Explanatory Memorandum to the Food Hygiene (Wales) (Amendment) (No.2) Regulations 2012

Explanatory Memorandum to the Food Hygiene (Wales) (Amendment) (No.2) Regulations 2012 This Explanatory Memorandum has been prepared by the Food Standards Agency and is laid before the National Assembly for Wales in conjunction with the above subordinate legislation and in accordance with Standing Order 27.1. Member s Declaration In my view the Explanatory Memorandum gives a fair and reasonable view of the expected impact of the Food Hygiene (Wales) (Amendment) (No.2) Regulations 2012. I am satisfied that the benefits outweigh any costs. Lesley Griffiths AM Minister for Health and Social Services, one of the Welsh Ministers 4 July 2012

Explanatory Memorandum for the Food Hygiene (Wales) (Amendment) (No.2) Regulations 2012 1. Description The Food Hygiene (Wales) (Amendment) (No.2) Regulations 2012 will provide for the enforcement in Wales of certain directly applicable EU Food Hygiene Regulations1. The SI also provides for any reference to the Annexes in those EU Food Hygiene Regulations to be ambulatory. It also contains provisions for the form of a special health mark for meat from animal subject to emergency slaughter. 2. Matters of Special Interest to the Constitutional and Legislative Affairs Committee None 3. Legislative Background The Regulations are made in exercise of the powers conferred on Ministers by section 48(1) of the Food Safety Act 1990 and section 2(2) of and paragraph 1A of Schedule 2 to the European Communities Act 1972. The Welsh Ministers have been designated for the purposes of that section in relation to measures relating to food (including drink) including the primary production of food. This instrument is subject to the negative procedure. 4. Purpose and Intended Effect of the Legislation The Food Hygiene (Wales) (Amendment) (No.2) Regulations 2012 will provide for the enforcement in Wales of a number of directly applicable EU Food Hygiene Regulations (as detailed in the following section) which provide amendments to the Annexes of existing EU Food Hygiene Regulations, which largely provide specific rules for the production and handling of food of animal origin or for its importation. The following EU Regulations amend existing EU Food Hygiene Regulations in the following way: Plant Inspection Assistants (PIAs) voluntarily taking over some activities from meat hygiene inspectors in poultry and rabbit meat slaughterhouses To allow PIAs to be trained and qualified to the satisfaction of the designated Competent Authority to carry out official control duties in rabbit and poultry slaughterhouses. The Food Hygiene (Wales) (Amendment) (No.2) Regulations 2012 will provide for the enforcement in Wales of Regulation (EC) 1021/2008, amending Annexes I, II and III to Regulation (EC) 854/2004. Regulation (EC) 1021/2008 makes permanent the exemption provided for by Regulation (EC) 2076/2008 which allows slaughterhouse 1 Regulations (EC) 1020/2008, (EC) 1021/2008, (EC) 1162/2009 & Regulations (EU) 150/2011, (EU) 151/2011, (EU) 1276/2011

staff to be trained to the satisfaction of the designated Competent Authority (the Food Standards Agency (FSA)), to carry out official control duties in poultry and rabbit slaughterhouses without the requirement to pass the same examination as official auxiliaries. This allows the continuation of the practice pre-2006 which had permitted slaughterhouse staff to carry out post-mortem checks of poultry and rabbit meat under the supervision of the Official Veterinarian (OV) on a voluntary basis, if they were of a standard acceptable to the FSA. The exemption was welcomed by businesses. The objective is to maintain sufficient official controls in slaughterhouses to ensure that public health is protected, while minimising the burden on food business operators and the FSA. Clarifying which establishment can apply ID marks To ensure that the identification marks are applied solely to products handled by establishments within the EU, and not by establishments in third countries. Businesses, consumers and enforcers will be assured that the identification of products of animal origin indicates the establishment where the products were manufactured. EU Food Hygiene legislation ((EC) Regulation 853/2004) sets out requirements for health and identification marking on products of animal origin handled in establishments within the EU subject to approval. These marks are applied solely to products of animal origin manufactured or handled in approved establishments within the EU. The legislation also requires identification markings on products of animal origin produced in countries outside the EU, which can be either then name of the country (whether EU or non-eu), in which the establishment is located, or the two letter code for that country under international standards. Member States reported to the European Commission that confusion was caused by the current wording, which led to some establishments outside the EU using abbreviations for EU Member States on products due for import into the EU. This was not the intention of the legislation. This Food Hygiene (Wales) (Amendment) (No.2) Regulations 2012 will provide for the enforcement in Wales of certain provisions of Regulation (EC) 1020/2008 which provide clarity that abbreviations for EU Member States should only be included in the identification markings for products of animal origin manufactured by approved establishments within the EU. Certification of the correct slaughter and bleeding of farmed game To allow food business operators (FBOs) to carry out certification of the correct slaughter and bleeding of farmed game, including the date and time of slaughter at the place or origin, subject to the food business operator or their slaughterer having had approved training, rather than it being necessary for this to be carried out by an Official Veterinarian or Approved Veterinarian (OVs or AVs).

This Food Hygiene (Wales) (Amendment) (No.2) Regulations 2012 will provide for enforcement in Wales of certain provisions of Regulation (EU) 150/2011 and Regulation (EU) 151/2011 which amend the EU food hygiene regulations (Regulation (EC) 853/2004 and Regulation 854/2004 respectively), to allow food business operators to certify that the correct slaughter and bleeding of farmed game has taken place and the date and time of slaughter. These Regulations require the food business operator or those carrying out the slaughter and bleeding of the animals to be competent to perform these tasks. They also require regular checks by OVs or AVs to assess the performance of those who shoot and bleed farmed game on the farm. Regulation (EU) 150/2011 and Regulation (EU) 151/2011 also make some amendments to the requirements for wild game. They allow the whole heads of animals susceptible to Trichinella infestation, such as wild boar, to be sent to an establishment for producing a hunting trophy, pending the result of the required test for Trichinella, provided that there is full traceability. They also allow for a single declaration by a trained person to cover a number of large wild game animals, rather than requiring a declaration for each animal to be provided. The declaration indicates that no evidence has been found following examination after killing that the meat presents a health risk and that the animal displayed no abnormal behaviour before it was shot. The FSA considered that the rules covering the slaughter of farmed game in Regulation (EC) 853/2004 were disproportionate when seen with comparative rules governing wild game and the domestic slaughter of cattle, sheep, goats and pigs, which are killed with no veterinary involvement in the assessment of the correct slaughter or bleeding. All farmed deer slaughtered on-farm in the UK are shot by trained marksmen/women holding a recognised qualification which includes the ability to bleed deer in the correct manner. An additional feature of the new legislation requires these trained marksmen/women to be authorised in the same way as slaughtermen working in an abattoir. This could be verified by a veterinarian and subject to a regularl check to assess the performance of these marksmen/women. The Regulation would require those who shot and bled game on farm to hold a certificate of competence and be authorised in the same way as abattoir slaughtermen to carry out slaughter operations. This reflects the requirements in the new EU protection at time of killing Regulation (1099/2009) which come into force on 1 January 2013 and which will require the authorisation of all those who slaughter animals for human consumption whether they work in a slaughterhouse or on farm. The number of on-farm slaughter establishments affected by the new Regulations is set out in the table below by country and size of business.

Number of on-farm slaughter establishments by country Location/ Micro <20 Small Medium Large Total Firm Size England 25 0 6 0 0 31 Wales 0 0 0 3 0 3 Scotland 9 0 1 0 0 10 GB 34 0 7 3 0 44 Note: Sizes are defined by number of employees per premises as follows: Micro less than 10 employees; < 20 10-20 employees; Small 20-49 employees; Medium 50-249 employees; Large more than 250 employees. Distribution of size of business is based on an estimate using FSA Operations data on approved establishments and previous consultation responses. Requirements for health marking To provide clarification for the correct and consistent implementation of the requirements for health marking of carcases, for those importing meat into the EU from slaughterhouses outside the EU. The application of the health mark on meat is an important part of the traceability system, as it incorporates the plant approval number and the country of origin which identifies the place of production. The health mark is the official control that indicates the meat comes from the body of an animal that has been subject to ante and post mortem inspection in accordance with the Regulation (EC) No.853/20042, and when there are no grounds for declaring the meat unfit for human consumption. This SI provides for the enforcement in Wales of Regulation (EC) 1021/2008 which clarifies the requirements for the health marking of carcases of meat which are contained in Chapter III of Section I of Annex I to Regulation (EC) No 854/20043, where there are no grounds for declaring the meat unfit for human consumption. The Commission considers that some of these requirements have created confusion in the identification of products produced within the EU and products produced outside the EU. Regulation (EC) 854/2004 requires slaughterhouse operators to apply the health mark on carcases from domestic ungulates (hoofed animals) such as cattle, sheep, goats, pigs and horses, farmed game mammals (other than rabbits, hares and rodents), and large wild game that have passed ante and post-mortem inspection and are, therefore, considered fit for human consumption. Annex I, Section I, Chapter III of Regulation (EC) 854/2004 sets the requirement for health marking of carcases declared fit for human consumption. Currently point 3 (c) of chapter III of Annex I reads: (c ) when applied in a slaughterhouse within the Community, the mark must include the abbreviation C, EC, EF, EG, EK, EY, ES, EÜ, EB or WE. 2 http://eur-lex.europa.eu/lexuriserv/lexuriserv.do?uri=oj:l:2004:226:0022:0082:en:pdf 3 http://eur-lex.europa.eu/lexuriserv/lexuriserv.do?uri=oj:l:2004:226:0083:0127:en:pdf

The Regulation replaces paragraph 3 of Chapter III of Section I, point (c) with the following: (c) when applied in a slaughterhouse within the Community, the mark must include the abbreviation C, EC, EF, EG, EK, EY, ES, EÜ, EB or WE. Those abbreviations must not be included in marks applied on meat imported into the Community from slaughterhouses located outside the Community. Requirements for samples from class B live bivalve mollusc production areas To allow Competent Authorities to classify live bivalve mollusc (LBM) production areas as class B, as long as 90% of samples do not exceed 4,600 E.coli/100g of flesh, and the remaining 10% of samples do not exceed 46,000 E.coli/100g of flesh. This Food Hygiene (Wales) (Amendment) (No.2) Regulations 2012 will provide for the enforcement in Wales of certain provisions of Regulation (EC) 1021/2008 which amends Annex II of Regulation (EC) 854/2004 on official hygiene controls to make permanent the criteria for Class B LBM production areas. This criterion reflects that the hygiene legislation extant prior to 1 January 20064, when Regulation (EC) 854/2004 did not include the provision for the 10% non-compliant samples. This effectively required 100% of samples to meet the 4,600 E.coli limit. The amendment corrects an omission to the EU hygiene legislation which had resulted in a requirement for 100% of Class B samples to meet 4,600 E.coli limit would have been disproportionately burdensome for industry. Regulation (EC) 1021/2008 also sets a new requirement for an upper level of 46,000 E.coli/100g flesh which the remaining non-compliant 10% of samples must not exceed. The change will mean legislative certainty for stakeholders by making permanent the 90% requirement in Class B mollusc production areas, which is seen as proportionate and adequate to protect public health. The Class B LBM production area standard has been applied continuously since the introduction of the EU Hygiene legislation in 2006, even when it became apparent that the 90% provision had been omitted. The Regulation rectifies that omission. Harvesting areas are classified by the level of E.coli contamination found in shellfish sampled from that site. These areas were classified in Regulation (EC) 853/2004 as set out below, and it is against the limit for class B areas below that the amendment is compared: Class A shellfish contains less than 230 E.coli/100g flesh; can be placed on the market for direct human consumption. 4 Council Directive 91/492/EEC of 15 July 1991 laying down the health conditions for the production and the placing on the market of live bivalve molluscs. This can be viewed at: http:/ec.europa.eu/food/fs/sfp/mr/me02_en.pdf

Class B 90% of shellfish contains less than 4,600 E.coli/100g flesh; must be purified or relayed before placing on the market for direct human consumption. Class C shellfish contain less than 46,000 E.coli/100g flesh; must be heat treated using permitted method or relayed for a longer period before being placed on the market for direct human consumption. Harvesting is prohibited from areas exhibiting levels above the class C limit. There are currently 384 classified beds in England and Wales (54 in Wales), of these 339 (43 in Wales) meet the class B status (87%). It is envisaged that all of these would have been affected (i.e. by down grading to Class C) were the 100% provision to become permanent. Criteria for platelet count testing of raw cows milk To ensure that food business operators FBOs manufacturing dairy products from raw cows drinking milk will not have to carry out testing to establish the platelet count levels of milk prior to processing, as long as the milk is processed within the time scales specified in the FBOs own HACCP procedures. This Food Hygiene (Wales) (Amendment) (No.2) Regulations 2012 will provide for the enforcement in Wales of certain provisions of Regulation (EC) 1020/2008 which amends Annexe II and III of Regulation (EC) 853/2004 by setting a platelet count criteria for raw cows milk intended for the manufacturing of dairy products that should be required where milk has not been processed within the pre-defined time set out in the HACCP procedures. In addition the same principle applies to heat treated (processed) cows milk intended for the manufacturing of dairy products. This supports the principle that it should be possible to ensure food safety within the provisions of the HACCP procedures providing the age of the milk is taken into account. Enforcing these parts of Regulation (EC) 1020/2008 in Wales will mean FBOs manufacturing dairy products from raw cows milk will continue not to have to carry out testing to establish the platelet count levels of milk prior to processing as long as that milk is processed within the timescales set in their HACCP procedures. Import certificates for composite products To harmonise the requirements for the importation into the EU of animal health and composite food products, thereby ensuring that all food products which contain products of animal origin (POAO) are subject to the same official controls. The Food Hygiene (Wales) (Amendment) (No.2) Regulations 2012 will provide for the enforcement in Wales of certain provisions of Regulation (EC) 1162/2009 which provides for a derogation from Article 6.4 of Regulation (EC) 853/2004, allowing FBOs who import composite products (i.e. products which contain both products of plant origin and processed products of animal origin) from Third Countries do not have to meet the same official controls as imports of products of animal origin.

The provisions of Regulation 1162/2009: require that composite products which are imported into the EU which contain any processed meat, and composite products which contain half or more processed milk or fishery or egg product or other POAO content, and composite products which contain less than half milk product which does not meet certain conditions5 will need to be accompanied by a health certificate. This will enhance current food safety measures by ensuring that composite products which are manufactured in third countries are produced to the same hygiene standards as stipulated in EU Regulations for other POAO foods; and harmonise the public health requirements with the animal health requirements with advantages for the efficacy of enforcement of the animal health rules Use of clean water with fishery products To allow food business operators to use clean water (clean sea/fresh water) when handling fishery products, providing measures are in place to ensure this water is not a source of contamination for foodstuffs. Regulation (EC) 852/2004, Annex II, Chapter VII, 1(b) provides for FBOs to use clean water 6 with whole fishery products and supply adequate facilities for its availability. The use of clean water on fishery products has been permitted on fishing vessels since the implementation of the consolidated hygiene legislation. It has also been allowed on land based establishments to allow these establishments to adapt progressively. Clean water is currently defined in Regulation (EC) 852/2004 as including clean seawater and fresh water of a similar quality. As the quality of clean sea water (and by definition therefore clean water) can vary along the coastline, it will not represent a risk to public health if adequate control procedures are put in place by businesses to ensure that the use of such water in these establishments is not a source of contamination. This would be achieved by amending Annex II, Section VII of Regulation (EC) 852/2004 by Regulation (EC) 1019/2008 and Annex III, Section VIII of Regulation (EC) 852/2004 by Regulation (EC) 1020/2008. The Food Hygiene (Wales) (Amendment) (No.2) Regulations 2012 will provide for the enforcement in Wales of Regulation (EC) 1020/2008 which allows land based establishments to use clean water when handling fishery products. 5 This where the final products in not shelf-stable at ambient temperature or where they have not clearly undergone in their manufacture a complete cooking or heat treatment process throughout their substance, so that any raw product is not denatured. 6 The definitions used in this IA relating to water are set out in Regulation (EC) 852/2004, Article2 (h) and (i) respectively: clean seawater means natural, artificial, or purified seawater, or brackish water that does not contain micro-organisms, harmful substances or toxic marine plankton in quantities capable of directly or indirectly affecting the health quality of food; and, clean water means clean seawater and fresh water of a similar quality.

Temperature of eggs during transportation To allow individual Member States to specify national temperature requirements for the storage and transportation of eggs. This SI will provide for the enforcement in Wales of Regulation (EC) 1020/2008 which allows individual Member States to continue to specify existing national temperature requirements with regard to climatic conditions which prevail in that Member State for the storage and transportation of eggs, where this may be considered necessary to maintain the eggs in the most hygienic condition as required by Regulation (EC) 853/2004. EU food hygiene regulations (including Regulation (EC) 853/2004), which have applied from 1 January 2006, require eggs to be stored and transported at a temperature, preferably constant, that is best suited to assure optimal conservation of their hygiene properties. However, those Member States which had before 1 January 2006 preferred to transport eggs under temperature requirements laid down in their own national legislation could continue to do so under Regulation (EC) 2076/2005. Since the implementation of Regulation (EC) 2076/2005, the use of national temperature requirements for the storage and transport of eggs has been considered further, and found not to interfere with the food safety objectives described in Regulation (EC) 853/2004. No specific temperature requirements beyond the basic requirements stipulated in Regulation (EC) 853/2004 are in force in Wales and the amendment does not impose any new requirements to be implemented for the storage and transportation of eggs. It is possible that if eggs were exported to another Member State, producers or wholesalers in Wales would need to comply with national requirements of that Member State. Requirements for cracked eggs and their transportation to approved establishments for processing To allow food business operators to be approved to break out cracked eggs and transport the frozen or refrigerated content for processing at an establishment approved for that purpose. Regulation (EC) 853/2004 lays down special hygiene measures for food businesses handling products of animal origin, including, in Annex III, Section X, Chapter II, measures for eggs and egg products. Regulation (EC) 853/2004 also consolidates the previous EC food hygiene legislation that applied to establishments handling food of animal origin, including EC Directive 89/437 on hygiene and health problems affecting the production, and the placing on the market of egg products. Since 1 January 2006, the legal requirements for egg products have been the liquid egg and processed egg content e.g. pasteurised egg yolk, can only be produced by approved establishments. However, the effect of these provisions was to prevent the breaking out (i.e. the removal of the white and yolk) of cracked eggs by

producers and packers for heat treatment at another approved establishment, which was previously allowed. This is a common practice in small and large businesses, because it is very simple and approval requirements are minimal. The Food Hygiene (Wales) (Amendment) (No.2) Regulations 2012 will provide for the enforcement in Wales of Regulation (EC) 1020/2008, which allows practices undertaken prior to 1 January 2006 to continue. Importation of fish oils To introduce a further limit for total volatile basic nitrogen (TVB-N) for all fishery products used directly in the preparation of fish oil. Article 10 of EC Regulation 852/2004 establishes that the hygiene of foodstuffs imported into EU Member States from establishments in third countries must comply with the requirements set out in Article 3 to 6 of the Regulation. This means that foodstuffs imported into the EU must have been manufactured under the same requirements as food manufactured in the EU. Due to the lack of marine resources in Europe, the supply of fish oil is almost exclusively dependent upon imports from third countries. Fish oils are mainly imported as crude or semi-refined oils that are refined for human consumption. Fish oils contain Omega 3, and are used mainly in infant food products and food for particular nutritional uses. Prior to January 2006, when the Food Hygiene (Wales) Regulations 2006 came into force, fish oil was not covered by EU legislation on the hygienic production of fish and fishery products, as it was not included in the definition of fishery products. However, in November 2006, Regulation (EC) 1662/2006, Annex II, point 2, (by amending Regulation (EC) 853/2004) introduced specific hygiene requirements as regards the raw material used in the preparation of fish oil for human consumption. The issue was raised at the meeting on the Commission Working Group on Hygiene Legislation held on 19 May 2008, where there was general agreement that the proposed TVB-N parameter of 60 plus a satisfactory organoleptic (flavour, odour, appearance, texture) assessment (with some fish species to have higher limits). The Food Hygiene (Wales) (Amendment) (No.2) Regulations 2012 will provide for the enforcement in Wales of Regulation (EC) 1020/2008 which introduces further specific hygiene measures as regards the TVB-N limits for fish oil. The TVB-N parameter is an indicator of protein quality, and the limit is now 60 mg of nitrogen/100g of whole fish products, used directly for the preparation of fish oils for human consumption. Member States may also set limits at a higher level for certain species pending the establishment of specific Community legislation.

Food chain information requirements To provide legislative clarification on the requirements for food chain information (FCI) to accompany animals for slaughter for human consumption to ensure they are implemented consistently between businesses and countries within the EU. The Food Hygiene (Wales) (Amendment) (No.2) Regulations 2012 will provide for the enforcement in Wales of Regulation (EC) 1020/2008 which seeks to clarify the requirements for FCI contained in Section III of Annex II to Regulation (EC) 853/2004, as regards the implementation of FCI within the EU and outside the EU. Annex II, Section III of Regulation (EC) 853/2004 lays down specific rules for food of animal origin, requires slaughterhouse operators to request, receive, check and act upon FCI for poultry, pigs, cattle, sheep and horses and calves sent to slaughterhouses. Regulation (EC) 1020/2008 will amend Annex II, Section III, Point 1 & 3 of Regulation (EC) 853/2004. It aims to replace the word Food Safety Information with Food Chain Information. This does not introduce any new requirement. Treatment to kill viable parasites in fishery products for human consumption To allow food business operators to adapt the freezing controls applicable to farmed fishery products under certain controlled conditions. The Food Hygiene (Wales) (Amendment) (No.2) Regulations 2012 will provide for the enforcement of Commission Regulation (EU) 1276/2011which amends Annex III of Regulation (EC) 853/2004 to allow FBOs to make evidence-based freezing exemptions for farmed fishery products reared under certain controlled conditions. A freezing exemption will be available for farmed fishery products exclusively reared in an environment that if free from parasites, or where FBOs can verify through procedures, approved by the competent authority, that they do not present a health hazard. The introduction of this specific freezing exemption for farmed fishery products will reduce regulatory burdens on the UK fish farming industry and address a long term issue for the UK salmon farming sector which, under the current legislation, is required to freeze raw ready to eat products derived from farmed salmon such as sushi, sashimi and gravadlax. Research carried out by the FSA in Scotland7 found that the risks to human health from Anisakis nematodes in farmed Atlantic salmon are negligible, a conclusion also reached by EFSA 8 following their evaluation of the FSA research. This provides the necessary evidence that will enable FBOs to apply the freezing exemption to farmed salmon. The Commission Regulation maintains the existing national flexibility that allows competent authorities in Member States to authorise a freezing exemption for fishery products when sufficient epidemiological evidence is available indicating that the fishing grounds of origin do not present a health hazard with regard to the presence of parasites, although this now specifically relates to wild catches. Retention of this national flexibility enables the UK to authorise such an exemption for wild catches 7 Petrie, A, et al. A Survey of Anisakis and Pseudoterranova in Scottish fisheries and the efficacy of current detection methods: Food Standards Agency in Scotland, Study S14008, 2007 8 http://www.efsa.europa.eu/en/scdocs/doc/1543.pdf

provided the fishing grounds of origin do not present a health hazard with regard to the presence of parasites. Freezing requirements for cold smoked fishery products have also been updated to ensure they are risk-based without compromising public health protection and extended to cover all species of fish that have not undergone a heat treatment of at least 60 C, unless there is sufficient evidence of negligible risk to allow a freezing exemption to be applied. Previously, Regulation (EC) No. 853/2004 only required that cold smoked herring, mackerel, sprat and wild Atlantic and Pacific salmon needed to be frozen before consumption. There is no change in the requirements applicable to marinated/salted fishery products. They will continue to be required to undergo a freezing treatment if the processing of such products is insufficient to kill viable parasites. The Regulation maintains current documentation requirements for fishery products that are subject to a freezing treatment. These must be accompanied by a document from the FBO performing the freezing treatment stating the type of treatment they have undergone, except when supplied to the final consumer. However, the Regulation introduces a new obligation on FBOs to ensure that any wild or farmed fishery products placed on the market without having undergone a freezing treatment to kill parasites originate from a fishing ground or fish farm that complies with the specific conditions set out in the exemptions. This may be met by information in commercial documentation or any other information accompanying the fishery products. Both of these requirements will ensure food business operators maintain traceability throughout the food chain and apply appropriate freezing controls to protect consumer health. Businesses Affected Farmed Salmon UK Salmon Fish Farming Businesses by Country and Size Micro Small Medium Large Total England 0 0 0 0 0 Wales 0 0 0 0 0 Scotland 20 5 1 4 30 Northern Ireland 0 0 1 0 1 UK Total 20 5 2 4 31 Firm size is based on the number of employees within an organisation. Micro 0-9 employees, Small 10 49 employees, Medium 50 249 employees and Large 250+ employees Note: totals may not sum due to rounding

Farmed Trout UK Trout Fish Farming Businesses by Country and Size Micro Small Medium Large Total England 128 2 0 0 130 Wales 25 0 0 0 25 Scotland 39 1 0 0 40 Northern Ireland 4 0 0 0 4 UK Total 196 3 0 0 199 Firm size is based on the number of employees within an organisation. Micro 0-9 employees, Small 10 49 employees, Medium 50 249 employees and Large 250+ employees Note: totals may not sum due to rounding Background information The existing EU Food Hygiene Regulations are directly applicable and have been in force since 1 January 2006. The Regulations apply to all food business operators (i.e. businesses or organisations supplying, handling, producing, transporting or manufacturing food on a regular basis) and to foodstuffs imported into and exported from EU Member States. EU Member States are required to provide enforcement of directly applicable EU Regulations. The EU Regulations are given effect in Wales by the Food Hygiene (Wales) Regulations 2006 (SI. 2006 No.31 (W.5)). Failure to provide enforcement could mean the European Commission raising infraction proceedings against the Member State concerned. In order that amendments to EU Regulations can also be enforced, amendments to the Food Hygiene (Wales) Regulations 2006 are required by the provision of amending national instruments at appropriate times, although the making of the Food Hygiene (Wales) (Amendment) (No.2) Regulations 2012, which contain the ambulatory reference, will mean that this will no longer be necessary in the majority of cases. The Food Hygiene (Wales) (Amendment) (No.2) Regulations 2012 also contains a provision laying down the format for the special mark that is applied to the meat from animals that were slaughtered outside the slaughterhouse (emergency slaughter). EU law requires that meat from animals slaughtered away from the slaughterhouse to be marketed only in the country of slaughter and to bear a special health mark. However, the format of such a special health mark has not been specified in EU legislation. Food Hygiene rules contained in Regulation (EC) 852/2004, Regulation (EC) 853/2004 and Regulation (EC) 854/2004. These lay down, respectively, hygiene requirements for all food businesses, additional hygiene requirements for food businesses dealing in products of animal origin, and requirements for the organisation of official controls on products of animal origin for human consumption. Annex III, Section I, Chapter VI of Regulation (EC) 853/2004 sets out the requirements relating to the emergency slaughter of certain animals. Slaughter of an animal outside the slaughterhouse is restricted to an otherwise healthy animal which

has suffered an accident preventing its transport to the slaughterhouse for welfare reasons. A veterinarian must carry out an ante-mortem inspection of the animal prior to slaughter. The slaughtered and bled animal must then be transported hygienically to the slaughterhouse without undue delay. Point 9 of Chapter VI requires that FBOs may not place meat from animals having undergone emergency slaughter on the market, unless it bears a special health mark which cannot be confused with the health mark provided for in Regulation (EC) No. 854/2004, or with an identification mark provided for in Annex II, Section I to Regulation (EC) No. 853/2004. It also requires that such meat may be placed on the market only in the Member State (MS) where slaughter took place, and in accordance with national law. The special health mark is both a health mark applied to carcases and an identification mark applied to cut meat and products derived from such meat. This will be made clear to enforcement authorities and interested parties when the Regulations come into force. In the UK, the format of the mark that is required is a square mark containing in legible form the letters UK in the upper part, the approval number of the premises in the centre and the letter N in the lower part. This format is the same format as a national mark used under previous legislation for a similar purpose, thus keeping costs to business to a minimum. The format of the health and identification mark to be used has already been determined by the Agency and was included in its Guide to Food Hygiene and other Regulations for the UK Meat Industry Guide (MIG) issued in December 2006 to FBOs at abattoirs and cutting plants. The MIG provides advice on what FBOs should do to comply with the requirements of the EU Regulations and the format of the mark is described in the MIG. It can be accessed at the Food Standards Agency website9. The format of the special mark will be set out in the Food Hygiene (Wales) (Amendment) (No.2) Regulations 2012. 5. Consultation The SI has been subject to two formal public consultations from 6 April to 23 June 2010. The ambulatory reference and special health mark provisions were included in that consultation version (a Regulatory Impact Assessment (RIA) on the special health mark was provided and is included in the RIA section of this Explanatory Memorandum and no objections were raised on either of these issues by respondents to the consultation (no responses were received to the consultation in Wales). A number of other RIAs relating to various (generally minor) amendments to EU Regulations which were also put out to consultation in 2010 are now finalised and included with this document. Two RIAs are also included which were consulted on later in 2010 and 2012. A formal public consultation on the draft Food Hygiene (Wales) (Amendment) (No.2) Regulations 2012 and two of the associated draft RIAs was held between 9 December 2011 and 9 March 2012. Two responses from industry representative bodies were received in Wales. Concerns were raised from industry bodies across 9 http://www.food.gov.uk/foodindustry/meat/guidehygienemeat, the relevant section is Part 2, Chapter 13, Paragraph C3.

the UK with regard to revised wording of the proposed special health mark provisions, objecting that the provisions now required the use of mark on various meat products (or their packaging) derived from emergency slaughtered meat and that EU regulations did not require this. However, this is not a new issue in that the EU Regulations anyway required the use of a national mark, but the UK has chosen to amend the provisions to make this clear. The European Commission has made it clear that national special marks must be introduced and used for the carcases, meat and other products derived from animals that have been slaughtered under the emergency slaughter arrangements. Failure to provide for such provisions could lead to infraction proceedings against the UK raised by the European Commission. 6. Regulatory Impact Assessment Plant Inspection Assistants (PIAs) voluntarily taking over some activities from meat hygiene inspectors (MHIs) in poultry and rabbit meat slaughterhouses 6.1.1 Options Do nothing. Enforcement of Regulation (EC) 1021/2008 would not be provided for in Wales and the UK would be in breach of its EU Treaty obligations. Provide for the enforcement in Wales of Regulation (EC) 1021/2008, which allows slaughterhouses to train their own staff to carry out official controls in meat plants under supervision of the Official Veterinarian (OV). This is the preferred option. 6.1.2 Costs There would be no incremental costs There may be costs associated with letting PIAs know that the Regulation will be adapted into law. Since this would simply be a continuation of the current practice, it should be quite easy to convey this information to both plants and PIAs. It is assumed that this will take a maximum of 1 hour for managers to understand and brief their PIAs, and 15 minutes for PIAs to understand this. This equates to a total one-off cost to industry of approximately 97, comprising of 42 (2 slaughterhouses 1 hour @ 21 per hour) for poultry managers, and 55 to PIAs (20 PIAs 0.25 hours @ 11 per hour). 6.1.3 Benefits There would be no incremental benefits.

There are considerable benefits to industry and the FSA by adopting option 2, as this would allow FBOs of poultry and rabbit slaughterhouses to continue to use PIAs instead of MHIs where they chose to, which is a more efficient way of carrying out official controls, while maintaining a high standard of public health protection. Since this would be a business decision for each individual slaughterhouse, it is not possible to predict how many may move to using PIAs in future, therefore, the benefit cannot be quantified. 6.1.4 Consultation An informal consultation took place with the British Poultry Council (BPC), the Royal Society for the Promotion of Health (RSPH), Meat Training Council (MTC), with FSA officials (who were at the time part of the Meat Hygiene Service, which has now become part of the FSA), Veterinary Advisers (VAs) and the Department of Agriculture and Rural Development (DARD) in Northern Ireland. No objections were raised. The BPC fully supports the move to make permanent the need for PIAs to be trained only for the specific tasks they perform, and to the satisfaction of the Competent Authority. They are particularly keen to increase uptake of PIAs, particularly in the context of the move to full cost recovery. Small businesses such as the operators of licensed poultry meat and wild game meat plants were also formally consulted. The FSA conducted a formal public consultation between 6 April and 23 June 2010 on the draft Food Hygiene (Wales) (Amendment) (No.2) Regulations 2012, together with an RIA on this Regulation. No further data was received in regards to the considered costs and benefits. 6.1.5 Enforcement The FSA will remain responsible for enforcement of official controls. FBOs performing official control duties will do so subject to that food business operator or those that slaughter and bleed the animals having had the appropriate training and being subject to regular verification checks by the OV/AV. 6.1.6 Competition Assessment The proposal is not expected to either directly or indirectly limit the number or range of suppliers. It should not limit the ability of suppliers to compete or reduce suppliers incentives to compete vigorously. The use of PIAs may actually open the market and encourage competition. It encourages efficiency in official controls in the poultry sectors. There is obviously a limited number of PIAs needed in the industry, but there will be an ongoing level of turnover that will support a small market for training and/or contracting. The market will be open to all interested parties.

Clarifying which establishment can apply ID marks 6.2.1 Options Do nothing. Enforcement of Regulation (EC) 1020/2008 would not be provided for in Wales and the UK would be in breach of its EU Treaty obligations. Provide for the enforcement in Wales of Regulation (EC) 1020/2008, which provides clarity on abbreviations for EU Member States should only be included in the identification markings for products of animal origin manufactures by approved establishments within the EU. This is the preferred option. 6.2.2 Costs There would be no incremental costs. As this option does not impose any new requirements on business or enforcement authorities in Wales, there are no costs expected to arise. However, there may be costs for third countries if they need to change their identification marking requirements, and for the European Commission in enforcing the requirements. 6.2.3 Benefits There would be no incremental benefits. Provides clarity to business and enforcement authorities on the use of health marks, which would ensure that the information provided by those exporting products of animal origin (POAO) to the EU is not misleading. It will also put the EU in a better legal standing to address any misuse of identification marks. This would have benefits in improving information to consumers and businesses, and contribute towards improved traceability. 6.2.4 Consultation The FSA is aware that the clarification will be welcomed by Competent Authorities as the issue was first raised by them. The FSA conducted a formal public consultation between 6 April and 23 June 2010 on the draft Food Hygiene (Wales) (Amendment) (No.2) Regulations 2012. No comments were received on this issue. 6.2.5 Enforcement There will be no significant change to enforcement authorities. However, the preferred option will make it easier for inspectors to identify products produced outside the EU.

6.2.6 Competition Assessment The proposal is designed to improve accuracy of information for industry and consumers. Therefore, it is not expected to either directly or indirectly limit the number or range of suppliers. It should not limit the ability of suppliers to compete or reduce suppliers incentives to compete vigorously. Certification of the correct slaughter and bleeding of farmed game 6.3.1 Options Do nothing. Enforcement of Regulation (EU) 150/2011 and Regulation (EU) 151/2011 would not be provided for in Wales and the UK would be in breach of its EU Treaty obligations. Apply the requirements of Regulation 853/2004 and Regulation 854/2004, which requires an approved AV/OV to confirm that the animals have been slaughtered correctly. Option 3 Provide for the enforcement in Wales of Regulations (EU) 150/2001 and 151/2011, which allow the certification of the correct slaughter and bleeding at the place of origin under the supervision of the FBO, subject to the FBO or their slaughterer having had appropriate training an being subject to regular verification checks by OVs/AVs. This is the preferred option. 6.3.2 Costs There are no incremental costs. Industry Farmers would incur inspection costs for an OV/AV carrying out an ante mortem inspection per slaughter occasions. In Wales an average of 6-19 animals were slaughtered and inspected per occasion during 2011/12. It is estimated that 186 farmed deer were slaughtered during that period at the 1 approved on-farm slaughtered facility in Wales. This equates to 13 slaughtering occasions in that year. It is envisaged that a typical inspection will last one hour with an additional two hours for travelling to and from the location; meaning a total inspection time of 3 hours. The cost per inspection can be quantified by multiplying the time a typical inspection takes (3 hours) by the hourly wage rate of an AV ( 23.8910), which results in a cost per inspection 10Wage rate obtained from The Annual Survey of Household Earnings (2011) (http://www.statistics.gov.uk/statbase/product.asp?vlnk=15313). Median hourly wage of Veterinarians is used ( 18.38 plus 30% overheads)

of 71.6711. To quantify the annual inspection cost per farm we multiply the number of inspections carried out per farm (ranging from 23 45 per year) by cost per inspection ( 67.70). We estimate an average inspection cost per farm of approximately 1,648 to 3,22512 per year, which will equate to the total average annual cost of inspections to farmers in Wales for the 1 on-farm slaughter establishment. Taking the midpoint we derive a best estimate of 2,301.9413. Certification costs We assume that the requirement for certification of slaughter and bleeding would have increased the cost from 45 per consignment of animals by an additional 45-90, depending on how long the process would have taken. Taking the midpoint we derive a best estimate of 67.5014. It is estimated that 13 slaughtering occasions are carried out in Wales during 2011/1215; resulting in an incremental annual total cost to industry for certification of around 1,035-4,050 per year. Taking the midpoint we derive a best estimate of 2542.5016. Familiarisation Costs There would be a reading and familiarisation cost to farmed game establishments for reading Regulation (EC) 853/2004. It is estimated that it would have taken 1 hour per business to read and become familiar with the Regulation s requirements and disseminate this through the business. Based on current estimation there is 1 farmed game establishments operating in Wales that could be directly affected. To quantify the one off familiarisation cost to industry we calculated the familiarisation cost per business by multiplying the hourly wage rate of a farm manager ( 17.52)17 by the one hour taken to understand the regulation, resulting in a familiarisation cost per business of 17.5218. The estimated one-off familiarisation cost to businesses in Wales is 17.52. Enforcement There are no additional costs associated with this option, other than familiarisation with the regulations. We estimate that each OV would have invested 1 hour reading and familiarising themselves with the Regulations and disseminating to key staff in the organisation. To quantify the familiarisation cost to the Agency we need to calculate the familiarisation cost per OV reading the regulation. A median hourly wage rate of 23.8919 has been applied to an OV, and when multiplied by the reading time equates to a familiarisation cost per OV of 23.89. To quantify familiarisation costs to the Agency in Wales we multiply the familiarisation cost per OV by the number of OV s in Wales (estimated to be around 35), which equates to a one-off familiarisation cost of 83620. 11 3 hours * 23.89 = 71.76 12 Lower bound estimate 1,557.19) = Cost per inspection per farm ( 1,557.19) * Number of on-farm slaughter establishments in Wales (1) Upper bound estimate ( 3,046.68) = Cost per inspection per farm ( 3,046.68) * Number of on-farm slaughter establishments in Wales (1) 13 Calculated by taking the midpoint of the range: ( 1,557.19+ 3,046.68)/2 = 3,301.94 14 Calculated by taking the midpoint of the range: ( 45 + 90)/2 = 67.50 15 Lower bound estimate (= 23 inspections per annum per farm * 1 on-farm slaughtering establishments in Wales Upper bound estimate = 45 inspections per annum per farm * 1 on-farm slaughtering establishments in Wales 16 Calculated by taking the midpoint of the range: ( 1,035+ 4,050)/2 = 2,542.50 17Wage rate obtained from The Annual Survey of Household Earnings (2011) (http://www.statistics.gov.uk/statbase/product.asp?vlnk=15313). Median hourly wage of a Managers In Farming, Horticulture, Forestry And Fishing is used ( 13.48 plus 30% overheads) 18 1 hour * 17.52 = 17.52 19 Wage rate obtained from The Annual Survey of Household Earnings (2011) (http://www.statistics.gov.uk/statbase/product.asp?vlnk=15313). Median hourly wage of a Veterinarians is used ( 17.36 plus 30% overheads) 20 35 * 23.897 = 836

The table below displays the number of OV s along with the familiarisation cost for the Agency broken down by country. Familiarisation cost to the Agency Country Number of OV's Total familiarisation cost England 271 6,474 Wales 35 836 Scotland 52 1,242 GB 358 8,553 Note: Totals may not sum due to rounding. Costs are estimated by multiplying wage rates uplifted by 30% to account for overheads. This means that the wage rates reported in the text are approximate to 2 d.p. and when grossed may result in rounding error. Option 3 Industry There will be an additional cost arising from the verification check on the competence of the person carrying out slaughter and bleeding operations. Although this will fall to a person, who is unlikely in most cases to be the FBO, the cost is likely to be passed on to the FBO as part of the overall cost of carrying out this work. The verification checks will need to be carried out on a regular basis but could be once every 2-3 years at a cost of about 20-30 each time. Training Costs There may be a small additional burden for those that undertake the slaughter and bleeding to undertake the necessary training. However, for those who currently carry out this work the FSA will seek to establish whether the training that they have carried out in the past is sufficient to meet the needs of this element of the proposal that such people who slaughter and bleed farmed game are competent to do so. We understand that a number of those who carry out this work are already trained to act as the trained person in wild game hunting parties. We have assumed that one employee per business will attend initial training. It is estimated that the average one-off training cost to industry in Wales would equate to 170. The cost of training is based on the cost of a farmer attending training for two days. The training cost applied is quantified by multiplying two working days of a farmer lost to training (14 hours) by the hourly wage rate of a farmer ( 12.1421), which equates to a cost per farmer being trained of 170. 6.3.3 Benefits There are no incremental benefits. 21 Wage rate obtained from The Annual Survey of Household Earnings (2011) (http://www.statistics.gov.uk/statbase/product.asp?vlnk=15313). Median hourly wage of a Farmers is used ( 9.34 plus 30% overheads)