The definition of a genetically modified organism (GMO) in Article 2(2) of Directive 2001/18 refers to organisms ‘in which the genetic material has been altered in a way that does not occur naturally by mating and/or natural recombination’. While the term ‘altered’ is not defined in the Directive, in the European Commission’s (EC) view it is not restricted to modifications of the nucleic acid sequence but encompasses any modifications of the genetic material that do not occur naturally by mating and/or natural recombination. This covers changes on the level of the transcriptome (i.e., RNA-level). Article 2(2) outlines that genetic modification occurs at least by modification techniques listed in Part 1 of Annex IA, whereas the techniques listed in Part 2 of Annex IA are not considered to result in genetic modification.
Under the current regulatory framework in the EU, if a food is produced ‘with a GMO’ and the final product itself does not contain recombinant DNA/RNA or a new combination of genetic material, then the product is not in the scope of GM Regulation and would not be classified as a GMO. For example, if a genetically modified microorganism (GMM) is used as a production strain to produce a protein, enzyme or vitamin for use in food, and there is no recombinant DNA//RNA in the final product then the resulting final product would not be GMO.
There can be regulatory ambiguity about the GMO status of certain food ingredients, particularly for cell-cultured products where the cells have been modified or induced to produce a certain protein or product.
The GMO registration process is long and it can take a significant amount of time to gain regulatory approval in the EU.
Atova can provide advice on whether a product is likely to fall in scope of the GMO regulation and what you can do to avoid this.
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