Overview
The European Commission has published a draft delegated regulation and annexes (Draft Regulation) to amend the data requirements for endocrine disrupting (ED) properties of active substances and biocidal products. This would see changes to the current Annexes II and III of the Biocidal Product Regulation (BPR). Feedback can be submitted to the Commission until March 12, 2020 (midnight CET).
Background
Criteria for the determination of ED properties under the BPR (Commission Delegated Regulation (EU) 2017/2100) have applied since 7 June 2018. These were supplemented by joint ECHA/EFSA Guidance, indicating the information requirements required to undertake the assessment.[1] In view of these developments, Annexes II and III of the BPR need to be "adapted to scientific and technical progress" concerning the determination of ED properties.[2] The amendments to the BPR Annexes also include "test methods ensuring a better protection of human and animal health or reducing the number of tests conducted on vertebrate animals."[3] They have been discussed on several occasions, since September 2018, in meetings of the Biocides Competent Authorities.
Consultation on the Draft Regulation
The current Draft Regulation addresses, amongst other things:
- Pre-submission meetings: Pre-submission meetings between applicant and evaluating competent authority (eCA) become mandatory to "contribute to the quality of the dossier and the progress of the evaluation process."[4] This applies to applicants for the approval of an active substance and to applicants for the authorisation of biocidal products.[5] The applicant is also required to include the conclusions of the meeting in its application.[6] However, in contrast to a previous version of the Draft Regulation, a failure of the applicant to take part in the pre-submission consultation (when requested by the eCA) cannot automatically lead to a rejection of the application under the Draft Regulation.[7] Moreover, the Draft Regulation foresees that the applicant can – in addition to the obligation of a prior inquiry under Article 62(2) – consult with the eCA on "proposed information requirements and in particular the testing on vertebrates that the applicant proposes to carry out."[8]
- Applicability: The Draft Regulation will enter into force 20 days after its publication in the Official Journal of the EU.[9] The new data requirements will start applying 12 months thereafter. Nonetheless, applicants can decide "on a voluntary basis" to apply the changes introduced by the Draft Regulation as of their entry into force and hence before their actual applicability.[10] We anticipate that pressure will be put on applicants to do so (as has been the case for the new guidance on Biocidal Product Families, which contains a similar "voluntary" early adoption clause).
- Tiered testing for ED assessment: The Draft Regulation sets out tiered testing for the assessment of ED properties. It lists the studies from which available information is taken into account and the circumstances in which "additional information or specific studies" are required. Such information may be waived if there is "sufficient weight of evidence to conclude on the presence or absence" of an ED mode of action.[11]
- Two-generation reproductive toxicity study (TGRTS): A TGRTS will only be considered if it had been initiated before the date of application of the Draft Regulation. If this is not the case, an extended one generation reproductive toxicity study (EOGRTS) has to be performed for the endpoint.[12] As an EOGRTS is a standard information requirement under the REACH Regulation in certain cases, this raises the question of data sharing across legal regimes.
- Non-actives (co-formulants) in biocidal products: The ED assessment of non-active substances (co-formulants) contained in the biocidal product at the product authorization stage is already subject to guidance, in the form of CA notes.[13] Where co-formulants have ED properties, they are considered substances of concern (SoC).[14] The Draft Regulation expressly foresees that for co-formulants the applicant has to provide (i) the supply chain information under Title IV of the REACH Regulation and (ii) information that is publicly available on the REACH dissemination website.[15] Where such information is not "sufficient or adequate" to decide whether the co-formulant has hazardous properties, the eCA can decide that further data is required.[16] The Draft Regulation also sets out which additional data may need to be provided for SoC included in a biocidal product. This enables the identification of the ED properties of that product.[17] Here also, sharing of data submitted under the REACH Regulation should be considered.
In parallel to the feedback period, the Draft Regulation has also been notified under the WTO's Technical Barriers to Trade (TBT) Agreement, where it is subject to a 60-day consultation period.[18] WTO members can submit written comments on the Draft Regulation until April 6, 2020,[19] so companies may want to make their own representations to the EU's trading partners.
In view of the potential impacts, stakeholders should consider submitting comments on the Draft Regulation by March 12, 2020. Aside from technical considerations, inherent to the assessment of ED properties of substances, stakeholders should consider the impact on these changes on their substantive and procedural legal rights.
Next steps
After the feedback period and consultation under the WTO TBT, the Commission will adopt the Draft Regulation, taking into account the comments received. Once adopted by the Commission, the Draft Regulation is then forwarded to Parliament and Council which may object to it within two months (which may be extended by an additional 2 months).[20] Only in case of an objection, would the Draft Regulation not be adopted.[21] If no objection is received, the amendment is published in the EU's Official Journal,[22] which is currently tentatively foreseen for September 2020. It would then apply in full 12 months thereafter.
[1] Guidance for the identification of endocrine disruptors in the context of Regulations (EU) No 528/2012 and (EC) No 1107/2009, available at: https://www.efsa.europa.eu/en/efsajournal/pub/5311
[2] See paragraph 1 of the Explanatory Memorandum to Draft Regulation and Article 85 of the BPR.
[3] See paragraph 1 of the Explanatory Memorandum to Draft Regulation.
[4] See Recital (3) to the Draft Regulation, Annex I (amending Annex II of the BPR), point (1)(a) of the Draft Regulation provides: “The applicant shall initiate a pre-submission consultation (…) The applicant shall document such presubmission consultations and their outcomes and shall include the relevant documents in the application” (emphasis added). Similar wording is proposed in Annex II, point 1(b) (amending Annex III of the BPR) of the Draft Regulation.
[5] Ibid.
[6] Ibid.
[7] Comments received during the Commission’s Inter-service consultation (ISC) stressed that such an approach would go beyond the Commission’s empowerment under Article 85 of the BPR, since rejections of applications are regulated by Article 29 of the BPR. See: Commission’s presentation (“CA-Feb20-Doc.3.1.”) during the 87 CA meeting in February 2020.
[8] Annex I (amending Annex II of the BPR), point (1)(a) of the Draft Regulation and Annex II, point 1(b) (amending Annex III of the BPR) of the Draft Regulation.
[9] Article 3 of the Draft Regulation.
[10] See Recitals (18)-(19) to the Draft Regulation and Article 3 of the Draft Regulation.
[11] Annex I, point (2)(j) of the Draft Regulation (amending Annex II, section 8.13.3 of the BPR).
[12] Recital (10) to the Draft Regulation and Annex I, point (2)(j) of the Draft Regulation (amending Annex II, section 8.10.2 of the BPR).
[13] CA-March18.Doc.7.3.b.-Final
[14] Paragraph 36 of Guidance CA-March18.Doc.7.3.b.-Final and Article 3(1)(f) and Annex VI, 23 and 48 of the BPR.
[15] Recital (17) to the Draft Regulation and Annex II, point 1(a) (amending Annex III of the BPR) of the Draft Regulation, which cross-refers to Article 77(2)(e) of the REACH Regulation.
[16] Ibid.
[17] Annex II, point 2(e) (amending Annex III, section 8.7 of the BPR) of the Draft Regulation: “Tests listed in Section 8 of the table in Title 1 of Annex II shall be carried out for the substance(s) of concern or a mixture that a substance(s) of concern is a component of if insufficient data are available and cannot be inferred through read-across, in silico or other accepted non-testing approaches."
[18] Commission’s WTO TBT Notification with reference G/TBT/N/EU/698 , available at: http://tbtims.wto.org/en/RegularNotifications/View/161741?FromAllNotifications=True
[19] Ibid.
[20] Paragraphs 18-19 of the Common Understanding on Delegated Acts, annexed to the Interinstitutional Agreement between the European Parliament, the Council of the European Union and the European Commission on Better Law-Making OJ L 123, 12.5.2016, p. 1–14.
[21] Ibid.
[22] Ibid., paragraph 24.
