Background to the complaint

1. Plant protection products (commonly referred to as pesticides) contain at least one ‘active substance’. In the European Union, such substances must be approved under a procedure laid down in the Pesticides Regulation^[1]. Such approvals are granted for a specified period of time.

2. To ensure that pesticides are used safely and that their approval for use is always based on the latest scientific information and knowledge, the Commission must regularly reassess active substances approved for use. To this end, producers of an approved active substance must apply for the approval to be renewed^[2] no later than three years before it is scheduled to expire.

3. The approval granted to active substances is renewed only if certain criteria are fulfilled, including that the substance presents a clear benefit for plant production, is not expected to have any harmful effect on human or animal health, and is not expected to have any unacceptable effects on the environment.^[3]

4. The procedure for renewing the approval of an active substance consists of several steps.^[4] The producer of an active substance applies to the designated EU Member State, the so-called ‘Rapporteur Member State’. The Rapporteur Member State determines whether the application is admissible and conducts a risk assessment (by preparing a ‘renewal assessment report’). The European Food Safety Authority (EFSA) then issues conclusions based on the risk assessment conducted by the Rapporteur Member State.^[5] It is then for the Commission to make a recommendation on whether or not to renew the approval, which is voted on by the representatives of Member State governments on the Standing Committee for Plants, Animals, Food and Feed (PAFF Committee)^[6]. Following the PAFF Committee’s vote, the Commission takes a final decision on whether or not to renew the approval.

5. According to Article 17 of the Pesticides Regulation, where the approval of an active substance is likely to expire before the above-mentioned renewal procedure has been completed, the Commission is required to extend the approval for the duration of the renewal procedure, provided the delay is “beyond the control” of the producer that applied for the substance to be reapproved.

6. This complaint to the Ombudsman was submitted by the NGO Pesticide Action Network (PAN) Europe. On 3 January 2018, the complainant wrote to the European Commissioner for Health and Food Safety, expressing concern about the Commission’s systematic practice of extending the approval of active substances when there are delays in the renewal procedure. The complainant was particularly concerned about the use of this practice for hazardous active substances, which are considered carcinogenic, mutagenic or toxic for reproduction.

7. On 30 January 2018, the Commissioner replied, stating that he shares the complainant’s concerns regarding the delays in the renewal procedure. However, he stated that, in order to ensure legal certainty and to respect the provisions of the Pesticides Regulation, the Commission cannot allow the approval of an active substance to expire before it has taken a decision on an application to renew the approval.

8. Dissatisfied with the Commission’s reply, the complainant turned to the Ombudsman on 9 April 2018.

The inquiry

9. The Ombudsman opened an inquiry into the complainant’s concerns that the Commission:

a) wrongly extends the approval period of active substances using Article 17 of the Pesticides Regulation, which is supposed to be a “derogation” to the rules and not a “standard procedure”; and

b) wrongly applies this provision to hazardous active substances.

10. In the course of the inquiry, the Ombudsman asked the Commission to reply to a number of questions based on the complainant’s concerns. The Ombudsman also received the comments of the complainant in response to the Commission's reply.

Arguments presented to the Ombudsman

By the complainant

11. The complainant argued that the Commission currently uses Article 17 of the Pesticides Regulation as a “standard procedure” for extending the approval of active substances - in some cases multiple times - whereas this provision should be understood as a “derogation” to the rules in the Pesticides Regulation. This approach is at odds with the purpose of the rules, which set out limited approval periods to be reassessed based on the latest scientific and technical information.

12. The complainant expressed particular concern about the Commission’s application of Article 17 to hazardous active substances. According to the Pesticides Regulation, active substances must not be approved if they are mutagenic^[7], carcinogenic^[8] or toxic for reproduction^[9]. Nor should active substances be approved if they are considered to be persistent organic pollutants.^[10]  

13.  The complainant mentioned five examples of active substances that are classified as toxic for reproduction (Glufosinate, Linuron, Iprodion, Flumioxazin and Thiacloprid) where the Commission extended the approvals.

14. The complainant contended that Rapporteur Member States often declare applications admissible without verifying if the applications for re-approval include all necessary relevant data. The complainant argued that the Commission should first verify whether applications are complete (or give EFSA the responsibility for doing so) in order to prevent delays at a later stage in the procedure.

Arguments presented by the Commission

15. The Commission pointed out that, under the Pesticides Regulation, there is a two-stage procedure for approving active substances, with a clear separation between assessing risks and managing risks. The risk assessment (the scientific evaluation) is carried out by a Rapporteur Member State and EFSA (as detailed above). The Commission, in consultation with the PAFF Committee, is then responsible for determining how to manage any risks identified with an active substance.

Extending the approval of active substances based on Article 17

16. The Commission argued that, according to Article 17 of the Pesticides Regulation^[11], it is required to adopt a decision extending the approval of an active substance “for a period sufficient to examine the application”, where the delay in the renewal procedure is caused by “reasons beyond the control of the applicant”^[12]. The Commission stated that, in such cases, it prefers to extend approvals for a limited period (and then extend again if necessary), rather than to extend for a longer period. Any extension becomes obsolete once the Commission has taken a decision on whether to renew an approval or not.

17. The Commission contended that the condition “for reasons beyond the control of the applicant” is met where the applicant has submitted its application and accompanying documents within the time limits set out in the applicable rules, and where the Rapporteur Member State has found the application to be admissible.^[13]

18. For active substances that have been classified, or should be classified, as carcinogenic, mutagenic or toxic for reproduction, the Commission argued that the evaluation is part of the scientific risk assessment, which is carried out by the Rapporteur Member State and EFSA. The Commission, as the risk manager, does not have a role in this risk assessment, and is obliged to extend the approval while the assessment is ongoing.

Delays in the procedure for renewing approvals

19. The Commission acknowledged that it frequently extends the approvals of active substances based on Article 17 of the Pesticides Regulation “because of a considerable backlog in concluding the renewal process”. It explained that the delays^[14] occur for various reasons, but happen mainly during the risk assessment by the Rapporteur Member State^[15].

20. The Commission stated that further delays in the procedure may occur during the subsequent peer-review by EFSA. For instance, delays occur where EFSA raises additional issues, which were foreseen neither by the applicant nor by the Rapporteur Member State. This can concern the potential exposure level linked to hazardous substances.^[16] This requires additional time, as the applicant must be given a chance to express its view on the issues raised by EFSA.

21. The Commission acknowledged that delays also occur during the risk management stage, such as for controversial or complex cases involving “difficult discussions” in the PAFF Committee.

How the Commission is addressing delays in the re-approval procedure

22. The Commission stated that it has repeatedly reminded Member States to respect the deadlines in the Pesticides Regulation and that it will continue to monitor progress by Rapporteur Member States. It argued that launching infringement proceedings against the Member States responsible for delays would not be an appropriate solution to the problem, and could risk diverting additional resources of Member States, further exacerbating the problem.

23. For future assessments, the Commission noted that it has created work programmes for Rapporteur Member States and EFSA, with the assessment of substances prioritised according to the hazard profiles of active substances.

24. The Commission also stated that, in the coming months, it intends to propose revising the applicable rules^[17] in order to better align the processes of risk assessment and classification of active substances.

25. Finally, the Commission pointed out that it is in the process of evaluating^[18] the legislation on pesticides. The applicable time limits set out in the legislation, and the delays incurred, are explicitly part of this evaluation.

The Ombudsman's assessment

26. Bearing in mind the potential implications for health and the environment, it is of utmost importance that active substances in pesticides are thoroughly assessed before a decision is taken on whether or not they should be approved or re-approved.^[19] The Ombudsman appreciates, therefore, that the procedure in question takes time.

27. However, she shares the complainant’s concerns that delays in the procedure for renewing the approval of active substances in pesticides could lead to the prolonged presence of (potentially) hazardous substances on the EU market. The main question for the Ombudsman in this inquiry is the extent to which these delays can be attributed to the Commission.

a. Extension of the approval of active substances based on Article 17

28. Article 17 of the Pesticides Regulation states that, where it is likely that, for reasons beyond the control of the applicant, the approval of an active substance will expire before a decision has been taken on the application to renew the approval, the Commission “shall” adopt a regulation extending the approval period for an active substance.

29. The wording “shall” implies that the Commission has, legally, no choice: it must extend the approval period in such situations.

30. The Ombudsman also notes that Article 17 does not distinguish between approval periods granted for potentially hazardous or non-hazardous active substances. From a legal point of view, the Ombudsman therefore considers that the provision also applies to (potentially) hazardous active substances.

31. While the Commission therefore has no choice under the Pesticides Regulation but to extend the approval in these cases, the question arises whether it is good administration for the Commission to find itself in a situation of having to apply Article 17 so frequently.

32.  The Ombudsman shares the complainant’s concern about the current systemic extension of approvals for active substances. This situation is difficult to reconcile with the Pesticides Regulation’s stated objective “to ensure a high level of protection of both human and animal health and the environment”^[20] in line with the precautionary principle^[21].

33. It is therefore necessary to examine the reasons for the delays that are encountered in renewing approvals.

b. Delays in the procedure for renewing approvals

34. The Pesticides Regulation requires producers to submit applications for renewing the approval of an active substance three years before the approval expires.^[22] Commission Implementing Regulation 844/2012 sets out time limits for the different steps of the renewal procedure.

35. The Commission provided the Ombudsman with an overview of the nature and extent of the delays with these different steps. Delays occur during the risk assessment stage ─ in the preparation and peer-review of the draft assessment report by the Rapporteur Member State and EFSA ─ and during the risk management stage ─ in the drafting of the renewal report by the Commission and in the deliberations in the PAFF Committee.

Delays during the risk assessment stage

36. According to the Commission, in the vast majority of cases (90%), Rapporteur Member States are unable to complete draft assessment reports within the 12-month time limit. Various Member State authorities informed the Commission that they consider this time limit too short, given the complex nature of assessments and, in some cases, the limited resources available. They also indicated problems with overlapping rules^[23] and the lack of clear guidance on how to determine exposure levels for hazardous substances.

37. The Ombudsman cannot assess whether the justifications given for the delays are valid. She recognises, however, that comprehensively assessing substances to determine potential risks to health and the environment takes time. 

38. As a matter of good administration, the Commission must make every effort to prevent, or at least to reduce, undue delays in the procedure for assessing applications to renew the approval of active substances in pesticides. In doing so, the Commission must, however, act within its mandate and comply with the applicable rules. As such, the Commission has no role in determining whether an application to renew an approval is admissible; this is the role of the Rapporteur Member State. Any involvement of the Commission in the risk assessment stage would contravene the clear separation between this stage and the risk management stage, which is required under the Pesticides Regulation^[24].

39. However, the Commission must ensure that it supports those involved in the risk assessment in any possible way. To this end, it should provide the necessary technical guidance on how to apply all the relevant provisions of the Pesticides Regulation (notably, concerning exposure levels). It should also make sure that the applicable rules are up-to-date and do not contain conflicting or non-aligned provisions. The Commission should adopt such measures whenever necessary and without undue delay. The Ombudsman will make a suggestion for improvement on this aspect of the case.

40. It appears that the delays are generally due to the complexity of the assessments and the lack of resources at national level. The Ombudsman takes note of the Commission’s argument in this case that launching infringement proceedings against the Rapporteur Member State concerned is not the appropriate solution. Given the wide discretion the Commission enjoys as regards launching infringement procedures, the Ombudsman will not second guess its position on this matter. If, however, there are particularly serious cases where a Member State consistently fails to comply with its obligations, the Commission should consider this possibility.

41. By adopting ‘work programmes’ that group together similar active substances and prioritise how they are assessed according to safety concerns, the Commission is taking further action to help avoid delays.

42.  At the same time, it appears that the significant delays with risk assessments are primarily caused by the systemic weaknesses of the decentralised system for approving active substances in pesticides. Addressing these weaknesses is the task of the EU legislature. To this end, the Ombudsman welcomes the Commission’s statement in its reply to her letter that “the ongoing REFIT evaluation will assess in-depth the reasons for the non-respect of the timelines and potential knock-on effects on the overall system, which will then be the basis for considering more appropriate solutions”.

Delays during the risk management stage

43. The Commission states that it respects the six-month deadline for finalising its ‘draft renewal report’^[25] to the PAFF Committee in 75% of cases. This implies that the Commission is not meeting this deadline in one quarter of all cases. While the Ombudsman acknowledges that procedural guarantees might require the Commission to extend this period in exceptional cases, the Commission should clearly strive to complete its work on time where possible. This is particularly important, as this stage of the renewal procedure is arguably the only stage the Commission has full control over. The Ombudsman will make a second suggestion for improvement in this regard.

44. The Ombudsman appreciates that there is limited scope for the Commission to speed up the deliberations between Member States in the PAFF Committee on ‘draft renewal reports’. Given the sensitivities linked to the approval of certain active substances, with risk perceptions and political considerations varying between Member States, discussions in the PAFF Committee can clearly take time. These delays cannot be attributed to the Commission.

Conclusion

Based on the inquiry, the Ombudsman closes this case with the following conclusions and suggestions:

The European Commission’s practice of extending the approval of active substances while the assessment of applications for their renewal is ongoing is in line with its legal requirements under the Pesticides Regulation.

While it is not good administration that the Commission is in the situation of having to extend approvals so frequently, the delays giving rise to this cannot, for the most part, be attributed to the Commission.

There is therefore no maladministration by the Commission in this case. The Ombudsman, however, welcomes the fact that the Commission is currently evaluating the legislation on pesticides, including the systematic delays with reapproving active substances.

Suggestions

To support those involved in risk assessment, the Commission should provide the necessary technical guidance on how to apply all the relevant provisions of the Pesticides Regulation (notably, concerning exposure levels). It should also make sure that the applicable rules are up-to-date and do not contain conflicting or non-aligned provisions. The Commission should adopt such measures whenever necessary and without undue delay.

The Commission should identify why it fails to respects the six-month deadline for finalising its ‘draft renewal report’ in 25% of cases and take the necessary measures to address this.

The complainant and the Commission will be informed of this decision.

 

Emily O'Reilly

European Ombudsman

Strasbourg, 08/04/2019

 

[1] Regulation (EC) No 1107/2009 of the European Parliament and of the Council of 21 October 2009 concerning the placing of plant protection products on the market: https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=celex%3A32009R1107.

[2] Article 15(1) of the Pesticides Regulation.

[3] Article 4 of the Pesticides Regulation.

[4] The procedure is outlined in Articles 3 to 14 of Commission Implementing Regulation (EU) No 844/2012 setting out the provisions necessary for the implementation of the renewal procedure for active substances (hereafter Commission Implementing Regulation 844/2012): https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=CELEX%3A32012R0844.

[5] More comprehensive information on the approval (and renewal) of active substances in pesticides can be found at https://www.efsa.europa.eu/en/applications/pesticides.

[6] Standing Committees deliver opinions that inform the Commission's work on measures that it is planning. Such measures relate to the implementation of legislation that is already in force. The Commission consults the relevant committee depending on the policy area: food and feed safety, animal health and welfare, and plant health. Committee members are national experts who represent EU governments and public authorities. More information on the Standing Committee for Plants, Animals, Food and Feed: https://ec.europa.eu/food/committees/paff_en.

[7] Point 3.6.2 of Annex II to the Pesticides Regulation.

[8] Point 3.6.3 of Annex II to the Pesticides Regulation.

[9] Except where the risk of exposure is determined to be below a level that is considered to be hazardous. See Point 3.6.4 of Annex II to the Pesticides Regulation.

[10] Point 3.7.1 of Annex II to the Pesticides Regulation.

[11] The Commission refers to Article 17, first paragraph, of the Pesticides Regulation, which states that “... a decision shall be adopted” (emphasis added).

[12] This is the wording of Article 17 of the Pesticides Regulation.

[13] In line with Article 8 of Commission Implementing Regulation 844/2012.

[14] Based on the time limits for assessing applications for the re-approval of active substances set out in Commission Implementing Regulation 844/2012.

[15] The Commission stated that, in 90% of the cases, Rapporteur Member States do not respect the 12-month deadline. The Commission wrote to Member States concerning these systematic delays in February 2017, and received responses from 13 Member States listing reasons for the delays, such as the complexity of assessments, workload and lack of resources.

[16] See footnote 9.

[17] In particular, Commission Implementing Regulation 844/2012.

[18] In the context of the Commission's regulatory fitness and performance (REFIT) programme for reviewing existing legislation: https://ec.europa.eu/info/law/law-making-process/evaluating-and-improving-existing-laws/refit-making-eu-law-simpler-and-less-costly_en.  

[19] See also the decision of the Ombudsman of 18 February 2016 in case 12/2013/MDC on the practices of the European Commission regarding the authorisation and placing on the market of plant protection products (pesticides), available at: https://www.ombudsman.europa.eu/en/decision/en/64069

[20] Article 1(3) of the Pesticides Regulation.

[21] Article 1(4) of the Pesticides Regulation. According to the precautionary principle, if there is a suspicion that an activity or substance may have harmful consequences for health or the environment, the activity or substance should be controlled first, rather than waiting for incontrovertible scientific evidence

[22] Article 15(1) of the Pesticides Regulation.

[23] In particular, the different requirements in Implementing Regulation 844/2012 and Regulation 1272/2008 on the classification, labelling and packaging of substances and mixtures (https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=celex:32008R1272).

[24] Recital 12 of the Pesticides Regulation.

[25] The six-month deadline for finalising ‘draft renewal reports’ is set out in Implementing Regulation 844/2012.