BfR NIAS Risk Assessment Guideline 2026: Food Contact Materials, Migration & Toxicological Requirements

What the New BfR Guidance Means for Food Contact Material Manufacturers, Packaging Companies and Dossier Submitters

The German Federal Institute for Risk Assessment (BfR) has published a new guideline outlining its approach to the risk assessment of non-intentionally added substances (NIAS) in food contact materials (FCMs).

Published on 10 September 2026, the guideline provides a structured approach to the analytical identification, migration assessment and toxicological evaluation of NIAS. BfR developed guidance with advice from its Commission for Consumer Products, consultation with stakeholders in the food contact materials sector and discussion with members of the EFSA Food Contact Materials Network.

The guidance is particularly relevant to companies preparing dossiers for the inclusion of new substances in the BfR Recommendations on Food Contact Materials and related German food-contact regulatory processes. It is not presented as a general compliance-testing standard, but its methodology may also inform broader NIAS risk assessments.

For manufacturers, packaging suppliers, converters, chemical suppliers and regulatory teams, the development reinforces an important principle: risk assessment must consider substances that migrate from the finished food contact material, not only substances intentionally used in its manufacture.

What Is Changing?

NIAS can arise from several sources during the manufacture, processing and use of food contact materials.

The BfR approach identifies NIAS as including substances such as:

• Impurities in substances used to manufacture FCMs
• Reaction intermediates
• Degradation products
• Reaction products
• Oligomers
• Products formed from initiators, stabilizers or antioxidants

BfR distinguishes between foreseeable NIAS and unforeseen NIAS. Foreseeable NIAS may be predicted from manufacturing chemistry, process conditions and intended use. Unforeseen NIAS may require broader analytical screening to identify or exclude additional migrating substances.

The guidance therefore places greater emphasis on the finished material and its migration profile, rather than limiting the assessment to starting substances.

BfR NIAS Assessment: Key Regulatory Elements

BfR's existing food-contact framework makes clear that its recommendations are not legally binding standards, although they represent the current state of science and technology for certain materials not fully covered by harmonized EU measures.

Why NIAS Assessment Matters

Under the European food-contact framework, food contact materials must not transfer substances into food at levels that could endanger human health.

This means the safety assessment cannot focus exclusively on intentionally added substances.

Materials may contain an intentionally added antioxidant, photo initiator, polymer additive or processing aid, while the manufacturing or use process can generate additional substances.

These may include:

• Oxidation products
• Hydrolysis products
• Reaction products
• Oligomers
• Degradation products
• Manufacturing impurities

BfR therefore expects the safety assessment to address all relevant migrating substances, including NIAS.

For companies, this changes the practical question from:

“Which substances did we intentionally add?”

to:

“Which substances could migrate from the finished article under foreseeable conditions of use, and can their safety be demonstrated?”

Analytical Assessment of NIAS

One of the most important aspects of the BfR approach is the need for a sufficiently comprehensive analytical strategy.

For non-predictable NIAS, screening should generally be performed on the commercial product and an extract of the finished food contact material.

Current descriptions of the BfR guideline indicate that analytical screening should generally include techniques such as GC-MS and LC-MS, or equivalent approaches, unless a scientifically justified alternative is used.

The analytical programme should be capable of detecting relevant migrating substances and supporting their identification and quantification.

Where migration above 0.15 µg/kg food is expected, BfR calls for an attempt at chemical structure elucidation. At or below this level, the guideline provides a different toxicological treatment, with no toxicological data required solely based on the migration level.

Companies should therefore ensure that their analytical strategy can demonstrate:

• What substances were detected
• Which substances were identified
• Which substances remain unidentified
• The approximate or measured migration level
• The analytical methods used
• The sensitivity and limitations of the methods
• Whether the analytical programme was sufficiently comprehensive

Migration Level Drives Toxicological Requirements

A central feature of the BfR guideline is its migration-based approach to toxicological data requirements.

The greater the potential exposure through migration, the more extensive the toxicological assessment becomes.

The framework can be summarized as follows:

These thresholds are particularly important for dossier planning because analytical results can directly influence the amount and type of toxicological evidence expected.

For identified NIAS migrating between 0.15 and 50 µg/kg food, the focus is on evaluating genotoxic potential. Depending on the available evidence, database searches, scientifically justified read-across and, where appropriate, in-silico methods may contribute to the assessment.

Where migration reaches 50–5,000 µg/kg, the assessment expands to include subchronic toxicity and consideration of potential accumulation in humans.

Above 5,000 µg/kg, the toxicological package becomes more extensive, including chronic toxicity/carcinogenicity, reproductive toxicity and absorption, distribution, metabolism and excretion (ADME).

Unidentified NIAS Require a Structured Strategy

A particular challenge with NIAS is that analytical screening can identify a signal without providing a definitive chemical structure.

BfR recognizes this practical difficulty.

Where a NIAS cannot be identified despite sufficient analytical effort, the guideline provides a differentiated approach. Migration levels up to 10 µg/kg of food may be tolerated for unidentified NIAS, while unidentified substances migrating between 10 and 50 µg/kg require case-specific expert judgement.

This means that companies should not automatically treat every unidentified analytical signal as equivalent.

Instead, they should document:

• Analytical effort undertaken
• Detection and quantification capabilities
• Attempts at structural identification
• Migration levels
• Manufacturing-process information
• Potential chemical classes
• Available toxicological information
• Scientific justification for the final assessment

Toxicological Evidence and Alternative Approaches

The BfR approach is aligned in significant respects with the broader EFSA framework for food-contact substance assessment.

The toxicological evaluation may consider available experimental data, published literature, structural information and scientifically justified alternative approaches.

BfR also recognizes read across as a possible approach where suitable toxicological data for the substance itself are unavailable, provided that the scientific rationale is adequately supported.

The approach does not treat the Threshold of Toxicological Concern (TTC) as a standalone risk-assessment method for FCMs. Instead, BfR considers TTC a screening and prioritization tool while applying the relevant data expectations for the assessment of food-contact substances.

For companies, this means that simply assigning a TTC category should not automatically be treated as a complete NIAS safety assessment.

What Should a BfR NIAS Dossier Contain?

BfR's established guidance for food-contact substance applications provides a useful framework for dossier preparation.

The dossier should address areas including:

• Substance identity
• Chemical properties
• Intended application
• Manufacturing information
• Potential impurities
• Reaction and degradation products
• Migration or transfer into food
• Food simulant information
• Analytical methods
• Toxicological evidence
• Relevant literature
• Exposure considerations
• Supporting calculations
• Scientific justification

BfR's guidance states that applications should include information on the identity and quantity of substances potentially transferred to food under the most unfavorable foreseeable conditions of use, with toxicological data determined according to the potential transfer level.

Application documentation can be submitted in German or English, and BfR requires appropriate electronic documentation, including searchable versions and the relevant substance overview information.

Migration Testing: What Companies Should Review

Migration assessment should reflect realistic but appropriately conservative conditions.

Important variables include:

• Food or food simulant
• Temperature
• Contact time
• Surface-to-volume relationship
• Intended food categories
• Storage conditions
• Material Composition
• Substance polarity
• Solubility
• Volatility
• Potential degradation
• Multi-layer construction

BfR's existing guidance states that migration measurements and modelling should use the most severe foreseeable conditions in practice, considering food or simulant, temperature and time.

For analytical migration testing, companies should also verify and substantiate the limit of detection, limit of quantification, recovery and measurement uncertainty.

Where modelling is used, it should be documented transparently and should not underestimate actual migration.

What This Means for Food Contact Material Manufacturers

The new BfR NIAS guideline is particularly relevant for companies that are:

• Developing new food contact substances
• Preparing BfR recommendation dossiers
• Manufacturing packaging materials
• Producing paper and board materials
• Developing plastics, silicones or elastomers
• Manufacturing printing inks or coatings
• Supplying adhesives or additives
• Using recycled materials
• Investigating oligomers or degradation products
• Conducting NIAS screening
• Supporting German market access

The guidance reinforces the importance of connecting analytical chemistry, migration science and toxicology within one regulatory assessment.

2026 NIAS Compliance Readiness Checklist

Frequently Asked Questions

1. What are NIAS?

NIAS are substances that were not intentionally added but may be present as impurities or form as reaction, degradation or other process-related products.

2. Does the BfR guideline apply to all food-contact compliance testing?

The guideline is primarily intended to support dossiers for new substances submitted for inclusion in BfR recommendations or relevant German processes. It is not presented as a general compliance testing standard.

3. Why is migration important?

Migration determines potential consumer exposure and therefore plays an important role in determining the extent of toxicological information required.

4. What happens when a NIAS cannot be identified?

BfR provides a differentiated approach based on migration level and the adequacy of analytical efforts, including expert judgement for certain unidentified NIAS.

5. Does BfR use the TTC approach as the primary NIAS risk assessment?

No. The guidelines do not adopt TTC as a standalone FCM risk-assessment method; it considers TTC a screening/prioritization tool within the broader assessment framework.

6. What should companies do now?

Companies preparing German food-contact substance dossiers should review their NIAS screening strategy, migration data, analytical methods, toxicological evidence and dossier structure against the new BfR approach.

Conclusion

The BfR's September 2026 guideline on NIAS risk assessment provides greater structure around how Germany approaches the analytical and toxicological evaluation of non-intentionally added substances in food contact materials.

The central message is clear: NIAS cannot be assessed solely by looking at intentionally added substances.

Manufacturers and dossier submitters need to consider the substances that may migrate from the finished material, including impurities, reaction products, degradation products and oligomers.

The new framework also creates a stronger connection between migration level and toxicological data requirements, making analytical strategy a critical part of regulatory planning.

For companies preparing new-substance dossiers for Germany, early alignment between manufacturing chemistry, NIAS screening, migration testing, structure elucidation and toxicological assessment can help establish a more defensible regulatory package.

As European and national food-contact requirements continue to develop, companies should monitor both BfR recommendations and wider EU regulatory developments when designing their food-contact material compliance strategy.

How Maven Regulatory Solutions Can Help

Maven Regulatory Solutions can support food contact material companies with:

• NIAS regulatory assessments
• BfR dossier strategy
• Food contact material compliance assessments
• NIAS analytical strategy reviews
• Migration assessment
• Toxicological data-gap assessments
• BfR recommendation submissions
• Technical dossier reviews
• Chemical identity and structure assessment
• Read-across strategy
• Regulatory gap assessments
• Food contact material market-entry strategy
• Regulatory intelligence and monitoring

Our approach helps manufacturers, packaging companies and regulatory teams prepare structured NIAS, migration and toxicological assessments aligned with evolving German and European food-contact requirements.