TY - JOUR
T1 - Safety of tetrahydrocurcuminoids from turmeric (Curcuma longa L.) as a novel food pursuant to Regulation (EU) 2015/2283
AU - Turck, Dominique
AU - Bohn, Torsten
AU - Castenmiller, Jacqueline
AU - De Henauw, Stefaan
AU - Hirsch-Ernst, Karen Ildico
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 - Frenzel, Thomas
AU - Heinonen, Marina
AU - Marchelli, Rosangela
AU - Neuhauser-Berthold, Monika
AU - Poulsen, Morten
AU - Maradona, Miguel Prieto
AU - Schlatter, Josef Rudolf
AU - van Loveren, Henk
AU - Ackerl, Reinhard
AU - Kouloura, Eirini
AU - Knutsen, Helle Katrine
PY - 2021/12/22
Y1 - 2021/12/22
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 tetrahydrocurcuminoids from turmeric (Curcuma longa L.) as a novel food (NF) pursuant to Regulation (EU) 2015/2283. Tetrahydrocurcuminoids are derivatives of curcuminoids, produced chemically by hydrogenation of curcuminoids extracted from the rhizomes of C. longa L. The NF consists of more than 95% of tetrahydrocurcuminoids. The applicant proposed to use the NF in food supplements at a maximum dose of 300 mg/day for adults excluding pregnant and lactating women. Taking into account the composition of the NF and the proposed conditions of use, consumption of the NF is not nutritionally disadvantageous. There are no concerns regarding genotoxicity of the NF. Based on a 90-day oral toxicity study and a reproduction/developmental toxicity screening test performed with the NF, the Panel derives a safe level of 2 mg/kg body weight per day. For the target population this level corresponds to 140 mg/day, which is lower than the use level as proposed by the applicant. The Panel concludes that the NF, tetrahydrocurcuminoids from turmeric (C. longa L.), is safe for the target population at 140 mg/day.
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 tetrahydrocurcuminoids from turmeric (Curcuma longa L.) as a novel food (NF) pursuant to Regulation (EU) 2015/2283. Tetrahydrocurcuminoids are derivatives of curcuminoids, produced chemically by hydrogenation of curcuminoids extracted from the rhizomes of C. longa L. The NF consists of more than 95% of tetrahydrocurcuminoids. The applicant proposed to use the NF in food supplements at a maximum dose of 300 mg/day for adults excluding pregnant and lactating women. Taking into account the composition of the NF and the proposed conditions of use, consumption of the NF is not nutritionally disadvantageous. There are no concerns regarding genotoxicity of the NF. Based on a 90-day oral toxicity study and a reproduction/developmental toxicity screening test performed with the NF, the Panel derives a safe level of 2 mg/kg body weight per day. For the target population this level corresponds to 140 mg/day, which is lower than the use level as proposed by the applicant. The Panel concludes that the NF, tetrahydrocurcuminoids from turmeric (C. longa L.), is safe for the target population at 140 mg/day.
KW - novel foods
KW - tetrahydrocurcuminoids
KW - Curcuma longa L
KW - turmeric
KW - food supplement
KW - safety
UR - https://pubmed.ncbi.nlm.nih.gov/34987620
U2 - 10.2903/j.efsa.2021.6936
DO - 10.2903/j.efsa.2021.6936
M3 - Article
C2 - 34987620
SN - 1831-4732
VL - 19
JO - EFSA Journal
JF - EFSA Journal
IS - 12
M1 - e06936
ER -