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Commission Implementing Regulation (EU) No 503/2013Show full title
Commission Implementing Regulation (EU) No 503/2013 of 3 April 2013 on applications for authorisation of genetically modified food and feed in accordance with Regulation (EC) No 1829/2003 of the European Parliament and of the Council and amending Commission Regulations (EC) No 641/2004 and (EC) No 1981/2006 (Text with EEA relevance)
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CHAPTER II GENERAL REQUIREMENTS
Article 3Preparation and presentation of applications submitted under Articles 5(1) and 17(1)
1.The application submitted under Articles 5(1) and 17(1) of Regulation (EC) No 1829/2003 shall:
(a)be submitted in accordance with the requirements for the preparation and presentation of applications set out in Annex I;
(b)contain all the information required by Annex I, in accordance with the specific requirements of Articles 4, 5 and 6.
2.The application shall include, for each of the specific requirements laid down in Articles 4, 5 and 6:
(a)the summaries and results of the studies referred to in the application;
(b)annexes where detailed information on those studies is provided.
3.The application shall contain a checklist demonstrating that the information required under Articles 4, 5 and 6 is complete.
4.Where an application is limited to either food or feed use, it shall contain a verifiable justification explaining why the authorisation shall not cover both uses in accordance with Article 27 of Regulation (EC) No 1829/2003.
5.The application shall, at the time of submission, clearly state which parts of the application are claimed to be confidential and provide verifiable justification in accordance with Article 30 of Regulation (EC) No 1829/2003.
Additional information submitted during the authorisation procedure shall, at the time of submission, clearly state which parts of this additional information is claimed to be confidential and provide verifiable justification in accordance with Article 30 of Regulation (EC) No 1829/2003.
6.When studies have been already submitted to the European Food Safety Authority (EFSA) for the purposes of an application and, where relevant, to the extent that they may be used by the applicant in accordance with Article 31 of Regulation (EC) No 1829/2003, a reference to such studies and the results of the EFSA’s assessment may, with the agreement of EFSA, be made in the framework of another application.
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