Chemical name: 3,5-dibromo-4-hydroxybenzonitrile 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: All applications as a plant protection product 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 plant protection products containing bromoxynil because bromoxynil is not approved as an active substance in accordance with Regulation (EC) No 1107/2009 of the European Parliament and of the Council of 21 October 2009 concerning the placing of plant protection products on the market. EU Member States had to withdraw all authorisations for plant protection products containing bromoxynil as active substance by 14 March 2021 at the latest. Disposal, storage, placing on the market and use of existing stocks of plant protection products containing bromoxynil is prohibited as of 14 September 2021. The reasons for the final regulatory action were relevant to: Human health and environment Summary of known hazards and risks to human health: In conclusion from the assessments made on the basis of the submitted information, no plant protection product containing the active substance bromoxynil is expected to satisfy in general the requirements laid down in Article 29(1) of Regulation (EC) No 1107/2009 and the uniform principles laid down in Regulation (EU) No 546/2011. According to the evaluation related to human health the following concerns were identified: A high risk to child residents even taking into account suitable mitigation measures. The information available is insufficient to satisfy the requirements set out in Article 4(1) to (3) of Regulation (EC) No 1107/2009, in particular with regard to: The consumer risk assessment could not be finalised for products of animal origin considering the lack of data to perform a comprehensive livestock exposure assessment; The assessment of the endocrine disrupting properties of bromoxynil could not be finalised while insufficient information is available to exclude an endocrine disrupting potential of bromoxynil and its esters. Additionally, the conclusion by EFSA indicates that during the peer review experts from Member States and EFSA suggested that bromoxynil, bromoxynil heptanoate and bromoxynil octanoate, which are currently subject to harmonised classification as toxic for reproduction category 2 (Repr. 2) in Annex VI to Regulation (EC) No 1272/2008, as well as bromoxynil butyrate should be classified as toxic for reproduction category 1B (Repr. 1B) in accordance with the classification criteria laid down in Regulation (EC) No 1272/2008. It should be noted that EFSA does not have a mandate to adopt an opinion on the classification of a substance in accordance with Regulation (EC) No 1272/2008. However, EFSA has the mandate to undertake the risk assessment for plant protection products in accordance with Regulation (EC) No 1107/2009, which also includes a hazard assessment. According to Annex II, Point 3.6.4 of Regulation (EC) No 1107/2009, substances that are or have to be classified as Repr. 1B can only be approved, if negligible exposure to humans is demonstrated, or if information is provided in the application that demonstrates that the active substance is necessary to control a serious danger to plant health which cannot be controlled via other available means (see Art 4.7 of Regulation (EC) No 1107/2009). In the case of bromoxynil, negligible exposure is not demonstrated since non-dietary exposure is confirmed for operators, workers, bystanders and residents (leading to an unacceptable risk for child residents, with exposure exceeding the AOEL even taking into account suitable mitigation measures). Expected effect of the final regulatory action in relation to human health: Reduction of risk for human health from the use of plant protection products containing bromoxynil. Summary of known hazards and risks to the environment: In conclusion from the assessments made on the basis of the submitted information, no plant protection product containing the active substance bromoxynil is expected to satisfy in general the requirements laid down in Article 29(1) of Regulation (EC) No 1107/2009 and the uniform principles laid down in Regulation (EU) No 546/2011. According to the evaluation related to the environment the following concerns were identified: A high long-term risk from dietary exposure for wild mammals for the representative uses. The information available is insufficient to satisfy the requirements set out in Article 4(1) to (3) of Regulation (EC) No 1107/2009, in particular with regard to: The risk assessment to aquatic plants when exposed to bromoxynil octanoate could not be finalised due to the lack of suitable data. Expected effect of the final regulatory action in relation to the environment: Reduction of risk for the environment from the use of plant protection products containing bromoxynil. Date of entry into force of the final regulatory action: 17/09/2020 Complete entry into force of all provisions of Commission Implementing Regulation (EU) 2020/1276 of 11 September 2020 concerning the non-renewal of the approval of the active substance bromoxynil, in accordance with Regulation (EC) No 1107/2009 of the European Parliament and of the Council concerning the placing of plant protection products on the market, and amending the Annex to Commission Implementing Regulation (EU) No 540/2011 was on 17 September 2020. |