Mapping of Food Contact Materials Compliance

Food comes into contact with many materials and articles during production, processing, storage, preparation, serving, and consumption. Such materials and articles include packaging, processing machinery, storage containers, kitchenware, tableware, coatings, seals, inks, adhesives, and other components that may transfer constituents into food.

To ensure a high level of food safety, all food contact materials (FCM) placed on the EU market must comply with Regulation (EC) No 1935/2004, as well as applicable Good Manufacturing Practice requirements under Commission Regulation (EC) No 2023/2006.

The regulatory assessment process can be represented using a Structured Assessment Logic (SAL). This logic translates the FCM framework into a structured and repeatable compliance methodology linking material qualification, migration assessment, material-specific legislation, GMP controls, and conformity documentation.

The SAL comprises the following steps:

1. Product qualification – Is the product a Food Contact Material (FCM)?

2. Determination of the applicable FCM regulatory regime

3. Conformity assessment – Demonstrate compliance with the applicable FCM requirements at design level

4. Good Manufacturing Practice (GMP) – Manufacturing control as a conformity requirement

5. Compliance documentation – Demonstration of conformity

6. Information and labelling obligations

7. Declaration of Compliance

Note: SAL is not an end in itself. It provides a repeatable methodology that translates regulatory principles into a clear, structured assessment logic.

This diagram illustrates the SAL workflow visually:

Product qualification

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Determination of the applicable FCM regulatory regime

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Conformity assessment at design level

↓

Good Manufacturing Practice (GMP)

↓

Compliance documentation

↓

Information & labelling obligations

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Declaration of Compliance

Parallel applicability of legislation / Norm hierarchy and conflict of laws

Other Union harmonisation legislation may need to be taken into account. As part of the applicability assessment, it must be determined whether such acts apply in parallel or whether, due to rules of precedence and lex specialis principles, individual requirements or an entire harmonisation act is displaced in favour of another. Where no normative conflict exists, the respective requirements apply in parallel and cumulatively.

Overview: Food Contact Materials Framework

• Framework Regulation: Regulation (EC) No 1935/2004

• GMP Regulation: Regulation (EC) No 2023/2006

• Purpose: Safety and inertness for all Food Contact Materials (FCMs)

• Public interest: Food safety and consumer protection

• Key principle: Prevention of harmful migration into food

• Further information is available from the European Commission – Food Contact Materials Legislation.

Scope

The Regulation applies to materials and articles which:

• are intended to come into contact with food,

• are already in contact with food and intended for that purpose,

• or can reasonably be expected to come into contact with food or transfer constituents to food under normal or foreseeable conditions of use.

Typical FCM include:

• coffee machines and beverage appliances,

• mixers, blenders, and food processors,

• food processing and filling machinery,

• conveyor and dispensing systems,

• refrigeration and ice-making equipment,

• pipes, seals, hoses, valves, and fittings intended for food contact,

• as well as coatings, adhesives, inks, and multi-layer material structures used in food-contact applications.

  
  

Determination of the applicable FCM regulatory regime

Article 3(1) of Regulation (EC) No 1935/2004 requires that food contact materials and articles are manufactured in such a way that, under normal or foreseeable conditions of use, they do not:

• release constituents into food at levels harmful to human health,

• cause unacceptable changes in food composition,

• or adversely affect taste or odour.

  
  

These requirements are operationalised through different regulatory layers:

• where available, through specific harmonised Union measures adopted under Article 5 of Regulation (EC) No 1935/2004, including plastics under Regulation (EU) No 10/2011, ceramics under Directive 84/500/EEC and recycled plastics,

• where no such harmonised Union measures exist, through applicable national legislation governing specific materials and applications,

• and, where neither Union nor national specific measures are available, through recognised scientific guidance, technical recommendations, and established risk assessment principles.

At this stage of the SAL, the applicable regulatory framework for the respective material must therefore be determined.

Conformity assessment – Demonstration of compliance with the applicable FCM requirements at design level

Following determination of the applicable regulatory framework (step 2), conformity of the food contact material must first be assessed at design and material specification level, independently from subsequent manufacturing process controls (step 4).

This assessment is based on:

• the composition of the material or article,

• the bill of materials (BOM),

• substance identities,

• additive systems,

• material specifications,

• intended food contact conditions,

• and foreseeable conditions of use.

The objective of this assessment is to determine whether the selected material composition is capable of complying with the applicable food contact safety and migration requirements determined in step 2.

Compliance with the applicable requirements is then demonstrated in accordance with:

specific harmonised Union measures,

applicable national legislation,

or recognised scientific guidance and risk assessment principles.

This may involve:

• migration testing,

• compositional analysis,

• modelling approaches,

• supplier declarations,

• toxicological evaluations,

• or other scientifically justified assessment methods.

The assessment must demonstrate that under foreseeable conditions of use no constituents migrate into food at levels that could:

• endanger human health,

• cause unacceptable changes in food composition,

• or adversely affect taste or odour.

Good Manufacturing Practice (GMP)

All food contact materials must be manufactured in accordance with Commission Regulation (EC) No 2023/2006.

This requires:

• documented quality assurance systems,

• process control and quality management,

• prevention of contamination,

• control of critical manufacturing parameters,

• and management of changes in formulation and raw materials.

Traceability as an integral system requirement

Traceability forms an integral part of the FCM compliance system and supports GMP-based manufacturing control throughout the supply chain.

It includes:

• identification of suppliers and raw material sources,

• identification of immediate downstream economic operators,

• batch and lot traceability,

• and systematic change control of materials and formulations.

Traceability is particularly critical in complex supply chains involving:

• multi-layer structures,

• recycled materials,

• imported substances,

• and multi-supplier production systems.

SAL principle: Traceability does not constitute an independent compliance step, but rather a cross-cutting system requirement. It serves to ensure the traceability of supply chains, responsibilities, and compliance evidence, and enables the manufacturer to assess whether upstream suppliers have fulfilled their relevant regulatory obligations.

Compliance documentation – Demonstration of conformity

Manufacturers and supply chain operators must maintain documentation demonstrating compliance with the applicable FCM framework.

Depending on the applicable legislation, this may include:

• Declarations of Compliance (DoC),

• migration test reports,

• toxicological evaluations,

• compositional information,

• supplier declarations,

• GMP documentation,

• supporting calculations,

• analytical reports,

• and technical justifications.

Particular importance is attached to:

• traceability of compliance evidence,

• justification of testing assumptions,

• and linkage between intended use and conformity demonstration.

Information and labelling obligations

Information and labelling requirements for food contact materials derive from Article 15 of Regulation (EC) No 1935/2004 and are specified by applicable material-specific Union legislation, where available.

Where harmonised Union measures exist, these define detailed requirements for identification, declaration of compliance, and user information. In the absence of such measures, national provisions and recognised guidance apply.

Labelling requirements are intended to ensure the safe and appropriate use of food contact materials by providing information necessary for correct handling, foreseeable use, and compliance with migration-related conditions.

Examples include:

• the food contact symbol,

• temperature restrictions,

• single-use indications,

• or instructions regarding compatible food types.

Declaration of Compliance

For many harmonised FCM categories, a Declaration of Compliance (DoC) is required before placing the material or article on the EU market.

The Declaration confirms that:

• the material or thw article complies with the applicable legislation,

• migration requirements are fulfilled,

• and supporting documentation is available to competent authorities upon request.

Conclusion

FCM compliance is a layered interpretation system of a single binding safety objective (Article 3(1)), operationalised through hierarchical regulatory and scientific instruments.

The SAL for Food Contact Materials transforms a complex and highly material-specific regulatory framework into a structured compliance workflow.