Substances in database
Example sheet
Database access
Last subscription

Safety of nicotinamide riboside chloride as a novel food pursuant to Regulation (EU) 2015/2283 and bioavailability of nicotinamide from this source, in the context of Directive 2002/46/EC

Undefined

Published on: Wed, 07 Aug 2019

Following a request from the European Commission, the EFSA Panel on Nutrition, Novel Foods and Allergens (NDA) was asked to deliver an opinion on nicotinamide riboside chloride as a novel food (NF) pursuant to Regulation (EU) 2015/2283, including an evaluation of the safety of its use in food supplements as a source of niacin, and the bioavailability of nicotinamide from this source, in the context of Directive 2002/46/EC. The NF, a synthetic form of nicotinamide riboside, is proposed to be used in food supplements for the healthy adult population at levels up to 300 mg/day. The production process, composition, specifications, batch‐to‐batch variability and stability of the NF do not raise safety concerns. Animal and human data indicate that the NF contributes to the nicotinamide body pool. There are no concerns regarding genotoxicity. Human studies do not raise safety concerns. The proposed maximum use level corresponds to an amount of nicotinamide, which is sixfold lower than the tolerable upper intake level (UL) set for adults, excluding pregnant and lactating women. The margin of exposure (MoE) of 70 derived from repeated dose toxicity studies with rats and dogs is considered sufficient for the adult population, excluding pregnant and lactating women. Regarding these two population groups, the MoE of 76 derived from a developmental toxicity study in rats is considered insufficient in the absence of data which could justify accepting a MoE lower than 100. The Panel concludes that the NF is safe under the proposed conditions of use for the healthy adult population, excluding pregnant and lactating women, and that an intake of the NF up to 230 mg/day is safe for pregnant and lactating women. The Panel also concludes that the NF is a source from which nicotinamide, a form of niacin, is bioavailable.

© European Food Safety Authority, 2015

Safety of nicotinamide riboside chloride as a novel food pursuant to Regulation (EU) 2015/2283 and bioavailability of nicotinamide from this source, in the context of Directive 2002/46/EC


Last Tweets

06/06/2016 - 11:11
Nuovo componente inserito: Simmondsia Chinensis (Jojoba) Seed Oil https://t.co/mGvGLRQ05k
29/05/2016 - 10:04
Nuovo componente inserito: Linum Usitatissimum seed oil Error
27/05/2016 - 16:38
Nuovo componente inserito: Soybean oil https://t.co/9prxB7xyiu

NOAEL-crew

Project coordinator

Content revision

Toxicological datasheet creation

Website Administration

Subscriptions & Contacts

To get more info about the NOAEL project, go to FAQ section or contact Roberto Narducci at this address:
 
infoATnoaelproject.it or robymagnoATgmail.com
 
For info about subscription costs click the following link or contact Federica Cambiganu:
 
federica.cambiganuATpin.unifi.it
+390574602511
PIN s.c.r.l. - Piazza Giovanni Ciardi 25, 59100 - Prato