Date: 2025-11-05Category: Not ApplicableState: Union GovernmentCountry: Europe
Commission Regulation (EU) 2025/2223 of 4 November 2025 refusing to authorise a health claim made on foods, other than those referring to the reduction of disease risk and to children’s development and health
Issued by European Commission
· Directorate-General for Health and Food Safety
**Executive Summary**
Commission Regulation (EU) 2025/2223, dated November 4, 2025, refuses to authorize a health claim related to citicoline and memory support based on an application from Edge Pharma Sp. z o.o. The regulation cites a lack of sufficient evidence to support the claim and enters into force twenty days following publication in the Official Journal of the European Union.
**Key Points / Main Content**
* **Health Claim Prohibition:** Health claims made on foods are prohibited unless authorized by the Commission and included in the Union list of permitted health claims, according to Regulation (EC) No 1924/2006.
* **Application and Assessment:**
* Applications for health claim inclusion can be submitted to a Member State's national authority, which forwards valid ones to the European Food Safety Authority (EFSA) for assessment.
* EFSA delivers an opinion on the health claim's scientific substantiation.
* **Rejection of Citicoline Health Claim:**
* An application from Edge Pharma Sp. z o.o. for a health claim related to citicoline and memory support was submitted. The proposed claim stated that citicoline intake supports memory function in healthy middle-aged and elderly persons encountering age-related memory impairment.
* EFSA published a scientific opinion on July 4, 2024, concluding that a cause-and-effect relationship between citicoline consumption and improved memory function in the target population was not established.
* The Commission did not receive comments on the EFSA opinion from the applicant or members of the public.
* Due to non-compliance with Regulation (EC) No 1924/2006, the health claim related to citicoline is not authorized and will not be included in the Union list of permitted health claims.
* **Effective Date:** This Regulation enters into force on the twentieth day following its publication in the Official Journal of the European Union.
**Impact Analysis**
**Edge Pharma Sp. z o.o.**
**Impact**
The company's application to use the health claim related to citicoline and memory support on their products has been rejected.
**Action Required**
Edge Pharma Sp. z o.o. cannot use the rejected health claim on their food products.
**Food Business Operators**
**Impact**
This regulation clarifies the requirements for health claims and reinforces the necessity of scientific substantiation.
**Action Required**
Food Business Operators should review the regulation and ensure that any health claims they wish to make are backed by adequate scientific evidence and comply with Regulation (EC) No 1924/2006.
**Consumers**
**Impact**
Consumers are protected from misleading health claims related to citicoline and memory support.
**Action Required**
No specific action required, but consumers may wish to be aware of the health claims that have been rejected.
**Member States**
**Impact**
Member States must ensure compliance with the regulation.
**Action Required**
Member States should ensure compliance with the regulation.
Key Entities Referenced
Regulation (EC) No 1924/2006: Regulation of the European Parliament and of the Council on nutrition and health claims made on foods.
European Food Safety Authority ('the Authority'): The agency responsible for scientific assessment of health claims on foods.
Commission Regulation (EU) 2025/2223: The regulation refusing to authorize a specific health claim made on foods.
Brussels: Location where the regulation was issued.
Official Journal EN
of the European Union L series
2025/2223 5.11.2025
COMMISSION REGULATION(EU) 2025/2223
of 4 November 2025
refusing to authorise a health claim made on foods, other than those referring to the reduction of
disease risk and to children’s development and health
(Text with EEA relevance)
THE EUROPEAN COMMISSION,
Having regard to the Treaty on the Functioning of the European Union,
Having regard to Regulation (EC) No 1924/2006 of the European Parliament and of the Council of 20 December 2006 on
nutrition and health claims made on foods(1), and in particular Article 18(5) thereof,
Whereas:
(1) Pursuant to Regulation (EC) No 1924/2006, health claims made on foods are prohibited unless they are authorised by
the Commission in accordance with that Regulation and included in the Union list of permitted health claims.
(2) Regulation (EC) No 1924/2006 also provides that applications for the inclusion of health claims in the Union list of
permitted health claims may be submitted by food business operators to the national competent authority of a
Member State. The national competent authority is to forward valid applications to the European Food Safety
Authority (‘the Authority’) for a scientific assessment, as well as to the Commission and the Member States for
information.
(3) Following the receipt of an application, the Authority is to deliver an opinion on the health claim concerned.
(4) The Commission is to decide on the authorisation of the health claim, taking into account the opinion delivered by
the Authority.
(5) Following an application from Edge Pharma Sp. z o.o. (‘the applicant’), submitted pursuant to Article 18(1) of
Regulation (EC) No 1924/2006, the Authority was required to deliver an opinion on the scientific substantiation of
a health claim related to citicoline and support of the memory (Question No EFSA-Q-2022-00411). The claim
proposed by the applicant was worded as follows: ‘Citicoline intake supports memory function in healthy middle-
aged and elderly persons encountering age-related memory impairment’.
(6) On 4 July 2024, the Authority published a scientific opinion(2)on that health claim.
(7) In its scientific opinion, the Authority concluded that, on the basis of the data presented, a cause-and-effect
relationship has not been established between the 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. Accordingly, as the health claim does not comply with the requirements
of Regulation (EC) No 1924/2006 for the inclusion in the Union list of permitted health claims, it should not be
authorised.
(8) The Authority forwarded its scientific opinion to the Commission, the applicant and the Member States. Upon
publication of that opinion, the Commission did not receive any comments from the applicant or members of the
public pursuant to Article 16(6) of Regulation (EC) No 1924/2006.
(9) The measures provided for in this Regulation are in accordance with the opinion of the Standing Committee on
Plants, Animals, Food and Feed,
(1) OJ L 404, 30.12.2006, p. 9, ELI: http://data.europa.eu/eli/reg/2006/1924/oj.
(2) EFSA Journal2024;22(7) :e8861.
ELI: http://data.europa.eu/eli/reg/2025/2223/oj 1/3EN
OJ L, 5.11.2025
HAS ADOPTED THIS REGULATION:
Article 1
The health claim set out in the Annex to this Regulation shall not be included in the Union list of permitted health claims as
provided for in Article 13(3) of Regulation (EC) No 1924/2006.
Article 2
This Regulation shall enter into force on the twentieth day following that of its publication in the Official Journal of the
European Union.
This Regulation shall be binding in its entirety and directly applicable in all Member States.
Done at Brussels, 4 November 2025.
For the Commission
The President
Ursula VON DER LEYEN
2/3 ELI: http://data.europa.eu/eli/reg/2025/2223/ojANNEX
Rejected health claim
Application – Relevant provisions of Regulation (EC)
Nutrient, substance, food or food category Claim EFSA opinion reference
No 1924/2006
Citicoline supports improvement,
Article 13(5) health claim based on newly maintenance or reduced loss of memory in
developed scientific evidence and/or including a Citicoline (CDP-Choline) inner salt healthy middle-aged or elderly adults Q-2022-00411
request for the protection of proprietary data encountering age-associated subjective
memory impairment
ELI:
http://data.europa.eu/eli/reg/2025/2223/oj
3/3
OJ
L,
5.11.2025
EN