rec_6

Commission Delegated Directive (EU) 2021/1980 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) in ion-selective electrodes for analysing human body fluids and/or dialysate fluids (Text with EEA relevance) · European Union

(6) A technical and scientific assessment study was carried out to evaluate the exemption application Study to assess three exemption requests relating to Annex IV to Directive 2011/65/EU (Pack 17). . The evaluation of the application concluded that alternatives to DEHP are currently not sufficiently reliable and that the substitution of DEHP in specific applications would result in negative environmental and health impacts that outweigh its benefits. The evaluation included stakeholder consultations in accordance with Article 5(7) of Directive 2011/65/EU. The comments received during those consultations were made publicly available on a dedicated website.

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