Abstract
Following a request from the European Commission, the EFSA Panel on Dietetic Products, Nutrition and Allergies (NDA) was asked to deliver an opinion on 1-methylnicotinamide chloride (1-MNA) as a novel food (NF) ingredient submitted pursuant to Regulation (EC) No 258/97 of the European Parliament and of the Council, taking into account the comments and objections of a scientific nature
raised by Member States. 1-MNA is a substance present naturally in the human body as a normal downstream product of niacin metabolism. The Panel considers that the information provided on the composition, the specification and the batch-to-batch variability of the NF is sufficient. The applicant intends to use 1-MNA in food supplements and proposes a maximum intake of 58 mg/day. 1-MNA is not genotoxic. In a subchronic rat study, epithelium degeneration of the non-glandular stomach was observed at all dose levels with increasing frequency. The Panel notes that the human stomach does not have non-glandular epithelium and considers this finding is toxicologically not relevant for humans. At doses of 500 and 1,000 mg/kg body weight (bw), changes of the urine pH, that did not reverse in the recovery period, were reported. As adversity of this finding cannot be ruled out, the Panel selected
250 mg/kg bw in this rat study as the reference point. The Margin of Exposure to humans weighing 70 kg and consuming 58 mg would be about 300. The Panel notes the upper level for nicotinamide, i.e. 900 mg/day for adults. Taking into account that 1-MNA is a main metabolite from nicotinamide, the Panel considers that it is unlikely that an intake of 58 mg 1-MNA from food supplements would result in adverse health outcomes in humans. The Panel concludes that the NF, 1-MNA, is safe under the proposed uses and use levels.
raised by Member States. 1-MNA is a substance present naturally in the human body as a normal downstream product of niacin metabolism. The Panel considers that the information provided on the composition, the specification and the batch-to-batch variability of the NF is sufficient. The applicant intends to use 1-MNA in food supplements and proposes a maximum intake of 58 mg/day. 1-MNA is not genotoxic. In a subchronic rat study, epithelium degeneration of the non-glandular stomach was observed at all dose levels with increasing frequency. The Panel notes that the human stomach does not have non-glandular epithelium and considers this finding is toxicologically not relevant for humans. At doses of 500 and 1,000 mg/kg body weight (bw), changes of the urine pH, that did not reverse in the recovery period, were reported. As adversity of this finding cannot be ruled out, the Panel selected
250 mg/kg bw in this rat study as the reference point. The Margin of Exposure to humans weighing 70 kg and consuming 58 mg would be about 300. The Panel notes the upper level for nicotinamide, i.e. 900 mg/day for adults. Taking into account that 1-MNA is a main metabolite from nicotinamide, the Panel considers that it is unlikely that an intake of 58 mg 1-MNA from food supplements would result in adverse health outcomes in humans. The Panel concludes that the NF, 1-MNA, is safe under the proposed uses and use levels.
| Originalsprog | Engelsk |
|---|---|
| Artikelnummer | 5001 |
| Tidsskrift | E F S A Journal |
| Vol/bind | 15 |
| Udgave nummer | 10 |
| Antal sider | 16 |
| ISSN | 1831-4732 |
| DOI | |
| Status | Udgivet - 26 okt. 2017 |
Emneord
- Det Natur- og Biovidenskabelige Fakultet
FN’s Verdensmål
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