2. Academic Validation
  3. Safety of phenylcapsaicin as a novel food pursuant to Regulation (EU) 2015/2283

Safety of phenylcapsaicin as a novel food pursuant to Regulation (EU) 2015/2283

  • EFSA J. 2019 Jun 14;17(6):e05718. doi: 10.2903/j.efsa.2019.5718.
EFSA Panel on Nutrition, Novel Foods and Food Allergens (EFSA NDA Panel),  Dominique Turck,  Jacqueline Castenmiller,  Stefaan De Henauw,  Karen Ildico Hirsch-Ernst,  John Kearney,  Alexandre Maciuk,  Inge Mangelsdorf,  Harry J McArdle,  Androniki Naska,  Carmen Pelaez,  Kristina Pentieva,  Alfonso Siani,  Frank Thies,  Sophia Tsabouri,  Marco Vinceti,  Francesco Cubadda,  Karl Heinz Engel,  Thomas Frenzel,  Marina Heinonen,  Rosangela Marchelli,  Monika Neuhäuser-Berthold,  Annette Pöting,  Morten Poulsen,  Yolanda Sanz,  Josef Rudolf Schlatter,  Henk van Loveren,  Mathias Amundsen,  Helle Katrine Knutsen
PMID: 32626340 DOI: 10.2903/j.efsa.2019.5718
Abstract

Following a request from the European Commission, the EFSA Panel on Nutrition, Novel Foods and Food Allergens (NDA) was asked to deliver an opinion on phenylcapsaicin as a novel food (NF) pursuant to Regulation (EU) 2015/2283. Phenylcapsaicin is a chemically synthesised analogue of capsaicin intended to be marketed in food supplements and in foods for special medical purposes to the general population above the age of 11 years old at a maximum level of 2.5 mg/day. The highest intake of the NF is 2.5 mg/day which corresponds to 36 μg/kg body weight (bw) per day for adults, and 58 μg/kg bw per day for adolescents (10-14 years). The Panel considers that there is no concern with respect to genotoxicity of the NF. The reference point derived based on a 13-week rat study was the lowest of the model averaged BMDL 20 values of 37.2 mg/kg bw per day in females for increased plasma alanine aminotransferase (ALAT) levels. The Panel concludes that the NF, phenylcapsaicin, is safe under the proposed uses and use levels.

Keywords

ingredient; novel food; phenylcapsaicin; safety.

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