Rejection of a health claim for Appethyl® confirmed
- Food safety
- Food supplements/dietetic foods
- Health claims
- Labelling
Summary
The European Union (EU) has refused the health claim submitted by Greenleaf Medical AB that Appethyl® (an aqueous extract from spinach) helps body weight reduction during mild calorie reduction.
EU rejects Appethyl® body weight reduction claim
Commission Regulation (EU) 2025/350 of 21 February 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 Greenleaf Medical AB that Appethyl® (an aqueous extract from spinach) helps body weight reduction during mild calorie reduction.
What is changing?
The EU has confirmed its rejection of an application, submitted by Greenleaf Medical AB, for a health claim 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). The health claim therefore does not comply with the requirements of Regulation 1924/2006 and was rejected.
Timeline
The Regulation will enter into force on 13 March 2025.
Background
Regulation (EC) No 1924/2006 establishes that health claims made on foods are prohibited unless they are authorised by the European Commission and included in the Union list of permitted health claims. For a health claim to be authorised, EFSA must deliver an opinion on the claim concerned, which the Commission considers when making a decision.
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
Commission Regulation (EU) 2025/350 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
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.
EU rejects Appethyl® body weight reduction claim
Commission Regulation (EU) 2025/350 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 authorisation of a health claim that Appethyl® helps body weight reduction during mild calorie reduction. This follows a scientific assessment by the European Food Safety Authority, which found no cause-and-effect relationship between Appethyl® and the claimed health effect.
Timeline
The Regulation will enter into force on 13 March 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.