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Commission Regulation (EC) No 340/2008 Article 9

Commission Regulation (EC) No 340/2008 Article 9

Charges for reviews of authorisations under Article 61 of Regulation (EC) No 1907/2006

Article 9

1.   The Agency shall levy a charge, as provided for in paragraphs 2 and 3 of this Article, for any submission of a review report under Article 61 of Regulation (EC) No 1907/2006. 2.   The Agency shall levy a base charge for submission of any review report, as set out in Annex VII. The base charge shall cover the submission of a review report for one substance, one use, and one applicant. The Agency shall levy an additional charge, as set out in Annex VII to this Regulation, for each additional use, for each additional substance that meets the definition of a group of substances as defined in Section 1(5) of Annex XI to Regulation (EC) No 1907/2006 and that is covered by the review report, and for each additional entity covered by the review report. For the purposes of this paragraph, each exposure scenario shall be considered a different use. 3.   Where the application is submitted by a medium enterprise or by two or more SMEs only, of which the largest enterprise is a medium enterprise, the Agency shall levy a reduced base charge and reduced additional charges, as set out in Table 2 of Annex VII. Where the application is submitted by a small enterprise or by two or more SMEs only, of which the largest enterprise is a small enterprise, the Agency shall levy a reduced base charge and reduced additional charges, as set out in Table 3 of Annex VII. Where the application is submitted by one or more micro enterprises only, the Agency shall levy a reduced base charge and reduced additional charges as set out in Table 4 of Annex VII. 4.   The date on which the charge levied for submission of the review report is received by the Agency shall be considered to be the date of receipt of the submission.

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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 Commission Regulation (EC) No 340/2008 (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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