The legal question is not “is creatine safe?”, but whether food labelling or advertising may claim that it improves cognitive function. Commission Regulation (EU) 2026/1118 of 26 May 2026 (OJ L 2026/1118, 27.5.2026; CELEX 32026R1118) refuses to authorise that claim. Entry into force: the twentieth day after publication — 16 June 2026.
1. What Regulation 2026/1118 decides
Commission Regulation (EU) 2026/1118 (ELI: http://data.europa.eu/eli/reg/2026/1118/oj; CELEX 32026R1118) provides:
- 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.
Legal basis: Article 18(5) of Regulation (EC) No 1924/2006. Application route: Article 13(5) — a claim based on newly developed scientific evidence and/or including a request for protection of proprietary data.
2. Application, proposed wording and Annex
Applicant: Alzchem Trostberg GmbH. EFSA question: EFSA-Q-2024-00106. Proposed claim (recital 5):
“Daily creatine supplementation can contribute to improved cognitive function”.
The Annex records the rejected claim as: nutrient/substance — Creatine; claim — Creatine supplementation improves cognitive function; EFSA reference — Q-2024-00106.
3. EFSA e9100: cause and effect not established
On 19 November 2024 the Authority published its scientific opinion (EFSA Journal 2024;22:e9100; DOI 10.2903/j.efsa.2024.9100). Recital 7 of Regulation 2026/1118 restates the NDA Panel’s conclusion:
- on the basis of the data presented, a cause and effect relationship has not been established between creatine supplementation and an improvement in cognitive function;
- in one or more domains such as memory, verbal fluency, attention, alertness, processing speed, psychomotor speed, executive function and general cognitive ability or flexibility and fluid intelligence.
In the opinion itself the Panel considered creatine sufficiently characterised and an improvement in cognitive function a beneficial physiological effect — but after weighing the evidence (including isolated acute findings at high short-term doses and no consistent effect at lower or longer regimens) it did not establish C&E. The Commission received no comments under Article 16(6) of Regulation 1924/2006 (recital 9).
4. Contrast: authorised muscle claim (2017/672)
Do not equate refusal of a cognition claim with the status of creatine “in general”. Commission Implementing Regulation (EU) 2017/672 (CELEX 32017R0672) authorised a different claim and inserted it into the Annex to Regulation (EU) No 432/2012:
| 2017/672 (authorised) | 2026/1118 (refusal) | |
|---|---|---|
| Relationship | Creatine + resistance training → muscle strength | Creatine → cognitive function |
| Population / conditions | Adults >55; 3 g/day; training ≥3×/week at 65–75% of 1RM | No authorisation — claim not listed |
| EFSA | C&E established (2016;14(2):4400) | C&E not established (e9100 / Q-2024-00106) |
| Legal effect | Union-list entry (432/2012) | No list entry (Article 1 of 2026/1118) |
Authorised wording: “Daily creatine consumption can enhance the effect of resistance training on muscle strength in adults over the age of 55” — with mandatory consumer information on target population, dose and training conditions.
5. Framework: 1924/2006 and the 432/2012 list
Under Regulation (EC) No 1924/2006, health claims on foods are prohibited unless authorised by the Commission and included in the Union list. Regulation (EU) No 432/2012 establishes the list of permitted claims other than those referring to the reduction of disease risk and to children’s development and health. Refusal under 2026/1118 means the cognition claim is not added to that list — and therefore may not be used as a health claim within the meaning of 1924/2006.
Ingredient, novel-food or additive status for creatine does not unlock a health claim. Claims need a separate 1924/2006 track.
6. Operational checklist
- Audit labels, websites and B2B materials for memory, attention, “brain” or “cognitive support” wording linked to creatine.
- Remove or rephrase content so it does not constitute a health claim on improved cognitive function.
- If using the 2017/672 muscle claim — meet the conditions of use (population >55, 3 g, training, mandatory information).
- Do not merge both relationships into one slogan (“creatine for muscle and brain”).
- Document the compliance decision against CELEX 32026R1118 and 32017R0672.
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 claims based on newly developed scientific evidence and/or proprietary data protection.
- Union list
- The list of permitted health claims (including Reg. 432/2012 for Article 13 claims).
- C&E
- Cause and effect — the relationship EFSA must establish for a positive opinion on a claim.
Conclusion
From 16 June 2026, Regulation (EU) 2026/1118 formally closes the Union-list route for a creatine cognitive-function claim. The basis was EFSA opinion e9100 (no C&E). The authorised muscle-strength claim under 2017/672 remains a separate, still valid list entry — subject to its conditions of use. A scientific opinion and a Commission decision are two steps; here both are negative for the cognition claim.
Primary sources
- Commission Regulation (EU) 2026/1118 — CELEX 32026R1118; ELI eli/reg/2026/1118/oj. Entry into force: 16.06.2026.
- EFSA NDA 2024 — Creatine and improvement in cognitive function (EFSA Journal 2024;22:e9100; Q-2024-00106).
- Commission Implementing Regulation (EU) 2017/672 — authorised creatine + resistance training → muscle strength claim (adults >55); CELEX 32017R0672.
- Regulation (EC) No 1924/2006 — nutrition and health claims.
- Regulation (EU) No 432/2012 — Union list of permitted health claims (Article 13).