COMMENTS OF THE COMPETENT AUTHORITIES OF THE CZECH REPUBLIC ON THE DRAFT REPORT OF THE MISSION DG(SANCO)/

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1 COMMENTS OF THE COMPETENT AUTHORITIES OF THE CZECH REPUBLIC ON THE DRAFT REPORT OF THE MISSION DG(SANCO)/ State Veterinary Administration (SVA) Page Findings Replace sentence: Methodological instructions of the SVA No 1/ and comprises sampling programmes for Salmonella in SHs (poultry carcasses, poultry and turkey cuts, cattle and pig carcasses) for shiga-toxin producing E. coli (STEC, serotypes O26, O103, O104, O111, O145 and O157) in cattle and pig carcasses and for Campylobacter in poultry with Methodological instructions of the SVA No 1/ and comprises sampling programmes for Salmonella in SHs (broiler and turkey carcasses, cattle and pig carcasses) for shiga-toxin producing E. coli (STEC, serotypes O26, O103, O104, O111, O145 and O157) in cattle and pig carcasses and for Campylobacter in broiler The SVA has not issued the Instruction Nr GIWbz-500 7a/09 of the SVA comprises instructions on the supervision of FBOs own controls regarding food safety and process hygiene criteria. We found out that this document issued Poland see Page 4 Department of the SVA manages the RASFF system in consultation with the MH. Department of the SVA manages the RASFF system in scope of RVAs and the National Contact Point (NCP) is CAFIA. Page For example, the SVA and the PH Inspectorate of MH have established an agreement on 26 August 2009 which clarifies the competencies of the two CAs in relation to controls of FBOs. For example, the SVA and the PH Inspectorate of MH have established an agreement of zoonoses information provision, on 31 August (Attachment 1) Attachment I.pdf Page 11 Observations Replace sentence: In a poultry SH visited, the neck skin samples obtained from poultry carcasses for Salmonella testing were sometimes dispatched before freezing. X In a poultry SH visited, the neck skin samples obtained from poultry carcasses for Salmonella testing were sometimes dispatched (to the laboratory) after freezing. Page Official sampling and testing 1

2 According to the Instruction Nr GIWbz-500 7a/09 of the SVA the number of the official samples taken by the RVA inspectors in the framework of inspections should be approximately 10 % of the samples taken by the FBO. The SVA has not issued the Instruction Nr GIWbz-500 7a/09 of the SVA comprises instructions on the supervision of FBOs own controls regarding food safety and process hygiene criteria. Page ,2 Page 22 Replace In relation to the reduction of sampling units from 5 to 1 when testing for carcasses for Salmonella this can be done after having satisfactory results for a period of 50 weeks. In relation to the reduction of sampling units from 5 to 1 when testing for carcasses for Salmonella this can be done after having satisfactory results for a period of 6 weeks. 2

3 Czech Agriculture and Food Inspection Authority (CAFIA) Executive Summary page I, 5th paragraph No NRL has been nominated for Chronobacter sakazakii. CAFIA changes: We recommend correcting Chronobacter to Cronobacter. Reason for this is mentioned further in the text, see Four FBOs out of seven visited for whom the requirement on shelf-life studies was relevant could not provide evidence that they had carried out shelf-life studies taking into account the requirements of Annex II to Regulation (EC) No 2073/2005. The FBOs visited did not make much use of the tools provided in the Regulation. Only one FBO visited had used challenge studies and none had used predictive modelling. The FBO producing sprouted seeds tested the sprouts but not the seeds for microbiological criteria. CAFIA comment: Our comment to this finding is mentioned further in the text, see Objectives and Scope page 1 - Table CAFIA changes in the text: Replace expression regional CAFIA office with regional CAFIA inspectorate. 5.1 National Legislation/criteria and guidelines page 4, bullet 3rd The legally non-binding standard CSN : However, the document does not include guidance on specific topics such as trend analysis or challenge tests. CAFIA changes: CSN is not correct - it shall be CSN Guidance for elaboration of performance of shelf-life studies for Listeria monocytogenes at food intended for direct consumption were elaborated in November 2012 by the NRL for L. monocytogenes and they are available here: They are based on a document which was not finalised so far elaborated by the EU Community Reference Laboratory for Listeria monocytogenes Technical guidance document on shelf-life studies for Listeria monocytogenes in ready-to-eat foods, Version 2, November 2008, corrected /04/2009. Guidance for performance of studies were approved by supervisory bodies CAFIA, SVA and representatives of MA and MH at the working meeting of the group for zoonoses on page 4, Conclusions Although the Czech CAs have issued several instructions and guidance documents on the contents and interpretation of Regulation (EC) No 2073/2005, these documents do not provide full coverage over the requirements stipulated in the Regulation 3

4 Guidance for elaboration of performance of shelf-life studies for Listeria monocytogenes at food intended for direct consumption were elaborated in November 2012 by the NRL for L. monocytogenes and they are available here: They are based on a document which was not finalised so far elaborated by the EU Community Reference Laboratory for Listeria monocytogenes Technical guidance document on shelf-life studies for Listeria monocytogenes in ready-to-eat foods, Version 2, November 2008, corrected /04/2009. Guidance for performance of studies were approved by supervisory bodies CAFIA, SVA and representatives of MA and MH at the working meeting of the group for zoonoses on CAFIA initiated the Ministry of Agriculture to compile the guidance for FBOs to carry out The analysis regarding trends Legal powers for performance of controls page 5, Finding The Veterinary Act No 166/1999 provides the CAs with necessary legal powers. The audit team did not note any shortcomings in this respect. CAFIA changes in the text: The Veterinary Act No. 166/1999 Coll. provides only SVA with necessary legal powers. CAFIA carries out the controls according to the Act No. 146/2002 Coll., on the Czech Agriculture and Food Inspection Authority and amendments of certain related Acts, as subsequently amended Staff qualifications and training page 7, Training organised by CAFIA 2012 Sampling of for microbiological analysis of foodstuffs. CAFIA text correction: Correct 2012 Sampling of for microbiological analysis of foodstuffs. 5.3 LABORATORY NETWORK page 8, Finding These external laboratories are audited by CAFIA following their internal audit criteria. Evidence of detailed audits carried out was available to the FVO audit team. The CAFIA has nominated the Veterinary Research Institute of the MA as a NRL for Shiga-toxin producing E. coli (STEC)/verocytotoxic E. coli (VTEC). The CAFIA uses its own laboratory at the CAFIA Inspectorate in Prague for determining staphylococcal enterotoxins and histamin in foodstuffs. CAFIA comment: Audit criteria for the external laboratories are described in the organizational directive 6/2006 Rules for carrying out the audits for choosing external laboratory used for CAFIA s official controls of the foodstuffs and selected products. The organizational directive uses adequately the manual which is in accordance with EN ISO called Directive for auditing the management system and criteria provided by EN ISO/IEC CAFIA as an inspection authority subordinate to the Ministry of Agriculture is not eligible to nominate the NRL. From these reasons, the text should be corrected. CAFIA changes in the text: The sentence CAFIA has nominated the Veterinary Research Institute of the MA as a NRL for Shiga-toxin producing E. coli (STEC)/verocytotoxic E. coli (VTEC). should be replaced 4

5 with The Veterinary Research Institute has been nominated by the Ministry of Agriculture as a NRL for coli-infection National reference laboratories page 9, Findings, sentence 3rd This laboratory has also been nominated by the CAFIA for E. coli diagnostics CAFIA changes in the text: The sentence: This laboratory has also been nominated by the CAFIA for E. coli diagnostics especially VTEC/STEC. page 10, Observations, bullet 5th The NRL do not organise, in general, proficiency testing for the laboratories belonging to their network. However, the SVIs that function as NRLs co-ordinate the participation of the laboratories in their network in other, commercial proficiency test rounds. NRL for coli-infection at the Veterinary Research Institute comments: NRL for coli-infection is carrying out the specialized molecular determination of virulence factors (stx gens, eae etc.) which is not provided by any other laboratory in the Czech Republic. From that reason, no proficiency tests and training organised by NRL for other laboratories took place as they do not such specialised diagnostics. NRL for E-coli keeps documentations related to commercial proficiency tests of other laboratories in the scope of their activities in the field of E-coli. page 10, Observations, bullet 6 The NRL for Listeria (the SVI) received information from the EURL. This information is then disseminated to the SVIs but not to the external laboratories used for official testing by the CAFIA. CAFIA comment: CAFIA initiated the co-operation with NRL for L.monocytogenes regarding dissemination of the information from EU-RL to external laboratories used for official testing by CAFIA. page 10, Observations, bullet 7 The two external laboratories used by the CAFIA for analysis of official food samples had not participated in any proficiency testing round organised by the national reference laboratories (NRLs). CAFIA comment: NRL for L. monocytogenes in the Czech republic do not organize any proficiency test rounds. NRL for L. monocytogenes just coordinate the participation of laboratories involved in veterinary surveillance network in other commercial proficiency test rounds. Selection and results of proficiency test rounds are presented by 2 external laboratories used for official testing by CAFIA to accredited authority during regular audits. From that reason, participation of NRL for L. monocytogenes is not necessary. The proficiency test rounds which are selected by 2 external laboratories used for official testing by CAFIA does not subject to coordination of NRL for L. monocytogenes, but to the requirements of laboratory to fulfil ISO EN/IEC (method validation, review of the management system etc.). page 10, Observations, bullet 8 The Czech Republic has not nominated a NRL for Chronobacter sakazakii. CAFIA changes in the text: The term Chronobacter substitute with Cronobacter CAFIA comment: 5

6 Within the EU-RL list of laboratories on the European Commission website: no NRL for Cronobacter sakazakii has been nominated in accordance with the Article 32 of Regulation (EC) No. 882/2004. Within the EU-RL list of laboratories, only EU-RL for milk and dairy products has been nominated. Thus the NRL for milk and dairy products by SVI in Prague has been nominated in accordance with the Article 33. With regard to the above mentioned, the NRL for C. sakazzakii cannot be nominated if the EU-RL for C. sakazzakii has not been nominated. The Reference Laboratory (hereinafter RL only) by SVI in Olomouc which deals with C. sakazakii, has been nominated for microbiology of infant and follow-up nutrition of animal origin. 5.5 Official controls page 12 Findings, 4th paragraph, sentences: The information of establishments of non-animal origin registered by the CAFIA is available in the CAFIA's database on official controls. In the case assessed, the FBO was registered for fruit and vegetables processing which according to the CAFIA also included the sprouted seeds activity although this was not specifically mentioned in the file. According to the internal criteria laid down in Annex 1 to Organizational Directive No. 1/2007 called Risk of the premises modul, both the sprouted seeds and processed vegetables fall within the category of food with high level risk. Thus the frequency of inspections set for these commodities is the same. There is only one producer of sprouted seeds in the Czech Republic, meanwhile the other one gave up their business due to financial difficulties at the end of page Observation, bullet 4: In a red meat establishment and the fruit and vegetable processing establishment visited by the audit team, the minimum frequency for inspection had not been increased although noncompliant test results in relation to food safety parameters had been obtained in these establishments, respectively. CAFIA changes The above mentioned observation is completely incorrect in the case of the establishment processing fruit and vegetables. As regards this FBO, in the last five years, no non-compliant test results in relation to food safety parameters and hygiene criteria had been obtained neither in food samples taken by CAFIA within the official controls nor within the FBO s autocheck. The non-compliant test results (from the reason of detection of L. monocytogenes) were presented to the FVO audit team during the visit of the regional CAFIA inspectorate in Olomouc and also during the next day at the premises of fruit and vegetable processing establishment. These non-compliant test results concerned to a confectionery, not to the fruit and vegetable processing establishment visited. Pursuant to CAFIA internal criteria, this incriminated regional confectionery producer with positive findings of L. monocytogenes in 2011, falls into the category of premises with at least 1 complex inspection per 5 years. The positive findings were detected in Thereafter, other three inspections were carried out during 7 months, which means that the frequency of official controls significantly increased. The audit team could be confused by the fact that the frequency of the control was the same as in year 2010 (3times). However in year 2010, other deficiencies were detected in this incriminated regional confectionery producer and not Listeria. It was the case of non- 6

7 compliance of the hygienic requirements laid down by Annex II of Regulation (EC) No. 852/2004, namely: - Chapter I paragraph 2 letter b): the accumulation of dirt, the shedding of particles into food and the formation of condensation or undesirable mould on surfaces, corrosion of metal components of appliances in premises - Chapter II paragraph 1 letter f): the presence of undesirable mould on surfaces of doors and doorframe in cooling box and on the seal of the fridge door - Chapter V paragraph 2 letter a) and b): dishes and equipment with which food comes into contact were not kept in good condition - Chapter IX paragraph 2: Part of raw materials and semi-finished products for confectionery production were not kept in appropriate conditions to protect them from contamination The remedial measure was imposed. The fulfilment of imposed measure was thoroughly checked within two following inspections in year Due to this, the frequency of inspections had been raised just before L. monocytogenes was found. Regarding to above mentioned, the observation concerning the fruit and vegetables establishment should be deleted from the text of draft report of an audit. page 13 Observation, bullet 6 The CAFIA does not require written notification from the FBO for the activities to be registered for, nor does it give written confirmation of the activities the FBOs are registered for. CAFIA changes: Above mentioned statement is not accurate. Pursuant to the Article 6 paragraph 2 of Regulation (EC) No. 852/2004 on the hygiene of foodstuffs as amended and pursuant to the section 3 (1) letter i) of Act No. 110/1997 Coll., on food and tobacco product as amended, CAFIA requires Announcement of FBO on initiation of business activities. The form for the announcement is available on the CAFIA s websites and was also presented to the audit team. However, in some cases the announcement of FBO on initiation of business by , exceptionally by phone, is also possible. In these particular cases, the official control by CAFIA is carried out as soon as possible. Within the official control, the form Announcement of FBO on initiation of business activities is filled and the data is fed into the CAFIA s informational system. This means that CAFIA obtains written announcement which is in accordance with the Act No. 110/1997 Coll. CAFIA does not have to give a written confirmation of the activities the FBOs are registered for. In contrast, SVA has to confirm and register processing businesses within its competence in accordance with the Act No. 166/1999 Coll Controls over HACCP based procedures page 18, Observations, bullet 3 The latest comprehensive inspection report of the establishment processing fruits and vegetables (including seeds for sprouting) included three non-compliances in relation to documentation of HACCP. However the follow-up in relation to these non-compliances was not documented. The 3 non-compliances detected by CAFIA at the producer of fruits and vegetables included: 1) The FBO fails to carry out swabs from the equipment and areas of the premises to detect L.mononocytogenes; 7

8 2) The number of units creating the sample of final products of the FBO taken to detect L.mononocytogenes does not correspond to n = 5; 3) The FBO failed to elaborate a laboratory challenge study of foodstuffs as regards products supporting growth of L. monocytogenes. However, the FBO monitors at the end of the shelflife of all groups of products (pre-cut fruit and vegetables, sprouted seeds) the levels for L. monocytogenes from testing portion of 25 g complying results from the previous period show that the limit for the absence of Lm in 25g was not exceeded at the end of the shelflife. With regard to the fact that removal of 3 detections means a significant financial burden for the FBO and the producer did not have any non-complying samples in the last 5 years, it was agreed after the visit of the mission team that the FBO would remove the detected deficiencies gradually in the course of 6 months. When carrying out storing studies of foodstuffs supporting growth of Lm, CAFIA will require that behaviour of consumers is taken into account, i.e. to store products until the end of the shelf-life during higher temperatures, namely at 8 o C for 1/3 of the total time and at 12 o C for 2/3 of the total shelf-life, as laid down by the national guidelines for the Methodology of shelf-life studies for Listeria monocytogenes foodstuffs intended for direct consumption, elaborated by the NRL for Lm. page 18, Observations, bullet 4 Raw material specifications in two establishments visited did not include compliance with microbiological criteria. Would be possible to specify more in detail which FBO was concerned? Requirement to check FBOs whether they require from their suppliers of raw materials laboratory testing for safety criteria will be added into the CAFIA internal regulation organizational directive 1/2007. A FBO producing RTE delicatessen products should require from their suppliers tests of raw materials for L. monocytogenes (absence in 25 g). A FBO producing pre-cut vegetables or fruit salads should require from their supplier tests of raw materials for Salmonella spp. (absence in 25 g), L. monocytogenes (absence in 25 g) and E. coli as required in point 2.5. of Chapter 2 of Annex I to Regulation (EC) No 2073/2005. page 18, Observations, bullet 5 In most of the HACCP plans seen no clear criteria within the HACCP-based procedures had been used to determine the sampling frequency (when not required by the legislation). The processor of fruit, vegetables, sprouted seeds has, within the sampling plan, defined a procedure for sending its final products into an accredited laboratory, namely so that products from all producing centres were always represented once in 6 months with regard to the quality, volume and level of risk of the products. Analyses are always carried out the last day of the shelf-life. Listeria is determinated always according to the stricter criterion (testing portion of 25g). Shiga-toxin producing E.coli is determined once a year Controls over FBOs' compliance with food safety criteria page 19, Observation, bullet 4 In the establishment producing pre-cut fruits and vegetables and sprouted seeds the action in case of non-compliant test results did not refer to food safety criteria and the FBO's food safety crisis procedure included only microbiological contamination in raw material, not in the final product. No limit for Salmonella was given in the sampling plan or in the procedure 8

9 for action in case of non-compliant test results. The latest comprehensive inspection report seen mentioned that the procedure in case of non-compliant test results had been audited. Nevertheless the audit had not picked up the above non-compliance in relation to this procedure. Furthermore, the seeds were not tested in the sprouted seeds establishment, nor were there any requirements for microbiological compliance in the specifications for the supplier. The sprouted seeds were tested, but only after packaging. After the visit of the mission team, the FBO was ordered to complete its crisis plan by a procedure for withdrawal products for the case when safety criteria in the final product are exceeded. In the last 5 years, the FBO has no unsatisfactory results related to the exceeding safety criteria and hygiene criteria laid down by regulation 2073/2005. Besides that, within the autocheck, the FBO monitors the indicators beyond the framework of the requirements of the Regulation mentioned above, e.g. total amounts of microorganisms, yeasts, Staphylococcus aureus. The FBO further withdraws the products that exceeded the limits laid down by the national standard CSN (which is not mandatory) for all the nonmandatory microbiological parameters mentioned above. After the visit of the mission team, the FBO was ordered to complete the sampling plan with the requirement for monitoring of Salmonella spp. in final products. As regards testing of seeds-raw material for sprouted seeds, within the applicable version of Regulation 2073/2005, rules for sampling of sprouts are not closely detailed. These rules for sampling of sprouts including explanation of preliminary examination of the seeds lot and definition of the stage when the probability of detection of Salmonella spp. is the highest are indicated only in the proposal stage of the Commission Regulation No. /.. of XXX amending regulation (EC) No. 2073/2005, as regards microbiological criteria for sprouts and rules for sampling of sprouts and the sampling rules for poultry carcases and fresh poultry meat. The FBO carries out testing of final products of sprouted seeds after packing if we suppose the contamination of seeds by Salmonella spp. with subsequent growth during the sprouting process, the growth of salmonellas would happen in the whole volume of the produced lot during mixing of sprouting seeds. The FBO would then probably detect them during the testing of the final product. However, from the reason that the guidelines specifying the procedure for testing of seedsraw materials were not finished yet on the European level, they will have to be elaborated on the national level. CAFIA wants to refer to the Ministry of Agriculture in this matter Controls over sampling and testing of processing areas and equipment (especially for Listeria monocytogenes when manufacturing ready-to-eatfoods) page 21, Observation, bullet 2nd Specific records of CA controls in relation to sampling and testing of processing areas and equipment were available for the FBO controlled by the CAFIA (processing fruits and vegetables and seeds for sprouting) only when a non-compliance had been identified by the CA and no environmental testing had been carried out by the FBO for Listeria although the FBO was producing RTE foods able to support the growth of this pathogen. The CA had made a recommendation to rectify the sampling plan but the recommendation did not include a deadline. At the time of the FVO audit the shortcoming had not yet been rectified. 9

10 The text is not clear it is not clear whether also CAFIA is supposed to carry out swabs for L. monocytogenes in the processing areas (in addition to the producer)? Article 5 (2) of Regulation 2073/2005 now refers to ISO 18593, which, however, is not specific for L.monocytogenes. Guidelines for sampling of processing areas and equipment with the aim to detect Lm in production, were elaborated by the EU-RL for L. monocytogenes only in April 2012, however, they are still in the proposal stage. With respect to the fact that removal of the detected deficiencies consisting in failing to carry out swabs for L.monocytogens means financial burdens for the FBO, and the producer had not any non-complying samples in the last 5 years, it was agreed after the visit of the mission team, that the FBO will remove the detected deficiencies in the course of next 6 months. Besides that, the producer has the procedures and results of the regular performance of verification of cleaning and disinfection documented Controls over alternative sampling and testing procedures page 22, Conclusion Although the FBOs visited had applied alternative methods largely correctly, there was insufficient evidence that the CAs had checked this aspect (see also 5.5.4). Within the CAFIA training plan, training for inspectors focused on the matter of checks of the use of alternative methods used by the FBOs is planned to be carried out by the end of Controls over shelf-life studies and over analyses of trends page 23, Observation, bullet 1st In general, little evidence was available in the official audit and inspection reports seen by the audit team that the CAs had checked documentation on shelf-life studies and analysis of trends carried out by the FBOs visited. Would you please be more specific what was not documented in the inspection reports at the producer of pre-cut vegetables, pre-cut fruit and sprouted seeds? E.g. in the inspection report of CAFIA of related to the inspected producer of precut vegetables, fruit and sprouted seeds, which was presented to the mission team, the aspects of regulation 2073/2005 mentioned above documented, namely: - producer carries out the trend analysis of the results of the microbiological testing in the own laboratory (total amount of microorganisms, yeasts, E.coli, moulds) there was a graph introduced during the check - FBO monitors in the end of the shelf-lifes of all groups of products (pre-cut vegetables and fruit, sprouted seeds) values of L.monocytogenes from testing portion of 25g which was shown by protocols on testing from the accredited laboratory with complying results from the previous period. The complying results from the previous period (historical data) show that the limit for absence of Lm in 25g is not exceeded in the end of the shelf-life. Beside this, the own laboratory carries out sensory assessment of ready products in the end of the shelflife. page 23, Observation, bullet 2 Little evidence was available that controls over Regulation (EC) No 2073/2005 included studies referred to in Article 3.2. and Annex II of Regulation (EC) No 2073/2005 and that these studies had been carried out by the FBOs visited. For example, only 3 FBOs out of 7 10

11 visited for whom the requirement on shelf-life studies was relevant had carried out shelf-life studies and most establishments visited had not determined the water activity of their RTE products. This statement is misleading. The FBO who wants to use the safety criterion with limit of 100 cfu/g for the category of food given in point 1.2. of Chapter I, Annex I of the Regulation, has to prove to the supervisory body that the product, during the whole period of its shelf-life, does not exceed the limit of 100 cfu/g for Lm (footnote 5 in chapter 1 of Annex I of Regulation 2073/2005). If the FBO does not have a suitable shelf-life study available which could prove that the limit of 100 cfu/g will not be exceeded, he is obliged to test for the limit absence of Lm in 25 g. This is the CAFIA attitude in relation to RTE producers producing foodstuffs supporting growth of Lm. Guidance document EC on Listeria monocytogenes shelf-life studies for ready-to-eat foods, under Regulation (EC) No. 2073/2005, in particular graph 1 A decision tree showing schematically the steps for shelf-life studies, confirms in us that the study of length of shelflife are required only for those producers who want to apply limit 100 cfu/g to products placed on the market during the time of the shelf-life, which was not the case of the producer of the pre-cut vegetables and pre-cut fruit and sprouted seeds which tests the products for limit absence Lm in 25g. Measuring the water activity of ready to eat products is indicated in Annex II of Regulation 2073/2005 as one example of many determinations of physically-chemical features of products, thus it is not in our opinion necessary that the FBO should always perform the determination of water activity. page 23, Observation, bullet 3 All FBOs visited tested their range of products on the last day of the shelf-life. However, in the documentation seen by the audit team, the storage temperature until the end of the shelflife was either not indicated, or it was according to the temperature range given on the label for the consumer. These studies did not take into account consumer behaviour (possible breaks in the cold chain etc.). The requirement for checking whether the producer provides proofs (when performing shelflife studies) suitable storing temperature which takes consumers behaviour into account will be incorporated into the CAFIA internal regulation with check-lists (organisational directive 1/2007, Annex No. 5). CAFIA will require from the food producers producing foodstuffs supporting growth of Lm, so that they take consumers behaviour into account (as regards products by which they demonstrate observance of the safety criterion absence of LM in 25 g shelf-life study). Namely at 8 o C for 1/3 of the total time of the shelf-life and at 12 o C for 2/3 from the total shelf-life, as it is laid down by national guidelines for the Methodology for performance of shelf-life studies for Listeria monocytogenes foodstuffs intended for direct consumption elaborated by NRL for Lm. page 23, Conclusions Little evidence was available that controls over Regulation (EC) No 2073/2005 include studies referred to in Article 3.2. and Annex II of Regulation (EC) No 2073/2005 and that these studies had been carried out by the FBOs visited. The FBOs visited had made very limited use of the tools available in the Regulation (EC) No 2073/2005. Within the CAFIA training plan, training focused on the matter of performance of shelf-life studies, performance of swabs from equipment and producing areas to detect 11

12 L.monocytogenes pursuant to the drafted guideline of EU-RL for Lm is planned in cooperation with the NRL for L. monocytogenes Supervision of in-house and other private laboratories used by the FBOs for microbiological analyses of foodstuffs page 23, first paragraph, sentence However, they do not supervise the laboratories used by the FBOs for microbiological analysis of foodstuffs. The obligation on CAs is to ensure appropriate laboratory methods are used. There is no obligation to assess the laboratories performance. 7 Overall Conclusion page 25, sentence 3rd Nevertheless, the controls in relation to the specific requirements of Regulation (EC) No 2073/2005 were, in general not documented sufficiently in detail to allow verification that all relevant aspects of the Regulation had been checked Could you please closer in detail clarify which of the specific requirements of Regulation 2073/2005 was not in the records from the inspection at the producer of pre-cut fruit and vegetables, sprouted seeds documented? See CAFIA reply in page 25, sentence 5th However, four FBOs out of seven visited for whom the requirement on shelf-life studies was relevant could not provide evidence that they had carried out shelf-life studies taking into account the requirements of Annex II to Regulation (EC) No 2073/2005. This statement is misleading. See CAFIA reply in Ministry of Health (MH) 5.5 Official controls page 12, Observations, bullet 1st However, the SVA and the MH had not done so and explained that this point was part of the FBO's history of non- compliance. MH comment: The reliability of the FBO's own checks is not really included as separate criteria in the risk criteria for establishing the frequency of inspection in the catering sector, and we are not going to do so. This criterion is not important for the catering sector where the frequency of official controls is significantly higher due to a high level of risk of food-borne diseases than in the case of food business supervised by CAFIA. Moreover, there is no legal list of risk criteria, which should be established by any competent authority and it is up to the evaluation by a competent authorities to decide, which criteria are relevant. 12