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.

Safety of tetrahydrocurcuminoids from turmeric (Curcuma longa L.) as a novel food pursuant to Regulation (EU) 2015/2283 / Turck, D.; Bohn, T.; Castenmiller, J.; De Henauw, S.; Hirsch-Ernst, K. I.; Maciuk, A.; Mangelsdorf, I.; McArdle, H. J.; Naska, A.; Pelaez, C.; Pentieva, K.; Siani, A.; Thies, F.; Tsabouri, S.; Vinceti, M.; Cubadda, F.; Frenzel, T.; Heinonen, M.; Marchelli, R.; Neuhauser-Berthold, M.; Poulsen, M.; Prieto Maradona, M.; Schlatter, J. R.; van Loveren, H.; Ackerl, R.; Kouloura, E.; Knutsen, H. K.. - In: EFSA JOURNAL. - ISSN 1831-4732. - 19:12(2021), pp. e06936-e06952. [10.2903/j.efsa.2021.6936]

Safety of tetrahydrocurcuminoids from turmeric (Curcuma longa L.) as a novel food pursuant to Regulation (EU) 2015/2283

Vinceti M.;Marchelli R.;
2021

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 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.
2021
19
12
e06936
e06952
Safety of tetrahydrocurcuminoids from turmeric (Curcuma longa L.) as a novel food pursuant to Regulation (EU) 2015/2283 / Turck, D.; Bohn, T.; Castenmiller, J.; De Henauw, S.; Hirsch-Ernst, K. I.; Maciuk, A.; Mangelsdorf, I.; McArdle, H. J.; Naska, A.; Pelaez, C.; Pentieva, K.; Siani, A.; Thies, F.; Tsabouri, S.; Vinceti, M.; Cubadda, F.; Frenzel, T.; Heinonen, M.; Marchelli, R.; Neuhauser-Berthold, M.; Poulsen, M.; Prieto Maradona, M.; Schlatter, J. R.; van Loveren, H.; Ackerl, R.; Kouloura, E.; Knutsen, H. K.. - In: EFSA JOURNAL. - ISSN 1831-4732. - 19:12(2021), pp. e06936-e06952. [10.2903/j.efsa.2021.6936]
Turck, D.; Bohn, T.; Castenmiller, J.; De Henauw, S.; Hirsch-Ernst, K. I.; Maciuk, A.; Mangelsdorf, I.; McArdle, H. J.; Naska, A.; Pelaez, C.; Pentiev...espandi
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