EFSA’s Genetically Modified Organisms (GMO) Panel has adopted a scientific opinion on strategies for assessing the risk of allergenicity of GM plants and microorganisms and derived food and feed. This opinion is part of EFSA’s ongoing effort to ensure that its risk assessment always reflects the latest scientific developments and addresses the widest range of potential concerns. Recommendations in the opinion are provided to update and complement EFSA’s allergenicity assessment of GM plants and microorganisms and derived food and feed.
The final opinion takes into consideration a total of 181 comments, received during a 10-week public consultation, from 17 interested parties including: national assessment bodies, non-governmental organisations, business associations and universities, as well as individuals. Comments mostly addressed the issue of how to implement the general approach for assessing the allergenicity of GMOs, as well as how to interpret the results of the methods discussed in the opinion. Some comments also covered more technical aspects and are addressed in a series of specific annexes to the opinion.
GM food and feed could contain quantities of new or existing proteins which might cause food allergies in people and animals. EU legislation therefore requires that the allergenicity of GMOs and food and feed derived from GMOs be assessed before they can be placed on the market.
EFSA’s GMO Panel initiated this work in order to review and update current methodologies used to assess the allergenic potential of GM plants and microorganisms. In its opinion, the Panel concludes that, as there is no single test to assess the allergenicity of a GM food or feed, a case-by-case evaluation based on a weight-of-evidence approach is the most appropriate way to do this.
In the opinion, the Panel describes how to analyse the sequence of the proteins in order to identify possible similarities with known allergens; how to test the potential of the proteins to bind with specific antibodies (suggesting they could trigger an allergic reaction); and how to assess the breakdown of the protein during digestion. In addition to assessing the new protein, the Panel recommends that for crops known to be allergenic, the whole GM plant is tested for allergenicity.
- Scientific Opinion on the assessment of allergenicity of GM plants and microorganisms and derived food and feed
- Outcome of the public consultation on the draft Scientific Opinion of the Scientific Panel on Genetically Modified Organisms (GMO) on the assessment of allergenicity of GM plants and microorganisms and derived food and feed