Germany introduces tiered framework for evaluating chemical risks in food packaging

The German Federal Institute for Risk Assessment (BfR) has released updated guidelines detailing a structured approach for evaluating non-intentionally added substances (NIAS) in food contact materials (FCMs). Published on September 10, 2026, and developed alongside the BfR Commission for Consumer Products, the framework establishes science-based expectations rather than rigid mandates for identifying and managing chemical impurities.

NIAS are chemical compounds that emerge in food packaging through degradation, manufacturing reactions, or starting-material impurities rather than intentional addition. Because many of these substances evade complete identification, ensuring safety remains a complex challenge for regulators and manufacturers.

Under the newly proposed guidelines, toxicological data requirements scale directly with how much of a substance migrates into food:
• Under 0.15 µg/kg: Generally exempt from toxicological data requirements, as risk projections suggest minimal public health concern at this trace level.
• 0.15 to 10 µg/kg: Triggers a requirement for limited toxicological information.
• 10 to 50 µg/kg: Requires case-by-case evaluation, including potential genotoxicity screening for unidentified components.
• Above 50 µg/kg: Demands extensive toxicological assessments.

Additionally, the guidance notes that substances exceeding a molecular mass of 1,000 Daltons usually experience poor gastrointestinal absorption, though exceptions are made for oligomers that can degrade or absorb more easily.

Recognizing that comprehensive chemical identification is not always feasible, the BfR framework allows for exposure estimates paired with expert judgment and bioassays. For higher-level migration of unidentified compounds, recommended strategies include the Ames test, in vitro micronucleus assays, and other new approach methodologies (NAMs).

While the BfR document centers heavily on genotoxicity, independent researchers highlight that food contact materials may also harbor compounds linked to endocrine disruption, metabolic interference, and developmental toxicity. Ongoing scientific efforts seek to expand standard testing panels to capture these broader biological endpoints more effectively.

Source:

BfR