Ref. Ares(2019)1399096 - 01/03/2019

2 TABLE OF CONTENTS INTRODUCTION ...... 3 SUMMARY...... 4 1 ARRANGEMENTS FOR THE IMPLEMENTATION OF CERTAIN REQUIREMENTS OF REGULATION (EC) NO 882/2004 ...... 5 Designation of Competent Authorities ...... 5 Resources for performing controls ...... 13 Organisation and implementation of official controls ...... 15 Enforcement measures...... 20 Verification and review of official controls and procedures ...... 23 2 COMPETENT AUTHORITIES AND DISTRIBUTION OF RESPONSIBILITIES IN RELATION TO INDIVIDUAL CONTROL SYSTEMS ...... 29 2.1 Control system for animal health...... 29 2.2 Control system for food of animal origin ...... 33 2.3 Control system for imports of animals and food of animal origin...... 35 2.4 Control system for feedingstuffs and animal nutrition ...... 37 2.5 Control system for TSE and Animal By-Products (ABP) ...... 40 2.6 Control system for veterinary medicinal products (VMP) and residues...... 43 2.7 Control system for foodstuffs and food hygiene...... 46 2.8 Control system for imports of food of plant origin...... 49 2.9 Control system for plant protection products (PPP) and residues ...... 54 2.10 Control system for animal welfare...... 60 2.11 Control system for plant health...... 62 2.12 Quality labelling...... 65 ANNEX I – STAFF RESOURCES ...... 72 ANNEX II — ACRONYMS, ABBREVIATIONS AND SPECIAL TERMS...... 76

2 DG(SANTE)2017-6055 Final Version date: February 2019 INTRODUCTION

This overview has been drawn up by the Directorate-General for Health and Food Safety of the European Commission. It is based on information supplied by .

The aim is to present, in summary form, the latest information on how control systems for food and feed safety, animal health, animal welfare, plant health and quality labelling are organised in Greece.

Chapter 1 describes the overall organisation of the Greek authorities and the responsibilities of the ministries and government agencies for the different components of the control system. It includes a chart to show the inter-relationships between the different bodies’ responsibilities.

Chapter 2 gives a more detailed description, also with charts, of the main responsibilities of each of the twelve separate systems that form the complete range of control systems in Greece, covering the whole chain of plant, animal and food production.

Annex I provides details of the number of control staff in Greece. The statistics on staff resources are provided on a non-standardised basis.

This overview was updated after the most recent general follow-up audit in December 2017 and will be updated at regular intervals on the basis of information from the Competent Authorities (CAs).

Acronyms are used extensively throughout this overview for the sake of brevity. A list of acronyms, abbreviations and special terms is given in Annex II as a guide for the reader.

3 DG(SANTE)2017-6055 Final Version date: February 2019 SUMMARY

Greece underwent an administrative reorganisation under the Kallikratis Law, approved in July 2010. As part of this process the former prefectures have been replaced by thirteen larger Regions and seven Decentralised Administrations. These administrative changes have direct consequences on the organisation and implementation of official controls.

Overall responsibility for the organisation and implementation of control systems for food and feed safety, animal health, animal welfare and plant health in Greece lies with the Ministry of Rural Development and Food (MRDF). Two more Ministries, namely the Ministry of Health (ΜΗ), the Ministry of the Interior and Administrative Reconstruction (MIAR) as well as the Independent Authority for Public Revenue are also involved in the implementation of the relevant control systems. Additionally, the Ministry of Environment & Energy (MEE) coordinates the implementation of plant health legislation of forestry services.

The Ministries mainly have responsibility for policy co-ordination, while the implementation of controls is decentralised to services at regional level (13 administrative regions).

MRDF underwent a reorganization through PD 97/2017.. MRDF and EFET have been appointed under Joint Ministerial Decision (JMD) No 088/06, for the implementation of the provisions of Regulations (EC) No 178/2002, 852/2004, 853/2004, 854/2004, and 882/2004 to carry out official controls on feed, food, animal health and welfare and plant health.

4 DG(SANTE)2017-6055 Final Version date: February 2019 1 ARRANGEMENTS FOR THE IMPLEMENTATION OF CERTAIN REQUIREMENTS OF REGULATION (EC) NO 882/2004

Designation of Competent Authorities

Ministry of Rural Development and Food (MRDF)

MRDF underwent reorganization through PD 97/2017. More details for the structure and responsibilities of the central and decentralized services of MRDF are presented in MANCP 2015-2019.

The new organization chart of the MRDF can be found on the following website: http://www.minagric.gr/images/stories/en_docs/ministry/organogramma_apostolou23021 7_eng.pdf

The Directorate General of Veterinary Services (DGVS) is responsible for implementing horizontal and vertical legislation on official controls for live animals, animal products, animal diseases, zoonoses, food safety up to the first processing (depending on the sector) and animal welfare, animal identification, registration, marketing and use of veterinary medicines and additives, and animal by-products.

It has the following five Directorates and one Division:  Directorate of Animal Welfare, Veterinary Drugs and Veterinary Applications (DAWVDVA)  Directorate of Animal Health (DAH)  Directorate of Veterinary Public Health (DVPH)  Directorate of Veterinary Center of (DVCA)  Directorate of Veterinary Center of (DVCT)  Planning and Coordination of Laboratory Testing Division (DiPCLT)

DAWVDVA has four departments: a) Department of Livestock and Laboratory Animals Welfare, b) Department of Pet Animals and Other Animals Welfare c) Department of Identification and Registration of Animals and Artificial Insemination, and d) Department of Veterinary Medicines and Residues.

DAH is responsible for the co-ordination, planning and control/eradication of animal health programmes jointly with the DAWVD and for contingency planning and epizootic disease control when the local authorities have insufficient resources or when a number of local authorities are involved. It has the following Departments: a)Department of Imports- Exports and Intracommunity Trade of Live Animals, and of Products of Animal Origin b)Department of Infectious and Parasitic Diseases c)Department of Zoonoses d)Department of Avian Pathology, of Aquatic Animals, Bees and Other Animals ‘s pathology e) Department of BIP of Piraeus (Including BIP of Piraeus, BIP of Athens National airport and BIP of -Aetoliaacarnania-) f) Department of BIP of Thessaloniki (Including BIPs of Thessaloniki port, Thessaloniki “Macedonia” Airport, Efzonoi of , Kakavia of , Neos Kafkasos in Florina) g) Department BIP of .

5 DG(SANTE)2017-6055 Final Version date: February 2019 DVPH is responsible for legislation covering animal products, food safety up to the first processing (depending on the sector) and animal by-products, co-ordinates and monitors implementation of legislation. To this end, it issues circulars, organises meetings, and establishes committees and working parties. It is also responsible for granting approval numbers. It has three Departments: a) Department of Slaughterhouses b) Department of Fisheries, Milk, Eggs and other Foodstuffs and c) Department of Animal By Products.

The Directorate-General of Agriculture (DGΑ) is responsible for implementing horizontal and vertical legislation concerning the plant health and plant protection products, livestock infrastructures, animal genetic resources, Animal Husbandry Systems, feed, conformity checks (marketing standards) and safety of fresh agricultural plant products at primary production including the stage of first processing at internal market, intercommunity trade and import/export stage.

It has the following Directorates:

 Directorate of Propagating Material of Cultivated Plant Species and Plant Genetic Resources

 Directorate of Cultivating Systems and Plant Production Products

 Directorate of Plant Production Protection (DPPP)

 Directorate of Animal Genetic Resources and livestock infrastructures (DMAGRALI)  Directorate of Animal Feed and Pasturelands (DANFP)  Directorate of Animal Husbandry Systems (DAHS)

According to the PD 97/2017 (Government Gazette 138/A), the General Directorate of Food consists of four directorates, among which the following two Directorates are responsible for food safety matters: - Directorate of Food Quality and Safety (DFQS) and - Directorate of Food Utilization and Technology (DFUT)

DFQS is responsible for organising, co-ordinating and monitoring the implementation of the official controls concerning food safety carried out in fresh fruit and vegetables packing premises (including packing in the farm). DFQS is also responsible for the organisation, co-ordination and the monitoring the implementation of official controls concerning the conformity of fresh fruit and vegetables to the marketing standards in all marketing stages. At import/export stage, the Directorate is one of the CAs for controls of food of plant origin, according to the JMD 15523/2006. GCSL is also responsible for official controls of food at import and export stage.

Concerning wine sector including PDO /PGI wines according to JMD 5833/155045/2013 DPQCFPP : a)Coordinates, informs, supervises and monitors; / Departments of Rural Economy and Veterinary Medicine (DREVM) and the Regional Plant Protection and Quality Control Centres (RCPPQC) in terms of carrying out checks at all stages of production, bottling, labelling and distribution of the PDO and PGI wines, b) Receives, monitors, evaluates, and publicly notifies the European Commission requests or registration appeals PDO, PGI wines and specifications modification requests already

6 DG(SANTE)2017-6055 Final Version date: February 2019 registered designations / indications or cancellation thereof, c)Transmits the above supervisory authorities, complaints coming to it concerning the production and marketing of PDO and PGI products to carry out the necessary checks.

DPPP is responsible for the coordination of controls on plant health and pesticides and the implementation of administrative sanctions.

The Directorate of Quality Systems and Organic Farming (DQSOF) is responsible for the implementation of legislation for quality schemes (PDO/PGI/TSG) and organic farming.

The four Meat Industry Schools belong to the Directorate of Research, Innovation and Education of the General Directorate of Rural Development.

Decentralised Services of MRDF, are: the Variety Research Institute of Cultivated Plants; the Control Station for Vegetative Propagating Material; the Seed Testing Station; the Vineyard Nurseries; the Pomological Stations; and the State Farms. The Regional Centres of Plant Protection , Quality and Phytosanitary Control (RCPPQPC) of Attiki, Thessaloniki, Achaia, Irakleio, , Ioannina, Nafplion and , belonging to the Decentralised Services of MRDF (PD 97/2017 – Government Gazette 138/A), are responsible inter alia for performing the official controls within their competencies as described in PD 97/2017 and according to specific circulars of DFQS. Concerning wine sector including PDO /PGI wines .according to JMD 5833/155045/2013 RCPPQC participate to certification procedure.

Hellenic Food Authority (EFET)

EFET is supervised by the MRDF according to PD 85/2012 (GG 141/A). It is responsible for controls of food of animal origin after first processing, food hygiene and materials and articles intended to come into contact with food. Food for special nutritional purposes is the competence of EOF.

It is the national contact point for the Rapid Alert System for Feed and food (RASFF) system pursuant to JMD No 77/2011 and the national contact point for Codex Alimentarius co-ordinating actions. Furthermore it is: - Focal point of contact with EFSA, - Contact point of INFOSAN, - Liaison body of Greece (General Liaison Body) for the purposes of the "System Administrative Assistance and Cooperation» (AAC system) between the M-S as provided for in Regulation (EC) No. 882/2004 (Circular No. 15688 / 09.25.2014 / EFET).

A seven-member administrative board governs EFET. The board is advised by the Scientific Food Control Council (ESET) and the National Food Control Policy Council (ESPET). ESET issues scientific opinions on topics related to EFET’s remit. ESPET submits proposals from scientific committees or working groups on food safety policies and action programmes to EFET’s administrative board.

EFET is organised at central and regional level. At central level, it consists of six directorates (Food Enterprises Control, Laboratory Control - including the Food Testing and Research Laboratories based in Athens and Thessaloniki), Appraisal and Licensing,

7 DG(SANTE)2017-6055 Final Version date: February 2019 Nutritional Policy and Research, Education and Communication and Administrative Support), a Legal Services Support Office and a Consumer Services Office. Moreover it has been in operation since 2013 the Department of Quality Assurance Provided Services. The head office is responsible for: drafting annual monitoring plans; evaluating their implementation; issuing circulars; proposing legislation; and shaping the institution’s policy. There are nine Regional Directorates:  Regional Directorate of , with headquarters in Athens,  Regional Directorate of , with headquarters in Thessaloniki,  Regional Directorate of , with headquarters in ,  Regional Directorate of , with headquarters in ,  Regional Directorate of , with headquarters in Ioannina,  Regional Directorate of , with headquarters in Irakleio,  Regional Directorate of East Macedonia and Thrace, with headquarters in ,  Regional Directorate of Northern Aegean, with headquarters in Mytilini,  Regional Directorate of Peloponnesus, with headquarters in Tripoli.

It was planned to establish offices in all of the 13 regions.

The Regional Directorates are organised into four sections (Food Enterprises Control, Appraisal Licences and Administrative Support) and a Consumer Services Office. These regional directorates are under the co-ordination, guidance and supervision of EFET central services. The relationship between EFET central services and the regional directorates is laid down in Law 2741/1999, PD 223/2000 and JMD No 15523/2006. The regional directorates are responsible, for implementing the MANCP, and for providing guidance, co-ordinating, supervising and evaluation of results of controls carried out by authorities at regional level, based on the relevant provisions of the JMD No 15523/2006.

EFET’s relationship with other services, is defined by Act No 2741/1999 and JMDs Β3- 32/2003, 052/2004, 088/2006 και JMD 15523/2006 and JMD 1288/2017.

Additional measures for the implementation of Regulations (EC) No 178/2002, 882/2004, 852/2004, 853/2004 and 854/2004 within the scope of EFET responsibilities have been established by JMD 15523/2006 , as it has been modified by JMD 1288/2017. New guides and circulars on the conduct of official controls, frequency of inspections, sampling and analyses, have been issued to the regional services.

Hellenic Agricultural Organization (ELGO-DIMITRA)

ELGO-DIMITRA (former Greek Milk and Meat Organisation) is an organization operating under private law, but for public benefit. It was established in 2011 by merging the following four organisations: i) O.G.E.E.K.A- DIMITRA, Organization of Agricultural Vocational Education Training and Employment, ii) AGROCERT, Organization for Certification and Inspection of Agricultural Products, iii) N.AG.RE.F., National Agricultural Research Foundation and iv) ELOGAK, Greek Milk and Meat Organization”. The General Directorate of Quality Assurance of Agricultural Products of ELGO consist of former AGROCERT, Organization for Certification and Inspection of Agricultural Products and former ELOGAK, ELGO has general competences and powers

8 DG(SANTE)2017-6055 Final Version date: February 2019 which exercise in accordance with JMD No 188763/10−10−2011 (Government Gazette 2284 B).

ELGO-DIMITRA has been appointed under JMD No 261611/2007, on the implementation of the provisions of Regulation (EC) No 1151/2012, to carry out controls on products with Geographical Indications (GI’s) and under JMD 245090/2006 on the implementation of Regulation (EC) No 834/2007 and (EC) 889/2008 as control authority on organic farming. ELGO has general competences and powers which exercise in accordance with JMD No 261611/2007(Government Gazette 406 B).

With regard to administration and financing, ELGO-DIMITRA is an independent body. However, it operates under the supervision of the MRDF and responsibilities within the scope of the audit are financed by the same Ministry. It operates a network of eight laboratories that analyse raw milk samples for hygiene and quality. The ELGO works in co-operation with the DGVS and DGSRD especially on the implementation and controls on organic farming and quality schemes legislation.

Ministry of Health (MH)

The MH has one central service, the Directorate General of Public Health (DGPH). In the same ministry belongs the Public Health Laboratory Service as well.

DGPH has responsibility for controls and licensing of certain premises through regional units food service sector, retail and warehouses). It also has competence for the control of quality of water intended for human consumption.

The National Organisation for Medicines (EOF) is an independent body governed by public law and supervised by the MH. Under law 1316/1983, as amended, the organisation's duties include control of pharmaceutical substances, cosmetics and other related products and controls of foods intended for special nutritional purposes and their authorisation and controls on placing on the market of veterinary medicinal products, medicated feedingstuffs.

EOF’s laboratories test medicines. Its organisational structure is described on the website www.eof.gr.

Ministry of Interior and Administrative Reconstruction (MIAR)

Greece underwent an administrative reorganisation, intended to simplify its structure. The Kallikratis Law (3852/2010) was approved in July 2010 and abolished the former fifty-four prefectures.

Local government comprises, seven DAs, thirteen regions (East Macedonia and Thrace, Central Macedonia, West Macedonia, Epirus, Thessaly, , West Greece, , Attica, Peloponnesus, , and Crete) 74 Regional Units and 325 Municipalities. The administrative changes have implications for all sectors with relevance in this country profile.

9 DG(SANTE)2017-6055 Final Version date: February 2019 The DAs are State bodies regulated by Article 6 of the Kallikratis Law. In general there is one DA for every two regions (the DA in Attica has only one region). The DAs are the representatives of the central administrations at regional level particularly for certain competences that have been maintained at state level (i.e. competences in Forestry). There is no hierarchical link between the DAs and the regions.

Each Region has a Directorate General of Regional Rural Economy and Veterinary Medicine (REVM) responsible for the implementation of the relevant controls.

In general, the Directorate General of Regional REVM is divided into a number of Directorates. Relevant to the country profile are the following: • Directorate of Rural Economy, which includes the Department of Plant and Animal Production; • Directorate of Veterinary Medicine (also referred to as of the Regional Unit's Veterinary Service (RUVS)), which includes the Department of Animal Health, the Department of Veterinary Public Health and the Department of Veterinary Support, Drugs, Applications and Animal Welfare; • Directorate of REVM, which includes five departments, three of which are relevant to this country profile: (Department of Quality and Phytosanitary Control; Department of Plant and Animal Production; and Department of Veterinary Medicine). In most regions, within the Directorate General of Regional REVM (competencies over the entire region) there are more than one Directorate of REVM (one per regional unit within the same region). However there are some exceptions (see below).

The Directorate General of REVM of each region, have competencies over the entire region. Each Directorate of REVM, on the other hand, has competences over their relevant regional unit only.

10 DG(SANTE)2017-6055 Final Version date: February 2019 Regardless of this general structure described above, there are differences between regions, mostly in the North and South Aegean regions:

 In most regions (continental Greece): each regional unit has the same geographic demarcation as the former prefecture. In these regions, for each regional unit a separate Directorate of REVM has been established with local competencies.

 In the Regions of South and North Aegean, and in some other islands: a single Directorate of REVM may have competencies over more than one regional unit. Likewise in some of these regions the Directorate General of Regional REVM, that has competencies over the entire region, has been assigned additional local competencies for specific regional units (of the same region) for which no separate Directorate of REVM has been established. As a result within the 13 Directorates General of Regional REVM (1 per region) there are (in total) 57 Directorates of Regional REVM (while the total number of regional units is actually 74).

The Directorates General REVM are responsible for the implementations of the relevant controls.

Independent Authority for Public Revenue — General Chemical State Laboratory (GCSL)

The GCSL is a General Directorate of the Independent Authority for Public Revenue. It has a central service of three (3) directorates and 15 Chemical services at regional level and 12 services at local level. The Chemical Services are not under the regional structure.

11 DG(SANTE)2017-6055 Final Version date: February 2019 Details on the organisation and structure of the GCSL are at www.gcsl.gr. According to the JMD 15523/2006, the GCSL is one of the CAs for the controls on the import of some food of plant non animal origin. GCSL provides also support for official control purposes by carrying out chemical laboratory analyses of foodstuffs and offers scientific and technical support to various Ministries.

The central service co-ordinates the Chemical Services dealing with official food controls. Currently, 9 Chemical Services accredited according to ISO 17025, act as official laboratories within GCSL, according to the Decision of the Secretary General for Public Revenue 30/003/000/4638/2015. Additionally, 2 of these laboratories have been designated as National Reference Laboratories (NRLs) in the area of Food Contact Materials (FCM), GMOs, Polycyclic Aromatic Hydrocarbons, mycotoxins, heavy metals and pesticide residues in cereals, food of animal origin and for single residue method.

GCSL has the responsibility of the implementation of national provisions regarding the approval of specific categories of foods.

Co-operation and co-ordination between and within CAs

Cooperation and Communication takes place between and within CAs through:  Regular exchange of information  Meetings and working groups  Joint efforts in response to specific cases or events

The main tool of coordination and cooperation are circulars prepared and circulated to regional services by the Central Competent Authorities, MRDF and EFET. Circulars and guidance documents aim at ensuring coordination both for technical matters as well as for procedural matters.

Working groups are not established by the central Competent Authorities across all sectors, but are organised in areas where the CAs consider this as necessary (e.g. meetings are held annually for the integrated multi-annual national control plan and the planning of control programmes between EFET and competent authorities and meeting agendas are prepared for specific topics such as for changes to standards for dairy products, animal by-products and legislation-related matters).

Also memoranda of collaboration are used as a tool of cooperation in order to define tasks and/or to avoid overlaps between different CAs:  EFET signed memoranda of collaboration with regional services. In some Regions this is done through less formal cooperation between EFET and regional services.  The memorandum of collaboration between the DGVS, DAH and the Customs Authorities has been signed in 2011 and came into effect in 2012.  Also some of the laboratory work is coordinated based on memoranda of collaboration signed with the CCAs.

Cooperation and communication between services of the regions and the regional units takes place on a regular basis including joint inspections for the approval of establishments, establishing joint committees (sanction and appeal committees), etc.

12 DG(SANTE)2017-6055 Final Version date: February 2019 Delegation

JMD 15523/2006 establishes the possibility for EFET to delegate specific tasks to control bodies. EFET indicated that there is no delegation of specific tasks related to official controls to control bodies within the scope of this country profile.

Resources for performing controls

Legal powers for controls are sufficient in all sectors.

The relevant legal powers are granted to EFET within its remit by Law 2741/1999, Joint Ministerial Decision No 15523/2006 and Law 4235/2014. In addition, EFET employees have the competences to carry out any investigation they consider necessary in accordance with the provisions of the Hellenic Code of Criminal Procedure.

The relevant legal powers are granted to the MRDF within its remit by Law 4235/2014 and other specific legislation in each sector.

The relevant legal powers are granted to the competent authorities for plant protection products and pesticide residues are clearly granted by law 4036/2012.

ELGO-DIMITRA has been appointed under JMD No 261611/2007(Government Gazette 406 B), on the implementation of the provisions of Regulation (EC) No 1151/2012, to carry out controls on products with Geographical Indications (GI’s) and under JMD 245090/2006 on the implementation of Regulation (EC) No 834/2007 and (EC)889/2008 as control authority on organic farming.

The obligation of Food Business Operators (FBOs) to undergo official inspection and the penalties imposed for refusal are laid down in Law 4235/2014. It provides for the structure and legal powers to enforce the requirements of EU legislation, to access establishments, examine documentation kept by FBOs, collect information and take samples for analysis.

Staffing provision and facilities

The legal provisions of the Civil Service Code (Law 3528/2007, as amended and in force) and Article 12 of JMD 15523/2006 provide for the avoidance of conflict of interests for staff involved in official controls.

For employees of EFET, Article 23 of Ministerial Decision No 12932/2006 requires that general rules based on established international standards be in place concerning independence, objectivity, confidentiality and impartiality. When there is a suspicion that can compromise objectivity, the inspector cannot be responsible for the control of the particular FBO.

Article 5 of the law establishing the EFET (Law 2741/1999) provides for disciplinary measures for infringement of the duty of confidentiality by anyone who releases confidential information to third parties without authorisation.

The Law 3833/2010 (Protection of the National Economy - urgent measures to deal with the fiscal crisis) and the relevant circular letter of the MIDE (14.04.2010) established that during 2010, no permanent staff recruitment could be approved and previously announced recruitment for permanent staff was suspended (exceptions: health, education

13 DG(SANTE)2017-6055 Final Version date: February 2019 and National Security sectors). Approvals for the recruitment of temporary employees and contractors were reduced by 30%.

From the beginning of 2011 until the end of 2013, different ratios for replacing retiring staff will be implemented.

Staff qualifications and training

Training courses are developed by the Central CAs and in particular by the IT and Training Directorate of EFET and the Training Directorate of the MRDF. Recommendations from the Directorates involved in official controls and general legislative requirements were taken into account. Training courses are approved by the Board of Directors of EFET and the General Secretary of MRDF.

A specific team has been formed in 2012 (Ministerial Decision 337/113028/14-11-2012) within the framework of the Ministry, whose main aim is to define the training needs of the different groups and provide for the relevant trainings in collaboration with the National center of Public Administration (NCPA).

In 2016, 2 training programmes were running and at least 5 had been planned to be included in the annual program of the center, always in collaboration with the MRDF.

Furthermore, the officials at both central and periphery level participate in at the BTSF courses and disseminate the knowledge by organising seminars or trainings at local level.

The training of staff of DFQS, RCPPQPC and DREVM depends on task requirements and may include: on site training at the workplace and specialized training, which is provided through BTSF seminars, seminars organized by Center of Public Administration, conferences, meetings at central and regional level, explanatory circulars etc. Concerning PDO/PGI wine.

All staff members form ELGO-DIMITRA had previous experience and relevant background. In order to keep their staff up-to-date, training is provided, including initial training at appointment and regular on-going training within their area of responsibility.

Training needs were defined by EFET at the end of 2009 with the participation of all Regional Services and the Regional Directorates of EFET (about 500 inspectors). The resulting 2010 programme included 30 seminars covering food of animal origin, HACCP, risk assessment and FCM.

At the end of the seminar the trainees had to undergo an evaluation. The evaluation reports were analysed by the Directorate of Training of the Central Service of EFET with a view to further improvements.

EFET carried out annual training programmes in the subsequent years (2011-2015), as follows: The following training programmes were conducted: 31 programmes in 2011, 29 programmes in 2012, 31 programmes in 2013, 33 programmes in 2014 and 26 programmes in 2015. These programmes covered all food-related sectors, falling under its scope of duties. The programmes were attended by auditors, both from EFET and other control authorities. Each programme was attended by 25 persons. More details will be made available to the mission.

14 DG(SANTE)2017-6055 Final Version date: February 2019 Organisation and implementation of official controls

Prioritisation of official controls

The individual annual action plans for the interim years up to the new plan (2015), have supported the strategic goals of the existing multi-annual plan, being adjusted, as necessary, according to the new information and issues that arose.

On an annual basis DFQS revises the relevant MANCP at the stage of import in order to adjust the priorities, taking into account new legislative requirements, the results of the official controls, import volumes, emerging health risk at country level as well as EU level (RASFF notifications), etc.

The MANCP 2015-2019 provides the framework for the planning of controls across sectors.

Control activities, methods and techniques

Official controls include:  checks on FBOs compliance with hygiene rules;  control of end products;  checks to ascertain that procedures based on HACCP principles are in place;  checks on correct management of identification marks, in addition to compliance with the traceability system;  checks of written materials and other files related to evaluating compliance with legislation.

Controls may be general inspections of establishments or targeted at specific issues.

As a rule, official controls are carried out without prior notice. Control findings, including non-compliances with requirements are recorded in official reports. The CAs provided reports to FBOs in cases where there are infringements or if they include comments or corrective measures. Deadlines for action are indicated and follow-up visits carried out when relevant.

At import of food of plant origin the official controls performed by the CAs may include documentary, identity and physical checks with or without sampling and analysis according to EU and national legislative requirements and priorities. DPQCFPP has drawn up a Process Management System for the performance of the official controls.

Sampling and laboratory analysis

JMD No 15523/2006, PD 79/2007 and JMD 323306/2007 establish provisions for sampling and analysis.

Sampling procedures are provided for in the following documents:

 MRDF: Circular 295788/20-5-2007 provides instructions on sampling and analysis of the water in the framework of FBO's own checks and official controls.

15 DG(SANTE)2017-6055 Final Version date: February 2019  Ministerial Decision no.1545/70158-2014 on the “Establishment of sampling procedures and laboratory analysis of products of animal origin in the framework of official controls in slaughterhouses and conditions to reduce sampling frequencies of the own checks.

 DANFP: Sampling in feedingstuffs is carried out in accordance with Reg. (EC) 152/2009. Also the manual on official controls in feedingstuffs (Ref. No 1685/110839-13-10-2015) provides with updated instructions on sampling and documentation of controls (check list, control report etc.).

 DFQS: Concerning food of plant origin the sampling is performed following procedures provided for in EU legislation, EU guidelines and circular 253173/15.03.2010 (sampling for HAV), circular no 161078/31.05.2011, (sampling guidelines for E. coli). Concerning PDO/PGI wines the sampling is carried out by RCPPQC/DREVM (co-operation) according to DPQCFPP’s instructions. (JMD 5833/155045/2013).

 ELGO: Sampling is carried out according to European legislation, depending on the kind of products. Only accredited laboratories are being used for the analysis of the samples taken. Due to the obligation of the operators (according to most of the products specifications) to carry out physicochemical analysis before GI products being set on the market, analyses by ELGO are performed after complains, denunciations, or for verification purposes.

 EFET: Circular No 15103/22-8-2007 contains guidelines for official sampling and microbiological analysis of food. In addition to these guidelines, the following documents are available:

o Guidance Document No 10772/08-06-2007 containing instructions for sampling and analysis of food, including official sampling of water.

o Document 4028/8-03-2010 contains procedures for official controls of microbiological criteria in food of animal origin and controls for Salmonella spp. in meat preparations.

o Document 17783/11-12-2009 on official controls of water in food producing establishments.

For planning purposes, EFET has established general guidelines, priorities and number of samples to be taken. The local inspector is responsible for selecting the specific premises to be sampled.

Under Law 2741/1999 (Government Gazette 199/A) the GCSL, the laboratories of MRDF, EFET and MH, including the laboratories of universities, technological educational institutes and private laboratories, are considered to be official laboratories.

Official laboratories are designated as such by law following the issuing of national implementation measures under Article 9 of JMD No 15523/2006. The Central CAs and the official laboratories conclude collaboration agreements on the obligations of both contracting parties.

16 DG(SANTE)2017-6055 Final Version date: February 2019 As regards the MRDF, DGVS has two Directorates involved in laboratory testing; the Directorate of Veterinary Center of Athens and the Directorate of Veterinary Center of Thessaloniki. Each Directorate (in Athens or Thessaloniki) has Departments contributing to official controls in the food and veterinary field located in Athens and Thessaloniki respectively. In addition, Departments - Laboratory Institutes belonging either to the Veterinary Center of Athens or to the Directorate of Veterinary Center of Thessaloniki exist, carrying out laboratory tests on food covering microbiological, biological, chemical factors/hazards and toxicology or animal health analyses.

The Directorate of the Veterinary Center of Athens, has 13 Departments:  Department for Administrative and Financial Affairs  Department of Diagnostic Pathology, Microbiology and Breast Physiopathology  Department of Parasitology, Parasitic diseases, Entomology and bees pathology  Department of Molecular Diagnostics, FMD, Virological, Rickettsial and Exotic Diseases  Department of Aquatic Organisms Pathology  Department of Food Hygiene  Department of Toxicology, Residues and Environmental Contaminants  Department – Laboratory Institute of Chalkis  Department – Laboratory Institute of Tripoli  Department – Laboratory Institute of  Department – Laboratory Institute of Iraklio  Department – Laboratory Institute of Patra  Department – Laboratory Institute of

The Directorate of Veterinary Center of Thessaloniki, has 10 Departments:  Department for Administrative and Financial Affairs  Department of Reproduction and Artificial Insemination  Department of Viral and Rickettsial Diseases and Transmissible Spongiform Encephalopathies  Department of Food Microbiology, Biochemical control, Residues, and Control of Marine Biotoxins and Other Water Toxins  Department of Avian, Bees and Aquatic organisms Pathology  Department of Microbiology, Infectious Diseases and Brucellosis  Department-Veterinary Institute of Ioannina  Department-Veterinary Institute of Kavala (including the Laboratory Institute of Komotini)  Department-Veterinary Institute of  Department-Veterinary Institute of Larisa

17 DG(SANTE)2017-6055 Final Version date: February 2019 The NRL for both FMD and Bluetongue form part of the Department of Molecular Diagnostics, Foot and Mouth Disease (FMD), Viral, Rickettsial and Exotic Diseases in Directorate of Athens Veterinary Centre.

The decentralised veterinary laboratories are: the Veterinary laboratories of , Chania, Chalkis, Rhodes, Komotini, Tripolis, Kavala, Ioannina, Serres, Larisa and Patras. All are accredited.

The decentralised laboratories carry out routine testing for animal health controls. The Veterinary Laboratory of Larisa is NRL for TSE (Transmissible Spongiform Encephalopathy) and Brucelloses. These methods are accredited according to ISO 17025. These laboratories also carry out analysis for residues under Regulations (EC) 2073/2005 and (EC) 1441/2007 and in the framework of official controls carried out by EFET (Co- operation Protocol, renewed on an annual basis).

The MRDF has three official laboratories for analysis of feedingstuffs. Also, the Regional Centre of Plant Protection and Quality Control in Magnisia carries out analyses for heavy metals in feed.

Furthermore, the Feed Control Laboratories in Attiki, in Larissa, and in Thessaloniki carry out laboratory tests in feed covering analytical constituents, feed additives, undesirable substances (e.g. aflatoxin B1, ochratoxin A, gossypol, Hg in fishmeal) PAP’s and ruminant DNA presence. Also, the Regional Centre of Plant Protection and Quality Control in Magnisia carries out analyses for heavy metals in feed.

The NRL for feed additives is the Feed Control Laboratory in Thessaloniki.

Analyses of official food control samples, imported products listed under EU Commission decisions and pesticide residues, are performed in a number of laboratories according to commodity type and sample. Among these are the GCSL, the laboratories of the RCPPQPC,, the veterinary laboratories and the Central Laboratory of Public Health (CLPH).

Residues of Veterinary Medicinal Products are tested in the network of residue control laboratories organised in seven NRLs, and nine regional laboratories and GCSL.

The Demokritos National Physical Sciences Research Centre is responsible for the analysis for radioactivity, dioxins, furans and PCBs in food and feed.

The Laboratory ‘Environmental Microbiology Unit, Department of Public Health, Medical School, University of Patras’ is responsible for the analysis of norovirus and hepatitis A virus.

The BPI is the main laboratory involved in plant health controls, supplemented by the regional laboratories and University and Research Foundation laboratories (for confirmation of certain pests).

ELOGAK (currently under ELGO – DIMITRA) has 8 milk quality control laboratories for raw milk in the context of legal requirements (not official testing).

The Maritime Toxic Micro-Seaweed Laboratory (Aristotle University of Thessaloniki) is authorised by Ministerial Decision No 293609/20.9.2004 to carry out laboratory tests for maritime toxic phytoplankton.

18 DG(SANTE)2017-6055 Final Version date: February 2019 The NRLs collaborate with the relevant European Union Reference Laboratories (EURLs) and ensure that information provided by them is notified to the official control laboratories and the central CAs. They also co-ordinate the activities of official control laboratories within their remit, and, where necessary, organise proficiency ring trials/tests and provide scientific and technical assistance to the central CAs.

More details about the official labs are presented in MANCP 2015-2019.

National accreditation bodies

The Greek National Accreditation Council is the national body for accreditation (www.esyd.gr).

Procedures for performance and reporting of control activities

Risk assessment guidelines are available to staff. In particular guideline MRDF- DVPH 219/7548/18-01-2013 on official controls for food of animal origin, includes the categorisation of FBOs based on risk analysis, definition of inspection frequencies, and control forms for all categories of FBO (for more information see section on sampling and laboratory analyses above). Numerous circulars and guidelines on various topics regarding the food sector have been issued and were sent to the relevant competent authorities.

Regarding feed, DANFP’s manual on official controls in feedingstuffs (Ref. No 1685/110839/13-10-2015) provides updated instructions on the categorisation of FBO’s based on risk analysis and on controls for all categories of FBOs. Checklist for the control of feed business operators is also included in the manual.

Other important points are:

 The commitments made in the action plan of audit 2009-8237. (Drafting of circular guidelines and manuals. See also section 2B2 of the updated manual for Salmonellosis control in poultry.

 Guidelines issued to all Regional Directorates of Veterinary Medicine (RDVM) with regard to food of non-animal origin, food additives and FCM.

 Documented procedures on pesticides.

 Progress on BIPs manual for sampling.

 Improved reporting and co-ordination on animal welfare including reminder to all Regional Veterinary Services on reporting and on the relevant corrective actions to be taken.

 Plant Health: guidelines for inspectors on registration of establishments; internal market inspections; the issuing of plant passports and recording of inspections at local level. On the website of the BPI survey methodologies are available to Plant Health Inspectors (http://www.bpi.gr).

 Guidelines to inspectors for reporting outbreaks to the central CA, and administrative measures (sanctions).

19 DG(SANTE)2017-6055 Final Version date: February 2019  Regulation on inspection and certification of protected destination of origin (PDO) and protected geographical indication (PGI) products issued by ELGO- DIMITRA.

Transparency and confidentiality

The MANCP is available on both the MRDF and EFET websites. Both CAs published numerous guidelines, legislation and other information. EFET publishes the list of FBOs subject to infringements. On the MRDF website, a video on Salmonella is available (http://www.minagric.gr/greek/video_parousiashs.htm together with the latest version of all ministerial decisions on Salmonellosis control as well as related manuals http://www.minagric.gr/greek/2.3.3.html.

The CAs indicated that in 2009 several activities were organized to provide guidance to FBOs, in particular: meetings with consumer groups and business associations related to labelling issues; changes in legislation; workshops on FCM; and a meeting in relation to food safety in Europe.

Annual reports on the results of controls are published (see page 38 for more information).

Enforcement measures

Measures in the case of non-compliance

There is a legal framework which includes: the actions to be taken by CAs to enforce non-compliance. This includes measures such as suspending operations or closing an establishment; suspension or withdrawal of food business authorisation; seizure, destruction or withdrawal of unsafe food; and imposition of criminal and administrative sanctions in cases of infringements of national and EU law in accordance with the provisions of law N.4235/2014.

Decisions imposing administrative penalties are dealt with at local, regional and central level. More specifically:

Import of food of plant origin:

In the case of a consignment not compliant with the requirements or the procedures of the EU and national legislation, whether or not sampling and laboratory analysis is carried out, the consignment is placed under official detention by decision of the competent authority and the provisions of L. 4235/2014, article 12. This decision is made after the detailed report by the inspectors and the CA informs the company thereof.

The FBO has a right to objection within two (2) working days of the decision notification. The relevant authority shall decide within seven (7) working days, and immediately communicates it to the FBO.

Taking into account the intention of the FBO, the following compliance measures are establishing, as appropriate: a) Special treatment in accordance with Article 20 of Reg. (EC) No. 882/2004. b) Re-dispatch in accordance with Article 21 of Reg. (EC) No. 882/2004.

20 DG(SANTE)2017-6055 Final Version date: February 2019 c) Destruction. d) Use for purposes other than those for which they were originally intended. e) Enforcement of corrective measures such as re-grading, repackaging, downgrading, and re-inspection in order to allow the import. f) Any other measure deemed appropriate by the competent authority.

Regulation on inspection and certification of protected destination of origin (PDO) and protected geographical indication (PGI) products issued by ELGO-DIMITRA describes the appropriate measures to be taken by FOBs in case of non-compliances.

Sanctions

Law 4235/2014 (Government Gazette, Series I, No 32/11.02.2014) provides for administrative measures and sanctions in application of national and Union legislation in the food and feed sector, in addition to other sectors in the food chain. This is a recent law, uniform in nature, which was drawn up with a view to setting up an effective, dissuasive and proportionate system for imposing measures and sanctions for non- compliances.

The administrative measures include restriction or ban on the marketing of a foodstuff, freezing/seizing, monitoring/recall/withdrawal/destruction, suspension/revocation of the operation of the undertaking, suspension/revocation of the approval/registration of the undertaking, food sanitation procedures, return of the food to the Member State of dispatch, approval of the use of the foodstuff for different purposes, as well as all such other measures as deemed appropriate by the authority. Administrative sanctions include fines to be imposed after the required measurement criteria are taken into account, with a view to making the penalty imposed fairer. Finally, provision is made for imposing criminal sanctions, too, in certain cases, which are then referred to the competent prosecuting authority.

The above administrative measures, fines and criminal sanctions are imposed, depending on the type and characteristics of each non-compliance, either individually or, usually, cumulatively.

In addition to publication of Law 4235/2014, and with a view to providing competent authorities with guidance aimed to ensure correct and uniform implementation of that law, the processing and issuance of clarifying circulars and of the necessary regulatory acts has been set in motion. In particular: a) document ref. 3701/26.02.2014 from EFET, provided clarifications to all Greek competent authorities, concerning high priority matters associated with the law concerned, to ensure correct and uniform implementation thereof, and document ref. 14995/11.09.2014 from EFET, provided clarifications to all Greek competent authorities, concerning the imposition of administrative sanctions; b) Ministerial Decision No 434/82574 (Government Gazette, Series II, No 1710/26.06.2014) was adopted, based on cooperation between EFET and the Directorate-General for Veterinary Medicine of the MRDF, setting out the coefficients to be used when imposing fines for non-compliances, in connection with the measurement criteria. More specifically:

21 DG(SANTE)2017-6055 Final Version date: February 2019 c) There are four measurement criteria established: the level of gravity, the number of non-compliances, the size of the undertaking and a possible recurrence of a non- compliance. The coefficients of the measurement criteria were specified in the above Ministerial Decision, in a way that ensured that, depending on the specificities of the case at hand, the points assigned would ensure that each criterion would make a more objective contribution and ensure a fairer distribution of the amount of the fine. d) Understanding the meaning of the four measurement criteria will largely determine whether, by assigning points, the issue is approached correctly. e) Ministerial Decision No 2158/121168 (Government Gazette, Series II, No 2623/02.10.2014) was adopted setting out the coefficients to be used when imposing fines for non-compliances in connection with the measurement criteria in feedingstuffs. f) Moreover, the templates of the forms required for implementing the procedures for enforcing compliance measures were updated. g) Furthermore, sections relating to the implementation of the law concerned have already been adapted to the training seminars for the employees of competent authorities. h) In addition, DFQS has issued relevant guidelines (circular no 3890/114378/12.09.2014 and the document 4460/103385/24.09.2015).

The most important differences between the new law and the previous regime are: a) repealing the different legal arrangements and setting up a uniform system for enforcing measures and imposing sanctions, in all official control fields; b) better integration of, and approach and adaptation to, the requirements set out in the Community legislation, and, in particular, in Regulations (EC) Nos 178/2002 and 882/2004 (designation of foodstuffs, risk analysis, the right of stakeholders to lodge an appeal, etc.); c) improving and establishing procedures for the restriction of foods, recall-withdrawal thereof, suspension of the operation/approval of operators; d) identifying the level and procedure of the administrative sanctions to be imposed, with due account taken of the measurement criteria, such as the risk, the number of non-compliances, the size of the undertaking and a possible recurrence of a non- compliance; e) identifying non-compliances which entail the imposition of criminal sanctions.6884.

There are decisions imposing administrative sanctions, at local, regional and central levels. More specifically:  decisions for fines of up to EUR 6 000.00 are made at a regional level by the CAs that identified the infringements concerned;  decisions for fines from EUR 6 000.00 to EUR 60 000.00 are made by the central agencies of the MRDF and the Board of Directors of EFET;

22 DG(SANTE)2017-6055 Final Version date: February 2019  decisions for fines of more than EUR 60 000.00 are made by the Minister for Rural Development and Food.

Objections can be filed by the parties concerned against fine imposing decisions, which are considered by the competent bodies.

Verification and review of official controls and procedures

Verification procedures

According to the MANCP, the CAs responsible for the implementation of official controls of food of animal origin send monthly to the central CAs, pre-printed forms which include data on the results of their controls.

According to the CAs, to verify the implementation of the planned actions, the central CAs process and evaluate the monthly reports and may request supplementary actions to be taken. Central services are responsible for sending data to the Commission, as required.

Central CAs organise co-ordinating meetings attended by the NRLs and the authorities carrying out the official controls. They analyse, evaluate and examine the need for adjusting or modifying the control systems. Revised circulars and guidelines to adjust the systems are issued, as necessary.

DFQS in its field of competency verifies control techniques, procedures and results through local visits to competent authorities. In some cases control procedures and requirements are verified by randomly examining selected copies of documents requested to be sent to DFQS offices.

As regards the areas of competence of the DGVS, PD 79/2007, is the national provision for implementing horizontal legislation as regards Regulations (EC) No 178/2002, 882/2004 and 852/2004.

With respect to the areas of competence of EFET, JMD No 15523/30.8.2006 is the national provision for implementing horizontal legislation in the food sector and contributes to the practical implementation of the general requirements of Regulations (EC) No 178/2002, 882/2004 and 852/2004 on food hygiene. All Ministerial Decisions and circulars have been revised to incorporate the requirements of this legislation.

Regarding the area of competence of DANFP, JMD 1156/82215/08-08-16 is the national provision for the implementation of verification of the effectiveness of official controls in feedingstuffs as required by art. 8.3. of Regulation 882/2004.

The CAs indicated, on their comments to the draft country profile, that the implementation of an Integrated Information System will ensure online validation/verification of controls, as the inspectors’ reports will be submitted to the central EFET service electronically.

23 DG(SANTE)2017-6055 Final Version date: February 2019 Audit

MRDF

The audit competencies are implemented by the new Directorate of agricultural, animal, veterinary and maritime controls, according to Article 9 of the PD 97/2017 (former DVAC).

The areas included in the audit plan and the services inspected for each action are determined based on risk criteria. Audits relate to organisation and operation of the services and the manner in which official controls are carried out.

Where there is no implementation or unsatisfactory implementation, the relevant bodies are informed (regional unit governor or head of region; head of the competent DG; heads of the MRDF’s departments and the MIAR). If necessary, measures may be taken, based on the Civil Servant's Code.

With regard to BIPS, Ministerial Decision 261390/18.08.2009 has been revised to include also supevision visits to the islands under derogation (Ministerial Decision 1213/36812/6-05-2015, Gazzette number 790B) is applicable. BIP audits take place on a five year cycle and as all BIPs were audited in the period 2006-2007 they are not foreseen to be audited again until 2011. Reports of audits carried out are available on the internet (weblink). A formal follow up procedure is in place. Issues not addressed were communicated to senior MRDF management.

EFET

On the basis of its Board of Directors’ Decisions Nos 377/16.05.2013 and 757/17.10.2013, EFET developed and operates a quality management system (QMS), covering all the official food control activities carried out by its central service and regional directorates, including, as well, the body’s internal audits. The QMS complies with the requirements of ISO 9001 ‘Quality Management Systems - Requirements’ and ISO 17020 ‘General criteria for the operation of various types of bodies performing inspection’ and is linked to ISO 17025, in respect of the functioning of EFET’s laboratories.

The QASD performs the following duties inter alia:  planning and implementing an internal audit mechanism, which will include procedures and specifications, in order to ensure the quality of services provided by the body and the effectiveness of its inspections;  monitoring and assessing the planning, implementation and effectiveness of food controls carried out by EFET, in order to meet the targets of the annual or multi- annual audit plans and to implement national and Union legislation on the food sector.

Internal audits are carried out by the QASD of EFET, based on the annual internal audit plan (ordinary audits) and in exceptional cases (extraordinary audits). The internal audits are planned for each process or sector in the official food control sector and based on the risk analysis procedure.

24 DG(SANTE)2017-6055 Final Version date: February 2019 The QASD prepares a rolling five-year internal audit programme, based on Decision 2006/677/EC, ensuring sufficient coverage of all relevant fields of activity within the sectors covered by the Regulation (EC) No 882/2004 and as frequently as the relevant risk requires.

In preparing the annual internal audit programme, the QASD also takes into account, in addition to the above (coverage of fields of activity and relevant risks), the requirements set out in the relevant standards (ISO 9001 and ISO 17020) and the requirements of the management of EFET.

In planning the annual ordinary internal audits, due account is taken of parameters relating to activities and/or sectors on which the body focuses, the results of previous internal audits and third-party audits, any changes to the QMS and the relevant applicable formative and regulatory documents, as well as the results of quality controls carried out on its services against the criteria of acceptance of those services (e.g. achievement of targets).

EFET’s five-year internal audit programme for the period 2014 -2019 was approved by Decision No 17284/06.11.2013 of the Chairman of the Board of Directors of EFET.

The key internal audit techniques used consist in horizontal and vertical internal auditing.

Based on the internal audit procedure, a draft audit report is prepared initially for each audit, accompanied by an action plan, setting out a timeframe for implementing corrective actions, also including the non-compliances and recommendations according to the audit criteria. After the parties concerned provide their feedback and commit to take specific corrective actions, the final audit report is drafted. The implementation of the action plan and corrective actions is monitored and assessed by the QASD.

Upon completion of the annual internal audit programme, the management is notified and then formulates its views and proposals on the follow-up actions it has to take concerning the most important findings identified, also reaching a common agreement on the implementation timeframe.

Upon completion of the monitoring of internal audits, a final report is prepared, setting out the results and conclusions of internal audits, with an encoded list of any deviations identified, depending on the progress made in implementing the relevant corrective actions, also notifying the management and central agency of EFET. As regards the findings relating to the scope of Regulation (EC) No 882/2004, the final report is posted on the website of EFET, for transparency purposes.

The results of internal audits and the implementation of the subsequent corrective and preventive actions are always a key item on the agenda of any QMS review carried out by the management of EFET at regular intervals.

Audit results for 2014 (see also MANCP report 2014)

In general official controls were considered inefficient due to:  lack of implementation of relevant legislation by the CAs;  delays and deficiencies in complying with annual plans;

25 DG(SANTE)2017-6055 Final Version date: February 2019  lack of enforcement;

The audits also identified a lack of supervision and co-ordination of the regional units by the Directorate General of Veterinary Services, and a lack of resources at regional level. Training needs were also identified.

The Greek CAs consider that audits made little contribution to improving the effectiveness of official controls due to:  Failure to use the findings to bring about corrective actions in accordance with Regulation (EC) No 882/04 and Commission Decision (EC) 677/ 07.  Lack of personnel, resources and incentives at DGVS level.  Staff shortages, lack of organisation, resources and equipment, lack of motivation in the Regional Veterinary Services. Multi-annual National Control Plan (MANCP)

The MANCP is prepared by the MRDF. The most recent MANCP, as submitted to the Commission, covers the period 2015-2019.

The Annual Report (2014) has been provided to the Commission in October 2015.

The MANCP and the annual reports are published on the MRDF's website: http://www.minagric.gr/index.php/el/the-ministry-2/poese

26 DG(SANTE)2017-6055 Final Version date: February 2019 The following chart gives an overview of the distribution of responsibilities in relation to control systems and operational levels. More detailed descriptions of the allocation of responsibilities between authorities for each control system are given in the following chapters.

Sector Policy Co-ordination Implementation Laboratories Risk co-ordination of controls of controls assessment, scientific advice 1. Animal health MRDF-DGVS (DAH, MRDF- DGVS Regions MRDF- Directorates MRDF- DGVS DAWVDVA) (DAH, of Veterinary Centres DAWVDVA) in Athens and Thessaloniki and their Departments MRDF- DGVS MRDF- DGVS Regions, ELOGAK, MRDF-Vet. MRDF- 2. Food of animal DGVS origin (DVPH)/EFET (DVPH)/EFET EFET Lab./GCSL/CLPH/E LOGAK/EFET EFET 3. Imports of animals MRDF- DGVS (DAH, MRDF- DGVS BIP MRDF- Directorates MRDF- DGVS and food of animal DVPH) (DAH, DVPH) of Veterinary Centres in Athens and origin Thessaloniki and their Departments. 4. Feedingstuffs and MRDF- DGA - Regions MRDF - DANFP animal nutrition (DANFP) Feedingstuffs. Control Lab

5. TSEs/ABP MRDF- DGVS (DAH, MRDF- DGVS Regions MRDF - , DVPH), DANFP (DAH, DVPH) , Feedingstuffs. DANFP Control Labs

6. Veterinary EOF Regions MRDF -Vet. Lab. EOF medicines EOF - authorisation, marketing Veterinary MRDF- DGVS MRDF- DGVS Regions MRDF- Directorates MRDF- DGVS medicines (DAWVDVA) (DAWMVA) of Veterinary Centres in Athens and - residues Thessaloniki and their Departments -GCSL EFET MRDF- DGF Regions, EFET MRDF -Control Lab. MRDF 7. Foodstuffs and (DFQS) food hygiene GCSL, CLPH, EFET EFET MRDF-DGFP (DFQS) EFET GCSL

SCC1 GCSL MRDF- DGF MRDF- DGSPP RCPPQPC GCSL MRDF- DGF 8. Imports of food of (DFQS) (DFQS) (DFQS) plant origin MRDF- DGF (DFQS) GCSL RCPPQPC/ Regions GCSL GCSL 9. Plant protection MRDF-DGSPP MRDF-DGSPP RCPPQC/Regions BPI/RCPPQC MRDF-DGSPP products — (DPPP) (DPPP) (DPPP) authorisation, marketing and use Plant protection MRDF-DGSPP MRDF-DGSPP RCPPQC/Regions BPI/RCPPQC/GCSL MRDF-DGSPP products — (DPPP) (DPPP) (DPPP) EFET EFET

1 SCC: Supreme Chemical Council

27 DG(SANTE)2017-6055 Final Version date: February 2019 Sector Policy Co-ordination Implementation Laboratories Risk co-ordination of controls of controls assessment, scientific advice residues 10. Animal welfare MRDF- DGVS MRDF- DGVS Regions MRDF- DGVS (DAWVDVA) (DAWVDVA) 11. Plant health MRDF-DGΑ (DPPP) MRDF-DPPP RCPPQC / Regions BPI, “ELGO- MRDF-DPPP (agriculture), DIMITRA”(ex [MEE (Ministry of Decentralized (NAGREF) and other Environment and Administrations cooperated Energy) coordinates (forests) laboratories the implementation of plant health legislation of forestry services.] 12. Quality Schemes MRDF-DGSRD ELGO-DIMITRA ELGO-DIMITRA / LABs Accreditaded MRDF-DGSRD Regions by ESYD ELGO- DIMITRA

28 DG(SANTE)2017-6055 Final Version date: February 2019 2 COMPETENT AUTHORITIES AND DISTRIBUTION OF RESPONSIBILITIES IN RELATION TO INDIVIDUAL CONTROL SYSTEMS

2.1 Control system for animal health

MRDF DGVS MRDF - DGVS cooperation MIAR DAH DAWVDVA

Co-ordination and control of eradication programmes Co-ordinationr aenpdo rctosntrol of contingency plans

Identification and registration of animals Operation of the bovine database Administrative management DGRREVM results reports DREVSs

Veterinary Samples Laboratories

Implementation of controls

Farms

DAH Directorate of Animal Health DGRREVM Directorate General of Regional Rural Economy and Veterinary Medicine DGVS Directorate General of Veterinary Services DAWVDVA Directorate of Animal Welfare, Veterinary Drugs and Veterinary Applications MIAR Ministry of Interior and Administrative Reconstruction MRDF Ministry of Rural Development and Food

Competent Authorities

The CCA for animal health is the DGVS of the MRDF. DAH is responsible for the co- ordination and supervision of eradication and control programmes.

29 DG(SANTE)2017-6055 Final Version date: February 2019 DAWVDVA, supports the above mentioned programmes via the bovine and other animals electronic database and the registration and identification system of animals.

Animal health controls (disease eradication programme)

Officials tasks and responsibility for implementing animal health controls rests with the DGRREVM. They may also provide free consultancy and treatment proposals for livestock and advice to farmers. The DAH holds annual training meetings with all regional representatives to discuss and provide information on disease control issues.

The DAH issues animal health control and eradication programmes to the PVDs listing the number of inspections and samples to be taken. Reports of inspections and test results are communicated back to the CCA on a monthly and quarterly basis.

DAH is responsible for central contingency planning and, in the event of an outbreak, providing advice to the Local Disease Control Centres. Where more than one regional unit is affected, DAH co-ordinates the activities of the regions.

Eradication programmes for bovine, ovine and caprine Brucellosis and Tuberculosis are regularly presented and approved for a financial contribution from the EU.

Two differentiated programme strategies for control and eradication of sheep and goat Brucellosis are implemented in the country. Testing and slaughter policy is applied on the islands and vaccination is applied on the mainland. The EU has approved Greek programmes for co-financing for the last 12 years. However, the failures in implementing the programme resulted in 100 % sanctions in recent years. These related to the lack of sufficient human resources, low level of supervision and co-ordination at regional level, and low level of actual testing and vaccination compared to targets. For 2009 and 2010, Greece did not submit any application for EU approval and co-financing of such programmes and thus the programmes were funded solely from national resources.

The 2011 sheep and goat Brucellosis control and eradication programme submitted to the Commission in October 2010, has been approved based on specific commitments from the Greek CAs to be implemented over time.

Contingency Planning

Responsibility for the management of an epizootic disease outbreak lies with the administration of the regions concerned. If they do not have the capacity to manage the outbreak, or if several regional units are affected, responsibility passes to the DGVS DGVS.

The DAH has prepared and approved, by Ministerial Decisions, contingency plans for FMD, Bluetongue and Classical Swine Fever (CSF). The DAH has also prepared contingency plans for Newcastle Disease and Avian Influenza. National contingency plans, as stipulated by Council Directive 92/119/EC and Council Directive 2002/60/EC, have also been approved.

Collaboration between the DAH and PVDs is required by Law 2288/1994. DAH acts as the national control centre and is responsible for co-ordinating the implementation of the relevant measures by all PVDs. The PVDs act as local disease control centres.

30 DG(SANTE)2017-6055 Final Version date: February 2019 Collaboration between the regional authorities, the veterinary centres and the decentralised veterinary laboratories which report to the MRDF, is required by Presidential Decree 107/2014. Collaboration between the PVDs and the rural veterinary clinics is laid down in the organisational chart of each regional authority.

Bird Flu Contingency Plan: This plan was introduced by MRDF through Decision No 279719/19.11.2004 in compliance with the Presidential Decree 31/1995 and Directive 92/40/EEC respectively. Scope: Immediate combating of bird flu in poultry. Application: the poultry farming sector (bird farms and pet birds). The main laboratories involved are located in the Athens and Thessaloniki Veterinary Centres and 11 decentralised veterinary laboratories.

Newcastle Disease Contingency Plan: This plan was introduced by MRDF through Decision No 279719/19.11.2004 in compliance with the Presidential Decree 141/1995 and Directive 92/66/EEC respectively. Application: the poultry farming sector (bird farms and pet birds) Scope: Immediate combating of Newcastle Disease in poultry. The main laboratories involved are located in the Athens and Thessaloniki Veterinary Centres and 11 decentralised veterinary laboratories.

Bluetongue Contingency Plan: This plan was introduced by MRDF by Decision No 276913/11.11.2003 in compliance with the Presidential Decree 33/2003 and Council Directive 2005/75/EC respectively. It is applied to the entire sheep population. The NRL for Bluetongue is located in the Athens Veterinary Centre.

Classical Swine Fever Contingency Plan: This plan was introduced by MRDF by Decision No 276914/11.11.2003 in compliance with the Presidential Decree 39/2005, and Council Directive 2005/75/EC respectively. . It is applied to the entire pig population. The laboratory involved is the Swine Pathology Laboratory of the Athens Veterinary Centre which is the NRL for CSF.

African Swine Fever Contingency Plan: Measures to combat African swine fever were introduced by Presidential Decree 37/2007 in compliance with Council Directive 2002/60/EC. The contingency plan will be brought into effect by a decision of the MRDF which is in the process of being issued. It will be applied to the entire pig population. The Laboratory involved is the Swine Pathology Laboratory of the Athens Veterinary Centre which is the NRL for African swine fever.

Foot and Mouth Disease Contingency Plan: This plan was implemented by MRDF by Decision No 276915/12.11.2003. A Presidential Decree currently being prepared will transpose Council Directive 2003/85/EC into national law. It will be applied to the entire biungulate animal population. Its scope is to immediately curtail primary outbreaks and prevent spread of the disease. The relevant laboratory in Athens is the FMD and Exotic Disease laboratory which is the NRL.

Sheep-Goat Bovine Spongiform Encephalopathy (BSE) Contingency Plan: This plan has been implemented by MRDF by Decision No 279690/8.11.2004 in compliance with Commission Regulation (EC) No 999/2001. It will be applied to the entire sheep-goat population. The laboratories involved are 1) the Larissa Veterinary Laboratory as NRL for rapid immunological diagnostic methods, and 2) the Department of Diagnostics, Pathology and Anatomy, Thessaloniki Veterinary Centre, as reference laboratory for histopathological and immune-histochemical diagnostic methods. Three further laboratories are authorised to use rapid immunological diagnostic methods (Athens

31 DG(SANTE)2017-6055 Final Version date: February 2019 Veterinary Centre - FMD and Exotic Diseases Laboratory, Ioannina Veterinary Laboratory and the Thessaloniki Veterinary Centre - Department of Viral and Rickettsial Diseases and Transmissible Spongiform Encephalopathies)

Holding and animal registration and identification systems comprise the followings:  in the case of bovines: o individual animal identification with two conventional ear tags o holding registers o animal passports  in the case of sheep and goats: o individual or batch identification of animals with conventional and electronic means o holding registers o movement documents  in the case of porcines: o individual or batch identification of animals o holding registers

Furthermore, a national central database is operational for the registration of all the relevant data (including details on animal movements), as well as for the extraction of the sample of holdings (bovine 10%, sheep and goats 5%) to be checked annually, based on risk analyses.

DAWVDVA is responsible at central level for laying down the legal framework for the implementation of the IR systems in place, for shaping guidelines and procedures to ensure the uniformly implementation over the national territory, for ensuring the operation of the national database and for supervising the level of implementation of the relevant legal provisions.

Routine samples for disease eradication programmes are dealt with by the network of MRDF veterinary laboratories (Heraklion, Ioannina, Kavala, Komotini, Larissa, Patras, Rhodes, Serres, Tripolis, Chalkida, and Chania) and two Veterinary Centres of in Athens and Thessaloniki (see also contingency plans description above).

A NRL for the confirmation of mycobacterium species has been established in the Veterinary Centre in Athens. The NRLs for FMD and Bluetongue are the relevant laboratories in the Athens Veterinary Centre.

The Veterinary Laboratory of Larissa is the NRL for TSE and Brucelloses . The relevant methods are accredited according to ISO 17025. The NRL for Tuberculosis performs G- interferon diagnostic test.

The NRL for both FMD and Bluetongue form part of the Department of Molecular Diagnostics, Foot and Mouth Disease (FMD), Viral, Rickettsial and Exotic Diseases in Athens Veterinary Centre.

32 DG(SANTE)2017-6055 Final Version date: February 2019 2.2 Control system for food of animal origin

CCA Primary Prodcution: CCA After Primary Coordination MRDF - DGSAPVS Production planning DHSFAO EFET (MH)

MIAR reports ELGO-DMITRA

Monitoring, Surveillance, Co-ordination Monitoring Surveillance, Coordination

Administrative managment EFET- Regional DGRREVMs Directorates (6)

Raw milk controls

Controls

LABORATORIES MRDF - 11 Veterinary laboratories 8 ELOG Laboratories, Dimokritos Food of animal origin Analyses IGME establishments BPI GCSL Central Laboratory of Public Health

BPI Benaki Phytopathological Institute DGRREVM Directorate General of Regional Rural Economy and Veterinary Medicine DGVS Directorate General of Veterinary Services DVPH Directorate of Veterinary Public Health EFET Hellenic Food Authority ELGO-DIMITRA Hellenic Agricultural Organization – DIMITRA GCSL General Chemical State Laboratory MH Ministry of Health MIAR Ministry of Interior and Administrative Reconstruction MRDF Ministry of Rural Development and Food

Competent Authorities

The CAs for controls on food of animal origin are the DGVS, EFET and the Veterinary services of the Regions and Regional Units under the DGRREVM.

ELGO-DIMITRA is responsible for controlling the hygiene and quality of raw milk used as a primary product in dairy establishments.

33 DG(SANTE)2017-6055 Final Version date: February 2019 DGVS is responsible for the design and monitoring of the control system and for the evaluation of the system relating to primary production up to first processing of products of animal origin, i.e. slaughterhouses, cutting plants, milk collection centres, fishery landing sites, egg candling centres. The DVPH co-ordinates and monitors the implementation of legislation by the Regions, which are responsible for official control of food of animal origin from primary production to the retail sector.

EFET is responsible for the design, monitoring and evaluation of this control system after first processing. In the regions where EFET is not yet fully operational, responsibility is with the Directorates of REVM, acting under a co-ordinated programme issued centrally by EFET.

The Centre for Disease Prevention and Control (KEELPNO) of MH is responsible for epidemiological monitoring of infectious diseases in humans, including Salmonellosis, through a compulsory disease reporting system.

Registration and approval of establishments

Establishments are authorised at regional level following an inspection visit. When all requirements are fulfilled, the DVPH is notified by the region for official approval and allocation of an approval number and the DVPH may conduct an additional inspection. Documentation and plans are kept at regional level while the DVPH is responsible for keeping the list of approved establishments. EFET carries out approval and registration of establishments within its competence after first processing.

The list of approved establishments is available on the MRDF website.

Official controls and inspection at establishments

Ante and post mortem inspections and the regular official controls are performed by the regions. Slaughterhouse attendance is daily. Frequency of official controls of other establishments is based upon perceived risk at local level, according to guidelines sent by DVPH. Reports are collated on an annually basis and sent to the DVPH.

ELGO-DIMITRA has established a quality control programme in dairies. It sends results of raw milk controls to the regions and cumulative data to the DVPH.

EFET is responsible for controls of FBO own controls after first processing. EFET controls include: microbiological checks and checks on contaminants, composition, labelling and presentation of food. Inspection reports are evaluated at regional level and forwarded to central services.

Laboratories

Laboratory analyses are carried out by the veterinary laboratories of MRDF dealing mainly with food of animal origin, the GCSL and its 3 Chemical Services, the Food Testing and Research laboratories of EFET in Athens and Thessaloniki, the Dimokritos laboratory and the CLPH and other regional laboratories of KEELPNO. In addition, EFET uses the services of other laboratories, mainly laboratories accredited to EN ISO 17025.

34 DG(SANTE)2017-6055 Final Version date: February 2019 2.3 Control system for imports of animals and food of animal origin

BIP Border Inspection Post DAH Directorate of Animal Health DGVS Directorate General of Veterinary Services DVPH Directorate of Veterinary Public Health MoF Ministry of Finance MRDF Ministry of Rural Development and Food

Competent Authorities

The central CA for controls on imports of animals and food of animal origin is the DGVS. The DAH, in co-operation with the DVPH, is responsible for co-ordination on BIP matters. BIPs are under the direct responsibility of the DGVS. The veterinary staff of the BIPs are directly employed by MRDF as official veterinarians. Customs authorities are part of the MoF.

The central services are responsible for supervision and monitoring of BIPs and communicating legislation to them. In addition the central service co-ordinate the TRACES database, provide training and liaise with Customs. Guidelines for implementing control procedures, mainly in the form of circulars or manuals, are sent

35 DG(SANTE)2017-6055 Final Version date: February 2019 regularly to BIPs. Co-operation with Customs exits both at central and at local level and meetings are organised regularly. An agreement between Customs and CCA on co- operation and allocation of responsibilities has been formalised in 2011.

Import controls

BIP staff enters the details on the Common Veterinary Entry Document (CVEDs) and the information on rejected consignments through the Trade Control and Expert System (TRACES) database. This information is available centrally to the DGVS staff. All BIPs have direct access to the RASFF database of the Commission via the internet. The BIP creates a RASFF message through the TRACES system and the information is delivered automatically to EFET (NCP for RASFF) which makes the final decision and can validate or not the RASFF notification.

Furthermore a separate manual dedicated to sampling procedures, has been drafted and is currently subject to consultation with the services involved before its release.

Listed BIPs

BIPs: Athens international airport, Piraeus, Thessaloniki (airport), Thessaloniki (port), Evzoni, Eidomeni, Neos Kafkasos, Peplo, Kakavia, Astakos.

Points of Entry, Regional Unit of: Rhodes, , , Lesvos, Limnos, , Chios, , Kefalonia, Chania, Herakleion, .

36 DG(SANTE)2017-6055 Final Version date: February 2019 2.4 Control system for feedingstuffs and animal nutrition

DGA Directorate General of Agriculture DANFP Directorate of Animal Nutrition, Feed and Pasturelands DREVS Directorates of Rural Economy and Veterinary Service of Regional Units EOF National Organisation for Medicines MRDF Ministry of Rural Development and Food

Competent Authorities

DANFP of the MRDF is the central authority responsible for feedingstuffs, premixes and additives. It is, inter alia, responsible for the transposition of legislation, implementation of controls and provision of general guidance on the approval and registration (authorisation) of feed operators. DANFP is also the contact point for RASFF and co- ordinates the national control programme for inspections and sampling.

The peripheral authorities involved are: i) the three official laboratories for feedingstuffs analysis in Athens, Larissa and Thessaloniki. Within their duties is to coordinate the feedingstuff supervisors of the Directorates of REVM that are in their jurisdiction, to perform official controls and to analyze feedingstuffs. ii) the agronomists who have been appointed as feedingstuffs inspectors at all Directorates of REVM of the regional units (one ordinary inspectors and, at least, one deputy inspectors). They are mainly responsible for inspecting feedingstuff operations and for sampling of feedingstuffs.

37 DG(SANTE)2017-6055 Final Version date: February 2019 EOF is responsible for controls on the marketing and the use of medicated feedingstuffs.

DANFP, after cooperation with REVM and laboratories, drafts the national annual control programme for feedingstuffs (covering feedingstuffs, pre-mixes and additives) and transmits it to the local levels for implementation. The programme provides for inspections of all establishments manufacturing feedingstuffs at least once a year.

DANFP (via Department of Control of Feed and Establishments’ hygiene and Department of Feed Additives) provides guidance in the form of circulars to feed inspectors and receives directly the results of non-compliant samples for further action. Sanctions are imposed by General Director of Sustainable Animal Production and Veterinary Services on the basis of a recommendation submitted by DANFP. This information is also sent to the public prosecutor, as provided for in Law 4235/2014.

Meetings between DANFP and the MRDF laboratories are organised, if needed, in order to establish the resources needed to analyse certain substances in the feedingstuffs control plan and to co-ordinate the implementation of national annual control programme.

Also, DANFP exchanges correspondence with other authorities (e.g. Customs, EFET) for issues related to feedingstuffs.

Registration and approval of establishments and intermediaries

An approval inspection visit is carried out either by the feed inspector alone, or together with a representative of DANFP. The report, including recommendations for improvements to be made prior to final approval, is sent to the General Director of DGVS who grants the final approval, and DANFP maintains a list of approved establishments.

DANFP maintains a list of registered establishments on the basis of information obtained from REVM’s.

The list of registered and approved feed businesses is posted on the website of the feedingstuffs section since 2011 and it is updated twice a year.

Official controls

Official controls are carried out under the national annual control programme for feedingstuffs.

Feedstuffs (feed additives, premixes, complementary and complete feed) are examined for: a) Labeling parameters: proximates, Ca, Mg, feed additives (Cu,Zn, Mn, Fe, coccidiostats), GMO’s, and b) the presence of: processed animal proteins; rendered ruminant fat; gossypol; mycotoxins (aflatoxin Β1;; ochratoxin A; zearalenone, DON, HT- 2, fumonisins) heavy metals; dioxins; GMO’s; coccidiostats (use in non authorised animal species), antibiotics (prohibited use as feed additives).

38 DG(SANTE)2017-6055 Final Version date: February 2019 The Greek authorities implement a risk-based framework for controls of undesirable substances and criteria have been drawn up. A risk description for sampling criteria is provided, i.e. the type of product considered at risk, and type of establishments for sampling.

DANFP is the central competent authority for feed import controls related to EU Regulations 669/2009, 884/2014, 322/2014. DPQCFPP coordinates the several MRDF services for all the above Regulations.

Laboratory services

The MRDF feedingstuffs laboratories carry out analyses for: proximates (protein, oil, fibre, ash, and moisture); Ca, Mg, inorganic elements (Cu, Fe, Zn, Mn); aflatoxin Β1; gossypol; ochratoxin A; mercury in fishmeal; and protein of animal origin (microscopy and PCR). The rest of the analysis performed in feedstuffs, as described above, is carried out by private accredited laboratories.

Furthermore the Regional Centre of Plant Protection and Quality Control in Magnisia carries out analyses for heavy metals (Cd, Pb, As) in feed.

According to the JMD n.323306/2007 GCSL is one of the designated laboratories to carry out the counter sample analysis for chemical parameters and GMOs and Demokritos is the designated laboratory to carry out analysis of dioxins and dioxin-like PCBs in feedstuffs.

39 DG(SANTE)2017-6055 Final Version date: February 2019 2.5 Control system for TSE and Animal By-Products (ABP)

DAH Directorate of Animal Health DANFP Directorate of Animal Nutrition, Feed and Pasturelands DGE Directorate General for the Environment DGRREVM Directorate General of Regional Rural Economy and Veterinary Medicine DGVS Directorate General of Veterinary Services DVPH Directorate of Veterinary Public Health EFET Hellenic Food Authority FBO Food Business Operator MEE Ministry of Environment and Energy MH Ministry of Health MIAR Ministry of Interior and Administrative Reconstruction MRDF Ministry of Rural Development and Food

TSE

Competent Authorities

The DAH is the central CCA for TSE controls.

Epidemio-surveillance

Within the DGVS, the Division of Communicable and Parasitic Diseases in DAH is responsible for TSE epidemio-surveillance. Its tasks include the co-ordination and management of the programme throughout the country in co-operation with the regional units, the NRL and the Veterinary Laboratories (DVL) belonged either to the Directorates of Veterinary Center of Athens or Thessaloniki.

40 DG(SANTE)2017-6055 Final Version date: February 2019 Specified Risk Materials (SRM)

The Regional Veterinary Services are responsible for Specified Risk Material (SRM) controls in slaughterhouses and supervision and reconciliation thereafter. Guidelines regarding the categorisation and disposal of SRM (as part of ABP controls) have been sent from the DVPH of DGVS to the regional services.

Laboratory services

Four MRDF laboratories (Thessaloniki Veterinary Centre, Larissa Veterinary Laboratory, Ioannina Veterinary Laboratory, Athens Veterinary Centre) carry out routine rapid test analysis.

Feed ban

DGVS is the authority involved. There is a national control programme providing inter alia a regional breakdown of the minimum numbers of samples to be taken in feed mills or farms for checks of compliance with feed ban rules. The breakdown is based on kind of production, and existing lines, annual production of compound feedingstuffs per operation, profile of operators and non-compliances found.

At the level regional unit, the control of the feed ban and sampling on-the-spot is carried out by the inspectors of the PRDDs.

Laboratory services for feedingstuffs

Feedstuffs Control Laboratory of Athens is the laboratory that performs investigations and analyses feed samples for the presence of PAPs using Light Microscopy. Feedstuffs Control Laboratory of Thessaloniki is also accredited to perform investigations using Real Time PCR along with Light Microscopy.

ABP

Competent Authorities

Within the DGVS, the DVPH through the Department of Animal By-Products (DABP) is responsible for ABP.

The responsible bodies for approved landfill sites are: the Ministry of Economy, Development and Tourism; the Ministry for Environment and Energy; the MH; and the MIAR.

PD 211/2006 contains supplementary implementing measures for application of Regulation (EC) No 1774/2002. The Department of Animal By-Products (DABP) of the DVPH supervises the regional services and sends instructions and guidance for provisional approvals of ABP plants and other premises handling ABP, including separation of the categories and guidance for implementation of controls. PVDs regional services record the results of inspections and suggested corrective action and send reports to the DABP.

41 DG(SANTE)2017-6055 Final Version date: February 2019 Approval of ABP plants and other premises

The regional services are responsible for issuing authorisation according to the procedure and checklists supplied in circulars issued by the DABP. The process for issuing authorisations requires establishments to apply and submit a dossier, which is checked and submitted to a committee representing each regional CA.

Official controls

The regional services control handling of ABP and carry out controls on disposal of animal by-products and documentary checks at slaughterhouses and rendering plants. Physical inspection at slaughter and control of consignments dispatched from the slaughterhouses or rendering plants, is the responsibility of official vets under the supervision of the regional services.

42 DG(SANTE)2017-6055 Final Version date: February 2019 2.6 Control system for veterinary medicinal products (VMP) and residues

BIP Border Inspection Post DGRREVM Directorate General of Regional Rural Economy and Veterinary Medicine DGVS Directorate General of Veterinary Services DAWVDVA Directorate of Animal Welfare, Veterinary Drugs and Veterinary Applications EOF National Organisation for Medicines MH Ministry of Health MIAR Ministry of Interior and Administrative Reconstruction MRDF Ministry of Rural Development and Food NRL National Reference Laboratory RCL Routine Control Laboratory

VMP

Competent Authorities  Department of Veterinary Medicines, Residues and Veterinary Supplies of Directorate of Animal Welfare, Medicines and Veterinary Applications is the CCA responsible for: • implementation of the legislation for distribution and use of VMP in co- responsible with EOF; • planning of the official controls; • implementation and monitoring of the National Residue Monitoring Plan; • legislation- guidelines- circulars instructions;

43 DG(SANTE)2017-6055 Final Version date: February 2019 • supervision-assessment; • coordination of all CAs and Laboratories involved in the official control system.  EOF is the CCA rresponsible for: • licensing and registering human and veterinary medicinal products, including medicated feeding stuffs; • controls on VMP manufacturers and medicated feeding stuffs.  Veterinary services of Regions and Regional Units are the CAs responsible for planning and implementation of the official controls at local or regional level.

Official controls on marketing/use  EOF is responsible for licensing and registering human and veterinary medicinal products, including medicated feeding stuffs.  EOF has an online database of all registered products.  EOF has sole responsibility for controls on VMP manufacturers and medicated feeding stuffs.  The DAWVDVA is responsible for the supervision of veterinary controls on VMP (wholesalers, retailers, private veterinary practitioners, farms, veterinary prescriptions and VMP farm registers) and for the registration of wholesalers, retailers and private veterinarians. • The CAs are responsible for licensing and registering the wholesalers, retailers and private veterinarians. • The CAs are responsible for official controls (wholesalers, retailers, private veterinary practitioners, farms, veterinary prescriptions and VMP farm registers). • EOF and the CAs share responsibility for controls on distribution.

EOF carries out controls on manufacturers at least once every three years.

The CAs carry out official controls on veterinary pharmacies (wholesalers and retailers), at least once annually and renewed their license every five years.

Controls on wholesalers are shared between EOF and CAs.

Controls on farms and private veterinary practitioners are carried out by the CAs according to the risk analysis in the guide lines of the DVMRVS.

DAWVDVA receives annually reports of CAs controls on veterinary pharmacies, farms and private veterinary practitioners.

Residues

Competent Authorities

The CCA responsible for the National Residue Control Plan is the Department of Veterinary Medicines, Residues and Veterinary Supplies of Directorate of Animal Welfare, Medicines and Veterinary Applications.

44 DG(SANTE)2017-6055 Final Version date: February 2019 The CCA: • is responsible for the drafting, together with the National Reference Laboratories, the routine control laboratories and the CAs, and implementation and monitoring of the National Residue Monitoring Plan (RMP). • sends annually, written instructions to the CAs regarding the residue monitoring plan. The distribution of samples for each Regional Unit is described in the plan.

The CCA is also responsible for: • legislation- guidelines- circulars instructions; • monitoring- supervision-assessment; • coordination of all CAs and Laboratories involved in the official control system.

Official controls on residues

All sampling for the NRMP is done by officials Vets at regional level. The CCA receives quarterly CAs sampling reports

Laboratories

The network of residue control laboratories is organised through 4 NRLs, and 6 RCLs, all of which are State laboratories.

NRLs in Greece:  Department of Toxicology, Residues Environmental Contaminants of Athens  Veterinary Laboratory of Chania  Veterinary Laboratory of Serres  Veterinary Laboratory of Tripolis

RCLs in Greece:  Department of Food Microbiology, Biochemical and Physicochemical Food Control, Residues, Feed and Specific Pathogens Microbes Control of Thessaloniki  Veterinary Laboratory of Ioannina  Veterinary Laboratory of Patras  Veterinary Laboratory of Chalkida  Veterinary Laboratory of Kavala  Veterinary Laboratory of Rhodes

45 DG(SANTE)2017-6055 Final Version date: February 2019 2.7 Control system for foodstuffs and food hygiene

MRDF EFET MIAR

MoF-GCSL Control Plan Coordination Monitoring of results Etc. MIAR Cooperation Administrative management

MH-DGPH EFET results 6 regional Detailed Directorates Control programme

Samples DGRREVM MRDF Laboratories CLPH, GCLS Samples Other Laboratories Official Controls Quality Inspections Licensing FoNAO Labelling FoAO Pesticides

FBOs

CLPH Central Laboratory of Public Health DAAVFC Directorate of Agricultural, Animal, Veterinary and Fishery Controls DGPH Directorate General of Public Health DGRREVM Directorate General of Regional Rural Economy and Veterinary Medicine EFET Hellenic Food Authority GCSL General Chemical State Laboratory GHPG Good Hygiene Practice Guide MoF Ministry of Finance MH Ministry of Health MIAR Ministry of Interior and Administrative Reconstruction MRDF Ministry of Rural Development and Food

Competent Authorities

JMD No 1288/17 designates MRDF, through its Services and EFET, as the central Competent Authorities with overall responsibility for controls of food and feed under Regulations (EC) No 178/2002, 882/2004 and 852/2004.

The MH through the DGPH is the CA for water intended for human consumption, including bottled natural mineral waters.

The central service of EFET is responsible for drawing up national control programmes in collaboration with MRDF. EFET is also responsible for: co-ordinating and monitoring the implementation of the official controls; organising training programmes for food inspectors; promoting the drawing up and implementation of Good Hygiene Practice Guides; and harmonising control standards.

46 DG(SANTE)2017-6055 Final Version date: February 2019 Co-operation between EFET and the other authorities involved in official controls of food is regulated by JMD 052/04 and JMD 15523/06 as amended by JMD 1288/17 in which the framework of responsibilities has been laid down.

DFQS is responsible for the organisation, co-ordination and the monitoring of the implementation of official controls concerning food safety carried out in fresh fruit and vegetables packing premises (including packing in the farm). DFQS is also responsible for the organisation, co-ordination and the monitoring of implementation of official controls concerning the conformity of fresh fruit and vegetables to the marketing standards in all marketing stages.

Licensing and registration of food premises

EFET carries out registration of establishments within its competence relating to processing after primary production.

Three different services are involved in licensing/registration at Regional Unit level. The PVDs are responsible for licensing of food premises in their area of competence. The Plant Health Directorates of the Regional Units (PHD) issues a binding opinion to the municipal authorities for food premises which are selling directly to the consumer. In the latter case, the municipality is ultimately responsible for issuing licences.

EFET completed the implementation of the integrated information system to manage the registration of food premises.

MENO system (drawn by DFQS) meets the requirements foreseen in Art 6 of Reg 852/2004 regarding the premises in fresh fruit and vegetables sector. Sprout producing premises are also registered according to a circular issued by the DFQS.

Official controls of food premises

Official controls are carried out by EFET’s regional directorates and by the Veterinary, Rural Development, Health and Trade Directorates of the Regional Units.

At regional level the directorates of EFET are responsible for the implementation of official controls, co-ordination, and monitoring programmes of regional services. EFET are currently operational in nine of 13 regions in Greece. In those regions where EFET are not operational, the services referred to in the following paragraph are solely responsible for implementing food controls. Where they are operational both services are responsible.

At prefectural level the following autonomous official services implement food control:  The PVD are responsible for carrying out official controls in the sector of foods of animal origin during the distribution and supply stages.  The PRDD have the responsibility of carrying out official controls for food of plant origin during the production, processing and distribution stages.  The PTD are responsible for the application of control programmes on food quality (composition, adulteration, labelling) during the production, processing and distribution stages.

47 DG(SANTE)2017-6055 Final Version date: February 2019  The PHD are responsible for food businesses which sell direct to the consumer; they provide opinions during the licence-granting procedure by Municipalities. They are also responsible for controls of water intended for human consumption.

Data on the results of official controls are submitted to EFET central service through its regional directorates or, where these are not yet established, directly by the directorates of the Regional Units.

Registration

FBOs follow the procedure laid down in Article 5 of JMD No 15523/2006 to register food establishments, as required by Article 6 of Regulation (EC) No 852/2004.

The FBO submits an application for the licence to the municipality before starting the activity. To issue this licence the opinion of the PHD is required. Once the licence is granted the Chamber of Commerce informs the FBO that it must have the inspection log- book authorised by the PVD and/or PHD. When the log-book has been authorised the establishment is manually registered. No electronic database is available for the registration of establishments.

Good Hygiene Practice Guides

The drafting of guides is carried out by the representative bodies of the specific food sectors involved. This is followed by an evaluation of the guidelines by a scientific committee which consists of EFET representatives, representatives of the sector involved and consumers’ representatives, as well as representatives of the Greek Standardisation Organisation (ELOT). Finally, the hygiene guides are approved by a Decision of EFET’s Administrative Council which, in collaboration with the sectors involved, ensures that the guidelines are circulated to the individual establishments and to the relevant authorities.

EFET has approved 22 Good Hygiene Practice Guides. The guides are listed on EFET’s website.

Rapid Alert System for Food and Feed (RASFF)

EFET is the national contact point for the operation of the EU RASFF. When a notification is received through the RASFF relating to foodstuffs, EFET informs involved CCAs or CAs who coordinate or take the necessary investigative and/or apply restrictive measures.

Laboratories

Laboratory services are provided by the following organisations: GCSL, the laboratories of the MRDF, the CLPH, other regional laboratories of KEELPNO and other laboratories of Universities and private Institutes. Samples taken by EFET are mainly sent for analysis to accredited laboratories. EFET uses the services of laboratories accredited to EN ISO 17025 and exceptionally laboratories in the process of accreditation to the same standard. Compliance with quality criteria set out in standard ISO 17025 is achieved through co-operation protocols between EFET and the laboratories carrying out official controls.

48 DG(SANTE)2017-6055 Final Version date: February 2019 2.8 Control system for imports of food of plant origin

MRDF MRDF MIAR EFET GCSL DFQS DPPP

Coodrination of Coordination of controls pesticides controls Administrative up to first processing management

Coordination of Coordination controls after first processing DGRREVM supervision 8 RCPPQPC

Customs Authorities GCSL, BPI Sampling (Mycotoxins, heavy metals Sampling nitrates, etc.) (3MCPD, Sudan red, Irratiation Pesticide residues in processed food)

Analysis

Foodstuffs

BPI Benaki Phytopathological Institute DAAVFC Directorate of Agricultural, Animal, Veterinary and Fishery Controls DGRREVM Directorate General of Regional Rural Economy and Veterinary Medicine DPPP Directorate of Plant Produce Protection DFQS Directorate of Food Quality and Safety EFET Hellenic Food Authority GCSL General Chemical State Laboratory MoF Ministry Finance MH Ministry of Health MIAR Ministry of the Interior and Administrative Reconstruction MRDF Ministry of Rural Development and Food RCPPQPC Regional Centres of Plant Protection, Quality and Phytosanitary Control

Competent Authorities

According to JMD 1288/2017, the central CA responsible for official controls of food of plant origin is the MRDF through its competent services and EFET.

DFQS is responsible for the organisation, co-ordination and the monitoring of the implementation of official controls concerning food safety, carried out in fresh fruit and vegetables packing premises (including packing at farm level). DFQS is also responsible for the organisation, co-ordination and the monitoring of the implementation of official controls concerning the conformity of fresh fruit and vegetables to the marketing standards in all marketing stages.

49 DG(SANTE)2017-6055 Final Version date: February 2019 Additionally, DFQS is responsible at the import stage for the official control system as regards the safety of processed foods of plant origin, mainly focusing on controls relating to mycotoxins (aflatoxins, Ochratoxin Α, patulin deoxynivalenol, zearalenone, fumonisins, -2 and ht- toxins), heavy metals, melamine, morpholine, nitrates, Sudan dyes, GMOs and microbiological hazards (Salmonella spp, Norovirus, HAV, E. coli).

Within its competence, DFQS co-ordinates the implementation of Regulations (EC) 669/2009, (EU) No 884/2014, (EU) No 2016/6, (EU) 2015/949, (EU) 208/2013, 209/3013, 210/2013, 211/2013 and Decision (EU) 2011/884 and 2015/1028.

Moreover, DFQS has been appointed as the co-ordinator for other MRDF services in matters relating to Regulation (EC) 669/2009. More specifically, it is responsible for:  disseminating, to all relevant CAs and stakeholders, information related to the implementation of the Regulation;  maintaining on the internet and updating the list of Designated Points of Entry;  submitting quarterly reports to the Commission.

DFQS has been appointed with similar co-ordination tasks for the different services of MRDF for issues related to Regulations (EU) 884/2014, (EU) 2016/6 and Decision (EU) 2011/884.

Concerning food of plant origin at import the sampling is performed following procedures provided for in EU legislation, EU guidelines and circular 253173/15.03.2010 (sampling for HAV).

The GCSL is responsible for import controls relating to chemical risks (e.g. food additives, flavourings, enzymes, contaminants, food irradiation), novel foods and GMOs (including Decision 2011/884/EU) depending on the product (processed and composite foods of non - animal origin).

The DPPP is responsible for import controls relating to phytosanitary controls and pesticide residues.

Import controls

Official controls at import are carried out by the RCPPQPCs or by the DREVMs as follows: a) Food of plant origin not falling under the scope of specific EU legislation

The FBO, intending to present food of plant origin for import, gives prior notification to the CA of the point of import at least 24 hours prior to the physical arrival of the consignment. This prior notification includes all the necessary information concerning the consignment including its identification details. The CA at the point of import carries out regular documentary control on the consignments. The frequency of the identity and physical controls is set out centrally at country level following annual risk assessment and taking into account the objectives and the priorities set out at import stage in the MANCP. For this purpose, DFQS draws an annual control plan, which includes the hazard, the food, the third country – if necessary - and the control frequency, to be applied by the CAs. This annual control plan does not include products originating in or consigned from specific third countries for which specific EU legislation applies. For the

50 DG(SANTE)2017-6055 Final Version date: February 2019 above mentioned products, the annual control plan may be applied for hazards other than those referred to in the specific EU legislation.

DFQS keeps a database with the details of consignments of cereals that are imported via ships (bulk) and the decision for sampling and analysis is made centrally by the DFQS based on risk analysis.

In case of consignments non-compliant with EU or national legislation, the CA decides for the official detention and applies art 19, 20 and 21 of Regulation 882/2014 and the procedures described in art 12 of L. 4235/2014.

In addition, traders are obligated to announce their consignments of fresh fruits and vegetables in exports, imports and intracommunity trade, via digital prior notifications, on the website of the MRDF (‘MENO’ system). The ‘MENO’ system automatically performs risk analysis and decision-making to carry out or not a compliance check in terms of quality marketing standards, for each one separate notification.

In the case of a satisfactory check of compliance, the competent authority issues a Certificate of Compliance, which is provided to traders according to the Annex II of Impl. Reg (EC) No. 543/2011. In the case of a decision of exemption from a check, the system issues a Certificate of Exemption which is provided to traders. The Certificates of Conformity or Exemption are indispensable documents for successful customs release (free circulation or closing declaration of exportation) of the consignments in compliance with the provisions or art.13 of Impl. Reg (EC) No. 543/2011. In case of findings of non- conformities to consignments during checks, the procedure is already described above.

Furthermore, MRDF has established the institution of ‘Approved Trader’ for exporters of fresh fruits and vegetables, based on the corresponding option of the Reg (EC) No. 543/2011. Those traders met a variety of strictly criteria, and as a benefit are subjected to a very low level of control in their consignments (less than 2%). b) Food of plant origin falling under the scope of specific EU legislation

In case of specific EU legislation, the FBO gives prior notification to the CA of the Designated Point of Entry (DPE). In Greece there are 6 DPEs for food in the framework of the Regulation (EC) 669/2009, as follows:

DESIGNATED POINT OF ENTRY COMPETENT AUTHORITY (DPE)

1 Port of Pireus RCPPQPC of Pireus

2 Athens International Airport RCPPQPC of Pireus «Eleftherios Venizelos»

3 Port of Thessaloniki RCPPQPC of Thessaloniki

4 Thessaloniki International Airport RCPPQPC of Thessaloniki «Makedonia»

5 Port of Astakos DREVM Aitoloakarnania

6 Kipi Evrou DRVEM Evros

51 DG(SANTE)2017-6055 Final Version date: February 2019 7 Evzoni Kilkis DRVEM Kilkis For palm oil, the following Designated Points of Entry additionally apply:

7 Port of Elefsina RCPPQPC of Pireus

8 Port of Patras RCPPQPC Achaia

9 Private Port of “SOYA HELLAS S.A.”, DRVEM Evia Psahna Evias 10 Private Port of “SOYA MILLS S.A.”, DRVEM Korinthia Kalamaki Korinthias 11 Private Port of “AGROINVEST”, DRVEM Fthiotida Achladi Fthiotidas

Until 15.08.2014 the DPE Kipi Evrou was the only DPE in Greece under the scope of the Article 19(1) of Reg (EC) 669/2009. According to the Regulation, the Competent Authority of Kipi Evrou carried out the documentary checks while the identity and physical checks were carried out by the Competent Authority at the Control Point “DPE Port of Thessaloniki”. Since 15.08.2014 the DPE Kipi Evrou complies with the minimum requirements of Article 4. More specifically, the DPE is located within the same facilities of EU approved Border Inspection Post of Peplo, the line of non-edible products is used for this purpose. Appropriate arrangements have been put in place to ensure that potential overlaps or conflicts do not impede the smooth functioning of border authorities, both for veterinary and non-veterinary checks.

Regarding Regulation (EU) No 884/2014 there are 20 Designated Points of Import (DPI), including ports and airports. Approximately 95 % of consignments come through the DPIs of Piraeus (Port of Pireus and Airport of Athens) and Thessaloniki (Port and Airport), which is controlled by the corresponding RCPPQPC of Pireus and Thessaloniki.

Regarding Regulation (EU) No 322/2014 and Decision (EU) 2011/884/EU there are four Designated Points of Entry, including ports and airports. The controls regarding the control of foodstuffs have been allocated at local level to the RCPPQPCs of Pireaus, and Thessaloniki.

In case of consignments non-compliant with EU or national legislation, the CA decides for the official detention and applies art 19, 20 and 21 of Regulation 882/2014 following the procedures described in art 12 of L. 4235/2014.

A special link on MRDF’s website called “Import Controls of Food and Feed of Non- Animal Origin” has been developed that includes all relevant information on import controls.

GCSL is responsible for the documentary, identity, and physical controls of imported processed and composite food products of non-animal origin as regards chemical risks, novel foods and GMOs (including those falling within the scope of the Decision 2011/884/EU). It is also responsible for the implementation of Regulation (EU) 2016/6 in imported processed and composite products of non - animal origin, under the co- ordination of EFET.. The samples are taken by Customs, together with the inspectors, in cases were specific and specialized controls are required.

52 DG(SANTE)2017-6055 Final Version date: February 2019 Concerning the implementation of Regulations (EC) No 669/2009 and 884/2014 GCSL carries out the laboratory analysis of the samples taken by the CAs.

Laboratories

For import controls public and private accredited laboratories are used. Public laboratories include GCSL, and its 14 9 Chemical Service laboratories, the Central Laboratory of Public Health, the laboratories of RCPPQPCs, the laboratories of NAGREF as well as university laboratories.

Within the GCSL, the Directorate of Alcohol and Foodstuffs, Department of Foodstuffs, Water and Environment, is responsible for drafting legislation through the Supreme Chemical Council (including transposition of EU Directives into national law), scientific co-operation, co-ordination of Chemical Services and for issuing circulars to the Chemical Services of the GCSL, concerning quality and safety control of foodstuffs as well as the competent authority for the applications submitted under the Regulations (EC) 258/97 (novel foods) and 1935/2004 (food contact materials). The independent Department of Chemical and Technical Tarification is responsible for local services that communicate with Customs and examining products for tarification purposes. All the laboratory activities have been transferred to regional Chemical Services and local services.

53 DG(SANTE)2017-6055 Final Version date: February 2019 2.9 Control system for plant protection products (PPP) and residues

Plant Protection Products (PPPs)

MRDF DPPP

BPI Coordination

Chemical Control DREVS /MIAR RCPPQC Laboratory

 Retailer/wholesaler  Labelling  Illegal PPPs authorisation  Packaging  Labeling  Manufacturers  Sales specifications,  Sampling of products BPI  Sustainable use  Treated seeds  E-register,  Advertisment  Parallel trade  prescriptions  Export/trade

2 Quality Control User Marketing PPP Other Laboratories ((RCPPQC)

BPI Benaki Phytopathological Institute DPPP Directorate of Plant Produce Protection DREVS Directorates of Rural Economy and Veterinary Service of Regional Unities MIDE Ministry of the Interior, Decentralisation and E-government MRDF Ministry of Rural Development and Food RCPPQC Regional Centre of Plant Protection and Quality Control

Competent Authorities

The Coordinating National Authority is the Plant Produce Protection Directorate of the Ministry of Rural Development and Food. The DPPP is responsible for: the authorisation of plant protection products (PPP); transposition of legislation; controls on the marketing and use; and reporting results of controls to the Commission.

The Benaki Phytopathological Institute is designated as the competent authority for the evaluation of the submitted data, which are required for the placing of plant protection products on the market.

The Directorates of Agricultural Economy and Veterinary of Regional Unities and the Regional Centers for Plant Protection and Quality Control of the Ministry of Rural Development and Food are designated as competent authorities for the controls on plant protection products.

The Chemical Control Laboratory of the Benaki Phytopathological Institute and two Plant Protection Products Quality Control Laboratories of the Regional Centers for Plant

54 DG(SANTE)2017-6055 Final Version date: February 2019 Protection and Quality Control of the Ministry of Rural Development and Food (Piraeus and Thessaloniki) are designated as competent authorities for the chemical controls (analysis) on plant protection products. The Benaki laboratory conducts full analysis of plant protection products and comparison analysis for parallel trade products.

Official Controls on marketing/use

The Coordinating National Authority is designated for the coordination of competent authorities regarding the official controls on plant protection products, the cooperation with Commission, with EFSA, with the competent Authorities of the other Member States, with the manufacturers, producers, farmers, professional users and others involved in pesticide matters.

On site controls are implemented by the competent authorities of the Directorates of Agricultural Economy and Veterinary of Regional Unities and with parallel capability for controls by the Regional Centers for Plant Protection and Quality Control of the Ministry of Rural Development and Food (http://www.minagric.gr/index.php/el/for-farmer-2/crop- production/fytoprostasiamenu/elenxoifitoprostateytikonmenu/524-programa- elegxon/1586-armarxeselegxoyfit).

The official controls cover all sectors of PPPs marketing and use as described in the above organogram.

For the implementation of the use of ppps in compliance with the provisions of Directive 2009/128/EC integrated pest management guidelines and early warning systems are in place. http://www.minagric.gr/index.php/el/for-farmer-2/crop- production/fytoprostasiamenu/oloklfytoprostasia-menu/2972-odhgies-fyto http://www.minagric.gr/index.php/el/for-farmer-2/agricultural-warnings

The national implementation measures for the official controls on ppps are published on Coordinating National Authority website: http://www.minagric.gr/images/stories/en_docs/plant_protection/National_Legislation_% CE%95%CE%9D_220815.pdf

The sanctioning system for infringements related to plant protection products is established by law 4036/2012: http://www.minagric.gr/images/stories/en_docs/plant_protection/L4036_2012_EN.pdf.

A system for the internal audit system and verification of the effectiveness of official controls on plant protection products and pesticides residues is established.

Annual Control Programs and outcome of the controls

The annual control program and the results of the controls (report and specific sanctions on each provision of the law 4036/2012 (OJ A8) are mentioned (in except of the report) on Ministry’s website: http://www.minagric.gr/index.php/el/for- farmer-2/crop-production/fytoprostasiamenu/elenxoifitoprostateytikonmenu/524- programa-elegxon/2088-etisio-pro-elegxou.

Prioritisation of official controls

55 DG(SANTE)2017-6055 Final Version date: February 2019 All official controls on plant protection products are risk based. Specific risk factors have been established for controls on users (http://www.minagric.gr/images/stories/en_docs/plant_protection/Farmer_control_proced ure.pdf), for controls on pesticide sales (http://www.minagric.gr/images/stories/docs/agrotis/Georgika_Farmaka/elenxoi/Emporia _Gewrgikwn_Farmakwn.pdf) and for controls on ppps (http://www.minagric.gr/images/stories/docs/agrotis/Georgika_Farmaka/elenxoi/KYA_E LEGXWN_FP_FEKB26-2015.pdf).

Authorisation of PPP

CNA is responsible for the implementation of Reg. 1107/2009 and Reg. 396/2005. Before a plant protection product is placed on the market, an authorization by the Coordinating National Authority (CNA) is required. All decisions on authorizations and circulars are published to the official web site of the Ministry of Rural Development and Food.

The Benaki Phytopathological Institute (ΒPI) is designated as the competent authority for the evaluation of the submitted data.

All the procedures followed by the CNA / BPI and the evaluation of the submitted data are according to Reg. 1107/2009, Reg. 396/2005 and the EU Guidance Documents.

56 DG(SANTE)2017-6055 Final Version date: February 2019 PPP Residues

MRDF DPPP

Authorisation Coordination of controls

Coordination (multiannual control plan) Resulst of analysis 8 RCPPQCs

Laboratories  BPI DREVS (MIAR)  8RCPPQCs Controls on mAanrkaelytsinisg and use (sampling) Controls on marketing and use (sampling)

Non-processed food

BPI Benaki Phytopathological Institute DPPP Directorate of Plant Produce Protection DREVS Directorates of Rural Economy and Veterinary Service of Regional Unities MIDE Ministry of the Interior, Decentralisation and E-government MRDF Ministry of Rural Development and Food RCPPQC Regional Centre of Plant Protection and Quality Control

Competent Authorities

The CNA is responsible for the planning and the co-ordination of the controls of pesticide residues on plant products up to first processing. It is also responsible for the annual collection of the results of the controls of pesticide residues and their submission to EFSA according to the SSD system.

CNA (MRDF) co-operates with EFET when planning residue controls on food after first processing. The organisation of controls in processed food of plant origin after first processing is the responsibility of EFET in co-operation with the Regional Units. Within the CNA, the Department of Plant Protection Products and Biocides is responsible for enforcement of residues controls on primary products of plant origin. EFET is responsible for controls on pesticide residues in products of plant origin after first processing. The EOF is the CA for control of pesticide residues in baby food.

57 DG(SANTE)2017-6055 Final Version date: February 2019 The training on the control of pesticide residues is planned and implemented in INEP (Training Institute of the National Centre for Public Administration and Local Government) in cooperation with the CNA.

The DREVs and the RCPPQCs are responsible for the sampling. They are also responsible for collecting all data and information when references to sanctions are sent by Department of Plant Protection Products and Biocides to the Minister of the MRDF or the justice.

Official controls on residues

Multiannual national control programmes of pesticide residues are established by CAN according to art. 30 of Reg. 396/2005 every three years and are updated annually in co- operation with the RPPCQCs of the MRDF and BPI. The Multiannual national control programmes of pesticide residues are notified to the Commission and to EFSA and are published on the official web site of MRDF ( http://www.minagric.gr/index.php/el/for- farmer-2/crop-production/fytoprostasiamenu/ypoleimatafyto).

The samples carried out by EFET are included in the multiannual control programme prepared by CAN. The criteria applied for planning the programme include: cultivated area and crop production; predicted rates of imports and exports; dietary intake of food of plant origin; results from previous years (MRLs exceedances); RASFF notifications, pesticides used in practice and the analytical capacity of the official laboratories.

The implementation of controls for which MRDF is responsible are performed by DREV of RUs and the RCPPQCs.

Sampling of pesticide residues for which EFET is responsible is performed by EFET, regional directorates and Regional Units authorities.

The results of the analyses are sent by the laboratories to the sampling bodies and to the MRDF or EFET central services. A new monitoring programme for pesticide residues in children’s food has been put in place by EFET.

When sampling bodies find non-compliant results, a dossier is sent to head office, where sanctions may be imposed directly, and also to the public prosecutor. Non-compliant companies are not permitted to supply without further testing.

EFET is the national contact point for the operation of the RASFF. When a notification is received relating to pesticide residues, EFET informs either the Department of Pesticides of the MRDF or other CAs depending on their competence.

Laboratories

Residue analyses are performed by the pesticide residue laboratories of the BPI, the RCPPQCs (8 laboratories) and the GCSL. In total a network of 10 laboratories is designated for analysis of pesticide residues. All laboratories performing analysis according to the multiannual national control programme of pesticide residues are accredited.

When a laboratory detects an exceedance of a pesticide MRL, the CNA is informed and the Department of Plant Protection Products and Biocides conducts a dietary risk assessment.

58 DG(SANTE)2017-6055 Final Version date: February 2019 In case of non–compliance, fines and administrative sanctions are imposed. Procedures, laid down in Law 4036/2012 are followed in cases of MRL exceedances. In cases of MRL exceedance the measures available include withdrawal from the market and destruction of the batch found to be non–compliant. In cases of MRL exceedance in imported plant produce, the consignment may be destroyed or re-dispatched to the country of origin. In both cases – domestic and imported produce – the next batch of the same produce with the same origin must be sampled and analysed for pesticide residues before being released on the market. Administrative and punitive sanctions may also be imposed.

59 DG(SANTE)2017-6055 Final Version date: February 2019 2.10 Control system for animal welfare

BIP Border Inspection Post DAAVFC Directorate of Agricultural, Animal, Veterinary and Fishery Controls DGRREVM Directorate General of Regional Rural Economy and Veterinary Medicine DGVS Directorate General of Veterinary Services DAWVDVA Directorate Animal Welfare, Veterinary Drugs and Veterinary Applications MIAR Ministry of Interior and Administrative Reconstruction MRDF Ministry of Rural Development and Food

Competent Authorities

The DAWVDVA is responsible for the implementation of all animal welfare legislation, including European and national one. Its duties include the transposition of European legislation into Greek law, the co-ordination, monitoring and reporting of the relevant activities of the Regional Units veterinary services, but also the provision of training to the personnel of the prefectural veterinary services and BIPs and information to external stakeholders.

The personnel of the Regional Units veterinary services carry out welfare inspections on- farm, at slaughter and during transport. They also register and license transporters and vehicles carrying live animals, organise the work of district veterinary stations and report on a quarterly basis, using summary report forms, to the welfare section of the MRDF.

The BIP personnel carry out animal welfare checks as part of the veterinary checks at Community entry points and report the results of their inspections to the animal and public health sections of DGVS and DAWVDVA.

60 DG(SANTE)2017-6055 Final Version date: February 2019 The animal welfare department of the DAWVDVA distributed an action plan to the regional veterinary services in response to animal welfare deficiencies identified during DG SANTE audits. The response from the regional veterinary services to the MRDF showed that action needs to be taken and that statistical data returns is incomplete. Although the number of animal welfare sanctions imposed by the Regional Units veterinary services in 2006-2007 has increased to six, the principal outcome of audits carried out by the DGVA in the animal welfare sector is still a shortage of systematic official controls and reporting from the Regional Units veterinary services on such controls.

The animal welfare division has no legal power to entitle the regional services to implement animal welfare legal policies. The animal welfare division has only the authority to send requests for reports and statistical data if these have not been forthcoming from the regional veterinary services. The suggested method for resolving disputes arising from lack of co-operation between the MRDF animal welfare office and non-responsive regional services is via MRDF senior management to the Secretary Generals of the MRDF and the MIAR. This route has not been used, to date, to enforce the implementation of animal welfare controls as a priority in the regional services.

Official controls on-farm

On-farm controls are carried out whenever possible simultaneously with other animal health duties by local and regional vets. Guidance has been issued to PVDs and local vets on carrying out checks. Results of the checks, including details of any corrective action taken, are recorded in audit checklists at PVD level and sent to the animal welfare office on a quarterly biannual basis.

Official controls during transport

There is an annual monitoring plan with the target of inspecting 30 % of all animal transports within the regional services. A pilot project for checking animal welfare during transport has been put in place in two regional services in co-operation with the police. However, due to staff constraints, the project has only started to implemented on December 2014.

Official controls at slaughter

Veterinarians of the district veterinary offices and regional veterinary services carry out routine control of animal welfare during slaughter when inspecting work in slaughterhouses and they also conduct checks on the unloading of transported animals. Guidance and monitoring forms have been sent from the animal welfare division of the MRDF to the regional veterinary services. Veterinarians of the regional veterinary services have been requested to re-inspect all slaughterhouses with regard to animal welfare at slaughter.

61 DG(SANTE)2017-6055 Final Version date: February 2019 2.11 Control system for plant health

DRDC MRDF coordination MEE MIAR specific authorizations DPPP

coordination DPFRE (Co-ordinates the implementation of plant Sampling and diagnosis health legislation of forestry services) DREVs RCPPQPCs Registration, BPI Import control inspections, plan checks, etc. passports, surveys etc. Sampling and diagnosis DFPs/FSs (inspections in relation to forests )

controls

Producers, businesses, importer

BPI Benaki Phytopathological Institute DFPs/FSs Directorates of Forest of the Regional Units /Forest Services (for forest crops) DPFRE Directorate for the Protection of Forests and the Rural Environment DRDC Department of Rural Development & Control DREVs Directorates of Rural Economy and Veterinary of Regional Units (for non forest crops) DPPP Directorate of Plant Production Protection MIAR Ministry of Interior and Administrative Reconstruction MRDF Ministry of Rural Development and Food MEE Ministry of Environment & Energy RCPPQPCs Regional Centre of Plant Protection, Quality & Phytosanitary Control

Competent Authorities

The DPPP in the MRDF, has been designated, based on Presidential Degree (PD) No 365/2002, as the Single Authority (SA) for plant health, as defined in Article 1(4) of Directive 2000/29/EC. The responsibilities of the SA are specified in Law No 2147/1952 and Presidential Degree 107/2014 and include:

 policy co-ordination;  co-ordination and contacts in matters relating to plant health within the meaning of Directive 2000/29/EC;  transposition of EU law into national legislation and issuing of guidelines;  co-ordination and co-operation with regional and local services.

Within the country, depending on local arrangements, the following authorities are involved in plant health controls and act as the responsible official body for plant health, control, as defined in Article 2(1)(g) of the Directive.

According to the PD No 365/2002, the Directorate for the Protection of Forests and the Rural Environment (DPFRE) of the Ministry of Environment and Energy (MEE) (ex- Directorate of Forests & Forest Environment Protection of the Ministry of Environment,

62 DG(SANTE)2017-6055 Final Version date: February 2019 Energy & Climate Change) is the designated authority which coordinates the implementation of plant health legislation of forestry services.

The phytosanitary services and their phytosanitary inspectors are responsible for the implementation of phytosanitary legislation:

a) Eight RCPPQPCs operate under the Directorate of Food Quality and Safety, Directorate General of Food under MRDF. The responsibilities of the services and the duties of the phytosanitary inspectors are based on the Ministerial Decision (JMD) No 8717/87833/2012 (B 2494). They are responsible for: official inspections at the entry points, sampling, in co-operation with other bodies (i.e. RUDREVs), issuing plant passports at entry points proposing administrative fines and sanctions.

b) Directorates for Rural Economy and Veterinary of Regional Units (DREVs) for non forest crops– operating at local/regional level are part of the Ministry of the Interior and Administrative Reconstruction. The responsibilities of the services and the duties of the phytosanitary inspectors are based on JMD No 101137/2011 (B 2384. They are responsible for: registration of stakeholders, inspections, sampling, authorisation to issue plant passports, participation in surveys, proposing administrative fines and sanctions; imposing official measures and import controls (where a RCPPQC is not present).

c) Directorates of Forest of the Regional Units (DFRUs) and Forest Services (FSs) for forest crops – operating at local/Decentralised Administrations (DAs) and belonging to the Ministry of Interior and Administrative Reconstruction (MIAR), based on JMD No102569/2011 responsible for: inspections for the registration of stakeholders for forest crops (DREVs keep the registry in total), sampling, authorisation to issue plant passports, participation in surveys, proposing administrative fines and sanctions, imposing official measures.

d) Departments of Rural Development and Control (DRDC) operate at regional level under the MRDF, are responsible for specific authorizations related to official controls of plants, plant products and other objects according to PD 30/2006 (A28), JMD 121285/665/2006 (V1416) (e.g. tasks related to the plant health supervision of seed production of potatoes; alfalfa: sunflowers: tomatoes: and beans).

Laboratories:

The Benaki Phytopathological Institute is designated as the laboratory testing surveys’ coordinator.

According to the PD No 365/2002, responsible laboratories for the sample analysis are depending on the category of the harmful organism.

The current responsible laboratories are:

a) The Benaki Phytopathological Institute (BPI): is designated (during the last years with relevants JMD) by the MRDF for submitting the annual survey programme

63 DG(SANTE)2017-6055 Final Version date: February 2019 to MRDF and is responsible for: collects the survey results, keeps the records of the survey programme, reports to the SA, issues the survey methodologies for the relevant pests (non-forest), sample analysis.

b) “ELGO-DIMITRA” (ex NAGREF) [for the forest and non-forest]: samples analysis, survey methodology, record keeping, report results to BPI.

c) University of Thessaly (non-forest): samples analysis, survey methodology, record keeping, report results to BPI.

d) Technological Educational Institute (T.E.I) of Crete (non-forest): samples analysis, survey methodology, record keeping, report results to BPI.

e) Control Station for Seeds (SEAPY): samples analysis, survey methodology, record keeping, report results to BPI.

f) MAICH: samples analysis, survey methodology, record keeping, report results to BPI.

All methodologies and surveys scheme for each harmful organism are uploaded at the BPI web site (www.bpi.gr). Restricted access (password required) to the phytosanitary inspectors and services is applied.

The DPPP co-operates with the DPFRE, the eight RCPPQCs, the 74 DREVs, the 118 DFPs/FSs and responsible laboratories. The RCPPQCs carry out phytosanitary inspections and monitor the Rural Economy and Veterinary Directorates of the Regional Units in relation to plant health controls, and provide assistance and guidance. Export and import controls related to plant health are carried out by the RCPPQCs and the RUDREVs. Registering businesses and issuing plant passports are the sole competence of the RUDREVs.

The DPPP provides the implementing bodies with instructions for survey sampling in cooperation with the responsible laboratories.

Administrative sanctions may be proposed to the DPPP by the RCPPQPCs, the DREVs or the DFPs/FSs. Responsible services send to the DPPP official reports in the case of findings of phytosanitary infringements. The DPPP proposes relative sanctions (e.g. penalties) which are imposed by the MRDF according to the Law 2147/1952 as amended by Law 2538/1997.

Communication between and within competent authorities and other parties involved is reached via email, telephone, fax and in writing. Each year seminars and meetings are organized for official involved parties.

64 DG(SANTE)2017-6055 Final Version date: February 2019 2.12 Quality labelling

Organic production

MRDF DQSOPGI ELGO - DEMETRA coordination

supervision

Control Bodies accrediation ESYD

controls

controls RCPPQC, BIP, operators foodstuffs imports DRREVM

MRDF Ministry of Rural Development and Food DQSOPGI Directorate of Quality Systems, Organic Production and Geographical Indications ELGO-DIMITRA Hellenic Agricultural Organization – DIMITRA CBs Control Bodies ESYD Hellenic Accreditation System BIP Border Inspection Post RCPPQC Regional Centre of Protection Plants and Quality Control DRREVM Directorate of Regional Rural Economy and Veterinary Medicine

Competent authorities and Control Bodies

The Directorate of Quality Systems, Organic Production and Geographical Indications (DQSOPGI) of the Ministry of Rural Development and Food (MRDF) is the competent authority of the control system for organic production in Greece.

The Greek Agricultural Organization “DEMETER” (ex ΟPΕGΕP-AGROCERT), from now on called ELGO-DIMITRA is the control authority of the above mentioned control system.

Fifteen (15) Control Bodies (CBs) have been approved to carry out the inspection and certification to the operators.

Control System

The control of operators shall be carried out by the authorized CBs, as provided for in paragraph 2 of Article 6 of Joint Ministerial Decision (JMD) 245090/06 (FEK 157 B/10.02.2006). These controls are carried out in all stages of production, marketing, manufacturing, storage, import of organic products from third countries and export, as follows:

65 DG(SANTE)2017-6055 Final Version date: February 2019 a) Initial inspection should be carried out not later than 60 days after the signing of the contract between the CB and the operator. b) Full controls inspections for the verification of specific measures and commitments which have been accepted by the operators with the CB. This control inspection is carried out at least once a year within the growing season of the crop species, or for livestock farming within the year of farming or for processing units within the manufacturing period. c) Additional random control visits carried out in accordance with Article 65(4) of at least 10% of operators under contract in accordance with the risk category are performed. d) At least 10% of all inspections and visits carried out in accordance with Article 65(1) and (4) are unannounced based on the risk analysis procedure. e) Sampling for laboratory analysis for the detection of non-permitted substances is made on the basis of the plan drawn up by CB sampling program, on the plant and animal products, plant and animal tissues and organs, soil, feed, at a rate of at least 5% of the controlled operators. The criteria (risk assessment) on which the program of sampling is established are the risk, the size and the location of the unit, the type, the history and the critical stages of the production process, consumer complaints, etc.

For the surveillance of the control system, controls are carried out in operators from ELGO-DIMITRA, as referred to in paragraphs 2b, 2c, 2d of Article 5 of JMD 245090/06. In addition, DQSOPGI may carry out controls, in the context of the supervision as specified in point 1 of Article 4 of JMD 245090/06.

The Control Bodies (CBs) carry out controls with objectivity and independence. To this point, they have been accredited by ESYD (Hellenic Accreditation System S.A.) that they meet the requirements of standard EN 45011. CBs ensure the impartiality and confidentiality of the performed controls as described in their Quality Control Manual.

In addition, DQSOPGI may carry out controls, in the context of the supervision as specified in point 1 of Article 4 of JMD 245090/06.

Supervision of CBs

For the surveillance of the control system, controls are carried out in CBs from ELGO- DIMITRA, as referred to in paragraphs 2b, 2c, 2d of Article 5 of JMD 245090/06. These controls are carried out as follows: a) Administrative audit: Document review of the relevant general documents describing the structure, functioning and quality management of the control body. Office audit of the control body, including checking of operator files and verification of handling of non-conformities and complaints, including the minimum control frequency, the use of risk based approach, unannounced and follow-up visits, the sampling policy and the exchange of information with other control bodies and control authorities. b) Review audit: inspection of an operator by the competent authority to verify compliance with the operating procedures of the control body and to verify its effectiveness.

66 DG(SANTE)2017-6055 Final Version date: February 2019 c) Witness audit: observation by the competent authority of an inspection by an inspector of the control body. In the case where during of the surveillance audits by the ELGO-DIMITRA is found that a CB does not meet the requirements of EU’s and national legislation on organic farming, as provided for in paragraph B1 of Article 11 of JMD 245090/06, then the surveillance authority advise the Sanctions’ Committee to impose sanctions. As regards audits by DRREVM to CB’s and operators, detailed reference is made in Ministerial Decision 296851/2007 and Joint Ministerial Decision 245090/2006.

Controls at market level

1. The Directorate of Quality Systems, Organic Production and Geographical Indications (DQSOPGI) may conduct controls.

2. The control on the market of organic products is carried out mainly by ELGO- DIMITRA, who is the control authority of the control system, is generally responsible for control in all areas of organic farming. The authority provided for in paragraph 2 (c) of Article 5 of the JMD 245090/06. ELGO-DIMITRA checks the labeling of organic products and whether this is consistent with the national and EU’s legislation on organic farming. Within the framework of surveillance controls, samples are taken where necessary, in order to detect possible persistence of prohibited for use in organic farming substances.

CB’s may conduct controls to all operators included in their registry in the control system.

Imports from Third Countries

Organic products can be imported from third countries, according to Regulation (EC) No 1235/2008. They are controlled by the Regional Centers of Protection Plants and Quality Control (RCPPQC) and Border Inspection Posts (BIPs) in collaboration with the regional Directorates of Rural Economy and Veterinary (DRREVM) and according to 1973/138399/12-11-2013 instructions paper and Article 9 ‘’Imports’’ of JMD 245090/31-01-2006.

Enforcement and Sanction System

According to Articles 10 and 11 of JMD 245090/31-01-2006: 1. When during the controls a CB notes non-conformities from the operator concerned, the implementation of corrective actions and other measures described in national legislation is applied. When the control is carried out and the CB ascertain and records irregularities or infringements of existing EU’s and national legislation, they must send directly the control report to the surveillance authority which shall ensure for the transmission to the First Grade Sanctions’ Committee for further examination of the case and the possible sanctions application. The CBs are obliged in a case-by- case basis and/or in combination, to carry out directly, regardless of any penalty imposed by the First Grade Sanctions’ Committee (article 10 of JMD 245090/06) the following actions: a) Refusal to issue certificate for products affected by the non-conformity.

67 DG(SANTE)2017-6055 Final Version date: February 2019 b) Suspension of the certificate and/or the licensing of a national trade mark and/or the EU organic logo and/or certificates. c) Withdrawal of the certificate and/or license of a national or/and the EU organic logo and/or certificates. d) Impose a suggestion to ELGO-DIMITRA to downgrade stage certification in fields, animals of the holding, which evaluates and submits the relevant file to the DRREVM for approval.

In each case, the control bodies shall inform immediately AGROCERT (currently under ELGO – DIMITRA) and not later than 5 days after the adoption of their decision, which assesses the relevant documentation and monitor their implementation.

2. When DRREVM and/or ELGO-DIMITRA have conducted controls to operators and non-conformities are found, then the follow up is relevant to the above.

All the relevant informations are posted at the site of Ministry of Rural Development and Food and especially at the electronic address http://www.minagric.gr/index.php/el/for- farmer-2/biologikgeorgiaktinotrofia.

According to the provisions laid down in JMD 205090, the main Competent Authority in charge of administering and supervision of the entire system is MRDF.

ELGO: Responsibilities with regard to supervision of CB’s as well as official controls of organic products placed on the market are transferred to ELGO. The operators are being controlled by private Control Bodies (CB’s), according to the article 5 of Reg (EC) 882/2004.

The transfer of responsibilities to ELGO Demeter is clearly laid down in JMD 205090. In addition, ELGO Demeter is involved in the assessment of applications and supporting documents for the following: approval of CBs and import of organic products requiring import authorisation. For these two, the final decision lies with the OFD by issuing a MD.

Official controls at operators are delegated to CBs which are to be approved.

Protected food names

Competent Authorities

The Directorate of Quality Systems, Organic Production and Geographical Indications (DQSOPGI) of the Ministry of Rural Development and Food (MRDF) is the central competent authority responsible for surveillance of the implementation of EU’s and national legislation, concerning the products of Protected Designation of Origin (PDO) and Protected Geographical Indications (PGI ) and Traditional Specialities Guaranteed (TSG) in Greece. These products are subject to special control system as described in Regulation No 1151/2012 and 261611 / 03.07.07 JMD (GG II / 406 / 3.22.07) as amended and applicable, and aims at the verification of compliance with the specifications of the products and the correct use of registered names, national and European symbols and indications.

68 DG(SANTE)2017-6055 Final Version date: February 2019 The geographical indications control scheme in Greece follows the article 4 § 3 of Reg (EC) 882/2004. The competence of carrying out controls has been conferred to the Greek Agricultural Organization “DEMETER” (ELGO DIMITRA) and PRDDs.

PRDDs participate with relevant personnel in controls performed by ELGO.

The transfer of responsibilities to ELGO DEMETER is clearly laid down in JMD 261611/2007. ELGO is involved in the assessment of applications and supporting documents submitted by operators, in order to be registered as approved (certified) operators. All operators using a certain protected name shall be registered in the Register of Approved Operators, kept by ELGO.

ELGO is involved in performing checks relating to the geographical indications scheme, that aim is: i) to verify compliance of a PDO or PGI product with a product specification before placing the product in the market. Checks are compulsory for approval (certification) of each operator (producer, packaging firms, firms producing private label products) and they are performed on the basis of risk assessment. Additionally, each operator is checked on the basis of risk assessment procedures. Controls are followed by a certification procedure, which leads to a relevant certificate’s issue. ii) to detect instances of disallowed use of a protected name, after the product has been placed to the market. These checks are performed on a regular basis. Moreover, checks are carried out in case of examination of denunciations.

If non conformities are detected in the above mentioned controls (both before and after the placement of the product on the market), measures have to be taken as corrective actions. If infringements occur, ELGO notify the MRDF, in order to decide on appropriate measures.

Control System

ELGO conducts regular or extraordinary inspections.

Regular checks are carried out based on the results of controls of the previous years, the case of relapse, the size of the enterprise and turnover of the company, the case of production of other products than PDO and PGI, etc.

Extraordinary inspections are carried out:  •based on relevant information received, or  based on the results of official controls of other control authorities.

Checks are carried out by a team of two (2) auditors which consists of an employee of ELGO and an employee of the Directorate of Rural Development of the relevant Regional Units, in companies engaged in production, processing, manufacturing and / or packaging products PDO / PGI.

When during the controls the auditors note non-conformities from the operator concerned, the implementation of corrective actions and other measures described in national legislation is applied. When the control is carried out and the auditors ascertain and record irregularities or infringements of existing EU’s and national legislation, they

69 DG(SANTE)2017-6055 Final Version date: February 2019 requests from the company the corrective actions in a certain period and imposes sanctions.

Checks are carried out with respect for the rights of controlled since the auditors inform them about control purposes.

DREVM:  Approve the applications of winemaking enterprises for inclusion in the 'Register “‘approved enterprises".  Checks the compliance of companies’ products with the product specifications of PDO PGI.  Carry out on the spot checks on compliance with specifications in primary production of grapes, wine production, bottling, labeling and handling trade.  Provide "PDO" and PGI certification.  Check at market level the presentation and labeling of PDO and PGI wines of Greece, other MS of EU and third countries.

RCPPQC:  Participate in the certification procedure (cooperation with DRREVM).

DPQCFPP  Coordinates, informs, supervises and monitors; / Departments of Rural Economy and Veterinary Medicine (DREVM) and the Regional Plant Protection and Quality Control Centers (RCPPQC) in terms of carrying out checks at all stages of production, bottling, labeling and distribution of the PDO and PGI wines.  Receives, monitors, evaluates, and publicly notifies the European Commission requests or registration appeals PDO, PGI wines and specifications modification requests already registered designations / indications or cancellation thereof.  Transmits the above supervisory authorities, complaints coming to it concerning the production and marketing of PDO and PGI products to carry out the necessary.

Certification procedure Listing of the producers in the register of approved establishments after competent authorities’ control.

CAs provide wine-GI certification to the producers whose product meet the specification of the relevant GI product.

Each operator wishing to participate in all or part of the production or packaging of a product with a protected designation of origin or geographical indication shall be notified to DREVM annually.

DPQCFPP in collaboration with DREVM perform the sampling of wine. The annual verification carried out by the competent control authority shall consist of an analytical testing for PGI wines. In case of PDO wines the annual verification carried out by the competent control authority shall consist of an analytical and organoleptic testing.

70 DG(SANTE)2017-6055 Final Version date: February 2019 DREVM provides PGI- PDO certification based on the results of:  analytical and organoleptic testing;  administrators checks;  on the spot checks.

For the labeling of PDO wines, DREVM provides quality control tapes and for the labeling of PGI wines DREVM provides a specific number.

71 DG(SANTE)2017-6055 Final Version date: February 2019 ANNEX I – STAFF RESOURCES

Number of Control Staff in Greece Summary Table

1 Ministry of Rural Development and Food Staff Comments (Directorate General of Veterinary Services)

DGVS Directorate General (CVO)

DAH Directorate of Animal Health 14

DVPH Directorate of Veterinary Public 14 Health

DAWVDVA Directorate of Animal Welfare, 12 Veterinary Drugs and Veterinary Applications

DVCA Directorate of Veterinary 52 Center of Athens

DVCT Directorate of Veterinary 46 Center of Thessaloniki

DiPCLT Planning and Coordination of Laboratory Testing Division

2 Ministry of Rural Development and Food Staff Comments (Directorate General of Agriculture)

DGSPP Directorate General (CVO)

DPQCFPP - Directorate of Processing and 11 (9 agronomists, 1 technical education, 1 DQSFPO Quality Control of Food of Plant administrative staff) Production – Department of Quality and Safety of Food of Plant Origin

DPQCFPP Directorate of Processing and 7 (6 agronomists, 1 technical education) Quality Control of Food of Plant DWS Production-

Department of Wines and Spirits  5 agricultural engineers DPPP Directorate of Plant Produce 5 (permanent servants), Protection  1 agricultural engineer on contract (temporary staff), Department of Phytosanitary  1 administrative staff on contract Control (temporary staff)

72 DG(SANTE)2017-6055 Final Version date: February 2019 DANFP Directorate of Animal Nutrition, 11 Feed and Pasturelands

Department of Control of Feed and DCFEH Establishments’ Hygiene, 4

Department of Feed Additives

DFA 3 

3 Ministry of Rural Development and Food Staff Comments (Directorate General of Sustainable Rural Development)

DGSRD Directorate General (CVO)

DQSOPGI Directorate of Quality Systems, Organic Production and Geographical Indications

4 Ministry of Rural Development and Food Staff Comments (Directorate of Audit)

DAAVFC Directorate of Agricultural, Animal, Veterinary and Fishery Controls

5 Ministry of Rural Development and Food Staff (Decentralised Services)

BIP Border Inspection Posts 15

DVL 11 Decentralised Veterinary 60 Laboratories

FCL Feedingstuffs Control Laboratories

FCL Athens 6

FCL Larissa 6

10

FCL Thessaloniki

73 DG(SANTE)2017-6055 Final Version date: February 2019 RCPPQPC 8 Regional Centres of Plant 66 (39 agronomists -18 inspectors for second Protection, Quality and level checks in both fresh fruits and Phtosanitary Control (quality vegetables and processed foods-, 8 inspectors, phytosanitary technical education, 19 administrative inspectors) staff) Phytosanitary inspectors are 64 in number* (according to the relevant MD) *Phytosanitary control is part of their duties

6a. EFET Hellenic Food Authority Staff

EFET Central Service 108

EFET 9 Regional Offices 149

8 Ministry of Finance Staff

GCSL General Laboratory staff* 110 ( *Chemists/Chemical engineers Chemical Chemists / State Chemical Laborato Engineers) ry Inspectors at import ** The inspectors have also other activities 115 points**

9 Ministry of Environment and Energy Staff involved in plant health

Directorate for the Protection of Forests and the 2 foresters Rural Environment (DPFRE) 2 Department of Forest Protection and Rural Security

10 Regional Unit level (not in all authorities)1 Staff

DREVM 61 Directorates of Rural Economy 480 vets and Veterinary Medicine 419 223 inspectors for regular checks in both fresh fruits and vegetables and processed foods (marketing standards and food safety

196 inspectors for regular checks in fresh fruits and vegetables only for a short period of time approximately 3 months per year during the peak of exports of certain fruits (peaches, oranges, watermelons etc)

(110 from the 419 abovementioned inspectors have also duties concerning PDO/PGI wine sector)

61 Feed 108 deputy feed inspectors (some with inspectors other duties as well)

74 DG(SANTE)2017-6055 Final Version date: February 2019 57 Inspectors for PDO/PGI/T SG 501 phytosanitary inspectors according to 501 the relevant JMD * *Phytosanitary control is part of their duties 11 Directorates of Forest of the Regional Units 224 224 Forest Plant Health inspectors /Forest services (local/decentralized according to the relevant JMD* administrations) *Phytosanitary control is part of their duties

75 DG(SANTE)2017-6055 Final Version date: February 2019 ANNEX II — ACRONYMS, ABBREVIATIONS AND SPECIAL TERMS

ACRONYM DESCRIPTION

ABP Animal By-Products

BM Brucella Melitensis

BIP Border Inspection Post

BPI Benaki Phytopathological Institute

BSE Bovine Spongiform Encephalopathy

CA Competent Authority

CBs Control Bodies

CLPH Central Laboratory of Public Health

CSF Classical Swine Fever

CVED Common veterinary entry document for products of animal origin and for live animals

DA Decentralised Administration

DAAVFC Directorate of Agricultural, Animal, Veterinary and Fishery Controls

DAH Directorate of Animal Health

DANFP Directorate of Animal Nutrition, Feed and Pasturelands

The Directorate of Animal Welfare, Veterinary Drugs and Veterinary DAWVDVA Applications

DGPH Directorate General of Public Health

Directorate General of Regional Rural Economy and Veterinary DGRREVM Medicine

DGA Directorate General of Agriculture

DG SANCO Directorate General for Health and Consumer Protection

Directorate General of Sustainable Animal Production and Veterinary DGVS Services

DGSRD Directorate General for Sustainable Rural Development

JMD Joint Ministerial Decision

76 DG(SANTE)2017-6055 Final Version date: February 2019 ACRONYM DESCRIPTION

DPPP Directorate of Plant Production Protection

Directorate of Processing and Quality Control of Food of Plant DPQCFPP Production

Directorate of Plant Genetic Resources and Propagating Material of DPGRPMCPS Cultivated Plant Species

DQSFPO Department of Quality and Safety of Food of Plant Origin

Directorate of Quality Systems, Organic Farming and Geographical DQSOFGI Indications

DVPH Directorate of Veterinary Public Health

Directorate of Veterinary Infrastructure and Animal Products DVIAPP Processing

DWS Department of Wines and Spirits

EFET Hellenic Food Authority

ELGO Hellenic Agricultural Organisation DIMITRA

EOF National Organisation for Medicines

ESET Scientific Control Council

ESPET National Food Control Policy Council

EU European Union

EURLs European Union Reference Laboratories

FBO Food Business Operator

FCM Food Contact Materials

FMD Foot and Mouth Disease

FNAO Food of non-animal origin

FSM Food Safety Management

FTE Full Time Equivalents

GCSL General Chemical State Laboratory

GFA General Follow-up Audit

77 DG(SANTE)2017-6055 Final Version date: February 2019 ACRONYM DESCRIPTION

GHPG Good Hygiene Practice Guide

GI’s Geographical Indications

GMO Genetically Modified Organism

GNAC Greek National Accreditation Council

HACCP Hazard analysis Critical Control Point

JMD Joint Ministerial Decree

KEELPNO Centre for Disease Prevention and Control

Centre of Control and Certification of Propagating Material and Control KEPPYEL of Fertilisers

LDCC Local Disease Control Centre

MANCP Multi-Annual National Control Plan

MD Ministerial Decision

MEE Ministry of Environment & Energy

MoF Ministry of Finance

MH Ministry of Health

MIAR Ministry of the Interior and Administrative Reconstruction

MRDF Ministry of Rural Development and Food

MRL Maximum Residue Limits

NAGREF National Agriculture Research Foundation

NDCC National Disease Control Centre

NRL National Reference Laboratory

PCR Polymerase Chain Reaction

PD Presidential Decree

PDO Protected Destination of Origin

PGI Protected Geographical Indication

PHD Health Directorates of the Prefectures

78 DG(SANTE)2017-6055 Final Version date: February 2019 ACRONYM DESCRIPTION

PPP Plant Protection Products

PPS Plant Protection Service

PRDDs Rural Development Directorates of the Regional Unit

PVDs Veterinary Directorates of the Regional Unit

PTD Trade Directorates of the Regional Unit

QMS Quality Management System

RAAC Regional Agriculture Advisory Centres

RASFF Rapid Alert System for Feed and Food

RCLs Routine control laboratories

RCPPQPC Regional Centres of Plant Protection, Quality & Phytosanitary Control

RUVS Regional Unit's Veterinary Service

DREVM Directorate of Rural Economy and Veterinary Medicine

RVL Regional Veterinary Laboratories

SA Single Authority

SRM Specified Risk Material

TCs Third Countries

TRACES Trade Control and Expert System introduced

TSE Transmissible Spongiform Encephalopathy

UKAS UK Accreditation Service

VFS Veterinary Field Stations

VMP Residues of veterinary medicinal products

SCC Supreme Chemical Council

79 DG(SANTE)2017-6055 Final Version date: February 2019