Article 1
Open ↗Annex IV to Directive 2011/65/EU is amended as set out in the Annex to this Directive.
Source
Commission Delegated Directive (EU) 2021/1978 of 11 August 2021 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 the use of bis(2-ethylhexyl) phthalate (DEHP), butyl benzyl phthalate (BBP), dibutyl phthalate (DBP) and diisobutyl phthalate (DIBP) in spare parts recovered from and used for the repair or refurbishment of medical devices (Text with EEA relevance)
Commission Delegated Directive (EU) 2021/1978 of 11 August 2021 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 the use of bis(2-ethylhexyl) phthalate (DEHP), butyl benzyl phthalate (BBP), dibutyl phthalate (DBP) and diisobutyl phthalate (DIBP) in spare parts recovered from and used for the repair or refurbishment of medical devices (Text with EEA relevance)
Data as of 2026-07-04 · Compiled from an official source version. Later amendments or repeals may not be reflected; the official text prevails. · Read the official text ↗
Article 2
Open ↗1. Member States shall adopt and publish, by 30 April 2022 at the latest, the laws, regulations and administrative provisions necessary to comply with this Directive. They shall communicate the text of those provisions to the Commission forthwith. They shall apply those provisions from 21 July 2021. 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. Member States shall communicate to the Commission the text of the main provisions of national law that they adopt in the field covered by this Directive.
Article 3
Open ↗This Directive shall enter into force on the day of its publication in the Official Journal of the European Union .
Article 4
Open ↗This Directive is addressed to the Member States.
Supplementary provisions
ANNEXSupplementary provisions
Open ↗ANNEX In Annex IV to Directive 2011/65/EU, the following entry 47 is added: ‘47 Bis(2-ethylhexyl) phthalate (DEHP), butyl benzyl phthalate (BBP), dibutyl phthalate (DBP) and diisobutyl phthalate (DIBP) in spare parts recovered from and used for the repair or refurbishment of medical devices, including in vitro diagnostic medical devices, and their accessories, provided that the reuse takes place in auditable closed-loop business-to-business return systems and that each reuse of parts is notified to the customer. Expires on 21 July 2028.’
Other acts of the same type
Commission Directive 2019/1832 of 24 October 2019 amending Annexes I, II and III to Council Directive 89/656/EEC as regards purely technical adjustmentsCommission Directive (EU) 2019/1833 of 24 October 2019 amending Annexes I, III, V and VI to Directive 2000/54/EC of the European Parliament and of the Council as regards purely technical adjustmentsCommission Directive (EU) 2019/1834 of 24 October 2019 amending Annexes II and IV to Council Directive 92/29/EEC as regards purely technical adaptationsDirective (EU) 2019/1936 of the European Parliament and of the Council of 23 October 2019 amending Directive 2008/96/EC on road infrastructure safety managementDirective (EU) 2019/1937 of the European Parliament and of the Council of 23 October 2019 on the protection of persons who report breaches of Union lawCommission Delegated Directive (EU) 2019/1845 of 8 August 2019 amending, for the purposes of adapting to scientific and technical progress, Annex III to Directive 2011/65/EU of the European Parliament and of the Council as regards an exemption for bis(2-ethylhexyl) phthalate (DEHP) in certain rubber components used in engine systems (Text with EEA relevance)Commission Delegated Directive (EU) 2019/1846 of 8 August 2019 amending, for the purposes of adapting to scientific and technical progress, Annex III to Directive 2011/65/EU of the European Parliament and of the Council as regards an exemption for lead in solders used in certain combustion engines (Text with EEA relevance)Commission Directive (EU) 2019/1258 of 23 July 2019 amending, for the purpose of its adaptation to technical progress, the Annex to Council Directive 80/181/EEC as regards the definitions of SI base units (Text with EEA relevance.)Directive (EU) 2019/1023 of the European Parliament and of the Council of 20 June 2019 on preventive restructuring frameworks, on discharge of debt and disqualifications, and on measures to increase the efficiency of procedures concerning restructuring, insolvency and discharge of debt, and amending Directive (EU) 2017/1132 (Directive on restructuring and insolvency) (Text with EEA relevance.)Directive (EU) 2019/1024 of the European Parliament and of the Council of 20 June 2019 on open data and the re-use of public sector information (recast)Directive (EU) 2019/1151 of the European Parliament and of the Council of 20 June 2019 amending Directive (EU) 2017/1132 as regards the use of digital tools and processes in company law (Text with EEA relevance)Directive (EU) 2019/1152 of the European Parliament and of the Council of 20 June 2019 on transparent and predictable working conditions in the European Union
Source: EUR-Lex (Publications Office of the EU), © European Union, reuse permitted under Commission Decision 2011/833/EU.
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