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DIRECTIVES DIRECTIVE APPOINTED (EU) 2015/863 DECISION of 31 March 2015 amending Annex II of Directive 2011/65 / EU of the European Parliament and of the Council as regards the list of restricted substances in use (Text with relevance EEA) THE EUROPEAN COMMISSION, Having regard to the Treaty on the Functioning of the European Union, Having regard to Directive 2011/65 / EU of the European Parliament and of the Council of 8 June 2011 on the restriction of the use of certain hazardous substances in electrical and electronic equipment (1), and in particular Article 6, paragraph 3, Whereas: (1) Directive 65/2011 / EU lays down rules on the restriction of use of hazardous substances in electrical and electronic equipment (EEE ) in order to contribute to the protection of human health and the environment, including the environmentally sound recovery and disposal of waste EEE. (2) Directive 65/2011 / EU prohibits the use of lead, mercury, cadmium, hexavalent chromium, polybrominated biphenyls (PBB) and polybrominated diphenyl ethers (PBDEs) in electrical and electronic equipment sold in the EU market. Annex II to the directive lists the substances subject to restrictions. (3) On the occasion of the periodic review of the list of substances subject to restrictions of use in Annex II should be considered on a priority basis the risks to human health and the environment from the use dell'esabromociclododecano (HBCDD ) phthalate bis (2-ethylhexyl) phthalate (DEHP), the benzylbutyl (BBP) and dibutyl phthalate (DBP). For the purpose of an extension of the restrictions on use, the Commission should review the substances previously assessed. (4) In accordance with Article 6, paragraph 1, of Directive 2011/65 / EU, were consulted interested parties, including economic operators, the industry of recycling and treatment, environmental organizations and associations workers and consumers and has carried out a thorough evaluation. (5) The bis (2-ethylhexyl) phthalate (DEHP), butylbenzyl phthalate (BBP), dibutyl phthalate (DBP) and diisobutyl phthalate (DIBP) are substances of very high concern (SVHC). The DIBP can be used as a substitute for DBP and has been subject to previous assessments by the Commission. The available evidence indicates that these four substances, if used in EEE, can have a negative impact on recycling, on human health and the environment during the operations management of waste from EEE. (6) For most of EEE substitutes are less negative impacts for DEHP, BBP, DBP and DIBP. It should therefore be restricted in the use of these substances in EEE. DEHP, BBP and DBP are already subject to restrictions of use in item 51 of Annex XVII to Regulation (EC) No. 1907/2006 of the European Parliament and of the Council (2), to ensure that toys containing DEHP, DBP and BBP in concentrations above 0.1% by weight of the plasticised material, calculated cumulatively for the three phthalates, they can not be marketed in the EU . In order to avoid double regulation, the restrictions in Annex XVII, item 51 of the regulation therefore continues to be the only restriction applicable to DEHP, DBP and BBP in toys. 06.04.2015 L 137/10 Official Journal of the European Union EN (1) OJ L 174, 1.7.2011, p. 88. (2) Regulation (EC) No. 1907/2006 of the European Parliament and of the Council of 18 December 2006 concerning the Registration, Evaluation, Authorisation and Restriction of Chemicals (REACH), establishing a European Chemicals Agency, amending Directive 1999/45 / EC and repealing Regulation (EEC) No. 793/93 and Regulation (EC) No. 1488/94 and Directive 76/769 / EEC and Commission Directives 91/155 / EEC, 93/67 / EEC, 93/105 / EC and 2000/21 / EC (OJ L 396, 30.12 .2006, p. 1).
(7) In order to facilitate the transition and reduce the possible socio-economic impacts, it should be granted an appropriate transitional period, that entitle operators to apply for exemption from the restrictions of the substance, in accordance with Article 5 of Directive 2011 / 65 / EU. In the determination of the transitional period it is necessary to take into account the innovation cycles longer than the medical devices and instruments for monitoring and control. The restriction of use of DEHP, BBP, DBP and DIBP should therefore apply to medical devices, including in vitro medical devices and monitoring and control instruments including industrial monitoring and control instruments, as from 22 July 2021 . (8) Any adjustments of Annexes III and IV of Directive 2011/65 / EU to exempt all questions related to DEHP or DBP should avoid double regulation and excessive burdens, to ensure consistency with the administration of any authorizations granted in 'scope of Regulation (EC) No. 1907/2006 in relation to the integration of these substances in EEE. Operators who plan to apply for exemption under Directive 2011/65 / EU should be aware that such exemptions may cover the entire life cycle of EEE, including manufacturing stage. (9) It is therefore necessary to amend Directive 2011/65 / EU, it HAS ADOPTED THIS DIRECTIVE: Article 1 Annex II to Directive 2011/65 / EU is replaced by the Annex to this Directive. Article 2 1. Within 31 December 2016 Member States shall adopt and publish the laws, regulations and administrative provisions necessary to comply with this Directive. They shall forthwith communicate to the Commission the text of those provisions. They shall apply those provisions from 22 July 2019. When Member States adopt those provisions, they shall contain a reference to this Directive or be accompanied by such a reference on the occasion of their official publication. The procedure for such reference shall be adopted by Member States. 2. Member States shall communicate to the Commission the text of the main provisions of national law which they adopt in the field covered by this Directive. Article 3 This Directive shall enter into force on the twentieth day following its publication in the Official Journal of the European Union. Article 4 Member States are recipients of this Directive. Done at Brussels, 31 March 2015 For the Commission The President Jean-Claude JUNCKER 06.04.2015 L 137/11 Official Journal of the European Union EN
ANNEX 'ANNEX II Substances with restrictions on use under Article 4, paragraph 1, and maximum concentration values ‚Äč‚Äčtolerated by weight in homogeneous materials Lead (0,1%) Mercury (0,1%) Cadmium (0.01 %) Hexavalent chromium (0,1%) Polybrominated biphenyls (PBB) (0,1%) Polybrominated diphenyl ethers (PBDE) (0.1%) phthalate bis (2-ethylhexyl) phthalate (DEHP) (0.1% ) benzylbutyl (BBP) (0.1%) Dibutylphthalate (DBP) (0.1%) diisobutyl phthalate (DIBP) (0.1%) The restriction of DEHP, BBP, DBP and DIBP applies to medical devices, including devices doctors in vitro, and tools for monitoring and control, including the instruments for industrial monitoring and control as from 22 July 2021. The restriction of DEHP, BBP, DBP and DIBP not apply to cables or spare parts for the repair , reuse, updating of functionalities or the ability of EEE placed on the market before 22 July 2019, and medical devices, including in vitro medical devices and monitoring and control instruments including industrial monitoring and control instruments, marketed before 22 July 2021. The restriction of DEHP, BBP and DBP does not apply to toys which are already subject to restrictions on DEHP, BBP and DBP in Annex XVII, entry 51 of Regulation (EC) No. 1907/2006. '06.04.2015 L 137/12 Official Journal of the European Union EN

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