Chemical name: methyl N-(phenylacetyl)-N-(2,6-xylyl)-DL-alaninate 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 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 benalaxyl because benalaxyl is not approved as an active substance in accordance with Regulation (EC) No 1107/2009 concerning the placing of plant protection products on the market of the European Parliament and of the Council of 21 October 2009. EU Member States had to withdraw authorisations for plant protection products containing benalaxyl as active substance by 5 April 2021. Disposal, storage, placing on the market and use of existing stocks of plant protection products containing benalaxyl is prohibited as of 5 October 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 benalaxyl is expected to satisfy in general requirements laid down in Article 29(1) of Regulation (EC) No 1107/2009 and the uniform principles laid down in Regulation (EU) 546/2011. According to the evaluation related to human health the following concerns were identified: the potential groundwater contamination by relevant metabolites; 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 possibility: to conclude whether benalaxyl has endocrine disrupting properties according to the scientific criteria for the determination of endocrine disrupting properties as set out in points 3.6.5 and 3.8.2 of Annex II to Regulation (EC) No 1107/2009, as amended by Commission Regulation (EU) 2018/605; to conclude on the consumer dietary risk assessment since, the risk assessment residue definition for fruit crops could not be finalised, the residue definitions for root crops and rotational crops remained open and the livestock exposure assessment could not be conducted; to finalise the consumer risk assessment through drinking water with regard to groundwater metabolites M2 (3-((1-carboxyethyl)(2,6-dimethylphenyl)amino)-3-oxopropanoic acid), F4-acetyl (methyl N-acetyl-N-(2,6-dimethylphenyl)alaninate), F7 and F8 (2-(2-carboxy-N-(1-methoxy-1-oxopropan-2-yl)acetamido)-3-methylbenzoic acid) and the nature of the residues that might be present in drinking water, consequent to water treatment following abstraction of surface water, is unknown; finalise the residue definition for human biomonitoring (i.e. body fluids and tissue). 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 benalaxyl. 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 benalaxyl 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) 546/2011. According to the evaluation related to the environment, the following concerns were identified: the long-term risk to birds and earthworm-eating birds from secondary poisoning; the long-term risk to in-field and off-field non-target arthropods for all 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 possibility: to finalise the risk from secondary poisoning of fish-eating birds and mammals because no valid BCF estimate was available. Consequently, also the B assessment of the PBT criteria, for which a valid BCF estimate is needed, could not be carried out. 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 benalaxyl. Date of entry into force of the final regulatory action: 05/10/2020 Complete entry into force of all provisions of Commission Implementing Regulation (EU) 2020/1280 of 14 September 2020 concerning the non-renewal of the approval of the active substance benalaxyl, 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 5 October 2020. |