rec_6

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) · European Union

(6) The evaluation of the exemption application concluded that the total negative environmental and health impacts of substituting refurbished parts containing DEHP, BBP, DBP and DIBP with new substance-free refurbished parts are likely to outweigh the total environmental and health benefits. The evaluation included stakeholder consultations required by Article 5(6) of the Directive 2011/65/EU. The comments received during those consultations were made publicly available on a dedicated website.

← rec_5 · All articles · rec_7 →

Source: EUR-Lex (Cellar) · retrieved 2026-10-18 · Text as adopted (Official Journal); later amendments are not incorporated in this text.