Safety of magnesium orotate dihydrate as a novel food pursuant to Regulation (EU) 2015/2283 and bioavailability of magnesium 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 the safety of magnesium orotate dihydrate as a novel food (NF) pursuant to Regulation (EU) 2015/2283 and to address the bioavailability of magnesium...
| Autores: | , , , , , , , |
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| Tipo de recurso: | artículo |
| Estado: | Versión publicada |
| Fecha de publicación: | 2025 |
| País: | España |
| Institución: | Universidad de Sevilla (US) |
| Repositorio: | idUS. Depósito de Investigación de la Universidad de Sevilla |
| OAI Identifier: | oai:idus.us.es:11441/179044 |
| Acceso en línea: | https://hdl.handle.net/11441/179044 https://doi.org/10.2903/j.efsa.2025.9528 |
| Access Level: | acceso abierto |
| Palabra clave: | Food supplement Magnesium Magnesium orotate dihydrate Novel foods Nutrient source Orotic acid Safety |
| Sumario: | 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 the safety of magnesium orotate dihydrate as a novel food (NF) pursuant to Regulation (EU) 2015/2283 and to address the bioavailability of magnesium from this source in the context of Directive 2002/46/EC. The NF is produced by chemical synthesis and is proposed to be used in food supplements at a maximum intake level of 6100 mg per day by adults. This intake level corresponds to around 5000 mg/day orotic acid and 400 mg/day magnesium. The Panel notes that this would exceed the established UL for supplemental magnesium of 250 mg/day, therefore the use of the NF could be nutritionally disadvantageous. The Panel also notes the previous safety assessment of magnesium orotate dihydrate, where concerns were raised regarding the exposure to orotic acid, based on several animal studies demonstrating tumour-promoting effects. The ANS Panel derived a no observed adverse effect level (NOAEL) for orotic acid of 50 mg/kg bw per day. The margin between the derived NOAEL for orotic acid and the exposure resulting from the proposed maximum use level of the NF is 0.7 (based on the average bw of an adult person of 70 kg) which is even lower than the margin considered by the ANS Panel of being inadequate. The applicant has not provided any toxicological data on the NF or on orotic acid that could address or mitigate these safety concerns. The Panel concludes that the safety of the NF, magnesium orotate dihydrate, cannot be established under the proposed conditions of use. The assessment of bioavailability of magnesium from the NF in comparison to natural sources was not conducted. |
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