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This draft Commission Delegated Directive concerns applications for a specific and temporary exemption from the Restriction of Hazardous Substances in Electrical and Electronic Equipment (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.

The proposal proposes to establish specific rules for the labelling of organic pet food. In order for pet food to be labelled as organic and bear the organic production logo of the European Union, at least 95% in terms of weight of the agricultural ingredients will have to be organic.

This draft Commission Implementing Regulation approves Alkyl (C12-16) dimethylbenzyl ammonium chloride (ADBAC/BKC (C12-C16)) as an active substance for use in biocidal products of product-type 1.

This draft Commission Implementing Decision does not approve d-Allethrin as an active substance for use in biocidal products of product-type 18. According to the opinion of the Agency, biocidal products of product-type 18 containing d-Allethrin cannot be expected to meet the criteria laid down in Article 19(1), points (b)(iii), and (iv), of Regulation (EU) No 528/2012. In its opinion, the Agency noted that the proposed reference specifications, established on the basis of data provided by one of the applicants, are not in line with the composition of the material that was used for testing to generate the toxicological data provided by the applicants. (...) According to the opinion of the Agency, based on the available toxicological data, an unacceptable risk has been identified for the general public due to secondary exposure to genotoxic photometabolites formed after the application of the representative products. In addition, according to the opinion of the Agency, an unacceptable risk to the environment has been identified for the aquatic compartment (surface water and sediment) and for soil. (...)

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programme of existing active substances listed in Annex II to Regulation (EU) No 1062/2014, all the participants have withdrawn or are considered to have withdrawn their support, and no notification has been submitted for those to the European Chemicals Agency. (...)

This draft Commission Implementing Decision does not approve 2,2-Dibromo-2-cyanoacetamide (DBNPA) as an active substance for use in biocidal products of product-type 4. DBNPA has endocrine disrupting properties that may cause adverse effects in humans and the environment (non-target organisms) in accordance with the criteria laid down in Commission Delegated Regulation (EU) 2017/2100. DBNPA therefore meets the exclusion criteria set out in Article 5(1), point (d), of Regulation (EU) No 528/2012. None of the derogation criteria under Article 5(2) of the Biocidal Products Regulation (BPR) are considered met, alternatives are available for its use in biocidal products of product-type 4. It is therefore appropriate not to approve DBNPA for use in biocidal products of product-type 4.

This draft Commission Implementing Regulation provides that the approval of the active substance captan is renewed with restriction to uses in greenhouses, in accordance with Regulation (EC) No 1107/2009. EU Member States shall amend/withdraw authorisations for plant protection products containing captan as an active substance. The restricted 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. This decision only concerns the placing on the market of this substance and plant protection products containing it. Separate action will likely be taken on maximum residue limits (MRLs) and a separate notification will be made in accordance with SPS procedures.

This draft Commission Implementing Decision does not approve cyanamide as an active substance for use in biocidal products of product-types 3 and 18. Due to uncertainties associated with the endocrine disrupting properties of cyanamide, it is not possible to conclude whether risks for both human health and the environment for the representative product used for product-type 3 (...) and product-type 18 (...) are acceptable or not. Therefore it has ultimately not been demonstrated based on the data available in the application submitted for the approval that the representative biocidal product containing cyanamide for product-types 3 and 18 may be expected to not have unacceptable effects itself, or as a result of its residues, on human and animal health, and on the environment. (...)

Draft Commission Delegated Regulation (EU) amending Regulation No 1272/2008 as regards hazard classes and criteria for the classification, labelling and packaging of substances and mixtures: Amendment of EU classification and labelling rules for chemicals to introduce new hazard classes for endocrine disruptors (ED) for human health and the environment as well as for other environmental hazards, namely persistent, bioaccumulative and toxic (PBT), very persistent and very bioaccumulative (vPvB), persistent, mobile and toxic (PMT), very persistent and very mobile (vPvB) substances and mixtures.

The purpose of this draft Implementing Regulation is to introduce requirements that will guarantee a high level of data protection and a common approach for the exchange of the certificate of conformity in electronic format through the secure use of electronic applications and systems used for the exchange of information between manufacturers and EU Member States.