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  4.  » Endocrine disruptor assessment in the scope of the Biocidal Product Regulation: current situation

Since the application of the new criteria on endocrine disruptor (ED) in the scope of the Biocidal Product Regulation (BPR- Reg 528/2012), the pressure is put on the ED-evaluation of the active substance and the co-formulants of the biocidal products.

This situation is illustrated by the recent ECHA news published 19/03/05 (ECHA/NR/19/09). It reports the conclusion of the last meeting of the Biocidal Products Committee (BPC). The BPC requested the respective evaluating Member States (eMS) to assess whether the active substances azametiphos (CAS# 35575-96-3) and epsilon-metofluthrin (CAS# 240494-71-7) meet the new criteria for endocrine-disrupting properties before the committee adopts its opinions on the approval/non-approval. These two active substance dossiers were submitted under the former regulation, the BPD (Dir. 98/8/EC), where the ED were not included in the requested information.

This request is in line with the document CA-March18-Doc.7.a on the implementation of the scientific criteria to determine the endocrine-disrupting properties of all the active substances currently under assessment. This may imply potential new data request to the applicant, with additional delay and uncertainties for the final approbation of these active substances. In addition, for some newly approved active substances, or some with a recent BPC opinion, this process could involve the re-opening of the dossier, with unpredictable consequences.

At the biocidal product authorization level, the ED-assessment of the co-formulants could be an underestimated issue. Contrary to the active substance, no harmonized methodology is currently available for the ED-assessment of the co-formulant. The ED regulation (Reg 2017/2100) is not applicable to the biocidal products. Recent discussion at the Coordination Group level reveals that discussions on this topic are ongoing (c.f. CG-32-M-2018_Final_Public.pdf). The absence of harmonized approach means uncertainties on the outcome of the evaluation by the Members state.

The coming months will be of huge interest and the first concerned dossiers will be the reference ones. However, ED becomes a major issue for many regulatory bodies worldwide and an increasing amount of information becomes available. A pragmatic weight-of-evidence approach could be an interesting and efficient way to tackle this issue, before any publication of an harmonized method for co-formulants. We learn by walking and by capitalizing on experiences.