European Association of Regulatory Consultants and Contract Research Laboratories

EACL

The association is a non-profit organisation.

Lobbying Activity

Response to Amendment of data requirements for applications for the approval of active substances

9 Oct 2025

1. In the introduction ANNEX, for the sake of consistency of biocontrol definition, there is the need of including "minerals" as category. In the Introduction there is the need of adding: A dossier shall be submitted in accordance with Part A if the active substance is: (c) minerals 2. In addition, minerals like copper e.g. in plant protection products, should no longer be considered subject to "PBT" classification according to Article 4.3.2.3 of Commission Delegated Regulation (EU) 2023/707 of 19 December 2022 amending Regulation (EC) No 1272/2008 as regards hazard classes and criteria for the classification, labeling and packaging of substances and mixtures. This hazard class now only applies to organic substances.
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