67 A common format for notifying this information shall be laid down by implementing legislation (c.f. Article 20(13) of Directive 2014/40/EU). The format for this notification is set out in the notified draft Decision. Objeto y razón de ser: Improving the functioning of the EU internal market while ensuring a high level of health protection. Notificación: G/TBT/N/EU/316 Draft Commission Implementing Regulation concerning the non-approval of the active substance 3‑decen‑2‑one, 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 (3 pages, in English). This draft Commission Implementing Regulation provides that the active substance 3-decen-2-one is not approved in accordance with Regulation (EC) No 1107/2009 and cannot be placed on the market in plant protection products in the EU. The substance is not currently authorised in the EU; the non-approval is based on the first evaluation of the substance for use as a pesticide active substance in the EU. Objeto y razón de ser: 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. Criteria are listed in Article 4 of the Regulation (and also detailed in Annex II) which must be met to enable approval. During the evaluation and peer-review of the substance, a number of concerns and areas that could not be finalised were identified. These are detailed in the conclusion of the European Food Safety Authority (EFSA); importantly, the evaluation of the maximum residue levels (MRL) application with the request to exempt 3?decen-2-one from MRL setting could not be finalised, since the available information was insufficient to conclude whether 3-decen-2-one will have no immediate or delayed harmful effects on human health, including that of vulnerable groups, through dietary intakes. Additionally, the presence of positive genotoxicity results and a limited toxicological data package prevented final toxicological reference values being established and therefore the risk assessment for operators, workers, bystanders, residents and consumers could not be finalised. These concerns mean that 3-decen-2-one does not meet the approval criteria as outlined in Regulation (EC) No 1107/2009 and cannot be approved currently. As 3-decen-2-one is a new active substance being considered for the first time in the EU, there are no existing authorisations to withdraw and therefore the draft Regulation does not refer to any withdrawal action or periods of grace. UNIÓN EUROPEA Notificación: G/TBT/N/EU/303 Draft Commission Implementing Regulation laying down uniform rules for the procedures for determining whether a tobacco product has a characterising flavour (8 pages, in English). Directive 2014/40/EU of the European Parliament and of the Council of 3 April 2014 on the approximation of the laws, regulations and administrative provisions of the Member States concerning the manufacture, presentation and sale of tobacco and related products and repealing Directive 2001/37/EC sets out, in Article 7(1), a ban of tobacco products with characterising flavours, i.e. a clearly noticeable smell or taste other than tobacco. Uniform rules for the procedures for determining whether a tobacco product has a characterising flavour shall be laid down by implementing legislation (c.f. Article 7(3) of Directive 2014/40/EU). These uniform rules for the procedures are set out in the notified draft Regulation. Objeto y razón de ser: Improving the functioning of the EU internal market while ensuring a high level of health protection. Notificación: G/TBT/N/EU/304 Draft Commission Implementing Decision establishing a format for the submission and making available of information on ingredients and emissions of tobacco products and on sales volumes (5 pages + Annex 9 pages, in English) Directive 2014/40/EU of the European Parliament and of the Council of 3 April 2014 on the approximation of the laws, regulations and administrative provisions of the Member States concerning the manufacture, presentation and sale of tobacco and related products and repealing Directive 2001/37/EC sets out, in Article 5(1) and (6), new reporting requirements for manufacturers and importers of tobacco products. In particular, manufacturers and importers must submit detailed information on these products to the competent authorities of the Member States in which they intend to place them on the market. A common format for reporting this information shall be laid down by implementing legislation (c.f. Article 5(5) of Directive 2014/40/EU). The format for this reporting is set out in the notified draft Commission Implementing Decision. Objeto y razón de ser: Improving the functioning of the EU internal market while ensuring a high level of health protection. Notificación: G/TBT/N/EU/305 Draft Commission Implementing Decision establishing a common format for the notification of electronic cigarettes and refill containers (5 pages + Annex 9 pages, in English) Directive 2014/40/EU of the European Parliament and of the Council of 3 April 2014 on the approximation of the laws, regulations and administrative provisions of the Member States concerning the manufacture, presentation and sale of tobacco and related products and repealing Directive 2001/37/ EC sets out, in Article 20(2), new notification requirements for manufacturers and importers of electronic cigarettes and refill containers. In particular, manufacturers and importers must submit detailed information on these products to the competent authorities of the Member States in which they intend to place them on the market.
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