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

EFSA Panel on Nutrition, Novel Foods and Food Allergens (EFSA NDA Panel)

doi:10.2903/j.efsa.2019.5718

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

EFSA Panel on Nutrition, Novel Foods and Food Allergens (EFSA NDA Panel)

The Rowett Institute of Nutrition and Health

Research output: Contribution to journal › Article › peer-review

3 Citations (Scopus)

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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.

Original language	English
Article number	e05718
Number of pages	24
Journal	EFSA Journal
Volume	17
Issue number	6
Early online date	14 Jun 2019
DOIs	https://doi.org/10.2903/j.efsa.2019.5718
Publication status	Published - Jun 2019

Keywords

phenylcapsaicin
novel food
ingredient
safety

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10.2903/j.efsa.2019.5718Licence: CC BY-ND

EFSA_Phenylcapsaicin_VOR
© 2019 European Food Safety Authority. EFSA Journal published by John Wiley and Sons Ltd on behalf of European Food Safety Authority. This is an open access article under the terms of the Creative Commons Attribution‐NoDerivs License, which permits use and distribution in any medium, provided the original work is properly cited and no modifications or adaptations are made. https://creativecommons.org/licenses/by-nd/4.0/
Final published version, 2.46 MBLicence: CC BY-ND

Cite this

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

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 = "phenylcapsaicin, novel food, ingredient, safety",

author = "Dominique Turck and Jacqueline Castenmiller and {De Henauw}, Stefaan and Hirsch-Ernst, {Karen Ildico} and John Kearney and Alexandre Maciuk and Inge Mangelsdorf and McArdle, {Harry J} and Androniki Naska and Carmen Pelaez and Kristina Pentieva and Alfonso Siani and Frank Thies and Sophia Tsabouri and Marco Vinceti and Francesco Cubadda and Engel, {Karl Heinz} and Thomas Frenzel and Marina Heinonen and Rosangela Marchelli and Monika Neuh{\"a}user-Berthold and Annette P{\"o}ting and Morten Poulsen and Yolanda Sanz and Schlatter, {Josef Rudolf} and {van Loveren}, Henk and Mathias Amundsen and Knutsen, {Helle Katrine} and {EFSA Panel on Nutrition, Novel Foods and Food Allergens (EFSA NDA Panel)}",

year = "2019",

month = jun,

doi = "10.2903/j.efsa.2019.5718",

language = "English",

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AU - Turck, Dominique

AU - Castenmiller, Jacqueline

AU - De Henauw, Stefaan

AU - Hirsch-Ernst, Karen Ildico

AU - Kearney, John

AU - Maciuk, Alexandre

AU - Mangelsdorf, Inge

AU - McArdle, Harry J

AU - Naska, Androniki

AU - Pelaez, Carmen

AU - Pentieva, Kristina

AU - Siani, Alfonso

AU - Thies, Frank

AU - Tsabouri, Sophia

AU - Vinceti, Marco

AU - Cubadda, Francesco

AU - Engel, Karl Heinz

AU - Frenzel, Thomas

AU - Heinonen, Marina

AU - Marchelli, Rosangela

AU - Neuhäuser-Berthold, Monika

AU - Pöting, Annette

AU - Poulsen, Morten

AU - Sanz, Yolanda

AU - Schlatter, Josef Rudolf

AU - van Loveren, Henk

AU - Amundsen, Mathias

AU - Knutsen, Helle Katrine

AU - EFSA Panel on Nutrition, Novel Foods and Food Allergens (EFSA NDA Panel)

PY - 2019/6

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N2 - 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.

AB - 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.

KW - phenylcapsaicin

KW - novel food

KW - ingredient

KW - safety

U2 - 10.2903/j.efsa.2019.5718

DO - 10.2903/j.efsa.2019.5718

M3 - Article

C2 - 32626340

VL - 17

JO - EFSA Journal

JF - EFSA Journal

SN - 1831-4732

IS - 6

M1 - e05718

ER -

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

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Keywords

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