ECHA public consultation: derogation to the exclusion criteria

Active substances meeting the following exclusion criteria should normally not be approved for use in biocidal products:

  • Carcinogens, mutagens and reprotoxic substances categories 1A or 1B according to the CLP Regulation
  • Endocrine disruptors
  • Persistent, bioaccumulative and toxic (PBT) substances
  • Very persistent and very bioaccumulative (vPvB) substances

If it is shown that the active substance meets certain conditions and there are no substitutes, it may be approved for a period of five years in derogation of the above regulations. These conditions are defined in Article 5(2) of the Biocidal Products Regulation (BPR).

It is important for interested parties (manufacturers, the sector concerned, users, authorities, etc.) to provide all the information on the existence (or absence) of suitable alternatives in the course of the public consultation. On the basis of the data collected a decision will be made on whether the active substance meets the conditions set out in Article 5(2) of the BPR and can be approved.

The public consultation is organised by the European Chemicals Agency (ECHA), to which relevant information can be sent directly.

Last public consultation:

  • Cholecalciferol (CAS Nr.: 67-97-0) product type 14

Deadline for communication of information: 31/03/2024

More information and commenting on ECHA website:

Consultation on derogation to the exclusion criteria - ECHA (

Last modification 28.02.2024

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