Rejection of a health claim for Appethyl
- Food safety
- Food supplements/dietetic foods
- Health claims
- Labelling
Summary
The European Commission has informed the World Trade Organization Technical Barriers to Trade (WTO TBT) Committee that it will reject a health claim for Appethyl® related to reduction of body weight (G/TBT/N/EU/1064).
EU to reject Appethyl health claim – WTO TBT consultation
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 will reject a health claim for Appethyl® related to reduction of body weight (G/TBT/N/EU/1064).
What is changing?
The European Commission proposes to reject an application for a health claim submitted by Greenleaf Medical AB that “Appethyl® helps your body weight reduction during mild caloric restriction”.
Why?
The European Food Safety Authority (EFSA) evaluated the proposed claim and found that no cause-and-effect relationship had been established between the consumption of Appethyl (an aqueous extract from spinach leaves) and a reduction of body weight under the conditions of use proposed by the applicant (EFSA 2023). Therefore the health claim does not comply with the requirements of Regulation 1924/2006.
Recommended Actions
Comments on the proposal can be submitted via the National TBT notification authority of the country concerned to the EU TBT Enquiry Point until 23 July 2024.
Resources
EFSA (2023) Appethyl® and reduction of body weight: evaluation of a health claim. EFSA Journal, 21(10): 8239.
Regulation (EC) No 1924/2006 on nutrition and health claims made on foods
Sources
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EU to reject Appethyl health claim – WTO TBT consultation
Regulation
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 EU proposes to reject an application for the following health claim made by Greenleaf Medical AB that the product “Appethyl® helps your body weight reduction during mild caloric restriction”. EFSA (2023) concluded that a cause-and-effect relationship has not been demonstrated between the consumption of Appethyl (an aqueous extract from spinach leaves) and a reduction of body weight under the conditions of use proposed by the applicant.
Actions
Comments on the proposal can be submitted via the National TBT notification authority of the country concerned to the EU TBT Enquiry Point until 23 July 2024.
Timeline
Final date for feedback to WTO: 23 July 2024.
Proposed date of adoption: fourth quarter of 2024.
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.