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Draft Commission Implementing Decision on the non-approval of certain active substances for use in biocidal products in accordance with Regulation (EU) No 528/2012 of the European Parliament and of the Council: This draft Commission Implementing Decision does not approve certain active substances in biocidal products pursuant to Regulation (EU) No 528/2012 of the European Parliament and of the Council. For these active substance/product-type combinations included in the review programme of existing active substances listed in Annex II to Regulation (EU) No 1062/2014, all the participants have withdrawn or are considered to have withdrawn their support. For these active substances either the role of participant had previously been taken over or not. For those that the role of participant had not previously been taken over, no notification has been submitted to the European Chemicals Agency. Therefore, all these active substance/product-type combinations should not be approved for use in biocidal products.

Draft Commission Implementing Regulation concerning the non-renewal of the approval of the active substance dimethomorph, 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: (...) provides that the approval of the active substance dimethomorph is not renewed in accordance with Regulation (EC) No 1107/2009. EU Member States shall withdraw authorisations for plant protection products containing dimethomorph as an active substance. The non-renewal of approval is based on the first evaluation of the substance for use as a pesticide active substance in the EU under Regulation (EC) No 1107/2009. The substance was formerly assessed and approved under Directive 91/414/ EEC. (...) In particular, dimethomoph has an harmonised classification as toxic to reproduction, category 1B (H360F 'may damage fertility') according to Regulation (EC) No 1272/2008 and, based on the available information submitted in the dossier, dimethomorph is considered to meet the criteria for endocrine disruptors for humans and wild mammals (...)

Draft Commission Delegated Regulation amending Regulation (EU) No 528/2012 of the European Parliament and of the Council to include nitrogen generated from ambient air as an active substance in Annex I thereto: : This draft Commission Delegated Regulation amends Regulation (EU) No 528/2012 of the European Parliament and of the Council to include nitrogen generated from ambient air as an active substance in Annex I thereto.

Draft Commission Implementing Regulation concerning the non-renewal of the approval of the active substance mepanipyrim, 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: This draft Commission Implementing Regulation provides that the approval of the active substance mepanipyrim is not renewed in accordance with Regulation (EC) No 1107/2009. EU Member States shall withdraw authorisations for plant protection products containing mepanipyrim as an active substance. The non-renewal of approval is based on the first evaluation of the substance for use as a pesticide active substance in the EU under Regulation (EC) No 1107/2009. The substance was formerly assessed and approved under Directive 91/414/ EEC. (...) a high long-term risk was identified for wild mammals exposed to mepanipyrim via dietary exposure, for all representative uses. There was also a need for further tests and risk assessment to unique human metabolites while an in vitro comparative metabolism study is not submitted. Mepanipyrim was considered phototoxic in the in-vitro study.

Draft Commission Delegated Directive amending, for the purposes of adapting to scientific and technical progress, Annex IV to Directive 2011/65/EU of the European Parliament and of the Council as regards an exemption for mercury in melt pressure transducers for capillary rheometers under certain conditions: This draft Commission Delegated Directive concerns applications for a specific and temporary exemption from the RoHS 2 (Directive 2011/65/EU) substance restrictions. The criteria for a new exemption are met and it is proposed to grant an exemption in Annex IV of that Directive. It differs from the draft notified under G/TBT/N/EU/940 in that the expiry date of the exemption is now given as 31 December 2025 instead of 31 December 2024.

Draft Commission Implementing Regulation withdrawing the approval of the active substance ipconazole in accordance with Regulation (EC) No 1107/2009 of the European Parliament and of the Council, amending Commission Implementing Regulation (EU) No 540/2011 and repealing Commission Implementing Regulation (EU) No 571/2014: (...) EU Member States shall withdraw authorisations for plant protection products containing ipconazole as an active substance

Draft Commission Implementing Regulation concerning the non-renewal of the approval of the active substance oxamyl, 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: (...) provides that the approval of the active substance oxamyl is not renewed in accordance with Regulation (EC) No 1107/2009. EU Member States shall withdraw authorisations for plant protection products containing oxamyl as an active substance. The non-renewal of approval is based on the first evaluation of the substance for use as a pesticide active substance in the EU under Regulation (EC) No 1107/2009.

Draft Commission Delegated Directive amending Directive 2011/65/EU of the European Parliament and of the Council as regards an exemption for lead as a thermal stabilizer in polyvinyl chloride used as base material in sensors used in in-vitro diagnostic medical devices: This draft Commission Delegated Directive concerns applications for a specific and temporary exemption from the RoHS 2 (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 IV of that Directive.

Draft Commission Implementing Regulation approving ozone generated from oxygen as an active substance for use in biocidal products of product-types 2, 4, 5 and 11 in accordance with Regulation (EU) No 528/2012 of the European Parliament and of the Council

Draft Commission Implementing Regulation approving (13Z)-Hexadec-13-en-11-yn-1-yl acetate as an existing active substance for use in biocidal products of product-type 19 in accordance with Regulation (EU) No 528/2012 of the European Parliament and of the Council