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rDNA Traces in Fermentation Products Using Genetically Modified Microorganisms (GMMs)


Hans-Georg Dederer


Certain products such as amino acids, flavourings, oligosaccharides, organic acids, or vitamins are obtained by fermentation using genetically modified microorganisms (GMMs). Such fermentation products may be used as or in food and feed. Although the GMMs are separated from the fermentation products during downstream processing these products may, nevertheless, contain traces of rDNA originating from the GMMs. The European Commission holds the view that fermentation products obtained by using GMMs are subject to Regulation (EC) No 1829/2003 of the European Parliament and of the Council of 22 September 2003 on genetically modified food and feed to the extent that rDNA is still present in the fermentation product irrespective of the amount of rDNA sequences. However, it follows from the travaux préparatoires as well as early discussions on the scope of Regulation (EC) No 1829/2003 starting immediately after its entry into force that it was neither designed nor framed to be applicable to fermentation products obtained by the use of GMMs. Accordingly, Regulation (EC) No 1829/2003 cannot be considered to be fit for purpose as regards regulation of such products. In particular, it is clear from the regulation’s wording and context that it does not apply to food or feed products obtained by fermentation using GMMs if the GMMs have been removed during downstream processing. In this case, the GMMs are mere ‘processing aids’ within the meaning of Recital 16, sentences 3 and 4, of Regulation (EC) No 1829/2003. Therefore, such food or feed products obtained by fermentation using GMMs are excluded from the scope of the regulation since, first, these products are not produced ‘from’ but produced ‘with’ GMMs (cf. Artt. 2(6), (7) and (10), 3(1)(c), 15(1)(c) of Regulation (EC) No 1829/2003 as construed in light of Recital 16, sentences 1, 3 and 4) and, second, the GMMs are not ‘source material’ of the fermentation products (cf. Art. 2(8) and (9), Art. 3(1)(a), Art. 15(1)(a) of Regulation (EC) No 1829/2003 as construed in light of Recital 16, sentences 1, 3 and 4). As GMMs are ‘processing aids’ within the meaning of sentences 3 and 4 of Recital 16 and the fermentation products are, therefore, produced ‘with’ the GMMs within the meaning of sentence 1 of Recital 16, sentence 2 of the recital has, logically, no relevance as regards the distinction between food or feed produced ‘from’ or ‘with’ GMMs. rDNA traces in fermentation products obtained by the use of GMMs are not ‘ingredients’ either. Rather, they constitute mere ‘residues’. Any health safety concerns related to the presence of rDNA traces are addressed by other Union legislation, e.g., on food additives, food enzymes and food flavourings or feed additives and other feed materials, respectively, or, as the case may be, on novel foods.

Prof. Dr. iur. Hans-Georg Dederer, Chair of Constitutional and Administrative Law, Public International Law, European and International Economic Law, University of Passau, Germany, Email: This contribution was inspired by a request of industry representatives.


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