Following a request from the European Commission, the EFSA Panel on Dietetic Products, Nutrition and Allergies (NDA) was asked to deliver a scientific opinion on 1-methylnicotinamide chloride (1-MNA) as a novel food (NF) submitted pursuant to Regulation (EC) No 258/97 of the European Parliament and of the Council. The assessment follows the methodology set in Commission Recommendation 97/618/EC of 29 July 1997 concerning the scientific aspects and the presentation of information necessary to support applications for the placing on the market of novel foods and novel food ingredients and the preparation of initial assessment reports under Regulation (EC) No 258/97 of the European Parliament and of the Council. The assessment is based on the data supplied in the original application, the initial assessment by the competent authority of the United Kingdom, the concerns and objections of a scientific nature raised by the other Member States and the responses of the applicant.
The NF ingredient is a synthetic organic compound, classified as a pure chemical compound from a non-genetically modified (GM) source (Class 1.1). 1-MNA is a substance present naturally in the human body as a normal downstream product of niacin metabolism. Niacin is a generic term referring to nicotinamide and nicotinic acid. The Panel notes that the limit proposed for ‘heavy metals’ (≤ 20 ppm) may not comply with the existing legislation. Provided that the limits for heavy metals are in compliance with existing legislation, the Panel considers that the information provided on the composition, the specification and the batch-to-batch variability of the NF is sufficient and does not raise safety concerns.
The applicant intends to use 1-MNA in food supplements and proposes a maximum intake of 58 mg/day. 1-MNA is proposed to be used by adults excluding pregnant and breastfeeding women. The applicant proposed to indicate on the label of the product that it should be ingested during or immediately after a meal, and that it should be consumed alongside at least half a glass of water.
Low intakes of 1-MNA may result from the consumption of specific foodstuffs and certain medicinal products. Most of the systemic exposure to 1-MNA however derives endogenously from metabolism of niacin.
Results of bacterial reverse mutation test and in vitro mammalian cell micronucleus test indicated that 1-MNA is not genotoxic. Three studies were used to assess the subacute toxicity of 1-MNA. The findings of the two studies did not show any reasons for concern. Nevertheless, some of the results of the third study could not be ruled out as adverse. To address this, the applicant commissioned a 91-day rat feeding study. In this subchronic rat study, epithelium degeneration of the non-glandular stomach was observed at all dose levels with increasing frequency. Since the human stomach does not have non-glandular epithelium, the Panel considers that 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.
One Member State expressed concerns that the intake of 1-MNA would add to endogenously formed 1-MNA from niacin metabolism. 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 in addition to the niacin intake from other sources diet 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.
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