Following an application from ICP Ltd, submitted for authorisation of a health claim pursuant to Article 13(5) of Regulation (EC) No 1924/2006 via the Competent Authority of Malta, the EFSA Panel on Dietetic Products, Nutrition and Allergies (NDA) was asked to deliver an opinion on the scientific substantiation of a health claim related to Preservation® and “rapid recovery of cellular activity post stress”.
The scope of the application was proposed to fall under a health claim based on newly developed scientific evidence.
The food that is the subject of the health claim is Preservation®, which contains an extract of prickly pear cactus Opuntia ficus-indica. The Panel considers that Preservation® is sufficiently characterised.
In the original application, the claimed effect was indicated as “improves the physiological response to stress by accelerating the appearance of heat shock proteins”. The Panel noted that “improved physiological response to stress” was not sufficiently defined. Upon request to define the claimed effect (i.e. the beneficial physiological effect), the applicant stated that the beneficial physiological effect is “the rapid recovery of cellular activity post stress to encounter cellular repair, which, although it is not localised to a particular organ of the body, is associated with the well-being of the individual following ‘that stressful event’”.
The outcome measures used in the three human studies provided were the appearance of heat shock proteins in blood after “thermal shock” or after diving, and a “hangover symptom index” following alcohol consumption.
The Panel notes that the claimed effect indicated by the applicant is general and non-specific, and that the references provided did not provide information which could be used to define a specific beneficial physiological effect.
The Panel considers that the claimed effect is general and non-specific, and does not comply with the criteria laid down in Regulation (EC) No 1924/2006.