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Regulation (EU) No 528/2012 Article 9

Approval of an active substance

Article 9

1.   The Commission shall, on receipt of the opinion of the Agency referred to in Article 8(4), either: (a) adopt an implementing Regulation providing that an active substance is approved, and under which conditions, including the dates of approval and of expiry of the approval; or (b) in cases where the conditions laid down in Article 4(1) or, where applicable, the conditions set out in Article 5(2), are not satisfied or where the requisite information and data have not been submitted within the prescribed period, adopt an implementing decision that an active substance is not approved. Those implementing acts shall be adopted in accordance with the examination procedure referred to in Article 82(3). 2.   Approved active substances shall be included in a Union list of approved active substances. The Commission shall keep the list up to date and make it electronically available to the public.

Read the full instrument → · Read this in context: CHAPTER II — APPROVAL OF ACTIVE SUBSTANCES →

Other provisions in CHAPTER II — APPROVAL OF ACTIVE SUBSTANCES

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 9 of Regulation (EU) No 528/2012 (LawPlayer, data as of 2026-07-04)

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