1. Affron® and increase in positive mood: evaluation of a health claim pursuant to Article 13(5) of Regulation (EC) No 1924/2006.
- Author
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Turck, Dominique, Castenmiller, Jacqueline, De Henauw, Stefaan, Hirsch-Ernst, Karen Ildico, Kearney, John, Knutsen, Helle Katrine, Maciuk, Alexandre, Mangelsdorf, Inge, McArdle, Harry J., Naska, Androniki, Pelaez, Carmen, Pentieva, Kristina, Thies, Frank, Tsabouri, Sophia, Vinceti, Marco, Bresson, Jean-Louis, and Siani, Alfonso
- Subjects
ADULTS ,COMPETENT authority ,HUMAN experimentation ,ALLERGENS - Abstract
Following an application from Pharmactive Biotech Products, S.L. submitted for authorisation of a health claim pursuant to Article 13(5) of Regulation (EC) No 1924/2006 via the Competent Authority of Spain, the EFSA Panel on Nutrition, Novel Foods and Food Allergens (NDA) was asked to deliver an opinion on the scientific substantiation of a health claim related to affron® and contributes to maintain a healthy mood. The scope of the application was proposed to fall under a health claim based on newly developed scientific evidence. The food proposed by the applicant as the subject of the health claim is affron®, an aqueous saffron extract with a content of the sum of crocins and safranal typically between 3.5% and 3.9%. The Panel notes that affron® is sufficiently characterised. The claimed effect proposed by the applicant is 'contributes to maintain a healthy mood'. The Panel notes that increase in positive mood is a beneficial physiological effect for individuals with low mood or anxiety. One human intervention study showed that consumption of affron® at a dose of 28 mg/day for 4 weeks improves mood in a population of adults with low mood. However, the results have not been replicated in other studies. The information supplied by the applicant did not provide evidence for a plausible mechanism by which affron® could exert the claimed effect. The Panel concludes that the evidence is insufficient to establish a cause and effect relationship between the consumption of affron® and increase in positive mood. [ABSTRACT FROM AUTHOR]
- Published
- 2021
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