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Commission Delegated Directive (EU) 2020/366 of 17 December 2019 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 lead as a thermal stabiliser in polyvinyl chloride used in certain in-vitro diagnostic medical devices for the analysis of blood and other body fluids and body gases (Text with EEA relevance) · European Union

(10) The exemption does not weaken the environmental and health protection afforded by Regulation (EC) No 1907/2006 of the European Parliament and of the Council. Regulation (EC) No 1907/2006 of the European Parliament and of the Council of 18 December 2006 concerning the Registration, Evaluation, Authorisation and Restriction of Chemicals (REACH) and establishing a European Chemicals Agency (OJ L 396, 30.12.2006, p. 1). In light of the restriction process on lead in PVC provided for in Regulation (EC) No 1907/2006, the exemption should be granted for a short validity period of 2 years to ensure full alignment with that Regulation once the relevant restriction process is concluded.

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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.