On 28 July 2026 the EFSA Journal published the NDA Panel opinion on freeze-dried viable Anaerobutyricum soehngenii CH106 as a novel food. The Panel concluded safety at 2.0×10⁹ AFU/day for adults — excluding pregnant and lactating women. That is a scientific milestone, not a Commission decision to add the strain to the Union list.
1. What exactly did EFSA assess?
Following a request from the European Commission, the Panel on Nutrition, Novel Foods and Food Allergens (NDA) assessed the safety of A. soehngenii CH106 under Regulation (EU) 2015/2283. The opinion carries DOI 10.2903/j.efsa.2026.10255 and covers a freeze-dried preparation of viable cells intended for food supplements for adults.
The applicant proposed a maximum of 2.0×10⁹ active fluorescent units (AFU) per day, corresponding to 2.9×10⁷ AFU/kg body weight per day. Information on identity, production process, composition, stability and specifications was considered sufficient and did not raise safety concerns.
2. Which safety data underpin the conclusion?
| Assessment element | Panel finding (per opinion abstract) |
|---|---|
| Genotoxicity | No concerns regarding genotoxicity of the novel food |
| Human intervention study | Half the proposed dose for 3 months — no safety concerns identified |
| 90-day oral toxicity (Wistar rats) | NOAEL = highest dose tested in males: 4.7×10¹⁰ AFU/kg bw per day |
| Margin of exposure (MoE) | 1621 versus the maximum proposed daily dose — considered sufficient |
| Final conclusion | Safe at 2.0×10⁹ AFU/day for adults, excluding pregnant and lactating women |
These figures come directly from the EFSA opinion abstract. They must not be read as medicinal doses or as proof of clinical efficacy — the novel-food procedure does not replace health-claim assessment.
3. Why exclude pregnancy and lactation?
The Panel explained that appropriate initial gastrointestinal colonisation profoundly affects health in infancy and childhood, that little is known about how the maternal microbiota shapes the maternal–fetal immune system, and that early-life microbiota disruption can have lasting effects into adulthood. That is a target-population limitation, not a general ban for all adults.
4. What still has to happen before EU market access?
- EFSA opinion — scientific stage (completed for CH106 in July 2026).
- Commission and Member State decision — an implementing regulation amending the Union list (Implementing Regulation (EU) 2017/2470).
- Listing conditions — including food category, maximum levels, target population and any extra labelling requirements.
- National compliance — for example, in Poland, GIS notification if the product is a food supplement.
Only step 2 opens a lawful route to market. Marketing that equates “positive EFSA opinion” with “already legal in the EU” is misleading.
5. What the opinion does not decide
- It does not authorise health claims (Regulation (EC) No 1924/2006).
- It does not approve other doses or product forms than those assessed.
- It does not replace QPS/FEEDAP pathways — this is a novel-food assessment for food/supplements, not a feed-additive decision.
- It does not confer an EU “proven probiotic effect” under health-claims law.
6. Practical next steps for manufacturers and importers
Monitor the Union list and draft Commission implementing acts. Do not schedule EU production runs that assume immediate marketability solely on the basis of the opinion. If health-benefit messaging is planned, prepare a separate substantiation and claim-authorisation strategy — independent of novel food. For non-EU jurisdictions, check local legal status separately; EU status does not travel automatically.
Conclusion
The NDA opinion on A. soehngenii CH106 is a concrete, positive safety outcome at 2.0×10⁹ AFU/day for adults excluding pregnancy and lactation. The fairest market message is: a scientific green light is not yet a regulatory green light. EU novel-food marketing still requires a Commission implementing regulation.
Primary sources
- EFSA NDA Panel. Safety of Anaerobutyricum soehngenii CH106 as a novel food pursuant to Regulation (EU) 2015/2283. EFSA Journal 2026. DOI: 10.2903/j.efsa.2026.10255 — primary opinion; source of the 2.0×10⁹ AFU/day dose, NOAEL, MoE 1621 and pregnancy/lactation exclusion.
- Regulation (EU) 2015/2283 on novel foods — procedural framework: EFSA opinion, then Commission decision.
- Implementing Regulation (EU) 2017/2470 — Union list of novel foods (where CH106 would be listed, if authorised).
- Regulation (EC) No 1924/2006 — nutrition and health claims (separate from novel food).
- Seegers et al. Toxicological safety evaluation of live Anaerobutyricum soehngenii strain CH106. J Appl Toxicol. 2021 — peer-reviewed toxicology context for CH106 (does not replace the EFSA opinion or authorisation).