Annex I Comments on the draft report, French version The comments are shown in blue, and the changes highlighted in grey

Transcription

1 Annex I Comments on the draft report, French version The comments are shown in blue, and the changes highlighted in grey Page 5: Comments and changes The DGAL procedures for carrying out inspections in different types of establishments manufacturing food of animal origin are compiled in a single structured source of information ( vademecum, hereafter referred to as the handbooks). Each handbook includes the legal framework for the inspections comprising both the EU Regulations (HP, Regulation (EC) No 2073/2005, Regulation (EC) No 178/2002) and the relevant national legislation and possible flexibility rules and comprehensive instructions and guidance on how to carry out the inspections. Each handbook, specific to the various kinds of foodstuff of animal origin, is divided into several chapters according to the five-step rule). The instructions for conducting health inspections at slaughterhouses in accordance with HACCP risk analysis rules have been omitted. The Service Notes concerned are: - Service Note DGAL/SDSSA/ of 17 March 2008 on controlling health risks in poultry abattoirs: inspection priorities link with HACCP procedure; - Service Note DGAL/SDSSA/ of 20 November 2008 establishing the list of hazards and priority inspection points in slaughterhouses; checklists and reporting forms. Page 6: Changes Delete the redundant reference to Service Note DGAL/SDSSA/N of 14 January Page 7: Comments The Decree on hygiene rules on certain foods and food preparations for human consumption of 28 May 1997 ( ). This Decree is to be repealed. Its provisions are covered by Regulation (EC) No 852/2004. The draft industry guidelines for raw RTE vegetables are of a general nature and do not specify, for example, the microbiological dangers on a microbial species level. The auditors have been sent a draft guide to good hygiene practice. The draft is currently being evaluated at the National Agency for Food, Environmental and Occupational Health and Safety (ANSES), which has been asked to verify the list of hazards and control measures. Annex 2 to the SCL Instruction IN-CS-01 of 18 April 2011 on sampling, interpretation and conclusions of microbiological analysis gives the same limits for L. monocytogenes in RTE foods regardless of whether the samples are taken from RTE that can support the growth of L. monocytogenes or not and regardless of whether the sample is taken from retail level or production level. No action is required if the level is less than 10 cfu/g, This is not in line with the requirements given in Chapter 1 of Annex I to Regulation (EC) No 2073/2005. Instruction IN.CS.01 is due to be revised by the SCL s Microbiology network (scheduled for 25/26 October 2012) and will specifically include the case of a sample supporting the growth of L. monocytogenes taken at the operator s establishment (no specific count possible but sole criteria = absence in 25 g.) Page 8: Changes The DGAL has responsibility for controls over primary agricultural production of foods of animal and nonanimal origin, production and processing of food of animal origin, fishery products and shellfish. The DGCCRF is responsible for, among other things, controls over foods of non-animal origin at stages subsequent to primary production, foods of animal origin at the distribution stage, labelling, contact materials, irradiation and additives. The DGAL and the DGCCRF share for example the responsibility for controls over distribution and direct sale, storage, transport. The DGS is responsible for general food hygiene, food-borne infections, water quality, and canteens in health and social facilities. Page 9: Changes The DGAL has been accredited (ISO 17020) by the French Accreditation Body (Comité Français d'accréditation, COFRAC) as an inspection body. Rapid Alert System for Food and Feed (RASFF) 1/11

2 The DGCCRF (Alerts Unit) and the DGAL (Missions for health emergencies) are central control points for the RASSF of the Commission. A protocol on inter-ministerial coordination was signed in The audit team received statistics on the alerts (both national and EU alerts) for 2010 and Page 10: Comments The slaughtering industry has devoted considerable time to training in connection with risk analysis and verification of heath control plans: - training courses : 3 days for staff - since 2009, training on health inspection in poultry abattoirs : 4 days, one or two sessions per year (20 or 40 staff) - since 2005, training on health inspection in slaughterhouses for domestic ungulates: 4 days for staff The training focused on microbiological criteria. Page 12: Comments The French CCA stated that another Decree relating to administrative penalties will be published in spring Decree No of 21 March 2012 on product, food and feed hygiene referred to in Article L of the Consumer Code was published in the Official Journal of the French Republic on 23 March Page 13: Changes In one of the approved DGAL laboratories visited, the anonymity of the samples was not guaranteed. The French authorities would like more details about this observation. In France (including the overseas departments), a total of 92 microbiological laboratories are involved in the analysis of official food samples (approved laboratories). Out of these 92 laboratories, 81 are approved by the DGAL and 6 are SCL laboratories under the authority of the DGCCRF. Page 14: Comments and changes The audit did not cover the EURL Listeria monocytogenes or staphylococci mandates, although some of the relevant activities were briefly mentioned during the visit. The Ministry of Agriculture, Food, Fisheries, Rural Affairs and Planning (MAAPRAT) and the Ministry of the Economy, Finance and Industry (MINEFI) have appointed 29 laboratories to be NRLs for a total of 87 areas of competence. These 87 areas include all areas covered by EURLs concerning food and feed. Of the NRLs, 24 laboratories are under the responsibility of the DGAL.» The SCL belonging to the DGCCRF is the NRL in 8 areas of competence (2 in food for human consumption, 4 mixed, food and feed, and 2 in feed only). It does not deal at all with food microbiology. The DGAL has designated 8 NRLs in the area of food microbiology covering 15 areas of microbiological contaminants in foodstuffs. The NRL had sent out a questionnaire to the laboratories in the network in 2011 in order to gather information on the type of samples they analyse, the methods they use, quality controls in place, training needs etc. and was currently analysing the results. The NRL also supports the DGAL in the areas of training and legislation (for example, it has been involved in the preparation of Service Notes). In addition, it is involved in the surveillance and the management of alerts and carrying out of and support with shelflife studies. The laboratory had participated in proficiency tests organised by a commercial proficiency test provider with satisfactory results. As regards the DGCCRF, the NRL has scheduled a meeting to which the SCL s 6 microbiology laboratories have been invited. The NRL laboratory has not yet taken up its tasks as required in Article 33(2) of Regulation (EC) No 882/2004. For example, no meetings and proficiency test rounds have yet been organised for the laboratory network and no information/guidance documents have been distributed to the network. As regards the activities of the Listeria monocytogenes NRL, we would point out that some of these tasks are already being performed: support to the DGAL for preparing Service Notes, scientific and technical support for shelf-life studies, epidemiological surveillance and investigation into the food-borne source of listeriosis cases. 2/11

3 The audit team noted that if a national alert on L. monocytogenes had been initiated as a result of FBO's own programme control sample, there was no procedure in place to send the isolate to the NRL for characterisation. This observation is not strictly accurate, since there is an agreement between the NRL and the NRC (national reference centre), validated on by the inter-ministerial committee on Listeria, specifying the procedure to be followed for isolated Listeria monocytogenes strains depending on the context : health alert, official checks or own-checks (see attachment). In particular, the NRL carries out molecular typing (by PFGE) of L. monocytogenes strains isolated in the course of the DGAL s and DGCCRF s surveillance or control plans. Page 15: Comments Finding could be amended in the light of the above clarifications.. In fact, since it was designated in 2009, the Listeria monocytogenes NRL has been performing several of its appointed tasks, in particular the provision of scientific and technical support to the DGAL. In 2011, it initiated the technical coordination of the official control laboratory network. Page 17: Comments Slaughterhouses and cutting plants for domestic ungulates have been classified according to their degree of conformity since Since 2005, this classification has been closely monitored and, since 2008, it has determined the frequency of inspections, as described in the restricted circulation letter of 8 July After four years of operation, a substantial improvement in slaughterhouses has been observed; the current system is to be modified in summer 2012 to place more emphasis on following up measures taken post-inspection. Page 18: Changes and comments In the DGAL s national control plan, food processing establishments are divided into three groups based on priorities, ( ) The end of the second paragraph states that the Commission Services had not authorised the pilot project in the poultry sector intended to test a new risk analysis-based inspection system. This is not true: the Commission did not officially oppose the project presented by France; on the contrary, the discussions at the time gave the impression that it was interested in the idea. Moreover, the Commission has sanctioned an official start to experimentation in September Page 19: Change and comments In the establishment visited producing sprouted seeds the DGCCRF staff had not yet carried out the local risk assessment before first placing of products on the market. In fact, before the HUS epidemic in Europe linked to eating sprouted seeds, this establishment had been classified as low risk. It has been placed in a higher risk category since. It is stated in paragraphs 2, 3 and 4 that first-level ante-mortem inspection is carried out by auxiliaries. For domestic ungulates, the French authorities have sent the Commission the Service Note of 23 June 2010 which provides for the ante-mortem inspection arrangements in the slaughterhouses concerned, including supervision of auxiliaries by the official veterinarian. Furthermore, one of the conclusions of the seminar on the modernisation of sanitary inspection in slaughterhouses held in Lyon in July 2008 during the French Presidency proposed that the Commission look into the possibility of extending the responsibilities of auxiliaries in view of their training. Finally, the French authorities undertook to improve the matching of needs with missions in the slaughtering industry. The method of calculating FTE staffing needs in the domestic ungulates sector, initially based on tonnage slaughtered, has proved to be inadequate, and adjustment factors are being introduced. 3/11

4 Page 20: Changes The CCA stated that plans are under way to establish a database ( Food Observatory ) comprising results of both official and of FBOs' own control sampling programmes( ) The funds for this project have been granted by the DGAL in the first instance; the DGCCRF, DGS and ANSES are involved in the data selection. Official sampling is carried out in the framework of official surveillance and monitoring plans, in connection with food alerts, food-borne disease outbreaks and the results of the official surveillance and monitoring plans of previous years, as part of the official controls carried out in an establishment before the first placing on the market of their products, as part of the controls of food imported or destined for export and in specific cases (for example, testing of detained carcasses). Page 21: Changes Sample type Foodstuffs at distribution level (meat products, seafood, cheese) Foodstuffs at distribution level Pork meat products at distribution level Pathogen DGCCRF L. monocytogenes Number Of samples Number of unsatisfactory samples exceeded 100 cfu/g DGCCRF Microbiological quality DGCCRF Salmonella Fishery products DGCCRF Vibrio sp % of unsatisfactory samples Page 22: Changes «plan de contrôle concernant la qualité microbiologique des graines germées à consommer crues; (2 échantillons dans toutes les régions quatre fois par an) ; Control plan for the microbiological quality of raw sprouted seeds to be consumed fresh and of seeds for germination. All 22 regions and the three overseas departments had to take samples twice every fortnight. Page 23: Changes Control plan regarding the microbiological quality of foodstuffs of plant origin (6 000 samples including 550 samples of sprouted seeds and 50 of not non-germinated seeds); and 4/11

5 Page 24: Comments The DGCCRF has not established detailed instructions for their inspection staff on checking of the HACCP-based principles. Although control of the FBO's test results as part of the own control plan is included in the check-list, no detailed instructions are available on what items need to be checked for under this heading. There is a permanent intervention plan instruction sheet which gives the following content for second-level checks: Inspection of the plant, microbiological sampling of raw materials, additives, semi-finished products, surface sampling to determine hygiene status, production safety, verifying reliability of processing and operations, evaluation of risk control. Page 25: Comments and changes The comments concerning the DGCCRF (bullet point and second paragraph of the conclusions) correspond to the remark made on page 24. Annex III to Service Note No includes instructions on enumeration of L. monocytogenes in sensitive products and interpretation of the results. If the enumeration of L. monocytogenes exceeds 100 cfu/g in raw RTE products or cooked RTE products, the food is unfit for human consumption. If the product is a raw product that has to be cooked before consumption by the consumer, the foodstuff is still fit for human consumption but the process needs to be monitored by the FBO. Annex III to Service Note No is no longer valid; it has been replaced by Service Note No , which sets out guidelines on scheduling microbiological sampling, the changes made to laboratory conclusions and the corresponding action to be taken by the decentralised services. It also gives instructions on the enumeration of L. monocytogenes in RTE foods and on interpretation of the results. This Note is due for revision before the end of Page 26: Comments In the sprouted seeds establishment, the LCA (DGCCRF) had not checked the FBO s compliance with food safety criteria and the CA on the spot was not aware that testing of the end product for L. monocytogenes is required. Testing for L. monocytogenes had been carried out only during the E. coli outbreak in 2011, while currently it was not part of the sampling plan (although indicated in the FBO's HACCP programme). This is because the establishment was classed as low-risk. Page 27: Comments Points 1 and 2: Both the operator and the official veterinarian were reminded of the method for carrying out own checks on surfaces. Page 29-30: Comment and changes In the DGAL's handbooks specific requirements for official controls over FBO shelf-life studies are included indirectly in Chapter E09 of the meat products section and of the fishery products section. In the above-mentioned two sections it is required that the FBO demonstrates to the satisfaction of the CA that L. monocytogenes does not exceed 100 cfu/g throughout the product shelf-life for RTE foods able to support the growth of this pathogen. In the Section dedicated to dairy products, this point is missing as the approach is different and the absence of L. monocytogenes in 25 g is required by default for RTE dairy products able to support the growth of Listeria. In the Section dedicated to egg products the microbiological testing in accordance with Regulation (EC) No 2073/2005 is mentioned under chapter G13 which specifies that the own control plan should include analysis of pathogens according to Regulation (EC) No 2073/2005. Service Note No of 09/03/2010 also gives a general overview of the means at the disposal of operators in the trade to determine and validate the shelf-life of the products they place on the market, and sets out the regulatory obligations and various tools available for conducting these studies. Page 33: Changes To ensure that official samples are taken when necessary, as laid down in point 8 (c) of Article 4 of Regulation (EC) No 854/2004 and provided for in the internal procedures of the CAs. 5/11