Ref. Ares(2016)5880917 - 12/10/2016
TABLE OF CONTENTS
INTRODUCTION ...... 3 SUMMARY OF THE PROGRESS MADE BY THE MEMBER STATE IN THE IMPLEMENTATION OF RECOMMENDATIONS MADE BY DG SANTE ...... 4 1. MAIN ISSUES ...... 5 2 FOLLOW UP STATUS OF RECOMMENDATIONS ...... 7 2.A HORIZONTAL RECOMMENDATIONS ...... 7 2. B SECTORAL RECOMMENDATIONS ...... 8 2. B.1 Animal Health...... 8 2. B.2 Food of animal origin ...... 15 2. B.3 Imports of animals and food of animal origin ...... 59 2. B.4 Feedingstuffs and animal nutrition ...... 65 2. B5 TSE and Animal By-Products (ABP) ...... 78 2. B.6 Veterinary medicinal products (VMP) and residues ...... 107 2 .B.7 Foodstuffs and food hygiene ...... 115 2. B.8 Imports of food of plant origin ...... 119 2. B.9 Plant protection products (PPP) and residues ...... 128 2. B.10 Animal welfare ...... 143 2. B.11 Plant health ...... 175 2. B.12 Quality labelling ...... 184 2. B.13 Overview of more recent audits ...... 187 ANNEX I – ACRONYMS, ABBREVIATIONS AND SPECIAL TERMS ...... 194
2 DG(SANTE) 2015-7657 Final Version date October 2016 INTRODUCTION The Directorate-General for Health and Food Safety of the European Commission, works to assure effective control systems and to evaluate compliance with EU standards. It does this mainly by carrying out audits in Member States and third countries. It makes recommendations to Member States to deal with any shortcomings revealed during its audits. Member States are requested to present action plans to the Directorate- General for Health and Food Safety on how they intend to address these shortcomings. Together with other Commission services, the Directorate-General for Health and Food Safety evaluates these action plans and systematically monitors their implementation through a number of follow-up activities. Verification of the completion and effectiveness of corrective action is an integral part of Directorate-General for Health and Food Safety activity. Article 45 (5) (a) of Regulation (EC) No 882/2004 requires that Member States take appropriate follow-up action in the light of recommendations resulting from EU controls. The instrument of general follow-up audits to review progress on the implementation of recommendations made was introduced in 2005. This process follows the Commission's "package meeting" approach whereby these audits provide an opportunity to discuss open issues with the competent national authorities. In the intervening period, Member States may provide additional information on progress and, following assessment by the Commission, this may result in an update of the follow-up status of recommendations. This part of the country profile gives the current status of actions undertaken by the Member State in response to recommendations. The aim is to provide a summary of progress by Greece on the implementation of the Directorate-General for Health and Food Safety recommendations. The information in this part of the country profile has been compiled on the basis of a general follow-up audit which was carried out by the Directorate-General for Health and Food Safety in Greece in December 2015 and on information received since then from the Greek authorities. The Directorate-General for Health and Food Safety regularly conducts general follow-up audits to the Member States to monitor progress in relation to the open recommendations. This part of the country profile will be updated at regular intervals based on the results of future audits and other relevant information received by the Commission from the Greek authorities.
3 DG(SANTE) 2015-7657 Final Version date October 2016 SUMMARY OF THE PROGRESS MADE BY THE MEMBER STATE IN THE IMPLEMENTATION OF RECOMMENDATIONS MADE BY DG SANTE The following table gives an overview of the Directorate-General for Health and Food Safety audits to Greece and shows the Commission's assessment of actions taken in response to these recommendations. This assessment is based on information and documentation received and reviewed during meetings with the Central Competent Authorities in the course of the 2015 general follow- up audit and on any subsequent information provided by Greece. The basis for the assessment of actions in relation to the individual recommendations is presented in a separate chapter for each control system. Overview of DG SANTE audits to Greece 2007-2014
Total Recommendations Closed number of Action Control system Action for In finalised Total still taken other progress audits required reasons Animal Health 3 16 8 1 5 2
Food of animal 10 106 62 34 8 2 origin
Imports of 8 71 38 31 1 1 animals and food of animal origin
Feedingstuffs and 1 13 11 1 1 0 animal nutrition
TSE/ABP 5 54 12 35 5 1
Veterinary 3 24 13 8 0 0 medicinal products and Residues
Foodstuffs and 3 20 18 1 1 0 Food hygiene
Imports of food of 3 24 16 4 3 1 plant origin
Plant Protection 3 31 11 17 3 0 Products (PPP) and residues
Animal welfare 5 29 10 6 6 7
Plant health 4 39 21 17 0 1
Quality labelling 1 4 2 0 1 1
Total 49 431 222 155 35 16
4 DG(SANTE) 2015-7657 Final Version date October 2016 1. MAIN ISSUES The main issues that have been identified in Greece through audits and that the Competent Authorities still have to address include: Horizontal issues
This document contains several recommendations which refer to horizontal provisions of Regulation (EC) NO 882/2004. However, all issues were followed-up through sector specific audit recommendations including the issue of control resources: In its judgment of 23 April 2009 in case C-331/07, the European Court of Justice declared that, by not having adopted all the measures necessary to remedy the shortage of staff assigned to the services responsible for veterinary controls in Greece, Greece has failed to fulfil its obligations under Article 4(2)(c) of Regulation (EC) No 882/2004 on official controls performed to ensure the verification of compliance with feed and food law, animal health and animal welfare rules. Recommendations 2007-7431-2 and 2007-7244-1, regarding this issue, are classified as 'action still required'. Sector specific issues
Animal Health
Greece can still not provide sufficient guarantees that conditions and procedures for achieving and maintaining the health status of bovine and ovine/caprine herds are performed in accordance with Council Directives 64/432/EEC and 91/68/EEC (recommendation 2008-7793-2) It is not ensured that all eligible herds and animals are tested for Brucellosis at the due intervals. The amount of herds and animals excluded from the Brucellosis Eradication Programme, without any on-the spot verification, compromises the reliability of the data used for planning, monitoring and evaluation of the effectiveness of the Programme measures (recommendation 2008-7793-3). Regarding the ovine and caprine brucellosis eradication programmes the Greek authorities had not taken to demonstrate the efficacy of the vaccination programme (recommendation 2008-7793-4).
Food of animal origin
The Greek authorities did not provide evidence that specific measures had been taken in order to ensure that FBO perform shelf-life studies for their products and that this issue is covered by the controls (recommendation 2013-6884-6).
Imports of animals and food of animal origin
No procedures on the verification of the effectiveness of official controls of TRACES users at regional/local level is in place (recommendation 2013-6895-2).
TSE and Animal By-Products
Greece does not comply with the monitoring targets set out in Chapter A, II (2) and (3) of Annex III to Regulation (EC) No 999/2001 (recommendation 2008-7735-3). On 9/6/2008, the Commission referred EL to the ECJ (case C-248/08) for failure to
5 DG(SANTE) 2015-7657 Final Version date October 2016 ensure compliance with Reg. 1774/2002 (infringements 2001/5217 and 2006/2221). In the context of the 2015 GFA the Greek authorities presented the measures put in place or planned to be taken as described in the action plan presented to the Commission in 2015.
Imports of food of plant origin
It is not ensured that training needs of inspectors are addressed within an appropriate period of time. The training needs identified by the CCA in 2013 were not addressed through appropriate training of inspectors (recommendation 2012-6275-1).
Animal welfare
Audits identified several non-compliances with EU animal welfare rules which are classified as "Action still required/Outstanding". The Commission has initiated specific follow-up measures in the case of this recommendation. This recommendation was not followed-up during the 2015 GFA (2007-7244-10). In its judgment of 10 September 2009 in case C-416/07, the European Court of Justice declared that Greece had failed to fulfil its obligations under the relevant provisions of the EU legislation on the protection of animals during transport and at the time of killing, by failing to take the measures necessary: to ensure that the competent authorities carry out obligatory checks of route plans; to provide for facilities in or in the immediate vicinity of ferry ports to enable animals to rest after unloading; to ensure that the inspections of the means of transport and the animals are actually carried out; to ensure that the rules on the stunning of animals at the time of slaughter are complied with; and to ensure that inspections and controls in slaughterhouses are carried out in an appropriate manner. CCA has not ensured that inspections have been carried out as required by Article 7 of Directive 91/630/EEC regarding laying hens (2007-7244-12). The Greek authorities have not taken measures to ensure that the information concerning the results of farm inspections collected and reported by all local CAs is accurate (2009-8243-4). Greece has not taken the necessary action to provide for facilities in or in the immediate vicinity of the two main ferry ports of Igoumenitsa and Patras to enable animals to rest after unloading if required (2011-6212-3). The Greek authorities have not taken appropriate measures to ensure that physical checks of animals at farm level and of transporters/at transporter premises are carried out (2011-6212-4).
Plant Health
No systematic and grid based survey is carried out for Gonipterus s. and Gilpina h.
6 DG(SANTE) 2015-7657 Final Version date October 2016 2 FOLLOW UP STATUS OF RECOMMENDATIONS This part of the country profile gives the current status of actions undertaken in response to DG Health and Food Safety's recommendations. The aim is to provide a summary of progress by Greece on the implementation of the recommendations.
For the purpose of assessment, the terms: "Action taken," "In progress", "Closed for other reasons" and "Action still required" are defined as follows:
"Action taken": Appropriate measures to address the recommendation have been implemented by the Competent Authority. The recommendation is therefore closed.
"In progress": Appropriate measures to address the recommendation have been initiated by the Competent Authority but not all of the measures have been implemented. The recommendation therefore remains open.
"Closed for other reasons": For administrative, technical or legal reasons, follow-up of the recommendation is no longer appropriate. The recommendation is therefore closed.
"Action still required": Appropriate measures to address the recommendation have not been initiated by the Competent Authorities. The recommendation therefore remains open.
Given the nature and scope of the general follow-up audit, no verification through audit on-the-spot was carried out. The assessment undertaken through the general follow-up audit is considered complementary to other follow-up actions and verifications that may be necessary and carried out as part of future sectoral audits by our services. Recommendations classified as “In progress" or "Action still required" are not considered to require any immediate specific legal or administrative action on the part of Commission services. These recommendations will remain the subject of monitoring by Commission services to assess progress. If as a result of this monitoring Commission services consider the situation in regard to any of these recommendations warrants additional action on its part, it will take the appropriate measures.
It should be noted that the number of recommendations in this overview does not represent, of itself, a measurement of the degree of responsiveness by the Competent Authorities or of the seriousness of problems. Some recommendations may be related to minor technical aspects while others may refer to more problematic, systemic, issues.
Acronyms are used throughout the following chapters for the sake of brevity. A list of acronyms, abbreviations and special terms is given in Annex I as a guide for the reader
7 DG(SANTE) 2015-7657 Final Version date October 2016
2.A HORIZONTAL RECOMMENDATIONS This document contains several recommendations which refer to horizontal provision of Regulation (EC) NO 882/2004. However, all issues are being followed-up through sector specific audit recommendations as described in the following chapters.
7 DG(SANTE) 2015-7657 Final Version date October 2016 2. B SECTORAL RECOMMENDATIONS
2. B.1 Animal Health
Inspection 2006/ 8193 of 7 October 2008 on ovine and caprine identification
Reference no. and recommendation Basis of assessment Assessment
2006-8193 This recommendation is based on findings and associated conclusion in Section 5.1.2 of the audit report Action taken that Article 13 of Law 2538/1997 (see point 5.2) gave the PVS the power to propose sanctions in (27259) veterinary matters, including animal identification, holding registration and movement controls. To ensure that measures are in place in However, the final decision was taken by the prefect. In the 3 prefectures visited, proposals by the PVS order to impose sanctions in case of non- for sanctions were seen, but the prefect had not signed the decisions. compliances in accordance with Article Situation after the 2010 GFA 8(3) b of Regulation (EC) No. 882/2004 The CA stated that eleven sanctions had been proposed in the first half of 2008, of which ten were actually imposed. The procedure for ovine and caprine follows the model for bovines. The relevant data is contained in a database. The CA added that a working group comprising representatives of all services affected by the requirements of Regulation (EC) No 882/2004 was set up to develop criteria and procedures for the imposition of sanctions across a wide range of sectors. The group presented their proposals to the hierarchy in November 2010 and the next step is its legal implementation. At the time of the 2010 GFA, no feedback had been received from the hierarchy and no deadline had been set for the implementation of the proposals. The working group has been disbanded. The Greek authorities provided the following updated information in the context of the 2015 GFA: Audit report DG(SANTE) 2015-7571 states that 'reports for 2012 and 2013 indicate that non- compliances were detected at 11% of holdings each year. Penalties were imposed on 14% and 3% of holdings with non-compliances in 2012 and 2013, respectively'.
8 DG(SANTE) 2015-7657 Final Version date October 2016 Inspection 2007-7369 of 22 April 2007 in order to evaluate the control system put in place for bluetongue
Reference no. and recommendation Basis of assessment Assessment
This recommendation is based on findings in sections 5.2 and 5.5 of the audit report, and on the 2007-7369-5 In progress associated conclusion in Section 6.2, that there is defective coordination between the different levels of To ensure efficient and effective authority on the implementation of the programmes, and that this (amongst other issues), represents an coordination between the CCA and all impediment to an effective delivery in the field of the policy defined at the central level. RCAs, as required by Article 4 (3) of Information from 2010 GFA: Regulation (EC) No 882/2004, and that official controls are carried out by a During the 2010 general follow-up audit process, the CA stated that the last training seminar was held in sufficient number of suitably qualified December 2009 and was addressed to all personnel involved in BT surveillance in high risk areas (East and experienced staff, as required by Aegean Islands, etc.). No training took place in 2010 Article 4 (2) (c) of Regulation (EC) No A comprehensive programme for on-the-spot visits/training seminars (representatives from the CCA) to 882/2004. the prefectures involved in active BT surveillance is being drawn up and implementation is expected in 2011. The Greek authorities provided the following updated information in the context of the 2015 GFA: regarding the plan for a comprehensive programme of on-the-spot visits/training seminars in 2011, the CCA stated that it had proved impossible to carry out visits or training in the high-risk areas due to the lack of staff and because all available resources were focussed on dealing with disease outbreaks. Regarding coordination, a large number of circulars had been issued by the CCA, together with guidance and instruction documents. The CCA provided a list of actions taken in the course of managing Bluetongue from 2011 to 2015: 1) Issuing of a Manual with guidance for the implementation of the surveillance program on BT; 2) Circulars for the implementation of control measures; 3) Annual publication of Ministerial Decision for the implementation of the surveillance program on BT; 4) Serological investigation in the country’s ruminants in order to determine the percentage of seropositive animals - results available from Athens Reference Laboratory; 5) Establishment of a working group on defining national measures for the control the BT;
9 DG(SANTE) 2015-7657 Final Version date October 2016 Inspection 2007-7369 of 22 April 2007 in order to evaluate the control system put in place for bluetongue
Reference no. and recommendation Basis of assessment Assessment
6) Instructions for the implementation of the vaccination program against BT; 7) In cooperation with the Directorate of Informatics a digital application has been designed in order for available vaccine doses to be recorded; 8) Instructions for registration of vaccines. Documentation in relation to these actions is available on the Ministry’s website and copies of the relevant documents were given to the GFA team. In relation to staff shortages, the CCA stated that resources to deal with Animal Health/Diseases were insufficient at both central and regional levels. At central level the Department responsible at the Ministry is the newly-created (2015) Department of Infectious and Parasitic Diseases in the Animal Health Directorate. The Department, like its predecessor Departments, suffers from a serious lack of veterinary and auxiliary personnel. Plans to recruit 7 veterinarians were shelved because of the recruitment embargo introduced following the crisis in Greece in 2010. An additional veterinarian was appointed in November 2015 (bringing the total staff of the Department to 3 veterinarians and one person dealing with administrative issues) and it is hoped to recruit another two veterinarians for the Department by the end of 2016. Regarding veterinary staff employed in the Greek regions, the CCA estimates that 150 official veterinarians are required, for all purposes, based on immediate needs. Specifically in the area of Animal Health/Disease Prevention, the CCA proposes the recruitment of 10 veterinarians (not included in the 150 mentioned above) to man a special task force whose aim would be to prevent animal disease coming into Europe from countries to the East. These 10 staff would be stationed in the Evros region but would be on the Ministry’s payroll. Private veterinarians are also used during disease outbreaks. Regarding ‘Farm Veterinarians’, the CCA envisages that Farm Veterinarians will assist with animal diseases in the future, probably from sometime in 2016, when it is hoped that certain legal issues related to contracts will be solved. The CCA stated that 440 people have registered for work as Farm veterinarians and that a Working Group is currently amending the legal aspects of the recruitment procedure. Recommendation 2008-7793-1 is being followed-up through this recommendation.
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Inspection 2008-7793 of 19 May 2008 in order to evaluate the operation of bovine tuberculosis and brucellosis and the ovine and caprine brucellosis eradication programmes
Reference no. and recommendation Basis of assessment Assessment
2008-7793-1 Situation after the 2010 GFA Closed for other reasons To provide sufficient resources, staff, On 1 March 2011, the CAs provided information regarding the recruitment of temporary staff equipment and adequate training to (veterinarians, animal production technicians, PC operators, workers) that will assist in the implement the eradication programmes in implementation of the Brucellosis programme in small ruminants. A total of 190 temporary posts (8- order to guarantee that official controls are month contracts) were to be allocated throughout the country. On 15 March 2011 progress was reported: performed competently and in a consistent The CAs, in their comments on the draft country profile (GFA 2010), indicated that manner and that procedure are in place to verify the effectiveness of the control • A total of 190 temporary staff for B. Melitensis programme was recruited, allocated to all the regions of carried out, as required by Regulation (EC) the Country working exclusively for the 2011 control and eradication programme. No 882/2004. • Following the additional requirements foreseen by circular letter (132719/08.03.2011), monthly supervision and monitoring of the B. Melitensis programme is well established and understood and also the reporting procedure. Raw records from Regional Veterinary authorities are available on a monthly basis for evaluating the progress and the effectiveness of the 2011 programme at central level. A "Specific Committee", acting as scientific advisor for the proper implementation of control and eradication programmes, as foreseen by the national legislation was re- activated and is fully operational (three meetings within 2011). Several meetings were organized by the Central Authority and the "Specific Committee" with the Regional veterinary Directors to encourage, train and emphasize the urgent need for the rapid implementation of the B. Melitensis programme at national level. For more information on verification, see chapter 1 of the country profile document "the organisation of food safety, animal health, animal welfare and plant health control systems". Audit report DG(SANTE) 2015-7571 states that this recommendation has only partly been addressed as the ' the instrument of using farm veterinarians had not been effective '. This issue is being followed-up through recommendation 2007-7369-5 in relation to the new system of farm veterinarians.
11 DG(SANTE) 2015-7657 Final Version date October 2016 Inspection 2008-7793 of 19 May 2008 in order to evaluate the operation of bovine tuberculosis and brucellosis and the ovine and caprine brucellosis eradication programmes
Reference no. and recommendation Basis of assessment Assessment
2008-7793-2 Decision no. 258963/20.08.08 provided an amendment to the first indent of Article 25 "Conditions for the Action still classification of ovine-caprine holdings in respect of brucellosis" of Ministerial Decision required To guarantee that conditions and 258735/17.07.2007 (B1220) by which animals over six months of age must be tested and show negative procedures for achieving and maintaining results. The words "a representative sample" were deleted. the health status of bovine and ovi/caprine herds are performed in accordance with The limited action taken to date by the CA cannot be considered sufficient to adequately address this Council Directives 64/432/EEC and recommendation. 91/68/EEC The CAs in their comments on the draft country profile indicated that frequent reminders, circulars, daily phone calls, communication and meetings as mentioned in recommendation 2008-7793-1 took place in order to intensify the proper implementation of the programme. Audit report DG(SANTE) 2015-7571 states the following: 'In the eradication zone, the criteria for granting a B. melitensis officially free (BMOF) status established in the Article 11 of the Ministerial Decision Ref. 4888/130873, are in compliance with Annex A, Chapter 1(I)(A) of Council Directive 91/68/EC, but the CCA does not follow them. Instead, they decided that as a "first test", representative sample (minimum 25% and minimum 50 animals) is taken in order to upgrade an “unknown herd status” to a “brucellosis free”. After this "first test", all animals over six months of age are tested, in order to classify the herd as BMOF. This amended and applied testing scheme is not in line with Annex A, Chapter 1(I)(A) of Council Directive 91/68/EC.'
2008-7793-3 The CA has sent Circular 258949 of 12/08/2008 to all Prefectural Veterinary Directorates, containing In progress some generic indications on implementation of the eradication programmes. To take action in order to guarantee that all eligible herds and animals are tested at the The limited action taken to date by the CA cannot be considered sufficient to adequately address this due intervals and that the official controls recommendation. are properly documented so that data The CAs, in their comments on the draft country profile, indicated that frequent reminders, circulars, provided about prevalence and incidence daily phone calls, communication and meetings as mentioned in recommendation 2008-7793-1 took place will be reliable. in order to intensify the proper implementation of the programme. Audit report DG(SANTE) 2015-7571 states the following: 'The amount of herds and animals excluded from the Programme, without any on-the spot verification,
12 DG(SANTE) 2015-7657 Final Version date October 2016 Inspection 2008-7793 of 19 May 2008 in order to evaluate the operation of bovine tuberculosis and brucellosis and the ovine and caprine brucellosis eradication programmes
Reference no. and recommendation Basis of assessment Assessment compromise seriously the reliability of the data used for planning, monitoring and evaluation of the effectiveness of the Programme measures.' To address the problem of inactive/idle holdings, the CCA has given clear instructions to the regional competent authorities (No 621/51809/17.04.2014), indicating, among other things, the procedure to be followed in a uniform manner, including on-the-spot and administrative checks.
2008-7793-4 The CA initially indicated that Circular no. 258949 of 12/08/08, addressed to all Prefectural Veterinary Action still Directorates, reminded them that according to Annex V to Circular 363134/17-11-1998, a sample of 15% required To carry out studies on the efficacy of of the flocks that were vaccinated had to be randomly selected. Of these flocks selected, a random sample vaccination in order to assess the level of of 25% of vaccinated animals should be tested and the results sent to the competent veterinary protection in the ovine population and laboratory". reconsider the importance of testing all males to disclose all possibly infected The CA subsequently confirmed that due to problems in the implementation of these programmes as well herds, as prescribed in the Ovine caprine as personnel shortages in the Veterinary Laboratories, the efficacy of the vaccination programme is only Brucellosis Eradication Programme. tested in a small percentage of the vaccinated small ruminant herds. The CAs in their comments on the draft country profile indicated that given the current situation and the available national resources, the additional contribution of the 190 temporary staff for running the 2011 programme for Brucella Melitensis has led to an increase of the percentage of the tested vaccinated small ruminant flocks based on monthly data records submitted by the competent regional authorities. Audit report DG(SANTE) 2015-7571 states the following: 'The CCA recommends testing of 25% of the vaccinated female animals three to four weeks after vaccination, in order to check the development of the immunity and as an indirect method of control of the work of PVs. This tool however, is not widely used. In 2014, 561 female animals were checked three to four weeks post vaccination. In 2015 (by September) 166 vaccinated females were tested. During the audit the CCA was not able to indicate from how many holdings tested female animals did come nor how these holdings and animals had been selected for testing. Satisfactory level of protective antibodies was found in around 90% of tested animals.'
13 DG(SANTE) 2015-7657 Final Version date October 2016 Inspection 2008-7793 of 19 May 2008 in order to evaluate the operation of bovine tuberculosis and brucellosis and the ovine and caprine brucellosis eradication programmes
Reference no. and recommendation Basis of assessment Assessment
2008-7793-5 The CAs, in their comments on the draft country profile (GFA 2015), indicated that: Action taken To improve the coordination between the • An electronic system for data management on animal health related to control and eradication DZ, the PVDs and the LVS, as required by programmes had been developed at national level Article 4.3 of Regulation (EC) No. • Circular no 132703/ 24.02.2011 had been addressed to four local veterinary authorities for the system to 882/2004, by establishing a reliable system be tested , operated and evaluated for a transition period in order to correct possible technical problems. for generating, transmitting and analyzing the data about the implementation of the The extension of the application to national level would be decided in 2012 when the results of the pilot programmes so they can be usefully used exercise become available. to assess the impact of the measures and to Audit report DG(SANTE) 2015-7571 states that appropriate action were taken in order to address this set targets for future programmes that recommendation. should be realistic, achievable and proportionate to the available resources.
2008-7793-6 Brucellosis NRL: The CA confirmed that accreditation of the laboratory, as well as the approved lab tests Action taken (Rose Bengal-Complement fixation), was In progress. Completion expected during 2011. To guarantee that the Brucellosis NRL will start the accreditation procedures, as The laboratory is performing the G-interferon diagnostic test since 2010. required by Article 18 of Commission TB NRL: The tendering procedure for the necessary equipment of the NRL has been finalised (a copy of Regulation (EC) official documentation was provided). Once the relevant contract is signed, it is planned that the No. 2076/2005 and that the TB NRL will equipment will be provided within 2 months. The laboratory is prepared to be fully operational and the be equipped in order to start the activities basic material and sampling equipment have been purchased. The laboratory has participated in the foreseen by Annex B, paragraph 4 of national tendering process for acquiring the necessary materials and reagents for performing the tests for Council Directive 64/432/EEC TB diagnosis. The laboratory has an open line communication for information exchange and collaboration with the EURL and Tuberculin products used for the TB eradication program have been sent to them in order to perform potency control test for Tuberculin. Training sessions will be organised with the EURL. The CAs, in their comments on the draft country profile, indicated that: • The TB laboratory is performing the G-interferon diagnostic test since 2010. Based on the relevant
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Reference no. and recommendation Basis of assessment Assessment contract the appropriate equipment has been provided and the laboratory is equipped and operational. • The head of the TB laboratory has completed a training session at the Community Reference Lab (EURL) in Madrid on 11-15 April 2011. Communication, information exchange and collaboration with the EURL is ongoing. The audit report DG(SANTE) 2015-7571 states that appropriate action were taken in order to address this recommendation.
2. B.2 Food of animal origin
Inspection 2007-7431 of 17 June 2007 in order to evaluate the follow-up of actions taken by the Competent Authority with regards to official controls related to the safety of food of animal origin, in particular meat, milk and their products.
Reference no. and recommendation Basis of assessment Assessment
2007-7431-2 The Commission has initiated specific follow-up measures in the case of this recommendation. Action still required To improve the staffing situation at all The Greek authorities provided the following updated information in the context of the 2015 GFA: levels as a matter of urgency in order to The CCA stated that between 2011 and 2015 the veterinary services faced a staff reduction of nearly 50% provide the necessary resources for since 2008 (38% reduction since the previous GFA in 2010). establishing a system of official controls in line with the provisions of Article 4(2)(c) The MRDF carried out an assessment of needs in 2014 which concluded that the control resources of the of Regulation (EC) No 882/2004. veterinary services were not sufficient to perform controls in compliance with planned arrangements. The report concludes that a 56% increase of staff would be required. During the GFA the CCA stated that an
update of this assessment of needs is underway.
15 DG(SANTE) 2015-7657 Final Version date October 2016 Inspection 2007-7431 of 17 June 2007 in order to evaluate the follow-up of actions taken by the Competent Authority with regards to official controls related to the safety of food of animal origin, in particular meat, milk and their products.
Reference no. and recommendation Basis of assessment Assessment Throughout the GFA the CAs argued that weaknesses in the control system very often have their root- causes in staff shortage, in particular as regards not meeting the established inspection targets. Meat inspections at slaughter houses are 60% below set target. The number of controls on food of animal origin by the veterinary services decreased between 2012 and 2014 by more than 50%. The GFA team noted that the CAs had put in place or had considered measures in order to mitigate problems related to staff shortage including efforts made to reduce overlaps between the controls of the veterinary services and Efet through cooperation agreements (4 Regions have MoUs in place).
2007-7431-3 This recommendation is based on findings and associated conclusion in the audit report that the Closed for other legislative framework does not provide for a clear and uniform allocation of responsibilities between the reasons To clarify the allocation of responsibilities 2 CCAs resulting in some overlap. Limited coordination and cooperation between central and regional at central and regional level in order to level was noted. provide a necessary basis for effective and efficient coordination and cooperation as Situation after the 2010 GFA: required by Article 4(3) and (5) of For more information on co-ordination and co-operation, see chapter 1 of the country profile document Regulation (EC) No 882/2004. "the organisation of food safety, animal health, animal welfare and plant health control systems".
Overtaken by recommendation 2013-6884-7 2007-7431-4 This recommendation is based on findings and associated conclusion in Section 7.1 of the audit report Action taken that legislation providing for a control system based on risk based frequencies has been adopted. To ensure that in all PVDs and RDs the However, it has not been implemented yet and as regards the DGVS is awaiting the circulation of risk official controls are carried out regularly, based criteria on a risk basis and with appropriate frequency, taking account of the criteria The DG SANTE audit 2012-6334 noted that a countrywide system is in place providing for the laid down in Article 3 (1)of Regulation supervision and auditing of the establishments on a risk-based frequency. This was also confirmed by (EC) No 882/2004. The system for risk categorisation of establishments described in the report following the audit the audit 2012-6334 applies also for the establishing the frequency of inspection in dairy establishments and collection centres.
16 DG(SANTE) 2015-7657 Final Version date October 2016 Inspection 2007-7431 of 17 June 2007 in order to evaluate the follow-up of actions taken by the Competent Authority with regards to official controls related to the safety of food of animal origin, in particular meat, milk and their products.
Reference no. and recommendation Basis of assessment Assessment
2007-7431-6 Overtaken by recommendations 2009-8237-2 and 3. Closed for other reasons To improve the official controls at establishment level in order to assure FBOs’ compliance with the general and specific hygiene requirements of Regulations (EC) No 852/2004 and 853/2004.
2007-7431-8 This recommendation is based on findings and associated conclusion in Section 5.4.4 of the audit report Action taken that In the PVDs visited, insufficient follow-up was provided by the OVs to check the corrective actions To ensure that in all PVDs and RDs, the in case of non-compliance as several shortcomings noted had still not been rectified despite previous follow-up and the actions taken in case of detection. breaches of the legislation are sufficient to ensure that the FBO remedies the situation, Situation after the 2010 GFA as required by Article 54 of Regulation In the CA's circulars for carrying out official controls, special reference is made on how to approach (EC) No 882/2004. infringements. Particular emphasis is given to the classification of non-conformances according to their seriousness and the need for sanctions (administrative, penal). Finally, Circular Nos. 5118/13-04-2010 and 5146/14-04-2010 provide clarifications on how to impose administrative fines. This is a result of a
request made by the prefectures during the joint meetings. The CA added that a working group comprising representatives of all services affected by the requirements of Regulation (EC) No 882/2004 was set up to develop criteria and procedures for the imposition of sanctions across a wide range of sectors. The group presented their proposals to the hierarchy in November 2010 and the next step is its legal implementation. At the time of the 2010 GFA, no feedback had 8840 been received from the hierarchy and no deadline had been set for the implementation of the proposals. The working group has been disbanded. The Greek authorities provided the following updated information in the context of the 2015 GFA: EFET stated that significant progress has been made regarding enforcement, although enforcement measures may make still be taken with some delay. The GFA team saw examples of follow-up which in 17 DG(SANTE) 2015-7657 Final Version date October 2016 Inspection 2007-7431 of 17 June 2007 in order to evaluate the follow-up of actions taken by the Competent Authority with regards to official controls related to the safety of food of animal origin, in particular meat, milk and their products.
Reference no. and recommendation Basis of assessment Assessment case of repeated offence triggered sanctions. MRDF stated that the new sanction system also had in impact on the enforcement situation (see recommendation 2011-8840-10).
2007-7431-10 Overtaken by recommendation 2009-8237-4 Closed for other reasons To review the approvals of all the food establishments in compliance with Regulation (EC) No 853/2004. 2007-7431-11 Overtaken by recommendation 2009-8237-6 Closed for other reasons To ensure that in all the PVDs the post- mortem examination in slaughterhouses complies with Article 5, (1) (d) and Annex I, Section IV, Chapters I, II and IV of Regulation (EC) No 854/2004. 2007-7431-12 Overtaken by recommendation 2009-8237-7 Closed for other To ensure that Trichinella testing is carried reasons out in compliance with the requirements of
Regulation (EC) No 2075/2005. 2007-7431-13 Overtaken by recommendation 2009-8237-5 Closed for other reasons To ensure that a fully readable health mark is only applied to carcasses for which official controls have not identified any deficiencies that would make the meat unfit for human consumption, in line with the provisions of Art. 5 (2) and Annex I, Section I, Chapter III of Regulation (EC) No 854/2004.
18 DG(SANTE) 2015-7657 Final Version date October 2016 Inspection 2007-7431 of 17 June 2007 in order to evaluate the follow-up of actions taken by the Competent Authority with regards to official controls related to the safety of food of animal origin, in particular meat, milk and their products.
Reference no. and recommendation Basis of assessment Assessment
2007-7431-14 Overtaken by recommendation 2009-8237-3 Closed for other reasons To ensure that the official controls of raw milk are carried out in line with the provisions of Article 8 of Regulation (EC) No 854/2004.
Inspection 2009-8237 of 21 June 2009 in order to evaluate the follow-up action taken by the Competent Authorities with regard to official controls related to the safety of food of animal origin, in particular meat, milk and their products
Reference no. and recommendation Basis of assessment Assessment
2009-8237-2 Overtaken by recommendation 2012-6334-2 Closed for other reasons To improve the official controls at establishment level in order to ensure that deficiencies related to general hygiene requirements as laid down in Annex II of Regulation (EC) No 852/2004, in particular in red meat establishments are identified and addressed. 2009-8237-3 Overtaken by recommendations 2012-6334-3 and 2012-6884-3 Closed for other reasons To ensure that deficiencies relating to specific hygiene requirements as laid down in Annexes II and III of Regulation (EC) No 853/2004 are identified and addressed, in particular with regard to raw milk criteria and operations in red meat establishments.
19 DG(SANTE) 2015-7657 Final Version date October 2016 Inspection 2009-8237 of 21 June 2009 in order to evaluate the follow-up action taken by the Competent Authorities with regard to official controls related to the safety of food of animal origin, in particular meat, milk and their products
Reference no. and recommendation Basis of assessment Assessment
2009-8237-4 This issue was followed up by audit 2012-6334 and 2013-6884 which both found that establishments Action taken were in general approved. However, audit 2013-6884 found that collection points and small collection To ensure urgently that products of animal centres were neither registered nor approved and some shortcomings with regards to the approval status origin can only be placed on the market if were recorded. This is being followed-up through audit 2013-6884. they have been prepared and handled exclusively in establishments meeting the requirements of Regulations (EC) No 852/2004 and No 853/2004 and that been approved by the CA as required by Article 4 of Regulation (EC) No 853/2004. 2009-8237-6 Overtaken by recommendation 2012-6334-7 (which has been closed for "Action taken") Closed for other To ensure that in all the PVDs the ante and reasons post-mortem examination in slaughterhouses complies with Article 5, (1) (d) and Annex I, Section IV, Chapters I, II and IV of Regulation (EC) No 854/2004 and their registration is consistent and documents required to be kept on the spot are available as is required in Article 4, Point 1 of Regulation (EC) No854/2004.
2009-8237-8 Overtaken by recommendation 2012-6334-4 (which has been closed for "Action taken") Closed for other reasons To ensure that FBOs shall put in place, implement and maintain a procedure or procedures based on the HACCP principles as is required by Article 5, of Regulation (EC) No852/2004.
20 DG(SANTE) 2015-7657 Final Version date October 2016 Inspection 2009-8237 of 21 June 2009 in order to evaluate the follow-up action taken by the Competent Authorities with regard to official controls related to the safety of food of animal origin, in particular meat, milk and their products
Reference no. and recommendation Basis of assessment Assessment
2009-8237-9 Overtaken by recommendation 2012-6334-4 (which has been closed for "Action taken") Closed for other reasons To ensure that official controls in respect of all products of animal origin in the scope of Regulation (EC) No 854/2004 shall include audits of HACCP-based procedures in line with Article 4(5) of Regulation (EC) No 854/2004.
2009-8237-10 Overtaken by recommendation 2013-6884-2 Closed for other reasons To ensure that the criteria for raw milk and colostrum are met as required in Annex III, Section IX, Chapter I, Point 3 (a) and (b) of Regulation (EC) No 853/2004 and the CA take appropriate action as required in Annex IV, Chapter II, Point 1 and 2 of Regulation (EC) No 854/2004.
Inspection 2011-8840 of 20 February 2011 in order to evaluate the food safety control systems in place governing the production and placing on the market of poultry meat and poultry meat products
Reference no. and recommendation Basis of assessment Assessment
2011-8840-4 This recommendation is based on findings and associated findings in Section 5.3.1 of the audit report. Action taken The frequency of official controls was set at 10% of all broiler farms per year. The audit team was The CA should ensure that official controls informed in one region that the selection of farms is based on production data (e.g. high mortality) are carried out using a risk based approach however no evidence of formally approved selection criteria could be provided. Additionally in another (including those at farm level) and that region visited it was stated that no specific criteria are taken into account to select the farms. frequency based on the risk assessment is respected. (Article 3 (1), Chapter I, Title II 21 DG(SANTE) 2015-7657 Final Version date October 2016 Inspection 2011-8840 of 20 February 2011 in order to evaluate the food safety control systems in place governing the production and placing on the market of poultry meat and poultry meat products
Reference no. and recommendation Basis of assessment Assessment of Regulation (EC) No 882/2004). The initial response of the Greek authorities stated the following: MRDF - Our Department has sent Circular No 322851/11-9-2007 to Veterinary Services nationwide so that official controls can be carried out using a hazard-based approach. This circular was notified to you during the audit. EFET - Evaluation of the 2010 annual data clearly shows that the frequency at which establishments handling food of animal origin meets the hazard analysis requirements. As part of its annual action plan for 2011 (ref. No 2519/11-02-2011) EFET has made specific comments about the need to adjust hazard analysis at local level, and the official food safety and quality inspection plans (sampling and analysis) prepared by the expert working group based on the hazard analysis were also sent. The Greek authorities provided the following updated information in the context of the 2015 GFA: The CCA provided the GFA team with a copy of circular no. 219/7548 of 18-01-2013, on the determination of the frequency of official controls on the basis of a risk assessment. As an example, they provided a report detailing the risk assessment, and the frequency of inspection, of establishments for one region in Greece for the year 2014. They also provided a copy of a report for one region on controls implemented in 2014. Ministerial Decision of 30/12/2011 (ref. 133362), sets out the risk assessment criteria in relation to the Salmonellosis control programme for broilers. Controls on farms are implemented by Regional Units. The CCA stated that the control frequency rate is set at 10% and that the rate had been achieved in 2014. As an example, the CCA provided a report from one regional unit stating that all official controls on FBO own checks before slaughter had been implemented in respect of the year 2014. As regards EFET, the relevant circular for the programming of inspection frequency based on risk assessment (17 784 / 11-12-2009) had previously been sent to the Commission services. As an example, they provided a report detailing the risk assessment, and the frequency of inspection, of establishments for one region in Greece for the year 2014.
2011-8840-6 This recommendation is based on findings and associated findings in Section 5.3.3 of the audit report: Action taken ante-mortem inspections were in general not carried out in line with the requirements of EU provisions The CA should ensure that EU (inspections were done solely by establishment staff; no evidence, in any of the cases reviewed by the 22 DG(SANTE) 2015-7657 Final Version date October 2016 Inspection 2011-8840 of 20 February 2011 in order to evaluate the food safety control systems in place governing the production and placing on the market of poultry meat and poultry meat products
Reference no. and recommendation Basis of assessment Assessment requirements on ante-mortem inspection audit team, that the official veterinarian at the slaughterhouse had undertaken the ante-mortem are respected, in particular those describe inspections, etc.). in Chapter V (A), Section IV, Annex I The initial response of the Greek authorities stated the following: Regulation (EC) No 854/2004 and point 1(a), Chapter V, Section II, and Annex I "Compliance-related comments are included in Circular No 172447/23-06-2011 which is attached Regulation (EC) No 854/2004), thus hereto." correcting the deficiencies mentioned in The Greek authorities provided the following updated information in the context of the 2015 GFA: this report. The CCA stated that the Department of meat and meat products had distributed model forms for ante- and post- mortem findings in all species including poultry. A copy of circular 1415/41595 of 03-04-2012, a copy of the model form for poultry, and examples of completed forms were provided to the GFA team. The CCA also stated that from 1-1-2016 all ante- and post- mortem findings are to be recorded in a new web-based database system. The new system was demonstrated to the GFA team. It will be rolled out as a pilot project first, for 2-3 months, and will become compulsory for the whole country within the course of the year 2016 (a law was recently passed making the filling-in of food database systems compulsory). An instruction manual is being drafted and seminars on the use of the system will be held in 2016. Official veterinarians will be able to enter the data online in slaughterhouses but the system doesn’t exclude the possibility of the veterinarian recording the data on paper first and inputting the data later. This is because inputting the data directly online would not be possible at times of high levels of throughput, such as at Easter. The question of how to analyse the data from the system is currently being considered. The CCA stated that a written procedure on the supervision of the regional veterinary services with regard to the official controls has been established. Supervision has been incorporated into the Quality Management System of the Directorate of Hygiene and Safety for Food of Animal Origin according to the ISO standard 9001. Two actions related to the certification of the procedure by a third party are currently pending.
2011-8840-8 This recommendation is based on findings and associated findings in Section 5.3.3 of the audit report: Action taken records of post-mortem inspection were not recorded by flock. The CA should ensure that poultry inspection records will be related to the The initial response of the Greek authorities stated the following: flock inspected to enable the CA, when "Compliance-related comments are included in Circular No 172447/23-06-2011 which was submitted to necessary, to communicate the inspection 23 DG(SANTE) 2015-7657 Final Version date October 2016 Inspection 2011-8840 of 20 February 2011 in order to evaluate the food safety control systems in place governing the production and placing on the market of poultry meat and poultry meat products
Reference no. and recommendation Basis of assessment Assessment results to the concerned parties. (Chapter DG SANTE." I,2(b), Section II, Annex I of Regulation The Greek authorities provided the following updated information in the context of the 2015 GFA: (EC) No 854/2004). See the response to recommendation 2011-8840-6, above. The model form provided by the CCA has a space for the flock number and in the completed examples provided to the GFA team by the CCA the flock number had been filled in. Regarding the database system being introduced in 2016, the flock number field will be mandatory.
2011-8840-9 This recommendation is based on findings and associated findings in Section 5.3.4 of the audit report. Action taken The system of official controls was implemented and covered the whole poultry production chain. The CA should improve the effectiveness However, deficiencies identified by the audit team in the establishments visited and not detected during of official controls at establishment level official controls called into question the effectiveness of the system. in order to ensure that all deficiencies in establishments are identified and addressed The initial response of the Greek authorities stated the following: (Article 4 (2a) ) Regulation (EC) No "Compliance-related comments are included in Circular No 172447/23-06-2011 which is attached 882/2004), in particular to ensure that hereto." poultry establishments comply with the requirements of Annex II of Regulation The Greek authorities provided the following updated information in the context of the 2015 GFA: (EC) No 852/2004 and Section II, Annex The CA referred to the response given in relation to recommendation 2011-8840-6 above (on the III of Regulation (EC) No 853/2004. incorporation into the Quality Management System of procedures for the supervision of the regional veterinary services with regard to the official controls, and on the new database system for ante- and post- mortem inspections). EFET stated that all control data is recorded is their computerised Integrated Information System. Analysis of the data allows them to check controls in a number of ways. Apart from quantitative trends they can draw some conclusions on the basis of geography or sector. The tools which EFET have for analysing quality and quantity assist them in identifying the need for corrective actions. EFET believe that progress in making inspectors more effective has been made, via the provision of training and special guidance. EFET provided the GFA team with a report on the assessment of controls done in 2014, detailing the number and type of controls, the percentage by sector, rate of non-compliance by sector, and type of non-
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Reference no. and recommendation Basis of assessment Assessment compliance. Regarding the effectiveness of inspectors in relation to HACCP, EFET stated that it was not easy to assess this. It is possible to some extent via the data in the Integrated Information System. Assessments are also made when joint EFET - Regional Unit controls were being conducted in the context of an approval process. Another way is that when applying sanctions EFET can see how controls have been carried out. EFET’s Department of Quality Assurance of Provided Services implements a Quality Management System and is responsible for internal audits. Audits are planned according to a five-year rolling programme and an annual programme. Audits are planned on a risk-basis, with an appropriate frequency. 6 audits were done in 2013-14 and 6 were planned for 2015.
2011-8840-10 This recommendation is based on findings and associated findings in Section 5.3.4 of the audit report: the Action taken system did not guarantee that the sanction applied for breaches of food laws was effective and The CA should ensure that breaches of proportionate. food law are subject to effective, dissuasive and proportionate sanctions. The initial response of the Greek authorities stated the following: (Article 55 (1) of Regulation (EC) No "MRDF - A working group was set up to review the system of sanctions to ensure that sanctions are 882/2004). effective, dissuasive and proportionate. Once its work is completed, we will communicate the new system of sanctions to you. EFET - In its endeavour to improve the system for taking measures about non-compliance and for imposing sanction, EFET issued circular No 5146/14-04-2010 to Veterinary Services nationwide which contains certain clarifications about how those sanctions are to be imposed. Moreover, a new committee was set by the Minister for Health and Social Solidarity to prepare a final proposal on the enforcement of compliance measures and imposition of sanctions in the food and animal feed, health and animal welfare sectors, which must be prepared by the end of June 2011. " The Greek authorities provided the following updated information in the context of the 2015 GFA: Please see the response to recommendation number 2007-7431-8 and 2011-8840-10, in relation to the
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Reference no. and recommendation Basis of assessment Assessment introduction, in 2014, of a new system of administrative measures and sanctions. This is a single system for the entire range of the food chain and is designed with a view to being effective, proportionate and dissuasive.
Audit 2011-8883 of 10 October 2011 in order to evaluate the food safety control systems in place governing the production and placing on the market of bivalve molluscs
Reference no. and recommendation Basis of assessment Assessment
2011-8883-1 This recommendation arose from the findings describe in Section 5.3 of the audit report: Regional Units Closed for other did not always provide the CCA with information as required (e.g. data on production of molluscs in reasons To ensure efficient and effective classified production areas) and the Coastal Guard did not communicate with the Regions and Regional coordination and cooperation between Units. competent authorities as required under Article 4.6 of Regulation (EC) No Among the jointly competent authorities that are involved in carrying out official controls on live bivalve 882/2004. molluscs, EFET (the Hellenic Food Authority) and the Directorate-General for Fisheries are services of the Ministry of Rural Development and Food (from June and August 2012, respectively). At the level of central competent authorities, meetings have already taken place between the Director for Veterinary Affairs and his counterparts in the other services involved – EFET, Directorate-General for Fisheries, the Environment, Harbour Guard. Many issues relating to the system for monitoring live bivalve molluscs (LBM) are already being dealt with jointly, inter alia: Meetings – consultations are held every year between the competent veterinary authorities of the local port services, the fisheries services, the associations/unions of mussel farmers/shellfish fishermen and LBM businesses; Examples of communication with the Harbour Guard, associations and unions of shellfish farmers regarding measures taken or lifted. Audit reports 2014-7127 states that "recommendation 2011-8883-1, with regard to efficient and effective coordination, is still considered as not fully addressed." Results were not communicated which prevents the CCA and the CAs from ensuring that the controls are effective (e.g. frequencies of sampling).
26 DG(SANTE) 2015-7657 Final Version date October 2016 Audit 2011-8883 of 10 October 2011 in order to evaluate the food safety control systems in place governing the production and placing on the market of bivalve molluscs
Reference no. and recommendation Basis of assessment Assessment Overtaken by recommendation 2014-7127-3.
2011-8883-2 Audit report 2014-7127 concluded that recommendation 2011-8883-2, with regard to internal audits, is Action taken considered as addressed. To carry out internal and external audits as required under Article 4.5 of Regulation (EC) No 882/2004.
2011-8883-4 Audit report 2014-7127 concluded that recommendation 2011-8883-4, with regard to establishment of Action taken boundaries for classified production areas, is considered as addressed. To comply with the requirements of Point A.1. of Chapter II of Annex II to Regulation (EC) No 854/2004 regarding the boundaries of classified production areas.
2011-8883-5 Background This recommendation arose form findings described in 5.2.1 (page 5) Closed for other reasons To comply with the requirements of Point Audit report 2014-7127 states that recommendation No 5, with regard to classification of production A.3. of Chapter II of Annex II to areas, is considered as partially addressed (due to the shortcomings noted in relation with the shoreline Regulation (EC) No 854/2004 regarding surveys). compliance with the health standards Overtaken by recommendation 2014-7127-6 described in Chapter V of Section VII of Annex III to Regulation (EC) No 853/2004 when classifying and maintaining the classification of Class A production areas.
2011-8883-6 Audit report 2014-7127 concluded that recommendation 2011-8883-6, with regard to the authorisation of Action taken LBM harvesting only from classified production areas, is considered as addressed. To comply with the requirements of Point A.2. of Chapter II of Annex II to Regulation (EC) No 854/2004 regarding the authorisation of harvesting of live bivalve molluscs from classified
27 DG(SANTE) 2015-7657 Final Version date October 2016 Audit 2011-8883 of 10 October 2011 in order to evaluate the food safety control systems in place governing the production and placing on the market of bivalve molluscs
Reference no. and recommendation Basis of assessment Assessment production areas only.
2011-8883-7 Audit report 2014-7127 concluded that recommendation 2011-8883-7, with regard to classification of Action taken production areas with seasonal production, is considered as addressed. To ensure that the procedures implemented for classified production areas with seasonal production are in line with the recommendations given by the relevant EU reference laboratory.
2011-8883-8 Audit report 2014-7127 concluded that recommendation 2011-8883-8, with regard to monitoring to check Action taken absence of malpractice, is considered as addressed. To comply with the requirements of Point B.1.(a) of Chapter II of Annex II to Regulation (EC) No 854/2004 regarding the periodic monitoring of classified production areas to check that there is no malpractice.
2011-8883-9 Audit report 2014-7127 concluded that recommendation 2011-8883-9, with regard to the monitoring of Action taken microbiological quality of LBM, is considered as addressed. Regarding the monitoring of classified production areas for the microbiological quality of live bivalve molluscs, to comply with the requirements of Point B.2. of Chapter II of Annex II to Regulation (EC) No 854/2004 regarding the geographical distribution of the sampling points and the sampling frequency.
2011-8883-10 Audit report 2014-7127 concluded that recommendation 2011-8883-10, with regard to monitoring of Closed for other production areas for phytoplankton, is considered as partially addressed (due to the shortcomings noted in reasons Regarding the monitoring of classified 28 DG(SANTE) 2015-7657 Final Version date October 2016 Audit 2011-8883 of 10 October 2011 in order to evaluate the food safety control systems in place governing the production and placing on the market of bivalve molluscs
Reference no. and recommendation Basis of assessment Assessment production areas for presence of toxic- relation to the geographical distribution of the sampling points). producing plankton, to comply with the Overtaken by 2014-7127-8/9 requirements of Point B.2. of Chapter II of Annex II to Regulation (EC) No 854/2004 regarding the geographical distribution of the sampling points and the sampling frequency. In addition, to ensure that samples for monitoring of classified production areas for toxic-producing plankton are representative of the water column as required by Point B.7. of Chapter II of Annex II to Regulation (EC) No 854/2004.
2011-8883-11 Audit report 2014-7127 concluded that recommendation 2011-8883-11, with regard to monitoring of Closed for other production areas for biotoxins, is considered as not adequately addressed. reasons Regarding the monitoring of classified production areas for biotoxins, to comply Overtaken by 2014-7127-9 and 11 with the requirements of Point B.2. of Chapter II of Annex II to Regulation (EC) No 854/2004 regarding the geographical distribution of the sampling points and the sampling frequency. In addition, to ensure that sampling frequency of toxic analysis in the molluscs is in line with Point B.5. of Chapter II of Annex II to Regulation (EC) No 854/2004.
2011-8883-12 Audit report 2014-7127 concluded that recommendation 2011-8883-12, with regard to monitoring of Closed for other production areas for chemical contaminants, is considered as partially addressed. reasons To ensure that the monitoring of chemical
29 DG(SANTE) 2015-7657 Final Version date October 2016 Audit 2011-8883 of 10 October 2011 in order to evaluate the food safety control systems in place governing the production and placing on the market of bivalve molluscs
Reference no. and recommendation Basis of assessment Assessment contaminants in live bivalve molluscs Overtaken by 2014-7127-8/9 includes all the relevant substances, in particular those required in Point B.8 of Chapter II of Annex II to Regulation (EC) No 854/2004. 2011-8883-13 Overtaken by Overtaken by 2014-7127-19 Closed for other reasons To ensure that samples are handled and labelled to guarantee their analytical validity as required in Article 11.7 of Regulation (EC) No 882/2004.
2011-8883-15 Audit report 2014-7127 concluded that recommendation No 15, with regard to additional monitoring of Action taken closed production areas, is considered as addressed. To ensure that harvesting of live bivalve molluscs in closed areas is prevented and to implement effective additional monitoring requirements to ensure that products harmful to human health are not placed on the market as required in Point D.1. of Chapter II of Annex II to Regulation (EC) No 854/2004.
2011-8883-16 Audit report 2014-7127 concluded that recommendation 2011-8883-16, with regard to additional Closed for other monitoring of LBM from classified production areas, is considered as not adequately addressed. reasons To ensure that a control system is set up comprising laboratory tests to verify FBOs' Overtaken by recommendation 2014-7127-1 compliance with the requirements as required in Point D.2. of Chapter II of Annex II to Regulation (EC) No 854/2004.
2011-8883-17 Audit report 2014-7127 concluded that recommendation 2011-8883-17of the previous audit report, with Action taken regard to recording and exchange of information, is considered as addressed To comply with the requirements of Point 30 DG(SANTE) 2015-7657 Final Version date October 2016 Audit 2011-8883 of 10 October 2011 in order to evaluate the food safety control systems in place governing the production and placing on the market of bivalve molluscs
Reference no. and recommendation Basis of assessment Assessment E. of Chapter II of Annex II to Regulation (EC) No 854/2004 regarding recording and exchange of information. 2011-8883-18 The CCA stated in its responses to the pre-audit questionnaire in preparation and confirmed during the Closed for other audit 2014-7127 that Greece does not produce and place on the market Pectinidae or non-filter feeding reasons. To carry out official controls over the live marine gastropods which are harvested outside classified production areas. Therefore, production and placing on the market of recommendation 2011-8883-18 is considered as no longer applicable. pectinidae and live marine gastropods which are not filter feeders harvested outside classified production areas as required in Chapter III of Annex II to Regulation (EC) No 854/2004.
2011-8883-19 Audit report 2014-7127 concluded that recommendation 2011-8883-19 is considered as partially Closed for other addressed. reasons. To ensure that the NRL for microbiology carries out all the tasks set out in Article Overtaken by recommendations 2014-7127-20+21 33.2 of Regulation (EC) No 882/2004 and to ensure that analyses methods used in all laboratories in the context of official controls are carried out as required by Article 11.1 of the same Regulation.
2011-8883-20 Audit report 2014-7127 concluded that recommendation No 20 of the previous audit report, with regard Closed for other to approval of establishments, is considered as not satisfactorily addressed. reasons To comply with Article 31.2.(c) of Regulation (EC) No 882/2004 when Overtaken by recommendations 2014-7127-18 granting approval to establishments, in particular in the case of purification centres regarding the requirements of Point A.3. of Chapter IV of Section VII of Annex III to Regulation (EC) No 853/2004 on the length of purification process.
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Audit2012-6334 of 23 April 2012 in order to evaluate the official controls related to slaughter and processing of fresh meat, in particular fresh ovine meat
Reference no. and recommendation Basis of assessment Assessment
2012-6334-9 This recommendation is based on several findings in the audit report that controls were not always Action taken effective. To improve supervision of staff performing official controls from central The initial response of the Greek authorities stated the following: and regional levels to ensure effectiveness "General Directorate of Veterinary Services and more specifically the Directorate of Veterinary Public of official controls, as required by Article health has increased the number of visits to slaughterhouses in order to ensure compliance with the 8 of Regulation (EC) No 882/2004. relevant provisions. To this, since this June the CCA has already visited 4 slaughterhouses and the CA of the Prefectural Units supervising them. The EFET, through its system for collecting, recording and evaluating the audit work of services, may: have a clearer view on the range and scope of controls, their frequency, analysis of cases of non- compliance; draw conclusions which help formulate the MANCP report; highlight problems and take corrective measures; communicate with the local authorities about the conclusions and problems in any appropriate way (letters, meetings, visits); make use of the capabilities of the integrated IT system (OPS). EFET will do its best to improve supervision and adaptation of the local authorities' audit work and measures to the priorities and support services of central planning.” The Greek authorities provided additional information on 18.01.2013: "General Directorate of Veterinary Services: The CCA will conduct 5 on the spot visits per year at meat establishments based on the feedback from the CAs and the findings of the official controls conducted." The Greek authorities provided the following updated information in the context of the 2015 GFA: “CCA has conducted several supervisory visits during 2015. More specifically, CCA conducted on the spot visits to the following meat establishments:
32 DG(SANTE) 2015-7657 Final Version date October 2016 Audit2012-6334 of 23 April 2012 in order to evaluate the official controls related to slaughter and processing of fresh meat, in particular fresh ovine meat
Reference no. and recommendation Basis of assessment Assessment S27 (slaughterhouse) :24-02-2015 (During CFIA audit) IMP 127 (meat products) :25-02-2015 (during CFIA audit) A738 (cutting plant), PE (cutting plant poultry meat) 454, F632 (cold store) : 2-06-2015 S140 (slaughterhouse):16-06-2015 S139 (slaughterhouse) :17-06-2015 S14 (slaughterhouse) :24-08-2015 S55 (slaughterhouse) :25-08-2015 S50 (slaughterhouse): 26-08-2015” The CCA provided copies of audit reports and tables of corrective actions in relation to some of the above visits. In cases where Official Veterinarians performed poorly during these visits, training courses were organised by the CCA for the OVs of the Region concerned. The CCA provided copies of attendance sheets for such courses. The CCA stated that they have plans for supervisory visits to two Regions in 2016, and that there would also be unplanned visits. Third Country inspections of establishments also provide the CCA with an opportunity for a supervisory visit (the CCA visited 20 establishments in 2015 for this purpose). Regions are administratively responsible for the Regional Units, the CCA does not have a direct administrative connection with the Units. The CCA stated that, with some exceptions, the Regions did not have an organised system of supervision of Regional Units. Regions which collect data on controls have an overview but conclusions are indirectly drawn. Regarding a computerised system for control data, the CCA stated that it would be desirable to have checklists online. At the moment, there are other priorities, e.g. to have the post-mortem and ante-mortem systems in force for January 2016. EFET stated that they have direct control over their own 9 decentralised administrations. Their system for the assessment of control data covers all controls in the food of animal origin sector. All the data is entered into their IT system, IIS. So, EFET can have direct information on range, orientation, distribution, trends on non-compliances etc., and this facilities them in deciding on whether corrective measures might be necessary. Admittedly, there is a time gap in making quality assessments, and this means that action is 33 DG(SANTE) 2015-7657 Final Version date October 2016 Audit2012-6334 of 23 April 2012 in order to evaluate the official controls related to slaughter and processing of fresh meat, in particular fresh ovine meat
Reference no. and recommendation Basis of assessment Assessment not taken immediately. EFET stated that data for 2015 will be collected by March/April 2016 and will be evaluated during the first semester of 2016. EFET does not have a direct administrative connection with Regional Units. In cases where Regional Unit control data is sent to the EFET region, uniformity of controls can be checked. For example on FBO checks, or licensing making use of flexibility. Also, when an establishment under EFET seeks approval for improvements made, both EFET and the licensing authority take part in the mandatory on-the-spot control. This presents an opportunity to see if the criteria for official controls are uniform. According to EFET, there has been significant improvement in this regard.
Audit 2012-6430 of 03 September 2012 in order to evaluate the Salmonella National Control Programmes in particular poultry populations (breeders, laying hens, broilers and turkeys)
Reference no. and recommendation Basis of assessment Assessment
2012-6430-1 This recommendation is based on findings and the related conclusion in the audit report: some Action taken shortcomings were noted in the performance of the official controls as deficiencies had not been detected The CCA should ensure that official or reported (e.g. inadequate Salmonella sampling frequency and breaches in biosecurity rules). controls at farms level are effective enough to detect deficiencies in the The initial response of the Greek authorities stated the following: implementation of the SNCP and in "1.Revised versions of the manuals on the implementation of official controls for breeding hens, laying biosecurity conditions in order to fulfil the hens, broilers of the species Gallus gallus and turkeys is being drawn up, in order to provide additional requirements of Articles 4.2(a) and 9 of detailed instructions to official veterinarians concerning detection of deficiencies in the implementation Regulation (EC) No 882/2004. of the SNCP and the evaluation of biosecurity conditions. The above mentioned revised versions are going to be completed by June 2013 the latest. 2. Circular letters with instructions regarding effective implementation of official controls at farm level (proper implementation of the SNCP and biosecurity measures) will be sent to the regional sections by June 2013 the latest. 3. Training seminars will be organised during 2013 by the Department of Zoonosis and NRL with the participation of all the stakeholders involved in the implementation of SNCPs, including poultry farmers 34 DG(SANTE) 2015-7657 Final Version date October 2016 Audit 2012-6430 of 03 September 2012 in order to evaluate the Salmonella National Control Programmes in particular poultry populations (breeders, laying hens, broilers and turkeys)
Reference no. and recommendation Basis of assessment Assessment and private veterinarians." The Greek authorities provided the following updated information in the context of the 2015 GFA: The CA provided a link to the revised SNCP manuals on the website of the Ministry (http://www.minagric.gr/index.php/el/for-farmer-2/animal-production/ptina/astheneiesptinon-menu/459- salmonelosi). Part 4 of the manuals for the implementation of SNCPs : “Official Controls-Instructions To Verify The Reliability Of Own-Checks” give further instructions to the official veterinarians with regard to the verification of the proper implementation of the programmes by the FBOs. Regarding instructions on the effective implementation of official controls at farm level, the CA provided the GFA team with a copy of Circular no. 1204/37199/23.03.2013 “Clarification and guidance on the implementation of SNCP”, referring in particular to parts A1 & A3. The CA stated that controls based on the revised instructions began in March 2013. The CA provided a copy of an email to regions in June 2013 about the availability of the updated manuals on the website. Regarding training, the CA stated that a seminar was organized by the Department of Zoonoses/Animal Health Directorate and the National Reference Laboratory on 10 April 2013 with the participation of all stakeholders involved in the SNCP. Another seminar on Zoonoses took place in Chios on 20-21 June 2013. On 11-12 December 2013 a seminar was organised for Regions and Regional Units concerning all the control and eradication programmes implemented by the Department of Zoonoses. Presentations with regard to the SNCPs were included. In 2014 and 2015 a series of seminars took place with regard to the implementation of eradication and control programmes against zoonoses in collaboration with INEP (Institute for the Training and Education of Public Servants). Another seminar is scheduled for 2016. The CA provided the GFA team with documentation relating to the seminars/training.
2012-6430-2 This recommendation is based on findings and the related conclusion in Section 5.8 of the audit report: Action taken the audit team was informed that official routine samples for breeders taken on the farm are always faecal The CCA should ensure that the number of and comprise two sub-samples of 150g. The audit team noted while reviewing the test records that these sub-samples tested in adult breeding flocks two sub-samples are pooled into one sample with one result. This is not in line with point 2.2.2.1 (a), is in line with the requirements of point Annex of Regulation (EC) No 200/2010 which stipulates that ''faeces may be pooled for analysis up to a 2.2.2.1(a), Annex of Regulation (EC) No minimum of two pools''. 200/2010.
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Reference no. and recommendation Basis of assessment Assessment The initial response of the Greek authorities stated the following: "CCA will send as soon as possible an inquire to the Competent EU Authority in order to clarify point 3.1.4. (a), of Annex of Regulation (EC) No 200/2010 where it is stated that "the faeces samples shall be pooled and thoroughly mixed" As soon as the required clarification is available, a circular letter with clarifications will be sent to Official laboratories involved in the SNCPs , in order to ensure that the number of sub-samples tested in adult breeding flocks is in line with the requirements of point 2.2.2.1(a), Annex of Regulation (EC) No 200/2010." The Greek authorities provided the following updated information in the context of the 2015 GFA: The CA provided a copy of the Circular No 1204/37199/26.03.2013 “Clarification and Guidance on the implementation of SNCP” and a copy of the manual on the implementation of official controls for breeding hens. The CA gave the following response: “1. Point 1 of Circular No 1204/37199/26.03.2013 on the clarification and guidance on the implementation of SNCP 2. Point 3b.α 1.b of the Manual with regard to implementation of SNCP in flocks of breeding hens of Gallus gallus: B. Pooled faeces method Pooled faeces obtained from individual samples of fresh faeces each weighing not less than 1 g taken at random from a number of sites in the house in which the flock or, where the flock has free access to more than one poultry houses of a holding, from each group of poultry houses of the holding where the flock. Faeces may be pooled for analysis up to a minimum of two pools. In any event will be sent for analysis to the laboratory at least two samples. The number of sites from which separate faeces samples are to be taken in order to make a pooled sample shall be as follows: Number of birds kept in the flock Number of faeces samples to be taken in the flock 250-349 200 350-449 220
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Reference no. and recommendation Basis of assessment Assessment 450-799 250 800-999 260 1000 or more 300 The composite sample shall be placed in suitable watertight plastic containers and labelled. 3. Point 5.2.2.1.b of the Manual with regard to implementation of SNCP in flocks of breeding hens of Gallus gallus: 2.2. Samples holding 2.2.1. Boot swabs and dust samples. B. Where five pairs of boot/sock swabs are pooled into two samples, place each pooled sample in of 225 ml bpw more if necessary, to fully submerge the sample and provide sufficient free liquid around the sample for migration of Salmonella away from the sample.” The CA provided the GFA team with spreadsheets which include the official laboratory results for 2013 and 2014. The data shows that all faecal samples are pooled into at least 2 pool samples and that 2 analyses are taking place in each case.
2012-6430-3 This recommendation is based on findings and the related conclusion in Section 5.4 of the audit report: Action taken the SNCP for layers has been implemented with a sampling frequency in general respected except that The CA should ensure that the frequency the sampling at the age of 22-26 weeks was not carried out in all flocks. of own-check sampling for laying hen flocks is implemented in line with the The initial response of the Greek authorities stated the following: requirements of point 2.1, Annex of "1. The CCA will send to CA by January 2013 a reminder circular letter with instructions concerning the Regulation (EC) No 517/2011 especially at collection of data of own-check sampling for layers, that has already been sent since 2012 (circular letter the age of 22-26 weeks. 841/20785-21-02-2012).The purpose of this circular letter is to ensure that data on own –check sampling will be sent to regional veterinary authority in a harmonized way and that regional veterinary authority is informed in a regular basis on the implementation of NSCP by the FBOs. 2. Circular letters with instructions will be sent by January 2013 to the regional veterinary authority in order to enable them to improve their assessment on the implementation of the SNCP by the FBOs. If the
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Reference no. and recommendation Basis of assessment Assessment competent authority identifies non-compliance, recommendations to FBOs will follow." The Greek authorities provided the following updated information in the context of the 2015 GFA: The CA referred to Point 2 of circular No 1204/37199/26.03.2013 “Clarification and guidance on the implementation of SNCP” (already provided to the GFA team). The CA stated that the circular was distributed to the regional veterinary authorities on 29/03/2013, and that it was uploaded to the Ministry’s website. The CA also referred to point 4 of the manual for the implementation of the SNCP in flocks of laying hens Gallus gallus. The CA stated the Regional Units have the data on sampling and that twice a year the CA collects this data from the Regional Units. However, the data cannot easily be linked to flocks at the moment and the CA cannot prove the age. Efforts have been made to create a sampling database system, including results. The database system will be used by Official Veterinarians and by Private Veterinarians. It is expected that the system will become available in 2016. Thanks to this database, the CA will be in a position centrally to check this data on the basis of a flock ID.
2012-6430-4 This recommendation is based on findings and the related conclusion in Section 5.6 of the audit report: Action taken the SNCP for turkey is being implemented; however, not all flocks are covered by the programme. The CA should ensure that the SNCP for turkey flocks is implemented in all flocks The initial response of the Greek authorities stated the following: of fattening and breeding turkey covered "Circular letter with instructions will be sent by January 2013 to the regional veterinary authority in by the scope of Annex II, B of Regulation region that have farms with turkeys to intensify official controls in all flocks of fattening and breeding (EC) No 2160/2003. turkey." The Greek authorities provided the following updated information in the context of the 2015 GFA: “1. By means of circular No 2006/60569/21-05-2013: "Information about the Publication of a National Decision and about the corrections in circulars with regard to the implementation of the National salmonella control programmes" we informed the regional veterinary authorities for the publication of the new Ministerial Decision for the implementation of the SNCP in flocks of breeding and fattening turkeys and urge them to faithfully implement the requirements of the above Decision.
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Reference no. and recommendation Basis of assessment Assessment 2. By means of circular no 1204/37199/26.03.2013 (part C) “Clarification and guidance on the implementation of SNCP”. Attached to the above mentioned circular there are tables with the schematic of sampling during own-check and official sampling.” The CCA also said that “the sampling of fattening turkeys is, in general, in line with the requirements of Annex II B of Reg. (EC) No 2160/2003 The majority of fattening turkey flocks was sampled by the FBO before slaughter. In the cases where the flocks were not sampled for salmonella in 2013 and 2014, the reason was either that the flocks were not at the appropriate sampling age (case of loannina) or that they were sold at local level as live birds for private /domestic use. Fattening turkey production in seasonal in Greece. For this reason most of the birds are slaughtered before Christmas. Regarding breeding turkeys, in 2013 there were 4 flocks (2 in Thessaloniki and 2 in Trikala). 3 out of the 4 flocks were tested for salmonella (2 with official sampling and 1 with own-check sampling in Thessaloniki and 1 with own-check sampling in Trikala. In 2014 there were 3 flocks (2 in Trikala and 1 in Hlia). Only 1 out the 3 was tested for salmonella by the FBO. The reason of non-compliance of official sampling with the requirements of Community legislation is the extreme lack of veterinary services in veterinary staff, the lack in state vehicles and fuels and the limitation in the number of days that an official can be out of his office (60 days while in the past it was 180 days). Finally, it is worth to note that the products of turkey breeding farms are mostly available at local level for private/domestic use.” The CA added that some very small producers who are registered as breeders do not in fact function as breeders – they sell their chicks at village markets. The CA is considering taking 3 such producers out of the programme. The CA stated that they are also looking at the idea of using private veterinarians for the programme but that nothing had been decided on this yet. The CA provided the GFA team with a copy of the summary reports for 2013 and 2014 for the implementation of the SNCP in flocks of Turkeys, copies of the relevant circulars, and a copy of the sampling plans for turkeys. 39 DG(SANTE) 2015-7657 Final Version date October 2016
Audit 2013-6884 of 16 September 2013 in order to evaluate the official controls and the follow-up action taken by the competent authorities with regard to the safety of food of animal origin, specifically milk and dairy products
Reference no. and recommendation Basis of assessment Assessment
2013-6884-1 This recommendation is based on finding(s) and related conclusion(s) in Sections 5.1.4 and 5.1.5 of the Action taken audit report that the collection points and small collection centres were neither registered nor approved. To ensure that all food establishments During the visit to an ELGO Dimitra Laboratory it was found that the laboratories of this network supplying raw milk are either registered or perform testing also for milk purchasers (milk dealers, farm cooperatives). The CAs interviewed on the approved as required by Article 4(2) of spot were not aware that milk purchasers were involved in the milk trade and consequently such Regulation (EC) No 853/2004. operators were not subject to official controls. The initial response of Greece and updated information provided the following clarification and suggested the following actions: "The milk collection tanks in dairy cooperatives will be inspected promptly by the regional veterinary services (to be implemented by 9/2014). Improving cooperation and communication between ELGO and veterinary services with respect to approval of milk purchasers and dairy cooperatives. The regional veterinary agencies will first register the milk collection tanks used in dairy cooperatives and those used for livestock farms, and then the relevant list will be posted on the website of the Ministry of Rural Development and Food. At least one official inspection will be performed thereon by the regional veterinary agencies every two years on the basis of risk analysis (circular 219/7548/18-1-2013). Milk purchasers are classified as traders as they engage only in trading activity, and they are almost obsolete given that dairy industries would rather procure milk directly from the producers. As part of the collaboration between the and the Hellenic Agricultural Organisation (ELGO), the very few milk purchasers operating will register in the Registry of traders of animal products and products of animal origin and will be given a registration number according to Joint Ministerial Decision No 278701/2005 (as food traders). They will have to fulfil all the obligations under the above Joint Ministerial Decision. New measures will be implemented by the regional veterinary agencies after guidelines are provided by the central competent authority in the form of clarifying circulars, and then follow-up action will be taken by means of on the spot visits and assessment of the official inspection information sent to the central competent authority by the regional veterinary agencies and ELGO-DIMITRA.
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Reference no. and recommendation Basis of assessment Assessment The Greek authorities provided the following up-dated information in the context of the 2015 GFA:
The CCA stated that early 2015 investigations had been carried out on whether dealers had milk tanks. Dealers of milk with milk tanks were registered. The CCA had requested and received from the regional units a report on the milk tanks registered by them The CCA stated that milk tanks and collection centres are registered/approved. The DG SANTE team received a copy of the report. According to this information, there are also no shared milk tanks between neighbours anymore. FBO were informed about the requirements for the approval of the collection points. The CCA provided also a register of milk purchasers (established in January and updated on September 2015).
2013-6884-2 This recommendation is based on a finding and related conclusion in Section 5.3 in conjunction with In progress findings in Section 5.1.5 of the audit report that approximately 30% of the raw bovine milk received in To take measures to further improve the the dairy establishments is not in compliance for the SCCs requirements and 20 % for the TPC level of compliance with the criteria for requirements of Regulation (EC) No 853/2004. As regards controls at holding level for compliance with raw cows' milk required in Annex III, the relevant dairy requirements of the Hygiene Package it could not be demonstrated that these controls Section IX, Chapter I, Point 3 (a) and (b) are carried out with a determined risk based frequency in any of the regions visited. This had been of Regulation (EC) No 853/2004 and, in identified as a weakness also in the recent dairy audit of the Veterinary Services Audit Unit at central particular, to implement a system of level. controls at holding level to verify that the hygiene requirements at holding level The initial response of the Greek authorities and updated information provided the following clarification provided by Regulation (EC) No 852/2004 and suggested the following actions: and Regulation (EC) No 853/2004 are "Actions already taken in 2013 The central competent authority (Directorate for Veterinary Public Health being complied with as required by Annex of the Directorate General for Veterinary Medicine) has drawn up and forwarded to all regions and IV to Regulation (EC) No 854/2004. regional units in the country Circular No 651/26864/26-2-2014, which lays down the guidelines for planning the official inspections of dairy farms based on risk assessment. Circular No 651/26864/26-2-2014 lays down the guidelines for planning the official inspections of dairy farms based on risk assessment. Official inspections will be performed on dairy farms on an annual basis according to minimum percentages by type of animals and number of animals (e.g. 10% for large sheep 41 DG(SANTE) 2015-7657 Final Version date October 2016 Audit 2013-6884 of 16 September 2013 in order to evaluate the official controls and the follow-up action taken by the competent authorities with regard to the safety of food of animal origin, specifically milk and dairy products
Reference no. and recommendation Basis of assessment Assessment and goat farms with >500 animals). The minimum official inspection frequency is calculated on the basis of the classification of holdings as high-risk (1 inspection every year), medium-risk (1 inspection every 2 years) or low-risk (1 inspection every 5 years). Drawing up an information brochure on the ‘Obligations of operators of milk production holdings’ and informing all operators of dairy farms (to be implemented within the first six months of 2014). A report will be drawn up after each inspection, providing a description of the purpose of the official inspection, the inspection method used, the results of the official inspection and, as appropriate, the measures to be taken by the farm operator subject to a specific time-frame. The official inspection of dairy farms will be performed by the competent authorities, by means of a uniform updated specific questionnaire aimed to verify fulfilment of the hygiene requirements at farm level provided for by Regulation (EC) No 852/2004 and 853/2004, to be used on a trial basis for 6 months in 5 Regional Districts. The questionnaire will cover such areas as animal health, farm hygiene (animal accommodation facility, milking facility and milk storage facility), the use of veterinary pharmaceutical products, the use of water, the animals’ diet, the management of animal by-products and the keeping of relevant files by the farm. The implementation will be followed up by the central competent authority through on-the-spot visits made by the regional veterinary agencies and through information sent by each Region on the inspection schedule for the current year, the results of the inspections performed in the previous year and the progress made by non-complying dairy farms in implementing necessary corrective actions. The Greek authorities provided the following up-dated information in the context of the 2015 GFA: In 2014, the level of compliance out of 16.129 samples taken was: TPC: - 84,18 % for cow milk - 98,6 % for goat milk - 97,3 % for sheep milk
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Reference no. and recommendation Basis of assessment Assessment SCC: 68,73 for cow milk The CCA stated that supervision of official controls on fresh milk was introduced and circulars were sent to the Regions and Regional units reminding them of the requirements. In line with the MANCP it is foreseen to focus on the milk sector in 2017. As regards to the 30% non-compliance level for SCC the CCA explained that specific measures are being implemented throughout the official controls programmes (frequency of controls) and corrective actions are being taken on the basis of the information communicated by ELGO-DIMITRA. An example was provided during the GFA. The issue of improving controls at holding level (see recommendation 2013-6884-3 is being followed-up through this recommendation including the planning of controls and the recording of the results of controls.
2013-6884-3 This recommendation is based on findings and related conclusions in the following sections: Section In progress 5.1.7: The results of controls in relation to the requirements of the Hygiene Package at holding level are To improve the implementation of official not always recorded. For two holdings, visited by the audit team, only reports of controls on milking controls to ensure that controls over food hygiene performed in 2013, but not for inspections of previous years. Section 5.1.9: A structured system business operators' general and specific for following up on non-compliances and in particular of re-occurring ones was not in place in any of the hygiene requirements ensure full regions visited (no deadlines given, repeated offences and lack of enforcement, or corrective action not compliance with the requirements of followed-up/not documented). Financial penalties were imposed only in a few cases in each of the Annex II to Regulation (EC) No 852/2004; regions visited, only at establishment level and were in general related to food-safety non-compliant test that official controls are documented as results. Only written notices were given following controls at holding level. The lack of fines following required by Article 9 of Regulation (EC) controls at holding level had also been identified during the recent internal dairy audit of the MRDF. No 882/2004 (particularly for official Section 5.2.1: In all establishments visited, the audit team noted shortcomings which had either not been controls for dairy hygiene at holding noted before by the CA or had not been enforced. Section 5.2.2: In two of the five establishments where level); that appropriate action is taken in this aspects was checked by the audit team, shortcomings related to the raw milk temperature had not case of identified non-compliances (as been noted by the CA. The limit given in the HACCP was often not adhered to in one establishment required by Article 54 of Regulation (EC) while in the other one no records of the raw milk temperature checks were available. Other findings in No 882/2004); and that the approval status sections 5.1.7, 5.1.9, 5.1.1 and 5.1.2 complement these recommendation including, Section 5.1.4 on of establishments is kept under review (as keeping the approval under review. required by Article 31.2(e) of Regulation
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Reference no. and recommendation Basis of assessment Assessment (EC) No 882/2004). The initial response of the Greek authorities and updated information provided the following clarification and suggested the following actions: "Prioritisation when planning and arranging the annual inspections for 2014 (document No 1684/ 30.01.2014 of EFET) including HACCP. Completion of legislative interventions that improve the scope of the official inspection (Law 4235/2014: The new law on the enforcement of compliance measures and sanctions was adopted by the Greek Parliament and published on 11 February 2014 as No 4235/2014 (Government Gazette, Series I, No 32, 11.02.2014). Under the new law, the DGVS may now enforce compliance measures (suspension or revocation of operational permit and licence) and administrative/criminal penalties when non-compliance is found [Articles 2(2), 9(2) and 18(9)]. Ongoing actions: Promoting the modernisation of the articles on milk and dairy products of the Food and Beverages Code. Developing education programmes for 2014 that support the milk and dairy products sector. Drawing up guidelines regarding official inspections and the enforcement of compliance measures and penalties in the milk and dairy products sector. Utilising the mission’s conclusions and informing the competent authorities of them. Supervision of the proper implementation of official inspections by the competent authorities. In addition to the 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 started. (a) (b) (c) Moreover, the templates of the forms required for implementing the procedures for enforcing compliance measures were updated. (d) Furthermore, sections relating to the implementation of the law concerned have already been adapted in the training seminars for the employees of competent authorities.
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Reference no. and recommendation Basis of assessment Assessment (e) New clarifying guidelines and circulars will follow, based on new requirements resulting from the implementation of the law. Following up on the actions of undertakings, to ensure that they comply. Such follow-up will be ensured: (i) During the process used for the approval of establishments, by setting up time frames and monitoring the progress made in complying with the legal requirements and (ii) additional follow-up capabilities are possible under Law 4235/2014. Description of the basic content of circulars: Circular ref. 651/26864/26-2-2014 on planning the official inspections of dairy farms, from the Directorate for Veterinary Public Health of the Ministry of Rural Development and Food. The key changes are described under recommendation 2. Circular ref. 1684/30.01.2014 from EFET. EFET issues an annual circular providing a concise presentation of the conclusions drawn from an analysis of the previous year’s information and highlighting the priorities to be used for planning the annual inspections for the following year. As part of this process, circular ref. 1684/30.01.2014 was issued, setting out a number of priorities for the official inspections to be performed in 2014: - the need for an integrated verification of the completeness of the processes relating to milk pasteurisation, taking into account a number of parameters (pasteurising equipment settings, meeting time-temperature requirements, substantiated correct functioning of measurement devices, alkaline phosphatase test, etc.); - the need to prepare plans for the sampling operations carried out as part of the HACCP based on the streamlined criteria set by Regulation (EC) No 2073/2005. It is also stressed that the sampling intended to detect Listeria on surfaces must be carried out during the production process, not after cleaning; - the need to thoroughly examine the water control programme used by the establishment. It should be stressed that, if water is supplied by a water supply organisation, the establishment should obtain regularly (e.g. once per year) a copy of the results of the laboratory tests performed by the organisation, which must meet the requirements set out in Directive 98/83/EC. The Greek authorities provided the following up-dated information in the context of the 2015 GFA: EFET stated that 2013 was a difficult year regarding the organisation of controls, but that significant
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Reference no. and recommendation Basis of assessment Assessment efforts had been made after the audits including intensification of controls and supervision of controls, for which the DG SANTE team saw an example. In January 2014 EFET prepared and circulated a circular covering different aspects of milk controls including criteria for the planning of controls and sampling and for water controls. The DG SANTE team received a copy of Circular 1684/ 30.01.2015. With document ref. 3701/26-02-2014 from EFET, clarifications were provided to all Greek competent authorities concerning high priority matters associated with the law concerned, to ensure the correct and uniform implementation thereof. The DG SANTE team received a copy of this document. On 27 May 2014 EFET, in cooperation with the Directorate-General for Veterinary Services of the Ministry of Rural Development and Food, prepared and promoted in due manner a draft Ministerial Decision setting out the coefficients to be used in connection with the measurement criteria when imposing fines for non-compliances. The DG SANTE team received a copy of this document. As a result of intensified controls the compliance rate of FBOs increased from 90% in 2012 to 93.5% in 2013 and 97% in 2014 with improvements seen regarding infrastructure, hygiene and own-controls. Non- compliances found mainly related to general hygiene and HACCP. The results are based on controls carried out by EFET and by the Regional Units (DAOKs) The progress achieved has also contributed to an increased interest from third countries for exports. Three training seminars on milk controls were organised by EFET in 2014. The Greek authorities have taken in general appropriate actions to address this recommendation. However, additional measures taken by the CA in order to further improve the implementation of official controls with regards to general hygiene and the implementation of the enforcement and sanction system will be raised at the next GFA. The issue of improving controls at holding level (including documentation of such controls) is being followed-up through 2013-6884-2
2013-6884-4 This recommendation is based on findings and related conclusions in the Section 5.2.2: Official controls Closed for other on HACCP-based own controls were largely well implemented, but not sufficiently thorough as regards reasons To further improve the official controls the critical limits, their monitoring, the corrective action taken by FBOs when deviations take place in 46 DG(SANTE) 2015-7657 Final Version date October 2016 Audit 2013-6884 of 16 September 2013 in order to evaluate the official controls and the follow-up action taken by the competent authorities with regard to the safety of food of animal origin, specifically milk and dairy products
Reference no. and recommendation Basis of assessment Assessment over food business operators' Hazard particular in relation to pasteurisation control and temperature requirements for raw milk. Analysis Critical Control Plan based The initial response of the Greek authorities and updated information provided the following clarification procedure, in particular as regards the and suggested the following actions: critical limits, their monitoring, the corrective action taken by food business As regards document ref. 1684/30.01.2014 from EFET, this was described under recommendation 3. As operators when deviations take place in regards the circular relating to controlling the milk pasteurising process which is expected to be order to ensure full compliance with the completed in 2014, it will look in depth into certain aspects of the control of the pasteurising process requirements of Article 5 of Regulation (pasteurising equipment settings, meeting time-temperature requirements, substantiated correct function (EC) No 852/2004. of measurement devices, alkaline phosphatase test) which have already been outlined in document ref. 1684/ 30.01.2014.
The implementation of the above circulars will be verified: Through assessment of the information from the inspections performed by EFET in the first half of 2014, which is expected to be collected in July 2014. That information will provide significant indications of the level of conformity with the guidelines provided in document ref. 1684/ 30.01.2014. Through on-site verification of compliance with these circulars whenever inspections are carried out to grant approval numbers (by EFET’s central or regional agencies). Through a follow-up on the inspection reports provided by EFET’s information system and drawing conclusions relating to the verification of compliance with them. This recommendation is being further followed-up through recommendation 9 of audit report DG (SANTE) 2013-6884.
2013-6884-5 This recommendation is based on findings and related conclusion in Sections 5.2.2 that in all In progress establishments visited, the audit team noted deficiencies in relation to controls on the pasteurisation To ensure that official controls on which had not been previously identified by the CA. (e.g. lower critical limit applied in practice than pasteurisation cover also the requirements described in the , lack of corrective action or of adequately documented corrective action when the of Regulation (EC) No 2074/2005, Annex critical, inadequate monitoring of the pasteurisation, FBOs visited used alternative test methods for VIa, Chapter II related to the determination alkaline which had not been validated against the ISO method provided by Regulation (EC) No of alkaline phosphatase activity and that 2074/2005). The CA controls on pasteurisation did not include controls on the method used for alkaline food business operators can demonstrate phosphatase testing. compliance with the requirements of this 47 DG(SANTE) 2015-7657 Final Version date October 2016 Audit 2013-6884 of 16 September 2013 in order to evaluate the official controls and the follow-up action taken by the competent authorities with regard to the safety of food of animal origin, specifically milk and dairy products
Reference no. and recommendation Basis of assessment Assessment Regulation for the methods used when The initial response of the Greek authorities and updated information provided the following clarification determining the alkaline phosphatase and suggested the following actions: activity. The National Reference Laboratory (NRL) in Patras is in the process of validating a method (ISO number 11816-1) to determine alkaline phosphatase, so that it is included in the scope of accreditation (to be implemented by 12/2014). The laboratory has filed the necessary requests with the financial agencies of the Ministry of Rural Development and Food, to ensure an increase in the relevant appropriation and to obtain approval for the procurement of the necessary consumables so as to proceed with the validation of the method concerned. Following ratification of the method concerned, the NRL, in consultation with dairy producers, is planning a process to validate the alternative methods used for determining alkaline phosphatase (to be implemented by 3/2015). The Greek authorities provided the following up-dated information in the context of the 2015 GFA: The issue has been subject of discussion at the meeting of 7th December 2015 with the National Service of Accreditation. The CCA confirmed that the NRL is participating to the inter-laboratory comparative testing. The issue of what FBO’s are doing in terms of alkaline phosphatase testing and how do they comply with R 2074/2005 will be addressed in more detail during the next GFA.
2013-6884-6 This recommendation is based on findings and related conclusion in Sections 5.2.3 that FBOs had no Action still proof that methods used for testing of microbiological criteria had been validated against the reference required To ensure that official controls over food methods provided by Regulation (EC) No 2073/2005. Other shortcomings found by the : FBOs did not business operators' compliance of test the environment for L. monocytogenes or only after cleaning. Some of the FBOs visited could not Regulation (EC) No 2073/2005 cover all demonstrate that they had carried out any shelf-life studies for their products, inspections had not checked the requirements of this Regulation this and checklist did not address this issue. applicable to the dairy sector and that food business operators comply with all The initial response of the Greek authorities and updated information provided the following clarification applicable requirements of this Regulation. and suggested the following actions: "Guidelines to the competent authorities, provided by means of document No 1684/ 30.01.2014 of EFET, with respect to the following: thorough check of the rationality of sampling plans by food business 48 DG(SANTE) 2015-7657 Final Version date October 2016 Audit 2013-6884 of 16 September 2013 in order to evaluate the official controls and the follow-up action taken by the competent authorities with regard to the safety of food of animal origin, specifically milk and dairy products
Reference no. and recommendation Basis of assessment Assessment operators, so that such plans meet all the requirements of Regulation (EC) No 2073/2005; checking the method of sampling from surfaces to detect Listeria monocytogenes, so that it takes place during production and not after cleaning. Document ref. 10931/20.06.2014 from EFET “Setting out guidelines to the competent control authorities” concerning microbiological testing highlights the need for laboratories to use standard reference methods or equivalent alternative methods. As regards training, 3 three-day training programme was planned for will be conducted in 2014 concerning the official inspections of dairy products. These will be attended by inspectors from both EFET and veterinary agencies (training content: raw milk and effective pasteurisation, technology and own-check systems, microbiological criteria, labelling, using additives and food contact materials). " The Greek authorities provided the following up-dated information in the context of the 2015 GFA: The CCA provided documentation on training. A specific part has been dedicated to the microbiological criteria for official controls. The CA ensured that findings from audits and recommendations resulting from non-compliances identified are taken into account for the preparation of the seminars. So far the CA accepted that FBO microbiological testing is based on methods that are considered to be equivalent to the standard reference methods. But these methods still need to be validated. The CCA did not provide evidence that specific measures had been taken in order to ensure that FBO perform shelf-life studies for their products and that this issue is covered by the controls. The following issues will be raised at the next GFA: proof that methods used by FBOs for testing of microbiological criteria had been validated; the need for shelf-life studies and testing the environment for L. monocytogenes.
2013-6884-7 This recommendation is based on findings and related conclusion in Sections 5.1.3 of the audit report that In progress there had been some weakness in relation to cooperation and coordination between CAs: In Central To further improve the co-ordination Macedonia the agreements between the RGDREVM and the EFET are only informal and both CAs between the competent authorities perform parallel official controls (same aspects). ELGO Dimitra issues written recommendations when it 49 DG(SANTE) 2015-7657 Final Version date October 2016 Audit 2013-6884 of 16 September 2013 in order to evaluate the official controls and the follow-up action taken by the competent authorities with regard to the safety of food of animal origin, specifically milk and dairy products
Reference no. and recommendation Basis of assessment Assessment responsible for carrying out official identifies shortcomings during the visits. Nevertheless, it does not inform the CA responsible for control controls at holding level, establishment at establishment level (neither the veterinary services, nor the EFET). A notification system of raw milk level and raw milk laboratory level in non-compliances and animal health issues between FBOs, farmers and the veterinary services was in order to ensure it is efficient and effective place in the cases assessed. No such system was seen for notifying the EFET. In certain establishments as required by Article 4 (3) of Regulation only the EFET carries out controls. (EC) No 882/2004 in all regions. The initial response of the Greek authorities and updated information provided the following clarification and suggested the following actions: Meetings of the Directorate-General for Veterinary Services, EFET, ELGO-DIMITRA and NRL were conducted. The following decisions were made: (a) to organise conferences of all jointly competent organisations twice a year, for planning and reporting purposes; (b) for ELGO-DIMITRA to notify any results falling outside the limits regarding raw milk criteria, to the Directorate-General for Veterinary Services and EFET; (c) for ELGO-DIMITRA to work together with EFET and the Directorate-General for Veterinary Services in order to update the registry of undertakings and of milk collection tanks as well as the registry of milk purchasers and dairy cooperatives (d) to have the milk quality laboratories of ELGO-DIMITRA supervised by the National Reference Laboratories. The Greek authorities provided the following up-dated information in the context of the 2015 GFA: The Ministerial Decision has been updated: the laboratories of ELGO-DIMITRA have been excluded from the organisation of the official controls in order to avoid eventual conflict of interests. Only Official Laboratories from the Ministry Departments will perform official control analyses. The CCA and EFET stated that there is good cooperation between the veterinary services and EFET at regional level, although this cooperation has been formalised in two Regions by signing MoUs which have to be renewed annually. Overlaps regarding the controls between EFET and the veterinary services can only be excluded if national legislation is changed, which is not foreseen. DG SANTE will monitor progress made regarding cooperation between the different CAs involved in milk controls.
2013-6884-8 This recommendation is based on findings and related conclusion in Sections 5.2.1 of the audit report in Action taken the four establishments using municipal water, no water test results for all chemical parameters of To ensure that the official controls on 50 DG(SANTE) 2015-7657 Final Version date October 2016 Audit 2013-6884 of 16 September 2013 in order to evaluate the official controls and the follow-up action taken by the competent authorities with regard to the safety of food of animal origin, specifically milk and dairy products
Reference no. and recommendation Basis of assessment Assessment potable water cover all the requirements of Council Directive 98/83/EC were available. This has not been identified by the CA. Council Directive 98/83/EC. The initial response of the Greek authorities and updated information provided the following clarification and suggested the following actions: Actions taken Document forwarded to the operators of municipal networks which are responsible for the primary inspection of the quality of water intended for human consumption, the obligation to implement all the parameters required during the laboratory examination of water from the water supply network, with the specified frequency (document No 3598/ 25.02.14 of EFET to the Central Union of Municipalities of Greece -KEDE). All the actions taken by EFET aim to ensure a stable framework for water inspection, to be used by food producers. Document ref. 1684/30.01.2014 from EFET stresses the need to verify conformity with the stipulations set out in Directive 98/83/EC during official inspections. Update of Circular No 17783/ 11- 12-2009 of EFET for the inspection of water in food businesses (end of the first six-month period of 2014). The new circular to be completed in 2014 will be intended also for veterinary agencies. Apart from making reference to points already referred to in a previous circular, guidelines will also be provided relating to chlorination testing (as appropriate) performed on the water used by food-producing establishments. The Greek authorities provided the following up-dated information in the context of the 2015 GFA: A circular on water used by FBOs and controls on water during inspections at FBOs was circulated in March 2015. During the GFA the CCA provided examples of checks on water testing by FBOs.
2013-6884-9 This recommendation is based on findings and related conclusion in Sections 5.1.10 of the audit report In progress that according to the regional veterinary CAs met, verification of effectiveness of controls carried out by To further improve the verification of the RVUs is performed during the joint visits for approval. However, in all regions visited, the effectiveness of official controls in order to shortcomings identified by the audit team indicate that official controls have not been effective for ensure full compliance with the certain aspects of the legislation (see chapters 5.2.1, 5.2.2, 5.2.3, 5.3, 5.1.9). requirements of Article 8 of Regulation (EC) No 882/2004. The initial response of the Greek authorities and updated information provided the following clarification and suggested the following actions: The verification of effectiveness of official inspections is a standard and dynamic procedure for EFET, 51 DG(SANTE) 2015-7657 Final Version date October 2016 Audit 2013-6884 of 16 September 2013 in order to evaluate the official controls and the follow-up action taken by the competent authorities with regard to the safety of food of animal origin, specifically milk and dairy products
Reference no. and recommendation Basis of assessment Assessment which aims at constant improvement of the inspection system by utilising all kinds of information, messages, findings and data. EFET has adopted and documented a procedure of internal audits as one of the instruments used to evaluate the effectiveness of the official food inspection system. From the period that followed the audit DG(SANCO)/2012-6334 to date, the Department of Quality Assurance for Services Provided (Department of QASP), which is responsible for internal audits, has undertaken the following: 1. Development of a five-year rolling programme of internal audits. 2. Preparation of an annual schedule of internal audits covering all operational units of the institution and all processes performed. As part of carrying out internal audits, 4 internal audits have already been carried out, and the operational units audited are in the process of submitting comments on the draft report. With respect to the establishment of documented procedures, EFET has developed documented procedures for all processes performed by the body, and such procedures have been included in the Quality Assurance System (QAS). The QAS of EFET has been certified to ISO9001:2008. Ministry of Rural Development and Food: The official inspection data for 2013 will be examined, conclusions will be drawn and a specific framework of actions improving the effectiveness of inspections will be established. All information from official inspections has been collected for the year 2013. The information will then be assessed, and conclusions will be drawn and a specific framework of actions improving the effectiveness of inspections will be established. EFET: With a view to utilising the information from the official inspections conducted in 2013 and ensuring effectiveness, EFET will fulfil its obligations relating to the following: notification of circulars (pasteurisation, water); training programmes concerning official inspections of dairy products; internal audits both on the central agency and on its regional agencies in the field of milk and milk products.
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Reference no. and recommendation Basis of assessment Assessment The Greek authorities provided the following up-dated information in the context of the 2015 GFA: EFET stated that internal audits system contributes to the verification of the effectiveness of controls and provided the audit. The GFA team received a copy of the 2015 internal audit programme which included audit activities related to milk. Joint inspections of CA at Regional/RVU level in context of the approval of FBOs is seen by the CCA as an additional element of verification. The CAs did not provide additional information in order to demonstrate how the system of verification is ensuring that controls are carried out in compliance with planned arrangements (compliance with the control programme and performance of controls in line with procedures including HACCP) and that the controls achieve their aim. The time available during the GFA did not allow to discuss this issue with the CAs in detail. This recommendation is being used to assess how the CAs verify that the controls are effective with regards to shortcoming identified by audit report DG(SANTE) 2013-6884 including the effectiveness of controls on HACCP and keeping the approval status of establishments under review.
2013-6884-10 This recommendation is based on findings and related conclusion in Sections 5.1 that the NRLs had not In progress organised any proficiency test rounds and had not co-ordinated the participation of the raw milk To ensure that the designated milk laboratories in any such schemes. The ELGO Dimitra laboratories do not send any information of their National Reference Laboratories perform participation in proficiency tests to the NRLs. their duties as required by Article 33, paragraph 2 of Regulation (EC) No The initial response of the Greek authorities and updated information provided the following clarification 882/2004. and suggested the following actions: The definition of NRLs for feed and food has been determined by Decision 3865/128713/22-10-2013 in application of Article 22 of Presidential Decree 79/2007 and includes, inter alia, the NRL for milk and dairy products, which is the veterinary laboratory in Larissa and the veterinary laboratory in Patras. In the document from the Directorate General for Veterinary Medicine forwarded to the NRLs (document 136/26529/25-2-2014), the obligations of NRLs in the raw milk sector, pursuant to Article 33 of Regulation No 552/2004, are once again, stressed. 10.2 Planned actions: Meeting of the Directorate General for Veterinary Medicine with the NRLs in Larissa 53 DG(SANTE) 2015-7657 Final Version date October 2016 Audit 2013-6884 of 16 September 2013 in order to evaluate the official controls and the follow-up action taken by the competent authorities with regard to the safety of food of animal origin, specifically milk and dairy products
Reference no. and recommendation Basis of assessment Assessment and Patras, as well as with ELGO, clearly determine the powers and role of all services involved, in official laboratory tests for raw milk which will fully comply with legislative requirements (to be implemented on 5/3/2014). A draft Ministerial Decision has been prepared concerning communication, co-ordination and supervision of the 8 accredited laboratories of ELGO with respect to raw milk criteria (total plate and somatic cell count) by the National Reference Laboratories in Larissa and Patras The Greek authorities provided the following up-dated information in the context of the 2015 GFA: The role of the NRLs (Larissa and Patras) has been clearly defined and annual activity reports are issued. Both laboratories are participating to inter-laboratory comparative testing. Documentary evidence (activity reports) regarding the coordination roles of the NRLs in 2015 is still needed in order to finalise the assessment.
Audit 2014-7128 of 17 November 2014 in order to evaluate the food safety control systems in place governing the production and placing on the market of fishery products
Reference no. and recommendation Basis of assessment Assessment
2014-7128-1 This recommendation is based a finding and related conclusion in Section 5.2 of the audit report that In progress fishing vessels operating in national waters were not officially registered, contrary to EU provisions. The CA should put a system in place to According to the EU Fishing Fleet Register, a total of 15,288 fishing vessels are listed for Greece. ensure that fishing vessels operating in national waters are officially registered in Recommendation 2014-7128-2 on inspections of vessels operating in national waters is being further accordance with the requirements laid followed-up through this recommendation. down in Article 6 of Regulation (EC) No The initial response of the Greek authorities stated the following: 852/2004. "Fishing vessels are registered in line with the applicable legislation. According to Circular 3397/108310 of 9 September 2013 concerning the registration of fishing vessels, fishing vessels must be registered pursuant to Article 6 of Regulation (EC) No 852/2004.
54 DG(SANTE) 2015-7657 Final Version date October 2016 Audit 2014-7128 of 17 November 2014 in order to evaluate the food safety control systems in place governing the production and placing on the market of fishery products
Reference no. and recommendation Basis of assessment Assessment As a result of the findings of the inspection, our service will step up its efforts to increase the number of fishing vessel registrations and inspections." The Greek authorities provided the following updated information during the 2015 GFA. The legal basis for the registration of fishing vessels operating in domestic waters, including an initial inspection, is Presidential Decree 79/2007. Circular 3397/108310 provides guidance for inspector for the registration and inspection of fishing vessels. At the CCA stated out of the about 15 000fishing vessels 170 had been registered an inspected by November 2014. In 2015 meeting took place with the Directorate General For Sustainable Fisheries. Fishing vessels fishing migrating species (tuna and swordfish) need to be registered in order to get a fishing license. The Regional Units and the fisherman were informed. As a consequence of this measures put the number of registered and inspected vessels increased to 388 at the time of the GFA. The CCA prepared a complementary circular in 2015 which categorises fishing vessels based on risk and establishes the priorities for registration: >12 meter (immediate priority), below 6 meter (low priority), between 12meter and 6 meter (priority depends on the type of activity). All registered fishing vessels need to undergo a full inspection once every two years. At the time of the GFA no specific time table had been established for the registration of all vessels. Recommendation 2014-7128-2 is being further followed-up through 2014-7128-1.
2014-7128-2 This recommendation is based on findings in Section 5.3.1.2 of the audit report that inspections of fishing Closed for other vessels operating in national waters are not carried out. reasons The CA should ensure that fishing vessels operating in national waters are regularly The initial response of the Greek authorities was the same as for recommendation 2014-7128-1. inspected to verify whether the fishery Recommendation 2014-7128-2 is being further followed-up through 2014-7128-1. products are handled correctly, the cleanliness of vessels and their equipment, staff hygiene and to check for compliance with the applicable hygiene and temperature requirements as laid down in Point 1(b), Chapter I of Annex III to
55 DG(SANTE) 2015-7657 Final Version date October 2016 Audit 2014-7128 of 17 November 2014 in order to evaluate the food safety control systems in place governing the production and placing on the market of fishery products
Reference no. and recommendation Basis of assessment Assessment Regulation (EC) No 854/2004.
2014-7128-3 This recommendation is based on findings and related conclusion in Section 5.3.1.3 of the audit report In progress that regular checks on the hygiene conditions of landing and first sale as well as the correct handling of The CA should ensure that the hygiene fishery products originating from local production, intra-EU trade and imports from third countries were conditions of landing and first sale are not satisfactorily carried out. From 2010 onwards, inspections have been carried out twice a week within regularly checked as laid down in Point regular working hours (not during the night when the auction takes place) without specific instructions. 1(a), Chapter I of Annex III to Regulation With the reduced staffing levels, in these inspections, inspectors try to fulfil their duties but do no record (EC) No 854/2004 all the results of their efforts. The initial response of the Greek authorities stated the following: "The checklist for the point of landing and first sale is under review. In cooperation with the managing body for points of first sale, our service has taken measures to improve hygiene conditions and run systematic checks on the basis of the risk analysis." The Greek authorities provided the following updated information during the 2015 GFA. The CCA has given priority to inspections of auction halls as, according to national legislation, all fish has to go through auction halls. New checklists were established in 2014 with one part dealing with landing sites and the second part with auction halls. The CCA verified that for the 10 registered auction hall in Greece the inspection forms were completed by inspectors and the CCA plans to visit auction halls. The CCA stated that the new system is operation since the end of 2015. Regarding the inspections of landings sites cooperation with the Fishery's DG and the Port Authorities is explored.
2014-7128-4 This recommendation is based on findings and related conclusion in Section 5.3.1.3 of the audit report Action taken that a HACCP plan was available for the processing establishment; but not for the auction hall or the The CA should ensure that a permanent wholesale market. procedure or procedures based on HACCP principles are put in place, implemented The initial response of the Greek authorities stated the following: and maintained up-to-date in fish auctions "The managing body for public auction halls has initiated the actions to establish and implement and wholesale markets according to the procedures based on the HACCP principles." requirements laid down in Article 5 of
56 DG(SANTE) 2015-7657 Final Version date October 2016 Audit 2014-7128 of 17 November 2014 in order to evaluate the food safety control systems in place governing the production and placing on the market of fishery products
Reference no. and recommendation Basis of assessment Assessment Regulation (EC) No 852/2004. The Greek authorities provided the following updated information during the 2015 GFA. The managing body of auction halls have to implement a system based on the HACCP principles at each auction hall of the country. For example, the Keratsini fish auction system had, at the time of the GFA, submitted to the CCA a plan for evaluation which was followed by an on-the-spot check. The GFA team received a copy of this report.
2014-7128-5 This recommendation is based on findings and related conclusion in Section 5.3.2 of the audit report that Action taken organoleptic checks to verify compliance with freshness criteria established in accordance with EU The CA should ensure that organoleptic legislation were not satisfactorily carried out. examinations to verify compliance with freshness criteria are carried out in line The initial response of the Greek authorities stated the following: with the requirements laid down in "A checklist of the organoleptic characteristics of fish catches and parasites has been created". regulation (EC) No 2406/96. The Greek authorities provided the following updated information during the 2015 GFA. The CCA clarified that for fish packaging centres the system for own checks is covered by inspections and included in the checklist. For auction hall the new checklist for controls, including organoleptic checks and checks for parasites, was tested in a pilot phase in October 2015 and will be applicable as from January 2016.
2014-7128-6 This recommendation is based on findings and related conclusion in Section 5.3.2 of the audit report that Action taken regular random testing to verify compliance with the relevant EU legislation on parasites was not carried The CA should ensure that random testing out at landing and first sale level. to verify compliance with the relevant EU legislation on parasites is carried out in The original response of the Greek authorities stated the following: accordance with the requirements laid "DGVS: A checklist of the organoleptic characteristics of fish catches and parasites has been created. down in Part F, Chapter II of Annex III to Regulation (EC) No 854/2004. ΕFΕΤ (Hellenic Food Authority): EFET included official laboratory tests to detect parasites in the annual actions for the sector of food of animal origin. In particular, Circular No 4022/16-03-2015 (attached to response) entitled: 'Actions in the sector of food of animal origin', which ΕFΕΤ sent to all the competent authorities (Regional Directorates of EFET, Directorates-General for Regional Agricultural Economy and 57 DG(SANTE) 2015-7657 Final Version date October 2016 Audit 2014-7128 of 17 November 2014 in order to evaluate the food safety control systems in place governing the production and placing on the market of fishery products
Reference no. and recommendation Basis of assessment Assessment Veterinary Medicine & Regional Veterinary Units), includes fish samples in the Sampling and Analysis Programmes for 2015 with a view to detecting Anisakis spp." The Greek authorities provided the following updated information during the 2015 GFA: In addition to the information provided with the original reply and in the context of recommendation 2014-7128-5, the CCA stated that an annual sampling and testing programme has been put in place for parasite testing, covering in particular high risk products (raw or almost raw fish products for consumption such as Sushi). Between May and November 2015 30 samples were taken for testing.
2014-7128-7 This recommendation is based on findings and related conclusion in Section 5.3.2 of the audit report that Action taken official water and ice testing is only carried out for microbiology. The CA should ensure that a regular monitoring of the quality of water and ice The initial response of the Greek authorities stated the following: used in the production of fishery products "ΕFΕT: Within the sphere of its competences, and following Circular No 17783 of 11 December 2009 is carried out in accordance with the which concerned the monitoring of water on the premises of food business operators, EFET has issued parametric values and requirements laid another circular under No 4024 of 16 March 2015,which EFET sent to all the competent authorities down in Directive 98/83/EC. (Regional Directorates of EFET, Directorates-General for Regional Agricultural Economy and Veterinary Medicine & Regional Veterinary Units). The circular clarified a number of issues regarding the monitoring of water within facilities which concern both the obligations of the business operators and the principles to be complied with during official tests." The Greek authorities provided the following updated information during the 2015 GFA: The GFA team received a copy of the Circular No 4024 of 16 March 2015,which EFET sent to all the competent authorities (Regional Directorates of EFET, Directorates-General for Regional Agricultural Economy and Veterinary Medicine & Regional Veterinary Units).
58 DG(SANTE) 2015-7657 Final Version date October 2016 2. B.3 Imports of animals and food of animal origin
Inspection 2007-7242 of 21 May 2007 in order to evaluate the import control system for products of animal origin and live animals
Reference no. and recommendation Basis of assessment Assessment
2007-7242-8 This recommendation is based on findings and related conclusion in Section 5.3 of the audit report. The Action taken systems for destruction of rejected consignments, seizures from personal luggage and kitchen waste from To ensure that the disposal and destruction international means of transport was not implemented in accordance with the requirements of Regulation of rejected consignments, kitchen waste (EC) No 1774/2002 and the situation did not assure adequate disposal of this material in approved from international operating means of incinerators. There were no rendering plants and incinerators approved according to Regulation (EC) No transport and seizures takes place in 1774/2002. In Athens airport the Customs prohibited to send detained consignments for destruction to accordance with the provisions of another customs district; therefore the consignments were send for deep burying to the landfill site Regulation (EC) No 1774/2002. without any treatment although this is not permitted under EU provisions. The initial response of the Greek authorities stated the following: The department responsible for implementing Regulation 1774/2002 informed all the BIPs and the list of establishments approved for processing and destroying Category 1 and 2 animal by-products had been put on the Ministry's webpage. The Greek authorities provided the following up-dated in formation in the context of the 2015 GFA: The Environmental Service of Athens International Airport is responsible for the management of the waste of the airport (which includes as well kitchen waste and rejected consignments). A waste management agreement is in place between the airport and a private waste disposal company. The BIP verifies and keeps all the relevant documentation regarding the disposal of rejected consignments. The Local Veterinary Unit of East Attika verifies and keeps the documentation regarding the disposal of the kitchen waste. Random checks are carried out at the waste disposal company by the LVU. The GFA team received appropriate documentary during the GFA.
59 DG(SANTE) 2015-7657 Final Version date October 2016 Inspection 2009-8077 of 19 October 2009 in order to evaluate the import/transit control system and border inspection posts
Reference no. and recommendation Basis of assessment Assessment
2009-8077-11 Situation after the 2010 GFA Closed for other reasons To take measures to correct the structural The report described the shortcoming detected at the BIPs. Exchanges of letters took place between the shortcomings in the BIPs of Evzoni and Commission and the Competent Authority in relation to the intended works in these BIPs. The Neos-Kafkassos in order to comply with Commission services requested on different occasions additional information on the intended the requirements of Commission Decision refurbishment of the BIPs and during and after audit 2011-6245. Both BIPs were visited during the audit 2001/812/EC and Directive 91/496/EEC. 2013-6977, which conclude that they were The BIP facilities partially compliant with the structural and operational requirements. Overtaken by 2013-6977-4
2009-8077-13 The recommendation relates to the finding that although the Idomeni BIP is only approved for live Closed for other animals, it continues to be used for exit checks on products of animal origin in transit, which was a reasons To provide immediate assurances that the longstanding issue. The Greek authorities indicated their intention to approve the BIP for HC products, BIP of Idomeni will no longer be used for and plans were submitted to the Commission in 2011. The visited the BIP during audit 2013-6977 and checks on animal products for which it is the report stated that the construction work for the proposed approval of HC(2)was almost completed. It not approved. also stated that after the necessary finishing works and completing the equipment, the BIP would be in compliance with the proposed new approval. Overtaken by 2013-6977-4
Audit 2013-6977 of 08 April 2013 in order to evaluate the follow-up action taken by the competent authorities with regard to the import/transit control system and implementation of Commission Decision 94/641/EC
Reference no. and recommendation Basis of assessment Assessment
2013-6977-1 This recommendation is based on the finding(s) in Section 5.1.1 (page 3) that not all BIPs had access to In progress the information, relevant to the official controls, which were available to Customs. To ensure that BIP staff have access to the information available to Customs when The initial response of the Greek authorities stated the following: this information is relevant to the The response from Greece provided information regarding the BIP of Thessaloniki port (access to the on- implementation and effectiveness of the line system provided by the Thessaloniki Port Authority) and the BIP of Pireas (access to the information 60 DG(SANTE) 2015-7657 Final Version date October 2016 Audit 2013-6977 of 08 April 2013 in order to evaluate the follow-up action taken by the competent authorities with regard to the import/transit control system and implementation of Commission Decision 94/641/EC
Reference no. and recommendation Basis of assessment Assessment official controls, in line with the regarding the incoming consignments delivered by the ship companies). It was stated that further efforts requirements laid down in Articles 6 and 7 will be focused to the improvement of the access of the staff of the BIP of Pireas to the information of Regulation (EC) No 136/2004. available to Customs. The response did not provide guarantees that other BIPs have access the relevant information contained in the Customs database. The Greek authorities provided the following up-dated in formation in the context of the 2015 GFA: This recommendation was followed-up in the context of 2015-7439. The draft-report states that the memorandum of cooperation between the competent authority and Customs covers the official controls on transits. However, although it foresees the granting of access of the official veterinarians at the BIPs to the Customs database, this was not implemented. During the GFA the CCA stated that due to the sensitivity of the data it was not possible to get permanent access to Customs data. However, it was planned for 2016 to get access to Customs data on a regular basis.
2013-6977-2 This response is based on findings in Section 5.1.4 and related conclusion that BIPs staff did not have Action taken access to certain instruction regarding procedures in relation to live animals not allowing them to verify To ensure that BIP staff have access, that transporters fulfil requirements of Article 6 of Regulation (EC) No 1/2005. specifically in relation to live animals, to the necessary information relevant to the The initial response of the Greek authorities stated the following: official controls, as required by Article The Greek response stated that existing manual for live animals has been updated (late update September 8(1) of Regulation (EC) No 882/2004. 2013) and that it covers the following issues: imports of birds (other than poultry) for commercial reasons, import of birds destined to a zoo (Greece has laid down national health requirements and a model health certificate), imports of aquaculture animals (including ornamental fish), imports of live snails (national health requirements and health certificate), imports of wild animals destined to an approved organization, imports of racing pigeons and the handling of the manure. It also contains a number of annexes in relation to the declaration that has to accompany the pet animals and the model health certificate for the import of birds destined to a zoo and for the import of live snails. A reminder as far as regards the contingency plan and how the BIP staff can be updated on the official lists as well as the contact details of the persons in the Ministry that have to be contacted in case of emergency or problem is also included in the manual. At the end of the manual, a list of all the amendments is provided. The CCA (Department of Veterinary Controls of the Animal health Directorate) is responsible for the
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Reference no. and recommendation Basis of assessment Assessment update of the manual which is foreseen on an annual basis, unless new legislation that comes into force or deficiencies found during the supervision or internal audit visits require/demand a more frequent amendment. The manual as well as the accompanying document delivered to the BIPs (reference number 3530/108644~10-09-2013) are attached. The CCA intends to organize a training for the staff of the BIPs in order to present the new version of the manual before the end of 2013. The Greek authorities provided the following up-dated in formation in the context of the 2015 GFA: This recommendation was followed-up in the context of 2015-7439. The draft-report states that the BIP manual for the import/transit controls of live animals was amended in September 2013 as per recommendation No 2 of DG SANCO 2013-6977. The competent authority stated the BIPs can further consult the central level if the need arises.
2013-6977-4 This recommendation is based on several findings recorded in Section 5.1.6 in relation to shortcomings Action taken identified in relation to BIP facilities, their equipment and hygiene. To ensure compliance of each of the BIPs in Greece with the requirements for The initial response of the Greek authorities stated the following: facilities and equipment laid down in The response from Greece provided a list of action proposed for the BIPs where shortcomings had been Directives 91/496/EEC and 97/78/EC and identified. in Decision 2001/812/EC. The Greek authorities provided the following up-dated in formation in the context of the 2015 GFA: BIP of Kakavia: 1. Works took place in order to enlarge the unloading ramp and a protection has been built. A manual is in relation to unloading of consignments up to 2 tons. The GFA team received pictures of the ramp. 2. A risk analysis plan providing detailed information on the use of the existing facilities for both HC and NHC products ( for the BIPs that make use of the derogation) has been delivered to the BIPs in 2013. The GFA team received a copy of the plan. BIP of Evzoni: 1. The facilities for O have been cleaned and are kept locked. The BIP has stipulated a 5 year contract with a private vet in order to provide medical assistance.
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Reference no. and recommendation Basis of assessment Assessment 2. Works have been done in order to prevent the entrance of pathogens through the unloading area of the facilities in HC. The GFA team saw pictures of the unloading area and noticed that the gap in question had been closed. 3. The ramp in NHC has been prolonged as it was unsuitable for the loading of heavy consignments. The audit team of audit SANTE 2015-7439 saw pictures of the unloading ramp in 2015. BIP Thessaloniki Airport 1. A risk analysis plan providing detailed information on the use of the existing facilities for both HC and NHC products ( for the BIP that make use of the derogation) has been delivered to the BIPs in 2013 . The GFA team received a copy of the plan (see BIP Kakavia). 2. The BIP staff has been granted a separate room, adjacent to the facilities for live animals, with toilets and a shower , in compliance with the requirements of the current EU legislation. The GFA team received a plan with the layout of the BIP facilities and saw pictures of the shower area including the sink.
2013-6977-5 This recommendation is based on findings in Section 5.2 (page 14) and related conclusions that the Closed for other products imported under derogation cannot be traced back and no sufficient guarantees were provided reasons To extend the procedure laid down in that the products remain on the islands. Article 8(3)(a) of Regulation (EC) No 882/2004 on verification of effectiveness The initial response of the Greek authorities stated the following: to the controls carried out over products "In its response the CA proposed actions for Crete in order to address this recommendation. This imported under Decision 94/641/EC, to included visits of the establishments of three main importers and a meeting with staff of the Periphery of verify that they are consumed locally and Crete who are performing the controls and the main importers of products under derogation. not re-shipped elsewhere in the EU. With the document with reference number 3588/110184/12-09-2013, the CCA addresses officially to the Periphery of Crete all necessary actions that have to be taken by the importers in order Iraklio to be conformed with Commission Decision 94/641The CCA (Department of Sanitary Veterinary Controls) is planning as well to carry out visits to verify the conformity. The effectiveness of controls will be evaluated during the internal audit that is planned for the year 2014 (possibly the second semester). The program of the internal audits will be finalized at the end of January 2014 (and will then be delivered to you) but both the CCA (relevant department) and the BIPs (including
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Reference no. and recommendation Basis of assessment Assessment some points of entry under derogation) will be included." This issue was followed-up in the context of audit DG(SANTE)2015-7439. The audit report states that this recommendation has been partially addressed. Overtaken by recommendation 2015-7439-3.
Audit 2013-6895of 9 April 2008 in order to evaluate the use of the TRACES system
Reference no. and recommendation Basis of assessment Assessment
2013-6895-2 This recommendation is based on findings and conclusion in Section 5.3 of the audit report. The Action still conclusion is also supported by findings recorded in Sections 5.4 and 5.5.Verification activity, including required To ensure that the procedures laid down in audit, in relation to the correct use of TRACES at BIPs was well developed and contributes to improving Article 8 (3) of Regulation (EC) No data entry. The verification is less developed at the LVU and SLVU levels, where this is competence of 882/2004 to verify the effectiveness of the Prefectures, and repeated errors remain undetected. official controls cover all TRACES users, and specifically LVUs, in order to The initial response of the Greek authorities stated the following: guarantee the effectiveness and As mentioned during the audit, the supervision of the LVUs is not under the responsibility of the CCA. appropriateness of the controls. The CCA will inform the local competent authorities (prefectures etc) that they need to supervise the use of TRACES. In addition, given the non-conformities found during the audit, the CCA intends to include the LVUs at unofficial supervision visits in order to verify the effectiveness of the use of TRACES, always in relation to the availability of resources. TRACES issues make part of the audits performed to the LVUs by the Directorate of Veterinary Audits and Controls. This issue was followed-up in the context of audit of 2015-7439. The audit team noted that the competent authority has not assessed the effectiveness of official controls as regards the use of TRACES at the LVUs. The Greek authorities provided the following up-dated in formation in the context of the 2015 GFA: 64 DG(SANTE) 2015-7657 Final Version date October 2016 Audit 2013-6895of 9 April 2008 in order to evaluate the use of the TRACES system
Reference no. and recommendation Basis of assessment Assessment The CCA stated that some verification of the correct use of TRACES including the verification activities of the LVUs is done, but this is not systematically recorded. LVUs have checked in 2013 16% of consignments and 21% and 20% in 2014 and 2015 respectively. The CCA provided the GFA team with some examples of verification and follow-up of TRACES related issues and admitted that in some cases issues arising from TRACES checks are resolved through direct contact with LVUs by phone. The CCA also stated that additional training is planned for 2016 in order to address this recommendation. The CCA also undertook to better document contacts with LVUs in relation to verification of the correct use and verification of TRACES entries by the LVUs. However, no specific measures were proposed to ensure that Local Veterinary Units make effective use of TRACES.
2. B.4 Feedingstuffs and animal nutrition
Inspection 2008-7724 of 27 January 2008 in order to evaluate the implementation of measures concerning official controls on feed and compliance with requirements for feed hygiene
Reference no. and recommendation Basis of assessment Assessment
2008-7724-1 This recommendation is based on a conclusion and associated findings in Section 5.2.1 of the audit report Action taken which stated that there was a lack of communication existing between EOF and DAPI (EOF did not To ensure efficient and effective provide information on imports, CCA was not aware that EOF decisions, feed inspectors were not always coordination between the competent informed about deficiencies found by EOF inspectors). authorities involved in official controls on feed as required by Art. 4.3 of Regulation Situation after the 2010 GFA: (EC) No 822/2004. Following the adoption of Law 3698/2008 (A'198): "Law on livestock and other provisions" under which DAPI was designated as Central CA for the control of additives, the Joint Ministerial Decision (JMD)
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Reference no. and recommendation Basis of assessment Assessment 326385/2009 (V'2103) was adopted, which contained the necessary implementing measures on additives for Regulation (EC) 1831/2003. The above was sent to CMD Directorates Rural Development for implementation. In addition to the above, documents have been sent to the Directorates of Rural Development, which clarified several points of both Regulation 1831/2003 and the JMD 326385/2009 and how controls should be performed. During the GFA, DAPI confirmed that inspectors had been instructed to inform EOF (the CA responsible for medicated feedingstuffs) whenever a non-compliance related to medicated feed is detected while performing feed controls. The Greek authorities consider that there is no need for a formal co-operation agreement between DAPI and EOF, based on the view that they consider the legal definition of competencies for both bodies to be sufficient. The CAs, in their comments on the draft country profile, indicated that the draft revised manual of controls includes the need for DAPI to inform EOF when medicated feedingstuffs would be identified during an inspection (see also recommendation 2008-7724-6). For more information, see chapter 1 of the country profile document "the organisation of food safety, animal health, animal welfare and plant health control systems". The Greek authorities provided the following up-dated information in the context of the 2015 GFA: Prior to the GFA 2015 the CCA provided the following update which applies since the reorganization of the Ministry: “The Ministry of Rural Development and Food is responsible for issues relating to feed additives in accordance with ν.3698/2008. More specifically and in accordance with the Π.Δ.107/28-8-2014, feed additives are the responsibility of the Directorate of Animal Nutrition, Feed & Pasture (DANFP), via the Department of feed additives. The Joint Ministerial Decision 326385/29-9-2009 26.5.2005 contains the detailed rules for the application of Regulation (EC) 1831/2003 on additives. Especially as regards imports of additives and pre-mixtures of additives, the collection of computerised data on imported feed entered into force on 1/9/2014, via circular No. Orig. 275/92366/16-7-2014. This makes available
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Reference no. and recommendation Basis of assessment Assessment detailed information on imports of additives. Under the national feed control programme, and in order to verify the elimination of antibiotics as feed additives, non-medicated feed is controlled for the presence of antibiotics. The Directorate of Animal Nutrition, Feed and Pasture shall inform the EOF and the Directorate for Animal Welfare, Medicines & Veterinary Applications in cases where antibiotics are detected.” During the GFA 2015 the CCA stated that with the creation of the database and the new organizational structure of the Ministry the Department of Feed Additives was now more effective. Labelling issues had been dealt with. The new database system makes available information on imports, raw materials and additives. The main users of the system are all the feed supervisors located at entry points (the CCA provided a copy of the User Manual for the Feed database to the GFA team). The EOF does not have direct access to the database but the Ministry provides them with relevant information in relation to antibiotics. The CCA provided the GFA team with copies of documents showing coordination with EOF, and with the Animal Welfare Directorate of the MRDF, regarding cases where antibiotics was found in Feed.
2008-7724-3 This recommendation is based on a conclusion and associated findings in Section 6.1 of the audit report Action taken that most of the feed inspectors met had a limited experience on the feed sector, some being totally new To ensure that official staff carrying out to it. In addition, a lack of training on the feed hygiene requirements set out by Regulation (EC) No official controls on feed receive 183/2005, in particular the principles underpinning HACCP, was undermining their ability to undertake appropriate training on the requirements of their duties competently and to carry them out in the consistent manner. Regulation (EC) No 183/2005 so that they can execute their duties competently and Situation after the 2010 GFA: consistently as required by Art. 6(a) of The 2008 training seminars for feed inspectors have been completed. Further training is planned for Regulation (EC) No 882/2004. inspectors on more general matters relating to controls. CA was requested to provide details of all training held in 2008, indicating the date(s), duration, agenda, Prefectures covered and number of participants from each Prefecture and also the plan for 2009 training. The Greek authorities provided the following up-dated information in the context of the 2015 GFA: Prior to the GFA 2015 the CCA provided the following update:
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Reference no. and recommendation Basis of assessment Assessment “In the context of preparation of the feed inspectors in the last years (from 2010), we have taken the following actions: (a) coordination for sending a total of 23 supervisors (30% of a total of 61 supervisors) to European Commission BTSF seminars on: Feed legislation (feed law, HACCP, contaminants in food and feed, controls on imports of certain feed and food of non-animal origin pursuant to Regulation (EC) No 669/2009. Trained inspectors shall endeavour to disseminate the information received from the seminars to their colleagues in the same Regional Unit and in some cases, feed inspectors of other regional units of the same region. (b) coordination to send 8 officials from a total 22 staff (at a rate of 36 %) from the country’s three feed control laboratories to BTSF seminars on feed law and feed law (undesirable substances in food and feed). c) because the responsibility of our department included the on-the-spot check code for granting approval of feed business operators, our Department has since 2010 carried out on-the-spot checks in 21 regional units in cooperation with the competent local feed inspectors, some of them more than once. In the context of that cooperation colleagues in local services are briefed on controls on feed. In some cases there is the presence of supervisors and other regional units, for example in the year 2010 in the Regional Unit of Drama (presence of supervisors of regional units of Kavala, Serres, Xanthi), and West Attica Regional Units (presence of supervisors of Ilia and Evrytania). In addition to the above, our department intends to undertake a update-training course for feed inspectors of all regions of the country for controls on feed, with particular attention being paid to where there have been major deficiencies, such as the application of HACCP principles by feed businesses. In addition, 7 officials from our department have participated in 28 European Commission BTSF seminars on subjects such as: Feed legislation (feed law, HACCP, contaminants in food and feed, controls on imports of certain feed and food of non-animal origin under Regulation 669/2009, Rapid Alert System for Food and Feed (RASFF) risk analysis of genetically modified organisms, internal audit (audit).” During the GFA 2015 the CCA stated that apart from BTSF training, the Ministry had arranged training
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Reference no. and recommendation Basis of assessment Assessment for 30 feed inspectors/substitutes. For 2015-2016, a program of a series of 2-day training courses has been approved by the Ministry and an agreement has been reached with the Regional Governors regarding travel expenses. The training started in November 2015 and will continue in the various regions in March to June 2016, and in September 2016 (the CCA provided the GFA team with documentation on the 2015-2016 courses). HACCP is included in the training. The CCA’s objective is that training will in future be organized through the Greek national training agency and they have made an application to the agency for that purpose. Regarding BTSF training courses, the material is disseminated to interested parties (a document to this effect was shown to the GFA team). The CCA’s Intranet also contains a register of feed inspectors who have been trained, and a register of those who would like to participate (documents were provided to the GFA team). The issue that appropriate official controls shall be performed in approved and registered feed operators (2008-7724-10) has partly been followed-up through recommendations 2008-7724-3. 2008-7724-4 This recommendation is based on a conclusion and associated findings in Section 6.1 of the audit report In progress that the arrangements aiming at ensuring internal supervision were based on the information To ensure that the effectiveness of official communicated by the feed inspectors. However, inspections were not documented and as the currently controls on feed is verified as required by available set of documentation needed to be further developed, this flow of information was incomplete Art. 8.3 of Regulation (EC) No 882/2004. and did not allow the CCA to verify, the effectiveness of official controls on feed.
Situation after the 2010 GFA:
During the 2010 GFA, the Greek authorities indicated that no additional audits had taken place since 2008 in the feed area. The audit team requested information on the systems in place to verify the effectiveness of controls between the prefectures and DAPI, including the reporting system in place. The Greek authorities provided the following up-dated information in the context of the 2015 GFA: Prior to the GFA 2015 the CCA provided the following update: “Under the new organisational structure of the Ministry, which applies from 1-1- 2015, a new Directorate of Agricultural, Animal, Veterinary and Fisheries Controls has been established, with the objective of monitoring the verification of effectiveness of official controls at central and regional level.
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Reference no. and recommendation Basis of assessment Assessment However, our service, within its powers and capabilities, makes random controls of procedures and the way official inspection is implemented by the regional services in connection with: A. Cases of non-compliance with the applicable legislation (documents, minutes and control reports) B. Cases of the approval of FBOs and related documents (correspondence, control reports) for which we receive the information C. Participation in the performance of on-the-spot checks D. Any other way of receiving knowledge of test cases.” The service referred to above is the Ministry’s Directorate of Animal Nutrition, Feed and Pasturelands – DANFP. During the GFA 2015 the CCA stated that they (i.e. the DANFP) undertake verification activities, in the cases mentioned above, with a view to making controls more effective. These activities include on-the- spot controls with the feed inspector and the examination of control reports (the CCA provided the GFA team with copies of some supporting documentation on this). The CCA also gave examples of some of the results. In one case where the performance of a Regional Unit was unsatisfactory, the CCA visited the Unit, and a solution was found by offering the staff member other fields of work. Another example is that laboratories no longer accept samples when a report has been incorrectly completed. The CCA stated that the verification of effectiveness of controls on a routine basis is not done at regional level. The DANFP is currently considering the development of specific procedures on the verification of effectiveness. They are in contact with other services of the Ministry to see how they are progressing in their respective areas. The DANFP hope to develop some procedures in 2016. Regarding internal audits, the CCA stated that an audit programme is being developed by the new Directorate of Agricultural, Animal, Veterinary and Fisheries Controls. This Directorate reports directly to the Minister. The audit programme will cover all areas of official controls and will be developed on a risk-basis. A five-year rolling programme will be established first, and then an annual programme. The CCA undertook to provide the Commission services with details of the programme when developed. The issue that that appropriate official controls shall be performed in approved and registered feed operators (2008-7724-10) is being followed-up through recommendations 2008-7724-4.
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Reference no. and recommendation Basis of assessment Assessment
2008-7724-5 This recommendation is based on a conclusion and associated findings in Section 6.6 of the audit report Action taken that the risk that phased out antibiotics might have continued to be used was not taken fully into account To carry out official controls on feed on a in the annual monitoring plan as no samples are foreseen to check for their presence in feed. risk basis as required by Art. 3.1 of Regulation (EC) No 882/2004 Situation after the 2010 GFA: During the 2010 GFA, the Greek authorities indicated that the national feed control programme implemented in 2009 and 2010 categorised feed business activities on a risk-basis. They provided a copy of the National Feed Inspection Programme dated 3 December 2009 which described how establishments should be classified on a risk basis, and included criteria for determining the frequency of inspections. This document had been provided to the prefectural services. In their comments on the draft country profile, the CAs stated, inter alia, the following: “Certain Directorates of REVM of the Regional Units had communicated to the DGAP the classification of businesses on the basis of the criteria laid down in the National Feed Inspection Programme. By the end of 2011, all Directorates of REVM must have communicated the information.” The Greek authorities provided the following up-dated information in the context of the 2015 GFA: Prior to the GFA 2015 the CCA provided the following update: “In accordance with the national feed control programme which is sent to the inspectors each year, there are instructions for the classification of companies according to the level of risk and type of activity. The categorisation of feed operators is notified to our department and is taken into account in the formulation and the targeting of the next national programme regarding the fields, type and number of sampling/analyses. The elements to be taken into account include the type of undertaking, the history of non-compliance, the potential risks which may affect the safety of the feed and the feed inspectors. The national feed control programme as regards undesirable substances shall be drawn up on the basis of a risk analysis of the type of feed and the animal species for which they are used. The classification of undesirable substances according to the level of risk they pose to the various feeds is based on the recommendations of the European Commission, any information from the RASFF and the history of laboratory analyses of the results of controls of previous years.”
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Reference no. and recommendation Basis of assessment Assessment During the GFA 2015 the CCA provided the GFA team with a copy of the National Feed Control Programme for 2015. The Programme sets out the priorities for inspections in the area of feed, the distribution of samples per regional unit and per category of analysis, and the frequency of inspections based on a risk analysis table. Regarding the risk categorisation returns from Regional Units for recent years, the CCA had not found any problems with the returns so far. According to the CCA, the codes help the regional units to make the categorisation. The CCA confirmed that press cakes, animal fats and fish oils are covered.
2008-7724-6 This recommendation is based on a conclusion and associated findings in Section 6.2 of the audit report Action taken that the CCA had developed and circulated a check-list for inspections to FBOs. However, the feed To carry out official controls on feed in inspectors met were not filling this document out. accordance with documented procedures as required by Art. 8.1 of Regulation (EC) Situation after the 2010 GFA: No 882/2004. CA stated that this recommendation is addressed by the procedures referred to under recommendation 2008-7724-5 (chapter 3.6.3). GFA 2010/8368 In their response to the inspection report the Greek authorities stated that document JMD 323306/2007 (Determination of the supplementary measures necessary for implementation of Regulation (EC) No. 178/2002 and Regulation (EC) No. 882/2004 of the European Parliament and of the Council regarding the general principles of safety and official controls for animal feed) contained a control report to be drawn up by inspectors. Documented procedures for conducting controls were also being prepared at the time. (A copy of JMD 323306/2007 was provided during the 2010 GFA.) During the 2010 GFA, the Greek authorities referred to the documentation provided in response to recommendation 2008-7724-5, as shown above (National Feed Inspection Programme dated 3 December 2009). They also stated that the Manual that had been drafted in 2008, had been under revision since September 2010, and was expected to be finalised early in 2011. The updated Manual would contain checklists for
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Reference no. and recommendation Basis of assessment Assessment completion by inspectors. The Greek authorities in their comments on the draft indicated that the editing of the revised feedingstuffs control manual has been completed and is now in the signature stage. It will be communicated to the Directorates of REVM for implementation and will be posted on the website of the feedingstuffs department shortly. The Greek authorities provided the following up-dated information in the context of the 2015 GFA: Prior to the GFA 2015 the CCA provided the following update: “The instructions of the revised manual have been largely incorporated in the documents which accompanied and accompany National Feed Inspection Program every year. The updated manual has been issued.” During the GFA 2015 the CCA provided the GFA team with a copy of the revised manual, which includes the checklists and instructions on completing them. This version of the manual is dated 13/10/2015 and was circulated on 28 October 2015. The CCA stated that inspectors are reminded to complete the checklists. To check that they are being completed, the CCA picks an inspector at random and ask him/her to send in their reports, which are then reviewed by the CCA. The CCA also asks for the control report in all cases where approval of an establishment is recommended. There were some cases where the checklists were poorly filled out.
2008-7724-7 This recommendation is based on a conclusion and associated findings in Section 6.3 of the audit report Action taken that the network of official laboratories in charge of feed controls had been reinforced to create To ensure that adequate laboratory supplementary analytical capacity for feed safety analyses. Solutions had been found to reduce the capacity for testing exists as required by administrative procedures delaying the selection of laboratories. However, there was a potential risk that Art. 4.2(c) of Regulation (EC) No this was affected by insufficient financial resources. 882/2004. Situation after the 2010 GFA: The Greek authorities in their response to the inspection report described the laboratory network responsible for testing animal feed in Greece involving three official feed controls laboratories, based in Likovrisi, Larissa and Thessaloniki, and in other private laboratories.
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Reference no. and recommendation Basis of assessment Assessment The Thessaloniki control laboratory specialises in the verification of feed analytical composition. The laboratory in Likovrisi carries out analyses for aflatoxins B1 and processed animal protein The laboratory in Larissa analyses for heavy metals. An agreement had also been signed with a private accredited laboratory for mycotoxins (zearalenone, ochratoxin A, fumonisins, Τ-2 and ΗΤ-2) Analysis of dioxins and dioxin-like PCBs, as JMD 323306/07 stipulates, will be assigned to the National Centre for Scientific Research “Demokritos”. In their response to the inspection report, the Greek authorities also stated that JMD 263233/2008 (Establishment of officials controls on feed and amendment of Decree 323306/2007 of the MoF MRDF) had secured the necessary resources to contribute to financing controls, including laboratory analyses. In addition, the necessary measures had been taken to secure further resources to conduct the analyses. The Greek authorities, in their comments on the draft country profile submitted data on the number of analyses conducted in 2009 and on the first four months of 2010. The date shows that 30 samples were analysed during this period for the analyses of dioxins and dioxin-like PCBs in National Centre for Scientific Research “Demokritos”. As regards Heavy metals, 75 samples have been analysed in a private laboratory. The Greek authorities provided the following up-dated information in the context of the 2015 GFA: Prior to the GFA 2015 the CCA provided the following update: “1. The three official laboratories to carry out analyses on feed samples, which are accredited in accordance with European standards (EN ISO/IEC 17025), extended after 2010 fields of accreditation and other analytical methods, as indicated in the accreditation certificates: A. Athens’: Determination of analytical constituents, detection of processed animal protein, additives (Cu, Zn) gossypol, insoluble solid in oils and fats, HG into fishmeal and ochratoxin A, aflatoxin B 1 B. Thessaloniki’s: Determination of analytical constituents and additives (Cu, Zn, Fe, Mn), detection of processed animal proteins (microscopic determination), DNA identification of ruminants by PCR.
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Reference no. and recommendation Basis of assessment Assessment C. Larissa’s: Determination of analytical constituents and additives (Cu, Zn, Fe, Mn). 2. The financial envelope for the implementation of the annual audit plan is covered by fees as set out in Article 8 of Joint Ministerial Decision 263233/08. The remainder of this to be deposited in an account in the τ.γ.κ. Decision Joint Ministerial Decision 334133/2006 (Government Gazette II 1829) to be used to cover the costs of official controls. 3. The three accredited State laboratories responsible for carrying out the analyses, which carry out the accreditation. For analyses which are not yet accredited, the competent authority shall take all necessary steps to ensure the appropriations for the tendering for private accredited laboratories.” During the GFA 2015 the CCA confirmed that the laboratory capacities were sufficient to implement the national control plan in 2014 and 2015. For the 1st time, pre-approval for funding for the next year (2016) was received in 2015. The CCA confirmed that the tendering procedures private laboratories allowed for timely results to be obtained in 2014 and 2015. All funds for private laboratories have been approved for 2015 and 2016. Progress has been made with the tendering procedures and 3 tenders have been issued, for dioxins (National Centre for Scientific Research “Demokritos”), for GMOs and for undesirable substances in feed. The CCA provided the GFA team with copies of supporting documents regarding the matters above.
2008-7724-9 This recommendation is based on a conclusion and associated findings in Section 5.5.2 of the audit report Action taken that no approval or registration have been yet granted according to Regulation (EC) No 183/2005. The To ensure without delay the CCA stated that once the draft joint ministerial decision is signed, instructions would be circulated to implementation of Regulation (EC) No launch the new approval and registration process. 183/2005 and particularly the approval and registration of all FBOs as required by Art. Situation after the 2010 GFA: 11 of the said Regulation. The Joint Ministerial Decision 340668 of 28-11-2008 for implementation of Regulation (EC) 183/2005 is in force since November 2008. At the time of the 2010 GFA, there were 109 approved establishments and 1535 registered operators. The Joint Ministerial Decision 340668/2008 had been modified in September 2010, to accelerate the
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Reference no. and recommendation Basis of assessment Assessment integration of controls and to register operators. A copy of the decision was provided. The Greek authorities indicated that the registration of feed business operators was expected to be completed in March 2011. The Greek authorities in their comments on the draft indicated that the register of feed businesses has been completed and posted on the website of the feedingstuffs department since 20/5/20011 (see also recommendation 2008-7724-6). The total number of registered businesses amounts to 3595 and of approved businesses to 152. Details per regional unit were submitted. This table also lists the stock farmers producing feedingstuffs only for their own animal holdings. Stock farmers producing additive- free feedingstuffs are registered in the databases kept by veterinary departments, which are available to each Directorate of Rural Economy and Veterinary. The Greek authorities provided the following up-dated information in the context of the 2015 GFA: Prior to the GFA 2015 the CCA provided the following update: “The process of approval and registration of feed operators within the meaning of the Regulation. (EC) No 183/2005 has been completed. It should be noted that the new entries/approvals and closures of undertakings constantly arise. Our service updates on a daily basis the records concerning the register of registered and approved establishments, on the basis of the information received from the regional services about the resulting changes. The business register which is available on the Internet, on the website of the Ministry, shall be updated at least 2 times a year.” During the GFA 2015 the CCA provided a link to the list of approved establishments on the CCA’s website: http://www.minagric.gr/index.php/en/farmer-menu-2/livestock-menu/461-feedingstuffs-cat/1385- feedingstuffs-art The CCA stated that the list on the web was updated twice a year, after consultation with the Regional Units, who keep their own data up to date. The CCA has an open channel of communication with the Regional Units and updated data is also requested when there is an approval or revocation. The CCA provided copies of documents showing exchanges with the Regional Units on the update process. Regarding proactive checks on FBO registration, inspectors are obliged to check if they notice anything
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Reference no. and recommendation Basis of assessment Assessment during controls. The CCA can also do this in the context of on-the-spot checks. Regarding FBOs involved in the direct drying of feed materials, the CCA stated that they are not registered by them. However, such FBOs are registered by EFET. The CCA told the GFA team that the latest numbers of FBOs registered/approved were 3890 and 164 respectively.
2008-7724-10 This recommendation is based on a conclusion and associated findings in Section 5.5.4.4 of the audit Closed for other report that the relevant recommendations of report 7295/2004 concerned ensuring that appropriate reasons To carry out appropriate official controls official controls are performed in approved and registered operators. The audit in 2008 found that none of to ensure compliance with the the shortcomings detected by the mission team had been previously identified during official controls. requirements laid down in Annex II to The feed inspectors met in one approved feed mills clearly stated that they were not monitoring the Regulation (EC) No 183/2005. correct implementation of the HACCP system as they did not have a sufficient knowledge. Situation after the 2010 GFA: The Greek authorities in their response to the inspection report confirmed that controls under the 2009 inspection programme would be in accordance with the new legislation. To ensure implementation of controls relating to the approval of feed establishments in accordance with Regulation 183/2005 and Ministerial Decision 340668/2008, seminars were held for all supervisors in the feed sector. In addition, guidelines had been sent by DAPI to the Directorates of Rural Development for better implementation of this legislation. This recommendation is being followed-up through recommendations 2008-7724-3 and 2008-7724-4.
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Inspection 2007-7611 of 15 October 2007 in order to evaluate the implementation of health rules on animal by-products (ABP)
Reference no. and recommendation Basis of assessment Assessment
2007-7611-1 This recommendation was overtaken by 2009-8333-8 and 10 Closed for other reasons To increase efforts to ensure that adequate arrangements and sufficient infrastructure are in place to meet the requirements of Art. 3 of Regulation (EC) No 1774/2002.
2007-7611-2 This recommendation was overtaken by 2009-8333-1 Closed for other reasons To ensure that sufficient staff are available within all levels of the relevant CAs to enable a system of official controls which satisfies the requirements of Art. 26 of Regulation 1774/2002, to be implemented effectively throughout the ABP chain, as required by Art. 4(2)(c) of Regulation (EC) No 882/2004.
2007-7611-3 This recommendation was overtaken by 2009-8333-2 Closed for other reasons To ensure that officials responsible for approving ABP plants and for controlling the ABP chain in accordance with Art. 26 of Regulation (EC) No 1774/2002 receive, for their area of competence, appropriate training enabling them to undertake their duties, as required by Art. 6 of Regulation (EC) No 882/2004.
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Reference no. and recommendation Basis of assessment Assessment
2007-7611-4 This recommendation was overtaken by 2009-8333-12 Closed for other reasons To ensure without delay that ABP plants are approved in compliance with Artt. 10 to 12 and 17 to 18 of Regulation (EC) No 1774/2002. 2007-7611-5 This recommendation was overtaken by 2009-8333-12 Closed for other reasons In the light of experience gained, to consider extending the scope of the final approval inspection performed by the CCA in processing plants to include other types of ABP plants, in order to ensure that all plants approved meet the relevant requirements of Artt. 10 to 12 and 17 to 18 of Regulation (EC) No 1774/2002. 2007-7611-6 This recommendation was overtaken by 2009-8333-4 Closed for other reasons To ensure that the documented procedures for the official control of ABP plants are followed and that the results of the inspections are documented, as required by Artt. 8(1) and 9 of Regulation (EC) No 882/2004 and that actions to correct shortcomings are implemented as necessary, as required by Art. 26 of Regulation (EC) No 1774/2002.
2007-7611-7 This recommendation was overtaken by 2009-8333-8 Closed for other reasons To ensure that commercial documents are used as required by Annex II to Regulation (EC) No 1774/2002.
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Reference no. and recommendation Basis of assessment Assessment
2007-7611-8 This recommendation was overtaken by 2009-8333-11 Closed for other reasons To ensure without delay that all ABP, and in particular SRM, are disposed of as required by Artt. 4(2), 5(2) and 6(2) of Regulation (EC) No 1774/2002, as applicable.
2007-7611-9 This recommendation was overtaken by 2009-8333-7 Closed for other reasons Pending the availability of the infrastructure necessary to comply with the requirements of disposal of ABP laid down in Artt. 4(2), 5(2) and 6(2) of Regulation (EC) No 1774/2002, to ensure that where ABP is landfilled or buried in ways not authorised by the said Regulation this does not present a risk to animal or public health.
2007-7611-10 This recommendation was overtaken by 2009-8333-3 Closed for other reasons To strengthen the system of supervision to ensure that when the audits identify deficiencies that suitable corrective measures are taken in order to ensure that the official controls satisfy the requirements of Regulation (EC) No 882/2004 and Art. 26 of Regulation (EC) No 1774/2002.
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Reference no. and recommendation Basis of assessment Assessment
2007-7611-11 This recommendation was overtaken by 2009-8333-13 Closed for other reasons To take all necessary measures to ensure that when recommended by the PVS sanctions for non-compliances with Regulation (EC) No 1774/2002 are applied which are effective, proportionate and dissuasive, as required by Art. 55 of Regulation (EC) No 882/2004 and in accordance with Art. 26 of Regulation (EC) No 1774/2002.
Inspection 2008-7735 of 19 October 2008 in order to evaluate protective measures against Transmissible Spongiform Encephalopathies in sheep and goats
Reference no. and recommendation Basis of assessment Assessment
2008-7735-3 The CA provided the following statistics for 2009 in relation to the minimum sample sizes set in Action still Regulation (EC) No 999/2001 Annex III, Chapter A.II in ovine and caprine animals, required To comply with the monitoring targets set out in Chapter A, II (2) and (3) of Annex Ovine II(2) 11,697, (3) 5,370 III to Regulation (EC) No 999/2001. Caprine (2) 5,809, (3) 2,656 The CA pointed out that in 2009 and 2010 they had reached the target set in the sheep for human consumption category. No data had been provided for goats. The Greek authorities provided the following up-dated information in the context of the 2015 GFA: The monitoring targets were not reached in the period 2008 to 2013 and have been significantly lower in 2015 compared to 2013 (for goats and sheep). The CCA stated that the laboratories are faced to lack of staff and that reagents need to perform the 81 DG(SANTE) 2015-7657 Final Version date October 2016 Inspection 2008-7735 of 19 October 2008 in order to evaluate protective measures against Transmissible Spongiform Encephalopathies in sheep and goats
Reference no. and recommendation Basis of assessment Assessment testing are not always available. For example, at the time of the GFA the laboratories had reagents sufficient to cover the next 3 weeks. However, the tender (which takes 3 months) had not been launched. Both factors, lack of staff and reagents, leads to delays in testing TSE samples. The CCA also admitted that the programme for the eradication of TSE was not successful in Greece so far. In order to improve the situation a new programme was launched in 2014 by which the Centre for Genetic Improvements of Animals breeds resistant breeds. So far 250 fully resistant animals have been offered to farmers. This programme will be continued in 2016 together with intensified sanitation measures. Data for the period 2008-2013 indicate that Greece still does not comply with the monitoring targets.
2008-7735-6 The Slaughterhouses and Other Facilities Unit takes account of the comments made during previous Closed for other checks on the inspections performed in order to identify and address the shortcomings observed. reasons To undertake follow-up controls on SRM in order to verify that action is taken to This recommendation was overtaken by 2009-8333-17 correct identified shortcomings, as it is required by Art. 54 of Regulation (EC) No 882/2004.
2008-7735-7 With regard to compliance with Regulations (EC) No 999/2001 and No 1774/2002 concerning SRM Closed for other produced, please note that in 2010, the programme for the collection and disposal of fallen animals will reasons To ensure that SRM produced as a result be implemented under the responsibility of the Regions. The measures are now being drawn up. of home slaughtering of small ruminants, and fallen animals are collected and This recommendation was overtaken by 2009-8333-11 disposed of in compliance with Regulations (EC) No 999/2001 and 1774/2002.
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Reference no. and recommendation Basis of assessment Assessment
2009-8333-1 The issue made by this recommendation is being followed-up through recommendation 2011-8810-3 Closed for other reasons To ensure that sufficient staff are available within all levels of the relevant CAs to enable the effective implementation of the system of official controls foreseen by Art. 26 of Regulation (EC) No 1774/2002, as required by Art. 4(2)(c) of Regulation (EC) No 882/2004.
2009-8333-2 This recommendation was overtaken by 2011-8810-1 Closed for other reasons To enhance efforts to ensure that officials responsible for approving ABP plants and controlling the ABP chain are competent to perform their tasks and are kept up to date, as required by Art. 6 of Regulation (EC) No 882/2004. Closed for other 2009-8333-3 This recommendation was overtaken by 2011-8333-2 reasons To strengthen the system of internal supervision to ensure that corrective measures are implemented to address deficiencies identified in the effective implementation of official controls, as required by Art. 8(3) of Regulation (EC) No 882/2004. Closed for other 2009-8333-4 This recommendation was overtaken by 2011-8333-3 reasons To ensure that the official controls of ABP plants are organised and implemented with a frequency that takes into account the
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Reference no. and recommendation Basis of assessment Assessment factors set out in Art. 26 of Regulation (EC) No 1774/2002 and Art. 3 of Regulation (EC) No 882/2004.
2009-8333-5 This recommendation was overtaken by 2011-8810-4 Closed for other reasons To ensure that the documented procedures for the control of ABP plants are followed and that the results of official controls are recorded as required by Artt. 8(1) and 9 of Regulation (EC) No 882/2004, respectively.
2009-8333-6 This recommendation was overtaken by 2011-8810-6 Closed for other reasons To put in place adequate arrangements and sufficient infrastructure to meet the requirements of Art. 3 of Regulation (EC) No 1774/2002, so that ABP are disposed of as required by Artt. 4(2), 5(2) and 6(2) of the said Regulation.
2009-8333-7 This recommendation was overtaken by 2011-8810-8 Closed for other reasons To make further progress in ensuring that commercial documents contain the information required by Chapter III of Annex II to Regulation (EC) No 1774/2002.
2009-8333-8 Overtaken by recommendation 2011-8810-9 Closed for other reasons To enhance efforts to ensure that records of ABP generated in establishments contain the information required by 84 DG(SANTE) 2015-7657 Final Version date October 2016 Inspection 2009-8333 of 17 May 2009 in order to evaluate the implementation of health rules on animal by-products (ABP)
Reference no. and recommendation Basis of assessment Assessment Chapter IV of Annex II to Regulation (EC) No 1774/2002.
2009-8333-9 Overtaken by recommendation 2011-8810-7 and 2011-8810-10 Closed for other reasons To ensure all ABP are categorised and kept separate and identifiable as required by Chapters I and II of Annex II to Regulation (EC) No 1774/2002. 2009-8333-10 Overtaken by recommendation 2011-8810-7 and 2011-8810-11 Closed for other reasons To implement fully the system of official controls concerning the disposal of SRM, as required by Point 11 of Annex V to Regulation (EC) No 999/2001, so that it can be ensured that SRM is handled in accordance with Art. 4(2)(a) of Regulation (EC) No 1774/2002. 2009-8333-11 Overtaken by recommendation 2011-8810-7 and 2011-8810-12 Closed for other reasons To complete the approval of all ABP plants in accordance with the requirements of Artt.10-15 and 17-18 of Regulation (EC) No 1774/2002. 2009-8333-12 Overtaken by recommendation 2011-8810-7 and 2011-8810-13 Closed for other reasons To ensure that ABP plants fulfil the relevant general and specific hygiene requirements set down in Annexes III, V, VI and VII to Regulation (EC) No 1774/2002, notably concerning the processing requirements and validation of processing plants. 85 DG(SANTE) 2015-7657 Final Version date October 2016 Inspection 2009-8333 of 17 May 2009 in order to evaluate the implementation of health rules on animal by-products (ABP)
Reference no. and recommendation Basis of assessment Assessment
2009-8333-13 Overtaken by recommendations 2011-8810-17 and 2011-8810-18 Closed for other reasons To require that appropriate action is taken to remedy non-compliances with Regulation (EC) No 1774/2002, in accordance with Art. 26 of the said Regulation and Art. 54 of Regulation (EC) No 882/2004 and, to impose sanctions which satisfy the requirements of Art. 55 of the latter Regulation.
Audit 2011-8810 of 17 January 2011 in order to evaluate the implementation of health rules on animal by-products (ABP)
Reference no. and recommendation Basis of assessment Assessment
2011-8810-1 This recommendation is based on findings and related conclusion in Section 5.1.3 of the audit report: Action taken The requirements concerning training laid down by Article 6 of Regulation (EC) No 882/2004 were To ensure that staff performing not satisfactorily complied with, given that most officials met had not received any training concerning official controls receive the ABP. This had a significant impact in their ability to carry out their tasks, jeopardising the appropriate training required by effectiveness of official controls under Article 26 of Regulation (EC) No 1774/2002. Article 6 of Regulation (EC) No 882/2004. The initial response of the Greece authorities stated that there is a training programme in place for the employees of the Prefectural Veterinary Offices (PVSs) and Veterinary Health Control Stations (VHCSs) performing official controls. The competent authority was unable to organise ABP seminars in 2010. In January 2015 the Greek Authorities provided an updated action plan with took into account the report of the Belgium expert of May 2014.
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Reference no. and recommendation Basis of assessment Assessment
The CCA provided updated information in the context of the 2015 GFA and submitted an action plan in January 2016: Between 2012 and 2015 about 17 inspectors participated in BTSF courses on ABP/HACCP. Two training courses were organised by two Regions. ABP officers from all regions were trained in 2015 on the use of the ABP database. Approval was given by the National Centre for Public Administration/Training Institute (INEP) for a certified training programme on ABP, starting in 2016 and to continue over the following years. The DG SANTE team has received the approval letter for the training courses. The schedule for the first half of 2016 includes two weekly training cycles (April and June), with 15 attendees in each cycle.
2011-8810-2 This recommendation is based on findings and related conclusion in Section 5.1.4 of the audit report: In progress The system of internal supervision continues to have a limited ability to ensure that corrective action is To implement the procedures to verify taken to rectify deficiencies identified in official controls. the effectiveness of official controls for the ABP chain required by Article The initial response of the Greece authorities stated that the central competent authority has 8(3) of Regulation (EC) No 882/2004. implemented adequate documented procedures (as referred to in the draft report too) to verify the effectiveness of official controls in accordance with Article 8(3) of Regulation EC) No 882/2004.
However, to ensure better implementation of official control procedures, the CCA undertook the following actions: In accordance with Circular No 159412/27- 04-2011, employees responsible for controlling the ABP management system were appointed in each Region in the country, also serving as contact persons Inclusion in the memoranda of understanding executed between the Ministry of Rural Development & Food (MRDF) and the 13 Regions in the country (which shall have been completed by 30-09-2011) of the strict implementation of documented official control procedures.
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Reference no. and recommendation Basis of assessment Assessment
A training seminar was conducted on 29 and 30 June 2011 for inspector veterinarians with a view to ensuring better and more effective implementation of official controls. New seminars were planned by the end of November 2011. Strengthening the supervising control system implemented by the ABP Management Office, in cooperation with the Veterinary Inspection and Control Directorate of the MRDF. Inclusion of ABP control in the 2011 plans of the Veterinary Inspection and Control Directorate of the MRDF. In January 2015 the Greek Authorities provided an updated action plan with took into account the report of the Belgium expert of May 2014: "Drawing up of a documented supervision process of regional veterinary services which will include horizontal checks of ABP destinations and quantities. It is planned to carry out supervisory checks each year in two Regions of the country based on risk assessment with a specific inspection form. Review and evaluation of official controls a) The inspection forms are sent electronically to the Department; non-compliances and measures taken by the competent authorities are evaluated and grouped. b) Creation of a database with all the information concerning official controls. c) Evaluation of the official control system for ABP management in the framework of supervision. d) Taking of specific corrective measures." The CCA provided updated information in the context of the 2015 GFA and submitted an action plan in January 2016: Supervisory activities including visits of establishments are carried since 2011. Between 2011 and 2015 22 RVUs and 9 Regions were subject to supervisory activities with more than 50 establishments being visited for this purpose. The CCA stated that also audits carried out in 2012, covering several Regions, contributed to the
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Reference no. and recommendation Basis of assessment Assessment
verification of the effectiveness of controls on ABP. The DG SANTE team received during the GFA examples of such supervisory activities and noted that when significant non-compliance was found actions were taken (e.g. withdrawal of the approval). The CCA also stated that at the same time new, modern establishment were create. The CCA stated that also the process of the approval of establishments contributes to the verification of the effectiveness of controls as this gives the Regions an opportunity to look into the work of the RVUs during the approval visits. A certified procedure is in place for the monitoring the official ABP inspection system, which was included in the quality management system (QMS) of the Directorate for the Hygiene and Safety of Food of Animal Origin, according to the requirements laid down in the standards ISO 9001 & 19011. The procedure was certified by an independent body (TUV Austria Hellas) on 30 November 2015. The ABP monitoring plan includes a five-year and an annual programme of supervised actions and services. Specific questionnaires were drawn up for monitoring competent authorities and ABP management plants. An electronic system for ABP was created in cooperation with the Directorate for IT of the MRDF, which meets traceability requirements throughout the ABP chain, from production to end use/disposal, pursuant to Article 22 of Regulation (EC) No 1069/2009 and Article 17 of Regulation (EU) No 142/2011. The initial planning provided for the quantities of ABP produced and managed to be recorded by the competent authorities every six months. It was then found necessary, however, that the quantities of ABP should be recorded directly by the operators themselves on a daily basis. The key principle is this: ‘Each ABP producer should enter the quantities produced and their intended destination. Each ABP management operator should confirm receipt of those quantities from the producer and record the quantities it produces and their intended destination’. It is planned that the electronic system for ABP will record the inspection plans and reports for official inspections carried out by the competent authorities. The DG SANTE team noted that the planned introduction of the electronic system for ABP could further improve the system for verification. It was planned that the electronic system for ABP will record the inspection plans and reports for official inspections carried out by the competent authorities.
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Reference no. and recommendation Basis of assessment Assessment
The inspection plan will include the facilities chosen for inspection every two months in the current year. The inspection report will include the number of inspections already carried out, the number and type of non-compliances, the sampling operations and laboratory results, and the number and type of penalty and enforcement measures imposed on each ABP management plant. This recommendation will be used to also follow-up recommendation 5,9,11 and 16 of audit DG(SANTE) 2011-8810.
2011-8810-3 This recommendation is based on findings and related conclusion in Section 5.2 of the audit report: In progress The requirements for official controls laid down in EU provisions had not satisfactorily complied with To ensure that the official controls on because: a) although administrative guidance for the organisation of official controls on the basis of the ABP chain required by Article 45 hazard analysis exists, these controls continue to be implemented without taking account of the said of Regulation (EC) No 1069/2009 are risk criteria; b) some ABP plants are still not subject to regular official controls, or controls are totally carried out in accordance with Article absent despite the requirements of PD 211/2006; c) official controls are unable to reveal major 32(1) of Regulation (EC) No shortcomings in the operation of ABP plants and in the handling of ABP at food establishments and 142/2011. farms. No official controls had been carried out on farms in all prefectures visited during 2009 and 2010 as regards fallen stock. Controls of butchers' shops to ensure that these obligations were fulfilled had not been carried out in most prefectures visited. The legal obligation of two visits per year, arising from PD 211/2006, was reached at 20% of the ABP plants and ▪ no inspections were carried out in 10 out of 54 prefectures although non-approved ABP plants were operational in these prefectures. The initial response of the Greece authorities proposed the same corrective actions as decried under recommendation 2011-8810-2. Scheduling of official controls on ABP management plants is done by the ABP group in each Region on the basis of a risk assessment for each establishment and the staff available, in accordance with the guidelines set out in Circular 4940/131223/ 28.12.12 which will include cross-checks of destinations and quantities (horizontal checks in the ABP chain) and traceability checks. The schedule is sent to the
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Reference no. and recommendation Basis of assessment Assessment
ABP Department and its implementation is monitored every six months. The CCA provided updated information in the context of the 2015 GFA and submitted an action plan in January 2016: The inspection forms for each type of plant are being modified and will also include a weighting factor for each claim in order to obtain an overall rating for each plant inspected and to propose a specific timetable of corrective actions by the plant and measures to be taken by the control authority.' The GFA team received copies of these forms. The Greek authorities have put in place a system for the supervision of controls which contributes to the verification of the effectiveness of controls and the verification of compliance of planned arrangements (see also recommendation 2011-8810-2). DG SANTE will further assess the actions taken in order to address this recommendation and recommendation 2009-8333-1 in relation to the implementation of the electronic system for ABP and the planning of controls and implementation of controls in 2016 through recommendation 2011-8810- 2.
2011-8810-4 This recommendation is based on findings and related conclusion in Section 5.2 of the audit report: Closed for other Although largely satisfactory documented procedures were available for carrying out official controls reasons To ensure that ABP official controls on ABP, these are frequently not followed or misinterpreted. For example. Checks relating to ABP are carried out in accordance with the were limited to indicating whether or not the establishment complied with Regulation (EC) No documented procedures required by 1774/2002 as regards the presence of commercial documents. No cross checks had been carried out to Article 8(1) of Regulation (EC) No confirm the proper disposal of ABP according to the requirements of Regulation (EC) No 1774/2002. 882/2004. No attention was paid by the inspectors to the real amount of ABP produced and the proper disposal of it: The initial response of the Greece authorities stated that To ensure that ABP official controls are carried out in accordance with the documented procedures required by Article 8(1) of Regulation (EC) No 882/2004, the central competent authority has undertaken the actions referred in recommendation No 3 above and has also tried to improve the coordination of the VDG and MRDF departments
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Reference no. and recommendation Basis of assessment Assessment
involved. In January 2015 the Greek Authorities provided an updated action plan which took into account the report of the Belgium expert of May 2014: Horizontal cross-checks for specific destinations and quantities of ABP produced and managed are organised at central and regional level. These are performed by the ABP groups in each Region and coordinated and evaluated centrally. The CA undertook to create an organised network for ABP and to establish systematic cooperation and communication (internally and externally). The CCA provided updated information in the context of the 2015 GFA: The ABP working group has been established and experts have been nominated. The experts were entrusted with specific task with the aim to further improve the ABP system including documented procedures and clear deadlines were set. This recommendation is being followed-up recommendation 2011-8810-2.
2011-8810-5 This recommendation is based on findings and related conclusion in Section 5.2 of the audit report that Closed for other the results of official controls based on procedures and the need for corrective action are not recorded reasons To ensure that the reports required by adequately. Finally, reports are not always produced following official controls. Article 9 of Regulation (EC) No 882/2004 are drawn up for ABP The original response of the Greek authorities stated that PVSs were accurately informed of official controls. documented official control procedures through relevant circulars. The reports (control forms) drawn up by the CCA and used by PVSs for carrying out and recording controls are in compliance with all the requirements laid down in Article 9 of Regulation (EC) No 882/2004. There is space at the end of such forms for the inspector to enter all the corrective actions that need to taken by the audittee, as well as the deadlines set for completion thereof. After being filled out, the form is communicated both to the audittee and the central competent authority. Furthermore, Circular No 159412/27-04-2011 stressed again to PVSs that they should record and document all controls and fill out control forms correctly. Compliance with these procedures would also be ensured by the measures referred to in
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recommendation No 3 above and the coordination meetings between the CCA and PVSs. This recommendation is being followed-up through recommendation 2011-8810-2.
2011-8810-6 This recommendation is based on findings and related conclusion in Section 5.3.1 of the audit report: In progress Although some progress had been made in developing the infrastructure and arrangements necessary To put in place the adequate system for the proper disposal of ABP, the systems in place for collection and transport of ABP were limited for ABP required by Article 4(4) of and they often prevented the full utilization of the existing infrastructure; moreover, no progress had Regulation (EC) No 1069/2009. been made as regards the collection of fallen stock. The initial response of the Greece authorities stated that to ensure a better system for ABP, the CCA has undertaken the following actions: "1. In cooperation with the Planning Directorate of the MRDF, it has issued Joint Ministerial Decision 731/2011 (Government Gazette 850Β/16-05-2011) and Ministerial Decision 165386/1386/28-07-2011 for Measure 1.2.3.Α of the 2007-2013 Rural Development Programme, with a view to providing economic incentives for realising the necessary infrastructures for processing animal by-products, mainly from carcasses, in accordance with evaluation criteria relating to the substantial coverage of the needs of the country. 2 .It prepared a draft Joint Ministerial Decision (which is currently being signed and its completion is expected by 15/09/2011) on the implementation of a pilot programme for collecting and disposing of carcasses (containing specified risk materials), which will be under the responsibility of the country’s Regions. The purpose of the Joint Ministerial Decision is to provide the Regions with financial aid in order to hold tenders for the award of the programme to, and its implementation by, private providers under the supervision of the MRDF. The implementation of the programme is expected to begin on 31/12/2011. 3. The programme for collecting and disposing of carcasses (containing specified risk materials) has been included in the memoranda of understanding executed between the MRDF and the Regions. " In January 2015 the Greek Authorities provided an updated action plan which took into account the report of the Belgium expert of May 2014:
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With the experience from the two pilot programmes for the management of dead animals in the Regions of East Macedonia-Thrace and Thessaly with state funding (EUR 1 000 000 each) and the legal basis for the development of dead animal management programmes across the country, with Ministerial Decision 236/47755/ 10.04.2014, the Greek authorities were seeking funding for these programmes. The CCA provided updated information in the context of the 2015 GFA and submitted an action plan in January 2016: 'Joint Ministerial Decision No 202841/2011 (Government Gazette, Series II, No 3223/30-12-2011) provided for the implementation of two pilot programmes for the collection of dead animals with state funding (amounting to EUR 1 000 000 each), aiming to ensure the long-term proper management of dead animals throughout Greece on a permanent and stable basis. In the Region of East Macedonia and Thrace the programme started on 7 June 2013 and was completed on 6 December 2015. The management involved a total of 815 cattle, 13 455 sheep and 129 goats (document ref. 697/88795/22-6-2015 from the Region of East Macedonia and Thrace). In the Region of Thessaly the programme started on 1 October 2014 and was completed on 30 September 2015. Based on the data available on 31 May 2015, the management involved a total of 423 cattle, 5 775 sheep and 479 goats (document ref. 2811/18-6-2015 from the Region of Thessaly). (b) Ministerial Decision No 236/47755/10-4-2014 created the legal basis for the development of dead animal management programmes all over Greece. (c) In looking into the possibility of having the dead animal management programmes funded by the EU, assistance was requested from: (1) the special service for the management of the programme for rural development in Greece of the MRDF, (2) SANCO, by document ref. 577/113935/12-9-2014, and (3) Task Force Greece (TFGR). Moreover, as part of the Operational Programme ‘Environment and Sustainable Development’ of the Ministry of the Environment, Energy and Climate Change (MEECC) and the national waste management plan relating to all waste produced in Greece, the possibility of funding from European, Community, national and private sources in cooperation with the MEECC was investigated.
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(d) Guidelines were provided to competent authorities on the management of dead animals due to bluetongue (circular ref. 2995/132192/21-10-2014). As regards the management of dead animals due to lumpy skin disease (LSD), the guidelines used are those provided in the contingency plan (Article 15, Section K ‘Destruction of carcasses - animal by-products’ of Ministerial Decision No 258933/2008). According to the decision on measures to be taken in cattle farms infected with lumpy skin disease, the measures to be imposed also include ‘destruction of carcasses of sensitive species dying in the farm under the supervision of veterinarians...’. Moreover, each regional district must fill out the weekly information flow form on the LSD epizootic, stating the number of animals slaughtered every week, the number of animals pending slaughter and the total number of anim As regards 2016 in particular, a collection and management programme for dead cattle, goats and sheep will be implemented, in which the carcasses must be tested for transmissible spongiform encephalopathies (TSEs). The programme will be funded from the budget of expenditure of the MRDF, pursuant to Article 15(6) of Law 4351/2015. Approval has already been given for EUR 1 000 000 by the General Accounting Office of the State and the appropriation for 2016 has been allocated by the Directorate- General for Financial Services of the MRDF in order to implement this specific programme. In application of the above Law, a draft Ministerial Decision was prepared setting out supplementary measures in application of Regulations (EC) Nos 999/2001 and 1069/2009 concerning the collection and management of dead cattle, goats and sheep, which must bear mandatory markings according to the applicable legislation and must be tested for TSE based on the programme for the monitoring, control and eradiation of transmissible spongiform encephalopathies (TSEs), in the 9 regions of mainland Greece (East Macedonia and Thrace, Central Macedonia, West Macedonia, Epirus, Thessaly, Continental Greece, West Greece, Peloponnese and Attica). The decision specifies the regions in which the programme is implemented, the competent authorities responsible for implementing, monitoring and assessing it, the requirements for choosing the bodies to implement the programme and their obligations, the cost of implementation and the allocation of appropriations for each region. The draft joint ministerial decision concerned has already been examined from a legal and financial perspective and is currently at the final signature stage, in order to be published in the Government Gazette of the Hellenic Republic soon. The Financial Department of the MRDF was publishing an international open call for tenders to choose one or more bodies to undertake the implementation of this programme. The technical specifications
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had been prepared in accordance with the draft joint ministerial decision and are currently being edited by the Financial Department of the MRDF. As regards 2016 in particular, a collection and management programme for dead cattle, goats and sheep will be implemented, in which the carcasses must be tested for transmissible spongiform encephalopathies (TSEs). The programme will be funded from the budget of expenditure of the MRDF, pursuant to Article 15(6) of Law 4351/2015. Approval has already been given for EUR 1 000 000 by the General Accounting Office of the State and the appropriation for 2016 has been allocated by the Directorate-General for Financial Services of the MRDF in order to implement this specific programme. In application of the above Law, a draft Ministerial Decision was prepared setting out supplementary measures in application of Regulations (EC) No.s 999/2001 and 1069/2009 concerning the collection and management of dead cattle, goats and sheep, which must bear mandatory markings according to the applicable legislation and must be tested for TSE based on the programme for the monitoring, control and eradiation of transmissible spongiform encephalopathies (TSEs), in the 9 regions of mainland Greece (East Macedonia and Thrace, Central Macedonia, West Macedonia, Epirus, Thessaly, Continental Greece, West Greece, Peloponnese and Attica). The decision specifies the regions in which the programme is implemented, the competent authorities responsible for implementing, monitoring and assessing it, the requirements for choosing the bodies to implement the programme and their obligations, the cost of implementation and the allocation of appropriations for each region. The draft joint ministerial decision concerned has already been examined from a legal and financial perspective and was awaiting final signature stage, in order to be published in the Government Gazette of the Hellenic Republic. The multi-annual national programme for the collection and management of dead animals was established under Article 15 of Law 4351/2015, which will start in 2017. The national programme for the collection and management of dead animals is funded by the Agriculture and Livestock Fund of the MRDF by imposing an annual fee per animal for the collection and management of dead animals on each livestock farm in Greece, according to the number of animals raised there, as declared for the number of goats, sheep and pigs during the annual census and for the number of cattle based on the annual data from the electronic register of the cattle farm at the end of each year.
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Every 3 years, the MRDF plans to launch an international call for tenders for the entire territory of Greece or a part thereof (region/s), to choose one or more contractors to carry out the transport and management of dead animals in approved ABP management plants.'
2011-8810-7 This recommendation is based on findings and related conclusion in Section 5.3.1 of the audit report: In progress ABP continued to be disposed of in ways not permitted by EU provisions, notably by burial or To dispose of ABP in accordance with landfilling without processing. the requirements laid down by Articles 12 to 15 of Regulation (EC) The initial response of the Greece authorities stated the following: No 1069/2009. "To dispose of ABP in accordance with the requirements laid down in Regulation (EC) No 1069/2009, the central competent authority has undertaken the actions referred to in recommendations No 3 and No 6 above." The CCA provided updated information in the context of the 2015 GFA and submitted an action plan in January 2016: See recommendation 2011-8810-6
2011-8810-8 This recommendation is based on findings and related conclusion in Section 5.2.2. of the audit report: Action taken ABP commercial documents were deficient in many cases, therefore the relevant requirements laid To ensure that commercial documents down in EU legislation were not satisfactorily complied with. for ABP and derived products comply with the requirements laid down by Deficiencies as regards commercial documents were noted by the audit team in relation to processing Article 21 of Regulation (EC) No method, the category, the species, the weight, the final destination, the transport and/or the approval 1069/2009. number not being mentioned. The initial response of the Greece authorities stated the following. "The central competent authority has repeatedly issued guidance through circulars concerning: (1) the intensification of controls by PVSs and a greater focus on proper completion of commercial documents and in the updating of ABP registers;
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(2) imposing sanctions for non-compliances. Circular No 159412/27-04-2011 points out inter alia that commercial documents should be completed properly, as well as that the end recipient, not the transporter, should be printed on all documents. (The instructions on the proper completion of commercial documents and the updating of ABP registers are posted on the Internet, on the MRDF website, which is accessible to all interested parties). Correct implementation of the above is also ensured in conjunction with the actions referred to in recommendation No 3 above"
2011-8810-9 This recommendation is based on findings and related conclusion in Section 5.2.2.of the audit report: Closed for other There were major deficiencies in records of ABP at food establishments and ABP plants. reasons To ensure that records of ABP and derived products comply with the Records for the processed ABP could not be shown to the audit team at three processing plants visited requirements laid down by Article 22 (see section 5.3.3). of Regulation (EC) No 1069/2009. According to representatives of PVSs, records of fallen stock kept at prefectural level were incomplete as farmers do not notify dead animals. Officials stated that the limited financial compensation was the main reason for farmers not declaring fallen stock The initial response of the Greece authorities stated the following " In Circulars No 305869/3-11-2010 and No 305885/8-11-2010, the central competent authority stressed the business operators’ obligation to complete special forms inter alia concerning the details of the businesses supplying them and of the businesses to which they dispatch ABP, as well as the details of the ABP quantities produced and managed per category of materials. These details are available to PVSs, which communicate them to the central competent authority. (The instructions on the proper completion of records of ABP are posted on the Internet, on the MRDF website, which is accessible to all interested parties). Correct implementation of the above is also ensured by the actions referred to in recommendation No 3 above and the intensification of controls." The CCA provided updated information in the context of the 2015: The CCA stated that this issue was covered by the supervision carried out on the controls carried out by the RVUs. During the GFA the DG SANTE team received examples of records, check by RVU
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inspectors, and which had been subject to supervisory activities by the Region/CCA. The DG SANTE team noted major deficiencies regarding these records and the CCA admitted that the discrepancies had not been found during the supervision. However, this was an isolated finding on records issued in 2012. As time did not allow the GFA team to check more files, it was agreed to evaluate the situation and effectiveness of the supervision of controls during the 2016 GFA. This recommendation is being followed-up through recommendation 2011-8810-2.
2011-8810-10 This recommendation is based on findings and related conclusion in Section 5.3.3 of the audit report: Action taken There were deficiencies in the requirements concerning collection and transport of ABP. To ensure that ABP are collected and transported in compliance with Article Examples of the audit findings: 21 of Regulation (EC) No 1069/2009. At two Category 3 processing plants visited, processed fat was stored in bins ready to be dispatched without bearing the necessary labels. At one slaughterhouse visited, SRM was sent to a Category 3 processing plant as,according to the inspector met, it concerned only small amounts. transport was done by non-approved transport vehicles. The initial response of the Greece authorities stated the following: " In Circular No 159397/19-04- 2011, the central competent authority issued guidance concerning the collection and transportation of ABP in accordance with Article 21 of Regulation (EC) No 1069/2009 and Annex VIII to Regulation (EC) No 142/2011. Business operators are required to provide their staff with appropriate training on the categorisation, keeping and identification of ABP. The CCA provided updated information in the context of the 2015 GFA The CCA stated that in 2011 and 2015 specific circulars/ clarifications were issued with the aim to provide instructions and clear guidance ABP transporters/transports including approval of transporters, hygiene, special cases (transporters used for ABP and food transports), identification of vehicles, disinfection, traceability, penalties and record keeping. A specific circular on ABP traders including (paper traders) was issued in 2015. The GFA team received copies of these documents. 99 DG(SANTE) 2015-7657 Final Version date October 2016 Audit 2011-8810 of 17 January 2011 in order to evaluate the implementation of health rules on animal by-products (ABP)
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2011-8810-11 This recommendation is based on findings and related conclusion in Section 5.3.4 of the audit report: Closed for other The EU requirements concerning the handling and disposal of SRM were not satisfactorily complied reasons To ensure that SRM is handled and with, because steps taken to enhance the system of official controls to ensure that SRM produced at disposed of in accordance with Point 3 slaughterhouses is properly disposed of, had little effect owing to weaknesses in their implementation of Annex V to Regulation (EC) No and in the recording of incineration by operators. 999/2001 and Article 12 of Regulation (EC) No 1069/2009, and that its In three slaughterhouses where the audit team examined the incineration records, the inspectors had incineration complies with the signed the records of SRM produced to certify that SRM had been incinerated, without performing the requirements laid down by Article 6 of controls requested by the internal instruction. At all ruminant slaughterhouses visited, the audit team Regulation (EC) No 142/2011. noted deficiencies in the implementation of the control procedures issued by the central competent authority. The initial response of the Greece authorities stated the following: "To ensure that SRM are handled and disposed of in accordance with the requirements laid down in Regulation (EC) No 999/2001 and Regulation (EC) No 1069/2009 and are incinerated in accordance with the requirements laid down in Article 6 of Regulation (EC) No 142/2011, the central competent authority has undertaken the actions referred to in recommendations No 3 and No 6 above. Moreover, in Circular No 159412/27-04-2011, it suggested that incineration plant operators should fill out a “monthly incinerator operation record” form which should be checked by the official PVS veterinarian once a month. The “monthly incinerator operation record” form is available to the central competent authority." The CCA provided updated information in the context of the 2015 GFA: The CCA stated that during controls at slaughterhouses the handling of SRM is checked and monthly records of the incineration are checked by the CCA based on information submitted by the Regional services. Between 2011 and 2014 about 25 incinerators were suspended as a result of these controls and the CCA provide two examples. As an additional measures a circular was issues in January 2015 on back-up incinerators for all low-capacity establishments. This issue is being further followed-up through recommendation 2011-8810-2, 2011-8810-6 and 2011- 8810-7.
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2011-8810-12 This recommendation is based on findings and related conclusion in Section 5.4.1 of the audit report: In progress The requirements concerning the approval of plants dealing with ABP laid down by Articles 10-15 and To ensure that ABP plants are 17-18 of Regulation (EC) No 1774/2002 were not satisfactorily complied with, because although some approved in compliance with the progress has been made in approving ABP plants, the central competent authority allows requirements laid down by Articles approximately 50% of all the ABP plants to continue their operation without being approved.. 24, 44 and 46 of Regulation (EC) No 1069/2009. The initial response of the Greece authorities stated the following: "The central competent authority has issued circulars and directives setting forth the specific requirements laid down in Presidential Decree 211/2006 concerning the approval of ABP plants in compliance with Regulation (EC) No 1774/2002. The procedures to be followed for the approval of ABP plants, as described in the above Presidential Decree, are in compliance with the requirements laid down in Regulation (EC) No 1069/2009, in particular as regards approvals, withdrawals and suspensions. (The above information and instructions are posted on the Internet, on the MRDF website, which is accessible to all interested parties). Circular No 275493/26-05-2010 stipulates that the operation of any ABP plants not complying with the requirements laid down in applicable laws should be prohibited. The central competent authority is preparing a new circular drawing the attention of PVSs to the ABP plant approval procedures, which must be in accordance with the requirements laid down in Regulation (EC) No 1069/2009, and is urging them to intensify the pressure on undertakings to comply with the above requirements. The central competent authority is making all possible efforts to ensure better cooperation with jointly competent bodies with a view to speeding up the relevant procedures for approving the rest of ABP plants. 73 ABP plants were approved in 2010 and yet another 10 ABP plants have been approved since early 2011. The time required for the completion of the approval is very long (1-2 years) as multiple authorisations must be obtained due to the increased requirements laid down in applicable law. The aim is, on the one hand, to reduce the time required for issuing the necessary authorisations with a view to cutting down on the time required for the completion of approvals and, on the other hand, to prohibit the operation of any plants not complying with the approval requirements.
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The CCA provided updated information in the context of the 2015 GFA: The CCA stated that all ABP plants are approved except 30 low-capacity establishments on the Islands. The CCA undertook to approve or suspend these remaining 30 establishments before the end of 2016 in order to comply with EU provisions.
2011-8810-13 This recommendation is based on findings and related conclusion in Section 5.4.3 of the audit report: Action taken The requirements concerning general and specific hygiene requirements with which ABP plants must To ensure that ABP plants comply comply were not generally satisfactorily complied with. In particular, the validation of processing with the general hygiene requirements plants has not been satisfactorily carried out in all cases and numerous deficiencies as regards general required by Article 25 of Regulation and specific hygiene requirements persist at approved plants, including the inability of operators to (EC) No 1069/2009, and with other ensure that the relevant processing requirements are met; therefore, the relevant recommendation of the requirements laid down by Articles 8 previous report has not been satisfactorily addressed. In the meantime the afore-mentioned and 9 Regulation (EC) No 142/2011. requirements have been replaced by those laid down in Article 25 of Regulation (EC) No 1069/2009 and in Articles 8 and 9 of Regulation (EC) No 142/2011.
Official controls on processing plants overlooked the above deficiencies in almost all cases. The initial response of the Greece authorities stated the following: "The central competent authority has issued circulars and directive setting forth the general and specific health requirements laid down in Annexes III, V, VI and VII to Regulation (EC) No 1774/2002 and Presidential Decree 211/2006, in particular those relating to processing and the validation of processing plants, which are in compliance with the requirements laid down in Article 25 of Regulation (EC) No 1069/2009 and such other requirements as laid down in Articles 8 and 9 of Regulation (EC) No 142/2011. (The above information and instructions are posted on the Internet, on the MRDF website, which is accessible to all interested parties). The central competent authority is preparing a new circular drawing the attention of PVSs to the general and specific health requirements, the requirements for own checks, and the HACCP system of ABP plants, as well as to the procedures followed for the validation of processing plants, in accordance
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with the requirements laid down in Regulation (EC) No 1069/2009 and Regulation (EC) No 142/2011 and is urging them to intensify the pressure on undertakings to comply with the above requirements. Correct implementation of the above is also ensured by the actions referred to in recommendation No 3 above. " The CCA provided updated information in the context of the 2015 GFA: The checklist for the controls were revised in order to address the recommendation of the DG SANTE audit report. The GFA team received documentary evidence of these checklists. For example checklist ' Permit control of processing plants' contains in Section (B) 'OPERATIONAL REQUIREMENTS' a sub-section on general hygiene. See also training ( recommendation 2011-8810-1)
This recommendation is based on findings and related conclusion in Section 5.4.4 of the audit report: 2011-8810-14 Action taken Although in most processing plants visited by the own checks were in place, these were incomplete or To ensure that the requirements for unable to demonstrate continuous compliance with certain processing parameters. own checks laid down by Article 28 of Official controls on processing plants overlooked the above deficiencies in almost all cases. Regulation (EC) No 1069/2009 are complied with. The initial response of the Greece authorities stated that to ensure that the requirements for own checks laid down by Article 28 of Regulation (EC) No 1069/2009 are complied with, the central competent authority has undertaken the actions referred to in recommendation No 13 above. The CCA provided updated information in the context of the 2015 GFA: The checklist for the controls were revised in order to address the recommendation of the DG SANTE audit report. The GFA team received documentary evidence of these checklists. For example checklist ' Permit control of processing plants' contains in Section (B) 'OPERATIONAL REQUIREMENTS' several points on own-controls. See also training ( recommendation 2011-8810-1)
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2011-8810-15 This recommendation is based on findings and related conclusion in Section 5.4.4of the audit report: Action taken HACCP based procedures were either absent or deficient in many cases. To ensure that the requirements for HACCP laid down by Article 29 of Official controls on processing plants overlooked the above deficiencies in almost all cases. Regulation (EC) No 1069/2009 are The initial response of the Greece authorities stated that complied with. To ensure that the requirements for HACCP laid down by Article 29 of Regulation (EC) No 1069/2009 are complied with, the central competent authority has undertaken the actions referred to in recommendation No 13 above. The CCA provided updated information in the context of the 2015 GFA: The checklists mentioned under recommendation 2011-8810-13 also cover HACCP. See also training (recommendation 2011-8810-1).
2011-8810-16 This recommendation is based on findings and related conclusion in Section 5.4.4 of the audit report: Closed for other Official controls on processing plants overlooked the deficiencies described in Section 5.4.4 of the reasons To carry out the official controls at audit report in almost all cases, therefore the relevant requirements laid down by Article 26 of processing plants required by Article Regulation (EC) No 1774/2002 are not satisfactorily complied with. In the meantime, the afore- 32(3)(a) of Regulation (EC) No mentioned requirements have been replaced by those laid down by Article 32(3)(a) of Regulation (EC) 142/2011. No 142/2011. The initial response of the Greek authorities stated that to ensure that official controls are carried out on processing plants in accordance with applicable laws, as regards the validation of such plants in particular; the central competent authority undertook the actions referred to in recommendation No 13 above. The CCA provided updated information in the context of the 2015 GFA: This issue is being followed-up through recommendations 2, 3 and 13
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2011-8810-17 This recommendation is based on findings and related conclusion in Section 5.5 of the audit report: Action taken The competent authorities continued not to impose systematically corrective action if their inspections To take the appropriate action reveal that the requirements of Regulation (EC) No 1774/2002 are not met. Moreover, non-approved required by Article 46 of Regulation ABP plants continue to operate without restriction or corrective action. Therefore, the requirements (EC) No 1069/2009 if official controls laid down by Article 26(3) of this Regulation and Article 54 of Regulation (EC) No 882/2004 are not reveal that the requirements of this satisfactorily complied with and the relevant recommendation of the previous report has not been Regulation are not met. satisfactorily addressed. In the meantime, the afore-mentioned requirements in Regulation (EC) No 1774/2002 have been replaced by those laid down by Article 46 of Regulation (EC) No 1069/2009 The initial response of the Greece authorities stated the following: "The central competent authority has issued circulars and directive concerning the general and specific requirements laid down in Presidential Decree 211/2006 relating to the operation of ABP plants. This Presidential Decree describes the procedures relating in particular to the suspension and withdrawal of the approvals of ABP plants. Circular No 275493/26-05-2010 stipulates that the operation of any ABP plants not complying with the requirements laid down in applicable laws should be prohibited. The central competent authority is preparing a new circular drawing the attention of PVSs to the measures that should be taken where non-compliances with the requirements laid down in Regulation (EC) No 1069/2009 are identified, in accordance with Article 46 of the Regulation." The CCA provided updated information in the context of the 2015 GFA: The CCA provided the GFA team with several concrete examples of enforcement measures (corrective actions, suspension) including two examples were a sanction committee decided to impose a fine on the operator. In one case the proposed fine was above 80 000 Euro. The decision of the Minister was pending at the time of the GFA.
2011-8810-18 This recommendation is based on findings and related conclusion in Section 5.5 of the audit report: Action taken Sanctions in case of infringements to the provisions laid down by Regulation (EC) No 1774/2002 To ensure that the penalties required continue to be applied in an inconsistent way, or not applied at all; moreover, the application of by Article 53 of Regulation (EC) No 105 DG(SANTE) 2015-7657 Final Version date October 2016 Audit 2011-8810 of 17 January 2011 in order to evaluate the implementation of health rules on animal by-products (ABP)
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1069/2009 are implemented to sanctions has been suspended by the recent administrative reform as of 1 January 2011. infringements of this Regulation. The initial response of the Greece authorities stated the following: "To ensure that penalties are implemented for non-compliances in accordance with Presidential Decree 211/2006, the central competent authority has included in the memoranda of understanding between the Ministry of Rural Development and Food (MRDF) and the 13 Regions in the country (Ministry of the Interior) (which shall have been completed by 30-09-2011) inter alia the strict implementation of penalties to be imposed on ABP plants. The aim is to ensure cooperation and better coordination of the MRDF actions with the different departments of Regions and Regional Units. Within the general framework of restructuring the system of penalties laid down in decision 271715/2- 8-2010 of the Minister for Rural Development and Food concerning “the establishment and setting up of a Task Group responsible for restructuring the system of compliance measures and penalties”, the central competent authority submitted its proposal at that time. The Task Group submitted a complete proposal on 24/11/2010. By virtue of decision ΔΥ1δ/41247/20-04-2011 of the Ministry of Health, a new Task Group was established for the same purpose, of which the central competent authority is a member; submittal of its proposals is pending. •Correct implementation of the above is also ensured by the measures referred to in recommendation No 3 above. " The CCA provided updated information in the context of the 2015 GFA: See recommendation 2007-7431-2 (new sanction system).
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Inspection 2008-7695 of 20 January 2008 in order to evaluate the control of residues and contaminants in live animals and animal products, including controls on veterinary medicinal products
Reference no. and recommendation Basis of assessment Assessment New Data collection forms, both for Veterinary Directorates and Veterinary Laboratories were designed 2008-7695-1 Action taken and tested for 2009. The Directorates entered data for every collection of samples and sent them by e- Improve supervision of implementation of mail to the CA every 3 months. In case of positive findings, the CA is informed immediately from the the national residue control plan in reference laboratories and investigates each case of non-conformity. accordance with the requirements of For further improvement of data collection, a new electronic database is being prepared, together with the Article 4 of Council Directive 96/23/EC in Directorate of Informatics. order to ensure that the plan presented for approval to the Commission services is Its pilot implementation is planned by the end of 2011 implemented as foreseen with regards to Audit report DG(SANTE) 2014-7027 states the following: both the sample numbers to be taken and the analyses to be performed. 'Supervision by the DVPH covers quarterly, semi-annual and annual evaluation of laboratory and RU reports, making phone-calls and sending reminder letters to intensify both sampling and processing samples in laboratories. A lot of evidence of those activities was seen by the audit team.' The issue of implementation of national residue control plan is overtaken by recommendation 2014-7027- 4. 2008-7695-2 Progress is being made with the validation of methods, nevertheless there are still a large number of Closed for other methods which will still not be validated until mid-2009. In addition, it is not feasible to validate those reasons Ensure that analytical methods listed in the methods in promised timetable because of lack of staff resources in laboratory and bulk of samples from above plan are validated in accordance NRCP 2008 (57% still has to be analysed). GFA 2010/8368 There are still some methods which are not with Commission Decision 2002/657/EC validated. There is no intention to outsource analysis to other Member States due to costs. The CAs stated and are demonstrably ‘fit for purpose’ in that the use of Greek wider public sector laboratories is being considered. The Greek CAs, in their order to provide reliable data on the comments on residues status of commodities tested collaboration with the laboratories had prepared a time-table for the validation of non-validated methods under the national residue control plan. (a detailed table was provided). The CCA had requested from all veterinary laboratories involved in the NRCP to prioritize the validation of methods; the relevant laboratories should report progress every 3 months. For more information on horizontal issues, see chapter 1 of the country profile document "the organisation of food safety, animal health, animal welfare and plant health control systems". This recommendation has been overtaken by recommendation 2011-8901-9. 107 DG(SANTE) 2015-7657 Final Version date October 2016 Inspection 2008-7695 of 20 January 2008 in order to evaluate the control of residues and contaminants in live animals and animal products, including controls on veterinary medicinal products
Reference no. and recommendation Basis of assessment Assessment
2008-7695-3 The Veterinary Laboratory Larissa which is the National Reference Laboratory has already purchased the Closed for other equipment and is in the process of developing a new method - high performance liquid chromatography reason In accordance with recital 10 of Council with mass spectrometers, HPLC-MS / MS. This method will be applied to the examination of Directive 96/23/EC, ensure that the range coccidiostats including the ionoforon in beginning of 2009. GFA 2010/8368 The Laboratory of Larisa of coccidiostats monitored for in poultry (Lab 06) has purchased the relevant equipment. The Albendazole sulfoxide (Benzimidazole) in raw milk under the national residue control plan have been validated (HPLC-DAD). The validation of methods for the determination of Anthelminthics reflects the usage of these additives and (Benz and AVERM) in raw milk, muscle, liver, fish, coccidiostats in eggs, muscle and fat, includes ionophores. nitroimidazoles in muscle, plasma/serum and egg, is pending. The Veterinary Directorate notified the political leadership several times about this issue (evidence shown). Audit report DG(SANTE) 2011-8901states the following: 'According to actions taken to address the recommendation No. 3 in the 2008 mission report the Veterinary Laboratory Larissa (NRL for substance group B2a and B2b) had purchased the necessary equipment for the analysis of coccidiostats (including ionophores). However, an analytical method is still not available and no samples have been tested for these substances' The issue of using validate methods has been overtaken by 2014-7027-3.
2008-7695-4 Each Veterinary Directorate has nominated at least one official (contact person) responsible for the Action taken national residue control plan in its Prefecture. That person should attend the seminar to be held at the Ensure that samples are taken, handled in beginning of 2009. CA has issued letter to Prefectures reminding of proper sampling procedures. an appropriate manner to ensure sample However, sampling time could not be considered improved as only 43% of samples are analysed for and analyte integrity and analysed in as 2008. GFA 2010/8368 Each Veterinary Directorate has nominated at least one official (contact person) short a time as possible in order to responsible for the NRCP in its Prefecture. These officials have been trained in the relevant subjects in facilitate effective follow-up investigations two seminars which took place in Athens (14 December 2009) and Thessaloniki (8 January 2010). as required by Article 16 of Council Furthermore, the training material was published on the Website of the MRDF, together with other Directive 96/23/EC. educational material. The manual has been updated and sent to the prefectures and it is regularly upgraded. The CA contacts the responsible persons in the Veterinary Directorates as soon as a positive sample is identified in the NRLs. The Laboratory notifies the positive findings to the CA and the relevant peripheral Directorate. The CA requests action and for a report on the situation. Whenever appropriate, the CA provides suggestions and advises the Veterinary Directorates on the corrective measures they should take in order to ensure public health in their region. During audit 2011-8901 deficiencies relating 108 DG(SANTE) 2015-7657 Final Version date October 2016 Inspection 2008-7695 of 20 January 2008 in order to evaluate the control of residues and contaminants in live animals and animal products, including controls on veterinary medicinal products
Reference no. and recommendation Basis of assessment Assessment this recommendation were identified (for more details see audit report, page 6). Audit report DG(SANTE) 2014-7027 states the following: 'Sampling is carried out correctly on the whole'
2008-7695-5 General tender (1.3 mil. €) for purchase of reagents has been completed in June 2008. All reagents and Closed for other consumables were distributed in October 2008. Two further tenders each one of 45000 € are still In reasons Ensure that procurement for laboratory progress. Emergency funding during 2008 was provided for some laboratories, but it was not sufficient chemicals and reagents proceeds without enough. To improve the situation CA decided to arrange 3 different tenders in future (chemicals, reagents delay in order to fulfil the obligations laid and microbiology). GFA 2010/8368 As regards the procurement of laboratory chemicals and reagents, down in Article 4(c) and (d) of Regulation the CAs are obliged to follow the fixed public sector annual procedures. Specifically for 2010, two (EC) No 882/2004. general tenders were In progress (final stage) and one tender was cancelled and has been re-launched (initial stage). The Greek CAs, in their comments on the draft country profile, indicated that the system of supplies had been already improved. The tender that was taking place before was replaced by three annual tenders: for reagents, for chemicals and for substrates. As a result the number of supplies per tender and the time of completion of each tender had been reduced. Overtaken by recommendation 2014-7027-3
2008-7695-6 Eight laboratories are accredited (Athens, Tripolis, Rhodos, Chalkida, Serres, Chania, Thesaloniki, Closed for other Ioannina), five are in the final stage of accreditation procedure (Athens, Larrisa, Heraklio, Komotoni, reasons Ensure that appropriate quality control and Kavala,) and should be finalised beginning of 2009. The pre-assessment exercise for one laboratory will quality assurance measures are be carried out in 2009 (Patras). GFA 2010/8368 All relevant Veterinary Laboratories are accredited. implemented across the entire laboratory However, as indicated in recommendation 2008-7695-2, several methods are still to be validated. network in order to increase confidence in the reliability of analytical results Audit report DG(SANTE) 2014-7027 states the following: generated and comply with Articles 3 and 'There has been significant progress compared to the 2011 audit report with regard to the availability of 5 of Commission Decision 2002/657/EC. accredited and validated methods and implementation of quality control procedures' The issue of adequate laboratory capacity is further followed-up trough recommendation 2014-7027-3
2008-7695-7 No progress has been reported on recruitment. Some progress was made in other areas (see also Closed for other recommendations 1, 3, 4 and 6). reasons Ensure that the laboratory resources 109 DG(SANTE) 2015-7657 Final Version date October 2016 Inspection 2008-7695 of 20 January 2008 in order to evaluate the control of residues and contaminants in live animals and animal products, including controls on veterinary medicinal products
Reference no. and recommendation Basis of assessment Assessment available (staff, equipment and expertise) The Greek CAs, in their comments on the draft country profile, indicated the following: are commensurate with the work load For 2011, recruitment of temporary personnel for the National Program for the Control of Residues has required in order to comply with Article been already approved (18 chemists and 4 food technologists)). 4(2) c of Regulation (EC) No 882/2004. Specifically in relation to those More than half of the above mentioned personnel have been employed and it is expected that before the laboratories carrying out mass end of the year the procedure of recruitment will be completed. The same process has been initiated for spectrometric confirmatory analyses, 2012, with the official request for the approval of the same number of personnel. suitably qualified and experienced staff Recruitment of permanent staff will depend on recruitment limitations, recently established in the wider need to be recruited in order to meet the public sector. requirements of the current national residue control plan. Report 2011-8901 indicated that the recruitment procedure for laboratory staff is centralised and gives priority to the longest unemployed personnel without taking into account the level of expertise. Temporary staff are widely used to address shortages. Contracts for such staff have a maximum duration of eight months, thus the training of such staff is to no avail as they cannot be retained in employment. Overtaken by recommendation 2014-7027-3
Audit 2011-8901 of 03 April 2011 in order to evaluate the monitoring of residues and contaminants in live animals and animal products, including controls on veterinary medicinal products
Reference no. and recommendation Basis of assessment Assessment This issue was followed-up by during audit DG(SANTE)2014-7027. The audit report states the 2011-8901-1 Closed for other following: reasons To ensure that the capacity for processing 'The capacity to process samples within the laboratory network is largely taken into account. However, samples by laboratories carrying out methods are not available for two substance groups and those analyses are not subcontracted to other residues analysis is taken into account laboratories.' during the planning of the residues monitoring plan to meet the requirements Overtaken by recommendation 2014-7027-3 laid down in Article 7 of Council Directive 96/23/EC. 110 DG(SANTE) 2015-7657 Final Version date October 2016 Audit 2011-8901 of 03 April 2011 in order to evaluate the monitoring of residues and contaminants in live animals and animal products, including controls on veterinary medicinal products
Reference no. and recommendation Basis of assessment Assessment
2011-8901-2 This issue was followed-up by during audit DG(SANTE)2014-7027. The audit report states that this Action taken recommendation had been addressed. To ensure that staff responsible for planning and supervising of implementation receives appropriate training and are kept up to date so that they can perform their task competently as required by Article 6 of Regulation (EC) No 882/2004.
2011-8901-3 This issue was followed-up by during audit DG(SANTE)2014-7027. The audit report states that this Action taken recommendation had largely been addressed. To ensure that sampling for residue monitoring plan is targeted and the plan is implemented through the year as specified in the Annex to Commission Decision 98/179/EC.
2011-8901-4 This issue was followed-up by during audit DG(SANTE)2014-7027. The audit report states the Closed for other following: reasons To ensure supervision of implementation of the residue monitoring plan by the 'As both the 2013 and 2014 RMP could not be implemented as foreseen, the recommendation has been central competent authority in order to only partially addressed.' comply with the requirements of Article 4 Overtaken by recommendation 2014-7027-4 of Council Directive 96/23/EC and ensure that the plan presented for approval to the Commission is implemented as foreseen.
2011-8901-5 This issue was followed-up by during audit DG(SANTE)2014-7027. The audit report states that this Action taken recommendation had been addressed. To ensure that follow-up on non-compliant results is carried out in a timely fashion 111 DG(SANTE) 2015-7657 Final Version date October 2016 Audit 2011-8901 of 03 April 2011 in order to evaluate the monitoring of residues and contaminants in live animals and animal products, including controls on veterinary medicinal products
Reference no. and recommendation Basis of assessment Assessment and is in line with all of the relevant articles of Council Directive 96/23/EC.
2011-8901-6 This issue was followed-up by during audit DG(SANTE)2014-7027. The audit report states that this Action taken recommendation had been addressed. To ensure that samples are handled in such a way as to guarantee their legal and analytical validity as required by point 2.6 of the Annex to Commission Decision 98/179/EC and Article 11 of Regulation (EC) No 882/2004.
2011-8901-7 This issue was followed-up by during audit DG(SANTE)2014-7027. The audit report states the Closed for other following: reasons To ensure that there is adequate laboratory capacity (e.g. staff, equipment, reagents, 'Whilst progress has been made, a number of shortcomings relating to the shortage of staff and consumables) available, as required by prolonged equipment breakdowns have been observed during the audit which lead to delays in sample Articles 4 of Regulation (EC) No 882/2004 analysis and longer than agreed turnaround times. Therefore the recommendation was partially in other that samples can be analysed addressed.' through the year as specified in point 2.1 Overtaken by recommendation 2014-7027-3 of the Commission Decision 98/179/EC. 2011-8901-8 This issue was followed-up by during audit DG(SANTE)2014-7027. The audit report states that this Action taken To ensure that all laboratories involved in recommendation had largely been addressed. analyses of official samples within the RMP apply methods which are included in their respective scopes of accreditation as required by Article 12 of Regulation (EC) No 882/2004. 2011-8901-9 This issue was followed-up by during audit DG(SANTE)2014-7027. The audit report states the Closed for other following: reasons To ensure that all analytical methods used for analysis of samples under the RMP are 'As there are some unvalidated methods remaining, the recommendation has been partly addressed.' 112 DG(SANTE) 2015-7657 Final Version date October 2016 Audit 2011-8901 of 03 April 2011 in order to evaluate the monitoring of residues and contaminants in live animals and animal products, including controls on veterinary medicinal products
Reference no. and recommendation Basis of assessment Assessment validated according to applicable EU Overtaken by recommendation 2014-7027-3 legislation: Commission Decision 2002/657/EC, Commission Regulation (EC) No 333/2007 (chemical elements in foodstuffs) and Commission Regulation (EC) No 401/2006 (mycotoxins) and are demonstrably “fit for purpose” in accordance with ISO 17025.
2011-8901-10 This issue was followed-up by during audit DG(SANTE)2014-7027. The audit report states the Closed for other following: reasons Consider that controls on the distribution and use of veterinary medicinal products 'Controls on the distribution and use of veterinary medicinal products are carried out throughout the are carried out throughout the distribution distribution chain. However, frequency of inspections is not met for pharmacies, veterinary offices and chain in line with the requirements of farms. Thus the recommendation has been only partially addressed.' Article 80 of Directive 2001/82/EC i.e. Overtaken by recommendation 2014-7027-1 ensure that all farms with food producing animals are regularly inspected and consider extending the scope of these controls also to the storage of veterinary medicinal products on farms.
2011-8901-11 This issue was followed-up by during audit DG(SANTE)2014-7027. The audit report states the Closed for other following: reasons Ensure that all medicinal treatments given to food producing animals are entered in 'While progress has been made with the availability and correctness of on-farm treatment registers, onfarm registers (i.e. that the identification shortcomings were found with regards to keeping of records for five years and registers for bee keepers. of the animals treated is always recorded) Thus the recommendation has been only partially addressed.' and that prescriptions are kept by farmers Overtaken by recommendation 2014-7027-2 in line with Article 10 of Council Directive 96/23/EC.
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Reference no. and recommendation Basis of assessment Assessment
2011-8901-12 This issue was followed-up by during audit DG(SANTE)2014-7027. The audit report states that this Action taken recommendation had been addressed. Ensure that if there is no nationally authorised veterinary medicinal product for a condition affecting a food producing species, the animals concerned on a particular holding are treated in accordance with conditions laid down in Article 11 of Directive 2001/82/EC i.e. that only medicinal products containing pharmacologically active substances listed in Table 1 of the Annex to Regulation (EU) 37/2010 are used and that appropriate withdrawal periods are specified.
2011-8901-13 This issue was followed-up by during audit DG(SANTE)2014-7027. The audit report states that this Action taken recommendation had been addressed. Ensure that food chain information is implemented for all relevant species in line with the requirements stipulated in Regulation (EC) No 853/2004 and those officials in charge of controls in slaughterhouses carry out inspection tasks related to the food chain information and take appropriate measures when necessary as required by Article 5 of Regulation (EC) No 854/2004.
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Reference no. and recommendation Basis of assessment Assessment
2011-8901-14 This issue was followed-up by during audit DG(SANTE)2014-7027. The audit report states that this Action taken recommendation had largely been addressed. Ensure that effective co-ordination (and co-operation) takes place between all levels (peripheral and central) of competent authorities involved in controls on the distribution and use of veterinary medicinal products in line the requirement of Article 4(3) of Regulation (EC) 882/2004.
2 .B.7 Foodstuffs and food hygiene
Inspection 2007-7199 of 11 November 2007 in order to evaluate the official control system for food, feed and seed containing or consisting of Genetically Modified Organism(s)
Reference no. and recommendation Basis of assessment Assessment
2007-7199-6 The inspection report concluded that the scope of accreditation was limited to screening methods only. In progress As a result, all positive samples were being subcontracted to other private laboratories for identification Consider extending the scope of analysis and quantification. for official control laboratories to include the qualitative and quantitative analysis of In their response to the inspection report, GCSL stated that they would consider this recommendation, GMOs which are authorised under taking into account their current resources and needs. Regulation (EC) No. 1829/2003. The private laboratory visited stated that in case of unaccredited methods their laboratory had a specific procedure for subcontractors, under which accredited laboratories would undertake the relevant analysis on behalf of their laboratory in order to issue valid results. An extension to the scope of accreditation,
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Reference no. and recommendation Basis of assessment Assessment was a decision made annually by laboratory management, based on commercial criteria. Management was expected to take the relevant decision at the end of 2008. During the 2010 GFA, GCSL stated that this recommendation was still under consideration due to limited financial resources. They stated that they carried out certain analyses using validated event-specific methods. In addition, the GCSL laboratory for GMOs, as the NRL for GMOs, was participating in proficiency tests organised by the EURL for GM food and feed. The CCA provided updated information in the context of the 2015 GFA: Before the GFA 2015, the GCSL provided the following update: “The General Chemical State Laboratory, A 'Chemical Service of Athens (Ministry of Finance, Secretariat-General for Public Revenue) has been designated as the national reference laboratory for GM food according to the Reg (EC) 882/2004 and one of the official control laboratories for GMOs. The scope of accreditation is “screening method for genetically modified organisms (GMOs) by the detection of the CaMV 35S promoter in foodstuffs (soya (beans, flour), feedingstuffs (flour) and maize [foodstuffs (grains, flour), feedingstuffs (grains, flour)]’ and it has not been changed since 2010. The scope of accreditation does not cover the event-specific quantification methods for the authorised GM events. The laboratory applies such methods after validation, participates in validation studies organised by EURL and in proficiency tests organised by EURL as well, with excellent results. A table containing the validated event — specific quantification methods, together with z-scores will in proficiency tests, is attached. The laboratory intends to acquire accreditation for event-specific quantification methods, for soy and maize Events - possibly in a flexible scope, depending on the available resources. The timeline is estimated to be about one year, due to objective factors such as limited financial and human resources and administrative difficulties in consumables supply system.” During the GFA 2015 the GCSL added that it had taken part in proficiency tests organised by EURL on GM soybean and GM maize, but only partly (i.e. in qualitative tests, not in quantitative tests). They also participated in 8 validation studies, 5 of which were for authorised events. The GCSL provided the GFA team with copies of reports of the proficiency tests and validation studies, where these were available. The GCSL stated that, subject to the availability of resources, they expect to apply, during the course of 2016, to the National Accreditation Body (ESYD) to include into the accreditation scope the event-
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Reference no. and recommendation Basis of assessment Assessment specific quantification methods for authorised GMOs. The GCSL said that they would have all the data in place before the application and that they would expect accreditation to take about 1 to 2 months. The GCSL said that they would send a copy of the application to DG Health and Food Safety.
Inspection 2007-7201 of 02 September 2007 in order to assess the official control systems in place for food hygiene (within the meaning of Regulation (EC) No 852/2004), traceability and labelling
Reference no. and recommendation Basis of assessment Assessment
2007-7201-2 Situation after the 2010 GFA: Action taken National measures for internal and external Audits had not started in EFET yet. Amendments of EFET founding laws are required for implementing audits regarding the requirements of Art the audits. 4(6) Regulation (EC) No 882/04 should be For more information on staff, see chapter 1 of the country profile document "the organisation of food put into operation. safety, animal health, animal welfare and plant health control systems".
The 2013 Annual Report of Greece contains the following information:
EFET has adopted and documented a procedure of internal audits (Decision of the Management Board No 377/2013) as one of the instruments used to evaluate the effectiveness of the Official Food Inspection System. All guidelines laid down in Commission Decision 2006/677/EC have been included in the internal audit procedure. The QASD has developed a five-year internal audit programme, covering the entire spectrum of food chain activities, as well as an annual plan of internal audits covering all operational units of the institution and all processes performed. In addition, as part of carrying out internal audits, four (4) internal audits have already been carried out, and the operational units audited are in the process of submitting comments on the draft report. The CCA provided updated information in the context of the 2015 GFA: EFET started to establish an internal audit system as required by requirements of Art 4(6) Regulation (EC) No 882/04 in 2011. The Department of Quality Assurance of Provided Services (DQAPS) of EFET 117 DG(SANTE) 2015-7657 Final Version date October 2016 Inspection 2007-7201 of 02 September 2007 in order to assess the official control systems in place for food hygiene (within the meaning of Regulation (EC) No 852/2004), traceability and labelling
Reference no. and recommendation Basis of assessment Assessment started its work based on its certified Quality Management System (ISO 9001:2008). EFET stated that audits are carried out in line with Commission Decision 2006/677/EC. In 2013/2014 3 horizontal and 3 vertical audits were carried out and 4 horizontal and 2 vertical in 2015. The audits are based on a five year programme with annual audit plans. The GFA team received examples of audit reports and of the internal audit procedures.
Inspection 2009-8152 of 29 March 2009 in order to evaluate the official controls systems in place for food additives and food contact materials
Reference no. and recommendation Basis of assessment Assessment
2009-8152-7 Regarding eating habits, EFET stated that they would participate in the EFSA pilot program. Closed for other reasons To take action in order to establish a At the same time, they were seeking financial support for monitoring the consumption and use of monitoring system for the consumption additives at national level. and use of FA as required by European European Commission expects to adopt a common methodology for the monitoring of Food Additives as Parliament and Council Directives indicated in Article 27 (2) of Regulation (EU) No 1333/2008. The guidance is expected to be available 94/35/EC (Article 8) on sweeteners for use by the end of 2015. in foodstuffs, 94/36/EC (Article 6) on colours for use in foodstuffs and 95/2/EC (Article 7) on food additives other than colours and sweeteners.
118 DG(SANTE) 2015-7657 Final Version date October 2016 2. B.8 Imports of food of plant origin
Audit 2012-6275 of 05 March 2012 in order to evaluate import controls on food of non-animal origin
Reference no. and recommendation Basis of assessment Assessment
2012-6275-1 This recommendation is based on findings and associated conclusions in Section 5.2.2 of the audit report that Action still training is not sufficient to keep inspectors up-to-date in their area of competence. required Ensure that all inspectors receive up- to-date training on import controls The response of the Greek authorities stated the following: and sampling techniques as required In 2012 31 inspectors from the local CAs as well as the CCAs participated in the training for the by Article 6 of Regulation (EC) No implementation of TRACES for food and feed of non-animal origin, in the framework of which discussions 882/2004 and Article 6(1)(a) of on import controls and sampling techniques also took place. Regulation (EC) No 1152/2009. The possibility of additional training courses on import controls and sampling techniques and the assessment of training needs was explored by the CAs. In their response the CCA also referred to the annual plan for on-site audit of all active DPEs/DPIs starting in September 2012. Inspectors from the local CAs as well as officers from the CCAs of the MRDF, the GCSL and the Customs attend the BTSF training, where matters of import controls and sampling are also discussed. The Greek authorities provided the following up-dated information in the context of the 2015 GFA: "In the framework of BTSF in 2014/2015, 38 inspectors from local authorities and employees from the Central Authorities attended the BTSF training programs and more specifically the following: Import controls on certain feed and food of non-animal origin (24 participants) Controls on contamination in feed and food – Food of plant origin (2) Food Hygiene at Primary production (3) HACCP (4) Setting up and implementation of an audit system (1) TRACES (4) DPQCFPP organised two on-site visits to Thessaloniki (R.N. 4662/122331/09.10.2013) and Kipi Evrou (R.N. 2285/48990/05.05.2015), which were chosen because they are DPE and DPI with high volume of imports. The aim of the visits was the verification of the official controls at import, implementing regulations (EC) 669/2009 and (EU) 884/2014. The inspectors of the relevant competent authorities were present (RCPPQC 119 DG(SANTE) 2015-7657 Final Version date October 2016 Audit 2012-6275 of 05 March 2012 in order to evaluate import controls on food of non-animal origin
Reference no. and recommendation Basis of assessment Assessment and DRVEM of Thessaloniki and Evros). During the visits meetings took place as well as inspection of the areas where sampling takes place. At the beginning of the meetings, DPQCFPP gave an overview of the main aspects/requirements of the abovementioned legislation followed by discussion of specific questions concerning the official controls and sampling, practices at import, problems, handling of special cases, random examining of CEDs and accompanying documents, completing standard questionnaires, which were prepared by DPQCFPP. The questionnaires were prepared based on the requirements described in the legislation and the guidelines issued by the EC with the intention to present the current situation in order to verify the implementation of the legislation. Following the visits DPQCFPP sent reports to the local competent authorities (R.N. 1478/41182/28.03/2013 and 3101/69458/22.06.2015) including the findings, conclusion and the corrective actions to be applied (see att 2012-6275-1_9 report Thessaloniki and 2012-6275-1_9-report Kipi Evrou). The Directorate of Education of MRDF in 2013 cooperated with the Centre of Public Administration in order to evaluate/assess the needs of MRDF for training and education, with the aim to organize training sessions. In this framework, DPSQCPVO submitted to the MRDF Directorate of Education its aspects for the training courses’ priorities relating to import controls and sampling techniques in order for these priorities to be incorporated in a general educational scheme of the Centre of Public Administration. The approval of the proposal was pending at the time of the 2015 GFA." During the GFA the CCA stated that some visits at local level took place in the past years in order to verify the effectiveness of the controls. However, due to budgetary constraints the number of such visits had to be reduced. The CCA provided documentary evidence of such visit to the DPE Kipi Evrou in May 2015. Guidelines and provisions regarding import controls are made available to inspectors and can be found on the website of the CCA. http://www.minagric.gr/index.php/el/component/content/article/515-greek-content/eisagoges- ejogoges/trofima-zoikh-proeleush/2013-12-11-11-52-59/2536-kan884-2014 Inspectors of the CAs participated in BTSF. The CCA also visited DPEs in order to identify problems and to resolve them. However, it is not ensured that training needs of inspectors are addressed within an appropriate period of time. The training needs identified by the CCA in 2013 were not addressed through appropriate training of inspectors. This recommendation has been followed-up through audit (SANTE) 2016-8867.
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Reference no. and recommendation Basis of assessment Assessment
2012-6275-3 This recommendation is based on findings and associated conclusions in Section 5.2.3 of the audit report that In progress in the DPE in Thessaloniki, physical checks of fresh fruit and vegetables are not carried out in hygienic Ensure that, at the Designated Point of conditions (sheltered place belonging to the DPP, were dirty and unhygienic). Entry (DPE) in Thessaloniki, physical checks are carried out under This recommendation is a repeat of recommendation No 3 of the Report DG(SANCO)2009-8142 appropriate hygiene conditions as The response of the Greek authorities stated the following: required by Article 16(3) of Regulation (EC) No 882/2004. In addition to the immediate reaction following the findings during the audit in March 2012, the following actions were required by the local CAs (PSQCPVO circular ref. no 2600/62191/29.05.2012): the CA responsible for implementing Reg. (EC) 669/2009 at the DPE of Thesssaloniki was asked to immediately restore, to a satisfactory level, the hygiene conditions of the place where the identity and physical checks are carried out, and retain them. in a horizontal approach, all CAs carrying out identity and physical checks on food of non animal origin (including the DPE Thessaloniki) are asked to appoint an inspector who will be responsible for the development and the keeping of a cleaning program for the places where above checks are carried out. The abovementioned cleaning program may be developed in cooperation with any relative party, where necessary: e.g. the FBO, if identity and physical checks take place in the FBO premises, the port authorities, if the checks take place within a port, etc. The Greek authorities provided the following up-dated information in the context of the 2015 GFA: The Greek authorities, in response to the pre-draft CP, stated in November 2015 the following: "Since August 2014, DPE Port Thessaloniki is no longer a control point under the provisions of Article 19 of Reg 669/2009 and consequently the number of consignments controlled by the DPE Port of Thessaloniki arriving by road is significantly reduced. RCPPQC of Thessaloniki in cooperation with the Thessaloniki Port Authorities has made appropriate arrangements for new facilities to be constructed, taking into account the EU legislation requirements. In this direction, plans have already been drawn up and Thessaloniki Port Authorities gave an oral verification that the facilities will be constructed soon. Concerning other points of physical control, the competent authorities have communicated to DQPCFPP either the name of a person responsible or that controls are carried out in warehouses in customs territory or at
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Reference no. and recommendation Basis of assessment Assessment FBOs premises, in which cases customs authorities and FBO are responsible for cleaning respectively. Regarding Thessaloniki: Since 01.01.2013 the physical checks of consignments arriving at the DPE Thessaloniki by road are carried out in the private warehouses of B’ Customs’ Territory. These warehouses have the appropriate hygienic conditions and the appropriate unloading equipment." During the GFA the CCA stated that inspectors from the local CAs do not perform documented hygiene inspections at these warehouses. However, it is there duty to check hygiene conditions and to report shortcomings if found. The CCA undertook to include this issue in the QMS which was planned to be implemented in 2016 This recommendation has been followed-up through audit (SANTE) 2016-8867.
2012-6275-8 This recommendation is based on findings and associated conclusions in Section 5.2.6 of the audit report that Action taken when the CA allows onward transportation to the other MS, the CA at the DPE does not notify the CA at the Ensure that, when the Competent point of destination and no arrangements are in place to ensure that the consignment remains under the Authority (CA) allows for the onward continuous control of the CAs. transportation to another Member State (MS), the CA at the DPE The response of the Greek authorities stated the following: notifies the CA at the point of "An SOP regarding the onward transportation has been documented in the SOPM. destination and appropriate arrangements are put in place to In addition, a DPSQCPVO circular (ref. No 3096/72484/28.06.2012) including the detailed procedure to be ensure that the consignment remains followed in cases of onward transportation to another MS haw been disseminated to the CAs and already been under the continuous control of the implemented. The updated list of contact points of the Member States for the purposes of onward CAs as required by Article 8(2) of transportation has been sent to the CAs for this reason. Regulation (EC) No 669/2009. An example of the correct implementation of the procedure of onward transportation is provided as evidence (see Attachment no 3 to cover letter)." The Greek authorities provided the following up-dated information in the context of the 2015 GFA: Up-dated information received in the context of the 2015 GFA: The Greek authorities stated in response to the pre-draft country profile in November 2015 that "the continuous control of the consignment during the OT is ensured through its resealing. The new seal number is written in the box II.19. It is foreseen neither in the legislation nor in the Q and A paper that the CA should expect a feedback from the CA at the point of destination that the consignment has arrived. The 122 DG(SANTE) 2015-7657 Final Version date October 2016 Audit 2012-6275 of 05 March 2012 in order to evaluate import controls on food of non-animal origin
Reference no. and recommendation Basis of assessment Assessment communication in cases of OT always takes place between the CA of the DPE and the Contact Point of the MS, as included in the list provided by EU." The Greek authorities provided several examples of communication on onward transportation between Greek CAs and between Greek CAs and authorities of MSs at the point of destination. The implementation of Article 8(2) of Regulation (EC) No 669/2009 has been checked in the context of Audit 2016-8867.
2012-6275-9 This recommendation is based on findings and associated conclusions in Section 5.2.15 of the audit report that Action taken some problems regarding controls of peppers from Turkey subject to Regulation (EC) No 669/2009 were Ensure efficient and effective co- observed due to lack of clear procedures and communication between the DPE at Kipi Evrou and the DPE ordination between different acting as control point at the port of Thessaloniki.. authorities involved in controls at local level as required by Article 4(3) The response of the Greek authorities stated the following: of Regulation (EC) No 882/2004. "In all procedures/guidelines included in the DPSQCPVO circulars to the CAs, the necessity of efficient and effective co-ordination between different authorities is pointed out and described in detail. Moreover, the SOPs describe in detail the actions of each competent authority and the way they should cooperate with each other in each case." The Greek authorities provided the following up-dated information in the context of the 2015 GFA: Since August 2014, DPE Port Thessaloniki is no longer a control point under the provisions of Article 19 of Reg 669/2009. The CA of DPE Kipi Evrou carries out all the necessary checks on consignments under the scope of Reg. 669/2009, so no consignment transfer to Thessaloniki takes place. "
2012-6275-11 This recommendation is based on findings and associated conclusions in Section 5.2.13 of the audit report that Action taken the NRL for mycotoxins is the GCSL - Division of Environment-Laboratory in Athens. Evidence of co- Ensure that when private laboratories operation between the visited laboratory and the NRL was provided, but no co-operation is in place in the case are used for the purposes of official of private laboratories involved in official controls. controls, they are clearly designated as required by Article 12(1) of The response of the Greek authorities stated the following: Regulation (EC) No 882/2004; and "DPSQCPVO: The procedure to designate the laboratories (state and private) for official controls is currently that the National Reference In progress. The designation will be finalised with the issuance of an MD of the Minister of MRDF and is Laboratory (NRL) carries out its tasks 123 DG(SANTE) 2015-7657 Final Version date October 2016 Audit 2012-6275 of 05 March 2012 in order to evaluate import controls on food of non-animal origin
Reference no. and recommendation Basis of assessment Assessment towards them in line with Article 33 estimated to be completed by the end of October 2012. GCSL: The National Reference Laboratory of the EU of Regulation (EC) No 882/2004. for Mycotoxins (Division of Environment - GSGL) intends to fully fulfill its duties to private testing laboratories, used by the authorities for the official control of mycotoxins (starting from the notification of participation in the meeting report of the National Laboratories petition, held in Belgium (Geel), on 26-27 April 2012), as soon as they are designated by the Central Competent Authorities." The Greek authorities provided the following up-dated information in the context of the 2015 GFA: “DPQCFPP: The procedure to designate the laboratories (state and private) for official controls has not been completed. GCSL: The National Reference Laboratory for Mycotoxins (Division of Environment – now A’ Chemical Service of Athens) informs regularly the private official laboratory about the results of official meetings organised by EURL, as well as about current EU legislation on mycotoxins. It is worth to note that the private laboratory that performs official testing in samples taken from imported commodities is used occasionally as an official laboratory by the Services of MRDF and a long term collaboration with NRL is not possible." During the GFA the CCA stated that private laboratories are used in exceptional cases, such as when laboratory equipment is maintained or repaired or during accreditation visits. In 2014 about 3 samples out of more than 300 samples were analysed by accredited private laboratories.
2012-6275-14 This recommendation is based on findings and associated conclusions in Section 5.2.13 of the audit report that Action taken some methods are not fully validated for some specific products. For some validated methods accreditation is Ensure that all methods used by pending. laboratories designated for import controls of food of non-animal origin, The response of the Greek authorities stated the following: are validated and they are included in MRDF: In the process of designating official laboratories, the methods used by the laboratories (validation the scope of accreditation as required and accreditation) are taken into account, so that to avoid non-validated methods. by Article 12 of Regulation (EC) No 882/2004. GCSL: In the view of the General Chemical State Laboratory, if a laboratory designated for the official control of food: a) applies a quality assurance system assessed by an accreditation body and b) includes in its scope of accreditation methods with specific analytical techniques and specific range of analyte concentrations, then for any other similar method (same technique and the same range of analyte) applied after full validation (trueness, repeatability, LOD - LOQ, participation in proficiency testing schemes etc.) the typical inclusion in the scope of accreditation is not necessary, since the laboratory has proved its technical
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Reference no. and recommendation Basis of assessment Assessment competence to produce reliable results, within the meaning of the standard ISO/IEC 17025. The Greek authorities provided the following up-dated information in the context of the 2015 GFA: GCSL: The method of Ochratoxin A in Coffee, raisins and cereals was included in the accreditation scope of the National Reference Laboratory (Division of Environment – now A’ Chemical Service of Athens) at the time of 2012-6275 mission. The same is for official laboratory visited (A' Chemical Service of Piraeus – now Chemical Service of Piraeus and Aegean) (Scope of accreditation: Ochratoxin A in cereals, dried fruits, coffee and cocoa, beer, wine and grape juice, and their products)"
2012-6275-15 This recommendation is based on findings and associated conclusions in Section 5.2.17 of the audit report that In progress although some improvement had been noticed in relation to the verification activities of the MRDF, there are Ensure that audits are carried out no audits required by Article 4(6) of Regulation (EC) No 882/2004 and there are no procedures in place to (Article 4(6) of Regulation 882/2004) verify the effectiveness of the official controls in the CAs responsible for import controls of FNAO and procedures are in place to verify the effectiveness of official controls The response of the Greek authorities stated the following: and to ensure that corrective action is "Pending the establishment of the internal audit system, DPSQCPVO has developed an annual plan for on-site taken when needed (Article 8(3) of audit of all active DPEs/DPIs, starting in September 2012. The aim is to evaluate the overall performance of Regulation (EC) No 882/2004). the local CAs and identify any major and minor non-conformities and points of improvement. The on-site audit of the CAs will be followed by a report including the findings, as well as a corrective action plan on behalf of the CAs. Regarding the procedures in place, DPSQCPVO has decided the development of a “Standard Operating Procedure Manual (SOPM)”, part of this has already been materialised. The aforementioned SOPM is expected to be completed by the end of 2012. (see also responses to rec. 4, rec. 8; rec. 16) The implementation of SOPM is included in the scope of this on-site audit system." The Greek authorities provided the following up-dated information in the context of the 2015 GFA: The CCA provided in response to the pre-draft country profile the following information "DPQCFPP is in the process of drawing up the Process Management System. Key Performance Indicators have already been used through which verification of the effectiveness of the controls performed is achieved (see e.g. MANCP import). "
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Reference no. and recommendation Basis of assessment Assessment The Greek authorities also referred to the visit of the DPQCFPP to Thessaloniki in 2013 and one on-site visit to Kipi Evrou in May 05.05.2015, which were chosen because they are DPE and DPI with high volume of imports. The aim of the visits was the verification of the official controls at import, implementing regulations (EC) 669/2009 and (EU) 884/2014. The inspectors of the relevant competent authorities were present (RCPPQC and DRVEM of Thessaloniki and Evros). In addition, DPQCFPP asked for a randomly selected sample of 7 CEDs from DPE of Thessaloniki and 11 CED from DPE Kipi Evrou and the relative documents, in order to verify if the CEDs are filled in correctly and to compare the data on the CEDs with the corresponding entries on TRACES system by CAs and to the relevant EU database by DPQCFPP. The results of this control were also transmitted to the CAs (see att 2012- 6275-15 CED control Thessaloniki and 2012-6275-15 CED control Kipi Evrou ). RCPPQC of Thessaloniki issued the RN 4277/12.06.2014 document as a response to the DPQCFPP report. As a follow up and taking into account the recommendations proposed in the relevant report, RCPPQC of Thessaloniki purchased the appropriate equipment and adjusted the random way of selecting consignments for physical controls with analysis. In the same direction, DPE Kipi Evrou also proceeded with the necessary corrective/preventive actions as proposed in the report, which were noted down in RN19944/21.10.2015 document. According to the Process Management System an indicator, which is reviewed every six months, is being used in order for corrective – preventive actions to be taken defined as the ratio of controls which have met the predetermined controls level. Additionally, an algorithm is established in order for deviations to be avoided from the control frequency levels foreseen." During the GFA the CCA presented the state of play regarding Process Management System: The “project” is an advanced stage. Process Management System is third party certified and all necessary steps are taken in order to be endorsed through a legislative process which is according to the CCA likely to happen in the first semester of 2016. The CCA expects that the system will be in place and operation during the cause of 2016. It is planned to perform audits at all DPEs, DPIs and entry points in a three year cycle if budgetary constraints allow for this. At least the most relevant locations (risk based) would be visited. This recommendation has been followed-up through audit (SANTE) 2016-8867.
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Reference no. and recommendation Basis of assessment Assessment
2012-6275-17 This recommendation is based on findings and associated conclusions in Section 5.2.14 of the audit report that In progress there are written instructions and updated information available for inspectors, but there are no written Ensure that written procedures are in procedures in place. place for inspectors performing import controls (Article 8 of The response of the Greek authorities stated the following: Regulation (EC) No 882/2004; Article "Written procedures for inspectors performing import controls are included in all the DPSQCPVO circulars 4(c) of Regulation (EC) No 669/2009 issued for the implementation of the mentioned regulations. Moreover, written procedures are included in the and Article 6(b) of Regulation (EC) form of SOPs in the framework of the SOPM." No 1152/2009). The Greek authorities provided the following up-dated information in the context of the 2015 GFA: “Written procedures for inspectors who are performing official controls are included in the Process Management System.” (see also recommendation 15). This recommendation has been followed-up through audit (SANTE) 2016-8867.
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Inspection 2007-7218 of 15 April 2007 in order to evaluate controls of pesticide residues in food of plant origin
Reference no. and recommendation Basis of assessment Assessment
2007-7218-4 Overtaken by recommendation 2012-6285-13 Closed for other reasons The CAs should implement audit systems as required by Article 4 (6) of Regulation (EC) No 882/2004.
Audit 2009-8162 of 7 September 2009 in order to assess the official control systems in place for pesticide residues in and on food of plant origin
Reference no. and recommendation Basis of assessment Assessment
2009-8162-4 Audit report 2012-6285 states that a documented procedure regarding sampling for pesticide residues Action taken analyses was established by DPPP in March 2012. Ensure that a documented procedure is in place in the case of sampling for pesticide residues as laid down in Article 8 (1) of Regulation (EC) No 882/2004.
2009-8162-5 Audit report 2012-6285 states that a documented procedure for taking account of the reliability of food Action taken business operators' own checks, especially when carrying out official controls on non – processed food of Take account of the reliability of food plant origin, was established and distributed by DPPP in March 2012. business operators' own checks, especially when carrying out official controls on non – processed food of plant origin, as stipulated in Article 3 (1) (c) of Regulation (EC) No 882/2004.
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Reference no. and recommendation Basis of assessment Assessment
2009-8162-6 Audit report 2012-6275 on imports of FNAO concludes that controls are risk based with appropriate Action taken frequency. Ensure that official controls on imported food of plant origin, including controls at points of entry, are risk – based and frequency of controls is considered in accordance with the requirements laid down in Article 15 and Article 16 (2) of Regulation (EC) No 882/2004.
Audit 2012-6285 of 01 May 2012 in order to evaluate controls of pesticides
Reference no. and Basis of assessment Assessment recommendation
2012-6285-1 This recommendation is based on findings and associated conclusion in Section 5.2.2 of the audit report that suitably Closed for other qualified and experienced staff is available. The training system has overall ensured the proper channelling of information. reason Ensure that staff Further training in principles for safe storage of pesticides would increase the effectiveness of controls. receive appropriate training, and are kept The initial response of the Greek authorities stated the following: up-to-date in their "According to article 8 of law 4036/2012, the Coordinating National Authority will set an official training program for the competencies, as staff involved to official controls on plant protection products, as mentioned in the audit report. required by Article 6 of Regulation (EC) No The program is expected to begin in 6 months and will cover the appropriate training including safe storage of pesticides." 882/2004. This applies In August 2015 the CA provided the following updated information: in particular to the safe storage of pesticides. An official training program started in 2013. Each course of the program was 35 hours, covering the following topics: 1. Introduction – presentation of the program 2. Legislation framework regarding marketing of pesticides – Risk based analysis
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Reference no. and Basis of assessment Assessment recommendation 3. Controls on PPPs use 4. Controls on PPPs marketing 5. Controls on PPPs guaranteed composition, packaging, labelling and advertisement 6. Authorization of PPPs 7. Evaluation of participants’ knowledge Due to the economic circumstances the program could not extend to cover all inspectors involved in official controls on pesticide and a lot of inspectors (among them the ones that were identified during the previous audit as lacking this training) were retired. So, descriptive instructions were given to all inspectors through Ministry’s website. For example, for the safe storage of pesticides in PPP retailers, which was the founding in 2012 Audit, a new Presidential Decree [P.D. 159/2013 (OJ A251) – 18/11/2013] was issued, setting clearly the specifications for safe storage of pesticides in PPP retailers (http://www.minagric.gr/images/stories/docs/agrotis/Georgika_Farmaka/elenxoi/Emporia_Gewrgikwn_Farmakwn.pdf) According to article 10 the specifications of safe storage are set and competent authorities are obliged to check them. In addition, with the circular 6876/72454/3-6-2014 of the General Secretary of the Ministry, the control procedure based on risk analysis, technical instructions, control reports and checklists were established for the control of pesticide sale, including safe storage of PPPs. (http://www.minagric.gr/images/stories/docs/agrotis/Georgika_Farmaka/elenxoi/Sales_control.pdf) All information is freely available and updated in Ministry’s website. Finally, a new training program is requested to be activated for the second half of this year. The CA provided evidence of the content of the inspectors training program and the request to the National Training Institute for the trainings of the total Ministry’s employees for the second half of 2015 including trainings for PPPs inspectors. Audit report 2015-7475 states the following: 'Although efforts have been made in preparing training material and training session have taken place, the economic restrictions have compromised the on-going training plan. The recommendation is in progress. A more specific recommendation on the training of inspectors being a requirement for conducting official controls is made as a consequence
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Reference no. and Basis of assessment Assessment recommendation of the shortcomings identified in the current audit.' Overtaken by recommendation 2015-7475-1.
2012-6285-2 This recommendation is based on findings and associated conclusion in Section 5.2.4 of the audit report that no measures Action taken were foreseen regarding additional training of PPP distributors to update the knowledge, in contrary to the requirement laid Ensure that down in Article 5 of Directive 2009/128/EC. professional users and distributors of PPPs The initial response of the Greek authorities stated the following: have access to "The establishment of training for all parties involved in the marketing and use of PPPs is covered from the terms of appropriate training by reference of the Commission for the Submission of the Proposal for the NAP (article 32 of law 4036/2012). The ministerial bodies designated by degree regarding the participants to this Commission is about to be finalized. " CAs. This shall consist of both initial and In August 2015 the CA provided the following updated information: additional training to "The directive 2009/128/EC was transposed to Greek legislation with law 4036/2012 (OJ A 8) as modified by law acquire and update 4235/2014 (OJ A32) and especially with the articles 15-31. The provisions of the articles 32- 46 of law 4036/2012 describe knowledge as the national implementation measures related to the sustainable use of the plant protection products, among which the appropriate, as required procedure and the content of the National Action Plan. A consolidated English version of the law 4036/2012, as it is in force by Article 5(1) of is freely available in internet (http://www.minagric.gr/index.php/en/farmer-menu-2/plantprotection-menu/control-distr- Directive 2009/128/EC. useplantprotprod-menu). The CA provided a screenshot of the relevant website containing information on the National Action Plan. The National Action Plan for the sustainable use of plant protection products was issued with the Common Ministerial Decision num. 8197/90920/22-7-2013 (OJ B 1883). An English translation of the whole Common Ministerial Decision is freely available in internet (the above mentioned internet site). According to the above Common Ministerial Decision, the training in sustainable use of PPPs is supplied by public and private bodies. The agenda of training is proposed according to document num. 521/7086/21-1-2015 (http://www.minagric.gr/images/stories/docs/agrotis/Georgika_Farmaka/elenxoi/Program_Yliko_SYSXOPIS.pdf) The training providers are published on Ministry’s website (http://www.minagric.gr/index.php/el/for-farmer-2/crop- production/fytoprostasiamenu/elenxoifitoprostateytikonmenu/525-ethniko-sxe-drashs/1590-sxedio-drashs-gevrgikon- farmakon) with addresses and telephone details, so the professional users can easily find them Ministry’s website.
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Reference no. and Basis of assessment Assessment recommendation According to the National Action Plan, the certification system is independent and certificates are granted only after e-exams made on multiple choice questions. There is a database of questions and answers and a demonstration system (http://ppp- usercert.minagric.gr/) where PPP professional user can check his knowledge and download the question database. The professional users can participate in the exams in recognized bodies in groups of 10-20 participants in certain announced groups and places." Audit report 2015-7475 states the following: 'IPM is a legal requirement in the EU. Forty five thousand growers in Greece have received official training, which includes an IPM component. This addresses recommendation No 2 of the previous audit 2012-6285.' 2012-6285-3 This recommendation is based on findings and associated conclusion in Section 5.2.5 of the audit report that Professional Closed for other users of PPPs do not have access to appropriate initial and additional training, and to facilities for the calibration of pesticide reason Ensure that application equipment. professional users shall conduct regular The initial response of the Greek authorities stated the following: calibrations and "As above point. Also: technical checks of the pesticide application The competent authority has attended four SPISE meetings where were presented all the aspects of technical inspections and equipment as required of regular calibrations of spraying equipment that take place in other European countries. They have also attended the by Article 8(5) of inspections carried out under the pilot program Life that occurred in Boeotia and they now evaluate the results to draw Directive 2009/128/EC. conclusions about the state of spraying equipment existing in the country. Pesticide application Also the competent authority prepares the necessary regulatory documents on the control of spraying equipment which it equipment in will submit to the Committee for the National Action Plan" professional use shall be subject to In August 2015 the CA provided the following updated information: inspections, and be " Τhe established training programme provides adequate information for the importance as well as the way to conduct inspected at least once regular calibrations of the pesticide application equipment. by 26 November 2016, as required by Articles The competent authority prepares guidelines in order: 8(1) and 8(2) of the - to raise awareness of the importance of calibrations same Directive. -to ensure technically thorough and detailed instruction for the users, The required regulatory Ministerial Degree for the adoption and operation of the system for technical inspections of the 132 DG(SANTE) 2015-7657 Final Version date October 2016 Audit 2012-6285 of 01 May 2012 in order to evaluate controls of pesticides
Reference no. and Basis of assessment Assessment recommendation pesticide application equipment has been issued (No Ε8 1831/39763/21-4-2015, B' 671). The certified bodies will have to meet the provisions set in articles 6, 7 and 8 in the above mentioned Ministerial Degree. Miscellaneous bodies have expressed interest in operating a Station for Technical Inspection of the pesticide application equipment. No inspections have been carried out so far. Audit report 2015-7475 states the following: 'No inspections of application equipment have taken place as of 14th September 2015 since no test centers have been officially designated yet. The actions planned in response to this recommendation are in progress.' Overtaken by recommendation 2015-7475-7
2012-6285-4 This recommendation is based on findings and associated conclusion in Section 5.2.5 of the audit report that No measures Closed for other have been taken to ensure the safe handling, recovery and disposal of pesticide packaging and remnants. reason Ensure that the recovery and disposal The initial response of the Greek authorities stated the following: of pesticide remnants Τhe Coordinating National Authority will issue a specific procedure for the recovery and disposal of pesticide remnants and and their packaging by their packaging by professional users and distributors in order not to endanger human health or the environment, after professional users and discussing with interested parties. distributors do not endanger human health The procedure is expected to be finalized by December 2012. or the environment, as In August 2015 the CA provided the following updated information: required by Article 13(1)(e) of Directive Τhe circular no. 10373/103613/8-10-2012 (http://www.minagric.gr/index.php/el/for-farmer-2/crop- 2009/128/EC. production/fytoprostasiamenu/elenxoifitoprostateytikonmenu/525-ethniko-sxe-drashs/1589-apoblita-fytoprostasia). In addition a pilot project was launched (2013-2015) from Hellenic Crop Protection Association (E.SY.F.) in cooperation with the Hellenic Recovery and Recycling corporation (HERRco), the only certified (by Hellenic Recycling Agency, officially supervised by the Ministry of Environment) existing recycling system in Greece, with great success. The project is expanded to four (4) different areas in Greece (Prefecture of Larissa – central Greece, Veria, Edessa – north Greece, Megara – Attika prefecture and some small hot spots around the country). The first year the pilot ran only in Kileler Municipality (biggest agricultural municipality in Greece) and 335 kilos of proper rinsed plastic packaging was collected and recycled in a 133 DG(SANTE) 2015-7657 Final Version date October 2016 Audit 2012-6285 of 01 May 2012 in order to evaluate controls of pesticides
Reference no. and Basis of assessment Assessment recommendation recycler plant in Thessaloniki. The second year the project was expanded to the whole Prefecture of Larissa (6 Municipalities) and 2,7 tons of proper rinsed plastic packaging was collected and recycled in a recycler plant in Thessaloniki. In 2015 apart from Larissa Prefecture other agricultural Municipalities are involved especially in the north-west of Greece, as well as some hot spots around the country. For the time being and after a partial first collection at the Prefecture of Larissa 1,9 tons of proper rinsed plastic packaging have been collected. Collections are scheduled till end of October 2015 in all pilot areas. Finally, the LIFE+ 07 ENV/GR/000266 Ecopest project: “Strategic Plan for the adaptation and application of the principles for the sustainable use of pesticides in a vulnerable ecosystem” was conducted by Benaki Phytopathological Institute (http://www.ecopest.gr/index.php?lang=en), with great success and EU Member States have selected it in the 4 “Best of Best” Life Environment Projects of 2012. Audit report 2015-7475 states the following: The actions taken in response of recommendation No4 of the previous audit 2012-6285 is in progress (see para. 90 on page 20): 'The results of the survey on professional use showed that 60 % of growers declared that empty containers are rinsed and recycled.' Overtaken by recommendation2015-7475-8
2012-6285-5 This recommendation is based on findings and associated conclusion in Section 5.2.8 of the audit report that Report formats Action taken in the form of check-lists for inspections of retailers and users have been distributed by DPPP, and were followed by the Include documentary DREVM visited by the audit team. The CA stated that new descriptive procedures are planned to be issued taking into checks in the account Law 4036. The check-lists verified during the inspections of growers and retailers did not provide guidance for inspections of users of inspectors to allow judgement of compliance. PPPs to ensure the effectiveness of official The initial response of the Greek authorities stated the following: controls, as required by "Τhe Coordinating National Authority will issue a specific procedure for documentary checks in the inspections of users of Article 4(2)(a) of PPPs to ensure the effectiveness of official controls in two months’ time." Regulation (EC) No 882/2004. In August 2015 the CA provided the following updated information: "Τhe procedure num. 10371/103604/8-10-2012 “Guidelines for the control of professional users of plant protection products” was issued (available in English:
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Reference no. and Basis of assessment Assessment recommendation http://www.minagric.gr/images/stories/en_docs/plant_protection/Farmer_control_procedure.pdf) The procedure is published in Ministry’s website: http://internet.minagric.gr/images/stories/docs/agrotis/Georgika_Farmaka/elenxoi/diadikasia_elexnoy_parag4102.pdf. This procedure includes documentary checks in the inspections of users of PPPs to ensure the effectiveness of official controls." Audit report 2015-7475 states the following: 'The audit team witnessed the use of this documentation in the field and has received copies of completed checklists and reports of finalised inspections. The recommendation has been satisfactorily addressed.'
2012-6285-6 This recommendation is based on findings and associated conclusion in Section 5.2.5 of the audit report that inspections at Action taken growers are announced and this is in contradiction with the requirements laid down in Article 3(2) of Regulation (EC) No Ensure that official 882/2004. controls of users of PPPs are carried out The initial response of the Greek authorities stated the following: without prior warning, Τhe Coordinating National Authority will issue a specific circular for the inspections of users of PPPs to ensure that they are as laid down in Article carried out without prior warning in two months’ time. 3(2) of Regulation (EC) No 882/2004. In August 2015 the CA provided the following updated information: Τhe procedure num. 10371/103604/8-10-2012 “Guidelines for the control of professional users of plant protection products” was issued (available in English: http://www.minagric.gr/images/stories/en_docs/plant_protection/Farmer_control_procedure.pdf) The procedure is published in Ministry’s website: http://internet.minagric.gr/images/stories/docs/agrotis/Georgika_Farmaka/elenxoi/diadikasia_elexnoy_parag4102.pdf. This procedure clearly states that inspections of users of PPPs are carried out without prior warning. The implementation of the document can be seen on practice or after interviews with the inspectors.
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Reference no. and Basis of assessment Assessment recommendation Audit report 2015-7475 states the following: 'The documented procedures state that controls are conducted without prior warning. The audit team received confirmation of this being the case from all DREVs visited and from growers and retailers that were visited for the audit. The recommendation has been satisfactorily addressed.'
2012-6285-7 This recommendation is based on findings and associated conclusion in Section 5.2.5 of the audit report that inspectors have Action taken no legal power for the access to growers’ premises except when a criminal investigation has been launched. that they have Ensure that staff have the legal powers to carry out official controls and to take the measures provided Article 8(2) of Regulation (EC) No access to premises of 882/2004. and documentation kept by users of PPPs, as Similar recommendations regarding the capability of official laboratories to cover an appropriate analytical scope were required in Article 8(2) contained in the audit reports 2004-7333(rec. 6), 2007-7218 (rec. 11.) and 2009-8162 (rec. 7). of Regulation (EC) No The initial response of the Greek authorities stated the following: 882/2004. "Article 8, paragraphs 2 and 3 empowers the access to premises of and documentation kept by users of PPPs. Τhe Coordinating National Authority will issue a specific circular for the inspections of users of PPPs to clarify the above provisions in two months’ time." In August 2015 the CA provided the following updated information: "Τhe procedure num. 10371/103604/8-10-2012 “Guidelines for the control of professional users of plant protection products” was issued (available in English: http://www.minagric.gr/images/stories/en_docs/plant_protection/Farmer_control_procedure.pdf). The procedure is published in Ministry’s website: http://internet.minagric.gr/images/stories/docs/agrotis/Georgika_Farmaka/elenxoi/diadikasia_elexnoy_parag4102.pdf. This procedure clearly states that staff have access to premises of and documentation kept by users of PPPs." Audit report 2015-7475 states the following: 'Article 8 of the National Law 4036/2012 lays down the obligation of operators to cooperate and supply any requested information during controls. This addresses recommendation No 7 of the previous audit 2012-6285.'
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Reference no. and Basis of assessment Assessment recommendation
2012-6285-8 This recommendation is based on findings and associated conclusion in Section 5.2.6 of the audit report that because of the In progress inadequate management of the available equipment and staff in the network of official control laboratories, the majority of Ensure that all analyses did not ensure efficient and effective controls of pesticide residues. designated pesticide residue laboratories The initial response of the Greek authorities stated the following: have LC-MS/MS and EU regulatory requirements (Regulations, SANCO document) ask for GC-MS equipment, not GC-MS/MS. Nevertheless, the GC-MS/MS equipment Coordinating National Authority is planning rearrangements in order to ensure that that all designated pesticide residue to ensure that staff can laboratories have LC-MS/MS and GC-MS/MS equipment. The whole procedure is expected to be finalized by the end of perform official January 2013. controls efficiently and effectively, as required In August 2015 the CA provided the following updated information: by Article 4(2)(d) of The CA provided an updated list of official laboratories being used for pesticide residue analyses including information on Regulation (EC) No the situation with the accreditation of these laboratories. All official laboratories are accredited. However, the analytical 882/2004. scope of the laboratories and the analytical equipment available varies between laboratories. Only two laboratories have LC- MS-MS and GC-MS-MS allowing them to cover at least the analytes mentioned in the EU coordinated programme. The Greek authorities provided the following updated information in the context of the 2015 GFA: During the GFA the CCA provided a road map for the pesticide residue laboratories. The existing laboratories were evaluated and a decision had been taken to reduce the number of official laboratories. It is planned that the remaining laboratories will be equipped with LC and GC-MS/MS. The CCA also stated that in some case a limited scope was sufficient in order to test samples of specific crops which are dominant in some regions (e.g. citrus), while the samples for the EU coordinated programme and national programme (samples taken at market level) are test by the NRL which can cover a wide scope of analytes going beyond the analytes listed in the EU coordinated programme.
2012-6285-9 This recommendation is based on findings and associated conclusion in Section 5.2.7 of the audit report that No control Closed for other plans, risk criteria nor target frequencies to prioritise inspections of retailers or growers have been documented. reason Ensure that official controls are carried out Recommendation 2007-7218-1 addressed a similar issue: The CAs should continue to establish a co-ordinated and regularly, on a risk comprehensive control plan for the marketing and use of plant protection products. basis and with The initial response of the Greek authorities stated the following: appropriate frequency, as required by Article Τhe Coordinating National Authority will issue a specific circular for the inspections of users of PPPs to ensure that they are 137 DG(SANTE) 2015-7657 Final Version date October 2016 Audit 2012-6285 of 01 May 2012 in order to evaluate controls of pesticides
Reference no. and Basis of assessment Assessment recommendation 3(1) of Regulation (EC) carried out on a risk basis and with appropriate frequency in two months’ time. No 882/2004. A Presidential Decree will be issued by December 2012 for the inspections of retailers and wholesalers to ensure that they are carried out on a risk basis and with appropriate frequency. In August 2015 the CA provided the following updated information: Τhe procedure num. 10371/103604/8-10-2012 “Guidelines for the control of professional users of plant protection products” was issued (available in English: http://www.minagric.gr/images/stories/en_docs/plant_protection/Farmer_control_procedure.pdf). The procedure is published in Ministry’s website: http://internet.minagric.gr/images/stories/docs/agrotis/Georgika_Farmaka/elenxoi/diadikasia_elexnoy_parag4102.pdf. This procedure clearly states that they are carried out on a risk basis and with appropriate frequency. The Presidential Decree [P.D. 159/2013 (OJ A251) – 18/11/2013] was issued regarding “Establishing the specifications and procedures for the pesticide sales operation start announcement and functioning pesticide sales shops”. In paragraph 2 of article 14 (Control procedure for pesticide sales) of P.D. 159/2013, the risk factors for the control of pesticide sales are set. (http://www.minagric.gr/images/stories/docs/agrotis/Georgika_Farmaka/elenxoi/Emporia_Gewrgikwn_Farmakwn.pdf) Evidence for the implementation of the above are control forms and cases with administrative sanctions that may be presented during audit. For the end of 2015 it is planned after discussions with the Directorate of Electronic Governance of the Ministry of Reconstruction of Production, Environment & Energy to develop an e-platform for the risk based official controls on pesticides. At the present moment, an e-platform for on-line registering of pesticides retail sales to the Ministry of Reconstruction of Production, Environment & Energy is in function and this will be connected with e-pesticide prescription service and the forthcoming e-risk based controls service. Audit report 2015-7475 states the following: 'The recommendation has been satisfactorily addressed with regard to retailers of PPPs. However there remain inadequate controls on manufacturers and packers of PPPs, and users of PPPs. (See recommendations 2015-7475-2).'
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Reference no. and Basis of assessment Assessment recommendation
2012-6285-10 This recommendation is based on findings and associated conclusion in Section 5.2.8 of the audit report that the documented Action taken procedures do not contain sufficient information and instructions for staff to perform effective official controls. The check- Ensure that lists verified during the inspections of growers and retailers did not provide guidance for inspectors to allow judgement of documented procedures compliance. contain sufficient information and The initial response of the Greek authorities states the following: instructions for staff to "Τhe Coordinating National Authority will issue a specific circular supplying sufficient information and instructions for staff perform effective to perform effective official controls for the inspections of users of PPPs. official controls, as required by Article 8 of A relevant circular will be issued two months of the above mentioned Presidential Decree. " Regulation (EC) No In August 2015 the CA provided the following updated information: 882/2004. "Τhe Coordinating National Authority will issue a specific circular supplying sufficient information and instructions for staff to perform effective official controls for the inspections of users of PPPs. A relevant circular will be issued two months of the above mentioned Presidential Decree. Measures taken to address the specific recommendation Τhe procedure num. 10371/103604/8-10-2012 “Guidelines for the control of professional users of plant protection products” was issued (available in English: http://www.minagric.gr/images/stories/en_docs/plant_protection/Farmer_control_procedure.pdf). The procedure is published in Ministry’s website: http://internet.minagric.gr/images/stories/docs/agrotis/Georgika_Farmaka/elenxoi/diadikasia_elexnoy_parag4102.pdf. This procedure clearly states that inspections of users of PPPs are carried out without prior warning. Evidence for the implementation of the above are control forms and cases with administrative sanctions that may be presented during audit." For procedures on the sale of PPP, see rec. 1. The CA did not provide evidence of revised procedures for controls of retailers.
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Reference no. and Basis of assessment Assessment recommendation Audit report 2015-7475 states the following: 'The CCA has issued documented procedures, circulars, guidelines, control forms, checklists and standardized inspection reports to all staff involved in the controls of PPPs. The recommendation has been satisfactorily addressed. (See paragraph 26).'
2012-6285-11 This recommendation is based on findings and associated conclusion in Section 5.2.9 of the audit report that DPPP stated Action taken that information on non-compliances regarding the use of PPPs is communicated to OPEKEPE. However, DPPP, RCPPQC Ensure effective co- and DREVM were not aware of any pesticide controls carried out by OPEKEPE. operation between the authorities performing The initial response of the Greek authorities stated the following: controls on pesticide "Effective co-operation is established between Coordinating National Authority and all authorities performing controls on use, as required by pesticide use. Horizontal co-operation between the CAs performing controls of pesticide use was established with the Article 4(3) of exception of the authority responsible for controls at growers for the purposes of cross-compliance, as mentioned in the audit Regulation (EC) No report. The authority responsible for controls at growers for the purposes of cross-compliance has already started the 882/2004. cooperation and the Coordinating National Authority will issue a specific circular in two months’ time supplying the procedure of the common beneficial use of control data." In August 2015 the CA provided the following updated information: "The co-operation between the main CA and the Payment Agency OPEKEPE, in the context of cross-compliance checks is described in the circular num. 417/2-10-2012 regarding “Official controls of pesticide residues and cross-compliance controls”, which is published on Ministry’s website. Based on the above circular, every decision issued by the main CA, the Plant Produce Protection Directorate of the Ministry of Reconstruction of Production, Environment and Energy regarding administrative sanctions for infringements on PPPs use is copied to OPEKEPE and causes cross-compliance sanctions. Examples of implementations can be examined in any file of infringement to professional user after 2012. Based on the above circular, the control circular 111318/4-8-2014 of OPEKEPE clearly states that the PPPs storage and use is controlled and for this purpose the local competent authorities - Directorates of Agricultural Economy and Veterinary of Regional Unities are informed and enabled to conduct official controls for PPPs."
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Reference no. and Basis of assessment Assessment recommendation Audit report 2015-7475 states the following: 'The audit team observed effective co-operation between the CCA and the regional authorities (DREVs) conducting the PPP controls. Excellent co-operation with customs was observed during the assessment. The recommendation has been satisfactorily addressed.'
2012-6285-12 This recommendation is based on findings and associated conclusion in Section 5.2.11 of the audit report that no procedures In progress for verification of the effectiveness of controls, and no systems for internal or external audit were in place. Ensure that procedures are put in place to The initial response of the Greek authorities stated the following: verify the effectiveness "An internal audit system will be established to ensure that audits are carried out (Article 4(6) of Regulation 882/2004) and of controls that they procedures are in place to verify the effectiveness of official controls and to ensure that corrective action is taken when carry out, as required needed (Article 8(3) of Regulation (EC) No 882/2004). The inspections will be carried out at Regional level by specifically by Article 8(3)(a) of designated and dedicated staff members of each Regional Centre for Plant Protection and Quality Control (RCPPQC). The Regulation (EC) No area of jurisdiction of the inspectors will be the Directorates of Rural Economy and Veterinary Service (DREVS) of the 882/2004. Prefectures of each particular Region and as well as their own RCPPQC."
In August 2015 the CA provided the following updated information including information on the national audit system. "With the Common Ministerial Decision num. 11935/134642/24-10-2014 “Establishment of necessary supplementary measures for the implementation of the Regulation (EC) no. 882/2004, regarding the competent authorities and the procedure for the internal audit system and verification of the effectiveness of official controls on plant protection products and pesticides residues” (Official Journal B’2958), the system for the verification of the effectiveness was established, according to the above action plan. This Common Ministerial Decision is published on the Ministry website: http://www.minagric.gr/images/stories/docs/agrotis/Georgika_Farmaka/elenxoi/fek_2958_2014.pdf. The multi-annual program has recently been signed (Ministerial Decision num. 6480/76829/9-7-2015). No implementation has been done yet." The Greek authorities provided the following updated information in the context of the 2015 GFA: The Regional Centres for Plant Protection and Quality Control are in charge of verification of effectiveness of controls. It is foreseen that as of 2016 the RCPPQCs submit report to the CCA. Audits will also be used in order to check whether
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Reference no. and Basis of assessment Assessment recommendation RCPPQCs perform their tasks. Ministerial Decision No. 6480/76829 of 23 June 2015 on Internal Audit in relation to official pesticides controls also aims at verification of effectiveness of controls.
2012-6285-13 This recommendation is based on findings and associated conclusion in Section 5.2.11 of the audit report that no procedures In progress for verification of the effectiveness of controls, and no systems for internal or external audit were in place. Carry out internal audits or have external The initial response of the Greek authorities stated the following: audits carried out, as An internal audit system will be established to ensure that audits are carried out (Article 4(6) of Regulation 882/2004) and required by Article 4(6) procedures are in place to verify the effectiveness of official controls and to ensure that corrective action is taken when of Regulation (EC) No needed (Article 8(3) of Regulation (EC) No 882/2004). The inspections will be carried out at Regional level by specifically 882/2004. designated and dedicated staff members of each Regional Centre for Plant Protection and Quality Control (RCPPQC). The Repeat of area of jurisdiction of the inspectors will be the Directorates of Rural Economy and Veterinary Service (DREVS) of the recommendation 2007- Prefectures of each particular Region and as well as their own RCPPQC. 7218 In August 2015 the CA provided the following updated information:
"With the Common Ministerial Decision num. 11935/134642/24-10-2014 “Establishment of necessary supplementary measures for the implementation of the Regulation (EC) no. 882/2004, regarding the competent authorities and the procedure for the internal audit system and verification of the effectiveness of official controls on plant protection products and pesticides residues” (Official Journal B’2958), the internal audit system was established, according to the above action plan. This Common Ministerial Decision is published on the Ministry website: http://www.minagric.gr/images/stories/docs/agrotis/Georgika_Farmaka/elenxoi/fek_2958_2014.pdf. With the Ministerial Decision 402/147651/21-11-2014 regarding the “Designation of the members of the Internal Audit Committee of article 5 of the num. 11935/134642/24-10-2014 Common Ministerial Decision”, the Internal Audit Committee which is responsible for the program was set. The members of the Internal Audit Committee were modified with the Ministerial Decision 1280/19057/16-2-2015. The multi-annual program has recently been signed (Ministerial Decision num. 6480/76829/9-7-2015). No implementation has been done yet."
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Reference no. and Basis of assessment Assessment recommendation The Greek authorities provided the following updated information in the context of the 2015 GFA: Ministerial Decision No. 6480/76829 of 23 June 2015 is the basis for the establishment of a specific internal audit system for pesticide related controls. The CCA stated that the new system will be put in place in 2016.
2. B.10 Animal welfare
Inspection 2007-7244 of 06 May 2007 in order to evaluate the system of control in relation to animal welfare on farms
Reference no. and recommendation Basis of assessment Assessment
2007-7244-1 This recommendation is based on findings and the associated conclusion in Section 6 of the report of Action still audit 2007-7244. The report of an earlier audit on animal welfare on farms (no. 8522/2002) had made a required The necessary staff are provided, as recommendation to ensure that adequate resources are in place at all levels for effective inspections of a required by Article 26 of Regulation (EC) statistically representative sample of holdings each year. Audit 2007-7244 found that there had been an No 882/2004, for official controls of inadequate response to the recommendation in the earlier report. There continues to be a chronic problem animal welfare on farms. in attributing adequate staff to the Prefectural CAs, which undermines the implementation of a control system for animal welfare on farms. Situation after the 2010 GFA The CA reported no change to date on the staffing situation. The Greek authorities provided the following updated information in the context of the 2015 GFA: The CA reported no change to date on the staffing situation. In the context of the 2015 GFA the CA stated that in some Regional Veterinary Services (e.g. Region of Central Macedonia) the control plans have been fully implemented despite the chronic lack of personnel. In other Regions however, due to more intense lack of personnel and disease outbreaks, it had not been 143 DG(SANTE) 2015-7657 Final Version date October 2016 Inspection 2007-7244 of 06 May 2007 in order to evaluate the system of control in relation to animal welfare on farms
Reference no. and recommendation Basis of assessment Assessment possible to fully implement control plans on animal welfare. Another factor is that inspectors are unable to travel because the number of days allowed for the reimbursement of travel expenses has been limited to 60 per year. The CCA has requested annual control planning from all Prefectural Veterinary Services since 2011. In some cases however, control plans and results have not been returned to the CCA. The GFA Team were provided with examples of control plans which were returned by Regions. The CCA stated that some Regional Units had been worse affected than others by the level of retirees and the lack of recruitment. Some Units had lost a large percentage of staff, while others had lost colleagues who were very experienced in Animal Welfare. In future, it is proposed to adopt a more targeted approach in order to balance out resources between the Regional Units. The CCA has recently made an assessment of the immediate needs for staff at both the central and the regional services. A proposal for the recruitment of veterinarians is currently under discussion at a high level.
2007-7244-2 This recommendation is based on findings and associated conclusion in Section 6 of the audit report. The In progress CCA's undertaking to provide training to officials carrying out checks, which was given following a The staff performing checks are recommendation in the report of audit no. 8522/2002, had not been fulfilled. appropriately trained, as required by Article 6 of Regulation (EC) No 882/2004. Situation after the 2010 GFA Training was carried out in 2008 on on-farm inspections, but no training was provided in 2009 or 2010. Two training seminars are planned in 2011, in Athens and Thessaloniki, with representatives from all PVDs to be invited. The CAs, in their comments on the draft country profile, indicated that training seminars will be conducted in the second half of 2011. For more information on horizontal issues, see chapter 1 of the country profile document "the organisation of food safety, animal health, animal welfare and plant health control systems". The Greek authorities provided the following updated information in the context of the 2015 GFA: The CCA stated that staff from both the central and regional services have attended BTSF training courses on Animal Welfare organised by the European Commission. The CCA keeps Regional Units informed about upcoming BTSF courses. This will continue in 2016. Training material from the BTSF courses is translated and will be disseminated to regions as a priority in 2016.
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Reference no. and recommendation Basis of assessment Assessment
Training events organized by the CA since 2010 included seminars on the inspection of animal welfare in farms which took place in Larissa on 21-9-2010, in Kalampaka on 7-10-2010, and in Drama on 15-09- 2011. Training courses on the use of the Laying Hens database have also been given. A seminar on pig welfare was organized in 2012 but none had been held since then. The CA provided the GFA Team with evidence of courses delivered. The CA stated that the Regional Units notify them of their training needs. The CA’s intention is to organize seminars on laying hens and on pigs in 2016, with a priority on pig welfare. The courses will be targeted at official veterinarians in the regional services. The CA may consider using the national training organization (NCPA) for courses in the future. Some regions also organize local training courses for inspectors. The CA intends to develop a Pig Welfare training manual in 2016, along the lines of their Manual for Laying Hens.
2007-7244-3 This recommendation is based on findings and associated conclusion in Section 6 and 6.1 of the audit In progress report. The quality of inspections was generally not sufficient and the results which had been reported Verification of the effectiveness of were unreliable. Insufficient measures have been put in place by the CCA to first identify, and then to inspections, as required by Article 8.3 of remedy, these issues. Regulation (EC) No 882/2004, is carried out to ensure the quality and consistency of Situation after the 2010 GFA controls of animal welfare on farms. The CA stated that at the beginning of each year, based on the results of the checks carried out, each of the responsible PVDs evaluates the system for monitoring the implementation of the legislation in order to verify the effectiveness of the checks carried out with regard to:
- the level of farms' compliance with the requirements of the legislation, - the follow-up to inspections in the event of non-compliance, - corrective measures taken and the time allowed for compliance, - the imposition of sanctions which serve as a deterrent and are proportionate to the seriousness of the infringement. However, as no such information was provided to the CCAs by the Prefectures in 2009, it was not
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Reference no. and recommendation Basis of assessment Assessment possible to carry out the verification as required by Article 8.3 of Regulation (EC) No 882/2004. The Greek CAs, in their comments on the draft country profile, provided additional information: Documents ref. 296779/17.11.2010 and ref. 134155/01.04.2011 were addressed to the Directorates of Veterinary Medicine of the Prefectural Authorities, laying down further instructions on the implementation of the recommendations made as part of the performance of official animal protection controls on farms. In addition, in document ref. 134155/01.04.2011, the CCA requested the competent veterinary departments of the Prefectural Authorities to provide a more detailed presentation of control results for the year 2010, in conjunction with the table referred to in Decision 2006/778/EC No verification activities have been carried out to ensure the quality and consistency of controls. The Greek authorities provided the following updated information in the context of the 2015 GFA: The CCA stated that the Veterinary Services of Regions are responsible for the supervision of the control systems of the Regional Units under their remit. On a biannual basis the Regional Units have to submit a report to the Veterinary Service of their Region regarding the statistics which are required under Directive 2006/778. The biannual reports contain data on the number of controls performed by the Regional Unit, and a table categorising non-compliances, deadlines for corrective actions and sanctions. Regions check the data in these reports and can do on-the-spot checks on the Regional Units. The CCA stated however that only one or two Regions had performed such on-the-spot checks (the CCA provided the GFA team with copies of the record of on-the-spot supervisory visits conducted by one Region). The CCA commented that the processes for reporting on controls are paper-based and time-consuming and that it would be more efficient if control data could be captured electronically. The CCA stated that they believed that in some cases controls had been performed but had not been recorded, and that these may not have been included in the statistics submitted in the tables. Regions carry out checks on control reports on a sampling basis. In the case of enriched cages, the Regions had collected all the reports. Regarding internal audits, the CCA stated that their auditing service (the Directorate of Veterinary Inspection and Control as it was then known) had carried out a series of internal audits in Regional Units in 2011-2012, including ones on animal welfare (Aetolia-Acarnania – pigs, 2011; West Attica - laying
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Reference no. and recommendation Basis of assessment Assessment hens, 2011; Corinthia and Evros – welfare on farms, 2012). The CCA provided the GFA team with supporting documentation, including a copy of a completed form used by a Regional Veterinary Service for the verification of the effectiveness of controls on farms which had been performed by Regional Units, one report on an on-the-spot visit to a Regional Unit, a list of internal audits performed in 2011-2012, and a document showing the results of sample checks on files by the Veterinary Service of one of the few Regions that performed sample checks. DG SANTE assessment: The CCA has put a system for verification in place, but this is mainly focused on collection of data on controls; the system does not allow to verify that official controls produce the intended effect or achieve the objective related to the control, or that controls are carried out in compliance with documented procedures. There are no clear procedure how the Regions should perform their verification tasks (e.g. systematic assessment of inspection reports, assessment of data collected, on- the-sport verification, etc.).
2007-7244-5 This recommendation is based on findings and the associated conclusion in Section 6 of the audit report. Closed for other Progress with the registration of laying hen farms, which should have been completed by 1 June 2003 reasons All laying hen farms covered by the scope (Article 1 of Directive 2002/4/EC), had been slow and incomplete with many errors in the data recorded. of Directive 99/74/EC are correctly As certain establishments had been operating without being registered, these operators had not been given registered and that the register is updated a code to be marked on the eggs when there are changes to the data, as required by Article 1 of Directive Situation after the 2010 GFA 2002/4/EC, in particular the maximum The CAs stated that instructions were issued to all PVDs on the procedures for controlling laying hen capacity of the establishment. farms. The CA stated that while no on-the-spot checks are carried out by the CCAs to ensure the correct implementation of these procedures, administrative checks are carried out on reports received from the PVDs. According to the CA, no discrepancies have been reported so no follow-up action was required. The CAs indicated that a letter of 17.06.2010, ref. 276795, to all PVDs resulted in 15 stating they had no laying hen farms, 32 that they would take action and 7 did not reply. In view of the general unsatisfactory response, the CA wrote again to all Divisions and gave a deadline of 03.12.2010 for information on the results of their controls. No response had been received at the time of the finalisation of the draft report. The Greek CAs, in their comments on the draft country profile, provided additional information:
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Reference no. and recommendation Basis of assessment Assessment The registry of laying hens drawn up by the relevant department included all laying hen farm operators and their respective farms falling within the scope of Directive 1999/74/EC. In accordance with Directive 1999/74/EC, maximum capacity and current capacity per room will be entered in the electronic database kept for laying hens. This recommendation has been overtaken by recommendation 2009-8243-5
2007-7244-6 This recommendation is based on findings and the associated conclusion in Section 6 of the audit report. In progress It was concluded that eggs placed on the market were not always being appropriately marked as, in Eggs placed on the market are addition to the failure to complete the registration of holdings and allocate the necessary codes, in one appropriately marked, as required by case the code for a barn system had been given to a cage production system and in another eggs bore an Article 8.2 of Regulation (EC) No illegible mark. 2295/2003. Situation after the 2010 GFA The CAs stated that a single code has been established for all laying hen farms. This code must be affixed to all eggs. The implementation of this requirement is to be checked during farm inspections. The Department of Veterinary Public Health is responsible for the control of egg labelling in packing stations. EFET is responsible for checking egg labelling on the market. A joint circular has been sent to all PVDs on 10.11.2010 to verify that each FBO has a registered number and that egg labelling is correctly done. A specific checklist accompanied the circular. No response had been received at the time of the General Follow-up Audit in December 2010. The Greek CAs, in their comments on the draft country profile, provided additional information: The Common document ref. 296773/10.11.2010 drawn up by the animal welfare department and the Directorate of Public Veterinary Health had been communicated to EFET, as the latter is responsible for monitoring retail sales. The document requested EFET to notify in the event of identifying any unmarked eggs placed on the market with a view to implementing measures at farming or packaging and standardising levels. No notification from EFET was received in 2010 for any unmarked eggs placed on the retail market. Controls were performed on egg packaging and standardising facilities by Directorates of Veterinary Medicine of the Prefectural Authorities in 2010.
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Reference no. and recommendation Basis of assessment Assessment The Greek authorities provided the following updated information in the context of the 2015 GFA: The CCA stated that they had sent a circular to Regional authorities (20/01/2015) asking for the results of their controls on eggs for 2014 and requesting their plans for 2015. However, the CCA did not receive responses from all Regions. The list of controls on egg collection centres for 2014 which was provided to the GFA team by the CCA shows a total of 16 controls in 6 Regional Units. The CCA believes that there are cases where controls were done but were not recorded, or were not communicated to the CCA. In advance of Easter the CCA reminds regional authorities about the need for controls because of the traditional upsurge in consumption at that time of the year (a copy of the 2015 instruction was provided to the GFA Team). The CCA stated that since the reorganisation of the Ministry in 2015 the responsible Department had concentrated on fish, milk and bivalve molluscs as priorities but that in 2016 they will apply pressure on regional authorities to perform controls on eggs and to provide results of those controls. The CCA gave some examples of non-compliances found in 2014, for example where codes on eggs did not correspond to any known code and where markings on eggs did not include all the required elements (e.g. date for consumption). The CCA provided documentation on the actions taken by the authorities in these cases (traceability checks, withdrawal of produce).
2007-7244-7 This recommendation is based on findings and the associated conclusion in Section 6 of the audit report Action taken that a comprehensive assessment of the risks that influence animal welfare had not been made. The risks that influence animal welfare on farm are identified and are taken into Situation after the 2010 GFA account when controls are carried out, as The CA gave a description of the risk-based controls carried out, and referred to tables which PVDs are required by Article 3.1 of Regulation (EC) required to complete in respect of pig and laying hen farms. The CA was requested to provide No. 882/2004 and the frequency for information on the inspection programme and the tables containing the parameters ranking the welfare of inspection of selected farms is appropriate. pigs and laying hens and the list of the pig and laying hen farms selected for inspections in some randomly selected prefectures. The CA provided some statistics on controls carried out, but it is not clear what basis was used for selecting the farms controlled. A circular was issued to all PVDs on 07.03.2008, ref. 262377, in relation to risk and providing details of how to carry out a risk analysis. While CA stated that all PVDs implement this circular, this has not been 149 DG(SANTE) 2015-7657 Final Version date October 2016 Inspection 2007-7244 of 06 May 2007 in order to evaluate the system of control in relation to animal welfare on farms
Reference no. and recommendation Basis of assessment Assessment verified by the CA. The Greek CAs, in their comments on the draft country profile, provided additional information: To verify the use of risk criteria in preparing the annual animal farm control plan, the CAs indicated the following actions: 1) LAYING HENS 1.a. The animal welfare Department, in cooperation with the IT Department, had proceeded to the design of an electronic database for registering laying hen farm operators and their respective farms. 1.b. The printouts required for using the information required by Decision 2006/778/EC had been completed. 1.c. User training for the management of the electronic database for registering laying hen farm operators and their respective farms, took place on 16, 22, 24 and 28 June 2011. 1.d. A database manual was issued (evidence was provided), including the options provided by the menu concerning the checklist, the production of a sample on the basis of risk criteria, and the printouts. 1.e. Plans had been made for entering information in the database by 31/12/2011, relating to the details of laying hen farms and their respective operators per farming method. This will allow starting operating the database and thus obtain a complete picture of laying hen farms in the country (their maximum capacity and their current population). 1.f. Further use of the database in order to produce a control sample, with risk criteria, registration of the results of the controls carried out, the penalties imposed, as well as preparation of the annual report referred to in Decision 2006/778/EC. 2) PIGS A new circular will be drawn up by 31/12/2011 addressed to Regional Departments with a view to verifying that risk criteria are used in preparing the annual farm control plan. The Greek authorities provided the following updated information in the context of the 2015 GFA: The CCA stated that a circular on risk had been drawn up in 2008 on foot of audit 2007-7244. This circular describes the criteria to be used for selecting farms to be inspected (a copy of the circular was
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Reference no. and recommendation Basis of assessment Assessment provided to the GFA Team). The CCA provided recent examples from a number of regional units listing the risk criteria used by them. The risk criteria in relation to controls on laying hens are also outlined in the CCA's Manual for the Welfare of Laying Hens. The CCA intends to develop a similar manual for pig welfare in 2016. The CCA stated that their intention is to develop a new circular on risk, based on up-to-date scientific evidence, in cooperation with an expert with whom they have an excellent relationship. The hope to do the preparatory work in 2016 and to have a pragmatic timetable by the end of the year. The CCA stated that control frequency depends on the regional units. The Census is a seasonal task (end of year) so there are no inspections in December. Another issue is disease. Quarterly reports reflect these factors. The authorities aim at synergies - when inspections are being done on an MRDF programmes they do an animal welfare inspection at the same time.
2007-7244-8 This recommendation is based on findings and the associated conclusion in Section 6 of the audit report In progress that standard checklists were used for inspections, but that these had been insufficient to facilitate Appropriate documented procedures, as inspectors in making assessments of certain requirements such as the slope of cages for laying hens. required by Article 8.1 of Regulation (EC) No 882/2004, are provided so that all the Situation after the 2010 GFA requirements of Directive 91/630/EEC and The CA stated that the checks carried out are documented using the inspection protocols for pigs and Directive 99/74/EC are adequately covered laying hens. These protocols contain all the requirements of the legislation, which are also checked in during inspections. their entirety. The CA subsequently stated that an instruction issued on 17.06.2010 giving specific guidance to PVDs on the type of material for manipulation for pigs and frequency of tail docking and teeth clipping. The CA acknowledged that some cages were non-compliant and sent a letter to PVDs on 17.10.2010 stating that if business operators do not conform, their approval status would be rescinded. This implies that they would not be able to trade in eggs. A deadline for reply was set for 03.12.2010. It was noted that the PVDs themselves decide on any withdrawal of approval. No response had been received at the time of the finalisation of this report (i.e. GFA 2010 report).
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Reference no. and recommendation Basis of assessment Assessment The Greek CAs, in their comments on the draft country profile, provided additional information: To establish that appropriate documented procedures are used in carrying out controls on laying hen and pig farms, the following actions have been implemented: 1) LAYING HENS Please see also recommendation 2007-7244-7. In accordance with Decisions 1999/74/EC and 2006/778/EC, non-compliances per farming method had been parameterised and entered in the abovementioned electronic database (by entering the inspection certificate), which is also required by the manual. 2) PIGS A new circular will be drawn up by 31/12/2011 addressed to Regional Departments concerning the procedure for verifying that risk criteria are used in preparing the annual pig farm control plan. The Greek authorities provided the following updated information in the context of the 2015 GFA: The CCA stated that a manual on the welfare of laying hens had been issued by the CCA on June 2013. This is the only version of the manual. It includes the manual for the use of the electronic database for the registration of laying hen farms (in the future it may be expanded to all categories of poultry farms). It can be downloaded from the webpage: http://www.minagric.gr/images/stories/docs/agrotis/poulerika/egxeiridio_ootokon050814.pdf An updated checklist for inspection reporting is available on the website, covering all aspects of the Directive 99/74/EC. The CCA stated that thanks to the Laying Hens database they can check the data for possible overstocking. The CCA had recently done such a check, and they provided the GFA team with a listing from a sample Regional Unit showing the maximum level and current population per farm. Regarding the protection of pigs, the CCA provided the GFA team with a copy of the checklist used for inspections conducted in relation to Directive 91/630/EEC. They also provided a copy of the circulars on pigs (and on laying hens) which had been issued to regional authorities in response to the 2007 and 2009 animal welfare audits.
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Reference no. and recommendation Basis of assessment Assessment Asked if a manual for pigs existed, similar to the one for Laying Hens, the CCA replied that they planned to launch the work on a manual for pigs in 2016. The CCA also clarified that the database on Laying Hens would not cover animal welfare of pigs on farms, but that this topic would be covered in another management information system in the future. This recommendation is based on findings and the associated conclusion in Section 6 of the audit report 2007-7244-9 Closed for other that documented procedures had been insufficient to facilitate inspectors in making assessments of certain reason All laying hen farms which fall within the requirements such as the slope and height of cages for laying hens. Although this issue had been the scope of Directive 99/74/EC meet the subject of recommendations in previous audit reports, CCA guidance was only provided one week before requirements of this Directive, in particular the mission and as a result there are cages in use which do not meet EU requirements.. that the slope and height of cages meet the Situation after the 2010 GFA requirements of Article 5.1(4)(5) of Directive 99/74/EC. The CA stated that guidelines were issued to inspectors on the requirements on height and slope of cages. PVDs were asked by the central CAs to report on the inspection findings. The CA had been requested to provide a summary of the information received from the prefectures regarding the compliance of un- enriched cages. At the time of the GFA, no such summary was provided apart from the statement that according to the results carried out by 35 PVDs, non-enriched cages were in line with the requirements of the 99/74/EC. The CA subsequently provided some statistics to show that 14 PVDs do not have laying hen farms, 23 have farms which comply with height and slope requirements, 12 did not reply and 3 do not comply. The Greek CAs, in their comments on the draft country profile, provided the results of the controls performed in 2010 concerning compliance with the cage height and slope requirements of Article 5.1(4)(5) of Directive 99/74/EC: Overtaken by recommendation 2009-8243-1.
2007-7244-10 This recommendation is based on findings and the associated conclusion in Section 6 of the audit report Action still that checklists used for inspecting farms up to April 2007 did not adequately reflect requirements for required All pig holdings built or rebuilt from group housing of sows. 1.1.2003 provide group housing of sows, as required by points 4(a) and 9 of Article The initial response of the Greek authorities stated the following 3 of Directive 91/630/EEC. Situation after the 2010 GFA The CA stated that PVDs were requested to confirm the status of the pig holdings in their jurisdictions 153 DG(SANTE) 2015-7657 Final Version date October 2016 Inspection 2007-7244 of 06 May 2007 in order to evaluate the system of control in relation to animal welfare on farms
Reference no. and recommendation Basis of assessment Assessment which were built or rebuilt since 1.1.2003. The CA could not provide a summary of the information received from the prefectures regarding the compliance of these pig farms. No such summary was provided apart from the statement that according to the results carried out by 35 PVDs only pig holdings operating before 01.01.2003 could not guarantee the group housing of sows. The CA provided some statistics on the level of conformity, based on responses from PVDs. However, it would appear that some 25% of the PVDs have still not provided the necessary information to the CCAs to enable a full assessment of the situation to be made. Information concerning the current situation relating to compliance of pig holdings providing group housing of sows will be made available by 15/11/2011. The relevant requirements of Directive 91/630/EEC have been replaced by those of Article 3(4) and (9) of Directive 2008/120/EC. The Commission has initiated specific follow-up measures in the case of this recommendation. This recommendation was not followed-up during the 2015 GFA.
2007-7244-11 This recommendation is based on findings and the associated conclusion in Section 6 of the audit report Action taken that non-compliances detected during previous checks, such as the poor condition of the roof, inadequate When non-compliances are detected, ventilation and the lack of an alarm system in case of a breakdown of the artificial ventilation on the pig appropriate actions are taken so that the farm in Larissa, had not been corrected. operator remedies the situation, as required by Article 54 of Regulation (EC) No Situation after the 2010 GFA 882/2004. The CA referred to the two new sections, IX and X of the inspection protocol relating to non-compliances and sanctions. The CA stated that at the start of each year, PVDs should submit to the CCAs relevant information on non-compliances and action taken in their prefecture. However, this information was often not submitted. It was noted that in 2008, 2009 and 2010 only one sanction each year was imposed for non-compliances on farms. The CA sent a note on 26.11.2010 to all PVDs again reminding them of the rules relating to non- compliances and sanctions.
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Reference no. and recommendation Basis of assessment Assessment No response had been received at the time of the finalisation of this report (i.e. the 2010 GFA report). The CA informed the audit team that a working group comprising representatives of all services affected by the requirements of Regulation (EC) No 882/2004 was set up to develop criteria and procedures for the imposition of sanctions across a wide range of sectors. The group presented their proposals to the hierarchy in November 2010 and the next step is its legal implementation. At the time of the 2010 GFA, no feedback had been received from the hierarchy and no deadline had been set for the implementation of the proposals. The working group has been disbanded. The Greek CAs, in their comments on the draft country profile, indicated that the working group’s proposal for imposing compliance measures and sanctions in the foodstuffs, feedingstuffs, and animal health and welfare sectors has been communicated to the Legal Department for legislative drafting. For more information, see chapter 1 of the country profile document "the organisation of food safety, animal health, animal welfare and plant health control systems". The Greek authorities provided the following updated information in the context of the 2015 GFA: The CCA provided the following update: "The outcome of this working group finally resulted in the imposition of a horizontal Greek law about sanctions in the sectors of food safety, animal health, animal welfare and plant health control systems. (Greek Law No. 4235/2014). Furthermore, an action plan is issued every year by the CCA summarising all outcomes of the non- compliances found in all PVD reported during their annual reporting of the Decision 2006.778.EC and asking for better follow up." The CCA provided the GFA team with examples of such action plans (the reviews of non-compliances for the years 2012, 2013 and 2014, respectively). The action plans encourage the Regional Units to focus on the most frequent non-compliances noted in the action plans. Regarding follow-up visits, the CCA stated that the Regional Units keep up the pressure on farmers but that the CCA did not always get reports/ information on this. Regarding sanctions and fines, the CCA stated that there were clearer criteria now, under the 2014 Law, and that this is the case in all sectors. Regional Unit inspectors on the spot are very well aware of the financial implications for farmers. Deadlines for remedial action are binding and the inspectors try to 155 DG(SANTE) 2015-7657 Final Version date October 2016 Inspection 2007-7244 of 06 May 2007 in order to evaluate the system of control in relation to animal welfare on farms
Reference no. and recommendation Basis of assessment Assessment achieve an understanding with farmers in relation to the necessary corrective actions. The CCA provided the GFA team with a control table showing the status of cases in recent years where fines were imposed or where fines are proposed but not have not yet been finalised. Documents on individual administrative sanctions imposed were also provided.
2007-7244-12 This recommendation is based on findings and the associated conclusion in Section 6 of the audit report. Action still Since a high proportion of prefectures had not reported carrying out any inspections in recent years, the required In the whole territory the CA carries out CCA has not ensured that inspections have been carried out as required by Article 7 of Directive inspections for checking compliance with 91/630/EEC the provisions of Article 7 of Directive 91/630/EEC and as by Article 8 of Situation after the 2010 GFA Directive 99/74/EC regarding laying hens. The CA could not provide information on how all the PVDs have carried out inspections for checking compliance of animal welfare requirements in pig and laying hen farms. Due to the non-responsiveness of many PVDs to requests by the CCAs, such data is difficult to obtain. The Greek CAs, in their comments on the draft country profile, referred to the following information: Results of controls on laying hen and pig farms in 2010, per Prefectural Authority in the country, as laid down in recommendation no 2007-7244-3. Annual report referred to in Decision 2006/778/EC for the year 2010, already provided. The Greek authorities provided the following updated information in the context of the 2015 GFA: "Unfortunately, due to lack of personnel, some PVDs continue not to respond to inspection reporting on farm welfare. The CCA has communicated with these PVDs via telephone conversations and the problem is similarly described by all colleagues." The CCA provided the following information after the 2015 GFA, in March 2016: The CCA wrote that “… only 8 prefectural units had actually sent control plans for farms for 2015 out of 55 that have to send us data. After your visit last December and our requests the control plans we received for 2016 rose. More specifically, to date 21 prefectural units have sent control plans for farm inspections for 2016, 18 prefectural units have sent control plans for transport for 2016 and 14 for slaughter welfare. The numbers are still low, but an improvement is to be noted given the dramatic situation regarding personnel and financial resources (car and petrol funding resources).” 156 DG(SANTE) 2015-7657 Final Version date October 2016 Inspection 2007-7244 of 06 May 2007 in order to evaluate the system of control in relation to animal welfare on farms
Reference no. and recommendation Basis of assessment Assessment
2007-7244-13 This recommendation is based on findings and the associated conclusion in Section 6 of the audit report. Closed for other Reports from the prefectures visited did not accurately reflect the inspections that had been carried out reasons Reports required by Decision 2000/50/EC and the CA have not ensured that the reporting requirements of Commission Decision 2000/50/EC have accurately reflect the inspections carried been met, as recommended in report 8522/2002. out. Situation after the 2010 GFA CA stated that PVDs are obliged to evaluate the results of the checks carried out during the previous period in its area of jurisdiction every six months, in accordance with the provisions of Presidential Decrees 215/2003 and 216/2003. This information should be submitted to the central CA at the beginning of 2009. CA was requested to provide information on its assessment of the 2008 reports required by Decision 778/2006 and whether these accurately reflect the inspections carried out by the prefectures. No such assessment was provided yet apart from the statement that the annual reports of the results of the inspections were dispatched from 35 PVDs. Overtaken by recommendation 2009-8243-4
Inspection 2009-8243 of 15 November 2009 in order to evaluate the implementation of controls for animal welfare on farms
Reference no. and recommendation Basis of assessment Assessment
2009-8243-1 This recommendation is based on findings and the associated conclusion in Section 5.13 of the audit Action taken report that although the CCA had taken steps to ensure that inspections are carried out by the CAs to Take measures to ensure that the quality of verify that the minimum standards are met, these were insufficient. Certain CAs did not inform the CCA farm inspections is improved, so that of the results of the inspections and in the case of one CA visited, the information provided was deficiencies are detected and reported and unreliable. In the same Prefecture the CA had not detected or not reported certain deficiencies including in particular, the minimum space of cage the use of cages which structurally do not comply with EU and national legislation and the introduction area per hen and the structural of unenriched cages after the legal ban. requirements of Article 5 of Directive 1999/74/EC are met. Situation after the 2010 GFA
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Reference no. and recommendation Basis of assessment Assessment See recommendation 2007-7244-9. The Greek CAs, in their comments on the draft country profile, provided additional information: Results of the controls performed in 2010 concerning compliance of cages with Article 5 of Directive 199/74/EC relating to the minimum per hen cage area and cage structural characteristics: A) There are no laying hen farms in the jurisdictions of the following (14) Prefectural Authorities: Athens, Arta, Grevena, Evrytania, Zakynthos, Ileia, Corfu, Kefallinia, Lasithi, Lefkada, Messinia, Preveza, Samos, Florina. B) There are no laying hen farms using cages in the jurisdictions of the following (6) Prefectural Authorities: Aitolokarnania, Achaia, Drama, Kavala, Thesprotia, Trikala. C) No controls were performed on laying hen farms by the following (17) Prefectural Authorities: Aitoloakarnania, Eastern Attica, Argolida, Achaia, Drama, Dodecanese, Imathia, Kavala, Kilkis, Thesprotia, Xanthi, Rethymnon, Rodopi, Fthiotida, Fokida, Chania, Chios. D) The following Prefectural Authorities have not complied with the requirement to provide claw- shortening devices: Western Attica, Thessaloniki. E) The following Prefectural Authorities have not complied with the minimum per hen cage area requirement laid down in Article 5 of Directive 199/74/EC: Viotia, Western Attica, Larissa, Chalkidiki. G) According to information obtained in 2009, laying hen farms in the jurisdictions of the following Prefectural Authorities have not complied with the requirement to provide claw-shortening devices: Imathia, Rethymnon It should be noted that the abovementioned Prefectural Authorities have not performed any controls in 2010, according to the results cited above in paragraph (C) hereof. H) The following Prefectural Authorities have complied with the minimum per hen cage area requirement laid down in Article 5 of Directive 199/74/EC for laying hen farms: Arcadia, Evros, Evia, Heraklion, Thessaloniki, Ioannina, Karditsa, Kastoria, Kozani, Corinthia, Cyclades,
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Reference no. and recommendation Basis of assessment Assessment Lakonia, Magnisia, Piraeus, Pella, Serres, Chalkidiki. I) The following Prefectural Authorities have complied with the requirement to provide claw-shortening devices in the cages used in laying hen farms: Arcadia, Evros, Evia, Heraklion, Thessaloniki, Ioannina, Karditsa, Kastoria, Kozani, Corinthia, Cyclades, Lakonia, Larissa, Magnisia, Piraeus, Pella, Serres, Chalkidiki. The Greek authorities provided the following updated information in the context of the 2015 GFA: The CCA presented a spreadsheet showing that all laying hens holdings have enriched cages. The holdings that were not able to change their structure to enriched cages have either switched to an alternative method or have ceased working. Inspectors have been given specific instructions and checklists in relation to the welfare of laying hens – these are available in the CCA's Manual on the Welfare of Laying Hens, which can be downloaded from the webpage: http://www.minagric.gr/images/stories/docs/agrotis/poulerika/egxeiridio_ootokon050814.pdf The CCA provided the GFA team with the annual report on farm welfare inspections carried out in 2014, and an analysis of the outcome of the farm welfare inspections in that year.
2009-8243-2 This recommendation is based on findings and the associated conclusion in Section 5.1.4 of the audit In progress report. Although the CCA provided sufficient guidance to inspect holdings with pigs, insufficient Take measures to ensure that the quality of attention was given to certain important requirements by one local CA visited, in particular concerning inspections in holdings with pigs is the provision of material for investigation and manipulation, the measures to avoid routine mutilations, improved, so that deficiencies are detected the maintenance of mortality records and adequate arrangements for killing sick or injured animals on the and reported, and in particular, material for spot. investigation and manipulation as required by Point 4 of Chapter 1 of Annex I to The initial response of the Greek authorities stated the following Directive 2008/120/EC is provided; Situation after the 2010 GFA measures are taken to avoid routine mutilations such as tail docking and teeth GFA 2010/8368 clipping, as required by Point 8 of Chapter See also recommendation 2007-7244-8. 1 of Annex I to Directive 2008/120/EC; mortality records are maintained as The CA has written to the PVDs and to farmers on all of the issues raised in this recommendation. 159 DG(SANTE) 2015-7657 Final Version date October 2016 Inspection 2009-8243 of 15 November 2009 in order to evaluate the implementation of controls for animal welfare on farms
Reference no. and recommendation Basis of assessment Assessment required by Point 5 of the Annex to However, the limited verification carried out by the central services and the non-responsiveness of the Directive 98/58/EC; and adequate PVDs to requests for information means that there is no overview of the action taken country-wide to arrangements for killing sick or injured address the recommendation. animals on the spot are taken as required The Greek CAs, in their comments on the draft country profile, provided additional information: by Article 12 of Directive 93/119/EC. Results of the controls conducted on pig holdings in 2010: 1) PROVISION OF MANIPULABLE MATERIAL A) The following Prefectural Authorities have complied with the requirement to provide manipulable material in pig farms: Eastern Attica, Arcadia, Arta, Viotia, Drama, Evros, Evia, Evrytania, Imathia, Ioannina, Karditsa, Kastoria, Kilkis, Kozani, Corinthia, Cyclades, Lakonia, Larissa, Lasithi, Lesvos, Magnisia, Pella, Rodopi, Trikala, Florina. B) The following Prefectural Authorities have not complied with the requirement to provide manipulable material in pig farms: Western Attica, Heraklion, Thessaloniki, Preveza, Serres, Chalkidiki. 2) AVOIDING ROUTINE MUTILATIONS SUCH AS TAIL DOCKING AND TEETH CLIPPING Α) The following Prefectural Authorities have reported that pig farms in their jurisdictions do not perform routine mutilations such as tail docking and teeth clipping: Southern Evros, Thessaloniki, Kozani, Lasithi, Lesvos, Samos. B) The following Prefectural Authorities have reported that some pig farms in their jurisdictions perform routine mutilations such as tail docking and teeth clipping: Arta, Messinia C) The following Prefectural Authorities have reported that they have informed pig farmers in their jurisdictions that they should not perform routine mutilations such as tail docking and teeth clipping: Northern Evros, Evia, Ioannina, Cyclades, Xanthi, Trikala. 3) MAINTAINING MORTALITY RECORDS
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Reference no. and recommendation Basis of assessment Assessment A) The following Prefectural Authorities have complied with the requirement for pig farms to maintain mortality records: Eastern Attica, Arta, Viotia, Drama, Evros, Imathia, Heraklion, Ioannina, Kilkis, Kozani, Corinthia, Cyclades, Lakonia, Lasithi, Lesvos, Magnisia, Pella, Rodopi, Trikala, Florina. B) The following Prefectural Authorities have not complied with the requirement for pig farms to maintain mortality records: Western Attica, Evia, Thessaloniki, Serres. C) The following Prefectural Authorities have not provided clear information concerning compliance with the requirement for pig farms to maintain mortality records: Arcadia, Evia, Karditsa, Kastoria, Kozani, Larissa, Preveza, Chalkidiki. 4) SECURING ADEQUATE ARRANGEMENTS FOR KILLING ANIMALS ON THE SPOT A) Following are the results of the controls performed in 2010 on pig farms in the jurisdictions of the following Prefectural Authorities: Arta, Evros, Zakynthos, Ioannina, Karditsa, Kastoria, Cyclades, Lasithi, Lesvos, Xanthi, Preveza, Trikala, Fthiotida, Chania. B) Only some farms in the jurisdictions of the following Prefectural Authorities have secured arrangements for on-the-spot slaughter: Eastern Attica, Arcadia, Western Attica, Evrytania, Imathia, Thessaloniki, Kozani, Magnisia, Messinia, Pella, Rodopi, Chalkidiki. C) The reminder circular to be communicated by 31/12/2011 will focus on the additional actions to be implemented at the level of each Regional Veterinary Medicine authority for following up on the implementation of this recommendation. The Greek authorities provided the following updated information in the context of the 2015 GFA: The CCA stated that they had issued a circular in June 2010 dealing with the findings of the 2009 audit. Tail-docking and other issues are covered in the Annexes to the document. This circular was never sent to the FBOs.
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Reference no. and recommendation Basis of assessment Assessment The CCA stated that they were exploring whether scientific opinion is changing, and that this presented an opportunity to revise the circular of 2010, with a view to improving inspections. The CCA is in touch with a renowned researcher who would like to see summary data on the number of controls, non- compliances etc. The expert would evaluate the data and could calculate a reliable sample per Regional Unit. The CCA stated that they intend to develop a manual on the welfare of pigs in 2016. An update of the circular of 2010 would be a part of the work.. The CCA provided the following information after the 2015 GFA, in March 2016: A Seminar with 57 participants from different Regions/RVUs was organised in March 2016. At this seminar the issue of adequate arrangements for the killing of animals on the spot was raised.
2009-8243-4 This recommendation is based on findings and the associated conclusion in Section 5.1.1 of the audit Action still report. The CCA had not sufficiently addressed the recommendation of report 2007-7244 concerning required Take measures to ensure that the inspections on farms to be carried on the whole territory of Greece. In particular, although inspections information concerning the results of farm had been carried in pig, calf and laying hen holdings, the feedback of information from the local CAs to inspections collected and reported by all the CCA was incomplete and inconsistent. As a consequence the information contained in the report to local CAs is accurate, so that the report to the Commission according to Decision 778/2006/EC was unreliable. the Commission as referred to in Article 8 of Decision 778/2006/EC is reliable. Situation after the 2010 GFA The CA stated that the PVDs send reports electronically every six months to the CCAs. In 2009, 31 such reports were received, representing slightly more than 50% of PVDs. The CA sent a reminder to the other PVDs on 06.07.2010 requesting the 2009 annual report. An instruction was also issued on 17.11.2010 to PVDs on how to correctly complete the report, the type of information required and the listing of non- compliances. This instruction followed the receipt by the CCAs of poor or erroneous reports in the original submissions.
See recommendation 2007-7244-13.
The Greek authorities provided the following updated information in the context of the 2015 GFA: The CCA stated the number of controls had increased and that more controls were being documented/recorded by Regional Units than had been the case in the past. The CCA stated that there had been a slight improvement in terms of the quality of information received, the scope had increased as 162 DG(SANTE) 2015-7657 Final Version date October 2016 Inspection 2009-8243 of 15 November 2009 in order to evaluate the implementation of controls for animal welfare on farms
Reference no. and recommendation Basis of assessment Assessment well as the number of Regional Units reporting. The CCA provided the GFA Team with a document sent to the regional authorities requesting the verification of the data submitted in the annual reports according to the Commission Decision 2006.778.EC. The CCA also provided copies of reports of on-the-spot visits to Regional Units by the Veterinary Services of Regions where, inter alia, the quality of the data in reports had been discussed. The CCA maintains a spreadsheet where all responses from regional authorities are summarised. Figures shown to the GFA Team indicate an increased number of controls recorded in 2014, on laying hens and on pigs, vis-à-vis 2013. Figures for 2015 are not yet to hand. However, the CCA does not receive data in respect of all Regional Units, and the extent of this non-reporting was not clear to the GFA Team at the time of writing. Regarding controls at farm level see recommendation 2007-7244-12.
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Reference no. and recommendation Basis of assessment Assessment
2009-8243-5 This recommendation is based on findings and the associated conclusion in Section 5.1.4 of the audit Action taken report. The recommendation of report 2007-7244 concerning updating of the maximum capacity in the Take measures to ensure that the register was not addressed by the local CAs. Updating of the register was made without assessing the information concerning the maximum information provided by the operators and the actual maximum capacity of holdings had never been capacity of holdings with laying hens assessed. recorded as required by the last paragraph of point 1 of the Annex of Directive Situation after the 2010 GFA 2002/4/EC, is accurate. See recommendation 2007-7244-5. In accordance with Directive 1999/74/EC, maximum capacity and current capacity per room will be entered in the electronic database kept for laying hens. The Greek authorities provided the following updated information in the context of the 2015 GFA: The CCA stated that data on the maximum capacity and current population had been entered into the database on Laying Hens. The CCA stated that the database can be checked for possible cases of overstocking. The CCA had recently done such a check, and they provided the GFA team with a listing from a sample Regional Unit showing the maximum stocking level and current population per farm. The CCA stated that the relevant instructions and checklists can be found in the CCA's Manual on the Welfare of Laying Hens, which may be downloaded via the webpage http://www.minagric.gr/images/stories/docs/agrotis/poulerika/egxeiridio_ootokon050814.pdf The CCA provided the GFA team with an example of a completed inspection report showing the numbers recorded. Capacities are also checked when an FBO applies for an initial approval or an expansion.
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Reference no. and recommendation Basis of assessment Assessment
2011-6212-1 This recommendation is based on findings and associated conclusion in Section 5.2.3 of the audit report Action taken that all the RUs visited, it was stated that it was not possible to fulfil the CCA's target of 30% checks on The CCA should take action to ensure that transported animals, especially checks on consignments arriving from other MS. Overall the CAs relied the level of official controls on transport almost exclusively on checks at slaughterhouses with little emphasis given to checks at destination on can be realistically planned and effectively consignments which had travelled for over eight hours. implemented as required in Article 3 of Regulation (EC) No 882/2004 where it The Commission has initiated specific follow-up measures in the case of this recommendation based on requires that official controls are carried the Court Judgement of 10 September 2009 in Case C-416/07. out regularly, on a risk basis and with The original response of the Greek authorities stated the following: appropriate frequency. In this regard, the CCA should consider collecting and With Circular ref. 170258/20.07.2011 to the Regions and Regional Units of Greece, relevant Veterinary utilising best practice from Regional Units Services Directorates were asked place particular emphasis on controls for the protection of animals and involving them in any future during transport so that these controls account for 5% of the total number of animals transported within proposals. the jurisdiction of the Regional Units over the course of each year. The Veterinary Services of the Regional Units were also asked to: Send the assessment of inspections/checks to the CCA (30 December each year) Use the risk criteria for planning controls: a. The high risk category includes all intra-Community trade transports. b (intra-Community trade) transports at the place of departure, checks must be carried out on all animal transports . c( intra-Community trade) transports at the place of destination, checks must be carried out at the farm and slaughterhouse, and these must include physical checks of those places. d. Checks during transport by road must be carried out in the Regional Units. The checks carried out by each Regional Unit for animal welfare during transport must be backed up by filling out the carrier inspection report in line with Joint Ministerial Decision ref. 314754/2009 and by providing the dossier for each carrier inspected. This dossier must include: • the carrier inspection report, citing the date of the inspection, the reference number and containing the 165 DG(SANTE) 2015-7657 Final Version date October 2016 Audit 2011-6212 of 01 February 2011 in order to evaluate the implementation of controls for animal welfare during transport and at the time of slaughter
Reference no. and recommendation Basis of assessment Assessment signature of the carrier. A copy must be provided to him. • A printout of the information from the satellite system, such as printouts of temperatures, animal rest periods, opening-closing of doors, etc. and the records made by the tachograph. • photographs documenting the findings. a. These inspections must also be input to the database which must include fields for recording the administrative sanctions. The Greek authorities provided updated information on controls performed in December 2014 and January 2015. Greek authorities provided the following updated information during the 2015 GFA: The control target has been lowered after the 2011 audit from 30% in 5% of transported animals and clear risk criteria for the planning of controls have been established and circulated to the OVs. The GFA team noted that the CCA has established a risk-based system for controls with a more realistic control target (5% of the total number of animals transported). The criteria/instructions for the planning of controls do still not cover traders and trader premises and places of destination, other than slaughter houses. Although the control target appears to be more realistic a significant number of Regional Units does not perform controls or at least does not report controls on animal welfare. The CCA has taken appropriate measures to organise and perform road controls on animal welfare and Greece has reported the results of the road controls with the new reporting template to the Commission. Greece has taken appropriate measures in order to address this recommendation with regards to road controls.
2011-6212-2 This recommendation is based on findings and associated conclusion in Section 5.1.5 of the audit report. Action taken The CCA had made a strong effort to provide regular training sessions on animal welfare during transport In conjunction with planned actions to and at slaughter since the previous inspection and most veterinarians were conversant with the main address recommendation No.1, the CCA requirements on slaughter, while less so for transport. OVs that were not familiar with transport should ensure that when controls on requirements had not received the relevant training and were therefore unable to perform tasks such as 166 DG(SANTE) 2015-7657 Final Version date October 2016 Audit 2011-6212 of 01 February 2011 in order to evaluate the implementation of controls for animal welfare during transport and at the time of slaughter
Reference no. and recommendation Basis of assessment Assessment journey logs are carried out, as required in checking journey logs effectively, whereas in another case the OV had received training but did not Article 15(1) of Regulation (EC) No implement the requirements effectively. 1/2005, they are carried out by trained The initial response of the Greek authorities stated the following: staff. The CCA should consider the targeting of such controls using "a. Immediate examination and use of the guidelines sent in our document ref. 296657/08.09.2010 to the information available in the TRACES Veterinary Services of the former prefectural authorities which contained advice and guidance on checks database in each Regional Unit to peform and inspections in implementation of Regulation (EC) No 1/2005 by veterinarians carrying out official an initial screening of the type and volume controls during the transport of animals. of trade entering and leaving the regional b. Those guidelines provide instructions on how to check each part of the journey log. unit using a desk based exercise and then targeting different types of transport c. Immediate examination and use of our document ref. 286046/21.04.2008 by veterinarians carrying out according to the local risk criteria set. For controls during the transport of animals, which contained instructions on how to estimate the number of this purpose, consideration could be given kilometres covered and the time required to cover each distance, to the verification of transporters' In the case where it is found that additional training seminars in the protection of animals during transport compliance with requirements in Chapter are required, we would ask the Veterinary Services Directorates of the Regions to collect requests for V of Annex 1 of Regulation (EC) No veterinary training and the issues they wish to cover. 1/2005 by requesting satellite navigation system records, tachograph records, Thereinafter, annual training needs for the years to come must be sent by 30 October of the previous year. temperature printouts, and copies of Greek authorities provided the following updated information during the 2015 GFA: journey logs. Inspectors of the CAs have participated in relevant BTSF courses and a training course for inspectors on animal welfare during transport took place in 2012. PVDs submit to the CCA periodically their training needs. The CCA intended to organise a seminar in 2016 and to translate BTSF training material. The CCA has provided RVUs with instructions on the use of TRACES for the preparation of the inspection plans and has provided guidance on how to provide information on the reporting of controls to the Commission.
2011-6212-3 This recommendation is based on findings and associated conclusion in Section 5.1.4 of the audit report. Action still The CCA had actively attempted to promote the setting up of control posts since the previous inspection, required The CCA should take the necessary action with some limited success, though there are still no facilities in place for the main transit ports of to provide for facilities in or in the Igoumenitsa and Patras and as a result these ports do still not have the facilities required in Annex 1, immediate vicinity of the two main ferry Chapter V, point 1(7)(b) of Regulation (EC) No 1/2005. ports of Igoumenitsa and Patras to enable 167 DG(SANTE) 2015-7657 Final Version date October 2016 Audit 2011-6212 of 01 February 2011 in order to evaluate the implementation of controls for animal welfare during transport and at the time of slaughter
Reference no. and recommendation Basis of assessment Assessment animals to rest after unloading if required, The initial response of the Greek authorities stated the following as laid down in Annex 1, Chapter V, point "1) Examination of the options for financing animal rest facilities under the Alexandros Baltatzis 1(7)(b) of Regulation (EC) No 1/2005. The Programme or the new development law. CCA should notify other Member States' Transport Contact Points to ensure that 2) Meeting with representatives of the local authorities in Igoumenitsa and Patras. local veterinary units involved in the 3) Establishment of animal rest facilities by 31.12.2013." verification of the planning sections of journey logs and the issue of TRACES Greek authorities provided the following updated information during the 2015 GFA: certificates for consigments destined for The Greek authorities informed the GFA team that, despite efforts made, no holding, organisation or Greece are fully aware that facilities are company had indicate interest to fund the construction or provide such facilities in the immediate vicinity not presently in place for transporters of the two main ferry ports of Igoumenitsa and Patras. using these ports. Similarly the CCA should notify all Greek transporters The CCA highlighted that controls at ports had been intensified but did not provide evidence that other authorised for long distance transport of Member States' Transport Contact Points' were notified in order to ensure that local veterinary units the implications for journey times relating involved in the verification of the planning sections of journey logs and the issue of TRACES certificates to the lack of these facilities. for consignments destined for Greece are fully aware that facilities are not presently in place for transporters using these ports.
2011-6212-4 This recommendation is based on findings and associated conclusion in Section 5.2.3 of the audit report. Action still Controls on journey logs were inadequate as no meaningful official controls were carried out on required The CCA should ensure that in transporters, the Control Post visited or IU consignments arriving at non-slaughterhouse destinations conjunction with actions taken to address which make up the majority of these consignments in the three RUs visited. recommendations No 1 and 2, physical inspections of the means of transport and The initial response of the Greek authorities stated the following the animals are actually carried out as ")a. In order to ensure that the physical checks are carried out on means of transport and animals, required required in Article 27(1) of Regulation by Article 27(1) of Regulation (EC) No 1/2005, the Veterinary Services Directorates of the Regions are (EC) No 1/2005. The CA should consider obliged, within the context of the supervision they carry out on the Regional Units: collecting and utilising best practice from Regional Units and involving them in any a. Every three months, relying on the quarterly transport reports collected by the Regional Units, to future proposals to ensure that the best use request on a random basis full carrier inspection dossiers in order to assess whether physical checks were of available resources is made e.g. in fact carried out: combining animal health and animal to verify that the scheduled checks are carried out. welfare inspections at transporters/dealers'
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Reference no. and recommendation Basis of assessment Assessment premises; ensuring staff trained on animal to carry out on-the-spot checks at the relevant Regional Units, if feasible. welfare and approval of vehicles are every quarter and every year, to send to the Animal Welfare, Medicines and Applications Directorate the present at slaughterhouses on days intra- ‘Report on evaluation of measures taken to implement the control system for animal welfare during Union consignments are expected. transport’ (in line with model form 1 in Annex II of our circular ref. 170258/20.07.2011) which must include verification that physical checks were carried out during the scheduled inspections carried out by the Regional Units, and the actions taken by the Regions in order to provide an overall evaluation for the entire country. b. This report should include the actions taken by the Veterinary Services Directorate of the Region to address any shortcomings by the competent Veterinary Services Directorates of the Regional Units. For instance, in the case of failure to send reports, a document is sent to the relevant Regional Unit pointing out such shortcomings. c. The 1st evaluation report must be sent to the Animal Welfare, Medicines and Applications Directorate no later than 30 April 2012. d. The Animal Welfare, Medicines and Applications Directorate / Ministry of Rural Development and; Food can, at any time (outside the scope of the evaluation reports on the measures to implement the control system in the field of animal welfare during transport / slaughter) -using the necessary documents attached to such report- randomly request all the necessary documents used to back up implementation of the stated control system in those fields. Greek authorities provided the following updated information during the 2015 GFA: Non-discriminatory inspections of animals, means of transport and accompanying documents, including journey logs at the place of destination are carried out but are limited to slaughterhouses; farms and transporters premises are not covered systematically. A register of transporters is available and has been updated. Action is still required regarding checks at farm level and of transporters/at transporter premises.
2011-6212-5 This recommendation is based on findings and associated conclusion in Section 5.2.3 of the audit report. Action still The CCA had not drafted any procedures to verify the effectiveness of official controls on transport. required The CCA should ensure that verification of the effectiveness of official controls on The initial response of the Greek authorities stated the following animal welfare during transport and at "1) According to our circular ref. 170258/20.07.2011, every 6 months and every year each Regional Unit slaughter as required in Article 4 of must verify the effectiveness of the controls carried out by filling out the form ‘VERIFICATION OF 169 DG(SANTE) 2015-7657 Final Version date October 2016 Audit 2011-6212 of 01 February 2011 in order to evaluate the implementation of controls for animal welfare during transport and at the time of slaughter
Reference no. and recommendation Basis of assessment Assessment Regulation (EC) No 882/2004 is included THE EFFECTIVENESS OF OFFICIAL CONTROLS DURING TRANSPORT / SLAUGHTER’ (in line in actions taken to address with model forms 1 and 2, Annex I of that circular)." recommendations No.1,2,4, 6 and 7. That form must be sent by each Regional Unit to the Veterinary Services Directorate of the Region it belongs to, which each year will send it to the Animal Welfare, Medicines and Applications Directorate accompanied by a relevant evaluation report. Greek authorities provided the following updated information during the 2015 GFA: The CCA presented the system for 'verification of the effectiveness of official controls' on animal welfare during transport and at slaughter is based on reports submitted by the RVUs to the Veterinary Services Directorate of the Region. The CCA did not provide evidence that the Veterinary Services Directorate of the Region verify the information submitted by the RVUs or verify that the controls achieve objectives set out in national law and EU provisions. The CCA stated that the Veterinary Services Directorate of the Region may ask for a copy of inspection reports or may verify information on the spot, but this not required. The DG SANTE team received 2014 data on the reporting of the RVUs for slaughter and transport and noted that a significant number of RVUs did not report or reported zero controls. The measures taken by Greece in order to address the recommendation were considered by the DG SANTE team as not being effective. The system does not provide sufficient guarantees that the official controls produce the intended effect. A functioning system 'of verification', in particular regarding compliance with planned arrangements, would be important in view of other recommendation made in the audit report 2011-6212. There are no clear procedure how the Regions should perform their verification tasks (e.g. systematic assessment of inspection reports, assessment of data collected, on-the- sport verification, etc.). Recommendation 2011-6212-5 will be used to followed-up recommendation 2011-6212-8 regarding the need to improve the reporting by Regional Units to the CCA.
2011-6212-6 This recommendation is based on findings and associated conclusion in Section 5.3 of the audit report. Action taken. The CCA do not have full information for the whole of Greece on the level of compliance with animal The CCA should ensure that inspections welfare requirements at slaughter and killing due to the lack of reports sent to them from RUs during and controls in slaughterhouses are carried 2007-2010. CCA audits carried out during 2006-2008 concluded that the system of official controls on out in an appropriate manner to ensure the animal welfare at the time of slaughter was ineffective due to inadequate enforcement of official controls requirements of Articles 3, 4, 5 and 6 of by RUs. The evidence seen by the team of variable reliability of reporting, the failure to detect any non- Directive 93/119/EC are effectively 170 DG(SANTE) 2015-7657 Final Version date October 2016 Audit 2011-6212 of 01 February 2011 in order to evaluate the implementation of controls for animal welfare during transport and at the time of slaughter
Reference no. and recommendation Basis of assessment Assessment implemented. conformities or take any enforcement action in the three RUs visited during the period 2007-2010, coupled with the lack of enforcement action taken regarding animal welfare non-compliances in slaughterhouses detected throughout Greece and reported to the CCA during this period, leads to a similar conclusion. The initial response of the Greek authorities stated the following 1)a. In our document ref. 134099/18.01.2011, for the purpose of implementing Presidential Decree 327/1996, we pointed out the need to carry out scheduled official controls under Article 12 of Presidential Decree 79/2007 (at least once a year) using forms S1 and S2 (which were sent along with our circular ref. 246191/27.08.2003) at each slaughterhouse, slaughterhouse line for animals (including poultry) while slaughterhouses are in operation, in order to evaluate the procedures used, the equipment used, the existing facilities and the animal treatment methods employed from the time of arrival at the slaughterhouse until slaughter. b. Moreover, where the case in Article 12(1)(B) of Presidential Decree 79/2007 exists, when non- compliance is found to exist and corrective measures are recommended by the official veterinarian, which must be implemented within the compliance deadline laid down, additional checks must be carried out. Their frequency will be determined by the Veterinary Services Directorate carrying out the checks. During that check: all points in forms S1 and S2 must be filled out. the findings must be clearly stated and corrective measures must be specified on each form. form S2 be sent to the slaughterhouse operator whether there are control findings or not forms S1 and S2 must be sent to the Veterinary Services Directorate of the Region with the findings of the annual scheduled official control (at the very least) by 30 June of each year and in the case of non- compliance, the results of any additional controls must be sent by 31 December of each year. c. In relation to the animal welfare inspections carried out before and during slaughter during your daily presence at the slaughterhouses, those inspections must be properly recorded in the inspection report sent to you in our circular ref. 373732 / 30-07-2001 for 5% of the daily veterinarian visits to the slaughterhouse during the year, in other words if a veterinarian visits a slaughterhouse 50 days a year, the stated form must be filled out for 3 days. To the extent possible, this form should be filled out on dates
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Reference no. and recommendation Basis of assessment Assessment allocated equally across the entire year. Cases of non-compliance must necessarily be recorded even if they exceed this 5% figure. The relevant provisions of Directive 93/119/EC have been replaced by the corresponding provisions of Regulation (EC) No 1099/2009 on the protection of animals at the time of killing d. In order to save resources, it is recommended that you make concerted efforts to ensure that the stated inspections are carried out in conjunction with the relevant hygiene inspections which are also carried out. Greek authorities provided the following updated information during the 2015 GFA: Until the second semester 2015 the system based on Forms S1 and S2 was in place, which was replace by a new system of reporting was introduced in September 2014 with 4 new templates (for slaughterhouse inspections (ungulates and poultry), general animal welfare instructions and slaughter practice). The GFA team verified the system that was in place until September 2015, as the new system just had been introduced.
2011-6212-7 This recommendation is based on findings and associated conclusion in Section 5.1.2 and 5.1.3of the Action taken audit report that coordination and cooperation between the CCA and the RUs throughout this period has The CCA should ensure that official been less effective with the CCA obtaining incomplete information on official controls and very little controls on animal welfare during transport enforcement action being taken by the RUs despite clear instructions from the CCA. There is an apparent and slaughter are effectively enforced lack of synergy between different departments at RUs in the organisation of official controls at places of according to the requirements of Articles destination and the effective use of staff resources (e.g. Staff carrying out animal welfare controls do not 54 and 55 of Regulation (EC) No have easy access to animal health information that would be of benefit to carrying out these controls, 882/2004. In this regard, the CCA should such as TRACES information or information on registration of dealers). ensure that efficient and effective coordination and cooperation is put in The initial response of the Greek authorities stated the following: place between different units carrying out "1) Controls carried out by each Regional Unit on animal welfare at the time of slaughter must also be official controls. To this end, backed up by having a dossier for each slaughterhouse checked both at the competent Veterinary Services improvements should be sought in the Directorate of the Regional Unit and at the slaughterhouse. complimentary work of the public health department and the animal welfare section This dossier must include: of the CCA and in the Regional Units • Forms S1 and S2 filled out for each slaughterhouse. regarding animal welfare at slaughter and 172 DG(SANTE) 2015-7657 Final Version date October 2016 Audit 2011-6212 of 01 February 2011 in order to evaluate the implementation of controls for animal welfare during transport and at the time of slaughter
Reference no. and recommendation Basis of assessment Assessment killing. Consideration should be given to • The inspection report which must cite the date and reference number, and bear the signature of the improving the sharing of information and slaughterhouse operator, who must be given a copy of the report. developing synergies to enhance the • Documentation of the training of staff with a signed attendance list and the training materials which enforcement of official controls e.g. at have been provided to slaughterhouse staff. CCA level, by actively liaising with RUs in those cases where enforcement action • Particular emphasis must be placed on recording infringements in the inspection report, and where has not been taken by the regions in necessary a timetable must be specified. Re-inspections must be carried out when that timetable expires. slaughterhouses where animal welfare 2) The manner of supervision of Regional Veterinary Services Directorates over each Regional Unit must non-compliances have been identified be recorded in the ‘Report on evaluation of measures taken to implement the control system for animal Consideration should be given to welfare during slaughter per Regional Unit’ prepared in line with model form 2 in Annex II of this developing new strategies in consultation document. This report must be sent to the Animal Welfare, Medicines; Applications Directorate / with the Regional Units to overcome the Ministry of Rural Development; Food every quarter and every year, with the quarterly reports being persistent lack of enforcement action. taken into account in the annual report. This report should include the actions taken by the Veterinary Services Directorate of the Region to address any shortcomings by the competent Veterinary Services Directorates of the Regional Units. For instance, in the case of failure to send reports, a document is sent to the relevant Regional Unit pointing out such shortcomings. Greek authorities provided the following updated information during the 2015 GFA: See recommendation 2011-6212-6. Non-compliances trigger follow-up inspections and OVs are requested to dedicate at least 5% of their time at slaughterhouse inspections. regarding the recording of non-compliance based on reporting templates S1 and S2. A new sanction system has been put in place in Greece. See recommendation 2011-8810-17.
2011-6212-8 This recommendation is based on findings and associated conclusion in Section 5.2.3 of the audit report. Closed for other The standard of the reporting at slaughterhouses was variable with many forms poorly completed and the reasons The CCA should ensure that the activity considered by some OVs and local CAs to be a form filling exercise. Non-compliances were implementation of the provisions of under-reported in the three regional units visited as, if detected; non-compliances are still being followed Articles 4(3) and (5) of Regulation (EC) by oral warnings, as opposed to a written warning as stated in CCA procedures. The CCA is still not No 882/2004 requiring efficient and aware of the true level of compliance in the Regions. effective coordination and cooperation between different units carrying out 173 DG(SANTE) 2015-7657 Final Version date October 2016 Audit 2011-6212 of 01 February 2011 in order to evaluate the implementation of controls for animal welfare during transport and at the time of slaughter
Reference no. and recommendation Basis of assessment Assessment official controls is improved regarding the Situation after the 2010 GFA persistent under-reporting by Regional "1) In line with our circular ref. 170258/20.07.2011 to the regional Veterinary Services Directorates, the Units to the CCA of the results of official 13 Regions of Greece are responsible for supervising dispatch of the quarterly reports on the results of controls on animal welfare during transport animal welfare controls during transport, and the corresponding annual report by each Regional Unit. and at slaughter and killing. In this regard the CCA should intensify efforts to Based on those reports the Region must prepare a quarterly and annual ‘Report on evaluation of measures develop a comprehensive IT reporting taken to implement the control system for animal welfare during slaughter per Regional Unit’ which must system for the practical input of data from include supervision and the way in which such matters were addressed. the Regional Units, whilst also addressing Regional Units must prepare such reports and start sending them to our Department (for the 1st quarter of the infrastructural problems associated the year) no later than 30 April 2012. with the smaller field offices' lack of equipment. 2) The CCA of the Ministry of Rural Development; Food has planned to abolish the hand-filled forms used to collect inspection results relating to the protection of animals during transport (Annual Report on the Protection of Animals During Transport) and to introduce a section entitled ‘Carriers’ to the Veterinary Services Database. This will be implemented before 31.12.2011." Greek authorities provided the following updated information during the 2015 GFA: The corrective actions proposed and taken by the Greek authorities to address this recommendation are based on the system of 'supervision' and reporting by the RVUs to the Veterinary Services Directorate of the Region. The DG SANTE team received 2014 data on the reporting of the RVUs for slaughter and transport and noted that a significant number of RVUs did not report or reported zero controls. This issue is being followed-up through 2011-6212-5.
2011-6212-9 This recommendation is based on findings and associated conclusion in Section 5.4.2 of the audit report In progress that the authorisation, listing and supervision of dealers' premises was not in accordance with the The CCA should ensure that prompt action requirements of Article 13 of Directive 64/432/EEC. Two dealers premises were visited. Both were is taken to address the deficiencies totally unacceptable in terms of structural approval as they were impossible to adequately cleanse and identified in the authorisation and disinfect (earth floors); no separation from owners' stock and no suitable records kept of animals on or off operational surveillance of dealers' the premises. premises throughout Greece in order to comply with the requirements of Article 13 The initial response of the Greek authorities stated the following
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Reference no. and recommendation Basis of assessment Assessment of Directive 64/432/EEC. "1) The Animal Health Directorate of DG Veterinary Services in collaboration with the IT Directorate of the Ministry of Rural Development and Food will complete publication of the updated list of dealers on the Ministry's website by 15.10.2011. 2) In order to update the list of approved dealers in implementation of Directive 64/432/EEC, the Animal Health Directorate of DG Veterinary Services is preparing a circular to remind Regional Veterinary Services Directorates about this matter which will be ready by 31.8.2011. Greek authorities provided the following updated information during the 2015 GFA: This recommendation was not in detail discussed during the GFA and is being followed-up during the 2016 GFA.
2. B.11 Plant health
MR 7087/2004 OF 26 JANUARY 2004 ON POTATOES
Reference no. and recommendation Basis of assessment Assessment
(18215) Lasithi Plateau (Crete) is considered a contaminated area for ring rot. The bacteria has been identified in Action taken laboratories but symptomatic plants have not been found (this fact makes the implementation of To no longer accept status quo in the ring eradication measures at farmer level difficult). rot situation on the Lasithi Plateau. It is now 8 years after the first discovery of the The following information was recorded in the country profile after the 2010 GFA: disease, and it is necessary that the Greek There are two Ministerial Decisions (94837/2000 and 94014/2001) relevant to Clavibacter michiganensis: Government finds a way to efficiently one prohibits the production of potato seeds and the other, the circulation of potatoes outside Crete. implement the control measures necessary According to the CAs, the Benaki Phytopathological Institute (BPI) visited Lasithi, co-operated with for reducing and eventually eradicating the local authorities and submitted to the MRDF the “report of implementation of the control measures in contamination – in accordance with order to eradicate the harmful organism Clavibacter michiganensis subsp. Sepedonicus in the Lasithi 175 DG(SANTE) 2015-7657 Final Version date October 2016 MR 7087/2004 OF 26 JANUARY 2004 ON POTATOES
Reference no. and recommendation Basis of assessment Assessment Council Directive 93/85/EEC Plateau in Crete". The control measures included in the report were not implemented at local level. The co-operation from farmers there was inadequate for implementing the key aspects of the control directive and bringing the contamination towards eradication. Council Directive 93/85/EEC is still not fully applied and the contamination is not being eradicated or adequately controlled. The Greek authorities provided up-dated information in the context of the 2015 GFA : The CA stated in reply to the pre-draft country profile in November 2015 that the two relevant Ministerial Decisions (94837/2000 and 94014/2001) regarding Clavibacter michiganensis are still in force. Annual survey are carried out at the Lasithi Plateau, including visual monitoring and sampling for laboratory testing. The CA provided the following information on the number of samples taken: 2009: 173 samples 2010: 210 samples 2011: 83 samples 2012: 56 samples 2013: 136 samples 2014: 157 samples For the Lasithi Plateau no positive findings, with potato ring rot (Clavibacter michiganensis subsp. sepedonicus) were detected by the surveys carried out during the period from 2009 to 2014. The CA provide documentary evidence of the surveys carried out (map with survey points, confirmation letter from RCPPQC of Heraklion and list of survey points )
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Inspection 2009-8146 of 25 January 2009 in order to evaluate the system of import controls for plant health, the status of protected zones for harmful organisms relevant for Greece, the situation and control for Rhynchophorus ferrugineus, the internal market controls of wood products of relevance for Bursaphelenchus xylophilus and to follow-up outstanding issues in the potato sector
Reference no. and recommendation Basis of assessment Assessment
2009-8146-1 This recommendation is based on a finding and related conclusion in Section 5.1.5.2 of the audit report Action taken that although Piraeus seaport had been authorised to unload oak (Quercus L.) logs with bark attached, Ensure that points of entry authorised for there were no specific fumigation colour reaction tests in house. Neither were there any devices to unloading of oak (Quercus L.) logs from measure moisture content of the wood imported. the United States of America are equipped with fumigation colour reaction tests, to be The initial response of the Greek authorities stated the following: able to carry out inspections as required by "Our Directorate has asked the plant health control service at the Port of Piraeus point of entry, which is Article 4(2)(c) of Commission Decision the Piraeus Regional Plant Protection; Quality Control Centre, to obtain the fumigation colour reaction 2005/359/EC. tests without delay." The Greek authorities provided up-dated information in the context of the 2015 GFA : The CCA provided evidence that the RCPPQC of Piraeus had purchased in 2009 a hydrometer and chemicals agents for the specific fumigation colour reaction tests in order to verify that oak (Quercus L.) logs imported from the US fulfil the criteria set out in EU provisions.
2009-8146-8 Overtaken by recommendation 2011-8974-1 Closed for other reasons Ensure that regular and systematic official surveys for the presence of organisms in respect of which Greece has been recognised as a protected zone based on Commission Regulation (EC) No. 690/2008, are organised and conducted, as required by Article 2(1)(h) of Directive 2000/29/EC and as specified by Directive 92/70/EEC.
177 DG(SANTE) 2015-7657 Final Version date October 2016 Inspection 2009-8146 of 25 January 2009 in order to evaluate the system of import controls for plant health, the status of protected zones for harmful organisms relevant for Greece, the situation and control for Rhynchophorus ferrugineus, the internal market controls of wood products of relevance for Bursaphelenchus xylophilus and to follow-up outstanding issues in the potato sector
Reference no. and recommendation Basis of assessment Assessment
2009-8146-13 This recommendation was overtaken by recommendation 2010-8609-7 which has been closed. Closed for other Furthermore, At the request of certain Member States, the Commission recently initiated a discussion on reasons Ensure that in cases where Rhynchophorus a possible revision of the emergency measures in the Plant Health Section of the Standing Committee on ferrugineus is found, the control measures Plants, Animals, Food and Feed. Most of the Member States of the endangered area called to limit the are imposed according to Annex II to compulsory eradication measures to more limited but essential areas in which the maintenance of pest Commission Decision 2007/365/EC. freedom is generally considered to be more realistic.
2009-8146-14 The CA, in co-operation with the official laboratory of the Benaki Phytopathological Institute, was Action taken planning to provide further information and training for plant health inspectors in the course of 2011, in Ensure that in case of findings of Ralstonia the implementation of this provision. The Greek CAs, in their comments on the draft country profile solanacearum, the extent of probable indicated the following: Training was provided in 2011 to 77 plant health inspectors from 13 to 14 July contamination is determined in accordance 2011. A brochure is in press to inform the organisations involved on the following harmful organisms: with Article 5(1)(a)(iii) of Council Directive 98/57/EC, and any plant material (Meloidogyne and Globodera). determined as probably contaminated is disposed of as specified in Article 6(2) of Greece submits annual report to the Commission on the situation regarding Ralstonia solanacearum. the same Directive. Acording to the information contained in the reports the number of regarding Ralstonia solanacearum in seed and ware poatatoes has significantly decreased with 19 cases in 2001 to no case in 2012 and one case in 2013. These data provide sufficient guarantee that the measures in place are appropriate. 2009-8146-15 The CA in co-operation with the official laboratory of the Benaki Phytopathological Institute is planning Action taken to provide further information and training for plant health inspectors in the course of 2011, in the Ensure that in case of findings of Ralstonia implementation of this provision. The Greek CAs, in their comments on the draft country profile solanacearum, the extent of the indicated that training was provided in 2011 to 77 plant health inspectors from 13 to 14 July 2011. The contamination is determined in accordance updated survey methodology for 2011 concerning the harmful organism Ralstonia solanacearum, as with Article 5(1)(a)(i) of Council Directive posted on the website of the Benaki Phytopathological Institute (http://en.bpi.gr) refers to the surface 98/57/EC, in particular that surface water water sampling methodology and the Regional Units must send surface water samples first. is considered as an element in the investigation, as specified in Annex IV of See recommendation 2009-8146-14. the same Directive. 2009-8146-18 Decision 2003/766/EC was repealed by Decision 2014/62/EU. Closed for other
178 DG(SANTE) 2015-7657 Final Version date October 2016 Inspection 2009-8146 of 25 January 2009 in order to evaluate the system of import controls for plant health, the status of protected zones for harmful organisms relevant for Greece, the situation and control for Rhynchophorus ferrugineus, the internal market controls of wood products of relevance for Bursaphelenchus xylophilus and to follow-up outstanding issues in the potato sector
Reference no. and recommendation Basis of assessment Assessment Ensure that official surveys for the reasons presence of Diabrotica virgifera in areas in
Greece, where maize is grown, are conducted, as required by Article 2(1) of Commission Decision 2003/766/EC. The results of those surveys are notified to the Commission and to the other Member States by 31 December of each year, as required by Article 2(2) of the same Decision. 2009-8146-19 This recommendation is based on findings and associated conclusion in Section 5.5.2 of the audit report Closed for other that systematic surveys for the Pepino mosaic virus were not carried out. reasons Ensure that official surveys on premises involved in the production of tomato plants The response of the Greek authorities stated the following: and tomato fruits, for the presence of Our service has asked the plant health control services to take part in the annual survey in accordance Pepino mosaic virus, are conducted in with the survey methodology which is available on the website of the Benaki Phytopathological Institute. Greece, as required by Article 4 of Commission Decision 2004/200/EC, and The note that the methodology for the survey of Pepino mosaic virus was updated in 2014 on the the the results of those surveys are notified to website of BPI the Commission and to the other Member http://www.bpi.gr/section.aspx?id=3&subid=58&subsubid=2246 States. In May 2013, COM agreed with MS to stop the surveys.
2009-8146-20 Decision 2006/464/EC was repealed by Decision 2014/690/EU. Closed for other reasons Ensure that official surveys for the presence of Dryocosmus kuriphilus in Greece are conducted, as required by Article 5(1) of Commission Decision 2006/464/EC, and the results of those surveys are notified to the Commission
179 DG(SANTE) 2015-7657 Final Version date October 2016 Inspection 2009-8146 of 25 January 2009 in order to evaluate the system of import controls for plant health, the status of protected zones for harmful organisms relevant for Greece, the situation and control for Rhynchophorus ferrugineus, the internal market controls of wood products of relevance for Bursaphelenchus xylophilus and to follow-up outstanding issues in the potato sector
Reference no. and recommendation Basis of assessment Assessment and to the other Member States by 31 December of each year.
2009-8146-21 Decision 2007/410/EC was repealed by Decision 2015/749/EU Closed for other reasons Ensure that official surveys, and where appropriate, testing, for the presence of Potato spindle tuber viroid on host plants, or evidence of infection by this harmful organism, are conducted in Greece, as required by Article 3(1) of Commission Decision 2007/410/EC. The results of those surveys are notified to the Commission and the other Member States.
2009-8146-22 Greece submits annually reports with the survey results on Gibberella circinata to the Commission. Action taken Ensure that official surveys for the presence of Gibberella circinata in Greece are conducted, as required by Article 5(1) of Commission Decision 2007/433/EC, and the results of those surveys are notified to the Commission and to the other Member States by 15 December of each year.
2009-8146-23 Inspections of Wood Packing Material are carried out by the plant health control services. Instructions Action taken have been given to them concerning the conduct of systematic and more frequent inspections on wood Consider carrying out more systematic and packaging material and on sampling for laboratory testing, particularly from countries where the presence 180 DG(SANTE) 2015-7657 Final Version date October 2016 Inspection 2009-8146 of 25 January 2009 in order to evaluate the system of import controls for plant health, the status of protected zones for harmful organisms relevant for Greece, the situation and control for Rhynchophorus ferrugineus, the internal market controls of wood products of relevance for Bursaphelenchus xylophilus and to follow-up outstanding issues in the potato sector
Reference no. and recommendation Basis of assessment Assessment frequent inspections of cargo with Wood of Bursaphelenchus xylophilus has been detected. These services do not send reports of controls to the Packaging Material, including random CA and there is not a national database available for the collection of such data. Data of inspections sampling even in the absence of symptoms carried out by the most important entry points for the year 2010 was provided but the number of samples or signs of infection or infestation. taken for laboratory analyses was very low. The Greek CAs, in their comments on the draft country profile for the 2010 GFA, indicated that 2492 macroscopic inspections were carried out and two samples were sent for laboratory control. The Greek authorities provided up-dated information in the context of the 2015 GFA : The CCA provided in response to the pre-draft country profile evidence that consideration was given to this recommendation. The CCA provided documents on checks of WPM including samples taken. including one example of a finding and notification of a non-compliant ISPM-15 mark originating from another MS found in Greece. In order to show that controls on WPM are performed one example was given for the RCPPQC in charge of controls at the port of Heraklion.: Controls of WPM between 2011-2014 2011 17 2012 18 2013 66 2014 55 Samples taken for laboratory testing: 2011 1 (high risk TC) 2012 6 (MS – PWN relevant) 2013 45 2014 16 (MS – PWN relevant) A second example of samples of WPM taken for laboratory testing was provided for Thessaloniki. In 181 DG(SANTE) 2015-7657 Final Version date October 2016 Inspection 2009-8146 of 25 January 2009 in order to evaluate the system of import controls for plant health, the status of protected zones for harmful organisms relevant for Greece, the situation and control for Rhynchophorus ferrugineus, the internal market controls of wood products of relevance for Bursaphelenchus xylophilus and to follow-up outstanding issues in the potato sector
Reference no. and recommendation Basis of assessment Assessment 2014 nearly 70 samples from WPM were analysed. Specific guidance was issued for controls on WPM originating from China in relation to the provisions of Commission Decision No 2013/92/EU.
2009-8146-24 The official laboratories have been asked to adapt the survey methodology in order to increase the Action taken number of pheromone traps used when carrying out the surveys and when establishing an area free of the Consider increasing the use of pheromone pest Rhynchophorus ferrugineus, in accordance with this recommendation. traps when carrying out the surveys prescribed by Article 5(1) of Commission Audit report 2010 carried out (32 prefectures out of a total of 51). In the Prefectures where R. ferrugineus Decision 2007/365/EC, and when was considered present, it was recommended to set up 5 traps, while in the Prefectures where R. establishing a pest free area as prescribed ferrugineus was not considered as present it was recommended to set up 1 trap. The BPI informed the in Annex I, Point 2(b), to the same mission team that in 2010 the number of traps for the two situations will be raised to 10 and 4 Decision. respectively. The Greek authorities have considered to increase the use of pheromone traps when carrying out the surveys for pest Rhynchophorus ferrugineus
Audit 2011-8974 of 24 January 2011 in order to evaluate the status of protected zones in Greece and to follow-up the recommendations of mission DG SANCO 2010-8609
Reference no. and recommendation Basis of assessment Assessment
2011-8974-1 This recommendation is based on a finding and related conclusion in Section 5..2.2 of the audit report. Action still The surveillance system was also not in compliance with Article 1(3) of Directive 92/70/EEC with regard required Ensure that regular and systematic official to the requirement to carry out systematic surveys and with Article 1(4) of the same Directive with regard surveys for the presence of organisms in to the requirement to establish a grid-based network of observation points for harmful organisms of respect of which the protected zones for animal kingdom. Greece have been recognised are 182 DG(SANTE) 2015-7657 Final Version date October 2016 Audit 2011-8974 of 24 January 2011 in order to evaluate the status of protected zones in Greece and to follow-up the recommendations of mission DG SANCO 2010-8609
Reference no. and recommendation Basis of assessment Assessment conducted throughout the protected zone in The initial response of the Greek Authorities stated the following: accordance with the national survey plan "In each Prefecture, official surveys for the presence of harmful organisms in respect of which the and in line with Article 2(1)(h) of protected zones for Greece have been recognised are conducted as follows: 1) for harmful organisms in Directive 2000/29/EC and Directive agriculture, they are conducted by the regional services for the rural economy and veterinary affairs; 2) 92/70/EEC and in particular thata) a for harmful organisms in forestry, they are conducted by the decentralised administrations' forestry systematic network of grid-based directorates and forestry authorities. The surveys are carried out in accordance with the methodology set observation points for harmful organisms out by the official laboratories and posted on the official website of the Benaki Phytopathological of the animal kingdom is established andb) Institute. a) The official laboratories will amend the methodology of the surveys for harmful organisms of sound scientific and statistical principles the animal kingdom in respect of which the protected zones for Greece have been recognised, posting the are taken into account for the planning of network of fixed observation points in the respective annexes, based on this year's risk analysis for the survey. harmful organisms of the animal kingdom. (a) and (b) Creation of a working group (official laboratories + competent authorities) for the establishment of a systematic network of grid-based observation points. " The Greek authorities provided up-dated information in the context of the 2015 GFA : The BPI provided a detailed description of the monitoring concept for forest pest for which Greece is recognised as protected zone. For the scolitidae survey a spatial database was developed with two main layers: a) the "basemap" with information the scolytidae host areas and geographical distribution of the survey points of a 2 km by 2 km survey grid and b) the survey data. At the time of the GFA the survey grid consisted of more than 34 survey points. In addition consideration is given to surveys at risk areas such as log yards, places were commodities are stored (harbours, warehouses at in the surrounding of railway stations, etc.) Regarding Gonipterus s. BPI stated that no database on the distribution of eucalyptus trees is availbale and that the surveys for this organism are limited and that not all regional services provide data. Spruce is only growing in Drama and according to BPI there is no need for a grid based approach. for the Gilpina h. surveys. Visual inspection are carried out every year and samples are taken. The Greek authorities have taken appropriate measures in order to address this recommendation with regards to surveys for scolytidae. However, still no systematic and grid based survey is carried out for Gonipterus s. and Gilpina h.
183 DG(SANTE) 2015-7657 Final Version date October 2016 2. B.12 Quality labelling
Audit 2013-6645 of 11 November 2013 in order to evaluate the control systems in place for organic production and labelling of organic products
Reference no. and recommendation Basis of assessment Assessment
2013-6645-1 This recommendation is based on a finding and related conclusion in Section 5.2.5 that random Action still inspections at operators are not always unannounced. required Ensure that random inspections at operators are unannounced as required by The response of the Greek authorities stated that CB2 has already taken appropriate corrective action by Article 3(2) of Regulation (EC) No issuing updated control procedures whereby operators are informed of random and unannounced control 882/2004 and Article 65(4) of Commission visits no later than 24 hours in advance. This applies to specific cases where controls are to be carried out Regulation (EC) No 889/2008. in less accessible, remote areas. The Greek authorities provided in the context of the 2015 GFA up-dated information: In 2014 more than 11% of all controls were additional risk based and more than 13% of inspections are unannounced. The percentage of unannounced inspections carried out by the CBs varied in 2014 between 10% and 20%, except three CBs which only performed 0%, 2% and 7% respectively. Two of the latter three CBs were approved for the first time during the cause of 2014. Therefore, they did not have in 2014 a full year with the opertors under contract with them. ELGO-DIMITRA notified the third CB to the CCA and suggested to take sanctions. The CCA stated that due to the reorganisation there is a delay in establishing the sanction committee, which is planned for early 2016. . The CCA stated that compliance with the requirement to inspect at least 10% of operators unannounced is checked in the context of the supervision of CBs by the CA. The CA stated that CBs may inform the operators of "unannounced" inspection 24h prior to the control if the operator is located in a remote area. 24h prior notification of an inspection cannot be considered as unannounced inspection.
2013-6645-2 This recommendation is based on a finding and related conclusion in Section 5.2.2.2 that at processors, Action taken where parallel production takes place, cleaning records are not checked and this is not an aspect covered Ensure that suitable cleaning measures are in the standard checklists of both CBs. implemented at food and feed processing plants and their effectiveness is monitored The response of EL stated that both CBs have already taken the necessary corrective action. Specifically, in order to verify compliance with the both CBs have made changes to the standard checklists and have added specific fields in order to fully requirements as laid down in Article 184 DG(SANTE) 2015-7657 Final Version date October 2016 Audit 2013-6645 of 11 November 2013 in order to evaluate the control systems in place for organic production and labelling of organic products
Reference no. and recommendation Basis of assessment Assessment 26(4)(b) and Article 26(5)(e) of cover the control of and monitor the effectiveness of cleaning records. Commission Regulation (EC) No The Greek authorities provided in the context of the 2015 GFA up-dated information: 889/2008. The CCA provided copies of the revised checklists for CB1 and CB2. The GFA team noted that specific
points on cleaning and avoiding cross-compliance including record keeping have been incorporated into the checklist of the two CBs (CB1: points 2.1, 3.3, 3.4 and 3.5 and CB2: fields E6, E7, E8, E9 and H3). During the GFA a representative of ELGO-DIMITRA stated that during annual office audits no non- compliance regarding this issue were encountered at the other CBs.
2013-6645-3 This recommendation is based on a finding and related conclusion in Section 5.2.2.1 of the audit report In progress that the lists of operators, including documentary evidence, were not publicly available which is not in Ensure that lists of operators are publicly compliance with the requirements laid down in Article 92(a) of Regulation (EC) No 889/2008. available, containing updated documentary evidence related to each operator and using The response of EL stated that the competent authorities are cooperating with the inspection and the model set out in Annex XII to certification bodies (ICB) for organic products and other services to establish a framework for making Regulation (EC) No 889/2008, as required public, handling and continuously updating the lists of operators as required by Article 92(a) of by Article 92(a) of the same Regulation. Regulation (EC) No 889/2008. Given the large numbers of operators to be included in the list (around 24 000) and the technical difficulties involved, efforts are under way to implement the system in late 2014.
The Greek authorities provided in the context of the 2015 GFA up-dated information: In response to the pre-draft country profile the CCA stated that the list of certified operators is published on the following-website http://agrocert.gr. However, the list of operators is updated up-dated only once a year and it is not ensured that the information made publicly available is containing updated documentary evidence related to each operator. During the GFA the CCA informed the GFA team that a new platform has been established and that CBs have been asked to provide comments on the platform by 12 December 2015. The platform, which will be updated on a regular basis will contain certificates, information on sanctions and will allow generate statistical data in real time.
185 DG(SANTE) 2015-7657 Final Version date October 2016 Audit 2013-6645 of 11 November 2013 in order to evaluate the control systems in place for organic production and labelling of organic products
Reference no. and recommendation Basis of assessment Assessment
2013-6645-4 This recommendation is based on a finding and related conclusion in Section 5.2.2.3 that sampling for Action taken pesticide residues observed by the audit team were not appropriate, in particular regarding sealing of bags Ensure that sampling for pesticide residues and transport, and these shortcomings could have an impact on the reliability of the analytical results. is performed in accordance with the requirements set out in Commission The response of EL stated that CB1 and CB2 have already taken corrective action by issuing updated Directive 2002/63/EC, in particular, guidelines to inspectors and auditors to ensure full compliance with Directive 2002/63/EC with regard to Chapter 4.6. in the Annex to the same sealing, storage and transport of laboratory samples. Directive with regard to sealing, storage The Greek authorities provided in the context of the 2015 GFA up-dated information: and transport of the laboratory sample. The CCA stated that it verified in the context of the annual office audits at CBs by the CA that
appropriate sampling procedures are in place. The CCA provided copies of the sampling procedures for all 15 CBs. The revised procedures include a reference to Directive 2002/63/EC. ELGO DIMITRA reported that for the year 2014 no failure of the CB to comply with the provision of Article 65(2) of Regulation (EC) No 889/2008 had been found.
186 DG(SANTE) 2015-7657 Final Version date October 2016 2. B.13 Overview of more recent audits The reports of two further audits have been published. The recommendations contained in these reports will be followed up and assessed in the next general follow-up audit and the update of the country profile.
Audit 2014-7027 of 23 September 2014 carried out in order to evaluate the control of residues and contaminants in live animals and animal products including controls on veterinary medicinal products
The audit focused on the legal and administrative measures in place to give effect to the relevant EU requirements and on the performance of the competent authorities in meeting these requirements. Attention was also paid to examining the implementation of corrective actions promised in response to relevant recommendations made in the report of a previous audit to Greece (DG (SANCO)/2011/8901) in April 2011. It is concluded that conditions governing the authorisation, distribution and use of veterinary medicinal products are in line with EU requirements. The system of official controls on the distribution and use of veterinary medicinal products has improved since the 2011 audit and progress was noted, in particular, with regard to food chain information and the correct use of prescriptions. Nevertheless, in practice the system is not functioning as effectively as it could due to some shortcomings found in the area of on-farm record-keeping and the competent authorities' failure to meet their own targets for carrying out controls on pharmacies, veterinary offices and farms. The structure of the residue monitoring plan (RMP) is in accordance with Council Directive 96/23/EC. Major risk factors are taken into account during the planning process. However, certain methods are not available in the indicated laboratories, therefore the plan is not fully in line with the legislation. Whilst there has been significant progress compared to the 2011 audit report with regard to the availability of accredited and validated methods and implementation of quality control procedures, there are still no methods in place for two substance groups and other methods are incomplete. In addition, laboratory performance has been compromised by several factors including the lack of properly functioning analytical equipment and, in one case, an inadequate level of staffing. Progress has been made with regard to training of staff and central supervision of the plan implementation. There is a clear legal framework in place governing the actions to be taken in the event of a non-compliant result and actions have been implemented in line with requirements of Council Directive 96/23/EC. Sampling is carried out correctly on the whole, but under-sampling remains an issue for structural reasons and lack of resources; this also has a negative impact on turnaround times. Thus the major problem of significant under-implementation of the RMP remains and weakens its effectiveness
Audit 2014-7127 of 14 October carried out in order to evaluate the control systems in place governing the production and placing on the market of live bivalve molluscs
The primary objectives of the audit were to assess whether the official controls of bivalve molluscs, echinoderms, tunicates and marine gastropods are organised and carried out in accordance with the relevant provisions of Regulation (EC) No 882/2004 of the European Parliament and of the Council of 29 April 2004 on official controls performed to ensure the verification of compliance with feed and food law, animal health and animal welfare rules and whether the control system in place for the production and placing on the market of bivalve molluscs, echinoderms, tunicates and marine gastropods is in compliance with European Union requirements.
187 DG(SANTE) 2015-7657 Final Version date October 2016 Audit 2014-7127 of 14 October carried out in order to evaluate the control systems in place governing the production and placing on the market of live bivalve molluscs The audit also verified the implementation of the recommendations of the previous 2011 Food and Veterinary Office audit visit covering the same subject. The current report concludes that considerable improvements have been made since the previous audit, however, the official control system in place covering live bivalve molluscs cannot yet be considered as fully in compliance with all European Union requirements. Important shortcomings are still present, notably related to the definition of sampling points for the collection of water for phytoplankton testing and live bivalve molluscs for biotoxins testing, the frequency of monitoring/testing of live bivalve molluscs for one group of toxins (Paralytic Shellfish Poison) and the absence of demonstration of the efficiency of the purification systems. Of the twenty recommendations of the 2011 audit, ten can be considered as addressed, three partially addressed, six not addressed (monitoring of biotoxins (for Paralytic Shellfish Poison); decisions taken after monitoring; additional monitoring requirements; purification centres; analytical and legal validity of samples; coordination between Competent Authorities) and one is no longer applicable.
Audit 2015-7437of 02 June 2015 carried out in order to evaluate the official controls on consignments in transit
The official control system for transits meets the general requirements in relation to communication, training, and resources supporting the functionality of controls. Only consignments eligible for transit are accepted at the BIPs, and the system ensures that consignments leave the EU territory as required by EU legislation. Specific shortcomings were noted in relation to some BIPs not making use of all available information in order to detect consignments that should undergo veterinary checks, and identity checks limited to tail checks, opening the possibility for consignments not being checked or containers being accepted with a load that does not necessarily match the accompanying paperwork. In addition, there are no instructions on official controls that need to be carried out on EU consignments transiting third countries when they re-enter the EU, which poses a potential risk to EU animal health. Verification activities are carried out but their effect is limited by the restricted ability to detect shortcomings and the lack of enforcement of necessary corrective actions.
Audit 2015-7475 of 14 September 2015 carried out in order to evaluate controls on marketing and use of plant protection products
There was a system of controls on the use of Plant Protection Products (PPPs). However, there is a lack of information, and hence controls, on users not claiming funds under the basic payment scheme. The risk assessment for the prioritization of controls did not take into account all the different users of PPPs and the frequency for controls had not been established based on risk. These weaknesses reduced the effectiveness of the controls. In addition, the majority of staff wer not adequately trained in PPP-specific issues and therefore, controls conducted on growers are not effective to verify that only authorised PPPs are used in accordance with their conditions of authorisation. There were regular, risk-based official controls on retailers of PPPs. The control of labels and revoked PPPs at this level are not effective. The absence of risk based routine inspections on manufacturers, packers and re-packers of PPPs for product destined for the national market also compromised the effectiveness of the control system to ensure 188 DG(SANTE) 2015-7657 Final Version date October 2016 Audit 2015-7475 of 14 September 2015 carried out in order to evaluate controls on marketing and use of plant protection products that authorised PPPs for marketing in Greece comply with their conditions of authorisation. Although there were weaknesses in controls for product destined for the domestic market, there were comprehensive controls on the manufacture and re-packing of PPPs intended for use in other Member States or Third Countries. These controls were enhanced by the excellent cooperation with relevant Competent Authorities (CAs) and there was an effective system in the fight against illegal PPPs. Growers had sufficient information and tools available to guide them in the implementation of Integrated Pest Management (IPM) and the CA had a pest monitoring system in place. However, there was no functioning system for sprayer testing so as to ensure that all pesticide application equipment in professional use can be inspected before the EU legal deadline on 14 December 2016. The systems for pest monitoring and controls on IPM provided assurances on the safe use of PPPs.
189 DG(SANTE) 2015-7657 Final Version date October 2016 ANNEX I – 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 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 DAH Directorate of Animal Health DAPI Directorate of Animal Product Inputs DGAP Directorate General of Animal Production DGPH Directorate General of Public Health DGPP Directorate General of Plant Produce Protection DG SANCO Directorate General for Health and Consumer Protection DGVS Directorate General of Veterinary Services DICP Directorate of Inputs for Crop Production DPPP Directorate of Plan Protection Produce DPSQCPVO Directorate of Processing, Standardisation and Quality Control of Products of Vegetable Origin DVPH Directorate of Veterinary Public Health DVAC Directorate of Veterinary Audit and Controls DVSDAAW The Directorate of Animal Welfare, Medicines and Applications EFET Hellenic Food Authority ELOGAK Greek Milk and Meat Organisation 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
194 DG(SANTE) 2015-7657 Final Version date October 2016 ACRONYM DESCRIPTION Food and Veterinary Office GCSL General Chemical State Laboratory GFA General Follow-up Audit GHPG Good Hygiene Practice Guide 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 Ministry of Development MoF Ministry of Economy and Finance MHSS Ministry of Health and Social Solidarity MIDE Ministry of the Interior, Decentralisation and E-government 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 PHD Health Directorates of the Prefectures PPP Plant Protection Products PPS Plant Protection Service PRDDs Rural Development Directorates of the Prefectures PVDs Veterinary Directorates of the Prefectures PTD Trade Directorates of the Prefectures QMS Quality Management System RAAC Regional Agriculture Advisory Centres RASFF Rapid Alert System for Feed and Food RCLs Routine control laboratories RCPPQC Regional Centres of Plant Protection and Quality Control REVM Rural Economy and Veterinary Medicine RVL Regional Veterinary Laboratories SA Single Authority SRM Specified Risk Material TCs Third Countries
195 DG(SANTE) 2015-7657 Final Version date October 2016 ACRONYM DESCRIPTION TRACES Trade Control and Expert System introduced by Commission Decision 2004/292/EC TSE Transmissible Spongiform Encephalopathy UKAS UK Accreditation Service VFS Veterinary Field Stations VMP Residues of veterinary medicinal products SCC Supreme Chemical Council
196 DG(SANTE) 2015-7657 Final Version date October 2016