Reviewed by The Nootropic Lab Editorial Team·Last updated: October 9, 2026

EU-Authorised Cognitive Health Claims for Supplements

Name: EU-Authorised (EFSA-Assessed) Health Claims for Cognitive Function
Creator: The Nootropic Lab
License: https://creativecommons.org/licenses/by/4.0/

Under Regulation (EC) No 1924/2006, only health claims authorised by the European Commission and listed in the EU Register may appear on supplement labels in the EU. The European Food Safety Authority (EFSA) assesses the science; the Commission decides. The authorised list for cognitive function is short: iodine, iron, pantothenic acid, vitamin B12, zinc and docosahexaenoic acid (DHA). Caffeine is not on it: EFSA assessed a 75 mg alertness claim favourably in 2011, but the Commission never authorised any caffeine claim, and it refused a 40–75 mg alertness claim in Regulation (EU) 2016/1411. Every row below is checked against the EU register. 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.

Cognitive claims: EU-authorised, not authorised, on hold and refused

Ingredient	Claim	Conditions	Status	Reference
Iodine	"Iodine contributes to normal cognitive function"	Food must be at least a 'source of' iodine as defined in the Annex to Regulation (EC) No 1924/2006	Authorised	EFSA Journal 2010;8(10):1800 · EU register POL-HC-6385
Iron	"Iron contributes to normal cognitive function"	Food must be at least a 'source of' iron as defined in the Annex to Regulation (EC) No 1924/2006	Authorised	EFSA Journal 2009;7(9):1215 · EU register POL-HC-6390
Iron (children)	"Iron contributes to normal cognitive development of children"	Food must be at least a 'source of' iron as defined in the Annex to Regulation (EC) No 1924/2006 (Article 14 children's development claim)	Authorised	EFSA question Q-2008-325 · EU register POL-HC-6273
Pantothenic acid (Vitamin B5)	"Pantothenic acid contributes to normal mental performance"	Food must be at least a 'source of' pantothenic acid as defined in the Annex to Regulation (EC) No 1924/2006	Authorised	EFSA Journal 2009;7(9):1218 and 2010;8(10):1758 · EU register POL-HC-6433
Vitamin B12	"Vitamin B12 contributes to normal psychological function"	Food must be at least a 'source of' vitamin B12 as defined in the Annex to Regulation (EC) No 1924/2006	Authorised	EFSA Journal 2010;8(10):4114 · EU register POL-HC-6485
Zinc	"Zinc contributes to normal cognitive function"	Food must be at least a 'source of' zinc as defined in the Annex to Regulation (EC) No 1924/2006	Authorised	EFSA Journal 2009;7(9):1229 · EU register POL-HC-6533
Docosahexaenoic acid (DHA)	"DHA contributes to maintenance of normal brain function"	Food must contain at least 40 mg of DHA per 100 g and per 100 kcal; the consumer must be told that the beneficial effect is obtained with a daily intake of 250 mg of DHA	Authorised	EFSA Journal 2011;9(4):2078 and 2010;8(10):1734 · EU register POL-HC-6366
Caffeine	"Increased alertness (at least 75 mg caffeine per serving)"	Assessed favourably by EFSA in 2011, but never authorised by the European Commission: the EU register lists no authorised caffeine claim	Assessed, not authorised	EFSA Journal 2011;9(4):2054 · not on the EU list of authorised claims
Caffeine	"Increased attention"	Assessed by EFSA in the same 2011 opinion; never authorised by the European Commission	Assessed, not authorised	EFSA Journal 2011;9(4):2054 · not on the EU list of authorised claims
Caffeine	"Caffeine helps to increase alertness (for intakes between 40 mg and 75 mg per serving)"	Article 13(5) application; EFSA found a cause-and-effect relationship had not been established at these doses	Refused	Refused by Commission Regulation (EU) 2016/1411 · EFSA question Q-2013-00399, EFSA Journal 2014;12(2):3574 · EU register POL-HC-8450
Bacopa monnieri	"(various proposed memory/cognitive claims)"	Botanical health claim	On hold (botanical)	Article 13 botanicals on hold pending re-evaluation
Ginkgo biloba	"(various proposed memory/circulation claims)"	Botanical health claim	On hold (botanical)	Article 13 botanicals on hold pending re-evaluation
Rhodiola rosea	"(various proposed cognitive/stress claims)"	Botanical health claim	On hold (botanical)	Article 13 botanicals on hold pending re-evaluation
Phosphatidylserine	"Memory and cognitive-performance claims (e.g. "May improve memory in the elderly")"	Proposed but not authorised	Refused	EFSA Journal 2010;8(10):1749 · EU register POL-HC-7749, POL-HC-7750, POL-HC-7751 (non-authorised)

Statuses, conditions of use and EFSA Journal references are checked against the European Commission's EU Register of nutrition and health claims (POL-HC codes are register entry IDs). The botanical rows are not listed in the register as authorised or refused. The register changes when the Commission adopts new authorisations or refusals.

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. caffeine, 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 8 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 in the EU — 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 Commission (after scientific assessment 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 (iodine, iron, pantothenic acid, vitamin B12, zinc and docosahexaenoic acid) carry authorised claims; the European Commission then decides which assessed claims to authorise. Caffeine shows the difference: EFSA assessed a 75 mg alertness claim favourably in 2011, but the Commission never added any caffeine claim to the authorised list, and in 2016 it refused a 40–75 mg alertness claim (Regulation (EU) 2016/1411). 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 EU-authorised claim. That includes caffeine: no caffeine alertness, attention or concentration claim is on the EU list of authorised claims, so we describe the trial evidence for caffeine rather than presenting it as an authorised claim. For Bacopa, Lion's Mane, Citicoline and similar, our copy describes the published clinical evidence rather than asserting health claims.

Regulatory sources (8)expand

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