On November 19, 2024, the Autorité européenne de sécurité des aliments (EFSA) Panel on Nutrition, Novel Foods, and Food Allergens (NDA) issued a scientific opinion evaluating a health claim application submitted under Article 13(5) of Regulation (EC) No 1924/2006. The application, filed by Alzchem Trostberg GmbH through Austria’s Competent Authority, sought to substantiate claims linking creatine supplementation to cognitive performance improvements.
Summary of Findings
- Creatine is sufficiently characterised as a food constituent.
- Improvement in cognitive function is recognised as a beneficial physiological effect.
- Evidence provided does not establish a cause-and-effect relationship between creatine supplementation and improved cognitive performance.
Key Evidence Reviewed
- Human Studies: 21 human intervention studies evaluated, along with additional literature.
- Effects observed at high doses (20 g/day for short periods) did not persist at lower doses or continuous consumption (3 g/day).
- No consistent cognitive benefits were found for memory, attention, executive function, or response inhibition in healthy individuals under normal or stress conditions.
- Diseased Populations: Three intervention studies in diseased individuals also failed to show significant cognitive benefits.
- Mechanism: Weak evidence was presented for a mechanism supporting the claimed cognitive enhancement in healthy adults.
Impact
- EFSA’s conclusion prohibits the use of health claims linking creatine to cognitive benefits on products marketed in the EU.
Prochaines étapes
- Businesses should review and adjust their marketing strategies for creatine supplements to ensure compliance with EFSA guidelines.
- It is recommended to monitor ongoing research on creatine’s cognitive effects and stay informed about potential regulatory updates that could affect product claims.
This decision highlights the importance of robust evidence to substantiate health claims in the EU market.
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