Recital 8

Commission Delegated Directive (EU) 2023/1526 of 16 May 2023 amending Directive 2011/65/EU of the European Parliament and of the Council as regards an exemption for lead as a thermal stabilizer in polyvinyl chloride used as base material in sensors used in in vitro diagnostic medical devices (Text with EEA relevance) · European Union

(8) The requested exemption thus meets at least one of the relevant conditions specified in Article 5(1), point (a), of Directive 2011/65/EU as the reliability of substitutes for the specific application subject to the exemption request is not ensured. Also, the overall negative environmental, health and consumer safety impacts and the socioeconomic impacts of not granting an exemption are being taken into account.

← Recital 7 · All articles · Recital 9 →

Source: EUR-Lex (Cellar) · retrieved 2026-10-17 · Text as adopted (Official Journal); later amendments are not incorporated in this text.