Consultations on potential candidates for substitution and on derogations conditions

Consultations on potential candidates for substitution and on derogations conditions

Consultations on potential candidates for substitution and on derogations conditions

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:

  1. 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;
  2. 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
  3. 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.

 

Submitting comments

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

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Substance Details

Scope
CfS & Derogation
Substance name
Iodine
EC Number
231-442-4
CAS Number
7553-56-2
Product type
3
Intended use
  • PT3 - Use 1: Teat disinfection - animal husbandry (Pre-milking disinfection of teats, Post-milking disinfection of teats, Pre and post-milking disinfection of teats]
  • PT3 - Use 2: Skin disinfectant - animal husbandry [Veterinary hygiene, corporeal hygiene/navel hygiene of newborn animals]
  • PT3 - Use 3: Fish egg disinfection
  • PT3 - Use 4: Disinfection of hard surfaces [Surface disinfection in animal houses, Surface disinfection of equipment, Disinfection of fish farm equipment, Surface disinfection of external milk cluster, Surface disinfection of vehicles for animal transport, Disinfection of boots and wheels]
  • Other uses, if applicable (to be specified by the information submitters)
Which conditions of Article 10(1) are met
10(1)(a): meets at least one of the exclusion criteria listed in Article 5(1): Endocrine disruptor in humans 10(1)(e): wndocrine disruptor in and non-target organisms
Which conditions of Article 5(1) are met
5(1)(d): Endocrine disruptor in humans
Consultation start date
24/05/2024
Consultation end date
23/07/2024
Link for providing information
Give Comments
Attachments
Additional information