News Details

The regulatory framework for food contact materials (FCMs) in Switzerland has been strengthened following the revision of Swiss Ordinance 817.023.21 on materials and articles intended to come into contact with food. New mandatory documentation requirements for printing inks and printing ink layers entered into force on 1 February 2026. 

Core Requirement: Mandatory Declaration of Compliance 

Under Article 35a, a Declaration of Compliance (DoC) is now mandatory at all marketing stages (excluding retail) for: 

• Printing ink layers in consumer products. 

• Printing inks as raw materials. 

• Substances used in the manufacture of printing inks. 

The DoC must be issued by a responsible person and strictly align with the information specified in Annex 15 of the Ordinance. 

Harmonizing the Supply Chain 

To prevent data gaps, industry guidance recommends a standardized flow of information. Compliance therefore requires coordination between suppliers, converters, and the food industry: 

• Supplier → Converter: Provides a Statement of Composition (SoC). 

• Converter → Food Industry: Transmits the final Declaration of Compliance (DoC). 

The SoC is a vital supporting document under Article 35b. While it does not transfer legal liability away from the converter, it provides the data necessary for the converter to verify compliance under the actual conditions of use, such as the surface-to-volume ratio and ink coverage. 

Substance Classification and Risk Assessment 

The Ordinance maintains a "positive list" approach, but clarifies how substances that are not listed should be handled. 

Migration Limits for Non-Intentionally Added Substances (NIAS) 

According to the guidance referenced in the regulatory framework: 

• Genotoxic/Non-threshold Carcinogens: Migration must not exceed 0.15 µg/kg. 

• Threshold Carcinogens: A limit of 10 µg/kg food may be accepted based on expert judgement. 

Converter Obligations: The Final Check 

If you are a converter, the supplier's SoC is only the starting point. You are responsible for: 

• Validating assumptions: Ensuring the actual ink coverage matches the supplier's model. 

• Testing: Conducting migration testing where calculations show a "worst-case" risk. 

• Functional Barriers: Where migration exceeds limits, demonstrating the effectiveness of a functional barrier in accordance with Regulation (EC) No 1935/2004. 

Handling Trade Secrets 

Confidentiality is protected. If a substance’s identity cannot be disclosed, suppliers must still provide the following: 

• The chemical classification (e.g., CMR, NIAS). 

• Specific risk management measures. 

• A clear pathway for how the converter should handle the data. 

Action Plan for Stakeholders 

Now that the enforcement date 1 February 2026 has passed, stakeholders are advised to: 

• Audit current ink inventory against Annexes 2 and 10. 

• Ensure that all templates for SoCs and DoCs match the SVI/FSVO guidelines. 

• Review protocols for NIAS risk assessment and migration testing to ensure full compliance.