# 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 1.2.3: Conclusions of the molecular characterisation

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

The molecular characterisation shall provide data on the structure and expression of the insert(s), and on the stability of the intended trait(s). This shall also apply to situations where transformation events have been stacked by conventional breeding.
It shall be specifically indicated whether the molecular characterisation of the genetic modification(s) raises safety concerns with regard to the interruption of endogenous genes or regulatory sequences.
The molecular characterisation shall also aim to identify whether the genetic modification(s) raise(s) any issues regarding the potential for producing proteins/substances other than those intended and in particular new toxins or allergens.
The potential unintended changes identified in this Section shall be addressed in the relevant complementary part(s) of the safety assessment.

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Source: https://www.legislation.gov.uk/eur/2013/503/annex/II/division/II/division/1/division/1.2/division/1.2.3 (the official version)
Page: https://openlegislation.uk/eu-regulation-2013-503/annex-II/division-II/division-1/division-1.2/division-1.2.3
Contains public sector information licensed under the Open Government Licence v3.0. Source: legislation.gov.uk, The National Archives.