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Commission Delegated Directive (EU) 2021/1979 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 plastic components in magnetic resonance imaging (MRI) detector coils (Text with EEA relevance) · European Union

(5) Two technical and scientific assessment studies were carried out to evaluate the exemption applications. The first study For the final report of the study (Pack 17), see: https://op.europa.eu/en/publication-detail/-/publication/df0ab036-8b52-11ea-812f-01aa75ed71a1/language-en/format-PDF/source-146143357. covered the first application received. Due to the similarity of the second application to the first, the second study For the final report of the study (Pack 20), see: https://op.europa.eu/en/publication-detail/-/publication/185e9d5b-d5fc-11ea-adf7-01aa75ed71a1/language-en/format-PDF/source-146144567. evaluated both applications together. The evaluation of the applications, which took into account the availability of technically practicable and reliable substitutes and the socioeconomic impact of substitution, concluded that no suitable alternatives to DEHP are sufficiently available on the market and that not granting the exemption is likely to result in total negative environmental, health and consumer safety impacts caused by substitution, which outweigh the benefits thereof. The evaluation included stakeholder consultations as required by 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.