In recent years, some manufacturers have begun using gene‑edited microbial strains to ferment wheat flour, achieving notable improvements in flavor, texture, and production efficiency. This shift highlights a growing intersection between food innovation and regulatory oversight .
EU: Gene‑Edited = GMO
European regulation is unequivocal: under the 2001 GMO Directive and a 2018 ruling from the Court of Justice of the EU (Case C‑528/16), organisms altered through gene editing are treated as GMOs, even without foreign DNA insertion. Consequently, using gene‑edited microbes in food processes requires the full GMO approval pathway—risk assessment by EFSA, authorization by member states, supply‑chain traceability, and labeling when GMO content exceeds 0.9% . Although some initiatives aim to ease these rules, the current legal framework remains stringent .
US: GRAS or Food Additive Approval
In the United States, the FDA regulates products from gene‑edited organisms under the “new plant variety” paradigm. Updated 2024 guidance encourages voluntary pre‑market consultation, particularly for products raising new safety concerns. Fermentation products from gene‑edited microbes—such as enzymes—must undergo either GRAS (Generally Recognized as Safe) recognition or food additives approval, accompanied by data on production methods, allergen potential, and downstream processing .
Moreover, FDA labeling rules require disclosure of major allergens; labeling for gene‑editing is voluntary unless the product affects allergenicity or composition in a way that misleads consumers.
If you already use—or plan to use—gene‑edited microbes for wheat flour fermentation, here’s what to consider:
1. EU Compliance
• Treat gene‑edited strains as GMOs.
• Prepare a full dossier including risk assessments, traceability plans, and labeling.
• Do not export to the EU before receiving GMO authorization.
2. US Compliance
• Engage with the FDA early in a voluntary pre‑market consultation.
• Prepare a GRAS notification or file a food additive petition.
• Include thorough production and safety documentation.
3. Supply‑Chain Transparency
• Verify with suppliers whether strains are gene‑edited or non‑GMO.
• Ensure your technical documents and labels clearly state the microbial origins.
While gene‑edited microbes can enhance wheat flour fermentation performance, they also introduce significant regulatory burdens. In Europe, they are automatically treated as GMOs, subject to strict controls and labels. In the US, successful market entry depends on GRAS or food additive approval and FDA communication. Companies must thoughtfully balance technological innovation with compliance, especially when targeting global markets.