C-374/20 P: Approval or renewal of approval of an active substance; confirmatory information according to Regulation 1107/2009; broad discretion of the administration; the admissibility of a dossier by the RMS does not constitute a decision on the quality; supplementary summary dossier; procedure for the approval or the renewal of an active substance; possibility of the RMS to review its assessment; main objectives pursued; applicability of the principle of subsidiarity to active substances.

“50      It is clear from Article 6(f) of, and point 2.2 of Annex II to, Regulation No 1107/2009 that the characterisation of information as ‘confirmatory information’, within the meaning of those provisions, assumes that the Commission has granted approval of an active substance subject to that information being provided.

51      Thus, in the absence of a Commission decision on approval of an active substance, information requested at the stage of the assessment of the renewal of such a substance cannot be characterised as ‘confirmatory information’, within the meaning of those provisions.

52      It must be found that those provisions do not establish an obligation, but merely the power of the Commission to grant such approval. In that regard, Article 6(f) of Regulation No 1107/2009 provides that approval may be subject to conditions, including submission of confirmatory information, and point 2.2(b) of Annex II to that regulation states that, in exceptional cases, an active substance may be approved even though certain information is still to be submitted, where the information is considered to be confirmatory in nature.

53      It follows from settled case-law that, in the case of complex factual assessments, the EU authorities enjoy, in some areas of EU law, a broad discretion, so that review by the EU judicature of those assessments must be confined to ascertaining whether there has been a manifest error of assessment or a misuse of powers, or whether those authorities have manifestly exceeded the limits of their discretion (see, to that effect, judgment of 28 January 2016, Heli-Flight v EASA, C‑61/15 P, not published, EU:C:2016:59, paragraph 101 and the case-law cited).

54      That applies in the case of a Commission decision granting first approval or renewal of approval of an active substance within the meaning of Regulation No 1107/2009.

71      … the fact that the dossier formally contains all the items in order for the rapporteur Member State to be able to declare that application to be admissible does not in itself constitute a decision on the quality of those items from a scientific point of view, which may necessitate an in-depth study and may result in diverging assessments by that Member State and EFSA.

73      … It is clear from Article 8(2) of Implementing Regulation No 844/2012 that, if the rapporteur Member State considers that that dossier is incomplete, it is to inform the applicant of which elements are missing and set a period of 14 days for the applicant to provide it with those elements.

76      It therefore follows from all of those provisions that, contrary to what the appellant claims, once the rapporteur Member State has declared the application for renewal of an active substance admissible, within the meaning of Articles 7 and 8 of Implementing Regulation No 844/2012, EFSA is entitled to call into question the completeness of the information provided by the applicant at the merits stage of its application for renewal. Any other interpretation would undermine the provisions of Regulation No 1107/2009 and of Implementing Regulation No 844/2012.

77      Thus, even if the rapporteur Member State declares the application for renewal admissible, it is expressly provided, in Article 11(5) and Article 13(3) of Implementing Regulation No 844/2012, respectively, that that Member State and EFSA may, at the assessment stage of that application, require that the applicant supply additional information.

78      In that connection, it should be observed that the information relating to the admissibility of the application, communicated to the applicant by the rapporteur Member State, in accordance with Article 8(1) of Implementing Regulation No 844/2012, serves principally, first, to confirm to the applicant that its application and complementary dossiers contain all of the elements required under Articles 2 and 7 of that implementing regulation and, second, to trigger the 12-month period, laid down in Article 11(1) thereof, which requires the rapporteur Member State to prepare and submit the draft renewal assessment report to the Commission, with a copy to EFSA.

81      It must be held that Article 11(5) and Article 13(3) of Implementing Regulation No 844/2012 fix specific periods for the applicant to supply that information, the exceedance of which has practical consequences for the next part of the procedure. Thus, Article 13(3) lays down a maximum period of one month and, under Article 13(5), the information that the applicant supplies after the expiry of that period is not taken into account, unless it is submitted in accordance with Article 56 of Regulation No 1107/2009, which provision is not applicable in the present case.

82      The imposition of those periods and the requirement that they be observed are, moreover, as the Commission states, consistent with the requirement that the duration of the procedure as a whole not exceed three years, as is clear from Article 1(1) of Implementing Regulation No 844/2012.

98     …although, by its draft assessment report, referred to in Article 11 of Implementing Regulation No 844/2012, the rapporteur Member State assesses whether the active substance concerns can be expected to meet the approval criteria in accordance with Article 4 of Regulation No 1107/2009, none of the provisions of Implementing Regulation No 844/2012 precludes that Member State from thereafter amending the position expressed in that report.

99      Conversely, first, the fact that Article 11 together with Articles 12 to 14 of Implementing Regulation No 844/2012 use the words ‘the draft renewal assessment report’ from the rapporteur Member State clearly indicates that, as a draft, that report is liable to be revised.

100    …it follows from Article 13(3) of that implementing regulation that where, as in the present case, EFSA, in the conclusions that it must adopt after receiving the draft renewal assessment report from the rapporteur Member State as well as the observations of the parties concerned, considers that additional information from the applicant is necessary, ‘the rapporteur Member State shall … evaluate the information received and send its evaluation to [EFSA]’.

101    It follows that if, in particular, in the light of the additional information sent by the applicant under Article 13(3) of Implementing Regulation No 844/2012, the rapporteur Member State finds that data gaps, identified by EFSA in its request for information, have not been filled, it may avail itself of the possibility of amending its initial assessment. Consequently, it does not follow from that provision that the rapporteur Member State is bound by its initial assessment, set out in its draft assessment report, if that assessment has changed on scientific grounds over the course of the process to which that regulation refers. On the contrary, it is clear from that provision that the procedure put in place seeks to afford that Member State the possibility, or even the obligation, to amend its draft renewal assessment report.

102    It should be added that this interpretation of the provisions of Implementing Regulation No 844/2012 and, in particular, of Article 13(3) contributes to achieving one of the main objectives pursued by Regulation No 1107/2009 which, as it follows from Article 1(3) of that regulation, read in the light of recital 8 thereof, consists in ensuring a high level of protection of both human and animal health and the environment, which objective Implementing Regulation No 844/2012 implements in so far as concerns the renewal procedure for active substances. This interpretation serves to ensure that EFSA’s conclusions, which take account of the rapporteur Member State’s assessment further to the additional information provided by the applicant under Article 13(3) of Implementing Regulation No 844/2012, and which the Commission must take into account in its renewal report as well as its draft regulation, as provided in the second subparagraph of Article 14(1) of that regulation, are based on all information deemed relevant in the light of current scientific and technical knowledge.

103    Lastly, as regards the arguments submitted in the alternative by the appellant, it should, first, be observed that the fact that, unlike the draft initial assessment report, the revised assessment report was not submitted to the various intervening parties for their observations does not mean that the latter report cannot be taken into account. The revised assessment report was in fact adopted by the rapporteur Member State in question further to the answers given by the applicant under Article 13(3) of Implementing Regulation No 844/2012. Furthermore, and in any event, the applicant still has the possibility of submitting observations on the renewal report adopted by the Commission which, as stated in the preceding paragraph, must take account, inter alia, of EFSA’s conclusions, since these include any assessments made by the rapporteur Member State and submitted by it after its initial assessment report.

124    First, it is clear from the wording of Article 1(4) of Regulation No 1107/2009 that the precautionary principle applies to active substances. That article provides that the provisions of the regulation are underpinned by the precautionary principle in order to ensure that active substances or products placed on the market do not adversely affect human or animal health or the environment. Furthermore, recital 8 of the regulation states that the precautionary principle should be applied and that this regulation should ensure that industry demonstrates that substances or products produced or placed on the market do not have any harmful effect on human or animal health or any unacceptable effects on the environment”.