Affron® and increase in positive mood: evaluation of a health claim pursuant to Article 13(5) of Regulation (EC) No 1924/2006. (2nd July 2021)

• Record Type: Journal Article
• Authors: 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; Siani, Alfonso
• Is Part Of: EFSA journal. Volume 19:Number 7(2021)
• Page Start: n/a
• Page End: n/a
• Publication Date: 2021-07-02
• Subjects: affron® -- saffron -- crocins -- safranal -- mood -- anxiety -- health claim; Food -- Europe -- Safety measures -- Periodicals; Food Safety; Food -- Safety measures; Europe; Periodicals; Periodicals; Fulltext; Government Publications, International; Internet Resources; Periodicals; Periodicals; 363.19209405
• DOI: 10.2903/j.efsa.2021.6669
• Languages: English
• ISSNs: 1831-4732

Abstract

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.