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Decision of the European Ombudsman in Case 268/2021/VS Against the European Commission in Relation to a Procedure to Renew the Approval of an Active Substance

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Decision of the European Ombudsman in Case 268/2021/VS Against the European Commission in Relation to a Procedure to Renew the Approval of an Active Substance European Ombudsman Decision of the European Ombudsman in case 268/2021/VS against the European Commission in relation to a procedure to renew the approval of an active substance Decision Case 268/2021/VS - Opened on 05/03/2021 - Decision on 05/03/2021 - Institution concerned European Commission ( No maladministration found ) | Dear Mr X, On 8 February 2021, you submitted a complaint to the European Ombudsman on behalf of your client. The complaint concerns the European Commission’s conduct in a procedure to renew the approval of an active substance. We identified the following concerns in your complaint. You contend that: 1. The Commission failed to consider your requests to mandate the European Food Safety Authority (EFSA) to evaluate a population modelling report. 2. The Commission refused to take into account an October 2020 study, which your client brought to the Commission’s attention on 30 November 2020. You consider that the Commission should immediately suspend the relevant regulatory procedure and request EFSA, as risk assessor, to take into account all eco-toxicological and human health data in the assessment of the substance. After a careful analysis of all the information submitted to us, our assessment is as follows. As a preliminary remark, we note that the substance of your complaint relates to an alleged error by EFSA in conducting its risk assessment. In particular, you are concerned that EFSA did not take into account certain studies that you consider relevant. Your complaint is, however, against the Commission. As such, the Ombudsman examined your concern as to whether the Commission provided adequate replies to the points that your client raised with it. As regards whether the Commission gave an adequate response to your client’s requests concerning the evaluation of the population modelling report, we note that in its reply dated 7 August 2020, the Commission informed you that it had received confirmation from EFSA 1 and the Rapporteur Member State that a full assessment had been performed, taking into account all available data, including the report in question. The Commission went on to explain that when a study put forward by an applicant was not accepted at the peer review stage, that per se did not constitute a breach of the rules but was “... a possible outcome of any scientific assessment and backed by scientific justifications and therefore also part of the normal peer review process ”. The Commission also informed you that until the risk assessment process is concluded, an applicant should engage with EFSA and with the Rapporteur Member State in case of concerns about the risk assessment. Finally, the Commission clarified that once the EFSA conclusion was available, the applicant would be invited to submit comments to be carefully considered by the Commission as part of the decision-making process. In view of the strict separation between risk assessment and risk management, as laid down in the General Food Law, the Commission’s reply and the explanations it provided to your client are reasonable. It is not for the Commission to interfere with EFSA’s scientific risk assessment. We also note that in accordance with Article 14(1) of Implementing Regulation 844/2012 [1] , your client submitted comments on the Commission’s renewal report, once the risk assessment process had been concluded. The Commission confirmed to your client that it will take the comments into consideration in the decision-making process (within the scope of the comitology procedure). We also consider this response of the Commission to be reasonable. Regarding the new study of October 2020, which you submitted to the Commission on 30 November 2020, we note that, referring to Article 13(5) of Implementing Regulation 844/2012, the Commission replied on 11 December 2020 that unsolicited information, or information sent after the deadline, could not be taken into account by EFSA. In this regard, we note that Article 13 of Implementing Regulation 844/2012 concerns EFSA’s risk assessment. In particular, Article 13(5) states that unsolicited information or information provided by the applicant after the expiry of the deadline set by EFSA, cannot be taken into account, “ unless it is submitted in accordance with Article 56 of Regulation (EC) No 1107/2009 ”. Your client submitted the study in question after EFSA’s conclusion was finalised. We also note that Article 13(5) allows for only one justification for submitting information late to EFSA, namely when that information relates to Article 56 of Regulation 1107/2009 [2] - information on potentially harmful or unacceptable effects. The information contained in the October 2020 study was not of that nature. Therefore, the Commission correctly explained the rules applicable to the submission of information by applicants. Based on the above analysis, our conclusion is that the Commission provided adequate replies to your concerns. We have decided to close the case as we have not identified any possible maladministration on the part of the European Commission in its handling of the matter to date. [3] We understand you may be disappointed with this outcome but we hope you find these explanations useful. 2 Yours sincerely, Rosita Hickey Director of Inquiries Strasbourg, 05/03/2021 [1] Commission Implementing Regulation (EU) No 844/2012 of 18 September 2012 setting out the provisions necessary for the implementation of the renewal procedure for active substances, as provided for in Regulation (EC) No 1107/2009 of the European Parliament and of the Council concerning the placing of plant protection products on the market, available here: https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=CELEX%3A32012R0844 [2] 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, available here: https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=CELEX%3A32009R1107 [3] Full information on the procedure and rights pertaining to complaints can be found at https://www.ombudsman.europa.eu/en/document/70707 3.
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