EUROPEAN COMMISSION DIRECTORATE-GENERAL FOR HEALTH AND FOOD SAFETY

Transcription

1 Ref. Ares(2016) /09/2016 EUROPEAN COMMISSION DIRECTORATE-GENERAL FOR HEALTH AND FOOD SAFETY Health and food audits and analysis DG(SANTE) MR FINAL REPORT OF AN AUDIT CARRIED OUT IN SWEDEN FROM 14 TO 25 SEPTEMBER 2015 IN ORDER TO EVALUATE THE CONTROLS SYSTEMS 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 in Sweden, carried out between 14 and 25 September 2015, under the provisions of Regulation (EC) No 882/2004 on official food and feed controls. The objective of the audit was to evaluate the controls on organic production and labelling of organic products. Overall, the system of official controls for organic production is largely effective, with clear responsibilities and communication between competent authorities and control bodies (CBs), good management of the seed database and a largely effective import control system. However, there are certain weaknesses which need to be addressed, and, in some cases, these were already in hand. These weaknesses mainly pertain to the planning and the delivery of controls by the CBs, and, in particular, concern additional and unannounced inspections and sampling, and the identification by operators of critical steps in order to put into place relevant precautionary measures. Moreover, the lack of a national catalogue of sanctions hampers the consistency and the effectiveness of the measures the CBs have to take in case of irregularities, although this was expected to be resolved by the end of Finally, the measures to ensure product traceability are generally effective, although this needs to be strengthened by making publicly available the list of operators, and by improving the feedback on the checks carried out by the municipalities on retailers. The report makes a number of recommendations to the Swedish competent authorities, aimed at rectifying the shortcomings identified and enhancing the implementation of control measures. I

3 Table of Contents 1 Introduction Objectives and scope Legal Basis Background and Conclusions Relevant National Legislation and Provisions Organisation and implementation of controls Competent Authorities, Control Authorities and Control Bodies Control Bodies: Approval, Supervision and Withdrawal Registration of operators Planning and Prioritisation of Controls Controls of operators Controls on Labelling and Traceability Sampling and laboratory analysis Exceptional production rules and other derogations Imports of Products from Organic Production Measures in cases of irregularities and infringements Seed Database Overall Conclusions Closing Meeting Recommendations...14 II

4 ABBREVIATIONS AND DEFINITIONS USED IN THIS REPORT Abbreviation CA(s) CB(s) CtrlA(s) EA EU MANCP MS(s) MUN(s) NFA SBA Swedac Explanation Competent Authority(ies) Control Body(ies) Control Authority(ies) European co-operation for Accreditation European Union Multi Annual National Control Plan Member State(s) Municipality(ies) National Food Agency Swedish Board of Agriculture Swedish Board of Accreditation and Conformity Assessment III

5 1 INTRODUCTION This audit took place in Sweden from 14 to 25 September It formed part of DG Health and Food Safety s planned programme. The team comprised two auditors from DG Health and Food Safety and a national expert from a Member State (MS). Representatives from the Competent Authorities (CAs) accompanied the audit team for the duration of the audit. An opening meeting was held on 14 September 2015 with the CAs and representatives from one Control Body (CB). At this meeting, the objectives of, and itinerary for, the audit were confirmed by the audit team and the control systems were described by the authorities. The report makes a number of recommendations to the CAs, aimed at rectifying the shortcomings identified and enhancing the implementation of control measures. 2 OBJECTIVES AND SCOPE The objective of the audit was 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 under Regulation (EC) No 834/2007 concerning: All stages of production, preparation and distribution of organic products, including controls at import and The use of indications referring to organic production in labelling and advertising. In pursuit of these objectives, the following sites were visited: Visits/Meetings No Comments Competent authorities Central 4 Opening, pre-final and final meetings. Meeting with Swedish Board of Accreditation and Conformity Assessment (Swedac) Local 1 Meeting with one Municipality (MUN) Control Bodies 2 Office audits of two of the main CBs in Sweden On-Site-Visits (witness visits) CB1 operators 3 Two large-scale food processors running conventional and organic production in parallel (one of which is an importer of organic products) and one farm with animals CB2 operators 2 One large-scale food processor and one farm with parallel conventional and organic crop production In terms of scope, the audit assessed the performance of the CAs, as well as the organisation of the controls carried out by CBs and Control Authorities (CtrlAs) including import controls, controls of operators producing, preparing and distributing organic products, and controls on the labelling and marketing of organic products. The audit also addressed verification procedures and audits. 1

6 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. Full legal references are provided in the Annex. Legal acts quoted in this report refer, where applicable, to the last amended version. 4 BACKGROUND Based on a Memorandum of Understanding (MoU) between DG SANTE and DG AGRI, a series of audits on organic production and labelling of organic products in MSs was initiated. Member States are selected for these audits based on priorities determined by DG AGRI. 5 FINDINGS AND CONCLUSIONS 5.1 RELEVANT NATIONAL LEGISLATION AND PROVISIONS Legal requirements Article 291 of the Treaty on the functioning of the EU. Article 35 of Commission Regulation (EC) No. 889/ A number of legal acts have been adopted in Sweden to facilitate the implementation of the requirements laid down by the EU organic legislation and to regulate a number of derogations (see section 5.2.8). The main ones are the Law on Control of Organic Production [Lag (2013:363) om kontroll av ekologisk produktion] and the Government Ordinance on Control of Organic Production [Förordning (2013:1059) om kontroll av ekologisk produktion]. In addition, the Federation of Swedish Farmers has developed national guidelines for organic production aimed at making the EU's rules more userfriendly and ensuring these rules are applied uniformly. The Swedish Board of Agriculture (SBA) and the National Food Agency (NFA) ensure that these guidelines are aligned to the EU legal framework. 2. According to these two legal acts, which entered into force on 1 January 2014, the CAs in charge of official controls on the requirements of the EU organic legislation are the following: the SBA as regards primary production and feed, the NFA as regards food and the Swedish Board of Accreditation and Conformity Assessment (Swedac) for the supervision of the CBs, although the NFA and SBA are also partly involved in supervisory activities (see finding 5). On the basis of the information provided by the CAs, Swedac is a government authority. However, the audit team noted that the indication of Swedac as CA had not been notified to the European Commission, contrary to the requirement laid down by Article 35 of Regulation (EC) No 889/2009, although the name of Swedac as CA was notified after the audit. 3. According to a representative of the Ministry of Enterprise, an amendment of the Law 2013:363 is necessary to facilitate the implementation of the provision to make the lists of organic operators publicly available, as laid down by Article 92f of Regulation (EC) No 889/2008. This provision is expected to enter into force by the end of 2015 (see finding 19). 2

7 Conclusion on the relevant national legislation and provisions 4. The measures of national law necessary to implement legally binding Union acts relevant to this audit have been largely adopted in Sweden. A new provision, expected to enter into force by the end of 2015, will facilitate the full implementation of the requirement regarding the obligation for MSs to make publicly available the lists of organic operators (see conclusion 21). 5.2 ORGANISATION AND IMPLEMENTATION OF CONTROLS Competent Authorities, Control Authorities and Control Bodies Articles 27(1), 27(4) and 27(14) of Regulation (EC) No 834/2007. Article 92 of Commission Regulation (EC) No 889/2008. Articles 4 and 6 of Regulation (EC) No 882/ The Law 2013:363 on Control of organic production together with the Government Ordinance 2013:1059 on control of organic production designate and clarify relevant responsibilities of CAs, control authorities (CtrlAs) and CBs for the organisation of official controls on the requirements of the organic legislation. In summary, controls of operators have been delegated by the SBA and NFA to six CBs. Until the first semester of 2015, the supervision of these CBs had been carried out by Swedac but, from November 2015 onwards, the SBA and NFA will start to carry out further supervision activities on the CBs, in addition to Swedac (see finding 12). 6. The NFA and the SBA have availed of the derogation to exclude certain operators selling products directly to the final consumer from the obligation to submit their undertaking to the control system as provided for in Article 28(2) of Regulation (EC) No 834/2007. According to the national legislation, the MUNs are the CtrlAs which have been conferred the controls to verify whether the conditions for such an exclusion are met. To facilitate these checks, the NFA has included various clarifications in the relevant guidelines for official controls at retail level. According to the national legislation, if a MUN does not fulfil its task in this regard, the NFA may order the MUN to rectify the situation. 7. A number of arrangements have been put in place to facilitate the communication between and within CAs, CtrlAs and CBs. The audit team saw several minutes of biannual meetings between the CAs (including Customs) and the CBs aimed at improving and harmonising official controls in the organic sector. Moreover, the NFA has recently launched an electronic platform to facilitate the communication with other CAs, CtrlAs and CBs. However, it was observed that the NFA does not have sufficient information on whether and how the MUNs implement controls to verify the conditions for exclusion of certain retailers from the obligation to be subject to controls by the CBs, because, as stated by representatives from the NFA, these types of checks are not reported by the MUNs in their annual reports to the NFA. This is not in line with Article 92(5) of Regulation (EC) No 889/2008 as far as the exchange of information between CtrlAs and CAs is concerned. 3

8 8. Official controls on organic products from non-eu Countries have been conferred to Swedish Customs which, on the basis of the information gathered during the audit (see finding 45), offers adequate guarantees of objectivity and impartiality and has qualified and sufficient staff to carry out relevant checks, as required by Article 27(4)(a) of Regulation (EC) No 834/2007. Conclusion on the competent authorities, control authorities and control bodies 9. The control system in place clearly assigns tasks and responsibilities to the actors involved. However, its effectiveness is partly undermined by poor communication between the MUNs and central level on the implementation of the necessary checks to verify the condition for the exemption of certain retailers from official controls Control Bodies: Approval, Supervision and Withdrawal Article 27(5) to (9) and Article 27(14) of Regulation (EC) No 834/2007. Article 5(2) and 5(3) of Regulation (EC) No 882/2004. Articles 92c and 92e of Commission Regulation (EC) No 889/ The national legislation on organic production indicates the SBA and the NFA as the CAs in charge of the delegation of official controls to the CBs. This legislation stipulates that delegation can be granted once the conditions laid down by Article 27(5) to (7) of Regulation (EC) No 834/2007 are met and can be withdrawn when these conditions are no longer met. From the information provided by the CAs, four out of the six delegated CBs, representing about 98% of the total number of operators in Sweden (1), had been delegated independently by the NFA and the SBA. The remaining two CBs had been delegated only by the NFA. However, the audit team noted that, although the SBA has a written procedure for the verification of the conditions for such a delegation, this is not yet the case for the NFA. Therefore, these arrangements are not yet fully in line with Article 92c(4) of Regulation (EC) No 889/ Swedac is the main CA responsible for the approval and supervision of CBs (2). All CBs active in Sweden have been approved by Swedac. According to the national legislation, this approval is valid as long as the result of the annual supervision does not indicate a major failure of the CB. In such circumstances, to be evaluated on a case-by-case basis, the approval can be withdrawn. The audit team noted that no withdrawal of approvals has taken place, so far. 12. Until 2014, Swedac carried out the supervision in the context of their accreditation surveillance and this included an office assessment every 16 months and at least one witness assessment for each CB and each product category in a four year cycle. From 2015 onwards, an extra office assessment has been planned for each CB within the accreditation cycle. The audit team reviewed the planning of Swedac for the next three (1) According to the information included in the Annual Report for 2014, about 6,400 operators were in operation at the end of 2014 in Sweden. (2) In their response to the draft report, the competent authorities added that Swedac verifies that the requirements for approval are met by the CBs. 4

9 years and noted that the annual inspections of CBs had been planned in line with Article 92e of Regulation (EC) No 889/ From the information gathered by the audit team, Swedac has procedures in place and sufficient and qualified staff to carry out the surveillance of the CBs in line with the guidelines for accreditation bodies, the European co-operation for Accreditation (EA) Policy (EA-3/12 M: Comprehensive checklists are also used by Swedac during their supervisory activities to verify relevant requirements of the organic legislation. However, it was noted that certain requirements of the organic legislation were overlooked, notably, the provisions related to the number of additional and unannounced inspections, as laid down by Article 92c of Regulation (EC) No 889/2008, and the provision related to the number of annual samples as laid down by Article 65(2) of the same Regulation (see finding 37). 14. In accordance with the national legislation, from January 2014, Swedac submits information to the NFA and SBA about the results of their supervision. Moreover, on the basis of the information provided by the CAs, from November 2015 the NFA and SBA will perform audits at the three largest CBs operating in Sweden, in addition to the supervision performed by Swedac. Conclusion on Control Bodies: approval, supervision and withdrawal 15. In general, despite the lack of written procedures, there is an effective system for the approval of CBs, the delegation of controls on organic production to the CBs, and for their supervision. However, some requirements in force from January 2014, namely the requirements for additional, unannounced visits and the number of annual samples to be taken by the CBs, had been overlooked during the supervisory activities in 2014 and, partly, in The plan of the SBA and NFA to be more actively involved in such activities should strengthen the supervision process Registration of operators Articles 28(1), 28(2) and 28(5) of Council Regulation (EC) No 834/2007. Article 92b of Commission Regulation (EC) No 889/2008. Article 63(2) of Regulation (EC) No 889/ The audit team noted that the delegation decisions issued by the CAs require the CBs to ensure that operators (wishing to produce, prepare, store or import organic products or placing on the market such products) notify their activity to them. In both the CBs visited, the audit team noted that this was clearly described in their websites. However, it was noted that, although an amendment of the legislation is in the pipeline, the current legislation does not include the obligation of these operators to notify their activities to the CAs. This is not in line with Article 28(1) of Regulation (EC) No 834/ In both the CBs visited, the application process can be summarised as follows: an operator starts the process by entering various information through the CB's website. The contract is then issued and a control is scheduled to check whether the relevant conditions of the organic legislation are fulfilled by the operator. If the outcome of the control is 5

10 overall positive, the operator is given the documentary evidence and is officially registered and included in the CB's list of registered operators. 18. According to representatives from both the CBs visited, during the first control, the inspector is requested to check, among other things, the appropriateness of the relevant precautionary measures put in place by the operator and the outcome of this evaluation is indicated in the report which is left with the operator. However, the audit team noted that CB1 does not require the operator to sign the declaration containing the operator's commitment to follow the applicable provisions of the organic legislation, the description of its activities and the relevant precautionary measures, contrary to the provisions laid down by Article 63(2) of Regulation (EC) No 889/ According to the information provided by the CAs, no lists of operators are publicly available yet. The audit team noted that every CB has its own list of operators but such lists are not accessible to the public. This is not in line with Article 92b of Regulation (EC) No 889/2008. An amendment of the national organic legislation is in the pipeline in order to facilitate the publication of these lists. According to the information provided by the CAs, its publication is expected by the end of In one MUN visited by the audit team, it was observed that during routine food hygiene controls, certain checks include the verification on whether retailers selling organic products are either certified by a delegated CB or meet the relevant conditions for their exclusion from the control system. However, a recent survey carried out by the NFA in seven MUNs (out of a total of 290 MUNs in Sweden) indicates that these checks are generally not carried out. The NFA stated they do not have an accurate picture of the situation in the other MUNs (see finding 7). Moreover, during the traceability exercise of two products taken by the audit team from a retailer, it was noted that a wholesaler supplying organic products was not registered as required by Article 28(1) of Regulation (EC) No 834/2007 (see finding 34). Conclusion on the registration of operators 21. There is a system which is partly effective in ensuring that operators which produce, prepare, store or import organic products or who place on the market such products are registered and subject to controls. In particular, operators are neither yet obliged to notify their activity to the CAs, nor are included in a publicly available list and this might hamper the traceability of the organic products. Moreover, the operators' commitment to follow the applicable provisions of the organic legislation and the information concerning the description of their activities and the relevant precautionary measures, are not consistently required by the CBs when the operators are first included in the system. This might impact the overall effectiveness of official controls (see conclusion 31). 6

11 5.2.4 Planning and Prioritisation of Controls Article 27(3) of Regulation (EC) No 834/2007. Articles 65(4), 92c(2) and 92f of Commission Regulation (EC) No 889/2008. Articles 3 of Regulation (EC) No 882/2004 Article 41 of Regulation (EC) No 882/ The Multi-Annual National Control Plan (MANCP) and the annual reports for 2013 and 2014 submitted by the CAs include sections with data and information on the organic control system as required by Article 92f of Regulation (EC) No 889/2008. Nonetheless, the audit team noted several discrepancies between the data regarding the number of operators and the number of additional visits contained in the annual report for 2014 and the same data, referring to the same year, provided by the CAs in preparation of the audit. These discrepancies were explained during the course of the audit where the overall accuracy of those included in the annual report for 2014 was confirmed with the exception of the missing data referring to a CB approved in 2014 (with 11 operators). 23. Both CBs visited have procedures to classify operators on a risk basis and several riskfactors are generally taken into account. These include the types of activity, the size/volume of production, previous non-compliances and additional factors (e.g. parallel production, subcontractors, etc.), as laid down by Article 65(4) of Regulation (EC) No 889/2008. It was noted that all operators reviewed by the audit team were risk-classified according to such procedures and that such classification is taken into account for the planning and the delivery of controls. This is largely in line with Article 3 of Regulation (EC) No 882/2004 and Article 27(3) of Regulation (EC) No 834/ Both CBs visited have put in place procedures/mechanisms to ensure that, annually, at least 10% of additional visits are carried out and that at least 10% of the total visits are unannounced. These additional and unannounced visits are generally carried out on those operators with the highest risk. This is in line with Article 92c(2) of Regulation (EC) No 889/2008, although the audit team noted that these measures were only introduced from 2015 and in 2014 both the CBs visited did not meet the relevant requirements. 25. Representatives of the CBs visited stated that the aforementioned unannounced visits are in general carried out without prior warning to the operator, although, in both cases, a prior notification of not more than 24 hours is allowed in case of particular circumstances. In this regard, the CAs have slightly different positions: according to representatives from the NFA and Swedac, no exceptions are allowed for the unannounced visit; on the other hand, the SBA s position allows a prior notification (of not more than 24 hours) when this notification could not jeopardise the possible outcome of the control. The audit team noted that this is not fully in line with Article 92c of Regulation (EC) No 889/2008 which requires that at least 10% of all visits to be carried out unannounced. Moreover, no information about the number of these unannounced visits with prior notification is available to the CAs. 7

12 Conclusion on the planning and prioritisation of controls 26. The measures put in place by the CBs for the planning and the prioritisation of controls are, in general, effective, although the new requirements related to the additional and unannounced visits, in force from January 2014, have been implemented by the CBs with a delay and they do not always carry out unannounced visits as required Controls of operators Titles II and III of Regulation (EC) No 834/2007. Titles II and IV and Article 65(1) and 65(3) of Regulation (EC) No 889/2008. Articles 8 and 9 of Regulation (EC) No 882/ Both CBs visited have procedures and checklists to carry out controls. During the visits to operators, and by reviewing a number of operators files at the CBs' headquarters, the audit team noted that relevant checklists containing all applicable requirements are routinely used and a report of the visit with an embedded irregularity report is always left with the operator who also has to countersign it. This is in line with Articles 8 and 9 of Regulation (EC) No 882/2004 and Article 65(3) of Regulation (EC) No 889/ During the visits to the operators, the audit team noted that, in general, these were carried out in a comprehensive manner. The inspectors were experienced and during their checks generally required to see the original documentation kept by the operator (e.g. delivery notes of products supplied, production logs, invoices of products sold, etc.) and they included a visual inspection of premises, animals and crops. Inspectors also checked lists of suppliers and the products supplied, lists of final products and the way the previous non-compliances had been addressed. Traceability exercises were also routinely carried out by taking a few products on a random basis and by verifying whether the raw materials came from organic suppliers. 29. In the farms visited, the audit team noted that the inspectors performed mass balance exercises comparing the feed and the number of animals, or the quantity of seed and the volume of production. To some extent this calculation was also performed in the food processors visited, although this was, in most cases, rather limited as it was not performed for those products more at risk (e.g. organic products resembling conventional ones, processed in the same establishment). 30. The audit team noted that the operators visited were largely in line with the relevant organic production rules. In a number of cases the inspectors of the CBs rightly identified a number of non-compliances (e.g. expired certificates of suppliers and the lack of notification to the CB of the conventional production, in the case of the farm). However, the audit team noted that the food processors visited, certified by CB1, were not required to document a risk analysis indicating the critical steps for the production of organic food and relevant precautionary measures (see finding 18). This is not in line with Article 26(2) of Regulation (EC) No 889/

13 Conclusion on the controls of operators 31. The CBs have set up broadly adequate systems to ensure effective controls of operators. However, the provision for food and feed processors to carry out a risk analysis to identify the critical steps and relevant precautionary measures for the production of organic food/feed is not regularly required by the CBs. This may affect the overall performance of the controls since additional efforts are required for the CBs to identify the areas which require more attention during their controls Controls on Labelling and Traceability Articles 23, 24 and 27(13) of Regulation (EC) No 834/2007. Title III of Commission Regulation (EC) No 889/ According to the information provided by the CBs visited, the label of the products is usually verified when the operators initially enter the control system since it is quite common for the operator to seek indications/guidance, in this regard, from the CB. During the planned controls witnessed by the audit team, it was noted that inspectors always check the list of products and ask for details of any changes that have taken place since the previous visit. During the course of the audit, the audit team did not note any anomalies in the labels of the products seen. 33. During the visits to operators of both CBs, the audit team noted that, although no regular traceability exercises for organic products throughout the whole chain are carried out by the CBs or by the CAs, inspectors of the CBs regularly carry out a comprehensive traceability exercise to verify the conditions laid down by Article 18 of Regulation (EC) No 178/2002 (see finding 28). Moreover, at the request of the audit team, the NFA carried out a traceability exercise on two food processed products randomly taken from a big retailer (certified as an organic operator). It was noted that the CA was able to trace back the ingredients selected by the audit team to the producers. Overall, this is in line with the requirement laid down by Article 27(13) of Regulation (EC) No 834/ During the process of obtaining the necessary documentation from the various operators along the chain, the NFA noted that a wholesaler was not certified as an organic operator. The audit team was informed that immediate actions were being taken against this operator by the NFA. Conclusion on the controls on labelling and traceability 35. Labelling and traceability checks are regularly performed by the CBs during their controls, although the traceability checks are only limited to one step back, one step forward of the operator subject to controls. 9

14 5.2.7 Sampling and laboratory analysis Article 65(2) of Commission Regulation (EC) No 889/2008. Articles 5 and 12 of Regulation (EC) No 882/ The audit team noted that the CBs visited have, in general, comprehensive procedures for sampling with sufficient guidance for inspectors. In both CBs, the inspectors are instructed to take samples on a risk basis. The decision on when and where to take the samples and which kind of product to sample is generally taken by the inspectors on the basis of the following elements: a) their knowledge of the operators allocated to them, b) the indications given to them by their heads of office during regular meetings, and c) the annual "focus area". The focus area is agreed during the meetings between CAs and CBs (see finding 7) and this decision entails the commitment of the CBs to allocate 50% of their samples to this area. In 2015, the focus area is "pesticides in potatoes and potato products", due to certain detections of unauthorised substances in Although in 2014 both CBs did not reach the legal requirement for the 5% of samples (reaching only 2.5% and 4.1% of the total number of operators, respectively), in 2015, both CBs have instructed their inspectors to take a number of samples corresponding to, at least, 5% of total operators. Moreover, as a general policy, in both CBs, the inspectors are instructed to take additional samples in case of suspicion, irrespective of the number of samples they have been allocated. This is largely in line with Article 65(2) of Regulation (EC) No 889/ According to information gathered by the audit team, CBs use only one laboratory to perform their analyses (mainly for pesticides residues). This laboratory is accredited to ISO and the methods used to analyse organic products are all included in the scope of accreditation. It is also used by the CAs for official controls on food and feed hygiene legislation. The audit team noted that the analytical scope for the analysis of pesticides is sufficiently broad and can detect low levels of residues. This is in line with Article 5 of Regulation (EC) No 882/2004. Conclusion on sampling and laboratory analysis 39. Although there has been a delay in the implementation of the new requirements concerning the number of samples, the CAs and the CBs are now well aware of such provisions and the CBs visited have put in place mechanisms to meet these requirements from this year. All analyses are carried out by an accredited laboratory which gives adequate guarantees of the reliability of the results of analyses carried out on organic products. 10

15 5.2.8 Exceptional production rules and other derogations. Article 22(2) of Regulation (EC) No 834/2007. Article 29 and Sections 2 to 4 of Chapter 6 of Title II of Commission Regulation (EC) No 889/ The audit team noted that a number of exceptions of a general and an individual nature have been granted by the CAs. The individual exceptions granted in 2014 include the following: a) use of non-organic female mammals brought onto the holding for the renewal of a herd or flock as laid down by Article 9(4) of Regulation (EC) No 889/2008, b) the recognition of the retroactive conversion period as laid down by Article 36(2) of the said Regulation, c) the conducting of parallel organic and conventional plant production as laid down by Article 40(1) of the said Regulation. In such cases an application has to be sent to the SBA which then takes a decision on the basis of the verification of the conditions laid down in the said Regulation. The audit team noted that these exceptions are verified during controls carried out by the CBs, although in one case, the inspector did not note the absence of the required authorisation to be granted by the SBA for a farm visited. The arrangements for granting individual exceptions are largely in line with the requirement laid down by Article 22(2) of Regulation (EC) No 834/ As regards the exceptions of a general nature, these have been regulated in the national legislation and include, among others, the following: a) use of non-organic seed (see paragraph 5.3), b) the exclusion from the control system of certain operators selling products directly to the final consumers (see finding 6), c) the tethering of animals in small holdings, as referred to in Article 39 of Regulation (EC) No 889/2008, and d) the introduction of non-organically reared poultry into an organic poultry production unit as referred to in Article 42 of the said Regulation. 42. The audit team noted that the exception granted for the tethering of animals in small holdings mentioned in the above paragraph, refers to a definition of "small holdings" included in the guide for organic production issued by the Federation of Swedish Farmers (see finding 1) and it is included in the checks carried out by the CBs. Moreover, according to the national legislation, this exception and the one referring to the introduction of non-organically reared poultry into an organic poultry production unit, as referred to above, may be subject to amendments, should the conditions on the basis of which these exceptions have been granted change. It was noted that, although the CAs do not have feedback in terms of how many such exceptions have been granted in the country, these arrangements are largely in line with Article 22(2) of Regulation (EC) No 834/ The SBA has granted a general authorisation allowing the dehorning of calves for safety reasons which is in line with Article 18(1) of the Swedish translated version of Regulation (EC) No 889/2008. Nonetheless, the audit team noted that the national legislation on animal welfare regulates dehorning which has to take place in accordance with a number of conditions including the following: a) the dehorning (heated iron) has to be carried out under the supervision of a vet, b) only animals younger than 8 weeks can be subject to this treatment, c) records of the treatments have to be kept by the farmer, d) anaesthesia and painkillers have to be used, as necessary. 11

16 Conclusion on exceptional production rules and derogations 44. The CAs and the CBs have set up a largely effective system of measures to manage exceptional production rules and other derogations Imports of Products from Organic Production Articles 32 and 33 of Regulation (EC) No 834/2007. Commission Regulation (EC) No 1235/2008, in particular, Article 7 of Chapter 3 of Title III, Article 19 and Annexes II, III, V and VI. 45. According to the national legislation, all consignments of organic products have to be notified to Customs by the importer. Customs officials then carry out documentary checks on all consignments. A specific instruction is available for Customs staff explaining the types of documentary checks to be carried out. The audit team reviewed the documentation for several consignments of organic products imported from non-eu Countries and noted that these were completed adequately and were endorsed by Customs, as required by Regulation (EC) No 1235/2008. Conclusion on imports of products from organic production 46. The measures put in place by the CAs for the documentary check of the imports of organic products are adequate Measures in cases of irregularities and infringements Articles 54 and 55(1) of Regulation (EC) No 882/2004. Articles 27(5)(d) and 30 of Regulation (EC) No 834/2007. Articles 91, 92, 92a and 92d of Commission Regulation (EC) No 889/ According to the national legislation the NFA, SBA and the MUNs have a variety of legal enforcement measures to address infringements of the organic legislation. Those affecting the organic status of the products include injunctions, fines and various measures on the products (e.g. removal of organic labelling, provisional ban from the market, recall of products, etc.). Since January 2014, with the entry into force of the new national organic legislation, CBs are also allowed to withdraw the certificate (fully or partly) and to remove the organic label or provisionally prohibit the marketing of a batch of products bearing the organic logo. Operators may appeal decisions regarding withdrawal of certificates by the CB. Nevertheless, the national legislation foresees that, if necessary, the CAs' orders can take effect immediately, notwithstanding the appeal. 48. In case of withdrawal of the certificate, or a labelling or marketing ban, the Paying Agency, which belongs to the SBA, is directly informed by the relevant office of the SBA 12

17 receiving the "irregularity report" (see finding 27). This is in line with Article 92(6) of Regulation (EC) No 889/ The national legislation requires CBs to report, within one week, all non-compliances found during their controls to the NFA or the SBA. In case of serious infringements, CBs have to inform the NFA or SBA immediately. The audit team noted that the CBs visited have procedures requiring that an "irregularities report" be attached to the report of the visit. This has to be sent to the operator with a copy to the CAs, within one week. This report contains the description of the non-compliances, the relevant legal requirements and a deadline (usually one month) to address them. In case of major non-compliances, the procedure requires that an immediate communication to the CAs is necessary. 50. The audit team reviewed several cases of infringements affecting the organic status of the products (e.g. detection of pesticides in samples) and noted that the CAs had been informed as required by Article 27(5)(d) of Regulation (EC) No 834/2007; moreover, it was noted that no thresholds for pesticides have been introduced either by the CBs or by the CAs, in line with the organic legislation. 51. The audit team noted that although most of the non-compliances reviewed during the visits to the CBs had been addressed with largely appropriate measures and had been followed up, none of the CBs had issued a comprehensive catalogue of measures in case of infringements and irregularities in order to harmonise their controls. Moreover, no national catalogue of measures in case of irregularities and infringements, as required by Article 92d of Regulation (EC) No 889/2008 has yet been adopted in Sweden. According to representatives from the CAs, work is in progress to set this up and a national catalogue of measures is expected to be finalised before the end of Conclusion on measures in cases of irregularities or infringements 52. Various measures have been put in place by the CAs, CtrlAs and CBs to manage irregularities and infringements. Those related to the obligations of communication between CBs and CAs are effective. However, the lack of a national harmonised sanction catalogue negatively affects the effectiveness and consistency of the measures taken in case of irregularities and infringements throughout the country. 5.3 SEED DATABASE Articles 45(5) and 45(8), 48 and 49 to 56 of Commission Regulation (EC) No 889/ The Swedish organic seed database is managed by the SBA and is publicly available on the SBA website. The database, which is divided between seed for agricultural and horticultural uses, is updated twice a year before the spring and autumn seasons or during the seasons if there are changes in the availability of a specific seed. Regular expert group meetings with the organic farmers' organisation, seed companies and advisors are organised by the SBA twice a year, before the spring and autumn seasons. 54. Annually, on the basis of the availability of varieties, the SBA may decide to grant general authorisations as laid down by Article 45(8) of Regulation (EC) No 889/2008. In 13

18 2015, a general authorisation was granted for seed potatoes, since there were no organic seed potatoes available in Sweden. 55. According to the SBA, Sweden has not delegated the responsibility for granting individual derogations for the use of non-organic seeds to the CBs. Approximately individual derogations are issued by the SBA annually in accordance with Article 45(5) of Regulation (EC) No 889/2008. During the visits to the CBs, the Audit team verified that no such derogations were granted by the CBs. 56. To inform the operators about the availability of seed, there is a subscription service on the SBA website. It includes information on the seed database. Users get updated information by . Conclusion on the seed database 57. A seed database has been established and managed by the CA in an effective way. 6 OVERALL CONCLUSIONS Overall, the system of official controls for organic production is largely effective, with clear responsibilities and communication between CAs and CBs, good management of the seed database and a largely effective import control system. However, there are certain weaknesses which need to be addressed, and, in some cases, these were already in hand. These weaknesses mainly pertain to the planning and the delivery of controls by the CBs, and, in particular, concern additional and unannounced inspections and sampling, and the identification by operators of critical steps in order to put into place relevant precautionary measures. Moreover, the lack of a national catalogue of sanctions hampers the consistency and the effectiveness of the measures the CBs have to take in case of irregularities, although this was expected to be resolved by the end of Finally, the measures to ensure product traceability are generally effective, although this needs to be strengthened by making publicly available the list of operators, and by improving the feedback on the checks carried out by the MUNs to retailers. 7 CLOSING MEETING A closing meeting was held on 25 September 2015 with representatives from the CAs and representatives from a CB visited. At this meeting, the CAs provided additional information requested during the course of the audit and the audit team presented the main findings and preliminary conclusions of the audit, which were provisionally accepted by the CAs. 8 RECOMMENDATIONS The CAs are invited to provide details of the actions taken and planned, including deadlines for their completion ('action plan'), aimed at addressing the recommendations set out below, within 25 working days of receipt of this audit report. 14

19 No. Recommendation 1. To ensure that sufficient information on controls related to organic products, conferred to the municipalities, is available at central level, as laid down by Article 92(5) of Regulation (EC) No 889/2008. Recommendation based on conclusion: 9 Associated finding: 7 2. To ensure that relevant competent authorities have in place documented procedures for the delegation of tasks to control bodies, as required by Article 92c of Regulation (EC) No 889/2008. Recommendation based on conclusion: 15 Associated finding: To ensure that the requirements concerning the number of annual samples and additional visits, as laid down, respectively, by Articles 65(2) and 92c of Regulation (EC) No 889/2008, are adequately taken into account during the supervisory activities of the control bodies carried out by the competent authorities, as required by Article 27(9) of Regulation (EC) No 834/2007. Recommendation based on conclusion: 15 Associated finding: To ensure that operators wishing to produce, prepare, store or import organic products or placing on the market such products, notify their activity to the competent authorities, as required by Article 28(1) of Regulation (EC) No 834/2007. Recommendation based on conclusion: 21 Associated finding: To ensure that control bodies require operators to sign the declaration containing the operator's commitment to follow the applicable provisions of the organic legislation, the description of its activities and the relevant precautionary measures as required by Article 63(2) of Regulation (EC) No 889/2008. Recommendation based on conclusion: 21 Associated finding: To ensure that operators are included in publicly available list(s), with updated documentary evidence related to each operator, as required by Article 92b of Regulation (EC) No 889/2008. Recommendation based on conclusion: 21 Associated finding: To ensure that, at least 10% of all visits carried out by the control bodies are unannounced, as required by Article 92c of Regulation (EC) No 889/2008. Recommendation based on conclusion: 26 Associated finding: 25 15

20 No. Recommendation 8. To ensure that control bodies require food and feed processors to carry out a risk analysis to identify the critical steps and relevant precautionary measures for the production of organic food/feed, as required by Article 26(2) of Regulation (EC) No 889/2008. Recommendation based on conclusion: 31 Associated finding: To adopt a catalogue of measures in case of irregularities and infringements, as required by Article 92d of Regulation (EC) No 889/2008. Recommendation based on conclusion: 52 Associated finding: 51 The competent authority's response to the recommendations can be found at: 16

21 ANNEX 1 LEGAL REFERENCES Legal Reference Official Journal Title Reg. 882/2004 OJ L 165, , p. 1, Corrected and re-published in OJ L 191, , p. 1 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 Reg. 834/2007 OJ L 189, , p Reg. 889/2008 OJ L 250, , p Reg. 1235/2008 OJ L 334, , p Council Regulation (EC) No 834/2007 of 28 June 2007 on organic production and labelling of organic products and repealing Regulation (EEC) No 2092/91 Commission Regulation (EC) No 889/2008 of 5 September 2008 laying down detailed rules for the implementation of Council Regulation (EC) No 834/2007 on organic production and labelling of organic products with regard to organic production, labelling and control Commission Regulation (EC) No 1235/2008 of 8 December 2008 laying down detailed rules for implementation of Council Regulation (EC) No 834/2007 as regards the arrangements for imports of organic products from third countries