BfR: guideline on assessing NIAS in food contact materials — at least GC-MS and LC-MS
On 10 September 2026 the German Federal Institute for Risk Assessment (BfR) published a guideline on the risk assessment of non-intentionally added substances (NIAS) in food contact materials. It sets out requirements for analytical screening, quantification and structure elucidation of migrating substances.
- The guideline is for preparing and assessing dossiers on new substances for the BfR Recommendations or Annex 14 of the German Consumer Goods Ordinance; it is not intended for compliance testing, although its concept can serve other assessments.
- NIAS screening must use at least one GC-MS and one LC-MS method or equivalent, with recovery evaluated; quantification requires at least a one-point (GC) or three-point (LC) calibration with known substances in the extract or migrate matrix.
- Structure elucidation must always be attempted where migration above 0.15 µg/kg food is expected, corresponding to an exposure of 0.0025 µg/kg body weight per day; the share of unidentified signals in the total migrating substances must also be estimated.
- NIAS with a molecular weight below 1000 Da are assessed, as are larger oligomers if they are degraded in the gastrointestinal tract; BfR does not use the TTC concept in this area but accepts the exposure threshold of 0.0025 µg/kg body weight per day for genotoxic carcinogens.