European Food Safety Authority (EFSA) has recommended changes to how the safety of food-contact materials, including packaging materials, is assessed.
As recommended, these changes include implementing a tiered approach to the amount of toxicological data required based on human exposure, establishing four categories to estimate consumer exposure and taking into account the migration of non-intentionally added substances (NIAS).
In a report prepared by EFSA’s Panel on Food Contact Materials, Enzymes, Flavourings and Processing Aids (CEF) which was first published in 2015 and contained the recommendation claims “Recent developments in the risk assessment of chemicals in food and their potential impact on the safety assessment of substances used in food-contact materials.”
EFSA evaluates the safety of certain substances prior to their authorization for use in food-contact materials. For example, petitions submitted to the European Commission (EC) to add a new monomer or additive to the Plastic Regulation’s ((EU) No. 10/2011) positive (or Union) list are initially reviewed by EFSA, which will issue a formal opinion on the safety of the substances with respect to their use with food and any limitations that should be observed. The current guidelines on this risk assessment process and the corresponding data requirements are based on guidelines developed by the Scientific Committee on Food (SCF) in 2001.
With respect to toxicology data, EFSA’s CEF panel proposed three threshold levels of human exposure (1.5, 30 and 80 mg/kg of bw per day) as triggers for requiring additional toxicity data. The panel also suggested that the toxicity data thresholds would apply to all migrating substances, both intentionally and non-intentionally added substances.
CEF also suggested that the first tier—genotoxicity testing—should be required for all migrating substances, even if the migration of those substances into food results in very low exposures. However, the panel did not rule out the use of alternative methods to animal testing, including for the assessment of genotoxicity of NIAS.
“This opinion reflects both advances in science and our experience over the last decade in applying existing EU guidelines,” says Dr. Laurence Castle, a member of EFSA’s CEF Panel and chair of the working group that developed the opinion, in a release on the report.