#32026R0391Commission Implementing Regulation (EU) 2026/391 amending conditions of use and labelling for pasteurised Akkermansia muciniphila
AI-generated summary for informational purposes only. Not legal advice. See the original source for the authoritative text.
This regulation expands the authorised use of pasteurised Akkermansia muciniphila as a novel food. It now permits its inclusion in food supplements and foods for special medical purposes for adolescents aged 12 to under 18 years, with maximum daily levels of 2.1×10^10 cells for those over 12, 3.0×10^10 cells for those over 14, and 3.4×10^10 cells for adults. The previous restriction excluding pregnant and lactating women remains in place, as EFSA could not confirm safety for them. The authorisation holder name has been updated to the Akkermansia Company SA. Labelling requirements have been revised to reflect the new age groups, requiring warnings that the product should not be consumed by pregnant/lactating women or children below the relevant age thresholds. Data protection for the original authorisation runs until 1 March 2027.
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Key Changes
- Extends use to general population from 12 to under 18 years in food supplements and FSMP
- Sets maximum levels: 2.1×10^10 cells/day (over 12 years), 3.0×10^10 cells/day (over 14 years), 3.4×10^10 cells/day (adults)
- Maintains exclusion for pregnant and lactating women due to insufficient safety data
+ 3 more changes with Pro
Obligations
What this law requires
Only place pasteurised Akkermansia muciniphila on the market when authorised and included in the Union list of novel foods in accordance with Regulation (EU) 2015/2283
Limit maximum daily levels of pasteurised Akkermansia muciniphila to 2.1×10^10 cells for adolescents aged 12 to under 14 years in food supplements and foods for special medical purposes
Limit maximum daily levels of pasteurised Akkermansia muciniphila to 3.0×10^10 cells for adolescents aged 14 to under 18 years in food supplements and foods for special medical purposes
Limit maximum daily levels of pasteurised Akkermansia muciniphila to 3.4×10^10 cells for adults in food supplements and foods for special medical purposes
Include labelling warnings that products containing pasteurised Akkermansia muciniphila should not be consumed by pregnant women, lactating women, or children below the relevant age thresholds (under 12 years)