On 17 June 2026, the European Food Safety Authority (EFSA) published a scientific opinion concluding that zinc l-carnosine, a chelate complex proposed as a novel food ingredient for food supplements, is insufficiently characterised and that neither its bioavailability nor its safety can be established. The opinion, adopted on 27 May 2026 by EFSA's Panel on Nutrition, Novel Foods and Food Allergens (NDA), follows a request from the European Commission and an application submitted by Hamari Chemicals Ltd. on 2 July 2024. The target population was individuals above 12 years of age, excluding pregnant and lactating women.
The opinion marks the second time EFSA has rejected the substance on similar grounds. In a 2022 assessment, the NDA Panel had already concluded that the novel food was in an insufficiently characterised particulate form, with safety not established and bioavailability not determined, owing to a lack of information on particle size distribution and physicochemical properties. The 2026 assessment notes that the applicant provided new scanning electron microscopy data in response to those earlier concerns, but EFSA deemed the data unreliable due to major deviations from its guidance on technical requirements for small particles, including insufficient magnification and poor image quality. The Panel stated that the concerns raised in the previous opinion remain unaddressed.
The novel food is a powder insoluble in water at neutral pH. EFSA noted that the available data do not allow exclusion of a fraction of small particles, including nanoparticles, and do not support quick dissolution in gastric conditions. The Panel also found that the actual bioavailability of zinc from the novel food at proposed use levels remains uncharacterised due to limitations in the studies provided. The tolerable upper intake level for zinc, set by the Scientific Committee on Food in 2003, is 25 mg/day for adults, with lower levels for children and adolescents.
The opinion impacts several stakeholders. For the applicant, Hamari Chemicals Ltd., the rejection blocks market access for the ingredient in the EU, potentially affecting its investment and commercial strategy. For the food supplement industry, the decision maintains the status quo, limiting the range of zinc sources available for product formulation. For consumers, the opinion prevents the introduction of a novel zinc supplement whose safety and bioavailability could not be verified, protecting public health. For EU regulatory bodies, the opinion reinforces the application of EFSA's stringent characterisation requirements for novel foods, particularly regarding nanomaterial assessment. The Commission will now decide whether to formally reject the application or request further data, but the scientific opinion effectively bars authorisation under current evidence.
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