Proposed refusal of a health claim for citicoline
- Health claims
Summary
The European Commission has informed the World Trade Organization Technical Barriers to Trade (WTO TBT) Committee that it intends to refuse a health claim for citicoline in support of memory function in healthy middle-aged and elderly persons (G/TBT/N/EU/1112).
EU proposes to refuse health claim for citicoline in support of memory function
Draft Commission Regulation 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 Commission has informed the World Trade Organization Technical Barriers to Trade (WTO TBT) Committee that it intends to refuse a health claim for citicoline in support of memory function in healthy middle-aged and elderly persons (G/TBT/N/EU/1112).
Impacted Products
Health foods
What is changing?
The European Commission has informed the WTO TBT Committee that it intends to refuse a health claim from Egde Pharma Sp. z o.o. that citicoline intake supports memory function in healthy middle-aged and elderly persons 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 the consumption of citicoline (CDP-Choline) inner salt and its effect on age-associated subjective memory impairment in healthy middle-aged or elderly adults.
The health claim should not be included in the Union list of permitted health claims because it does not comply with the requirements of Regulation 1924/2006.
Timeline
The Regulation is expected to be adopted in approximately the third quarter of 2025.
Recommended Actions
Competent authorities of non-EU countries that are members of the WTO may comment on the EU proposal by emailing the EU TBT Enquiry Point until 4 May 2025 (G/TBT/N/EU/1112).
Background
Regulation EC 1924/2006 prohibits health claims made on foods unless they are authorised by the Commission and, supported by a favourable European Food Safety Authority (EFSA) opinion, included in the Union list of permitted health claims (Regulation No 432/2012).
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
Regulation 432/2012 establishing a list of permitted health claims made on foods, other than those referring to the reduction of disease risk and to children’s development and health
Sources
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EU proposes to refuse health claim for citicoline in support of memory function
Draft Commission Regulation 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 Commission intends to reject a health claim related to citicoline in support of memory function in healthy middle-aged or elderly adults with age-associated subjective memory impairment. The European Food Safety Authority concluded that a relationship between the consumption of the substance and its effect on age-associated subjective memory cannot be established.
Actions
Competent authorities of non-EU countries that are members of the World Trade Organization may comment on the EU proposal by emailing the EU TBT Enquiry Point until 4 May 2025 (G/TBT/N/EU/1112).
Timeline
The Regulation is expected to be adopted in approximately the third quarter of 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.