# 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), Division 3.1: Introduction

Extent: E+W+S+N.I.

The applicant shall base its risk characterisation of genetically modified plants and foods and feed on data from hazard identification, hazard characterisation, and on exposure/intake data. The applicant shall ensure that the risk characterisation is comprehensive by considering all the available evidence from several analysis including molecular analysis, phenotypic, agronomical and compositional analysis, toxicity and allergenicity testing. The applicant shall consider indications resulting from the risk characterisation that may require specific activities for post-market monitoring of genetically modified food and feed.
In performing its risk characterisation, the applicant shall demonstrate that the hazard identification and hazard characterisation are complete. The applicant shall discuss the quality of existing data and information. The discussion shall clearly indicate how this body of information has been taken into account in the determination of the final risk characterisation.
The applicant shall provide estimations of the uncertainties associated to each test as well as to the different stages of the risk assessment. The applicant shall quantify them to the possible extent. A distinction shall be made between uncertainties that reflect natural variations in biological parameters (including variations in susceptibility in populations), and variation amongst different species’ responses.
Depending on the issue to be addressed and the available data, the applicant shall perform a qualitative and, where possible, quantitative risk characterisation. The conditions for the estimated risk, and associated uncertainties, shall be as precise as possible.

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Source: https://www.legislation.gov.uk/eur/2013/503/annex/II/division/II/division/3/division/3.1 (the official version)
Page: https://openlegislation.uk/eu-regulation-2013-503/annex-II/division-II/division-3/division-3.1
Contains public sector information licensed under the Open Government Licence v3.0. Source: legislation.gov.uk, The National Archives.