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Commission Implementing Regulation (EU) 2017/12 Article 2

Commission Implementing Regulation (EU) 2017/12 Article 2

General requirements for applications and requests

Article 2

1.   The information and documentation submitted as part of an application or a request for the establishment of MRLs shall be accurate and conform to the current state of scientific knowledge and the scientific guidance issued by EMA relating to the safety of residues. 2.   An application or a request for the establishment of MRLs shall include any information relevant to the evaluation of the safety of residues of the substance concerned, whether favourable or unfavourable to the substance. In particular, all relevant details shall be given of any incomplete or abandoned test or trial relating to the active substance. 3.   An application or a request for the extension of existing MRLs to other animal species or other food commodities shall consist of an application or request form and a residue file. EMA may request safety data if the risk assessment performed with regard to the establishment of the existing MRL is not applicable to the extension proposed.

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Other provisions in Commission Implementing Regulation (EU) 2017/12

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 2 of Commission Implementing Regulation (EU) 2017/12 (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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