Safety of zinc l-carnosine as a novel food pursuant to Regulation (EU) 2015/2283 and bioavailability of zinc from this source in the context of Directive 2002/46/EC

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 zinc l-carnosine as a novel food (NF) pursuant to Regulation (EU) 2015/2283 and as a source of zinc for use in food supplements. The NF is produced by chemical synthesis. The target population is individuals above the age of 12 years, excluding pregnant and lactating women. The NF which is the subject of the application is a chelate complex, formed between Zn 2+ and l-carnosine. The material is a powder with a particulate nature and is insoluble in water at neutral pH. The Panel considers that the available data do not allow to exclude the presence of a fraction of small particles including nanoparticles in the NF under assessment and do not support its quick dissolution in gastric conditions. In addition, due to the limitations of the studies provided, the actual bioavailability of the zinc provided by the NF at the proposed use levels remains uncharacterised. The Panel concludes that the NF is insufficiently characterised and neither its bioavailability nor its safety can be established.