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EFSA Issues Scientific Opinion on Nanoforms of Zinc Oxide for Food-Contact

June 9, 2015

The European Food Safety Authority (EFSA) recommended that the European Commission reconsider the specific migration limit (SML) for zinc based on consumer exposure from sources other than food-contact materials. This recommendation was made by the EFSA Panel on Food Contact Materials, Enzymes, Flavourings and Processing Aids (CEF Panel) as part of a scientific opinion on nano forms of zinc oxide for food-contact.

The CEF Panel was asked by the Dutch Ministry of Health, Welfare and Sport on behalf of Umicore Zinc Chemicals, Belgium, for a safety assessment of zinc oxide, nanoparticles, uncoated and coated with [3-(methacryloxy)propyl] trimethoxysilane, for use as a transparent ultraviolet light absorber in polyolefins for food-contact. Nanoparticles are present in the final polymer, but are largely aggregated. Migration testing demonstrated that there was no mass transfer of the zinc oxide in nanoform.

In 2003, EFSA's Scientific Committee on Food established for a no observed adverse effect level of 50 mg/day for zinc, and recommended an upper limit of 25 mg/person per day. Therefore, the CEF Panel's safety evaluation focused on the migration of soluble ionic zinc. The CEF panel found that while the available migration data for ionic zinc coming from the intended application are in compliance with the current SML, the upper limit of 25 mg/person per day could be exceeded when dietary exposure from other sources was taken into account. Therefore, the Panel recommended that the Commission reconsider the SML of 25 mg/kg for zinc.