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Ref. Ares(2017)2066048-21/04/2017 EUROPEAN COMMISSION DIRECTORATE-GENERAL FOR HEALTH AND FOOD SAFETY Health and food audits and analysis DG(SANTE) 2016-8748 - MR FINAL REPORT OF AN AUDIT CARRIED OUT IN GREECE FROM 15 NOVEMBER 2016 TO 25 NOVEMBER 2016 IN ORDER TO EVALUATE THE CONTROL SYSTEMS RELATED TO PROTECTED DESIGNATION OF ORIGIN (PDO), PROTECTED GEOGRAPHICAL INDICATION (PGI) AND TRADITIONAL SPECIALITIES GUARANTEED (TSG) FOR AGRICULTURAL PRODUCTS AND FOODSTUFFS In response to information provided by the competent authority, any factual error noted in the draft report has been corrected; any clarification appears in the form of a footnote.

Executive Summary This report describes the outcome of the Directorate-General for Health and Food Safety audit in Greece carried out between 15 to 25 November 2016, under the provisions of Regulation (EC) No 882/2004 on official food and feed controls. The objectives of the audit were the evaluation of: (i) the official control systems in place for the implementation of European Union (EU) legislation concerning the EU quality schemes for Protected Designations of Origin (PDO), Protected Geographical Indications (PGI), and Traditional Specialities Guaranteed (TSG) for agricultural products and foodstuff and (ii) traceability and labelling. Overall, there is a system of official controls in place for PDO/PGI/TSG agricultural products and foodstuffs. Authorities involved in controls are clearly designated and relevant legislation is in place. Inspectors are provided with written guidelines and inspections observed were adequate and well-documented. However, the effectiveness of the control system in place is reduced as a more systematic risk-based approach to the planning of controls has only recently commenced. Moreover, market controls focus mainly on national products. This report makes recommendations to the Competent Authorities, aimed at rectifying the shortcoming identified and enhancing the implementation of control measures. I

Table of Contents 1 Introduction...1 2 Objectives and scope...1 3 Legal Basis...2 4 Background...2 4.1 Country Profile...2 4.2 EU Quality Schemes...2 4.3 Status of Registered Products in Greece...3 5 Findings and conclusions...3 5.1 Relevant National Legislation...3 5.2 Organisation And Implementation of Official Controls...3 5.2.1 Competent Authorities...3 5.2.2 Prioritisation of Official Controls...4 5.2.3 Procedures and Performance of Official Control Activities...5 5.2.4 Enforcement Measures...7 6 Overall Conclusions...7 7 Closing Meeting...8 8 Recommendations...9 II

ABBREVIATIONS AND DEFINITIONS USED IN THIS REPORT Abbreviation CA(s) CCA(s) CEIMRDF COM CtrlA(s) DOOR DREV(s) ELGO-DIMITRA EU JMD MRDF MS(s) PDO(s) PG(s) PGI(s) RCPPQC TSG(s) Explanation Competent Authority (ies) Central Competent Authority(ies) Committee for the Examination of Infringements European Commission Control Authority(ies) Database of Origin and Registration Directorate(s) of Rural Economy and Veterinary Service of Regional Unities, the local CA(s) for official controls of PDO/PGI/TSGs Hellenic Agricultural Organization, the CtrlA for official controls of PDO/PGI/TSGs European Union Joint Ministerial Decision Ministry of Rural Development and Food Member State(s) Protected Designation(s) of Origin Producer Groups Protected Geographical Indication(s) Regional Centre of Protection Plants and Quality Control Traditional speciality(ies) Guaranteed III

1 INTRODUCTION The audit formed part of the Directorate General for Health and Food Safety planned programme. The audit took place from 15 to 25 November 2016. The team comprised two auditors from the Directorate General for Health and Food Safety and one official from the Directorate General for Agriculture and Rural Development of the European Commission (COM), as well as one expert from a European Union (EU) Member State (MS). Representatives from the Central Competent Authority (CCA), the Ministry of Rural Development and Food (MRDF), accompanied the audit team for the duration of the audit. An opening meeting was held on 15 November 2016 with the attendance of the MRDF and the Control Authority (CtrlA), the Hellenic Agricultural Organization (ELGO-DIMITRA), involved in official control in this area. At this meeting, the objectives of, and itinerary for the audit were confirmed and the control systems were described by the authorities. 2 OBJECTIVES AND SCOPE The objectives of the audit were: The evaluation of the official control systems in place for the implementation of EU legislation concerning: Protected Designations of Origin (PDOs), Protected Geographical Indications (PGIs), Traditional Specialities Guaranteed (TSGs) for agricultural products and foodstuffs: Regulation (EU) (No) 1151/2012 of the European Parliament and Council, Commission Delegated Regulation (EU) No 664/2014 and Commission Implementing Regulation (EU) No 668/2014: and Traceability and labelling: Article 18 of Regulation (EC) No 178/2002 and Directive 2000/13/EC. In terms of scope, the audit reviewed the organisation and performance of the CAs for PDO/ PGI/TSG schemes, and the official controls system in place covering production, distribution and placing on the market of these products. In pursuit of these objectives, a sample of PDOs/PGIs/TSGs was selected and the following sites were visited: Visits/meetings Comments CCA/CAs CCA/CtrlA 2 The attendance at the opening and closing meeting included representatives from the MRDF and the ELGO-DIMITRA. 1

Local CAs 2 The attendance at these meetings included representatives of the MRDF, ELGO- DIMITRA as well as the Directorates of Rural Economy and Veterinary Service of Regional Unities (DREVS). Establishments PDO products 3 1 small and 2 medium processors/ packaging entities Supermarket 1 Visit to a large supermarket 3 LEGAL BASIS The audit was carried out under the general provisions of EU legislation, in particular Article 45 of Regulation (EC) No 882/2004 of the European Parliament and of the Council. EU legal acts quoted in this report refer, where applicable, to the most recently amended version. Full references to the EU acts quoted in this report are given in Annex 1. 4 BACKGROUND 4.1 COUNTRY PROFILE DG Health and Food Safety has published a Country Profile for Greece, which describes in summary the control systems for food and feed, animal health, animal welfare and plant health as well as quality labelling and gives an overview of the state of play concerning recommendations from previous audits. The country profile for Greece can be found at: http://ec.europa.eu/food/audits-analysis/country_profiles/details.cfm?co_id=gr 4.2 EU QUALITY SCHEMES The EU quality schemes for PDO/PGI/TSG protect and promote quality agricultural products and foodstuffs and aim to ensure the protection of their names from, inter alia, misuse, evocation and imitation and help consumers by giving them information concerning the specific character of the products: PDO covers agricultural products and foodstuffs which are produced, processed and prepared in a given geographical area using recognised know-how. PGI covers agricultural products and foodstuffs closely linked to the geographical area. At least one of the stages of production, processing or preparation takes place in the area. 2

TSG highlights traditional character, either in the raw materials, composition or means of production. Further details on the quality schemes are available on the following website: http://ec.europa.eu/agriculture/quality/schemes/index_en.htm 4.3 STATUS OF REGISTERED PRODUCTS IN GREECE At the time of the audit there were 29 PGI and 75 PDO from Greece registered on the Database of Origin and Registration (DOOR). In conjunction with DG AGRI, two registered geographical indications (names) were selected to form part of this audit as a sample, in order to evaluate how the system of official controls works in Greece. 5 FINDINGS AND CONCLUSIONS 5.1 RELEVANT NATIONAL LEGISLATION Legal requirements Article 291 of the Treaty on the Functioning of the EU. Findings 1. The relevant legislation relating to PDO/PGI agricultural products and foodstuffs is the Joint Ministerial Decision (JMD) No 261611/07.03.2007 (OJ 406/B ), as amended by JMD No 290398/11.04.2008 (OJ 694/B ) and by JMD No 318764/07-08-2008 (OJ 1683/B ). Conclusions on Relevant National Legislation 2. Relevant national measures are in place to implement EU Regulations relating to official controls of PDO/PGI/TSG. 5.2 ORGANISATION AND IMPLEMENTATION OF OFFICIAL CONTROLS 5.2.1 Competent Authorities Legal requirements Articles 36(1), 36(2), 37(1) and (3) and 39(1) of Regulation (EU) No 1151/2012. Regulation (EC) No 882/2004, in particular Articles 4 and 6. Findings 3. According to JMD No 261611/07.03.2007 as amended, the CAs in the context of this audit are as follows: 3

4. The CCA is the Directorate of Quality Systems, Organic Production and Geographical Indications of MRDF and is competent to monitor the implementation of EU legislation on PDO/PGI/TSG agricultural products and foodstuffs. 5. The ELGO-DIMITRA is responsible for carrying out official controls to verify compliance with the legal requirements related to PDO/PGI/TSG agricultural products and foodstuffs. This is an organisation operating under private law for public benefit under the supervision of the MRDF. 6. ELGO-DIMITRA is tasked with the certification of enterprises, undertaking official controls with the DREVs, ensuring conformity with Product Specifications and appropriate use of the registered names in the market place. In addition, it is responsible for establishing and maintaining a public register of certified enterprises and referring non-compliances to the Committee for the Examination of Infringements (CEIMRDF). 7. Further information on the authorities involved in official controls of PDO/PGI/TSG agricultural products and foodstuffs is available on: http://www.minagric.gr/index.php/en/farmer-menu-2/pdo-pgi-tsgproducts-menu Conclusions on Competent Authorities 8. The authorities are designated for the verification of compliance of product specification prior to placing PDO/PGI/TSGs on the market and the monitoring and use of registered names in line with Article 36 (EU) No 1151/2012. 5.2.2 Prioritisation of Official Controls Legal requirements Articles 37(1) and 38 of Regulation (EU) No 1151/2012. Article 3 of Regulation (EC) No 882/2004. Findings Verification of compliance with product specification prior to placing a product on the market 9. At the level of primary producers, no targeted on-site inspections are undertaken by the CtrlA/relevant CAs apart from random, on the spot, inspections, in the area of PDO/PGI products of plant origin. 10. In order to initiate the verification prior to placing a product on the market, the operators submit an application to ELGO-DIMITRA, in order to be included in the ELGO- DIMITRA public Register of Approved Operators for PDO/PGI agricultural products and foodstuffs. 4

11. Once the application and all supporting documents are assessed and approved by ELGO-DIMITRA an official control at the operator's premises is scheduled and includes the verification of the conformity of a product with the corresponding Product Specification. If non-compliances are detected the operator is obliged to implement corrective actions in a specified time period to ensure registration. Assuming all is in order, the operator will be included in the ELGO-DIMITRA Register of Approved Operators. The details relating to making such an application and the register can be found on www.elgo.gr 12. ELGO DIMITRA, in cooperation with the DREVs, carries out on site visits of producers for verification prior to placing the product on the market as well as for surveillance controls. These controls consist of checking production process, traceability and labelling in order to ensure product specification. 13. Operators are obliged to submit production information to ELGO-DIMITRA which enables the CA to have an overview of the sector. In addition, the information relating to primary production is available at the DREVs and this administrative information is useful to verify that primary producers are located within the demarcated areas. 14. To enable a more structured and systematic approach to the planning of official controls, ELGO-DIMITRA informed the audit team that since June 2016 an electronic risk assessment tool had been developed for PDO/PGI food of animal origin. It is anticipated that it would be extended to all other PDO/PGI by the end of 2017. Official controls on the market 15. ELGO-DIMITRA carries out market controls on a regular basis for all Greek PDO/PGI products. In addition, targeted market controls are carried out, following complaints received either from other Member States or non-eu countries or the CCA. Conclusions on Prioritisation of Official Controls 16. At the time of the audit, the planning of official controls was not fully based on a risk assessment of all PDO/PGI agricultural products and foodstuffs, although efforts have commenced to improve this situation. 5.2.3 Procedures and Performance of Official Control Activities Legal Requirements Articles 12, 13(1), 23, 24(1), 36(3), 44 and 46(1) of Regulation (EU) No 1151/2012. Commission Delegated Regulation (EU) No 664/2014, in particular Article 1. Commission implementing Regulation (EU) No 668/2014, in particular Article 4. Article 18 of Regulation (EC) No 178/2002. 5

Articles 8(1), 9 and 10(2)(b)(vi) of Regulation (EC) No 882/2004. Regulation (EU) No 1169/2011 Findings Official controls of producers / processors of PDO/PGI agricultural products and foodstuffs 17. The audit team observed official controls of two PDO products of non- animal origin. The inspections were undertaken by one ELGO-DIMITRA inspector and one DREV inspector in each case. A comprehensive preparation had been undertaken at the office prior to the onsite visits. The inspectors in both cases were knowledgeable and had been provided with detailed checklists. A template for the inspection report was also available. The inspectors also checked labelling, traceability and input output quantities. The audit team reviewed the inspection reports from previous inspections and noted that they were satisfactory. The inspectors had noted a number of non-compliances and these were handled in accordance with the written procedures from ELGO-DIMITRA. At the end of the inspection a report was prepared for the operator. Official controls on the Market 18. This official control of PDO/PGI/TSG agricultural products and foodstuffs was undertaken by ELGO-DIMITRA. The inspectors undertake official controls in a wide variety of retail and wholesale establishments throughout the country. The control of PDO/PGI/TSG is included in their tasks. The main focus of the observed controls was related to national PDO/PGI products and products from other MSs and non-eu countries were not considered which is not in line with Article 36(3)(b) of Regulation (EU) No 1151/2012. The inspector stated that the national legislation (Horizontal legislation on Certification of Rules for Marketing and Distribution of product and provisions of services, 31 July 2014) does not require the Union symbols to be visible on the stickers or showcase signs of bulk or unwrapped PDO/PGI/TSG products when displayed. This is not in line with Article 12(3) of Regulation (EU) No 1151/2012. 19. The inspector reviewed a number of PDO/PGI products and prepared a report for the operator. Conclusions on Procedures and Performances of Official Control Activities 20. There are adequate procedures in place and on-site visits were adequately performed. However, according to national legislation it is not compulsory for the Union symbols to be displayed on the stickers printed by the weighing device for bulk/unwrapped products or on the showcase sign at retail level. This is not in line with EU requirements. In addition, market controls did not include PDO/PGI/TSGs from other MSs and non-eu countries except in the case of complaints. 6

5.2.4 Enforcement Measures Legal Requirements Article 13(3) of Regulation (EU) No 1151/2012. Articles 54 and 55 of Regulation (EC) No 882/2004. Findings 21. In relation to agricultural products and foodstuffs the enforcement measures in place under the JMD 261611/2007 are the following: Withdrawal of Certification (Permanent or Temporary) Refusal to grant certification Withdrawal from the market, in cooperation with other Authorities Fines imposed by the Committee for the examination of infringements of MRDF. 22. These enforcement measures may be imposed following infringements found during controls or as a result of complaints reported to the relevant CCA. The audit team reviewed files, which followed up complaints and although they did not result in fines, the operator was required to withdraw and re-label the product. Conclusions on Enforcement Measures 23. Relevant legislation is in place for enforcement measures and implemented. 6 OVERALL CONCLUSIONS Overall, there is a system of official controls in place for PDO/PGI/TSG agricultural products and foodstuffs. Authorities involved in controls are clearly designated and relevant legislation is in place. Inspectors are provided with written guidelines and inspections observed were adequate and well-documented. However, the effectiveness of the control system in place is reduced as a more systematic risk-based approach to the planning of controls has only recently commenced. Moreover, market controls focus mainly on national products. 7 CLOSING MEETING A closing meeting was held on 25 November 2016 with the attendance of representatives of the different CAs. At this meeting, the audit team presented the main preliminary findings of the audit and a number of points were clarified. The CAs provisionally accepted the preliminary findings. 7

8 RECOMMENDATIONS The CAs are invited to provide details of the action taken and planned, including deadlines for their completion (action plan), aimed at addressing the recommendations set out below, within 25 working days of receipt of this audit report. The CAs should: No. Recommendation 1. Continue to develop the risk based approach for the planning of official controls to include all PDO/PGI/TSGs, as required by Article 3 of Regulation (EU) No 882/2004. Recommendation is based on conclusions No 16. Associated findings: No 14. 2. Ensure that the Union symbols are displayed in the same field of vision on the stickers printed by the weighing device for bulk/unwrapped products or on the showcase sign at retail level, in line with Article 12(3) of Regulation (EU) No 1151/2012. Recommendation is based on conclusions No 20. Associated findings: No 18 3. Ensure that official controls cover the monitoring of the use of registered names to describe product placed on the market, as established in Article 36(3)(b) of Regulation (EU) No 1151/2012. Recommendation is based on conclusions No 20. Associated findings: No 18. The competent authority's response to the recommendations can be found at: http://ec.europa.eu/food/audits-analysis/rep_details_en.cfm?rep_inspection_ref=2016-8748 8

ANNEX 1 LEGAL REFERENCES Legal Reference Official Journal Title Horizontal Legislation 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 Regulation (EC) No 178/2002 of the European Parliament and of the Council of 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 European Parliament and of the Council of 29 April 2004 on official controls performed to ensure the verification of compliance with feed and food law, animal health and animal welfare rules Labelling Legislation Reg. 1169/2011 OJ L 304, 22.11.2011, p. 18-63 Regulation (EU) No 1169/2011 of the European Parliament and of the Council of 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 PDO/PGI/TSG Legislation Reg. 1151/2012 OJ L 343, 14.12.2012, p. 1-29 Regulation (EU) No 1151/2012 of the European Parliament and of the Council of 21 November 2012 on quality schemes for agricultural products and foodstuffs

Reg. 664/2014 OJ L 179, 19.6.2014, p. 17-22 Reg. 668/2014 OJ L 179, 19.6.2014, p. 36-61 Commission Delegated Regulation (EU) No 664/2014 of 18 December 2013 supplementing Regulation (EU) No 1151/2012 of the European Parliament and of the Council with regard to the establishment of the Union symbols for protected designations of origin, protected geographical indications and traditional specialities guaranteed and with regard to certain rules on sourcing, certain procedural rules and certain additional transitional rules Commission Implementing Regulation (EU) No 668/2014 of 13 June 2014 laying down rules for the application of Regulation (EU) No 1151/2012 of the European Parliament and of the Council on quality schemes for agricultural products and foodstuffs