Article 1
Annex II to Directive 2011/65/EU is replaced by the text in the Annex to this Directive.
Commission Delegated Directive (EU) 2015/863 of 31 March 2015 amending Annex II to Directive 2011/65/EU of the European Parliament and of the Council as regards the list of restricted substances (Text with EEA relevance)
Commission Delegated Directive (EU) 2015/863 of 31 March 2015 amending Annex II to Directive 2011/65/EU of the European Parliament and of the Council as regards the list of restricted substances (Text with EEA relevance)
Data as of 2026-07-04 Β· Compiled from an official source version. Later amendments or repeals may not be reflected; the official text prevails. Β· Read the official text β
Article 2
1.Β Β Β Member States shall adopt and publish, by 31 December 2016 at the latest, 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. Member States shall determine how such reference is to be made. 2.Β Β Β 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 that of its publication in the Official Journal of the European Union .
Article 4
This Directive is addressed to the Member States.
Supplementary provisions
ANNEXSupplementary provisions
ANNEX βANNEX II Restricted substances referred to in Article 4(1) and maximum concentration values tolerated 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 %) Bis(2-ethylhexyl) phthalate (DEHP) (0,1 %) Butyl benzyl phthalate (BBP) (0,1 %) Dibutyl phthalate (DBP) (0,1 %) Diisobutyl phthalate (DIBP) (0,1 %) The restriction of DEHP, BBP, DBP and DIBP shall apply to medical devices, including in vitro medical devices, and monitoring and control instruments, including industrial monitoring and control instruments, from 22 July 2021. The restriction of DEHP, BBP, DBP and DIBP shall not apply to cables or spare parts for the repair, the reuse, the updating of functionalities or upgrading of capacity of EEE placed on the market before 22 July 2019, and of medical devices, including in vitro medical devices, and monitoring and control instruments, including industrial monitoring and control instruments, placed on the market before 22 July 2021. The restriction of DEHP, BBP and DBP shall not apply to toys which are already subject to the restriction of DEHP, BBP and DBP through entry 51 of Annex XVII to Regulation (EC) No 1907/2006.β
Implementing measures in the Member States
Transposition links come from the Member Statesβ notifications published on EUR-Lex. Only high-confidence matches held on LawPlayer are listed; see EUR-Lex for the complete list.
Source: EUR-Lex (Publications Office of the EU), Β© European Union, reuse permitted under Commission Decision 2011/833/EU.
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