dg(sante) 2019-6704 final report of an audit carried …

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.

EUROPEAN COMMISSIONDIRECTORATE-GENERAL FOR HEALTH AND FOOD SAFETY

Health and food audits and analysis

DG(SANTE) 2019-6704

FINAL REPORT OF AN AUDIT

CARRIED OUT FROM 21 TO 30 JANUARY 2019

IN ORDER TO

EVALUATE THE IMPLEMENTATION OF THE ORGANIC PRODUCTION STANDARDS AND CONTROL MEASURES APPLIED BY A RECOGNISED CONTROL

BODY OPERATING IN PERU

Ref. Ares(2019)4123390 - 28/06/2019

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Executive Summary

This report describes the outcome of a DG Health and Food Safety audit carried out between 21 and 30 January 2019 in order to evaluate the application of the organic production standards and control measures applied by a recognised Control Body operating in Peru. The audit comprised on-site inspections and an office audit at the Peruvian branch office.

The report concludes that the control system implemented by the Control Body ensures that all operators are inspected annually and a sufficient number of operators are selected for additional inspections and sampling based on their level of risk. Inspections carried out by the control body are overall satisfactory, in particular at individually certified operators. However, the fact that all inspections are announced in advance undermines the effectiveness of controls.

The procedure implemented by the Control Body is not adequate to evaluate the effectiveness of controls carried out by producer groups and the shortcomings found by the Control Body during the inspections of individual farmers of the groups do not usually lead to enforcement measures being taken against the producer group as a whole.

Some of the production rules and control measures for which the Control Body was recognised by the European Commission are not effectively applied. A large number of applications submitted by operators for the shortening of the conversion period are approved by the Control Body without sufficient proof that the farmers fulfil the relevant conditions.

The procedure followed by the Control Body for the issuance of certificates of inspection is not adequately implemented to ensure that all products and ingredients certified for export to the EU have been obtained in accordance with the Control Body production rules.

The report contains recommendations to the Control Body aimed at rectifying the shortcomings identified and enhancing the implementation of control measures.

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Table of Contents

1 Introduction ....................................................................................................................................1

2 Objectives and scope......................................................................................................................1

3 Legal Basis .....................................................................................................................................2

4 Background ....................................................................................................................................2

5 Findings and Conclusions ..............................................................................................................2

5.1 Organic Production rules and Control measures .....................................................................2

5.2 Surveillance and Re-Assessment.............................................................................................3

5.3 National Authorities and National Legal Requirements .........................................................4

5.4 Structure and Organisation of the Control System..................................................................4

5.4.1 Organisation and planning of controls .............................................................................4

5.4.2 Off-farm input verification system...................................................................................7

5.4.3 Handling of derogations and exemptions.........................................................................8

5.4.4 Sampling ..........................................................................................................................9

5.5 List of Organic Operators ......................................................................................................11

5.6 Controls on Organic Production............................................................................................12

5.6.1 Controls of operators......................................................................................................12

5.6.2 Labelling ........................................................................................................................14

5.6.3 Traceability ....................................................................................................................15

5.7 Export certification system....................................................................................................15

5.8 Irregularities and Follow-up of EU notifications ..................................................................17

6 Overall Conclusions .....................................................................................................................20

7 Closing Meeting ...........................................................................................................................20

8 Recommendations ........................................................................................................................21

III

ABBREVIATIONS AND DEFINITIONS USED IN THIS REPORT

Abbreviation ExplanationCoI(s) Certificate(s) of Inspection

CB(s) Control Body(ies)

EC European Community

EU European Union

ICS(s) Internal Control System(s)

ISO/IEC International Organisation for Standardization/International Electro-technical Commission

OFIS Organic Farming Information System

OSP(s) Organic System Plan(s)

PG(s) Producer Groups(s)

PPP(s) Plant Protection Products

WI(s) Control Body´s Working Instructions

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1 INTRODUCTION

The audit took place from 21 to 30 January 2019 in order to evaluate the application of the organic production standards and control measures applied by a recognised Control Body (CB). The CB was selected for the audit by Directorate-General for Agriculture and Rural Development based on a risk assessment. The audit formed part of DG Health and Food Safety's planned programme.

The audit comprised an office audit at the branch office of the CB and visits to operators certified by the CB in Peru.

An opening meeting was held on 21 January with representatives of the CB branch office and of the CB Headquarters. At this meeting, the objectives of, and itinerary for, the audit were confirmed by DG Health and Food Safety's team and the control systems were described by the CB.

The audit on the CB will provide an input to the Commission services' supervision of the CB under Article 33(3) of Regulation (EC) No 834/2007.

2 OBJECTIVES AND SCOPE

The CB is recognised by the European Commission for applying, in non-EU countries, equivalent production rules as foreseen in Titles III and IV of Regulation (EC) No 834/2007 and control measures having equivalent effectiveness to that of the EU (Title V of Regulation (EC) No 834/2007).

Therefore, the system should give assurances that organic products exported to the EU have been produced in accordance with the CB's organic production rules and control measures.

The objectives of the audit were:

to verify that the production rules applied by the CB as regards the product categories listed in Annex IV of Commission Regulation (EC) No 1235/2008 are those for which the CB has been recognised by the European Commission as competent to carry out controls for the purpose of equivalence.

to verify that the control measures recognised by the European Commission as having equivalent effectiveness to that of the EU have been permanently and effectively applied by the CB.

In pursuit of this objectives, the following sites were visited:

Visits/meetings Days CommentsControl BodyBranch office in Peru 2 Office audit and closing meetingOn-Site-VisitsVisit 1 2 Large size banana producer and exporter

(producers group)

2

Visit 2 2 Medium size cocoa and coffee producer and processor (producer group)

Visit 3 1 Medium size processor and exporter

In terms of scope, the audit focused on the organisation and performance of the CB, in particular, on the effective implementation of the production rules and control measures in place covering the whole production, preparation and distribution chain of organic products intended for export to the EU.

3 LEGAL BASIS

The audit was carried out under the general provisions of EU legislation and, in particular, Article 11(4) of Regulation (EC) No 1235/2008.

Full legal references to EU legal acts in this report are provided in Annex 1 and refer, where applicable, to the last amended version. International standards referred to in this report are provided in Annex 2.

4 BACKGROUND

The CB has been recognised by the European Commission for applying, in non-EU countries, equivalent production rules as foreseen in Titles III and IV of Regulation (EC) No 834/2007 and control measures having equivalent effectiveness to that of the EU (Title V of Regulation (EC) No 834/2007). Consequently, the CB is included in the list of recognised CBs established in Annex IV to Regulation (EC) No 1235/2008. The audit focused on the CB's activities in Peru.

5 FINDINGS AND CONCLUSIONS

5.1 ORGANIC PRODUCTION RULES AND CONTROL MEASURES

Legal requirements

Articles 10(2) and 12 of Commission Regulation (EC) No 1235/2008.

Findings

1. At the time of the audit, the CB was applying version R01(04.7) of the production rules and control measures applied by the CB (hereinafter referred to as the CB standards), dated October 2018. The CB representatives stated that whenever relevant changes are made to the CB standards, these are notified to the Accreditation Body to be evaluated for the purpose of equivalence to the requirements of EU Regulations. After the assessment has been made by the Accreditation Body, these changes are notified to the European Commission when submitting the annual report on the control activities carried out by the CB. The audit team was shown evidence that changes are also notified

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to the CB staff and to operators. Working instructions and procedures (WIs) are also in place with the aim of harmonising the implementation of control measures by CB staff.

2. The most recent version of the CB standards did not contain any change (in relation to the most recent version notified to the European Commission) which may have an impact on the production rules or control measures applied by the CB in Peru. However the audit team noted that some of the production rules and control measures were not equivalent to the relevant EU requirements.

3. For example, one of the Annexes to the CB standards includes the possibility that operators in Peru may use a substance which is not in the Annexes to Regulation (EC) No 889/2008, and therefore cannot be used for organic production. The CB representatives stated that the substance was not allowed in practice and that an informative letter had been sent to the operators on this issue in 2015. Evidence of this communication was shown to the audit team. Another example is the possibility that the CB may re-interpret the analytical results reported by laboratories (see paragraphs 41 and 70).

4. The audit also noted that the Annual Report does not provide the Accreditation Body´s assessment of the equivalence of the CB production rules and control measures to EU requirements. The CB representatives stated that in this case the assessment of the Accreditation Body had not been included in the annual report as it had already submitted to the European Commission before the submission of the annual report. The annual report also does not contain accurate information on the control activities carried out by the CB in Peru. For example, no information is provided on the number of derogations granted to operators on the shortening of the conversion period, for the use of non-organic seeds (see paragraphs 32 and 33), or on quantities certified for export from some third countries, and the number of samples reported as taken is not accurate.

Conclusions on Organic Production Rules and Control Measures

5. Although the CB fulfils its obligation to notify the European Commission of any changes that are made to the production rules and control measures applied, the annual reports submitted do not contain complete and accurate information, which is not in line with Article 12(1)(b) of Regulation (EC) No 1235/2008.

5.2 SURVEILLANCE AND RE-ASSESSMENT

Legal requirements

Article 33(3) of Council Regulation (EC) No 834/2007.

Findings

6. The CB is accredited to the International Organisation for Standardization (ISO)/International Electrotechnical Commission (IEC) 17065. The CB headquarters are annually subjected to surveillance by one internationally recognised Accreditation Body.

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The most recent one took place in February 2018, where some non-conformities were raised in relation to the CB activities in the field of organic production. At the time of the audit, the non-conformities had already been closed by the Accreditation Body.

7. Although the CB Peruvian office is considered as a critical location where certification decisions and the issuance of Certificates of Inspection (CoIs) take place, the audit team noted that the most recent surveillance activity by the Accreditation Body was dated November 2014. The CB representatives stated that an audit was planned to be carried out in March 2019.

Conclusions on Surveillance and Re-assessment

8. The CB undergoes regular evaluation/surveillance/multi-annual re-assessment of its activity by an Accreditation Body which is in accordance with Article 33(3) of Council Regulation (EC) No 834/2007

5.3 NATIONAL AUTHORITIES AND NATIONAL LEGAL REQUIREMENTS

Legal requirements

Article 11(3)(d) of Commission Regulation (EC) No 1235/2008.

Findings

9. The audit team was shown evidence that the CB had notified its activities to the Competent Authorities in Peru. When an extension of the scope of recognition is granted by the European Commission, this has to be notified to the authorities.

10. According to the CB, the conditions to be authorised to operate in Peru are, inter alia: to have a branch office in Peru, to certify products for national organic standards and to be subject to annual supervision by the Peruvian Competent Authority. The CB representatives stated that they are audited annually by the Competent Authorities.

Conclusions on National Authorities and National Legal Requirements

11. According to the CB it takes measures in order to respect the national requirements imposed on it.

5.4 STRUCTURE AND ORGANISATION OF THE CONTROL SYSTEM

Legal requirements

Article 33 of Regulation (EC) No 834/2007.

5.4.1 Organisation and planning of controls

Findings

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12. An office audit was carried out by the audit team in the Peruvian branch office of the CB as it is a critical location for the CB and all necessary documents were made available to the audit team. The Peruvian office is responsible for the planning and execution of controls and for taking certification decisions. Evidence was provided to the audit team that internal audits are regularly carried out by the CB headquarters of the Peruvian office.

Recruitment, training and evaluation of inspectors

13. The CB provided details on the recruitment policy and of the induction procedure for newly recruited staff. Inspectors have to undergo theoretical and practical training and must pass a successful on-the-spot evaluation by a senior inspector before being allowed to perform inspections on their own. Moreover, the performance of all established inspectors is witnessed at least once a year by senior inspectors or certifiers. All inspectors must also fill in a declaration of absence of conflict of interest, which is taken into account by the CB when preparing the annual planning. Evidence of implementation of these procedures was provided to the audit team.

Risk assessment, planning of controls and timing of inspections

14. The certification process is set up in Annex A10 of the CB standards. The CB issues certification to operators after finalising all necessary control arrangements to confirm that operators comply with the CB standards. The certificate issued, which is equivalent to the documentary evidence described in article 29 of Regulation (EC) No 834/2007, is valid for one year. The certificate includes details on the scope of certification (operators´ activities and production/processing units which have been certified as compliant by the CB) as well as the range of products for which CoIs for export to the EU can be issued during the period of validity of the certificate.

15. According to article 65.1 of the CB standards, all operators under contract must be inspected at least once a year, to confirm operators´ compliance with the CB production rules before granting the renewal of the certificate. The CB plans the inspections at plant producers for the production season, while inspections may take place at processors at any time during the year. According to section 4d of the WI for the execution of inspections, all production and processing units must be physically inspected and all aspects of the CB standards checked. As set up in the WI for the planning of inspections, additional inspections are planned to a minimum of 10% of operators under control. Operators are selected for these additional controls based on a risk assessment procedure.

16. The risk assessment criteria are developed by the Peruvian branch office and then submitted to the CB headquarters for approval. The audit team reviewed the criteria and noted that they are overall adequately factored in for the selection of operators. Criteria such as operators´ past non-conformities and risk of commingling of organic and non-organic products are taken into account. Groups of small producers and producers of certain high-risk crops (e.g. banana) are directly classified as high risk. Operators who

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grow annual crops are inspected twice, close to sowing and to harvest respectively. Operators who are classified as high risk are targeted for at least one additional inspection and for sample taking. The audit team reviewed a number of files and noted that overall the annual and additional inspections take place as planned by the CB.

17. Although the risk assessment is overall well designed, the audit team noted that quantities produced by operators, which is a compulsory criterion to be taken into account when selecting operators for additional visits according to article 65.4 of Regulation (EC) No 889/2008, are not taken into account. In addition, the CB does not consider as a non-conformity the fact that operators do not fulfil their obligation to notify the CB in cases of irregularities or their likelihood and consequently this element is not reflected in the risk profile of the operators concerned.

18. All inspections are announced in advance. This is not in line with Sections 2 and 4(c) of the WI Plan.Org.W02(06). This is also not in line with Article 92c(2)(c) of Regulation (EC) No 889/2008, which is quoted as a reference in the CB standards. The CB stated that the practice is only to give short notice to operators before carrying out the inspections, as indicated in Annex A10 of the CB standards. The same instruction also foresees the possibility of carrying out totally unannounced inspections, although in practice prior warning (minimum 24 hours before the inspections) is always given to operators. In addition, the CB does not require that internal inspections carried out by Producer Groups (PGs) are carried out unannounced.

19. The preparation of inspections is described in several WIs. According to the instructions, operators have to submit before the inspections the Organic System Plans (OSPs) with the full description of the production/processing units and of the precautionary measures to be taken to avoid the risk of contamination of organic products. If the OSPs are not complete or accurate they must be sent back to operators for completion before inspections take place.

20. However, the audit team noted that a number of OSPs, including the files of the operators visited during this audit, were incomplete and/or inaccurate. For example, one of the OSPs contained a reference to the use of an off-farm input, which according to the statement of the relevant operator during the inspection, had not been used in the last five years. Another two OSPs did not describe changes made in relevant quality management documents, such as checklists and reports used by inspectors of the PGs. This lack of adequate evaluation of OSPs is not in line with the working instructions and jeopardises the preparation of the inspections. The audit team noted that inspectors spend a significant part of the documentary checks at operators on the evaluation and completion of the OSPs instead of verifying their effective implementation (see paragraph 53), which is also not in line with Section 4b of the WI Insp.W01(2.3) (document review before on-site inspections).

21. The audit team noted that the CB office does not supervise the exchange between operators and inspectors or the evaluation of the OSPs made by inspectors. The email exchange between operators and inspectors (e.g. when OSPs were submitted) was not

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accessible from the office and inspectors do not have to produce any evidence (e.g summary of evaluation of the OSPs) to the CB of the evaluation made. The lack of systematic supervision by the CB does not ensure that the working instructions are implemented as regards the preparation of the inspections.

22. The audit team also noted that the CB does not record non-conformities for the fact that significant changes are not notified by operators, which is also not in line with the WI Insp.Org.W01(28) (OSP review).

New operators previously certified by other CBs

23. Annex I of the WI Cert.W01(2.5) of the CB standards requires that new operators applying for a contract to this CB must declare whether they are or were under the control of a previous CB for organic certification. In this case the CB must contact the previous CB and request information on the current status of the operator and on any pending non-compliance which would need follow-up. The audit team was shown examples of this exchange of communication.

24. However, the information requested by the CB was limited (last inspection report and summary of pending non-compliances), while other relevant aspects of the control file (previous inspection reports or past non-conformities) and the reports referred to in Article 63(2) of Regulation (EC) No 889/2008 are not requested. This is not in line with Article 92(2) of the CB standards.

Conclusions on Organisation and Planning of Controls

25. The CB overall adequately plans the annual controls of operators (including additional inspections and the taking of samples). Relevant risk criteria are taken into account for the selection of operators except quantities produced, which is a compulsory criterion of the EU organic legislation. Operators´ failure in their duty to notify non-conformities is also not taken into account to determine the risk profile of the operators.

26. In addition, the CB cannot ensure an adequate risk-based planning of controls for new operators as not all information necessary to determine their risk profile is requested from previous CBs.

27. The fact that all inspections are announced undermines their effectiveness. Moreover, the CB does not supervise the communication exchange between operators and inspectors and cannot ensure that inspections are adequately prepared.

5.4.2Off-farm input verification system

Findings

28. Operators have to notify the CB of their intention to use new off-farm inputs. When submitting their requests, operators may attach declarations made by other recognised CBs on the suitability of the inputs for use in organic production. These third-party

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declarations can be taken into account by the CB, however inspectors must cross-check that all active substances of the off-farm inputs are listed in the Annexes of Regulation (EC) No 889/2008.

29. During the inspections witnessed by the audit team, the CB verified the compliance of the inputs used by operators. Inspectors checked that all active substances listed in the technical dossiers of the off-farm inputs declared by operators were in the relevant Annexes to the EU Regulations. They also requested further information on any off-farm input or package found during the inspection of the operators´ premises, to confirm that only the off-farm inputs declared in the OSPs were used.

Conclusions on Off-farm input verification system

30. The CB applies its production rules on off-farm input products, including adequate verification during the inspections of the use of approved products

5.4.3Handling of derogations and exemptions

Findings

31. The CB has procedures in place to implement the control measures for the handling of derogations. The audit team was informed that in recent years the CB had only granted derogations relating to the use of conventional seeds. The CB also has procedures to grant retroactive recognition of a previous period as part of the conversion period from non-organic to organic production.

32. As regards conventional seeds, the CB does not grant a large number of derogations (eight in 2018) as operators usually produce their own seeds/seedlings. Operators must justify the use of conventional, non-treated seeds, and apply to the CB before using them. The audit team reviewed two files and noted that the applicants had attached all necessary information to demonstrate fulfilment of the conditions to be granted the derogation (such as proof of unavailability of the same seed in organic condition).

33. The CB however, approved in 2017 and 2018 a large number of applications for the retroactive recognition of a previous period as part of the conversion period that land has to undergo in order to be certified as organic. Moreover, the files reviewed by the audit team demonstrated that the approvals had not been granted in line with the CB procedures. According to section 36.02 of the CB standards, the parcels of land must be natural or agricultural areas which have not been treated with products not authorised for organic production, provided that several requirements are met (independent third-party declaration on the absence of use of unauthorised substances, physical inspection of the whole growing season of the product and satisfactory result of a sample of product harvested from the parcels).

34. However, the audit team noted that the data provided to the audit team did not refer to all farmers who had requested retroactive recognition of their parcels but rather to the PGs or production units to which the farmers belonged. The CB randomly selected

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parcels of land managed by some of the individual farmers, for the verification of compliance with the requirements described in paragraph 33. However the retroactive recognition was also granted to other individual farmers without inspection and samples taken, and thus without evidence of fulfilment of the CB requirements. In addition, the fulfilment of some requirements was not sufficiently documented, or the evaluation made by the CB did not follow the CB standards (e.g. samples taken from final product instead of products harvested from the parcels, no statement from the Competent Authority for one of the crops for which the retroactive recognition was granted).

Conclusions on Handling of derogations and exemptions

35. The CB grants derogations for the use of conventional seeds in accordance with its procedures. However, the CB does not adequately follow its procedure for the recognition of a previous period as part of the conversion period. In the case of PGs, approvals are granted to all individual farmers without sufficient proof of fulfilment of the conditions set up in the CB standards.

5.4.4Sampling

Findings

Sampling strategy

36. The planning of samples is decided by the CB Peruvian office. A number of samples at least equal to 5% of the total number of operators under control has to be taken annually for the detection of use of products not authorised in organic production. To decide on the substances to be tested for, the CB takes into account the likelihood of the use of certain non-authorised farm-inputs (e.g. when similar crops are grown under conventional and organic management). In practice the CB focuses on the detection of the use of unauthorised plant protection products (PPPs). This decision is based on the outcome of the CB inspections as well as the information gathered from complaints and notification of irregularities received through the Organic Farming Information System (OFIS) of products imported to the EU from Peru, which usually involved PPPs and not fertilizers or genetically modified organisms. According to the CB, the risk of use of genetically modified organisms is not high in Peru as their use is not allowed by the Peruvian legislation.

37. For the selection of operators, the results of the risk assessment are taken into account. The sample planning also includes specific additional requirements for Peru. According to the planning, at least 10% of operators with storage of organic products and at least 15% of individually certified farmers must be targeted for sampling, while all PGs are targeted with at least one sample. The audit team noted that the number of samples taken by the CB in 2017 and 2018 in Peru significantly exceeds the minimum 5% set up in the CB standards.

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38. However, the fact that samples are taken during announced controls reduce the effectiveness of the controls. Moreover, most samples are taken during the annual controls, where the date of inspections is agreed with operators weeks before they take place. An operator intending to use an unauthorized substance may adapt the timing of use accordingly, thus reducing the likelihood of detection by the CB. The audit team noted that the number of positive results obtained by the CB was very low (around 1% of the samples taken) compared to the number of positive cases notified from the EU of organic consignments imported from Peru.

39. Most of the samples were taken from products and not from leaves or soil. The CB explained that, unlike in tropical countries, the risk from pests in the production of banana in Peru is mainly from insects, with a low incidence of fungi due to the climatic conditions. Therefore, the CB expects application of insecticides directly on the fruit and no aerial spraying of PPPs.

40. However, the audit team noted that a small number of samples are foreseen to be taken at packaging centres of banana to verify the use of unauthorised off-farm inputs for the preservation of the bananas during transport to Europe. However, a number of OFIS notifications in recent years refer to the use of substances which are likely to be applied at post-harvest level, and the sample planning for bananas is not covering this risk accordingly. This is not in line with Article 65(2) of the CB standards.

Laboratories and evaluation of analytical results

41. Some sections of the CB standards refer to a limit of 0.01 parts per million (ppm) for considering actions to be taken, which is not in line with EU organic requirements Nevertheless, the audit team was shown evidence that the Peruvian branch office does not apply the action limit and takes action in all cases where the analytical results show the presence of unauthorised substances.

42. The audit team noted that up to the end of 2018 the information collected by the CB inspectors in the sample sheets was not detailed enough to allow the CB to adequately evaluate the results obtained. For example, there was no information on how the sample had been collected or on crops grown in the neighbouring plots. In order to improve this aspect, a new sampling instruction had been provided from the CB headquarters in late 2018. This instruction requires attaching the maps of the plots where samples are taken from to the sampling sheet and including all information necessary to evaluate the analytical results. The audit team noted that both inspectors followed this instruction during the sampling observed at operators. Samples were also kept in cooling boxes in the case of samples of perishable products.

43. The sample procedure as implemented by the CB still does not allow for evaluation of the results obtained. According to the CB standards (section 5e of Annex XV) samples must be taken preferably from the borders of the plots to factor in the risk of spray-drift from neighbouring plots. This is, however, not adequate for also detecting and providing evidence for use by the sampled farmer himself. The CB does not foresee the possibility

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of testing separately sub-samples taken from the middle and from the borders. In the case that the sample tests positive for the presence of an unauthorised PPP, it cannot be concluded whether it is due to use by the operator himself or to spray-drift from neighbouring plots. The same approach is followed in the case of sampling at PGs, where the sub-samples taken from several farmers are used to produce a composite sample but are not kept separately for further analyses. Therefore, the CB cannot identify the origin of the presence of any unauthorised PPPs detected in the composite sample.

44. In addition, the CB does not necessarily supervise the sampling procedures/strategies implemented by Internal Control Systems (ICS) of PGs. The audit team noted that the CB procedure does not give specific guidance to inspectors to evaluate corrective actions taken by ICSs. For example, one of the PGs visited had planned the taking of samples on the border of plots with conventional neighbours, to detect the risk of spray-drift. The risk of use of unauthorised substances by farmers was simply disregarded by the ICSs.

45. Samples taken by the Peruvian office are sent to laboratories approved by the CB headquarters. Accreditation to ISO/IEC 17025 is a compulsory requirement for laboratories to be used by the CB. In addition, laboratories have to be accredited for the methods and substrates requested. The audit team reviewed the accreditation report of one of the laboratories used by the CB, as well as some analytical reports issued by the laboratory. It was noted that the methods used by the laboratory for the relevant matrixes (substances tested for and the substrates analysed) were included in accreditation scope. However, the range of PPPs included in the tests was limited (around 192 active substances), which may have an impact on the reliability of the results obtained. Nevertheless, the CB representatives provided evidence that before deciding on the use of the laboratories, it had been verified that their scope covered the most common PPPs used in Peru.

Conclusions on Sampling

46. The CB takes a number of samples which significantly exceeds the minimum requirements of the CB standards, in particular at producer level, taking into account the risk profile of operators and the risk of use of unauthorised products. However, samples are not taken at all stages of production as necessary and they are always taken during announced controls, thus undermining their effectiveness.

47. In addition, the sampling procedure does not always allow the CB for proper evaluation of the analytical results.

5.5 LIST OF ORGANIC OPERATORS

Legal Requirements

Article 11(3)(e) of Commission Regulation (EC) No 1235/2008.

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Findings

48. The CB keeps a list of operators subject to its controls, which is published on the CB website. The list contains the names of operators, the country where they operate as well as the current certification status, including information on suspended operators. Details of the products covered by the certification are provided. This list is updated regularly (within the deadlines established in the CB standards) to incorporate new operators and to update operator´s status after renewal of certification.

Conclusions on List of organic operators

49. The CB publishes on its internet website, an updated list of operators subject to the control system in line with Article 11(3)(e) of Commission Regulation (EC) No 1235/2008.

5.6 CONTROLS ON ORGANIC PRODUCTION

Legal Requirements

Articles 23 to 25, 27(13) and 33 (1) and (3) of Council Regulation (EC) No 834/2007. Title III of Commission Regulation (EC) No 889/2008.Codex alimentarius guidelines CAC/GL 32-1999 (Guidelines for the production, processing, labelling and marketing of organically produced foods), in particular Annex 3.

Findings

5.6.1Controls of operators

50. The CB has documented procedures in place which serve as the basis for the performance of inspections. WIs and checklists are developed giving specific guidance to inspectors. Although the use of the checklists is not compulsory, all inspectors followed them during the inspections observed by the audit team at the operators visited. The inspections comprised an opening meeting where CB inspectors confirmed the audit plan submitted before inspections as well as the scope of the inspections. After the documentary checks and the on-the-spot visits take place, a closing meeting is held where the outcome of the inspection is communicated and a copy of the report is provided to operators.

51. The on-the-spot inspections observed by the audit team were overall effectively carried out by the CB inspectors, who were knowledgeable and experienced. The visits included a walk across the plots, where special attention was paid to farm boundaries with the aim to verify the information of the maps provided by operators. Inspections also covered non-organic crops grown by operators. In the case of PGs, the CB carries out inspections at a number of individual farmers. The farmers are selected based on

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documented procedures and the number of CB inspections is decided taking into account the risk category of the PG. The aim of these inspections is to evaluate the effectiveness of the inspections carried out by the ICS to the same farmers, so that any deviation in the outcome of the inspections should be noted as a shortcoming in the performance of ICS inspectors. However, the timing of the CB inspections is not necessarily planned taking into account the dates of ICS controls. The audit team noted that in some cases several months may elapse since the ICS inspections took place, which limits the value of the CB inspections to conclude on the effectiveness of the ICS inspections carried out at the same farmers.

52. According to section 1(b) and 2(c) of Annex IX of the WI Insp.Org.01, the witnessing of the performance of internal inspectors is a critical element for the evaluation of the effectiveness of the ICSs. However, it is drafted as a suggestion and not as a compulsory requirement for CB inspectors to systematically observe and evaluate the performance of ICS inspectors. The audit team reviewed a number of reports issued to PGs and noted that when such supervisory activity does takes place, it is for a particular reason. For example, in one case the CB inspector explained that the ICS inspectors had been selected for the lack of evidence of training provided to them. However the CB inspectors did not conclude on the lack of capability of internal inspectors even if severe shortcomings in their performance had been noted by the CB inspectors.

53. The documentary checks performed by inspectors were found by the audit team to be superficial, in particular at PGs, not ensuring the verification of all aspects of the CB standards, as required by Section 4 OSP review of the WI Insp.Org.W01. The CB allocates by default one day for the verification of the functioning of the ICS implemented by PGs. However, a significant part of the time is not used for verification purposes but rather for evaluation of OSPs. This is not in line with section 4.b of the WI Insp.W01, which requires the documentary review of the OSPs to take place before the on-site visit and to use the visit to verify their effective implementation. As a consequence, some requirements were not sufficiently verified:

Only a few reports/checklists filled in by the ICSs inspectors of PGs were reviewed to verify that all PG members have been subject to internal controls, as required by section 1(e) of Annex IX to the WI Insp.Org.W01.

The inspectors did not explicitly require operators to keep records with the results of verification at reception of organic purchases, as required by article 66(2) of the CB standards;

Although exercises to verify input-out balance kept by operators are systematically carried out by the CB inspectors, they are not always fit for purpose. For example, at one processor only one type out of several products which were processed from the same input was selected as output for the calculation of the balance. At one PG, the balance for banana production was calculated for the entire year which did not serve to demonstrate that the weekly productions had not been exceeded;

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Original documents are not necessarily requested. The CB inspectors reviewed the same scanned copies of the documents submitted by operators to the CB when requesting the issuance of CoIs, thus missing the opportunity to verify the accuracy and authenticity of the information submitted;

No attention is paid to the handling of products harvested from buffer zones, which is not in line with Section 1.ICS inspection (c) of the WI Insp.Org.W01.The quantities of these products are not registered by the PGs and this is not requested by the CB either.

54. The audit team also noted that inspectors did not have a harmonised approach for the evaluation of the ICSs. For example, one inspector signalled as non-compliance that the internal checklist used for the ICS inspections had not been included in the OSP. However, this non-conformity had never been signalled in the past by any other CB inspector. Another CB inspector did not record as non-conformity that the internal checklist used by the ICS of other PGs had been changed without notifying the CB. The new format was not evaluated by the inspector, thus not ensuring the fulfilment of Section 1(c) of Annex 9 to the WI Insp.Org.W01. The audit team noted it did not contain all items necessary to verify farmers´ compliance with all ICS requirements.

55. Although section 1(b) of Annex nine to the WI Insp.Org.W01 of the CB standards highlights the importance of evaluating the effectiveness of ICS, there is no clear guidance for CB inspectors to allow them to reach conclusions on this, based on the shortcomings found during inspections. As a consequence, recurrent non-conformities found at individual operators are not interpreted as shortcomings in the performance of ICSs (e.g. lack of accuracy of maps, lack of estimation of harvest yields by internal inspectors, poor performance of ICS inspectors) which may impact the PG as a whole. The audit team reviewed some cases of notification of irregularities made by EU Member States via OFIS and noted that in some cases there was enough evidence to have concluded that the ICS was not reliable (see last bullet point of paragraph 75). However, the CB did not reach such conclusion and did not impose on the PGs any of the measures foreseen in the CB procedures.

5.6.2Labelling

56. Operators intending to use labels for products exported to the EU must submit the labels to the CB for prior approval. This can also be notified by operators when submitting the OSPs to the CB. According to the CB standards, the CB code of the operator who carried out the last preparation operation of the product must be applied on the label. During inspections the CB must verify that the approved label is applied by operators.

57. However, the audit team noted that in practice the use of the approved labels is not adequately verified during the inspections. For example, in one of the operators visited the labels applied on the product for export to the EU were not the labels that had been approved by the CB. The labels applied were not in line with EU provisions, as the CB code indicated on the package was that of the importer´s CB. An operator´s

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representative stated that one of the labels had been in use since 2011 and this had never been recorded as a non-conformity by the CB.

5.6.3Traceability

58. Traceability exercises are systematically carried by the CB during the inspections at operators. They usually take place with the purpose of verifying the information submitted by operators at the time of requesting the issuance of CoIs. Those observed by the audit team were satisfactorily carried out. In the case of the processors, internal processing sheets are requested to trace organic ingredients. This is an essential element that ensures traceability where processors also purchase the same type of raw materials with a view to processing non-organic processed products.

59. However, as observed by the audit team during the office audit, the internal processing sheets are not requested among the necessary documents before CoIs are issued (see paragraph 64).

5.7 EXPORT CERTIFICATION SYSTEM

Legal Requirements

Article 30 of Council Regulation (EC) No 834/2007.

Article 13 of Commission Regulation (EC) No 1235/2008.

Findings

62. The CB has a working instruction (Orgitc.W01(13)) for the issuance of CoIs. All necessary documents as required by Article 13(4)(a) and (c) of Regulation (EC) No 1235/2008 must be verified at the CB office, including inspection, transport and financial documents. A specific form is used by the CB staff with the aim of verifying

Conclusions on Controls on organic production

60. Although some aspects of the CB standards are not always thoroughly verified, inspections carried out by the CB are generally satisfactory, in particular at individually certified operators. However, CB inspections at PGs are not necessarily planned at the most suitable time to adequately evaluate the effectiveness of ICSs. Moreover, documentary checks performed by CB inspectors at PGs are superficial and there is not detailed guidance for the evaluation of the effectiveness of ICSs. Thus, the detection of any systematic failure in the functioning of the ICS is not ensured and increased control measures are not adopted by the CB.

61. Although the CB has a procedure for the approval of labels to be applied on products exported to the EU, the lack of proper verification during inspections does not ensure that correct labels are applied.

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all information contained in CoIs. The CB staff responsible for the issuance of CoIs must verify that all products and all ingredients used for the processed products intended for export to the EU have been certified by CBs recognised by the European Commission for the purpose of equivalence.

63. The working instruction also takes into account the maximum quantities of products that operators may request for export to the EU. The amounts available are recorded in excel files and reduced with every CoI that is issued. In the case of products that are harvested all year, such as banana, this calculation is done weekly. In the case of processors, documents proving internal traceability must be also requested.

64. However, the audit team noted some weaknesses in the system for the issuance of CoIs as implemented by the CB:

Estimations of harvest submitted by PGs to the CB, which are the basis for establishing the maximum quantities that can be certified for export, were often not realistic;

The CB does not request operators to submit information on quantities sold to destinations other than the EU. Even if this information is available due to issuance of domestic transaction certificates it is not taken into account; Therefore, the CB is not in the position to know at the time of issuance of CoIs whether the estimation of production has already been exceeded by operators;

The CB does not request PGs to record quantities harvested from buffer zones or not sold as organic; these quantities are not deducted from the maximum quantities that can be produced and certified by the CB;

Internal traceability documents proving the organic origin of all ingredients of processed products were either not available in the files reviewed by the audit team or the link between input/output could not be established.

Labels applied on the product were not the ones approved by the CB.

65. Moreover, the CB did not have a system in place to ensure that CoIs are not issued for suspended operators or for products harvested from suspended production units. The CB stated that it is the responsibility of the certifier responsible for the operator´s file to notify the staff responsible for the issuance of CoIs in cases where operators are suspended, and that this communication usually takes place by email. However, no evidence of such notification could be provided by the CB. The audit team reviewed two files related to suspension of operators and noted that in one case the issuance CoIs had been discontinued during the period of suspension, However, in the other case, the issuance of CoIs continued during the suspension period for products harvested from production units that had been formally suspended by the CB.

66. At the time of the DG Health and Food Safety's audit, the CB had not yet implemented a risk assessment procedure to decide on the need to conduct physical checks before

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issuing CoIs, which is not in line with Article 13(4) of Regulation (EC) No 1235/2008. Moreover, it should be noted that a number of COIs are issued after the shipments have left Peru, which is not in line with Article 33(1) of Regulation (EC) No 834/2007.

Conclusions on Export certification system

67. The system for the issuance of CoIs for organic products exported to the EU does not guarantee the fulfilment by operators of all conditions established in the CB standards and it cannot ensure that all CoIs are issued in compliance with Article 13 of Commission Regulation (EC) No 1235/2008 and with Article 33(1) of Regulation (EC) No 834/2007.

5.8 IRREGULARITIES AND FOLLOW-UP OF EU NOTIFICATIONS

Legal Requirements

Article 33(1) and (3) of Regulation (EC) No 834/2007.

Article 15 of Regulation (EC) No 1235/2008.

Findings

Handling of irregularities by the CB

68. According to section 65(6) of the CB standards, the CB categorises the severity of non-compliances as minor and major. Major non-conformities are those which might affect the organic condition of the products while minor ones do not compromise it. When non-conformities are detected during inspections, operators have to propose corrective actions within a concrete deadline. The CB has to evaluate the corrective actions proposed and operators must submit evidence of implementation of the actions before certification can be granted by the CB. The maximum period for implementation of actions is two months for minor and three months for major non-conformities. When minor non-conformities are not corrected within the deadline, they become major.

69. However, the audit team noted that renewal of certification took place without evidence of full implementation of actions by operators. It was the case for one of the PGs visited by the audit team. The actions proposed in May 2018 had not been fully implemented by January 2019, but the certificate had been renewed within the three months period after the inspection had taken place.

70. Although the CB standards foresee the possibility that the CB interprets the laboratory results of the samples taken, the audit team noted that the Peruvian office takes actions in all cases where the results indicate the presence of any unauthorised substance. In all files reviewed by the audit team, the CB carried out investigations where additional samples were taken, and operators were suspended during the investigations. However, as indicated in paragraph 43, the sampling methodology did not allow the CB to reach any conclusion as regards operator´s lack of compliance with the CB standards.

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71. If the CB receives information pointing to non-compliance or its likelihood (e.g. OFIS cases notified from the EU or complaints received from clients), the CB may provisionally suspend the issuance of CoIs of the operator concerned until further information is obtained (either from operators or from investigations carried out by the CB), which serves to confirm or disregard the suspicion of irregularity.

72. In addition to suspension of the issuance of CoIs, the CB also may apply increased control measures to non-compliant operators, as non-conformities is one of the criterion to be taken into account in the risk assessment implemented for the planning of controls. In the case of PGs, the CB standards foresee the increase in the number of individual farmers to be subject to the CB inspections.

73. However, the audit team noted several weaknesses in the manner that the CB handles non-conformities:

The inspectors relate findings at PGs to the individual members and not to the lack of effectiveness of ICS. Recurrent findings during several years do not have any impact on the PG, but only affect individual members. This leads to the CB not taking increased control measures for the PG as foreseen in the CB standards;

The CB did not record non-compliances in cases where operators failed to notify the CB of changes which were relevant for controls (see paragraph 54) or cases related to possible irregularities affecting the organic status of their products (see last bullet point of paragraph 75);

The CB did not record as non-compliance the fact that one PG requested the issuance of CoIs for products harvested from a production unit that had been suspended by the CB (see paragraph 65).

In the cases reviewed by the audit team, the suspensions did not have any real impact on the operators concerned. The products harvested during the suspension period could still be sold as organic if the outcome of the investigation did not prove lack of compliance by the operators concerned. However, the investigations carried out by the CB were not effective to find the root cause of the problems, even if enough information was available to conclude on the lack of operators´ compliance with the CB standards (see last bullet point of paragraph 75).

Follow-up of EU notifications

74. The audit team reviewed a number of OFIS cases notified by EU Member States in 2017 and 2018. The notifications related to the presence of unauthorised substances in organic products exported to the EU from Peru. The CB representatives stated that they were aware of delays when submitting replies to OFIS, and for this reason dedicated staff had been allocated with the specific task of following-up the OFIS cases.

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75. In all cases reviewed, the CB requested the operators to carry out an investigation and submit a response within five days with the possible reasons for the presence of the unauthorised substance. Additional inspections were carried out by the CB and samples taken in most cases. However, the audit team noted recurrent shortcomings during the follow-up done by the CB:

Long time elapses between different steps of the follow-up, which in turn resulted in long delays in submitting the replies in OFIS, which is not in line with Article 15(4) of Regulation (EC) No 1235/2008;

In some cases, the operators knew about the potential irregularity several weeks before the CB received the formal notification in OFIS. This lack of notification, which is not in line with Article 91(1) of the CB standards, caused a considerable delay of the follow-up actions undertaken by the CB, making it difficult for the CB to find the origin of the problem. However, the CB is not preventing this situation to happen again as this is not recorded as non-conformity by the CB and no enforcement measures are taken against operators who fail to fulfil their notification duties;

Some replies submitted by operators were not supported by objective evidence. In one case the ICS attributed the presence of an insecticide to spray-drift. However, the information gathered on the farmers involved was not sufficient to accept such explanation. Moreover, the manner in which insecticides are applied on bananas in Peru (directly on the fruit at the time when it is already covered by a plastic bag) makes the possibility of spray-drift very unlikely;

In a number of OFIS cases, the operators´ replies pointed out the possibility of contamination during transport of the products from the individual farmers to the collection centres of the PGs. In one of the cases the delivery of products had been made in a non-authorised vehicle where other non-organic products were also present with no separation from the organic products. This situation, which clearly indicates a significant failure in the performance of the ICS did not lead to a conclusion by the CB on the lack of compliance of the operator to the CB standards.

Conclusions on Irregularities and follow-up of EU notifications

76. The enforcement measures applied by the CB are limited to the suspension of renewal of certification or to the suspension of the issuance of CoIs while the follow-up or investigation of non-compliances take place. Furthermore, these measures are not always correctly implemented by the CB, which may result in renewal of the certification without proof of implementation of corrective actions by operators or in issuance of CoIs during the suspension period.

77. No increased control measures are applied by the CB when operators fail to fulfil their obligation of communication or in cases of failure of the ICS implemented by PGs.

78. At the time of the DG Health and Food Safety's audit, the CB was not yet able to submit replies to OFIS notifications within the required deadlines. Moreover, the investigations

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made by the CB did not generally find the cause of the irregularities, and no conclusion was reached on lack of compliance by operators, even in cases where the information was available.

6 OVERALL CONCLUSIONS

The control system implemented by the Control Body ensures that all operators are inspected annually and a sufficient number of operators are selected for additional inspections and sampling based on their level of risk. Inspections carried out by the control body are overall satisfactory, in particular at individually certified operators. However, the fact that all inspections are announced in advance undermines the effectiveness of controls.

The procedure implemented by the Control Body is not adequate to adequately evaluate the effectiveness of controls carried out by producer groups and the shortcomings found by the Control Body during the inspections of individual farmers of the groups do not usually lead to enforcement measures being taken against the producer group as a whole.

Some of the production rules and control measures for which the Control Body was recognised by the European Commission are not effectively applied. A large number of applications submitted by operators for the shortening of the conversion period are approved by the Control Body without sufficient proof that the farmers fulfil the relevant conditions.

The procedure followed by the Control Body for the issuance of certificates of inspection is not adequately implemented to ensure that all products and ingredients certified for export to the EU have been obtained in accordance with the Control Body production rules.

7 CLOSING MEETING

A closing meeting was held on 30 January with representatives of the CB. At this meeting, the DG Health and Food Safety team presented the main findings and preliminary conclusions of the audit.

The representatives of the CB offered some initial comments and provisionally accepted the findings.

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8 RECOMMENDATIONS

No. Recommendation

1. Ensure that annual reports contain all information required by Article 12(1) (b) of Regulation EC) No 1235/2008, in particular:

Information on number of derogations granted; Quantities exported to the EU.

Conclusion upon which this recommendation is based: No 5

Associated findings: No 2, 3 and 4

2. Ensure that risk assessment implemented by the CB takes into account all criteria relevant to determine the risk profile of operators, and in particular that:

Quantities produced and all operators´ past non-conformities are considered for the risk assessment, as required by Article 64(5) of Regulation (EC) No 889/2008;

In case of new operators, the relevant elements of the control file of the operators are requested from the previous CB, as required by Article 92(2) of the CB standards.

Conclusions upon which this recommendation is based: No 25 and 26

Associated findings: No 17 and 243. Ensure that a minimum 10% of all inspections carried out annually are

unannounced, as required by Section 2 and 4(c) of the WI Plan.Org.W01(06) of the CB standards and by Article 92c(2)(c) of Regulation (EC) No 889/2008.


Associated finding: No 184. Ensure that OSPs submitted by operators before inspections are complete and

accurate to allow for an adequate preparation of the inspections, as required by section 4(b) of the WI Insp.Org.W01(28) of the CB standards.


Associated findings: No 20, 21 and 225. Ensure that retroactive recognition of a previous period as part of the

conversion period is granted only after the CB is satisfied for each applicant farmer that the conditions established in section 36.02 of the CB standards are fulfilled.


Associated findings: No 33 and 34

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6. Ensure that a sampling strategy is adequately designed and implemented, and in particular that:

The planning includes taking samples at all stages of production and during unannounced controls as appropriate according to the risk profile of operators, in order to comply with Article 65(2) of Regulation (EC) No 889/2008;

It allows for evaluation of the analytical results obtained.


Associated findings: No 38, 40, 43, 44, 45 and 707. Ensure that inspections carried out at PGs are able to adequately evaluate the

effectiveness of the ICSs, as required by Section 1(b) of Annex IX to the WI Insp.Org.W01 of the CB standards, and in particular that:

Documentary checks are representative to the size of the PG; An explicit, documented evaluation of the effectiveness of the ICS

takes place, including the description of concrete failures which must lead to conclude on lack of reliability of the ICSs;

The performance of ICS inspectors is systematically evaluated and records of the evaluation kept.


Associated findings: No 51, 52, 53, 54 and 558. Ensure that CB inspections verify compliance of operators with all relevant

requirements of the CB standards, and in particular that:

Records kept by operators demonstrating the results made at reception of organic products are verified;

Verification is based in the revision of original documents kept; Calculations of the balance between the input and the output are fit for

purpose and representative of the annual production; Records kept by operators demonstrating the separation between

organic products and products harvested from buffer zones.


Associated finding: No 539. Ensure that labels used by operators on products exported to the EU are only

the labels approved by the CB, and that they contain the information required by Section 8.2 of the OSP and Article 23 and 24 of Regulation (EC) No 834/2007.


Associated finding: No 5710. Ensure that the system for the issuance of CoIs for products exported to the

EU is implemented in line with the CB standards to guarantee the fulfilment of

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article 13 of Regulation (EC) No 1235/2008, and in particular that:

Risk assessment is developed in order to decide on physical checks to be carried out for consignments for export to the EU;

CoIs are not issued for suspended operators or for products harvested from suspended production units;

Estimation of maximum production is based on realistic harvest estimations carried out by ICSs;

All quantities produced by operators are taken into account by the CB before the issuance of CoIs, including quantities exported to destinations other than the EU and quantities harvested or sold as non-organic;

Documents demonstrating the organic origin of all ingredients are requested for the issuance of CoIs for processed products;

CoIs are issued before consignments leave Peru, to ensure that the original of the certificate accompanies the goods, as required by Article 33(1) of Regulation (EC) No 834/2007.


Associated findings: No 64, 65, 66 and 73

11. Ensure that certification is only granted to operators who have demonstrated the implementation of corrective actions after the detection of non-conformities, in line with Article 65(6) of the CB standards.


Associated finding: No 6912. Ensure that increased control measures are applied to PGs where the CB finds

lack of reliability of the ICS implemented, and in particular that the CB increases the number of individual farmers subject to direct controls by the CB, as required by section 4.2.1 of Annex IX to the WI Insp.Org.W01 of the CB standards.


Associated finding: No 7313. Ensure effective follow-up of irregularities notified relating to products

exported to the EU, and in particular that replies are submitted within the 30 deadline required by article 15(4) of Regulation (EC) No 1235/2008.

Conclusion upon which this recommendation is based: 78

Associated finding: No 75

The competent authority's response to the recommendations can be found at:

http://ec.europa.eu/food/audits-analysis/rep_details_en.cfm?rep_inspection_ref=2019-6704

http://ec.europa.eu/food/audits-analysis/rep_details_en.cfm?rep_inspection_ref=2019-6704

ANNEX 1 – LEGAL REFERENCES

Legal Reference Official Journal TitleReg. 882/2004 OJ L 165, 30.4.2004,

p. 1, Corrected and re-published in OJ L 191, 28.5.2004, p. 1

Regulation (EC) No 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, 20.7.2007, p. 1-23

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

Reg. 889/2008 OJ L 250, 18.9.2008, p. 1-84

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

Reg. 1235/2008 OJ L 334, 12.12.2008, p. 25-52

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

ANNEX 2: STANDARDS QUOTED IN THIS REPORT

Reference Title PublicationISO/IEC 17065:2012

Conformity assessment -- Requirements for bodies certifying products, processes and services

http://www.iso.org/

Codex Alimentarius guidelines CAC/GL 32

Guidelines for the Production, Processing, Labelling and Marketing of Organically Produced Foods

http://www.codexalimentarius.org/standards/list-of-standards/

http://www.iso.org/

