1. Safety of phenylcapsaicin as a novel food pursuant to Regulation (EU) 2015/2283
- Author
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Turck, Dominique, Castenmiller, Jacqueline, De Henauw, Stefaan, Hirsch-Ernst, Karen Ildico, Kearney, John, Maciuk, Alexandre, Mangelsdorf, Inge, McArdle, Harry J., Naska, Androniki, Pelaez, Carmen, Pentieva, Kristina, Siani, Alfonso, Thies, Frank, Tsabouri, Sophia, Vinceti, Marco, Cubadda, Francesco, Engel, Karl Heinz, Frenzel, Thomas, Heinonen, Marina, Marchelli, Rosangela, Neuhauser-Berthold, Monika, Poting, Annette, Poulsen, Morten, Sanz, Yolanda, Schlatter, Josef Rudolf, van Loveren, Henk, Amundsen, Mathias, Knutsen, Helle Katrine, Nutr Novel Foods Food A, EFSA Panel, Department of Food and Nutrition, Helsinki One Health (HOH), Food Quality & Safety, and Food Sciences
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Agriculture and Food Sciences ,safety ,Veterinary (miscellaneous) ,Novel food ,TP1-1185 ,Plant Science ,010501 environmental sciences ,01 natural sciences ,Microbiology ,Ingredient ,0404 agricultural biotechnology ,Medicine and Health Sciences ,TX341-641 ,ingredient ,novel food ,phenylcapsaicin ,Marketing ,0105 earth and related environmental sciences ,2. Zero hunger ,Nutrition. Foods and food supply ,Chemical technology ,04 agricultural and veterinary sciences ,040401 food science ,3. Good health ,Scientific Opinion ,416 Food Science ,Animal Science and Zoology ,Parasitology ,Business ,Food Science - 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 mu g/kg body weight (bw) per day for adults, and 58 mu g/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 BMDL20 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. (C) 2019 European Food Safety Authority. EFSA Journal published by John Wiley and Sons Ltd on behalf of European Food Safety Authority.
- Published
- 2020
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