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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.

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Title: 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.
Authors: Turck, Dominique (AUTHOR), Bohn, Torsten (AUTHOR), Cámara, Montaña (AUTHOR), Castenmiller, Jacqueline (AUTHOR), De Henauw, Stefaan (AUTHOR), Jos, Ángeles (AUTHOR), Maciuk, Alexandre (AUTHOR), Mangelsdorf, Inge (AUTHOR), McNulty, Breige (AUTHOR), Naska, Androniki (AUTHOR), Pentieva, Kristina (AUTHOR), Siani, Alfonso (AUTHOR), Thies, Frank (AUTHOR), Cubadda, Francesco (AUTHOR), Frenzel, Thomas (AUTHOR), Gundert‐Remy, Ursula (AUTHOR), Marcon, Francesca (AUTHOR), McArdle, Harry J. (AUTHOR), Neuhäuser‐Berthold, Monika (AUTHOR), Wright, Matthew (AUTHOR)
Source: EFSA Journal. Jun2026, Vol. 24 Issue 6, p1-10. 10p.
Subject Terms: *Bioavailability, *Zinc compounds, *Food additives, Chemical synthesis, Dietary supplements, Safety standards, Nanoparticles
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 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 Zn2+ 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. [ABSTRACT FROM AUTHOR]
Copyright of EFSA Journal is the property of European Food Safety Authority and its content may not be copied or emailed to multiple sites without the copyright holder's express written permission. Additionally, content may not be used with any artificial intelligence tools or machine learning technologies. However, users may print, download, or email articles for individual use. This abstract may be abridged. No warranty is given about the accuracy of the copy. Users should refer to the original published version of the material for the full abstract. (Copyright applies to all Abstracts.)
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  Data: 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.
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  Data: <searchLink fieldCode="JN" term="%22EFSA+Journal%22">EFSA Journal</searchLink>. Jun2026, Vol. 24 Issue 6, p1-10. 10p.
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  Data: *<searchLink fieldCode="DE" term="%22Bioavailability%22">Bioavailability</searchLink><br />*<searchLink fieldCode="DE" term="%22Zinc+compounds%22">Zinc compounds</searchLink><br />*<searchLink fieldCode="DE" term="%22Food+additives%22">Food additives</searchLink><br /><searchLink fieldCode="DE" term="%22Chemical+synthesis%22">Chemical synthesis</searchLink><br /><searchLink fieldCode="DE" term="%22Dietary+supplements%22">Dietary supplements</searchLink><br /><searchLink fieldCode="DE" term="%22Safety+standards%22">Safety standards</searchLink><br /><searchLink fieldCode="DE" term="%22Nanoparticles%22">Nanoparticles</searchLink>
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  Data: 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 Zn2+ 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. [ABSTRACT FROM AUTHOR]
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  Data: <i>Copyright of EFSA Journal is the property of European Food Safety Authority and its content may not be copied or emailed to multiple sites without the copyright holder's express written permission. Additionally, content may not be used with any artificial intelligence tools or machine learning technologies. However, users may print, download, or email articles for individual use. This abstract may be abridged. No warranty is given about the accuracy of the copy. Users should refer to the original published version of the material for the full abstract.</i> (Copyright applies to all Abstracts.)
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        Value: 10.2903/j.efsa.2026.10144
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        Text: English
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