Simplification of rules on fermentation using GMMs

Proposal for a Regulation of the European Parliament and of the Council amending Regulations (EC) No 999/2001, (EC) No 1829/2003, (EC) No 1831/2003, (EC) No 852/2004, (EC) No 853/2004, (EC) No 396/2005, (EC) No 1099/2009, (EC) No 1107/2009, (EU) No 528/2012, (EU) 2017/625 as regards the simplification and strengthening of food and feed safety requirements

Update

Genetically modified micro-organisms (GMMs) can be used in fermentation to make food or animal feed. In these cases the micro-organisms are removed during production, but their residues (minute amounts of DNA fragments) may still remain in the final product. There has been some uncertainty about whether these food and feed products should be considered as “produced from genetically modified organisms (GMOs)” when GMM residues are present in the final products. If these products are considered to be “produced from GMOs”, they would need to be assessed and authorised under the EU’s GMO Regulation 1829/2003.

The European Commission proposes to clarify that food and feed produced using GMMs as production strains in fermentation processes should not be considered as “produced from GMOs”, as long as any remaining traces in the final product meet certain safety conditions.

Impacted Products

Food and feed additives, food enzymes, novel foods

What is changing?

Foods that “consist of or are produced from” GMOs have to be assessed and authorised before they can be put on the EU market (GMO Regulation 1829/2003).

Some foods and feeds are produced through a fermentation process using GMMs. These foods do not “consist of” GMOs and are not “produced from” GMOs, but they are “produced using” GMMs that are later removed during the production process. However, residues of the GMMs may remain in the final product.

There is uncertainty under current rules whether foods produced using GMMs require authorisation under the GMO Regulation.

The European Commission proposes to clarify that the term “produced from GMOs” does not include food and feed products produced using GMMs as production strains if those micro-organisms are not present in the final product. If final products contain residues of the GMMs, those residues must:

• be limited to non-viable cells (cells that cannot grow, divide, or reproduce)
• be reduced to a minimum by making reasonable attempts to remove them in accordance with good manufacturing practice
• have no technological effect on the food or feed.

Under this proposal, the safety of food and feed produced using GMMs does not need to be assessed under the GMO Regulation. In each case, the safety of each product type will be assessed under the relevant Regulation:

• feed additives (Regulation 1831/2003)
• food additives (Regulation 1333/2008)
• flavourings (Regulation 1334/2008)
• novel foods (Regulation 2015/2283).

Why?

Competent authorities of EU Member States have adopted different interpretations on the legality of GMM residues in final products. Some consider that these products should not be considered GM foods, while others currently require them to be authorised under the GMO Regulation and have therefore removed unauthorised products that contain GMM residues from the market. This inconsistency has created uncertainty for producers of food and feed. Uncertainty has been aggravated by increasingly sensitive analysis that more frequently identifies minute amounts of DNA.

GMM fermentation processes are of growing importance to the European food and feed sectors. This initiative is part of a broader EU strategy aimed at strengthening the competitiveness of the European biotechnology sector (European Commission 2024, 2025).

Timeline

This proposal will be discussed by the Council of the EU (Member States) and the European Parliament, a process that can take up to 2 years. So its application is possible in the second half of 2027.

Background

The EU defines a GMM as “a micro-organism in which the genetic material has been altered in a way that does not occur naturally by mating and/or natural recombination” (Directive 2009/41/EC, Art. 2(b)).

Resources

Sources