EFSA-Approved Cognitive Supplement Claims (EU)
Under Regulation (EC) No 1924/2006, only health claims authorised by the European Food Safety Authority and listed in the EU Register may appear on supplement labels in the EU. The authorised list for cognitive function is short: caffeine (alertness/concentration), iodine, iron, pantothenic acid, vitamin B12, and zinc. Most of the well-known nootropic ingredients (Bacopa, Ginkgo, Rhodiola, Phosphatidylserine, Lion's Mane) sit on the on-hold botanical list or have been rejected. This page is the full reference.
EFSA-authorised cognitive claims
| Ingredient | Authorised claim | Conditions | Status |
|---|---|---|---|
| Caffeine | "Caffeine helps to increase alertness" | At least 75 mg per quantified portion | Authorised |
| Caffeine | "Caffeine helps to improve concentration" | At least 75 mg per quantified portion | Authorised |
| Iodine | "Iodine contributes to normal cognitive function" | Source of iodine (≥15% RNV per 100 g/100 ml) | Authorised |
| Iron | "Iron contributes to normal cognitive function" | Source of iron (≥15% NRV) | Authorised |
| Iron (children) | "Iron contributes to the normal cognitive development of children" | Source of iron; targeted at child consumers | Authorised |
| Pantothenic acid (Vitamin B5) | "Pantothenic acid contributes to normal mental performance" | Source of pantothenic acid (≥15% NRV) | Authorised |
| Vitamin B12 | "Vitamin B12 contributes to normal psychological function" | Source of B12 (≥15% NRV) | Authorised |
| Zinc | "Zinc contributes to normal cognitive function" | Source of zinc (≥15% NRV) | Authorised |
| Bacopa monnieri | "(various proposed memory/cognitive claims)" | Botanical health claim | On hold (botanical) |
| Ginkgo biloba | "(various proposed memory/circulation claims)" | Botanical health claim | On hold (botanical) |
| Rhodiola rosea | "(various proposed cognitive/stress claims)" | Botanical health claim | On hold (botanical) |
| Phosphatidylserine | "Memory function claim" | Originally proposed but not authorised | Rejected |
Sources cited per row above. Claims update as EFSA publishes new opinions.
What this means for product copy in the EU
A supplement sold in the EU may use the authorised claims above when conditions of use are met, but cannot extend cognitive claims to ingredients without authorised claims (e.g. Bacopa, Lion's Mane). Product copy that asserts cognitive benefits for non-authorised ingredients is in breach of Regulation 1924/2006 and may attract enforcement action by the competent national authority. Compliant product copy describes the ingredient and its mechanism without making a health claim.
Audit of our EU catalog
We track 7 products in our EU catalog. Editorial copy on this site describes ingredient mechanisms studied in clinical trials and does not assert label-grade health claims. Our reviews flag products whose marketing material uses cognitive claim language not authorised by EFSA — this is informational for the reader, not a regulatory determination.
Frequently asked questions
What is Regulation (EC) No 1924/2006?
Regulation (EC) No 1924/2006 governs nutrition and health claims made on foods sold in the EU, including dietary supplements. It established the principle that only health claims authorised by the European Food Safety Authority (EFSA) and listed in the EU Register may appear on product labels and in advertising. Unauthorised claims are prohibited regardless of evidence base.
Why are so few cognitive claims authorised?
EFSA applies a high evidentiary bar: claims must be supported by generally accepted human scientific evidence under the conditions of use proposed. For cognitive function, only a handful of nutrients (caffeine, iodine, iron, pantothenic acid, vitamin B12, zinc) have met this bar. Botanical ingredients (Bacopa, Ginkgo, Rhodiola, Phosphatidylserine) have either been rejected or remain "on hold" pending re-evaluation of the Article 13 botanical claim list, which has not been completed since the regulation entered force.
What does "on hold" mean for botanical claims?
When Regulation 1924/2006 was implemented, the European Commission decided to evaluate health claims for botanicals separately from non-botanical claims. That evaluation was suspended in 2010 and has not been completed. Botanical health claims (Bacopa, Ginkgo, Rhodiola, etc.) are in regulatory limbo: not authorised, but not formally rejected. Some Member States permit traditional-use language pending the EU-level decision.
Can a supplement that contains Bacopa make any cognitive claim in the EU?
Not under the harmonised EU framework. Member-state-level traditional-use language may be permitted under THMP (Traditional Herbal Medicinal Products) Directive 2004/24/EC for products registered as traditional herbal medicines. Most cognitive supplements in the EU sidestep this by using ingredient-mechanism descriptions ("contains 250 mg Bacopa monnieri standardised to 50% bacosides") rather than health claims about what the ingredient does for cognition.
What does this mean for our editorial framing on EU pages?
On EU pages we describe ingredient mechanisms studied in clinical trials and avoid asserting label-grade cognitive claims for ingredients without an EFSA-authorised claim. Caffeine + alertness/concentration claims are explicitly authorised and used straightforwardly. For Bacopa, Lion's Mane, Citicoline and similar, our copy describes the published clinical evidence rather than asserting health claims.