EUROPEAN COMMISSION HEALTH AND CONSUMERS DIRECTORATE-GENERAL

Transcription

1 Ref. Ares(2014) /07/2014 EUROPEAN COMMISSION HEALTH AND CONSUMERS DIRECTORATE-GENERAL Directorate F - Food and Veterinary Office DG(SANCO) MR FINAL FINAL REPORT OF AN AUDIT CARRIED OUT IN FRANCE FROM 09 TO 20 SEPTEMBER 2013 IN ORDER TO EVALUATE THE CONTROL FOR ORGANIC PRODUCTION AND LABELLING OF ORGANIC PRODUCTS In response to information provided by the Competent Authority, any factual error noted in the draft report has been corrected; any clarification appears in the form of a footnote.

2 Executive Summary This report describes the outcome of an audit which took place in France from 9 to 20 September 2013 in order to evaluate the control systems for organic production and labelling of organic products; a previous audit to France on the same topic was carried out in 1999 (ref. DG(SANCO)/1131/99 MR Final). There is an overall effective system for controls of organic production and labelling of organic products in France, while national provisions provide a clear legal framework for the implementation of organic production rules although some of them differ from the requirements as laid down in the European Union (EU) legislation. Control Bodies (CBs) are not always accredited before being approved by the National Institute of Origin and Quality (INAO). This is not in accordance with EU requirements, as accreditation according to norm EN may sometimes occur a long time after their approval. Although CBs have in general a sufficient number of suitably qualified and experienced staff, deficiencies in the performance of newly recruited staff without appropriate tutoring were noted. Some controls carried out by the CBs were found to be ineffective. Differences in interpretation of analytical results for residues of pesticides and contaminants were noted between the CBs visited. In some cases, the threshold for initiation of an investigation was not in accordance with EU legislation. In some cases, CBs did not immediately notify the Central Competent Authority (CCA) when deficiencies, affecting the organic status of the products, had been detected. In a limited number of cases enforcement was weak or missing. Documentation, issued to operators, setting out their approval status is not published, which is contrary to the requirements of Article 92(a) of Regulation (EC) No 889/2008. As a consequence, those receiving product along the supply chain, those performing controls and consumers, cannot readily verify that suppliers and products have been appropriately certified. In general, controls on labelling of organic and in-conversion products were effective. Traceability from retailer to the producer was satisfactory (in one case, identifying an ingredient erroneously declared as organic). The French instructions delegate to CBs the administration of certain exceptions to organic production standards, which is not in compliance with EU requirements, whilst in other cases (e.g. mutilations) derogations have been granted countrywide without any effective control or verification. Procedures for communication, co-ordination and co-operation between the CBs and the CCA, and among the different Competent Authorities (CAs), are in place, with the only exception being the French Paying Agency (ASP); with the effect that important information concerning controls carried out by the ASP are not being used to target or prioritise the controls operated by other CAs. The report makes a number of recommendations to the French CAs aimed at rectifying the shortcomings identified and enhancing the implementation of control measures. I

3 Table of Contents 1 INTRODUCTION OBJECTIVES LEGAL BASIS BACKGROUND FINDINGS AND CONCLUSIONS RELEVANT NATIONAL LEGISLATION AND PROVISIONS ORGANISATION AND IMPLEMENTATION OF CONTROLS COMPETENT AUTHORITIES AND CONTROL BODIES CONTROLS ON ORGANIC PRODUCTION PLANNING AND PRIORITISATION OF CONTROLS SAMPLING AND ANALYSIS CONTROLS ON LABELLING AND TRACEABILITY EXCEPTIONAL PRODUCTION RULES AND OTHER DEROGATIONS IMPORTS OF PRODUCTS FROM ORGANIC PRODUCTION DOCUMENTED PROCEDURES AND CONTROL REPORTS COMMUNICATION, CO-ORDINATION AND CO-OPERATION ENFORCEMENT MEASURES SEED DATA BASE OVERALL CONCLUSIONS CLOSING MEETING RECOMMENDATIONS...23 ANNEX 1 - LEGAL REFERENCES...26 II

4 ABBREVIATIONS AND DEFINITIONS USED IN THIS REPORT Abbreviation Agence Bio ASP CA(s) CCA CAP CB(s) CEBIO COFRAC DGAL DGCCRF DGDDI DGPAAT DG(AGRI) DG(SANCO) DDTM EDI EU FBO(s) FVO GMO GNIS Explanation The French Agency for Development and Promotion of Organic Farming (Agence française pour le développement et la promotion de l'agriculture biologique) The French Paying Agency (Agence de services et de paiements) Competent Authority(ies) Central Competent Authority(ies) Common Agricultural Policy Control Body(ies) : CB1 = first Control Body visited; CB2 = Second Control Body visited; CB3 = Third Control Body visited during the audit Association Des Organismes Certificateurs Pour La Certification D Opérateurs En Agrobiologie The French accreditation body (Comité français d'accréditation) The General Directorate for Food (Direction générale de l'alimentation) The General Directorate for Competition, Consumers and Fraud Repression (Direction générale de la concurrence, de la consommation et de la répression des fraudes) The General Directorate of Customs and Indirect Redevances (Direction générale des douanes et des droits indirects) The General Directorate for Agricultural Policies, Agrifood and Forests (Direction générale des politiques agricole, agro-alimentaire et de la forêt) Directorate General for Agriculture and Rural Development Directorate General for Health and Consumers Directions départementales des territoires et de la mer Procedure for exchange of electronic information (échanges de données informatisés) European Union Food Business Operator(s) Food and Veterinary Office Genetically Modified Organism The National Interprofessional Organisation of seeds and plants (Groupement national interprofessionel des semences et plants) III

5 INAO MAAF MANCP MRL MS(s) OJ PPP(s) TC The National Institute of Origin and Quality (Institut national de l'origine et de la qualité) The Ministry of Agriculture, Agrifood and Forests (Ministère de l'agriculture, agro-alimentaire et de la forêt) Multi-Annual National Control Plan Maximum Residue Limit Member State(s) Official Journal Plant Protection Product(s) Third Country IV

6 1 INTRODUCTION The audit formed part of the FVO's planned programme and took place from 9 to 20 September The audit team comprised two auditors from the FVO and a national expert from a Member State of the EU. Representatives from the CCA accompanied the FVO team for the duration of the audit. An opening meeting was held on 9 September with the CAs (the INAO Institut national de l'origine et de la qualité, the DGCCRF Direction générale de la concurrence, de la consommation et de la répression des fraudes, the DGPAAT Direction générale des politiques agricole, agro-alimentaire et de la forêt, and the DGDDI Direction générale des douanes et des droits indirects) and representatives from the Accreditation Body (COFRAC Comité français d'accréditation), from the Agence Bio (Agence française pour le développement et la promotion de l'agriculture biologique) and from the GNIS (Groupement national interprofessionel des semences et plants). Representatives from the three CBs to be visited during the course of the FVO audit were also present at the opening meeting. At this meeting, the objectives of, and itinerary for, the audit were confirmed by the FVO audit team and further information on the control system was provided by the authorities. 2 OBJECTIVES The objectives of the audit were to evaluate the control systems in place for organic production and labelling of organic products, and in particular, the implementation of the requirements set out in Regulation (EC) No 834/2007 concerning all stages of production, preparation and distribution of organic products and the use of indications referring to organic production in labelling and advertising. In pursuit of these objectives, the following sites were visited: Competent authorities : Competent authorities Central 2 Opening and closing meetings with INAO. Regional 3 Accreditation Body 2 COFRAC (present at both opening and closing meetings) Control Bodies 3 CB1, CB2 and CB3 On-Site-Visits (listed below) : Retail shops 2 One specialised shop with the purpose of sampling of organic products to carry out a traceability exercise. Bee-keepers 1 One belonged to a chain of large supermarkets selling organic products under their own and other labels. 1

7 Vegetables producer 1 Processors 2 One processor of fruits and vegetables and one slaughterhouse with cutting plant and premises for production of minced meat and meat products. Production farm 1 On-farm producer of goat and sheep meat and of cheeses manufactured with goat milk. Aquaculture producer 1 An aquaculture business in sea water. 3 LEGAL BASIS The audit was carried out under the general provisions of EU legislation in particular Article 45 of Regulation (EC) No 882/2004 of the European Parliament and of the Council. EU legal acts quoted in this report refer, where applicable, to the last amended version. Full reference to documents quoted in this report is given in Annex 1. 4 BACKGROUND Between 1999 and 2004 the FVO carried out a total of 16 audits on organic farming in 9 Member States (MSs) and seven Third Countries (TCs). The FVO carried out an audit on organic farming in France in 1999 (ref. DG(SANCO)/1131/99); the report of the audit has been published on the website of the Directorate-General for Health and Consumers DG SANCO ( At that time a board, both the Direction Générale de l'alimentation (DGAL) under the Ministry of Agriculture and Fisheries and the DGCCRF under the Ministry of Economy, Finances and Industry acted as Competent Authorities (CAs) for the approval and supervision of the CBs. This report made a number of suggestions to the French CCAs regarding: simplifying the system of supervision of organic operators and allocating more human resources; strengthening the supervision on labelling, quantitative traceability and origin of organic products, including the verification of authenticity of certificates used; strengthening the collaboration between CBs and CAs when irregularities and/or infringements are detected. Such infringements should also been used for evaluation and correction of the control system in place; simplifying the import authorisation procedures. Based on a Memorandum of Understanding between the DG (SANCO) and the Directorate-General for Agriculture and Rural Development (DG(AGRI)), the FVO has undertaken a new series of audits on organic production to MSs and TCs. 2

8 According to data provided by the various CCAs involved, the organic farming sector in France (data at 31 December 2012) involves farms (4.7% of the French farms) for hectares (3.72% of the French agricultural area). In addition operators are involved in processing, import-export and distribution of organic products. The national market for organic products accounts for 4.17 billion. 5 FINDINGS AND CONCLUSIONS 5.1 RELEVANT NATIONAL LEGISLATION AND PROVISIONS Legal Requirements Article 291 of the Treaty on the functioning of the EU establishes that MSs shall adopt all measures of national law necessary to implement legally binding Union acts. Article 27(7)(b) of Regulation (EC) No 834/2007 indicates that the competent authorities may not delegate the competence to grant exceptions, as referred to in Article 22. Findings Article L640-2 of the Rural and Fishing Code (Code rural et de la pêche maritime) includes organic labelling among the signs identifying quality and origin of foodstuffs, while at Article L642-5 the INAO is designated as the national authority responsible for the implementation of the national provisions in the sector. Three national Decrees laying down provisions for organic products not covered by EU legislation are also in force: National Decree for livestock raised under organic farming, integrating the provisions laid down by Regulation (EC) No 834/2007 and Regulation (EC) No 889/2008 of the Commission for snails, rabbits, ostriches and young poultry animals. (approved by the Arrêté of 05/01/2010, published in OJ of 15/01/2010). It also contains some provisions relevant for species for which the EU provisions lay down specific requirements and for plant production: defining low growing (less than 27 g/day) poultry strains to be used when animals are slaughtered before 81 days of age, in accordance with Article 12(5) of Regulation (EC) No 889/2008; defining stocking densities for poultry, ensuring compliance with the limits of 170 Kg/N/ha as laid down in Article 15 of Regulation (EC) No 889/2008; defining certain practices concerning the management of animals, and in particular mutilations which are allowed in the different species of animals (see 5.2.6); defining the minimum period for which poultry runs must be empty, as laid down in Article 23(5) of Regulation (EC) No 889/2008; allowing aquaculture producers to grow simultaneously organic and conventional juveniles or fishes if the production units are clearly physically separated and a separate water distribution system exists, as required by Article 25(c) of Regulation (EC) No 889/2008; defining the minimal duration of fallowing in tanks used for shrimps, as laid down in Article 25(s)(3)(a) of Regulation (EC) No 889/2008; retroactive recognition of conversion periods by CBs on the basis of official criteria validated by the INAO. However, according to Article 36(2) of Regulation (EC) No 889/2008, this decision has to be taken by the CA only; 3

9 use of non organic vegetative propagating material (with the exception of potatoes) in case the same material produced according to organic rules is not available on the market, in accordance with the prescriptions of Article 45(1)(b) of Regulation (EC) No 889/2008; allowing operators, when the available organic feedingstuffs do not contain the necessary quantities of vitamins A, D and E, to administer synthetic vitamins to ruminant animals, keeping the appropriate records of their use. The national interpretative guide to the EU Regulations, in its last version dated June 2013, provides clarifications on several requirements of the EU legislation. However, some prescriptions differ from those of the EU provisions and/or the national standards: certain exceptional production rules as laid down in Article 22 of Regulation (EC) No 834/2007 and in Articles 39 to 47 of Regulation (EC) No 889/2008 (see 5.2.6). The contract signed between the CB and the organic operator allows the CB s inspector to have full access to the undertaking. An administrative procedure called theorie de l apparence allows relatives of the operator, present on site at the moment of the inspection, to sign the inspection report on his/her behalf. Other national legislation and provisions are described in the relevant sections of this report. Conclusion French national provisions provide a clear legal framework for the implementation of organic production rules, with some of them differing from the requirements as laid down in the EU legislation, which may create confusion in application of the same provisions. In particular, the legal power granted to CBs to administer certain exceptions (see 5.2.6) is not in compliance with EU requirements. 5.2 ORGANISATION AND IMPLEMENTATION OF CONTROLS Competent Authorities and Control Bodies Legal Requirements Competent Authorities According to Article 27(1) of Regulation (EC) No 834/2007 MSs shall set up a system of controls and designate one or more CAs responsible for controls in respect of the obligations established by this Regulation in conformity with Regulation (EC) No 882/2004. Article 27(4) of this Regulation lays down, that CAs may confer its control competences to one or more other control authorities or delegate control competences under certain conditions to one or more CBs and shall designate authorities responsible for the approval and supervision of CBs. Article 4 of Regulation (EC) No 882/2004 requires the CAs to ensure that they have access to a sufficient number of suitably qualified and experienced staff; that appropriate and properly maintained facilities and equipment are available. Article 6 requires CAs to ensure that staff receive appropriate training and are kept up-to-date in their competencies. Article 4(6) of Regulation (EC) No 882/2004 requires CAs to carry out internal audits, or have external audits carried out, to ensure that the requirements of this Regulation are achieved. 4

10 Findings Different CCAs are in charge of controls over the production and distribution chain of organic products in France: the INAO (Institut national de l origine et de la qualité) is the public administration under the Ministry of Agriculture, Agri-food and Forests (MAAF) and is the main CA responsible for the compliance of operators with the rules laid down in Regulation (EC) No 834/2007 and its implementing regulations. Controls are not carried out by the INAO staff, but by inspectors of the CBs to which the INAO has delegated certain tasks (see ). The INAO is organised in central headquarters in Paris and in 8 Regional Units with 240 staff in total. Specific training in organic farming has been provided in 2010, 2011 and 2012 to technical assessors, based in the territorial units of the INAO, who are responsible for the supervision of CBs, with the aim of improving audit techniques. This training has also been provided to all staff (79 persons) involved in controls over the organic farming sector. Moreover additional training is planned in October 2013 for the staff in charge of the coordination of territorial units of the INAO. An Internal Audit Unit of the INAO has been created, and an audit over the procedures for auditing the CBs has been completed in 2010; another similar audit is part of the audit plan, but not scheduled yet; the DGCCRF is the central public administration under the Ministry of Economy and Finances. Organised in central headquarters in Paris, 22 Regional Directorates and in 96 Departemental Directorates (DDPP Direction départmentale de Protection des populations, or DDCSPP - Direction départmentale de la cohésion sociale et de la protection des populations), it may carry out labelling controls, traceability checks and laboratory analyses on organic products and operators, including those not submitted to the control system in accordance with provisions of Article 28(2) of Regulation (EC) No 834/2007. Its staff (part-time involved in organic farming) belong to the so-called Reseau Agrobiologie and has a dedicated web page on the intranet with the updated information concerning the legal requirements for organic farming, statistics and specific thematic files. Moreover, such staff participate in annual meetings (three days) in which new legislation and topics arising from previous inspections are discussed; the DGPAAT is the central public administration under the MAAF responsible for issuing import authorisations under provisions of Article 19 of Regulation (EC) No 1235/2008 and for ensuring surveillance over the INAO on behalf of the MAAF. It is also competent for granting derogations for the use of non-organic agricultural ingredients in processed organic products according to the provisions laid down in Article 29 of Regulation (EC) No 889/2008 and ensures the presence of French representatives at the Standing Committee on Organic Farming meetings; the DGGDDI (Direction générale des douanes et des droits indirects) is the central administration under both the Ministry of Economy and Finances and the Ministry of External Trade, organised at central headquarters in Paris, 12 Inter-regional Directorates, 42 Regional Directorates and 181 Customs Offices. Their staff are in charge of import controls (including completing box 17 of the inspection document accompanying all organic products imported in France) according to the provisions of Article 33 of Regulation (EC) No 834/2007. Bureau E2 in Paris issues Service Notes to inform staff when new import procedures come into force or when import conditions under the system of recognised TCs or of recognised CBs for the purpose of equivalence are modified; a specific web-page on the intranet is also available to inform staff about urgent issues. Other national organisations are involved in controls over organic farming: 5

11 Agence Bio (Agence française pour le développement et la promotion de l agriculture biologique) gathers representatives of the public administration and of the organic sector (including the Federation of Co-operatives - COOP de France, the National Federation of Organic Farming FNAB and the National Union of Organic Enterprises SYNABIO). It ensures the management of the mandatory notifications of activities by operators, as prescribed in Article 28 of Regulation (CE) No 834/2007. Moreover, it ensures the management of the national lists of organic operators on its website (see ). The GNIS (Groupement national interprofessionnel des semences et plants) gathers representatives of the sector of seed and plants and manages the seed database (see ). The ASP is responsible for payments of funds under the Common Agricultural Policy (CAP): the DDTM (Directions déepartementales des territoires et de la mer) are the decentralised offices of both the MAAF and the Ministry of Environment at Départément level, responsible for receiving applications for funds related to the CAP (including attestations of surfaces managed according to organic production rules) and for controls on eligibility of such applications. Conclusions There are clearly designated roles for controls of organic production, and staff of all relevant CAs have been trained and provided with sufficient guidance to carry out their duties. Internal audits have been carried out and planned by the INAO to ensure that the requirements of Article 4(6) of Regulation (EC) No 882/2004 are complied with. Legal Requirements Control Bodies: Accreditation, Approval, Supervision and Withdrawal The CA may delegate specific tasks related to controls to a particular CB only if the general conditions laid down in Article 5(2) of Regulation (EC) No 882/2004 are fulfilled. Article 27(5) to (7) of Regulation (EC) No 834/2007 lays down further conditions under which the CA can delegate controls tasks to CBs, the criteria that the CA has to take into account whilst approving CBs, the tasks that cannot be delegated. Article 27(5)(b) of Regulation (EC) No 834/2007 requires that there is proof that CBs have the expertise, equipment and infrastructure required to carry out the tasks delegated to it, have a sufficient number of suitably qualified and experienced staff; and are impartial and free from any conflict of interest as regards the exercise of the tasks delegated to them. Article 27(8) of Regulation (EC) No 834/2007 provides that, in accordance with Article 5(3) of Regulation (EC) No 882/2004, CAs delegating specific tasks to CBs shall organise audits or inspections of CBs as necessary. In addition, paragraph 9 of the same Article requires that the CA shall ensure that the controls carried out by the CB are objective and independent, verify the effectiveness of its controls, take cognisance of any irregularities or infringements found and corrective measures applied and withdraw approval of that CB where it fails to satisfy the requirements. Findings Eight CBs are currently approved by the INAO and accredited by the COFRAC (Comité Français d Accréditation) on the basis of NF EN norm. The Rural and Fishing Code (Code rural et de la pêche maritime) in its Article L642-3 stipulates 6

12 that CBs accredited and recognised can carry out controls on operators; Article L attributes to CBs controls and certification tasks, while Articles from R to R stipulates procedures for approval of CBs by the INAO. Directive INAO-DIR rev.2 describes the procedures to be followed for initial approval of CBs and its follow-up, as well as its withdrawal: the applicant CB must include several documents, including the list of sub-contractors (comprising analytical laboratories, which must be included in the list of laboratories designated by the INAO) and its control plan. INAO-CIRC states that as a consequence of the delegation of tasks, the CB must be accredited according to EN norm or ISO Guide 65; however, applications for approval by the INAO are currently accepted if they include a request to the COFRAC for acreditation. No deadlines have been set for achievement of accreditation by the COFRAC, with the result that CB1 visited by the FVO audit team was accredited 15 months after its approval by the INAO. The COFRAC procedures (document CERT REF 05) states that the decision for accreditation of a CB cannot be taken only on the basis of the desk evaluation of the CB's procedures; the applicant CB must already have certified operators in the sector for which it is seeking accreditation. The INAO representatives acknowledged this finding and stated that a draft Decree is in preparation to set a maximum timeframe of one year for obtaining accreditation after being approved by the INAO and will require that applications to the INAO must include an initial favourable evaluation of the application for accreditation (following a desk evaluation) issued by the COFRAC. The COFRAC does not transmit its report to the INAO, due to the confidentiality clause (4.4) and independence clause (4.3.1) of EN norm, and the INAO inspectors did not check the report when auditing CBs; thus, the INAO has no additional tools to target its controls over CBs. In the transition of accreditation from EN to ISO/IEC 2012:17065, the COFRAC has issued instructions explaining the contextual changes in product certification; all CBs visited by the FVO audit team were aware of the new procedures and that all accreditations granted on the basis of EN ISO Guide 65 have a validity up to 15 September The tasks to be delegated to CBs are clearly detailed in INAO-CIRC and include checks on operators' compliance with the EU and French provisions on organic farming; checks on compliance with rules on labelling and on import of organic products from third countries; notification of infringements and related imposed sanctions to non-compliant operators; issuing of documentary evidence and checks on compliance with regard to the use of «AB» (Agriculture Biologique - collective mark owned by the Ministry of Agriculture and used on voluntary basis) national organic mark on labelling of organic products. Other delegated tasks include derogations according to Article 22 of Regulation (EC) No 834/2007 and those granted as laid down in Articles 9(4), 18(1), 36(2), 36(3), 95(1) and 95(2) of Regulation (EC) No 889/2008 (see 5.2.6). As prescribed in Directive INAO-DIR , each CB must undergo a technical evaluation onsite every months (12 months if in their first 5 year approval cycle) by specialised staff of the territorial regional units of the INAO; this should include a visit to the CB s headquarters and one or more witness audits. However, the FVO audit team noted that only one witness audit per CB was performed as a routine. Verification of independence and impartiality of CB s staff is not included in the scope of such supervision, as the INAO considers that it is a relevant point of NF EN norm and is satisfactorily covered by a valid accreditation certificate. Training was provided to staff of the three CBs visited; however, in the case of CB1 it was not sufficient to bring the overall performance of staff evaluating organic operators to a satisfactory level. In the other two CBs more training at recruitment, tutoring, continuous training and annual verification led in general to more effective performance, with some weaknesses with regard to 7

13 recently recruited new staff when the tutorial period has been completed. Conclusions CBs are not always approved by the INAO in accordance with Article 5(2)(c) of Regulation (EC) No 882/2004 and Article 27(5)(c) of Regulation (EC) No 834/2007, as the CB may be approved prior to achieving accreditation according to ISO norm and accreditation may then be significantly delayed. The INAO and the COFRAC work independently in monitoring the effectiveness of CB controls, leading to a possible risk of the overall efficiency of the supervision being jeopardised. Moreover, the number of witness audits is insufficient for the verification of the effectiveness of controls carried out by the CBs. Although CBs have in general a sufficient number of suitably qualified and experienced staff, deficiencies in performance of newly recruited staff without appropriate tutoring were noted Controls on Organic Production Legal Requirements Registration of operators According to Article 28(1) of Council Regulation (EC) No 834/2007 any operator who produces, prepares, stores, or imports from a third country products in the meaning of Article 1(2) of the same Regulation or who places such products on the market shall, prior to placing on the market of any products as organic or in conversion to organic notify his activity to the competent authorities of the Member State where the activity is carried out and submit his undertaking to the control system referred to in Article 27 of the same Regulation. Article 28(2) of Regulation (EC) No 834/2007 provides that MSs may exempt from the application referred to in the same Article operators who sell products directly to the final consumer or user provided they do not produce, prepare, store other than in connection with the point of sale or import such products from a TC or have not contracted out such activities to a third party. Findings Agence Bio is the CA for management of notifications from organic operators and for their listing in a publicly available section of its website ( When requesting approval, operators are obliged to notify their proposed activities to the approving CB (on-line or by post) either before signing their contract with the CB or within 15 days from the date of signature; then, such notification needs to be validated on-line by the CB. Annual renewal of notification is not requested. However, renewal of notification is required when relevant changes in production occur, or when the undertaking changes ownership or CB. Change of activities made by the operator following his/her first notification does not require further on-line validation or control by the CB and, as a consequence, is not in compliance with the requirements of Articles 63 and 64 of Regulation (EC) No 889/2008. In case of withdrawal of an operator from the control system, a de-notification is made by the CB directly within the Agence Bio database. All notifications verified by the FVO audit team in the database were in line with the rules in force, with the exception of one producer who had modified the ownership of the undertaking before modifying his contract with the CB, thus supplying the wrong information to the database. France has made use of the provisions of Article 28(2) of Regulation (EC) No 834/2007 granting an exemption from the mandatory notification to operators storing organic products on the place of sale and selling to consumers or final users only pre-packaged products. 8

14 Adherence to the control system by organic operators implies that they are provided with documentary evidence according to the requirements laid down in Article 63 of Regulation (EC) No 889/2008. Directive INAO-DIR revision 3 prescribes that two types of documented evidence can be issued by a CB to an operator who has submitted his/her activity to the control system: Documentary evidence (document justificatif) as described in Annex XII of Regulation (EC) No 889/2008, granted to any organic operator in its second or third year of conversion, or in organic status. Models vary slightly among the CBs visited but always have the requested information. Attestation of conversion, granted to any operators in its first year of conversion, not allowing any sales of products with an organic reference, but not supplying all informations (and in the same model) as foreseen in the documentary evidence. This document is not in line with the requirements of Article 29(1) of Regulation (EC) No 834/2007, that prescribes that documentary evidence must be issued to any operator subjected to controls by a CB and complying with the production rules foreseen for his/her activities, nor with those of Article 68 of Regulation (EC) No 889/2008, which prescribes the use of the model set in Annex XII. Only one of the CBs visited publishes the documentary evidence of operators on its website; however, the attestations of conversion issued by the same CB are not. The missing publication of the documentary evidences of all organic operators in France is not in line with the requirements of Article 92(a) of Regulation (EC) No 889/2008; the FVO audit team was informed by the CCAs that discussions are still on-going with regard to the way CBs should provide such information (scanned copy of the documentary evidence, or data to be used to recreate the document in the database). In addition, not all CBs have so far been able to provide the requested data in real time. Directive INAO-DIR (revision 3, last modified in December 2012) exempts from the control system any operator re-selling to final consumers organic products in bulk, even prepared, under the condition that no storage occurs outside the point of sale and that the maximum amount of purchases of such an operator is less than euro per year; this is not in compliance with the requirements of Article 28.2 of Regulation (EC) No 834/2007. These operators, however, are not exempt from the obligation to register themselves with Agence Bio. Conclusions There is no published documentary evidence issued to operators, contrary to the requirements of Article 92(b) of Regulation (EC) No 889/2008, which does not facilitate those receiving product along the supply chain, and for those involved in controls as well as consumers, to verify readily that suppliers and products have been appropriately certified. Moreover, the fact that operators can modify their data without being validated by their CB could make the database managed by the Agence Bio not fully reliable. The database managed by the Agence Bio may not be fully reliable as the operators can modify their data without it being validated by their CB. Some points of sale are exempted from the control system, which is not in compliance with the requirements of Article 28 of Regulation (EC) No 834/

15 5.2.3 Planning and Prioritisation of Controls Legal Requirements Article 41 of Regulation (EC) No 882/2004 requires MSs to prepare a single integrated MANCP. Article 3 of Regulation (EC) No 882/2004 requires that official controls are carried out regularly, on a risk basis and with appropriate frequency, taking account of (a) identified risks; (b) the food business operators (FBO) past record with regard to compliance; (c) the reliability of any self checks that have already been carried out; and (d) any information that might indicate noncompliance. In addition, Article 27(3) of Regulation (EC) No 834/2007 requires that the nature and frequency of the controls shall be determined on the basis of an assessment of the risk of occurrence of irregularities and infringements as regards compliance with the requirements laid down in this Regulation and that all operators, with some exceptions, shall be subject to verification of compliance at least once a year. According to Article 65(4) of Commission Regulation (EC) No 889/2008 control authorities or CBs shall carry out, in addition to the annual physical inspections referred to in paragraph 1 of the same Article random control visits, primarily unannounced, based on the general evaluation of the risk of non-compliance with organic production rules, taking into account at least the results of previous controls, the quantity of products concerned and the risk for exchange of products. Findings Planning, prioritisation and implementation of controls over organic operators are some of the tasks that, according to Circular INAO-CIRC , have been delegated to the CBs, which are asked to present their control plans to the INAO for formal approval at the start of their activities and also when further changes are made in the plans. Control plans include provisions for annual and additional visits, risk-criteria for categorisation of operators, sampling and analyses, irregularities/infringements and related sanctions that the CB intend to apply. To help the CBs in drafting their control plans, the INAO has issued the Directive INAO-DIR (revision 3 modified in December 2012) setting minimum inspection frequencies to be complied with in relation to the potential risk of certain categories of operators; in addition to the annual inspection, for instance, the following categories must undergo compulsory additional visits: primary producers: 50% of the total number of operators, and a physical check on each group of poultry when the producer rears and finishes several cycles per year; processors (including feedingstuffs units): 100% of the total number of operators; wholesalers: one storage site/year/operator; retailers: 50% of the total number of operators. The Directive also defines the criteria for risk-based sampling plans and for analyses. Risk evaluation was carried out by all CBs visited, with two classes (risk no risk), making it very difficult for operators to get into the risky class (due to the high level of points needed). Moreover, operators with recurring infringements/high numbers of NCs do not necessarily get into the risk category, but they can get additional controls at their own expense. The FVO audit team noted that the risk analysis for operators and the prescribed frequencies were complied with by all CBs visited; however, CB3 had not carried out the annual inspection on 62 10

16 organic operators in 2011 (0.28% of the total) and on 19 operators in 2012 (0.08% of the total), due to exceptional circumstances (e.g. operators not available because hospitalised or travelling abroad, etc.). This CB was granted a derogation by the INAO according to the requirements of Directive INAO-DIR-CAC (now replaced by the INAO-DIR-CAC-1 of July 2013) : this derogation was limited in time and all such annual inspections were carried out within the first quarter of the following year, with the issuing of a temporary documented evidence with three months validity. However, this is not in line with the requirements of Article 65 of Regulation (EC) No 889/2008. Although Article 65 of Regulation (EC) No 889/2008 prescribes that random control visits should be primarily unannounced, none of the CBs visited was able to give the total number or the percentage of such unannounced inspections, and this has not been noted by the CCA during its audits; however, one CB is going to amend its database to get such information in The FVO audit team noted that in general no specific visits were carried out following the detection of non-compliances; there was only a desk evaluation of corrective measures proposed by the operators, while the follow-up on-the-spot was delayed until the next planned annual or additional visit. The DGCCRF is implementing several annual Control Plans targeting or comprising the organic farming sector, called National Tasks ( Tâches Nationales ), of which one is the annual control plan on organic farming. In 2012 this Plan was implemented controlling operators and premises, in which 480 non-conformities have been detected. The infringements to the rules on organic farming (e.g. operators not certified, incorrect labelling of products, use of products not allowed, etc.) represented 41.2% of such non-conformities. In addition, 229 samples have been taken within the Plan, with 26 non-conformities for pesticides and 2 for GMOs (11.35%). Another National Task implemented by the DGCCRF is a specific surveillance programme for pesticides (see 5.2.4). Specific instructions and information to the staff of the DGCCRF with regard to the 2013 Annual control plan on organic farming have been issued and diffused. The MANCP for includes controls on organic production, defining the INAO and the DGCCRF as CCAs, as well as the organisation and management of official controls by both CCAs. The Report of the MANCP for 2011 stated that official controls carried out on organic products under the responsibility of the INAO (and delegated to 9 CBs) accounted for a total of (of which were unannounced). The ASP is responsible for payments of funds under the environmental schemes of agriculture: the DDTM are the decentralised offices of both the MAAF and the Ministry of the Environment and are in charge of controls over applications by operators, and of the reception of attestations of surfaces managed according to organic production rules. According to the ASP website, files have undergone desk evaluation and/or on-site controls in 2012 with the purpose of verifying their eligibility; however, results of these evaluations have not been brought to the attention of the other CCAs and/or CBs. Conclusions As required by the EU provisions, the MANCP and annual reports contain sufficient information on the control system for organic production which has been delegated to the CBs. In addition, the DGCCRF has implemented effective surveillance and control plans. Results of controls carried out by the ASP, however, were not shared among the other CCAs, and were thus not available to target their controls. CBs had developed their own risk based prioritisation in accordance with CCA guidelines, but were unable to indicate how many controls were unannounced ; therefore, no evidence was provided 11

17 that provisions of Article 65(4) of Regulation (EC) No 889/2008 were complied with. Contrary to the requirements of Article 65 of Regulation (EC) No 889/2008, not all operators undergo a physical inspection once a year. Legal Requirements Controls of operators Specific rules on production, processing, packaging, transport and storage of products are laid down under Title II of Regulation (EC) No 889/2008. Title IV of Regulation (EC) No 889/2008 provides, in accordance with Article 27 of Council Regulation (EC) No 834/2007 for general minimum control requirements as well as for specific control requirements for plants and plant products, livestock and livestock products, preparation of products, imports, units using contracts to third parties, units preparing feed. According to Article 65 of Commission Regulation (EC) No 889/2008 CBs shall carry out at least one physical inspection per year of all operators. Moreover, the control authority or control body shall carry out random control visits, primarily unannounced. Findings Such controls are based on a control plan drafted by the CB, which includes labelling controls, traceability checks and sampling and laboratory analyses. During the visits, CB inspectors carried out controls at a selection of different operators and the FVO audit team witnessed that: during the audit to a vegetable producer, where the CB1 has previously not noticed any non-conformity, the full description of the unit was not up-to-date and did not include storage and nursery facilities, while there were no records on plant production (fertilisation, treatments with Plant Protection Products - PPPs) since the producer was certified in 2012; during the audits to a supermarket specialised in organic food and to a processing unit for fruits and vegetables, vegetables were found in unlabelled boxes and their link with the invoice could not be established; the FBOs had not established written procedures to deal with this kind of non-conformity and no proof of corrective action could be demonstrated. In the processing unit a well documented mass balance was done by the CB1 auditors, showing 230 jars in excess with a consequent request for clarification to the FBO; at an aquaculture producer, the introduction of conventional juveniles following the absence of the same species in organic form was already noted as a non-conformity in August 2012; the same producer had a history of stocking densities above legal limits, and this was again noted by the CB2 auditor. Moreover, the FVO audit team checked the feedingstuffs used and investigated the ingredients which should have been obtained from sustainable fishing for human consumption, as required by Article 25(k)(c) of Regulation (EC) No 889/2008; documents provided by the feedingstuff producer (which was controlled by the same CB2) made reference to the IFFO standard, which regulates the catch of fish for the specific purpose of manufacturing fishmeal and fishoil. In addition, one of the feedingstuffs contained krill meal, for which no specification was received; at a slaughterhouse visited with annexed cutting facilities the continuous use of labels not bearing the EU logo and CB code was not spotted by the CB3 inspector. This FBO had 12

18 slaughter and cutting activities on site, along with production of meat products in another site; however, a mass balance check was not performed; during the visit to a beekeeper, an invoice concerning inputs (apples used to manufacture jam with honey) did not indicated that the fruits were organic; the check of the supplier documented evidence showed that operator was also producing apples on parcels of land currently in conversion. Moreover, several jars of final products were stored at the premises without any labelling. All these non-conformities had not been identified by the CB3 inspector; at a farm raising sheep and goats for meat and cheese production, the operator had systematic and recurrent annual records of use of milk powder used for feeding kids; it was explained to the FVO audit team that the operator wanted to keep all organic milk produced for manufacturing organic cheese, and that the only action taken by the CB3 in this regard was to disqualify the kid goats (whose meat was sold as conventional) and to impose a six months conversion period on the replacement young females. During the audit the CB3 identified several other non-compliances (not spotted by his colleague who was in charge of the previous annual check) such as an absence of records of individual treatments administered to animals since 2007 and some unlabelled ingredients (salt and pepper). The mass balance exercise carried out during the visit over the cheese production gave unreliable results. Conclusion The CBs' inspections have resulted in not always effective controls of operators to ensure compliance with EU standards and requirements Sampling and analysis Legal Requirements According to Article 65(2) of Commission Regulation (EC) No 889/2008 the control authorities or CBs may take samples. Samples shall be taken and analysed where the use of products not authorised for organic production is suspected. In relation to feed mills, Art 88(3) of Regulation (EC) No 889/2008 requires the control authority or control body to carry out a general evaluation of the risks attendant on each preparation unit and to draw up a control plan. This control plan shall provide for a minimum number of random samples depending on the potential risks. Laboratories used in the context of official controls should meet the requirements laid down in Article 12 of Regulation (EC) No 882/2004 or in Article 5(2) of the same Regulation in case official controls have been delegated to CBs. Findings The sampling and analyses plan is included in the control plan drafted by each CB; the plan is based on risk evaluation carried out annually by all CBs, following the risk criteria established in Directive INAO-DIR revision 3. In addition, CB's inspectors can carry out sampling in case of suspicion. Subcontracted Analytical laboratories are all accredited and designated by the INAO; in a very limited number of cases, analytical methods might not be accredited, or accredited for other matrix 13

19 (e.g. Glyphosate in sunflower seeds), when the number of analyses to be performed is so low that accreditation of the method for the given matrix could result in an unacceptable cost for the laboratory. There are no national guidelines on interpretation of analytical results for residues of pesticides and contaminants, resulting in different reactions by the CBs visited: one CB had set a limit of 0,01ppm/10ppb, above which an investigation on the causes of the contamination is mandatory. The declassification of the batch of product involved is currently automatic, but following the amendment of the control plan notified to the INAO in July 2013 this will no longer be the case; another CB considered the residues between Level of Detection and Level of Quantification, which includes the calculation of analytical uncertainty as the limit to start an investigation following which, if the responsibility of the operator is ascertained, sanctions are applied and the INAO is notified. In case of detection of residues above the Level of Quantification, the non-conformity is considered as affecting the organic status of the products and the application of sanctions is mandatory. The DGCCRF is implementing a surveillance programme for pesticides, in accordance with the requirements of Regulation (EC) No 1274/2011: this programme includes a small amount of organic products, and 57 samples have been collected from organic products in 2012, among which one positive result for pesticide was detected. Another sample was tested positive for Pyperonyl butoxyde, a substance added to natural pyrethroids to improve their activity as insecticides in cereals and for which no Maximum Residue Limit (MRL) has been set in EU legislation; however, France has defined for organic cereals the same MRL (10 mg/kg) as for conventional products. Conclusions Sampling has been carried out in compliance with the control plans drafted by the CBs, and also following suspicions detected on-the-spot by inspectors. Analyses are carried out in laboratories accredited and approved by the CCA. However, differences in interpretation of analytical results for residues of pesticides and contaminants were noted between the CBs visited, and limits set by certain CBs, above which an investigation on the causes of the contamination is mandatory, are not in line with the EU organic legislation currently in force. France has defined for some organic products cereals the same MRL as for conventional products with regard to certain contaminants, which is not in line with the EU organic legislation currently in force Controls on Labelling and Traceability Legal Requirements Article 23 of Regulation (EC) No 834/2007 provides for the use of terms referring to organic production and according to paragraph 5 of the same Article, MSs shall take the necessary measures to ensure compliance with this Article. Compulsory indications concerning the use of the terms as referred to in Article 23(1) of Regulation (EC) No 834/2007 are laid down in Article 24 of the same Regulation. Article 27(13) of Council Regulation (EC) No 834/2007 provides that MSs shall ensure that the control system as set up allows for the traceability of each product at all stages of production, preparation and distribution in accordance with Article 18 of Regulation (EC) No 178/