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New version applies from 23/09/2013. 165 provisions change. Later versions: 25/04/2014, 20/11/2019, 29/03/2021, 10/06/2021, 15/04/2022, 26/05/2024, 11/06/2024, 15/06/2026, 19/08/2026. Article 9 changes in this version: compare with the current text.

Article 9 - Approval of an active substance

Article 9
Approval of an active substance

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.

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