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Commission Implementing Regulation (EU) 2025/2154 Article 22

Commission Implementing Regulation (EU) 2025/2154 Article 22

Specifications

Article 22

1.   Specifications shall be established and laid down for: (a) raw materials; (b) intermediates; (c) active substances; (d) labelling and packaging materials. 2.   Specifications shall be established for any other materials used during the production of active substances and intermediates thereof that could critically impact the quality of active substances and intermediates thereof. 3.   Acceptance criteria shall be established and documented for in-process controls.

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Other provisions in CHAPTER VI — DOCUMENTATION

Compiled from an official source version. Later amendments or repeals may not be reflected; the official text prevails. · Read the official text ↗ · Data as of 2026-07-04

CitationArticle 22 of Commission Implementing Regulation (EU) 2025/2154 (LawPlayer, data as of 2026-07-04)

© European Union, https://eur-lex.europa.eu, 1998-2026. Reuse authorised under Commission Decision 2011/833/EU, provided the source is acknowledged.

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