Rejection of a health claim for citicoline
- Health claims
Summary
The European Union (EU) has refused the health claim submitted by Edge Pharma Sp. z o.o. that the consumption of citicoline (CDP-Choline) inner salt supports memory function in healthy middle-aged and elderly people.
EU refuses health claim for citicoline in support of memory function
Commission Regulation 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
Update
The European Union (EU) has refused the health claim submitted by Edge Pharma Sp. z o.o. that the consumption of citicoline (CDP-Choline) inner salt supports memory function in healthy middle-aged and elderly people.
Impacted Products
Health foods
What is changing?
The EU has confirmed its rejection of an application submitted by Edge Pharma Sp. z o.o. for a health claim that citicoline (CDP-Choline) intake supports memory function in healthy middle-aged and elderly people with age-related memory impairment.
Why?
The European Food Safety Authority (EFSA 2024) concluded that, based on the data presented, a cause-and-effect relationship cannot be established between consumption of citicoline (CDP-Choline) inner salt and its effect on age-associated subjective memory impairment in healthy middle-aged or elderly adults.
This health claim is not included in the Union list of permitted health claims because it does not comply with the requirements of Regulation 1924/2006.
Timeline
This Regulation applies from 25 November 2025.
Background
Regulation EC 1924/2006 prohibits health claims made on foods unless they are authorised by the European Commission and included in the Union list of permitted health claims (Regulation No 432/2012), supported by a favourable EFSA opinion.
Resources
EFSA (2024) ‘Citicoline’ and support of the memory function: Evaluation of a health claim pursuant to Article 13(5) of Regulation (EC) No 1924/2006. EFSA Journal, 22(7): e8861.
Regulation 1924/2006 on nutrition and health claims made on foods
Sources
Commission Regulation 2025/2223 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
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EU refuses health claim for citicoline in support of memory function
Commission Regulation 2025/2223 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
What is changing and why?
The European Union (EU) has refused the health claim submitted by Edge Pharma Sp. z o.o. that the consumption of citicoline (CDP-Choline) inner salt supports memory function in healthy middle-aged and elderly people. The European Food Safety Authority has concluded that no relationship can be established between consumption of this substance and its effect on age-associated subjective memory.
Timeline
This Regulation applies from 25 November 2025.
Disclaimer: Under no circumstances shall COLEAD be liable for any loss, damage, liability or expense incurred or suffered that is claimed to have resulted from the use of information available on this website or any link to external sites. The use of the website is at the user’s sole risk and responsibility. This information platform was created and maintained with the financial support of the European Union. Its contents do not, however, reflect the views of the European Union.