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Draft Commission Regulation amending Annex XVII to Regulation (EC) No 1907/2006 of the European Parliament and of the Council as regards undecafluorohexanoic acid (PFHxA), its salts and PFHxA-related substances: This draft Regulation would introduce a new entry to Annex XVII to Regulation (EC) No 1907/2006. It would prohibit the use of undecafluorohexanoic acid (PFHxA), its salts and PFHxA-related substances for textiles and leather in consumer products, paper and cardboard used as food contact materials, mixtures for consumer use, cosmetic products and some firefighting foams applications.

Draft Commission Implementing Regulation approving formic acid as an existing active substance for use in biocidal products of product-types 2, 3, 4 and 5 in accordance with Regulation (EU) No 528/2012 of the European Parliament and of the Council

Draft Commission Regulation amending Annex XVII to Regulation (EC) No 1907/2006 of the European Parliament and of the Council concerning the Registration, Evaluation, Authorisation and Restriction of Chemicals (REACH) as regards octamethylcyclotetrasiloxane (D4), decamethylcyclopentasiloxane (D5) and dodecamethylcyclohexasiloxane (D6): (...) The European Chemicals Agency identified D4, D5 and D6 as having very persistent and very bioaccumulative (vPvB) properties. Moreover, the Agency identified D4 as having persistent, bioaccumulative and toxic (PBT) properties, and D5 and D6 as having PBT properties when they contain 0.1% or more by weight of D4. The hazard properties of D4, D5 and D6 give rise to specific concerns for the environment when present in consumer and professional products that end up released into both the aquatic and the atmospheric compartments. The draft restriction aims to minimise the emissions of D4, D5 and D6 caused by leave-on cosmetic products and other consumer and professional products, as well as the emissions of D6 from wash-off cosmetic products (...)

Draft Commission Delegated Directive amending Directive 2011/65/EU of the European Parliament and of the Council as regards an exemption for cadmium and lead in plastic profiles in electrical and electronic windows and doors containing recovered rigid polyvinyl chloride: This draft Commission Delegated Directive concerns applications for a specific and temporary exemption from the RoHS (Directive 2011/65/EU) substance restrictions. The criteria for a new exemption are met and it is proposed to grant a time-limited exemption in Annex III of that Directive.

Draft Commission Implementing Regulation concerning the non-renewal of approval of the active substance triflusulfuron-methyl, in accordance with Regulation (EC) No 1107/2009 of the European Parliament and of the Council, and amending Commission Implementing Regulation (EU) No 540/2011: (...) Member States shall withdraw authorisations for plant protection products containing triflusulfuron-methyl as an active substance. (...) EFSA identified a critical area of concern in relation to the contamination of groundwater by one toxicologically relevant metabolite of triflusulfuron-methyl, IN-JU122, which is predicted to occur above the parametric value of 0,1 μg/L in all geoclimatic conditions represented by the groundwater assessment scenarios for all proposed uses of triflusulfuron-methyl. Therefore, it cannot currently be established that the presence of metabolites of triflusulfuron-methyl in groundwater will not result in unacceptable effects on groundwater and in harmful effects on human health as required by Article 4(3)(b) of Regulation (EC) No 1107/2009. (...)

Draft Commission Implementing Regulation concerning the non-renewal of approval of the active substance clofentezine, in accordance with Regulation (EC) No 1107/2009 of the European Parliament and of the Council and amending Commission Implementing Regulation (EU) No 540/2011: (...) In order for an active substance to be approved in accordance with Regulation (EC) No 1107/2009 (concerning the placing of plant protection products on the market), it must be demonstrated that the substance is not harmful to human health, animal health or the environment. (...) Furthermore, a high long-term risk to birds and wild mammals for the representative uses not grown in permanent greenhouses was identified. The consumer risk assessment could not be performed and maximum residue levels cannot be proposed based on the available data. Finally, the risk assessment for non-target arthropods could also not be finalised for the representative uses not grown in permanent greenhouses.(...)

Draft Commission Delegated Regulation amending Commission Delegated Regulation (EU) 2021/1342 as regards the information to be sent by third countries and by control authorities and control bodies for the purpose of supervision of their recognition under Article 33(2) and (3) of Council Regulation (EC) No 834/2007 and the measures to be taken in the exercise of that supervision: (...) This regulation aims to contribute to transparency, consumer confidence and protection, as well as to ensure that production processes do not harm the environment, human health, plant health or animal health and welfare.

Draft Commission Implementing Regulation concerning the non-renewal of the approval of the active substance Metiram, in accordance with Regulation (EC) No 1107/2009 of the European Parliament and of the Council, and amending Commission Implementing Regulation (EU) No 540/2011: (...) These critical areas of concern have been identified: Metiram is considered to meet the criteria for endocrine disruption (ED) for humans for the T modalities. Operator, bystander and resident exposure estimates are exceeding the reference values (relevant for all representative uses evaluated) . High risk to aquatic organisms was identified for all representative uses. A high in-field risk for non-target arthropods was identified for all representative uses.

Moreover, part of the risk assessment could not be finalised by EFSA, thus precluding the renewal, such as, among others, the consumer dietary risk assessment, the genotoxic potential and general toxicity of metabolite M222F001, the assessment of the long-term risk to birds and the risk to honey bee larvae. Therefore, the outcome of the risk assessment is not favourable to the renewal given that it can be concluded that several application scenarios are not acceptable. These concerns mean that Metiram does not meet the approval criteria as outlined in Regulation (EC) No 1107/2009. (...)

Draft Commission Implementing Regulation concerning the non-renewal of the approval of the active substance Benthiavalicarb, in accordance with Regulation (EC) No 1107/2009 of the European Parliament and of the Council, and amending Commission Implementing Regulation (EU) No 540/2011: (...) In order for an active substance to be approved in accordance with Regulation (EC) No 1107/2009 (concerning the placing of plant protection products on the market), it must be demonstrated that the substance is not harmful to human health, animal health or the environment. (...) In the case of Benthiavalicarb, the outcome of the risk assessment, as documented in the EFSA Conclusion, is not favourable and identifies critical areas of concern.

Draft Commission Implementing Decision not approving silver zeolite as an existing active substance for use in biocidal products of product-type 4 in accordance with Regulation (EU) No 528/2012 of the European Parliament and of the Council: This draft Commission Implementing Decision does not approve silver zeolite as an active substance for use in biocidal products of product-type 4. Unacceptable risks for infants (6 to 12 months old) have been identified for the use of water filters treated with silver zeolite, and no adequate risk mitigation measure could be identified to mitigate those risks.