MEAT HYGIENE SECTION TRADER NOTICE REF MHS 6 /2006 SUBJECT: IMPLEMENTATION OF COMMISSION REGULATION ON MICROBIOLOGICAL CRITERIA FOR FOODSTUFFS. TO THE MANAGEMENT AT MEAT PROCESSING ESTABLISHMENTS Background Commission Regulation (EC) No. 2073/20051 harmonises the microbiological criteria for foodstuffs and came into effect on 1 January 2006. The Regulation applies to all Food Business Operators (FBOs) involved in the processing and distribution of Food (fresh meat, meat preparations, minced meat, meat products) [NB – Primary Production and Retail not included]. The microbiological criteria have been adopted in accordance with the procedure referred to in Article 14(2) of Regulation 852/2004 giving rise to the Commission Regulation on Microbiological Criteria in Foodstuffs. The criteria outlined in the Regulation are based on scientific risk assessment and are necessary to protect public health. Food Business Operators (FBOs) are obliged to comply with the microbiological criteria requirements as referenced under Regulation (EC) No 178/20022 of the European Parliament and of the Council and Article 4.3 (a) of Regulation (EC) No 852/20043 [H 2]. Information Links DAF http://www.agriculture.gov.ie/index.jsp?file=trade_exports/app_meat_est/index.xml 1 OJ L 338 of 22.12.2005, p. 1 OJ L 31 of 1.2.2002, p. 1 3 OJ L 226 of 25.6.2004, p. 3 2 FSAI http://www.fsai.ie/publications/leaflets/new_food_law/new_food_law_micro_criteria. pdf EU Commission http://europa.eu.int/comm/food/food/biosafety/salmonella/microbio_en.htm National Food Centre – Teagasc http://www.teagasc.ie/publications/2003/microbiologicaltesting.htm The Commission Regulation lays down the microbiological criteria for certain microorganisms and the implementing rules to be complied with by FBOs when implementing the general and specific hygiene rules referred to above. The Competent Authority shall verify compliance with the rules and criteria laid down in this Regulation without prejudice to its right to undertake further sampling and analyses for the purpose of detecting and measuring other micro-organisms, their toxins or metabolites, either as a verification of processes, for food suspected of being unsafe, or in the context of risk analysis. Testing against the criteria should be undertaken by FBOs when validating and verifying the correct functioning of their HACCP based procedures. In general these should be in proportionate to the risk associated with the foodstuff and the nature and size of the business. The Regulation also allows flexibility in relation to the analytical reference method and the sampling plan. Alternative analytical reference methods are acceptable once they have been validated, certified or authorised under the provisions of the Regulation. The number of sample units in the sampling plan can be reduced if the FBO can demonstrate that effective HACCP based procedures are in place. Some Useful Definitions Chapter 1 of Annex 1 to Regulation 2073 / 2005 includes explanatory references to 26 food categories. However for the purposes of this Trader Notice the definitions specified below are referenced as key definitions. “microbiological criterion” means a criterion defining the acceptability of a product, a batch of foodstuffs or a process, based on the absence, presence or number of microorganisms, and/or on the quantity of their toxins/metabolites, per unit(s) of mass, volume, area or batch. “food safety criterion” means a criterion defining the acceptability of a product or a batch of foodstuff applicable to products placed on the market. These criteria define the acceptability of a foodstuff in terms of its microbiological safety. They are applicable to foodstuffs placed on the market and through their shelf life. If a sample is unsatisfactory for a food safety criterion, the product or batch of foodstuff should be withdrawn or recalled from the market. “process hygiene criterion” means a criterion indicating the acceptable functioning of the production process. Such a criterion is not applicable to products placed on the market. It sets an indicative contamination value above which corrective actions are required in order to maintain the hygiene of the process in compliance with food law. These criteria indicate if the production process is operating in a hygienic manner. They are applicable to foodstuffs at various stages throughout their production process. If a sample is unsatisfactory for a process hygiene criterion, improvements in production hygiene should be undertaken. General Requirements FBOs shall ensure that foodstuffs comply with the relevant microbiological criteria set out in Annex I of the Regulation. FBOs responsible for the manufacture of foodstuffs shall conduct studies in accordance with Annex II of the Regulation in order to investigate the compliance with the criteria throughout the shelf-life. In particular, this applies to ready-to-eat foods that are able to support the growth of Listeria monocytogenes and that may pose a Listeria monocytogenes risk for public health. It is recognised that there may be an issue of resources for some FBOs (especially SMEs) and the Regulation allows for collaboration between FBOs in conducting these studies. Sampling The sampling rules are laid down in Annex I of the Regulation, including sampling plans and general rules for sampling and preparation of samples It also includes sampling in slaughterhouses and at premises producing minced meat and meat preparations, sampling frequencies for carcases, minced meat, meat preparations and mechanically separated meat. The sampling plans and methods in Annex I shall be applied as reference methods. The Regulation requires that samples shall be taken from processing areas and equipment used in food production, when such sampling is necessary for ensuring that the criteria are met. FBOs manufacturing ready-to-eat foods which may pose a Listeria monocytogenes threat for public health, shall sample processing areas and equipment for Listeria monocytogenes as part of their sampling scheme. Testing FBOs shall perform testing as appropriate against the microbiological criteria set out in Annex I of the Regulation when they are validating or verifying the correct functioning of their procedures based on HACCP principles and good hygiene practice. FBOs shall decide the appropriate sampling frequencies, except where Annex I provides the appropriate sampling frequencies, in which case the sampling frequency shall be at least that provided for in Annex I. FBOs shall make this decision in the context of their procedures based on HACCP principles and good hygiene practice, taking into account the instructions for use of the foodstuff. The frequency of sampling may be adapted to the nature and size of the food business, provided that the safety of foodstuffs will not be endangered. Unsatisfactory Results When unsatisfactory results are obtained from testing against food safety criteria set out in Chapter I of Annex I, the product or batch of foodstuffs shall be withdrawn or recalled. In the event of unsatisfactory results as regards process hygiene criteria, the actions laid down in Annex I, Chapter 2 shall be taken. These include improvements in slaughter hygiene and review of process controls, origin of animals and biosecurity measures in the farms of origin. Trend Analysis FBOs shall analyse trends in the test results and when a trend towards unsatisfactory results is observed, they shall take appropriate actions without undue delay to remedy the situation in order to prevent the occurrence of microbiological risks. Process Hygiene Criteria The Process Hygiene Criteria for carcases of food animals and also minced meat, meat preparations and mechanically separated meat are laid down in Chapter 2 of Annex I of the Regulation. The criteria in relation to carcases are similar to the existing regime laid down in the European Communities (Fresh Meat and Poultry Checks on General Hygiene) Regulations, 2003 for which the National Food Centre provided a Guidance Note (June 2003 Note No: NFC/Meat/1/2003). However, there is one significant difference in relation to carcases in that Salmonella is now included as an indicator of process hygiene. The criteria that apply to minced meat and meat preparations are similar to those laid down in the 2nd and 3rd Schedule to the European Communities (Minced Meat and Meat Preparations) Regulations, 1996. The criteria applying to minced meat now also apply to mechanically separated meat. Food Safety Criteria Listeria monocytogenes in ready-to-eat foods able to support its growth The limit is absence in 25 g and applies before the food has left the immediate control of the FBO who has produced it and who is unable to demonstrate to the satisfaction of the Department that the product will not exceed the limit of 100 cfu/g throughout the shelf life. Salmonella in Minced meat, Meat Preparations, Mechanically Separated Meat and Meat Products from Poultry Meat Placed on the Market and Intended to be Eaten Cooked The limit is absence in 10g (and absence in 25g for poultry products from January 1 st 2010) and applies to products placed on the market during their shelf life. If any one of the 5 units comprising the samples taken (n=5) are positive (c=1 or more), the product or batch must be withdrawn or recalled from the market. (i) Labelling Requirements When the above requirements for Salmonella (c=0) have been met, the batches of those products placed on the market must be clearly labelled by the manufacturer in order to inform the consumer of the need for thorough cooking prior to consumption. (ii) Unsatisfactory results In the event of unsatisfactory results (c=1 or more), the product or batch of foodstuffs shall be withdrawn or recalled in accordance with Article 19 of Regulation (EC) 178/2002. However, products placed on the market which are not yet at retail level and which do not fulfill the food safety criteria, may be submitted to further processing by treatment eliminating Salmonella. This treatment may only be carried out by FBOs other than at retail level. The FBO may use the batch for purposes other than those for which it was originally intended, provided that this use does not pose a risk for public or animal health and provide that this has been decided within the procedures based on HACCP principles and good hygiene practices and authorised by the Veterinary Inspector. In the case of Mechanically Separated Meat (MSM), produced in accordance with the provisions of Regulation (EC) 853/2004, with unsatisfactory results in respect of Salmonella, may be used in the food chain only to manufacture heat-treated meat products in approved establishments. (iii) Transitional Derogation – Special Mark A transitional derogation until the end of 2009 is provided for under Article 8 of Regulation 2073 / 2005 for batches of products which do not comply with the above requirements (n=5, c = 0). Member States availing of this derogation shall guarantee that the appropriate means, including labelling and a special mark, which cannot be confused with the identification mark are in place to ensure that the derogation applies only to the products concerned when placed on the domestic market and that products dispatched for intra-Community trade comply with the above requirements (n=5, c=0). The batches of these products must be clearly labelled by the manufacturer indicating the need for thorough cooking prior to consumption. Member States also must undertake that when testing against the Salmonella criterion, no more than one out of five sample units shall be found to be positive (n=5, c=1) for the results to be acceptable as regards the Transitional Derogation. Salmonella in Meat Products intended to be eaten raw, excluding products where the manufacturing process or the composition of the product will eliminate the Salmonella risk. The limit is absence in 25g and applies to products placed on the market during their shelf life. Requests from the meat processing sector for this transitional arrangement should be forwarded to Meat Hygiene Section, Meat Hygiene and Animal By Products Division, Agriculture House, Kildare Street, Dublin 2. Sampling Frequencies for Carcases, Minced meat, Meat Preparations and Mechanically Separated Meat. Sampling shall be conducted at least once a week. In the case of E coli and TVCs (Minced Meat and Meat Preparations only) and Enterobacteriaceae and TVCs (carcases), the frequency may be reduced to fortnightly testing if satisfactory results are obtained for 6 consecutive weeks. In the case of (minced meat, meat preparations and carcases), the frequency can be Salmonella reduced to fortnightly if satisfactory results have been obtained for 30 consecutive weeks. Amendment of SOP Plant Management should amend the relevant SOP and make the amended SOP available to the Veterinary Office. Auditable records must be kept to provide evidence of compliance with the legislation. Copies of this trader notice may be printed from the Department’s website www.agriculture.gov.ie - select heading “AGRI FOOD INDUSTRY ”, scroll down to “TRADE AND EXPORTS”, select “APPROVED MEAT ESTABLISHMENTS”, select “Trader Notices”. Signed Liam Walsh __________________________ Liam Walsh Assistant Principal Officer Meat Hygiene Section Meat Hygiene and Animal By Products Division Agriculture House Phone Dublin 01 – 6072830 3 August 2006 The Department of Agriculture and Food does not guarantee the accuracy of the information provided, nor does it accept responsibility for any use made thereof. Users should therefore take all necessary precautions before using this information, which they use entirely at their own risk.