Commission denies health claim related to body weight reduction
European Union
Feb 25, 2025
With the implementation of Regulation (EU) 2025/350 of 21 February 2025, the Commission 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.
Following an application from Greenleaf Medical AB (‘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 Appethyl® and reduction of body weight (Question No EFSA-Q-2022-00096). The claim proposed by the applicant was worded as follows: ‘Appethyl® helps your body weight reduction during mild caloric restriction’.
On 31 August 2023, the Authority adopted the scientific opinion (2) on that health claim and forwarded it to the Commission and the Member States on 11 October and 9 November 2023 respectively.
In its opinion, the Authority concluded that, on the basis of the data presented, the food/constituent Appethyl®, an aqueous extract from spinach leaves standardised by the manufacturing process and its lipase/colipase inhibition capacity in vitro, which is the subject of the health claim, is sufficiently characterised. However, a cause-and-effect relationship has not been established between the consumption of Appethyl® and a reduction of body weight under the conditions of use proposed by the applicant. Accordingly, as the health claim does not comply with the requirements of Regulation (EC) No 1924/2006, it should not be authorised for the inclusion in the Union list of permitted health claims.
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