approval. 3 - Lists of establishments requiring approval in L B Hackney. 4 - Enforcement options for dealing with establishments operating without approval. 5 - Discussions - some suggested answers In a separate file - Flow Diagram to determine if approval is required (Simplified). 2 pages. 1 - Reminder of what officers already know something about 1.1 - Food hygiene regulations 1.1.1 - Requirements for food business operators Regulation (EC) 852/2004 - The general hygiene requirements for all establishments, including HACCP-based procedures, training, etc. Regulation (EC) 853/2004 and amendments - The specific hygiene rules for food of animal origin. (In addition to those in Reg 852). - Applies mainly to approved establishments. A few parts apply at retail level, eg fishery products. - Many Annexes containing extra requirements for specific foods, eg for Meat of domestic ungulates, Meat products, Fishery products, Raw milk and dairy products, Gelatine, etc. Regulation (EC) 2073/2005 - Microbiological Criteria for foodstuffs. Includes many foods produced in Approved establishments. Approval of food establishments June 08.doc Page 1 of 10

1.1.2 - Requirements for food authorities Regulation (EC) 882/2004 - Approval procedure. (Art 31). Regulation (EC) 854/2004 - What to audit on an inspection. (Art 4). Food Hygiene (England) Regulations 2006 - Remedial action notice, and Detention notice. (Reg 11). For establishments subject to approval. - Temperature control requirements. (Sch 4). Do not apply to Approved establishments. 1.2 - Approval codes UK HY001 EC - Health mark for carcasses of large mammals. Applied by Official Veterinarian. Reg 854, Annex I - Identification mark for other products of animal origin. Applied by food business operator. Reg 853, Annex II. - How to find whether an establishment is approved, using the approval code. See the FSA and EC websites. (www.foodstandards.gov.uk and http://ec.europa.eu) 1.3 - Enforcement authorities for meat establishments subject to approval Food Standards Agency. Enforced by the Meat Hygiene Service, (the Official Veterinarian). - Slaughterhouses, and Meat cutting plants, including catering butchers and some butchers shops (which supply significant amounts of meat to other retailers). - combined premises, (eg, doner kebab manufacturers who also cut and supply fresh meat). Food Authority. Enforced by Food Safety or Environmental Health. - All other approved establishments handling meat, eg, minced meat, meat preparations, meat products, cold stores. - All meat establishments subject to approval but which have not been approved. (Eg, the one which was in Carpenters Road). 2 - What further guidance on approvals will the EC and the FSA provide for food business operators and food officers? - EC: nothing expected. - FSA: have just started issuing it. The first is the enforcement letter on Retailers' distribution centres, and the supply by the producer to the final consumer at markets, (ENF/E/08/036). 3 - How do you to determine if Approval is required? See the separate paper - 'Flow Diagram to determine if approval is required (Simplified)' (2 pages). See Appendix 1 - Map showing the 'local' area for an establishment in London 'Approval Determinator'. An interactive on-line version of the Approval's Group's 'Flow Diagram to determine if approval is required' has been developed by ABC Courses and is available free on their website at www.abc-courses.com. See the approval determinator link on the home page. Approval of food establishments June 08.doc Page 2 of 10

4 - What Approved establishments are there in Hackney? See Appendix 3 - 'Lists of establishments requiring approval in L B Hackney'. (Trainer to describe some of them). 5 - What difference do the requirements for Approval make to a business? Think of a ham factory, which requires approval because it takes in fresh meat, and processes it, and supplies the ham to other establishments. Compare this with a sandwich factory, which does not require approval, for the reason that it takes in processed foods of animal origin, (eg, ham and cheese). Before approval. The ham factory, (unlike the sandwich factory) - - Must not operate until it is approved by the food authority. Approval is a type of licensing. - Must comply with the one extra requirement for all approved establishments, ie, print the identification mark on the wrapping and packaging, (for the authorities to check). - Must comply with the extra requirements for approved meat products establishments, which are similar to those for meat cutting plants, (eg, chilled temperatures of meat and cutting rooms, non-hand operated taps, tool disinfection facilities). After approval. The ham factory - - May be prohibited from operating immediately, without the food officer having to go to court, by service of a 'remedial action notice'. - May have its approval suspended, or withdrawn. DISCUSSION (briefly) - Is Approval a burden on businesses? 6 - The procedure for approving an establishment An establishment subject to Approval - - Must not operate until it meets 'all the infrastructure and equipment requirements'. The establishment must first be inspected by a food officer, and may be granted Conditional Approval by the food authority. - Must complete all the remaining requirements of relevant food law within six months. The establishment must be inspected one or two more times by a food officer, and may be granted Full Approved by the food authority. 7 - What standards are required for Conditional Approval? See Appendix 2 - 'Checklist of the relevant requirements of food law... for Approval'. DISCUSSION (briefly). Contrast the standards required for an establishment for Conditional Approval with those for an establishment which is 'broadly compliant' with the law on food hygiene. Approval of food establishments June 08.doc Page 3 of 10

8 - What is the purpose of Approvals? Is the purpose of approving small establishments: - a pointless bureaucratic exercise? - or is it to ensure a strong control over food safety? 8.1 - Bureaucracy? The food officer must: - Record which legal requirements the establishment has yet to meet, and update this record after one or two revisits. - Send a Notification of Conditional Approval, or of Full Approval, to the FBO, or a notification of Refusal. - Inform the FSA of this. - Food officers when inspecting shops etc should check any foods of animal origin on the premises to see if they have an identification mark or health mark, and then check the approval code on the FSA or EC websites, and/or check with the Home Authority or the Originating Authority. The food business operator must: - Fill in an Application form. - Provide information on the proposed activities before operating. - If approved, apply his establishment's identification mark to food of animal origin which he supplies to other establishments. DISCUSSION (briefly). Which of these do you think is bureaucratic? or pointless? 8.2 - A strong control over food safety? Regulations (EC) 853/2004 and 882/2004, as interpreted by the Food Law Practice Guidance, ensure the safety of certain foods of animal origin by a tight procedure on approval, backed up by tough enforcement. - A food officer may prohibit from operating an establishment, which does not meet the important hygiene requirements. This really does ensure food safety. - A food officer can require an establishment to meet most of the hygiene requirements before it may even start operating. The express purpose of this stage is to ensure that a business is able to produce safe food. - After granting conditional approval, a food officer can require compliance with all the remaining hygiene requirements within six months. This fully controls the safety of the food within a tight timeframe. What greater controls over businesses could enforcement officers want for the purpose of benefiting public health? Examples of where immediate enforcement action was taken to control food safety. (Trainer to give the two examples in the article in Appendix 10). DISCUSSION (briefly). What do you think? Approval of food establishments June 08.doc Page 4 of 10

9 - What foods have officers found coming from establishments operating without approval, which involved Hackney? Food of animal origin found Smokies (singed mutton carcasses) Various cuts of meat African-style smoked turkey in small sealed plastic bags Fried fish balls on a tray wrapped in clingfilm Smoked prawns in plastic bags Salted mackerel in vacuumpacked bags Cut meat in large plastic bags Establishment they came from farms in Wales a meat cutting plant in Carpenters Road via a computer shop in Pearson Street a fish shop which also makes delicatessen products in Dunsmure Road a warehouse for storage and wholesale distribution, with some re-wrapping, in Waterden Road. a home in Bushberry Road a butchers shop in Chatsworth Road Establishments they were supplied to butchers shops in Ridley Road shops? (but surprisingly not butchers shops in Ridley Road) grocers shops in Thurrock shops in Barnet the cash and carry next door shops in Islington a shop in Cardiff 10 - Procedures on discovering an establishment operating without Approval - suggestions What you could do if you do find an establishment which is operating without approval. See Appendix 4 - Enforcement options for dealing with a business operating without approval Approval of food establishments June 08.doc Page 5 of 10

Appendix 1 - Map showing the 'local' area for an establishment in London A retail establishment in London may be subject to Approval if it supplies food of animal origin to other retail establishments beyond the 'local' area - Shown below. Approval of food establishments June 08.doc Page 6 of 10

Appendix 2 - Checklist of the relevant requirements of food law which an establishment must comply with for Conditional Approval or Full Approval London Food Co-ordinating Group's Approvals Sub Group. 18/04/2008. NWh This interpretation is based on: Regulation (EC) 882/2004, Article 31, (the approval procedure), Regulation (EC) 854/2004, Article 4, (the official controls), and Food Law Code of Practice, paragraph 5.1.8, (which states: 'Professional judgement should be used in deciding whether it would be appropriate to grant conditional approval, on a case by case basis',) The infrastructure and equipment requirements - for Conditional Approval which include 'the systems and services necessary... to produce safe food'. (Practice Guidance, A.3.4) Requirement Regulation General requirements of food law Regulation (EC) 178/2002, Articles 11-19. - See Reg 854, Art 4.4(i) Satisfactory Y / N Officer Manager General hygiene requirements Specific hygiene requirements for food of animal origin - for most products of animal origin, particularly imported products Regulation (EC) 852/2004, Annex II Regulation (EC) 853/2004 - Articles 3-8, & Products of Animal Origin Regulations - for specific products of animal origin - Annex III, the relevant Section(s) HACCP-based procedures (possibly excluding verification) Microbiological criteria including initial shelf-life studies... Conditional Approval for short shelf lives only until longer shelf lives are validated. Residues, contaminants and prohibited substances, & physical hazards (possibly excluding analysis) Regulation (EC) 852/2004, Article 5 Regulation (EC) 2073/2005 - See: Reg 854, Art 4.5(a) and Food Labelling Regulations - use-by date, storage conditions, conditions of use. Community legislation - See Reg 854, Art 4.5(b) & (c) Animal by-products Regulation (EC) 1774/2002 - See Reg 854, Art 4.2(c) The remaining requirements of food law - for Full Approval The general requirements (including minor matters) HACCP-based procedures (including verification) Microbiological criteria including testing... to validate longer shelf lives. Residues, contaminants & prohibited substances (including analysis) The regulations listed above Regulation (EC) 852/2004, Article 5 Regulation (EC) 2073/2005 Community legislation - See Reg 854, Art 4.5(b) Approval of food establishments June 08.doc Page 7 of 10

Appendix 3 - Lists of establishments requiring approval in L B Hackney. (Shortened for training purposes) M- Meat of domestic ungulates, poultry, game, etc (Sec I-IV). MM Minced meat (Sec V). MPrep Meat preparations (Sec V). MP Meat products (Sec VI). FP Fishery products (Sec VIII). DP Dairy products (Sec IX). EP- Eggs & egg products (Sec X). Others (Sec VII, XI-XV). PoAO- Products of animal origin. FoAO- Food of animal origin. PoPO- Products of plant origin. Approved establishments (enforced by the food authority) Trading name Address PoAO entering the establishment Operations FoAO supplied to other establishments Business customers Approval code Type of establishment Notes Manufacturing Fresh meat Cures, steams, etc. Fishmongers shop with manufacturing. Fresh fish. Fillets, minces, adds PoPO, cooks, etc. MP - Ham. FP- Fried fish balls, fish pate etc Restaurants, distributors, etc Grocers shops HY005. HY010. Conditional approval. Establishments to be investigated to determine whether approval is required Listed in order of priority for investigation Trading name Address PoAO entering the establishment Operations FoAO supplied to other establishments Manufacturing Eggs Boils, adds PoPO, & minces Manufacturing Dips containing egg products, in tubs. Fresh meat Cooks Meat-based ready to eat meals Frozen raw kebabs, & cut meat. at home Butchers shop Fresh meat Minces. Cuts & rewraps. Business customers Shops Shops in London Supplies kebab takeaways & restaurants, some outside 'local' area. Type of establishment Notes Officer Also makes dips from canned fish & vegetables. Wants to supply shops in Manchester. Private dwelling. Intends cooking at home and delivering to local shops. Butchers shop. Requires approval by FSA for cutting meat, and producing meat preparations. - Told FBO to stop supplying establishments outside the 'local' area. Approval of food establishments June 08.doc Page 8 of 10

Appendix 4 - Enforcement options for dealing with establishments operating without approval. (Some suggestions) (Establishments which most businesses and officers know require approval). The appropriate action could be decided on a case by case basis, and may depend on a range of matters. Eg: - An establishment which has been operating for years but which did not require approval before Jan'06, (eg, a fishmonger who supplies more than a marginal amount of his fish to restaurants). - An establishment whose operations include those which require approval, but which the food authority did not know about until recently, (eg, a delicatessen shop who supplies mainly the final consumer, but whose supplies to other shops has increased considerably). - A type of establishment which officers recognise might require approval, but no-one in the country has done so yet, (eg, a school with a large kitchen supplying other schools with satellite kitchens). - The apparent willingness and ability of food business operator to comply with the remaining items quickly. Type of establishment Suggested enforcement action Type Management of food safety Prosecution Require withdrawal of products Remedial Action Notice Manufacturing Poorly run Possibly Possibly Yes - Stop operations immediately Retail with Poorly run Possibly - Yes - Reduce operations manufacturing immediately to less than 25% food of animal origin per week, Manufacturing Controversial Retail with manufacturing Well run, but not quite up to standard for Conditional Approval. Well run, but not quite up to standard for Conditional Approval, (or 2 tonnes/week of meat). Possibly Possibly Possibly - Stop operations immediately Hygiene Warning letter Improvement Notice - - Possibly Possibly - Possibly - Permit operations to continue, but warn of prosecution if not fully compliant within 6 months. (See the suggested procedure in Appendix 5). Possibly - Possibly - Reduce operations immediately to less than 25% food of animal origin per week, (or 2 tonnes/week of meat). - Require improvements. Approval of food establishments June 08.doc Page 9 of 10

Appendix 5 - Discussions - some suggested answers (5) - What difference do the requirements for Approval make to a business? Discussion - Is Approval a burden on businesses? - Not operating until approved. "A business with no customers is no business". (7) - The standards required for Conditional Approval Discussion - Contrast the standards required for an establishment for Conditional Approval with those for an establishment which is 'broadly compliant' with the law on food hygiene. - Conditional Approval - high standards - 'Broadly compliant' - lower standards? (NI 184. Score <30 for food hygiene + structure + management) (8.1) - Is the purpose of approving small establishments a pointless bureaucratic exercise? Discussion - Recording what requirements have been met. - Tedious but necessary. - Information on proposed activities. HACCP and tracing suppliers and customers are the only legally required documents. Providing documented information on other matters may be unnecessarily bureaucratic for small businesses. (Craft bakers have complained to the FSA about this). - Applying the identification mark. Bureaucratic to require this for an establishment only supplying others in its own ownership. - Checking FSA websites or the Originating Authority. - Time-consuming, but food officers enquiring about food without identification marks is the main way we discover establishments operating without approval. (8.2) - Is the purpose of Approvals to ensure a strong control over food safety? Discussion - A food officer may prohibit from operating an establishment, which does not meet the important hygiene requirements. Quick. FBO may appeal against a RAN. - A food officer can require an establishment to meet most of the hygiene requirements before it may even start operating. In practice we discover that most establishments are already operating. - After granting conditional approval, a food officer can require compliance with all the remaining hygiene requirements within six months. In practice it takes a lot longer. Approval of food establishments June 08.doc Page 10 of 10