On August 21, 2019, law firm Keller and Heckman LLP (KH) re-printed an article originally published in Food Safety Magazine that discusses non-intentionally added substances (NIAS) in food contact materials (FCMs) and the general safety requirements within existing U.S. and European regulations that relate to them. Neither region is reported to have published official guidelines or regulations specifically for evaluating and controlling the amounts of NIAS in FCMs. In the U.S., existing Good Manufacturing Practice (GMP) regulations define purity requirements for food contact substances. KH explains that under this regulation “all foreseeable impurities based on the manufacturing process—such as residual monomers, starting reactants, aids to polymerization, catalysts, and products of incomplete reaction—should be considered.” Notable is that U.S law considers oligomers as being part of the polymer, which “is in contrast to EU law.” Title 21 of the Code of Federal Regulations (CFR) also provides limits for some expected impurities for food contact substances approved as indirect food additives.

In the EU, GMP must also be followed for manufacturing FCMs. In the EU’s plastics regulation No 10/2011, the term NIAS is defined as an “impurity in the substances used or reaction intermediates formed during the production process or a decomposition or reaction products.” This does not include residual monomers or polymerization aids since they are intentionally added, but it does include impurities in the monomers and additives as well as reaction intermediates and breakdown products. Any specific migration limits set within the regulation’s positive list of monomers and additives must be followed. The law also defines that if any of the NIAS “are relevant for the risk assessment of the main impurities of a substance or the main reaction and degradation products of the intended application of a substance, they should be included in the specifications and/or restrictions of that substance.”

The article goes on to discuss specific steps to conduct a risk assessment for NIAS in food packaging including chemical identification, exposure assessment, and safety evaluation.

Read more

Keller and Heckman LLP (August 21, 2019). “U.S. and EU Approaches to Defining and Evaluating Impurities and NIAS in Food Contact Materials.”

George G. Misko (August 2019). “U.S. and EU Approaches to Defining and Evaluating Impurities and NIAS in Food Contact Materials.” Food Safety Magazine