Chemical name: Chlorophene Final regulatory action has been taken for the category: Pesticide Final regulatory action: The chemical is Banned Use or uses prohibited by the final regulatory action: Use as active substance in biocidal products for product-type 2 (Disinfectants and algaecides not intended for direct application to humans or animals) and product-type 3 (Veterinary hygiene). Not relevant Use or uses that remain allowed: Not relevant Pesticide use or uses that remain allowed: Not relevant The final regulatory action was based on a risk or hazard evaluation: Yes Summary of the final regulatory action: It is prohibited to place on the market or use biocidal products containing chlorophene. Chlorophene has not been approved for its use in biocidal products of product-type 2 (disinfectants and algaecides not intended for direct application to humans or animals) and product-type 3 (veterinary hygiene) under Regulation (EC) No 528/2012 of the European Parliament and of the Council of 22 May 2012 concerning the making available on the market and use of biocidal products. The reasons for the final regulatory action were relevant to: Human health and environment Summary of known hazards and risks to human health: Product type 2 (disinfectants and algaecides not intended for direct application to humans or animals) The overall conclusion from the evaluation is that biocidal products in product type 2 containing chlorophene as an active substance used for heavy-duty disinfection for both professional and private use may not be expected to meet the criteria laid down in points (b)(iii) and (b)(iv) of Article 19(1) of Regulation (EU) 528/2012. Consequently, it was proposed that chlorophene shall not be approved and included in the Union list of approved active substances. The following concerns for human health were identified during the evaluation: - An unacceptable risk (even when relevant PPE is taken into account) was identified for human health when chlorophene is used by professionals to treat institutional areas. - An unacceptable risk to human health was identified for small scale sanitary non-professional use (e.g. use in lavatories) due to the local effects of the representative product. Product type 3 (veterinary hygiene) The overall conclusion from the evaluation is that biocidal products in product type 3 containing chlorophene as an active substance may not be expected to meet the criteria laid down in point (iii) of Article 19(1)(b). Consequently, it was proposed that chlorophene shall not be approved and included in the Union list of approved active substances. In view of the conclusions of the evaluation, the use of chlorophene as a disinfectant in product type 3 gives rise to concerns for human health when considering exposure to professional users. Overall, no safe use has been identified for human health when a chlorophene containing product is used by professional workers to control pathogenic micro-organisms in poultry barns.Expected effect of the final regulatory action in relation to human health: Reduction of risk for human health from the use of biocidal products containing chlorophene. Summary of known hazards and risks to the environment: Product type 2 (disinfectants and algaecides not intended for direct application to humans or animals) The overall conclusion from the evaluation is that biocidal products in product type 2 containing chlorophene as an active substance used for heavy-duty disinfection for both professional and private use may not be expected to meet the criteria laid down in points (b)(iii) and (b)(iv) of Article 19(1) of Regulation (EU) 528/2012. Consequently, it is proposed that chlorophene shall not be approved and included in the Union list of approved active substances. An unacceptable risk was identified during the evaluation for the aquatic environment for all uses except for the professional use as ready to use disinfectant in the institutional areas scenario. Expected effect of the final regulatory action in relation to the environment: Reduction of risk for the environment from the use of biocidal products containing chlorophene. Date of entry into force of the final regulatory action: 13/05/2018 Complete entry into force of all provisions of Commission Implementing Decision (EU) 2020/1765 was 16 December 2020. Complete entry into force of all provisions of Commission Implementing Decision (EU) 2018/622 was 13 May 2018. |