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Commission Implementing Regulation (EU) No 564/2013Show full title
Commission Implementing Regulation (EU) No 564/2013 of 18 June 2013 on the fees and charges payable to the European Chemicals Agency pursuant to Regulation (EU) No 528/2012 of the European Parliament and of the Council concerning the making available on the market and use of biocidal products (Text with EEA relevance)
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CHAPTER IIU.K. SUPPORT FOR SMEs
Article 6U.K.Recognition of SME status
1.Before submission of an application to the Agency for approval, renewal or inclusion in Annex I to Regulation (EU) No 528/2012 of an active substance or for Union authorisation of a biocidal product or biocidal product family, submitted in accordance with Articles 7(1), 13(1), 28(4), 43(1) or 45(1) of that Regulation respectively, containing a claim for SME reduction, the prospective applicant shall submit to the Agency the relevant elements proving entitlement to such reduction by virtue of the status of SME in the meaning of Recommendation 2003/361/EC.
2.In the case of an application for approval, renewal or inclusion of an active substance in Annex I to Regulation (EU) No 528/2012, the question shall be determined by reference to the active substance manufacturer that is represented by the prospective applicant. In case of an application for product authorisation or renewal of product authorisation, the question shall be determined by reference to the prospective authorisation holder.
3.The Agency shall publish a list of the relevant elements to be submitted in accordance with paragraph 1.
4.Within 45 days of receipt of all the relevant elements referred to in paragraph 1, the Agency shall decide what SME status, if any, can be recognised.
5.A recognition of an enterprise as an SME shall be valid for applications submitted under Regulation (EU) No 528/2012 for two years.
6.An appeal may be brought, in accordance with Article 77 of Regulation (EU) No 528/2012 against a decision taken by the Agency under paragraph 4.
Article 7U.K.Fee Reductions
1.Reductions of fees payable to the Agency as set out in Table 2 of Annex I and Table 2 of Annex II shall be granted to SMEs established in the Union.
2.Reductions for applications for active substance approval, renewal of approval or inclusion in Annex I to Regulation (EU) No 528/2012 shall only be granted when the active substance is not a candidate for substitution.
3.Reductions for applications for biocidal product authorisation or renewal of authorisation shall only be granted when the product does not contain an active substance which is a candidate for substitution.
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