HEALTH AND FOOD SAFETY DIRECTORATE-GENERAL
Directorate E – Food and feed safety, innovation
E4 - Pesticides and Biocides
67th meeting of representatives of Members States Competent Authorities for the implementation of Regulation (EU) No 528/2012 concerning the making available on the market and use of biocidal products
Subject: Submission of applications for the renewal of approval of active substances for the period 2016-2020
According to Article 13(1) of Regulation (EU) 528/2012, an application for the renewal of approval of an active substance shall be submitted at the latest 550 days before the current expiry date of approval.
The objective of this document is to present an overview of the deadlines to submit applications for the renewal of approval of active substances for the period 2016-2020. It also provides a return of experience on some cases and identified issues and presents some proposals to ensure that the renewal process can run as smoothly as possible.
1- Overview of the deadlines for submissions for the period 2016-2020
An overview of the coming deadlines for the submission of the application for renewal of approval is presented in Appendix I to this document. This overview does not include anticoagulant rodenticides, for which separate discussions already took place.
From this overview it can be noted that :
· 33 applications for the renewal of active substance/product-type combinations (AS/PT) may be submitted by the end of 2020 included.
· Among these 33AS/PT combinations, 10 relates to active substances meeting the exclusion criteria, and 6 to substances meeting the substitution criteria.
· Most applications will concern wood preservatives (PT08) and insecticides (PT18) active substances.
· Applications relates to substances which were assessed by various original eCAs.
2- Using past experience, identified issues for further attention and proposals
On the basis of the experience on the first cases of applications for renewal of active substances (i.e. anticoagulant rodenticides), some areas have been identified for discussion with ECHA, Member States and prospective applicants. Proposals are made to remedy the issues encountered.
- Coordination of the renewal process
From the experience on anticoagulant rodenticides, it is shown that some coordination is needed to ensure that the process of renewal will run smoothly.
On the recent case of creosote, for which the application for renewal should be submitted by 27/10/2016, the applicant entered into contact with potential evaluating competent authorities very lately.
Proposal: an increased coordination shall take place before the submission of application for renewal, and that this process is operated by ECHA. This could include sending reminders 1.5 year before the deadline of submission to the original participants and suppliers listed on article 95 list. In any case, the original participant and prospective applicants shall contact ECHA and the eCA at least 1 year in advance to inform about its intention to submit or not an application for renewal for its active substance. This 1 year period will be useful for ECHA and the eCA to plan resources, to organise pre-submission meetings with the eCA, discuss the data requirement and specific data to be included in the application, and to ensure that any applicants interested on the same AS/PT combination can have sufficient time to collaborate. Pre-submission meetings between the prospective applicants and the future eCA are considered essential to facilitate the renewal process.
ECHA will inform Commission and Member States regularly about the state of play.
- Original participants, article 95 suppliers and other prospective applicants for the same active substance/product-type combinations
The provisions of the BPR ensure that companies interested on an active substance contribute to the process, and costs, of having an active substance approved, or its approval renewed. This was in particular the objective of the provisions of Article 95 and the list of active substance suppliers to correct the former situation where some suppliers were not contributing to the system. Actions still have to be taken by alternative suppliers so that they can remain on the article 95 list, as provided in Article 95(7) of the BPR.
Similarly to the approval process, there is no obligation for companies to co-operate and to submit one single application for the renewal of the same AS/PT combination, but there is an obligation for ECHA to deliver one opinion as to whether or not the approval may be renewed. Submission of separate multiple applications generate additional costs, need for additional resources, work and complications for both companies and authorities. This happened for the renewal of brodifacoum where a single BPC opinion and one single Assessment Report had to be prepared by the eCAs.
In case a new company, not present on the EU market yet, would like to join the other prospective applicants, the technical equivalence of its source of active substance will need to be ensured in accordance with the procedure set under Article 54 of the BPR.
Proposal: companies interested to support the same active substance/PT combination shall cooperate and submit, as much as possible, one unique collective application for the AS/PT combination. Prior to the submission, these companies shall also ensure that their sources are all considered technically equivalent to the reference specification set for the active substance.
- Finding the evaluating competent authority for the renewal[1]
Although flexibility was introduced in the BPR concerning the choice of the eCA, the Commission reads this provision as a flexibility offered to prospective applicants to change by mutual agreements between all parties involved (original eCA, new eCA and applicant). It should not lead to a situation where finding an eCA becomes problematic, for instance, in case the original eCA refuses to assess a substance. Such a situation may jeopardize the organisation of the work, and could lead to a situation where all Member States could refuse to be an eCA on a substance. It can also create difficulties in resources in Member States. The situation might even be more complex in case several different applicants finally submit separate applications to different eCAs[2]. In addition, the original eCA has generally more expertise on the active substance, having worked extensively on the original approval and most of the times on many applications for product authorisation as reference or concerned MS. This should facilitate its work as the eCA for the renewal and ensure better continuity (although staff might have been subject to turn over).
Proposal: Member States should take necessary actions to ensure a proper implementation of the legislation and try to ensure continuity in the work. By default, the eCA shall be the same for the renewal as for the original approval, unless mutually agreed between the original and the new eCA (and with the applicant(s)'s agreement whenever possible). This implies that other Member States should not accept to be the eCA unless such agreement can be found. The situation of having a different eCA than the original one should remain exceptional to try to ensure continuity and to benefit from most of the knowledge and expertise that this CA holds on this AS/PT combination. This would also have the advantage that the work remains equitably shared across Member States.
- Setting the deadline for submission of the application for renewal when the active substance is approved, or under evaluation, for several product-types
The second sentence of Article 13(1) of the BPR mentions that where there are different expiry dates for different product types, the application shall be submitted at least 550 days before the earliest expiry date. The objective would be to renew the approval of all PTs at the same time to benefit from some synergies.
With more experience with the approval process of active substances and a better organisation of the work programme set in Regulation EU No 1062/2014, this provision in the BPR seems to create some unexpected complications. Among others:
· Different applicants might have supported the original approval for different PTs, and might be interested in renewing the approval for different PTs.
· An existing active substance might be approved for a "new PT" (i.e. not in the review programme) only a few years or months before the expiry of the approval for the existing PT(s). In such situation, asking for the renewal of approval for that new PT at the same time as the existing one(s) could be seen as of little value, and considered unfair to the participant who would not benefit from a "normal" duration of approval for that new PT.
· An example is DDAC (CAs n°7173-51-5, entry 397 in the Review regulation): the substance might be approved in the end for PT1, 2, 3, 4, 8, 10, 11 and 12. The approval decision has already been taken for PT08 which will expire on 31/01/2025, with an application for renewal to be submitted by 31/07/2023. PT 10 might be approved only in 2021 or 2022 as it is part of the 5th priority list, and PT12 might be approved only in 2023 or 2024 as it is part of the last priority list of the review programme. In such case, it would make no sense to ask companies for the renewal application for PT10 or PT12 in 2023 although the substance for that PT would just have been approved at that time and no product authorisation would have yet been given at that time for those PTs.
· Specific category approach has been established on some substances or product-types, and may also be established for other active substances/product-types in the future. For instance, for active substances supported for PT21 "antifouling products", a specific approach has been agreed that the renewal of approval should take place at the same time, with applications for renewal to be submitted by 31/06/2024[3]. Certain active substances supported for PT21 are also supported for other PTs. This is the case for tolylfluanid already approved for PT08, with a deadline to submit the application for renewal on 28/02/2020, also approved for PT21 (expiry date of approval of 31/12/2025), and is still under evaluation for PT07 (5th priority list, CA reports expected by 31/12/2020).
· Such approach goes against the organisation of the work by category/product-types of biocidal products (i.e. priority lists).
Proposal: Since its origin in 2003, the review of active substances has been organised per priority lists, which have been re-organised in Regulation 1062/2014. From now on, for the first approvals, the priority lists shall be better followed by Member States and ECHA in the organisation of the review programme. As seen with experience, a review per priority lists also helps to better ensure i) that biocidal products for same uses are subject to the same rules at the same time, ii) a better use of resources, iii) that specific issues on specific PTs can be handled properly, and iv) a better identification of alternatives for active substances subject to exclusion/substitution.
An option could be to apply the provisions of Article 13(1), where possible, by setting the deadline by grouping product types per priority list of the review programme as set in Annex III to Regulation 1062/2014. In other words, the deadline for submission for a PT of a given substance should be the earliest deadline of the priority list to which the PT belongs for that substance. This may limit the unforeseen issues mentioned above, but will not make them totally disappear (e.g. for tolylfluanid, the applicant interested to support PT8 and 21 would thus still normally submit its application for both PTs by 28/02/2020, although it was agreed to assess PT21 renewals only in 2024…).
In a spirit of pragmatism, another option would be to ignore the provisions of the second sentence of Article 13(1) if Member States agree, and only rely on the first sentence of Article 13(1) to set the deadline of submission of an application: the application for renewal for a PT shall only be submitted at the latest 550 days before the expiry date of approval for that PT. This will make disappear most, if not all, the issues listed above. The deadlines for the renewal process would therefore directly depend on a better organisation of the current first approval process of the review programme.
The Commission proposes to follow the second option if Member States agree.
- Timing for the submission of applications for the renewal of approval
The BPR sets the deadline for the submission of application for the renewal of approval, but does not set the time as from when such an application may be submitted. In practise, this has not been an issue as past applications were submitted a few days/weeks before the deadline. Nevertheless, establishing a 1-month period for submission may be useful for the planning of the work and resources needed both in ECHA and in evaluating Competent Authorities.
Proposal: applications for renewal of approval shall be submitted by applicants during a period of 1 month preceding the deadline. This would also ensure that time is used in the most efficient manner to avoid the issues expressed in the previous sections 1, 2, 3 of this document.