Consultas sobre potenciais candidatos para substituição e condições de derrogação
Consultas sobre potenciais candidatos para substituição e condições de derrogação
Consultas sobre potenciais candidatos para substituição e condições de derrogação
If an active substance meets any of the criteria for substitution listed in Article 10(1) of the Biocidal Products Regulation (BPR), then the evaluating competent authority may identify the substance as a potential candidate for substitution (CfS).
If this is the case, normally before submitting its opinion on the approval or renewal of the renewal of the active substance to the Commission, ECHA will launch a consultation to collect information on potential alternatives to this substance (Article 10(3) if the BPR).
In addition to be a candidate for substitution, an active substance might meet the exclusion criteria listed in Article 5(1) of the BPR:
- 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
Active substances meeting these exclusion criteria should normally not be approved. However, 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.
Moreover, Article 5(2) of the BPR specifies that the availability of suitable and sufficient alternative substances or technologies shall be a key consideration when deciding on the approval of substances meeting the exclusion criteria.
If at least one of the derogation conditions is met, 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.
ECHA collects additional information whether these substances meet at least one of the derogation conditions through third-party consultations.
This page lists the ongoing third-party consultations on the availability of alternatives for substances which are potential candidate for substitution and, in addition, for substances meeting the exclusion criteria, on argumentation for meeting at least one of the derogation conditions.
The information submitted may be non-confidential or confidential. However, it is highly recommended to submit the information as much as possible as non-confidential and to keep the information claimed confidential to a minimum. Please see the file “Instructions for comments on CfS and derogations” below for more details on how to submit information and how the received information will be handled.
For substances meeting the exclusion criteria of BPR Art.5(1) the availability of suitable alternatives is a key consideration for deciding on the approval of the substance. Therefore, if you wish to provide justifications on derogation conditions according to BPR Art.5(2) please also provide information on alternatives and explain how this is linked with your argumentation related to the derogation conditions.
Public consultation on potential candidates for substitution-biocidal active substances - previous consultations link
| CfS & Derogation | Alpha-bromadiolone | - | - | 14 | 24/05/2024 | 23/07/2024 | Details |
| CfS & Derogation | Brodifacoum | 259-980-5 | 56073-10-0 | 14 | 24/05/2024 | 23/07/2024 | Details |
| CfS & Derogation | Bromadiolone | 249-205-9 | 28772-56-7 | 14 | 24/05/2024 | 23/07/2024 | Details |
| CfS & Derogation | Chlorophacinone | 223-003-0 | 3691-35-8 | 14 | 24/05/2024 | 23/07/2024 | Details |
| CfS & Derogation | Coumatetralyl | 227-424-0 | 5836-29-3 | 14 | 24/05/2024 | 23/07/2024 | Details |
| CfS & Derogation | Difenacoum | 259-978-4 | 56073-07-5 | 14 | 24/05/2024 | 23/07/2024 | Details |
| CfS & Derogation | Difethialone | 600-594-7 | 104653-34-1 | 14 | 24/05/2024 | 23/07/2024 | Details |
| CfS | epsilon-metofluthrin | - | 240494-71-7 | 18,19 | 24/05/2024 | 23/07/2024 | Details |
| CfS & Derogation | Flocoumafen | 421-960-0 | 90035-08-8 | 14 | 24/05/2024 | 23/07/2024 | Details |
| CfS & Derogation | Iodine | 231-442-4 | 7553-56-2 | 3 | 24/05/2024 | 23/07/2024 | Details |
| CfS & Derogation | Polyvinylpyrrolidone iodine | - | 25655-41-8 | 1, 3 | 24/05/2024 | 23/07/2024 | Details |
- Instructions for comments on CfS and derogations [PDF][EN]
- Submission of information in the consultation on potential candidates for substitution under the Biocidal Products Regulation [PDF][EN]
- Analysis of alternatives to biocidal active substances for applicants and authorities: a recommended framework guidance [PDF][EN]
- Guidance on the preparation of socio-economic analysis as part of an application for authorisation [PDF][EN]