Regulation (EU) 2025/2223
Health claim refusal: citicoline and memory

The operator question is not “may citicoline be in supplements?”, but whether labels or food advertising may claim that it supports memory. Commission Regulation (EU) 2025/2223 of 4 November 2025 (OJ L 2025/2223, 5.11.2025; CELEX 32025R2223) refuses to authorise that claim. Entry into force: twentieth day after publication — 25 November 2025.

1. What does Regulation 2025/2223 do?

Commission Regulation (EU) 2025/2223 (ELI: http://data.europa.eu/eli/reg/2025/2223/oj; EUR-Lex: CELEX 32025R2223; PL, DE) adopts two operative rules:

• Article 1 — the health claim set out in the Annex shall not be included in the Union list of permitted health claims under Article 13(3) of Regulation (EC) No 1924/2006;
• Article 2 — the Regulation enters into force on the twentieth day following its publication in the Official Journal of the European Union.

Procedural basis: Article 18(5) of Regulation (EC) No 1924/2006. Application route: Article 13(5) — claim based on newly developed scientific evidence and/or including a request for protection of proprietary data.

2. Application, proposed wording and Annex

Applicant (EN version of the act): Edge Pharma Sp. z o.o. (the PL OJ and EFSA opinion spell “Egde Pharma”). EFSA question: EFSA-Q-2022-00411. Claim proposed by the applicant (recital 5):

“Citicoline intake supports memory function in healthy middle-aged and elderly persons encountering age-related memory impairment”.

In the Annex to 2025/2223 the Commission records the rejected claim as: substance — Citicoline (CDP-Choline) inner salt; claim — Citicoline supports improvement, maintenance or reduced loss of memory in healthy middle-aged or elderly adults encountering age-associated subjective memory impairment; EFSA reference — Q-2022-00411.

3. EFSA e8861: no cause-and-effect relationship

On 4 July 2024 EFSA published its scientific opinion (EFSA Journal 2024;22(7):e8861; DOI 10.2903/j.efsa.2024.8861). Recital 7 of Regulation 2025/2223 restates the NDA Panel’s conclusion:

• on the basis of the data presented, a cause-and-effect relationship has not been established between consumption of citicoline (CDP-Choline) inner salt and improvement, maintenance or reduced loss of memory;
• in healthy middle-aged or elderly adults encountering age-associated subjective memory impairment.

In the opinion itself the Panel considered citicoline sufficiently characterised and improvement/maintenance/reduced loss of memory a beneficial physiological effect for that population. In weighing the evidence the Panel took into account, among other things:

• only one RCT in healthy participants showed a beneficial effect on episodic memory at 500 mg/day for 12 weeks;
• the effect was not observed in another study at 1 g/day for 3 months;
• data from dementia patients (1 g/day for 12 weeks / 12 months) did not support the claim in healthy adults;
• no convincing evidence of a plausible mechanism by which citicoline or its components (beyond endogenous synthesis) could affect memory in humans.

The Commission received no comments under Article 16(6) of Regulation 1924/2006 (recital 8).

4. Operator answer: sales ban or claim refusal?

Regulation 2025/2223 refuses only this specific health claim — it does not ban placing citicoline on the market as a food supplement.

Citicoline is a novel food: originally Commission Implementing Decision 2014/423/EU, conditions carried into the Union list under Implementing Regulation (EU) 2017/2470 (CELEX 32017R2470). Among other entries:

• food supplements (Directive 2002/46/EC): maximum 500 mg/day;
• foods for special medical purposes (Reg. 609/2013): 250 mg per serving, maximum 1 000 mg/day;
• labelling designation: “Citicoline”;
• statement that the product is not intended to be consumed by children.

Novel-food status and dose maxima are the ingredient market-access track. Health claims are a separate track under Reg. 1924/2006 + list 432/2012. Ingredient presence on the market does not unlock a memory claim.

5. What may still appear on labels / in ads under 1924/2006?

Under Regulation (EC) No 1924/2006, health claims on foods are prohibited unless authorised by the Commission and included in the Union list. After 2025/2223 the citicoline–memory claim is not listed — so it may not be used as a health claim.

What may still be possible (if separate conditions are met):

• Novel-food designation and mandatory statements from list 2017/2470 (name “Citicoline”, not-for-children warning, maxima);
• Other health claims — only if they concern another relationship and are authorised and listed; authorisation for another substance (e.g. choline) does not automatically transfer to citicoline;
• Nutrition claims (Art. 8 / Annex to 1924/2006) — only where the nutrient-specific conditions are met; they must not be used to circumvent a prohibited health claim;
• Communication that does not constitute a health claim under Article 2(2)(5) — assessed in context (label, website, B2B).

Same logic as for the creatine cognitive-claim refusal (EU 2026/1118): refusing a health relationship ≠ banning the ingredient; there, a separate authorised muscle-strength claim (2017/672) still exists — here there is no “backup” listed memory claim for citicoline.

6. Operator checklist

1. Separate novel-food compliance (maxima, designation, children warning) from 1924/2006 claims compliance.
2. Review labels, websites, marketplaces and B2B materials for memory / “memory support” / age-related memory impairment wording linked to citicoline / CDP-Choline.
3. Remove or rephrase so the text does not constitute a memory health claim.
4. Do not transplant choline claims or generic “brain” claims onto citicoline without a Union-list entry.
5. Document the decision against CELEX 32025R2223, DOI 10.2903/j.efsa.2024.8861 and CELEX 32017R2470.

Glossary

Health claim

Any claim that states, suggests or implies a relationship between a food category, a food or one of its constituents and health — Reg. (EC) No 1924/2006.

Article 13(5)

Application route for a claim based on newly developed evidence and/or requesting protection of proprietary data.

Union list of claims

List of permitted health claims (including Reg. 432/2012 for Article 13 claims).

C&E

Cause and effect — the relationship EFSA requires for a positive opinion on a claim.

Novel food

Food under the EU novel-food rules; citicoline has a separate Union-list entry — that is not health-claim authorisation.

Conclusion

From 25 November 2025, Regulation (EU) 2025/2223 formally closes the Union-list route for a citicoline and memory-support claim. The basis was EFSA opinion e8861 (no C&E despite one positive 500 mg RCT). Citicoline as a novel food may still be used in supplements within the 2017/2470 conditions — but without the memory claim. Scientific opinion and Commission decision are two steps; here both are negative for this claim.

Primary sources

1. Commission Regulation (EU) 2025/2223 — CELEX 32025R2223; ELI eli/reg/2025/2223/oj. Applies: 25.11.2025.
2. EFSA NDA 2024 — Citicoline and support of the memory function (EFSA Journal 2024;22(7):e8861; Q-2022-00411).
3. Commission Implementing Decision 2014/423/EU — citicoline as novel food; CELEX 32014D0423.
4. Commission Implementing Regulation (EU) 2017/2470 — Union list of novel foods (Citicoline entry); CELEX 32017R2470.
5. Regulation (EC) No 1924/2006 — nutrition and health claims.
6. Regulation (EU) No 432/2012 — Union list of permitted health claims (Art. 13).
7. Contrast: EU 2026/1118 — creatine / cognitive function claim refusal.