# 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 1.5.2: Assessment of allergenicity of the genetically modified food or feed

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

When the recipient plant is known to be allergenic, the applicant shall assess any potential change in the allergenicity of the genetically modified food or feed by comparison of the allergen repertoire with that of its conventional counterpart. The potential over-expression of natural endogenous allergen(s) in the genetically modified plant shall, in particular, be investigated.
The applicant shall follow a case-by-case approach depending on the available information on the allergenic potential of the recipient plant. It is generally performed by analytical methodologies such as proteomics in association with the use of allergic human sera as probes. Sera from clinically well-characterised allergic individuals that are the reference material for IgE binding studies may be available in limited number and quantity. In order to minimise the use of human sera, preliminary important information on the likelihood of an unintended alteration of the overall allergenicity of the genetically modified plant can be obtained by using sera of animals experimentally sensitised in well-defined conditions and by including relevant identified endogenous allergens in the comparative compositional analysis.
In addition, the applicant shall provide, where available, information on the prevalence of allergy in persons working with, coming into contact with or in the vicinity of genetically modified plant cultivation.

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Source: https://www.legislation.gov.uk/eur/2013/503/annex/II/division/II/division/1/division/1.5/division/1.5.2 (the official version)
Page: https://openlegislation.uk/eu-regulation-2013-503/annex-II/division-II/division-1/division-1.5/division-1.5.2
Contains public sector information licensed under the Open Government Licence v3.0. Source: legislation.gov.uk, The National Archives.