France Amends Food Additive Regulations, Impacting Enzyme Use in Supplements
ANSES has issued an opinion on proposed changes to the 2006 decree governing technological auxiliaries, specifically affecting enzyme applications in food and supplement manufacturing within France. This signals tighter control and potential reformulation requirements for brand owners.
Paris, France — 28 July 2026
The French Agency for Food, Environmental and Occupational Health & Safety (ANSES) has published its opinion, dated 13 May 2026, on a draft decree poised to amend the existing legislation from 19 October 2006 concerning technological auxiliaries in food production. This move primarily targets the use of enzymes within human nutrition, encompassing their application in supplement manufacturing. The proposed modifications indicate a tightening of regulatory oversight, demanding specific attention from manufacturers and brand owners operating or importing into the French market.
The current decree, in place since 2006, defines and regulates substances permitted as processing aids without necessarily appearing in the final product. ANSES's latest review, referenced as 2025-SA-0066, signals a re-evaluation of specific enzyme categories. While the full scope of changes will be detailed in the forthcoming decree, the opinion underscores a drive for enhanced safety and traceability regarding these auxiliaries. This aligns with broader European trends towards stricter control over food additives and processing aids, aiming to harmonise national regulations with EU frameworks.
For the supplement industry, this means a granular examination of enzyme functions. Manufacturers must ascertain whether their current enzyme-based processes or formulations fall under new, more stringent approval requirements. Any unapproved enzyme applications, even as processing aids, will necessitate immediate action, ranging from securing new authorisations to complete process overhauls. This could particularly affect products relying on novel or less common enzymatic processes.
The advisory from ANSES serves as a critical pre-notification. Supplement companies active in the French market should proactively audit their ingredient lists and manufacturing processes, focusing on all enzymatic steps. Engaging with legal and regulatory counsel now will be essential to mitigate future compliance risks and avoid potential product withdrawals or market access restrictions once the decree is formally adopted.
What this means for France
French supplement manufacturers and brand owners face imminent compliance updates. The forthcoming decree will necessitate a review of all products utilising enzymes as technological auxiliaries, potentially triggering reformulation costs between €10,000 and €50,000 per affected SKU, depending on complexity. Regulatory teams must prepare for new approval dossiers or updated declarations for enzyme use by late 2026. This also presents a competitive opportunity for compliant domestic producers and suppliers of approved enzymes, while non-compliant imports may face increased border scrutiny and rejection. Brand owners must budget for increased regulatory affairs spending and potential production delays.
Brand owners increasingly rely on contract-manufacturing partners such as Supplement Factory to navigate these requirements.