Improving risk assessment in Non-Intentionally Added Substances
What are the main goals and projects of TSC33?
Michelle Callow: The TSC33 NIAS group is a Technical Subcommittee of the Technical Joint Industry Group (T-JIG) of the coated rigid metal packaging sector. Its members include the value chain stakeholders i.e. food and drink manufacturers, can makers, coatings suppliers and raw material suppliers. In July 2015, the International Life Sciences Institute (ILSI) published ‘Guidance on Best Practices on the Risk Assessment of Non-Intentionally Added Substances (NIAS) in Food Contact Materials and Articles’. It is very comprehensive, but due to our current knowledge and available analytical techniques, some of the suggested practices are not technically possible at this time.
Michelle Callow, CEPE NIAS Task Force
We want to raise the standard of risk assessment of NIAS using the ILSI guidance as a basis and provide guidance explaining how to deal with the areas which are currently not technically feasible. Our draft guidance is currently being approved by the trade associations who have contributed to it. Our sector is committed to continually improving risk assessments e.g. by reducing the number and level of detectable migrants; improving identification and quantification of NIAS and utilising bio-assays suitable for mixtures of materials once they have been critiqued by ILSI. To facilitate this, a new activity will be initiated. We will update and review the guidelines as knowledge about NIAS and genotoxicity testing increases.
What is the focus of the NIAS guideline?
Callow: It supplements the ILSI guidance and summarises the steps which are necessary to perform a risk assessment on NIAS. The first step is to screen the coating using various analytical techniques. Any substances which are detected above a level of interest (LOI) of 10µg/dm2 are identified, quantified and risk assessed using internationally recognized toxicological approaches. If no toxicological data is available for a substance then, using the techniques and arguments available today to demonstrate absence of genotoxicity, the Cramer Class can be determined and the Threshold of Toxicological Concern (TTC) approach can be used.