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New Guide on Safety Assessments of NIAS in Food-Contact Materials Available from ILSI Europe

The International Life Sciences Institute (ILSI) Europe has published a guidance document that provides recommendations on conducting safety assessments of non-intentionally added substances (NIAS) in food-contact materials (FCMs). The publication, Guidance on Best Practices on the Risk Assessment of Non Intentionally Added Substances (NIAS) in Food Contact Materials and Articles, includes:

    • A definition/description of NIASs and intentionally added substances (IAS);
    • A discussion on good manufacturing practices, including how the selection of raw materials and application of efficient processes can decrease the presence of NIAS;
    • Recommendations on the exchange of information along the supply chain to help determine the origin of a detected NIAS;
    • Tools to determine NIAS in FCMs; and
    • Strategies on how to assess the safety of NIAS.

The guidance document notes that within the scope of the monograph, NIAS means only the part of NIAS which has a molecular weight below 1000 daltons. Types of NIAS specifically mentioned are: impurities, oligomers, reaction intermediates (including remaining pre-polymers), contaminants, by-products/unintended reaction products, and degradation products. With respect to "oligomers," the guidance defines two types:

  1. Oligomers that are an integral part of the polymer formed during the polymerization reaction. These oligomers are often formed during a polymerization reaction between monomers; they might contain side reaction products (e.g. cyclic oligomers) or might be present because the polymerization process was incomplete.
  2. Oligomers can intentionally be used as pre-polymers. These are reactive species that will be used as reacting blocks to manufacture polymers.

Noting that that NIAS in food-contact materials and articles should be subject to risk assessment using scientifically recognized principles, the guidance discusses the four steps of risk assessment—hazard identification, hazard characterization, exposure assessment, and risk characterization—with respect to NIAS.