EUROPEAN COMMISSION DIRECTORATE-GENERAL FOR HEALTH AND FOOD SAFETY

Ref. Ares(2015)2539389-17/06/2015 EUROPEAN COMMISSION DIRECTORATE-GENERAL FOR HEALTH AND FOOD SAFETY Directorate F - Food and Veterinary Office DG(SANTE) 2014-7232 - MR FINAL REPORT OF AN AUDIT CARRIED OUT IN LUXEMBOURG FROM 25 NOVEMBER 2014 TO 04 DECEMBER 2014 IN ORDER TO EVALUATE THE OPERATION OF OFFICIAL CONTROLS OVER THE POST- SLAUGHTER TRACEABILITY OF MEAT, MEAT PRODUCTS AND PREPARATIONS, COMPOSITE PRODUCTS In response to information provided by the Competent Authority, a factual error noted in the draft report has been corrected.

Executive Summary An audit to Luxembourg was carried out from 25 November to 4 December 2014. The main objective of the audit was to evaluate the operation of official controls over the traceability of meat (meat of domestic ungulates, poultry, lagomorphs and game meat), minced meat, mechanically separated meat (MSM), meat preparations, meat products (hereafter referred to as meat and products thereof), and composite products containing meat and products thereof and other ingredients. Particular attention was paid to the traceability, labelling and identification systems of meat and products thereof, and to composite products containing meat and products thereof and traceability of quantities of each ingredient used. The Competent Authority (CA) responsible for official controls in the scope of the audit has been designated in compliance with Article 4 (1) of Chapter II of Regulation (EC) No 882/2004. The CA is still in the process of amending the National Food Law of 1953 in order to ensure that appropriate action is taken and applicable sanctions are imposed and enforced when non-compliances are identified, as required by Articles 54 and 55 of Regulation (EC) No 882/2004. Within the scope of the audit, the official control plans are implemented as foreseen and are carried out in accordance with documented procedures. Official controls cover identification, labelling and traceability. However the limited controls on additives, labelling and composition, the lack of systematic control of quantitative traceability or procedures for an in depth verification of food business operators (FBOs) traceability procedures and the lack of the possibility to impose administrative sanctions are undermining the effectiveness of official controls. The CA s control results for the selected samples indicated non-compliances, but some significant non-compliances related to traceability, labelling and/or the use of additives were not detected. While the system of official controls includes verification of FBOs compliance with traceability, application of identification marks and labelling, it is not sufficiently developed. Several deficiencies had not been identified during official controls, in particular, verification of the correctness of the information and content on the label, links between different traceability documents and comprehensive control on the use of ingredients additives and/or spices. The report makes a number of recommendations to the Luxembourg CAs with a view to addressing the deficiencies identified during this audit. 1

TABLE OF CONTENTS 1. INTRODUCTION...4 2. OBJECTIVES OF THE AUDIT...4 3. LEGAL BASIS FOR THE AUDIT...5 4. BACKGROUND...5 5. FINDINGS AND CONCLUSIONS...5 5.1. Competent Authorities...5 5.2. Official controls on traceability systems, identification marking and labelling...6 5.3. Miscellaneous...11 6. OVERALL CONCLUSIONS...12 7. CLOSING MEETING...12 8. RECOMMENDATIONS...13 ANNEX 1 Legal References...14 2

ABBREVIATIONS AND DEFINITIONS USED IN THIS REPORT ABBREVIATION ASV CA(s) CCA(s) COM DG(SANCO) DG(SANTE) EU FBO(s) FVO MSM SECUALIM EXPLANATION Veterinary Service Administration (l Office l`alimentaire et Vétérinaire) Competent Authority(ies) Central Competent Authority(ies) European Commission Directorate-General for Health and Consumers Directorate-General for Health and Food Safety European Union Food Business Operator(s) Food and Veterinary Office Mechanically Separated Meat Food Safety Service 3

1. INTRODUCTION This audit took place in Luxembourg from 25 November to 4 December 2014 as part of the Food and Veterinary Office s (FVO) planned audit programme. The FVO audit team comprised two auditors from the FVO. The FVO audit team was accompanied throughout the audit by representatives of the Central Competent Authority (CCA), l Office l`alimentaire et Vétérinaire (Veterinary Service Administration - ASV). An opening meeting was held in Luxembourg on 25 November 2014 with the CCAs. At this meeting the FVO audit team confirmed the objectives of, and itinerary for the audit, and additional information required for its satisfactory completion was requested. 2. OBJECTIVES OF THE AUDIT The objectives of the audit were to: - evaluate the operation of official controls over the traceability of meat (meat of domestic ungulates, poultry, lagomorphs and game meat), minced meat, mechanically separated meat (MSM), meat preparations, meat products (hereafter referred to as meat and products thereof), and composite products containing meat and products thereof and other ingredients. - evaluate the implementation of, and official control over, Union legislation on the labelling and identification systems of meat and products thereof. Particular attention was paid to the following: Traceability, labelling and identification systems of meat and products thereof; Composite products containing meat and products thereof and traceability of quantities of each ingredient used. In pursuit of these objectives, the audit itinerary included the following meetings and visits: Meetings and visits Comments CAs 3 Initial and final meetings; clarification meeting Distribution centres 1 Meat product processing establishments Establishment producers of composite products containing meat and products thereof 4 6 Including evaluation of CA controls over production and/or storage of fresh meat, meat preparations, minced meat 1 Including evaluation of CA controls over production and/or storage of fresh meat, meat preparations, minced

meat Registered establishment 1 Including evaluation of CA controls over production of meat preparations and minced meat. 3. LEGAL BASIS FOR THE AUDIT The audit was carried out under the general provisions of Union legislation and, in particular, Article 45 of Regulation (EC) No 882/2004 of the European Parliament and of the Council on official controls performed to ensure the verification of compliance with feed and food law, animal health and animal welfare rules. Full legal references are provided in section 9. Legal acts quoted in this report refer, where applicable, to the last amended version. 4. BACKGROUND The FVO carried out a series of audits in certain Member States between 2009 and 2011 in order to evaluate the controls over the traceability of beef and beef products. Another series of audits was conducted in certain Member States between 2011 and 2012 in order to evaluate the official controls related to slaughter and processing of fresh meat, in particular fresh equine meat. Both series of audits resulted in overview reports (reference numbers DG(SANCO)/2012-6624 and 2013-6950 respectively). The overview reports are available on the Directorate-General for Health and Food Safety (DG(SANTE) web-site at: http://ec.europa.eu/food/fvo/specialreports/overview_search_en.cfm Recent events, including the horsemeat scandal, have highlighted deficiencies in the control of traceability of meat traded as a commodity on a European Union (EU) wide basis. Weaknesses in food business operators (FBOs) compliance with their responsibilities and official controls, in particular with regard to traceability systems (qualitative and quantitative) and labelling requirements, were identified in several Member States. This audit paid attention, in particular, to these areas in targeted food businesses. 5. FINDINGS AND CONCLUSIONS 5.1. Competent Authorities Legal requirements Chapter II of Regulation (EC) No 882/2004. Audit findings With regards to the scope of the audit the ASV is the main CA responsible for the control of traceability of meat and meat products throughout the whole food chain. The Food Safety Service (SECUALIM) is responsible for the control of composite products. 5

The control of food additives and colorants is the responsibility of the SECUALIM. There is an agreement between both CAs, giving the ASV responsibility for official controls of additives and colorants for food of animal origin. The SECUALIM has a national control and sampling programme at retail level to control food, including composite product placed on the market, but foods of animal origin are excluded. The SECUALIM and the ASV plan to include food of animal origin in the 2015 programme. As reported in a previous FVO audit report (reference DG(SANCO)/2014-7219), the CA confirmed that in response to previous FVO audits, an amendment of the Food Law of 15 March 1953 was drafted and is still in the process of adoption. The objective of the amendments is to ensure that appropriate action is taken and applicable sanctions are imposed and enforced when non-compliances are identified, as required by Articles 54 and 55 of Regulation (EC) No 882/2004. The amendment is proposed for discussion at the National Parliament of Luxembourg in the first semester of 2015. A more detailed description of the CA can be found in the Country Profile for Luxembourg on the following website: http://ec.europa.eu/food/fvo/country_profiles_en.cfm Conclusions The CA responsible for official controls in the scope of the audit has been designated in compliance with Article 4 (1) of Chapter II of Regulation (EC) No 882/2004. The CA is still in the process of amending the National Food Law of 1953 in order to ensure that appropriate action is taken and applicable sanctions are imposed and enforced when non-compliances are identified, as required by Articles 54 and 55 of Regulation (EC) No 882/2004. 5.2. Official controls on traceability systems, identification marking and labelling Legal requirements General requirements on traceability systems, identification marking and labelling are laid down in Regulations (EC) No 178/2002, (EC) No 931/2011, (EC) No 853/2004, (EC) No 854/2004, and Directive 2000/13/EC 1. More specific traceability and/or labelling requirements are laid down in Regulations (EC) No 1760/2000, (EC) No 1825/2000, (EC) No 1332/2008, (EC) No 1333/2008 and (EC) No 1334/2008. Audit findings 1 Legal reference from 15 December 2014: Regulation (EU) No 1169/2011. 6

5.2.1. Organisation of official controls The organisation and implementation of official controls is also described in the Country Profile for Luxembourg. The system of official control is based on risk assessment. The official controls in establishments are carried out following the annual control plan. Comprehensive official controls are carried out in approved establishments annually as a minimum frequency. Targeted controls on traceability took place in establishments involved in the horse meat scandal. The ASV use a checklist to carry out comprehensive controls in approved establishments. The checklist includes controls on labelling and use of additives and food ingredients and since 4 February 2014, also includes traceability and microbiological results. Documented control procedures are in place to explain the use of the checklist. The ASV stated that the official controls on labelling of additives and colorants in meat and meat products were documentary controls only. Verification on the use and the amount of additives and colorants through laboratory analyses did not take place. In 2013 one SVA official participated in a Better Training for Safer Food seminar regarding additives. The relevant information was thereafter shared between colleagues and the training documents are available on the intranet of the ASV. Observations: Comprehensive controls were carried out in line with the annual control programme. Since February 2014 the results were documented and included in the findings on traceability. Reports of official controls are made available to the FBOs. The CA does not yet have the legal power to impose administrative sanctions (see chapter 5.1). Documented control procedures are in place, but do not include explanatory notes regarding controls on additives and other food ingredients and do not require quantitative traceability (collation and reconciliation of quantities of meat and ingredients along the chain). During official controls, when a traceability exercise was carried out, this was limited to a qualitative traceability and backwards only from the final product to the raw materials. Quantitative tracing has never been carried out. In a few cases, the official controls of traceability systems in place did not include in-depth verification on FBO s internal traceability procedures. Official control on additives and other ingredients was often not carried out. 7

Conclusions The system of official controls is well designed, with risk based prioritisation of controls, documented procedures and reporting of results. The omission of detailed instructions for the verification of traceability systems, including additives and other ingredients, as well as the omission of quantitative checks, weakened these controls. 5.2.2. Implementation of official controls During the first day of the visit, the FVO audit team selected seven samples of meat and products thereof at retail level. The CA was asked to trace back these seven samples of meat to the slaughterhouse of origin based on available documentation. Furthermore, the CA was requested to provide documented evidence on the accuracy of the labelling of the goods selected, in relation to the ingredients and the composition and to reconcile quantities of raw materials received and in stock with quantities used in production. During the second week, the FVO audit team visited different establishments, which were identified during the above mentioned exercise in order to evaluate six out of seven dossiers on-the-spot, checking the accuracy of the data provided by the CA. 5.2.2.1. Official controls on the food processing chain The CA was able to provide information concerning the tracing to the establishments involved for all seven samples. The CA concluded that out of the seven randomly chosen samples: Traceability of one sample was lost. The FBO could not provide evidence on the origin of repacked meat. Two samples were fully traceable. The non-compliances identified by the CA were mainly related to missing links between documentation provided by the FBOs (e.g. product delivery labelled with a production date later than the delivery date s absence of delivery note to retail outlet). Quantitative traceability was not carried out by the CA for the seven samples. Two samples were non-compliant regarding labelling and use of additives: in one case the label mentioned an additive which was not used. Another additive was used instead, but was not mentioned on the label. The label attached to a meat preparation contained information on the use of an additive which is prohibited for use in meat preparations. The FVO audit team verified six of the seven dossiers on-the-spot, evaluating the accuracy of the data provided by the CA. In three out of six cases the qualitative tracing was complete and reliable, in the other three cases some documents or partial 8

information were missing or were not reliable (e.g. registration of rewrapping, delivery date of pork meat, lack of registration of incoming materials). In one out of six cases the quantitative tracing was done and conclusive. In two out of six cases there were issues related to the use of additives and to the labels attached to the products. A number of additional observations were made by the FVO audit team concerning the tracing exercises: Five dossiers were incomplete, relevant documentation was missing but was mostly available on-the-spot. In one establishment, the FBO s register did not link the information between the original and the re-wrapped product. The new labels of the re-wrapped products were not registered in the book. In a small capacity establishment, key elements of the FBOs traceability system were missing such as proper documentation of incoming raw materials and ingredients, links between incoming raw materials, internal batch numbers and proper documentation of outgoing final products. In a third establishment, proper documentation for the traceability of the pork meat used in the sample was not available. Quantitative traceability of the pork meat was impossible. In the same establishment, due to human error, the use of a spice mixture in another type of product sampled was not registered in the FBO s database. When identified the FBO took corrective action, but incorrect data was re-entered. Consequently traceability of spices used over two months was lost. In a fourth establishment, the pork meat traceability was incompletely carried out by the CA. The date of the production of the pork meat and meat preparation was 24 and 25 November 2014 respectively. However, the date of the arrival of the pork meat into this establishment was 26 November 2014. The FBO could not provide an explanation. In the same establishment, the FBO used a spice mixture for meat preparation in a higher concentration than recommended on the mixtures specifications. The mixture contained different additives of which some (E450, E451) had a maximum level of use in certain meat products. The technical fiche of the mixture did not contain the concentration of these additives. The FBO could not provide evidence that the maximum level of these additives was respected. The FVO audit team did not identify any problem on traceability of bovine meat throughout the food chain. 9

Conclusion The CA control results for the selected samples indicated non-compliances, but some significant non-compliances related to traceability, labelling and/or the use of additives were not detected. 5.2.2.2. Official controls on FBO s obligations Audit findings The CA provided reports with results of comprehensive inspections carried out in all establishments visited. The FBOs were asked to carry out traceability exercises during the FVO onsite visits. The CA control reports in all but one establishment did not identify non-compliances on traceability, labelling and use of additives. In one establishment, the CA made observations regarding the absence of traceability of food ingredients used. The FVO audit team noted that in two establishments robust traceability systems were not in place, but only comprised some elements such as documents of incoming raw materials, partial information on outgoing products, internal batch numbers. The CA did not report these findings in their control reports. In two other establishments full comprehensive systems were in place providing evidence on qualitative and quantitative traceability, although the CA did not verify the latter. FBOs of five establishments visited have traceability systems in place for qualitative traceability, however, with some shortcomings. Generally, spices and other additives used were not traceable due to a lack of labelling. There was no link between the different documents used by the FBOs. The systems were not effective in providing sufficient details for quantitative traceability. Some of the FBOs systems were under development and should be capable of providing a robust traceability system, including quantitative. The FVO audit team also noted that some FBOs had already carried out traceability exercises and/or mock recalls, however these did not include quantitative traceability exercises. In one of the five establishments, the CA did not identify that animal by-products at different stages of production, were not identified in the traceability system as such and remained in the system fit for human consumption. In the same establishment, there was no documentation on the best before dates for the spices used. In two establishments, the FVO audit team observed final products with two different identification marks. This is not in line with the requirements of Annex II, Section I of Regulation (EC) No 853/2004. 10

In one registered establishment visited, several types of minced meats, meat preparations and meat products were produced on-site and sold directly to the final consumer. Several labels of minced meats and meat preparations did not contain the required information laid down in Directive (EC) No 2000/13, (for example, the incorrect name of the products, used but not labelled additives, missing information such as collagen content). Individual consumer packs arrived in a distribution centre (approved cold store) visited without identification marks. In this distribution centre the products were labelled with the identification mark of the producing establishment. This procedure is not in line with the requirements of Annex II Section I of Regulation (EC) No 853/2004. Conclusions While the system of official controls includes verification of the FBOs compliance with traceability, application of identification marks and labelling, it is not sufficiently developed. Several deficiencies had not been identified during official controls, in particular, verification of the correctness of the information and content on the label, links between the different traceability documents and comprehensive control on the use of ingredients, additives and/or spices. 5.3. Miscellaneous 5.3.1. General hygiene requirements: Some hygiene and maintenance issues were noted by the FVO audit team in two establishments visited, but not during official CA controls, such as direct contamination due to condensation of casings and final products and insufficient ventilation systems. The lay out of the establishments gives several possibilities for cross-contamination between raw materials and products with different hygiene status. Conclusion Hygiene requirements were in general respected with the exception of two establishments visited. 11

6. OVERALL CONCLUSIONS The CA responsible for official controls in the scope of the audit has been designated in compliance with Article 4 (1) of Chapter II of Regulation (EC) No 882/2004. The CA is still in the process of amending the National Food Law of 1953 in order to ensure that appropriate action is taken and applicable sanctions are imposed and enforced when non-compliances are identified, as required by Articles 54 and 55 of Regulation (EC) No 882/2004. Within the scope of the audit, the official control plans are implemented as foreseen and are carried out in accordance with documented procedures. Official controls cover identification, labelling and traceability. However the limited controls on additives, labelling and composition, the lack of systematic control of quantitative traceability or procedures for an in depth verification of FBOs traceability procedures and the lack of the possibility to impose administrative sanctions are undermining the effectiveness of the official controls. The CA s control results for the selected samples indicated noncompliances, but some significant non-compliances related to traceability, labelling and/or the use of additives were not detected. While the system of official controls includes verification of FBOs compliance with traceability, application of identification marks and labelling, it is not sufficiently developed. Several deficiencies had not been identified during official controls, in particular, verification of the correctness of the information and content on the label, links between different traceability documents and comprehensive control on the use of ingredients additives and/or spices. 7. CLOSING MEETING A closing meeting was held on 4 December 2014 with the representatives of the CCA, the ASV. At this meeting the FVO audit team presented the main findings and preliminary conclusions of the audit and advised the CCA of the relevant time limits for the production of the report and their response. The representatives of the CCA acknowledged the main findings and conclusions presented by the FVO audit team. 12

8. RECOMMENDATIONS An action plan describing the action taken or planned in response to the recommendations of this report and setting out a time table to correct the deficiencies found should be presented to the Commission within 25 working days of receipt of the report. No Recommendation 1. To take the necessary steps, that the actions in case of non-compliances have to be effective, proportionate and dissuasive and to provide a legal basis for administrative sanctions in accordance with Articles 54 and 55 of Regulation (EC) No 882/2004. 2. To ensure that official controls relating to traceability of food of animal origin include checks related to both the quantity of product and the type of product involved. Checks on the use of additives and food ingredients should also be included. Corrective action should be taken when non-compliances are identified. (Article 8.3 of Regulation (EC) No 882/2004). 3. During official controls, to ensure that food business operators comply with the requirements set out in Article 18 of Regulation (EC) No 178/2002 with regard to traceability, including qualitative and quantitative aspects. 4. To ensure that official controls guarantee that food business operators comply with the requirements laid down in Regulations (EC) No 1333/2008 and (EC) No1334/2008. 5. To ensure that the information on the labels attached to products of food of animal origin comply the requirements of Regulation (EC) No 1169/2011. 6. To ensure that the use of the identification marks complies with the requirements of Annex II Section I of Regulation (EC) No 853/2004. 13

ANNEX 1 LEGAL REFERENCES Legal Reference Official Journal Title Reg. 1760/2000 OJ L 204, 11.8.2000, p. 1-10 Regulation (EC) No 1760/2000 of the 17 July 2000 establishing a system for the identification and registration of bovine animals and regarding the labelling of beef and beef products and repealing Council Regulation (EC) No 820/97 Reg. 1825/2000 OJ L 216, 26.8.2000, p. 8-12 Reg. 178/2002 OJ L 31, 1.2.2002, p. 1-24 Reg. 882/2004 OJ L 165, 30.4.2004, p. 1, Corrected and re-published in OJ L 191, 28.5.2004, p. 1 Reg. 852/2004 OJ L 139, 30.4.2004, p. 1, Corrected and re-published in OJ L 226, 25.6.2004, p. 3 Reg. 853/2004 OJ L 139, 30.4.2004, p. 55, Corrected and re-published in OJ L 226, 25.6.2004, p. 22 Reg. 854/2004 OJ L 139, 30.4.2004, p. 206, Corrected and re-published in OJ L 226, 25.6.2004, p. 83 Commission Regulation (EC) No 1825/2000 of 25 August 2000 laying down detailed rules for the application of Regulation (EC) No 1760/2000 of the European Parliament and of the Council as regards the labelling of beef and beef products Regulation (EC) No 178/2002 of the 28 January 2002 laying down the general principles and requirements of food law, establishing the European Food Safety Authority and laying down procedures in matters of food safety Regulation (EC) No 882/2004 of the 29 April 2004 on official controls performed to ensure the verification of compliance with feed and food law, animal health and animal welfare rules Regulation (EC) No 852/2004 of the 29 April 2004 on the hygiene of foodstuffs Regulation (EC) No 853/2004 of the 29 April 2004 laying down specific hygiene rules for food of animal origin Regulation (EC) No 854/2004 of the 29 April 2004 laying down specific rules for the organisation of official controls on products of animal origin intended for human consumption

Reg. 2074/2005 OJ L 338, 22.12.2005, p. 27-59 Reg. 1333/2008 OJ L 354, 31.12.2008, p. 16-33 Reg. 1334/2008 OJ L 354, 31.12.2008, p. 34-50 Reg. 1162/2009 OJ L 314, 1.12.2009, p. 10 12 Reg. 931/2011 OJ L 242, 20.9.2011, p. 2-3 Commission Regulation (EC) No 2074/2005 of 5 December 2005 laying down implementing measures for certain products under Regulation (EC) No 853/2004 of the European Parliament and of the Council and for the organisation of official controls under Regulation (EC) No 854/2004 of the European Parliament and of the Council and Regulation (EC) No 882/2004 of the European Parliament and of the Council, derogating from Regulation (EC) No 852/2004 of the European Parliament and of the Council and amending Regulations (EC) No 853/2004 and (EC) No 854/2004 Regulation (EC) No 1333/2008 of the 16 December 2008 on food additives Regulation (EC) No 1334/2008 of the 16 December 2008 on flavourings and certain food ingredients with flavouring properties for use in and on foods and amending Council Regulation (EEC) No 1601/91, Regulations (EC) No 2232/96 and (EC) No 110/2008 and Directive 2000/13/EC Commission Regulation (EC) No 1162/2009 of 30 November 2009 laying down transitional measures for the implementation of Regulations (EC) No 853/2004, (EC) No 854/2004 and (EC) No 882/2004 of the European Parliament and of the Council Commission Implementing Regulation (EU) No 931/2011 of 19 September 2011 on the traceability requirements set by Regulation (EC) No 178/2002 of the European Parliament and of the Council for food of animal origin

Reg. 1169/2011 OJ L 304, 22.11.2011, p. 18-63 Dir. 2000/13/EC OJ L 109, 6.5.2000, p. 29-42 Regulation (EU) No 1169/2011 of the 25 October 2011 on the provision of food information to consumers, amending Regulations (EC) No 1924/2006 and (EC) No 1925/2006 of the European Parliament and of the Council, and repealing Commission Directive 87/250/EEC, Council Directive 90/496/EEC, Commission Directive 1999/10/EC, Directive 2000/13/EC of the European Parliament and of the Council, Commission Directives 2002/67/EC and 2008/5/EC and Commission Regulation (EC) No 608/2004 Directive 2000/13/EC of the European Parliament and of the Council of 20 March 2000 on the approximation of the laws of the Member States relating to the labelling, presentation and advertising of foodstuffs