German Officials Publish Guidance on Risk Assessment of Non-Intentionally Added Substances in Food Contact Materials
The German Federal Institute for Risk Assessment (BfR) has published a guideline outlining its approach to the risk assessment of non-intentionally added substances (NIAS) in food contact materials (FCMs), including analytical and toxicological requirements based on migration levels.
The guideline is primarily intended to support dossiers for new substances submitted for inclusion in the BfR Recommendations for FCMs or Annex 14 of the German Consumer Goods Ordinance. It is not intended for compliance testing, although BfR said parts of the approach could inform other NIAS risk assessments.
Under EU requirements, intentionally added substances (IAS) and NIAS must meet the same safety requirements for FCMs. NIAS can include impurities and byproducts associated with substances used to manufacture FCMs, as well as reaction and degradation products formed during production. BfR generally considered NIAS with molecular weights below 1,000 Daltons (Da) relevant for evaluation; substances above 1,000 Da should also be considered if they are expected to degrade in the gastrointestinal tract.
BfR developed the guideline with input from its Commission for Consumer Products, FCM stakeholders, and members of the European Food Safety Authority (EFSA) FCM Network.
Analytical and Toxicological Requirements for NIAS
For non-predictable NIAS, BfR said screening should be conducted on the commercial product and an extract of the finished FCM. At minimum, screening should generally use gas chromatography-mass spectrometry (GC-MS) and liquid chromatography-mass spectrometry (LC-MS), or equivalent methods, unless deviations are scientifically justified.
An attempt at structure elucidation must be made when migration above 0.15 micrograms per kilogram (µg/kg) of food is expected. At or below 0.15 µg/kg, BfR said no toxicological data are required, regardless of whether the NIAS structure has been identified.
Identified NIAS migrating between 0.15 and 50 µg/kg food must be evaluated for genotoxic potential. When experimental data are unavailable, BfR would accept approaches including database searches, justified read-across, and, under certain circumstances, in silico predictions. Evidence of genotoxic potential would require experimental testing.
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When a NIAS cannot be identified despite sufficient analytical efforts, BfR said a formal risk assessment is not possible, but migration up to 10 µg/kg food can be tolerated. Unidentified NIAS migrating between 10 and 50 µg/kg would require case-specific expert judgment.
For NIAS migrating between 50 and 5,000 µg/kg food, subchronic toxicity and accumulation potential in humans must also be evaluated. Above 5,000 µg/kg, requirements additionally include evaluation of chronic toxicity and carcinogenicity, reproductive toxicity, and absorption, distribution, metabolism, and excretion.
