On March 27, 2017 the European Commission’s (EC) Directorate-General for Health and Food Safety (DG SANTE) released the minutes of the latest meeting of the EC with EU Member States (MS) competent authorities (CAs) for biocidal products regarding the criteria to identify endocrine disrupting chemicals (EDCs) in the field of plant protection products and biocides. The meeting took place on February 28, 2017 in Brussels, Belgium. On the same date, the EC’s Standing Committee on Plants, Animals, Food and Feed (PAFF) also discussed the latest version of the EC’s draft EDC criteria (FPF reported). The PAFF Committee did not cast a formal vote on the criteria because “no qualified majority would have been achieved.”
During the CA meeting, the EC explained that under the Plant Protection Products Regulation (PPPR), adoption of the EDC criteria requires a vote in the PAFF Committee. Under the Biocidal Products Regulation (BPR), no vote by the Standing Committee on Biocidal Products is required for adoption of the EDC criteria. Instead, the European Council and European Parliament (EP) can object the criteria, preventing their publication and entering into force.
The EC highlighted the main differences between the previous version of the EDC criteria of December 2016 (FPF reported) and the most recent version of February 2017 (FPF reported), which include “a transition clause of 6 months, a revision clause, and the redrafted provision for growth regulators.” The EC also outlined “the few changes introduced to the draft [criteria] as a consequence of the discussion with MS” during the PAFF Committee meeting in the morning of February 28. MS as well as EP experts then provided extensive feedback on the EC’s draft EDC criteria, expressing concern as well as approval regarding various points.
The EC noted the concerns raised regarding the redrafted provision on growth regulators, which exempts active substances with “intended endocrine modes of action to control harmful organisms” from the EDC criteria. Another issue discussed was the impact of applying the EDC criteria to co-formulants on product authorizations. Further, the EC took note of points raised on read-across and the horizontal applicability of the EDC criteria to other regulations, such as the Medical Devices Regulation.
The EC assured to “keep MS informed regarding the date and venue of another meeting to discuss further the draft delegated act and conclude the discussions on it before moving to the adoption procedure.”
DG SANTE (March 27, 2017). “Draft minutes – 69th 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 – 28 February 2017.” (pdf)