Consultation on derogation to the exclusion criteria
Active substances meeting the following exclusion criteria should normally not be approved:
- 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
Derogations may be possible as laid down in Article 5(2) of the BPR, when it is shown that:
- the risk to humans, animals or the environment from exposure to the active substance in a biocidal product, under realistic worst-case conditions of use, is negligible, in particular where the product is used in closed systems or under other conditions which aim to exclude contact with humans and release into the environment;
- there is evidence that the active substance is essential to prevent or control a serious danger to human health, animal health or the environment; or
- not approving the active substance would have a disproportionate negative impact on society when compared with the risk to human health, animal health or the environment arising from the use of the substance.
In this case, approval of an active substance may be granted for a maximum period of five years, and for restricted uses. In addition, Member States may only authorise biocidal products where they consider that conditions are met on their territory.
To decide if the active substance may be approved or not, a public consultation is organised to collect information on whether the conditions for derogation set out in Article 5(2) of the BPR are satisfied.
During the public consultation, the following information is made public:
- substance identity (name and EC/CAS numbers)
- evaluating competent authority
- a description of the representative uses presented by the applicant
- information on the exclusion criteria met by the active substance
It is important that interested parties (manufacturers, users of biocidal products, sector concerned, authorities etc.) contribute to the public consultation to collect valuable information for the decision-making process, in particular on the existence or absence of suitable alternatives.
Contributors must provide information with justifications, and not mere statements that a substance is needed or not needed.
Information collected through the public consultation is made publicly available.
The European Commission together with Member States will take into account the information collected when deciding whether to approve or not the concerned active substance.
How to submit a contribution to the public consultation?
The public consultation lasts for 60 days.
Interested third parties wishing to contribute to the public consultation must submit the contribution and relevant information using a secure webform.
To facilitate the analysis of the contribution and the decision-making process, the submitter must:
- indicate clearly which derogation of Article 5(2)(a), (b) and/or (c) of the BPR the submitter considers met or not met, and
- provide a detailed justification.
When a public consultation is organised on the same active substance for several product-types at the same time, the submitter must provide separate submissions for each product-type, as the derogation to exclusion is analysed product-type per product-type, and use per use within the product-type.
The submitter should also consider the recommendations provided for in the guidance on "Submission of information in the public consultation on potential candidates for substitution under the Biocidal Products Regulation". For instance, when the submitter indicates the existence or absence of alternatives in its contribution, they must be precise about the use that they refer to, the name and identity of alternative active substances or non-chemical methods to control target organisms etc.
The information submitted may be non-confidential or confidential. If you claim information to be confidential, you will need to provide a proper justification (see the guidance on "Submission of information in the public consultation on potential candidates for substitution under the Biocidal Products Regulation"). Any confidential information will only be available to the European Commission and the Member State competent authorities.