In May 2026 the EFSA Journal published the NDA Panel opinion on L-alpha-glycerylphosphorylcholine (L-alpha-GPC) from soya phospholipids as a novel food. The Panel concluded that the NF does not raise safety concerns at a maximum of 203.7 mg/day in food supplements — for individuals above 3 years, including pregnant and lactating women. That is a scientific milestone, not a Commission decision to add the ingredient 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 L-alpha-GPC under Regulation (EU) 2015/2283. The opinion carries DOI 10.2903/j.efsa.2026.10008. Title: Safety of L-alpha-glycerylphosphorylcholine (L-alpha-GPC) from soya phospholipids (lecithin) as a novel food pursuant to Regulation (EU) 2015/2283.
The NF is produced by chemical means from phosphatidylcholine (PC)-enriched soya lecithin. Two forms were assessed: a viscous liquid GPC 85% and a powder Alpha Size 100P. Identity, production process, composition and specifications did not raise safety concerns according to the Panel.
2. Which safety data underpin the conclusion?
| Assessment element | Panel finding (per opinion abstract) |
|---|---|
| Proposed use | Food supplements, max 203.7 mg/day (= 82.5 mg choline/day) |
| Target population | Individuals above 3 years of age, including pregnant and lactating women |
| NF characteristics | Endogenous PC metabolite; rapidly absorbed; choline source; not nutritionally disadvantageous |
| Applicant animal data | Several limitations; NOAEL 1000 mg/kg bw/day from published 90-day and teratogenicity studies |
| Margin of exposure (MoE) | Children >3 y: 111; adults: 345 — Panel considers sufficient in this case |
| Final conclusion | NF does not raise safety concerns under the proposed conditions of use |
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. Choline on the label: the 203.7 → 82.5 maths
The proposed maximum use level of 203.7 mg L-alpha-GPC per day corresponds — per the opinion — to 82.5 mg choline per day. For manufacturers that is a concrete figure for nutrition-labelling planning, if and when authorisation conditions and claims rules allow. The novel-food opinion itself does not “unlock” choline health claims.
4. What still has to happen before EU market access?
- EFSA opinion — scientific stage (completed for this application in May 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. Soya origin and allergens — handle carefully
The starting material is PC-enriched soya lecithin. The full EFSA opinion (not only the abstract) indicates a low probability of allergenicity/sensitisation risk, but does not completely exclude reactions in people allergic to soy. Allergen labelling assessment must follow Annex II to Regulation (EU) No 1169/2011, depending on the final product specification and residual soy protein content.
6. What the opinion does not decide
- It does not authorise health claims (Regulation (EC) No 1924/2006) — including cognitive or “nootropic” claims.
- It does not approve other doses or product forms than those assessed (GPC 85% and Alpha Size 100P within this application).
- It does not list the ingredient on the Union novel-food list — that is the Commission’s role.
- It does not replace the vitamin/mineral sources list under Directive 2002/46/EC.
7. 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.
- Prepare choline maths (82.5 mg from 203.7 mg GPC) for labelling — subject to future authorisation and 1924/2006 compliance.
- Run soy allergen due diligence (1169/2011) without over-reading the EFSA opinion.
- If choline health-benefit messaging is planned — a separate substantiation and claim-authorisation strategy.
Conclusion
The NDA opinion on L-alpha-GPC from soya phospholipids is a concrete, positive safety outcome at 203.7 mg/day (82.5 mg choline) for individuals above 3 years, including 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 L-alpha-glycerylphosphorylcholine (L-alpha-GPC) from soya phospholipids (lecithin) as a novel food pursuant to Regulation (EU) 2015/2283. EFSA Journal 2026. DOI: 10.2903/j.efsa.2026.10008 — primary opinion; source of 203.7 mg/day, 82.5 mg choline, NOAEL 1000 mg/kg bw/day, MoE 111/345.
- 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 the ingredient would be listed, if authorised).
- Regulation (EC) No 1924/2006 — nutrition and health claims (separate from novel food).
- Regulation (EU) No 1169/2011 — food information to consumers; Annex II (allergens, including soy) — labelling due-diligence context.