What Is a Declaration of Compliance for Plastic FCM?

A Declaration of Compliance is a written document provided by a supplier to its customer at relevant stages of the supply chain, except the retail stage.

It has two main purposes:

• To confirm that the product complies with relevant requirements of the EU Plastics Regulation and the Framework Regulation.
• To provide the customer with the information needed to establish or check compliance for the next stage of use.

In practical terms, the DoC is not just a certificate. It is a communication tool that connects supplier data, material composition, restrictions, intended use and compliance evidence.

For companies placing plastic food contact materials on the EU market, the DoC should be treated as part of a wider compliance system, supported by technical documentation, supplier records, risk assessments and traceability controls.

Why Information Exchange Matters Across the Plastic FCM Supply Chain

Plastic food contact compliance is complex because no single business operator usually has all the information needed to complete the full compliance assessment.

For example:

• A substance supplier may know the identity, purity and restrictions of a substance.
• A polymer manufacturer may know formulation and processing conditions.
• A converter may know the structure, layer thickness and intended packaging format.
• A food business operator may know the real food type, contact time, temperature and storage conditions.

Because of this, compliance depends on communication both upstream and downstream.

The supplier must provide enough information for the customer to perform its own compliance work. At the same time, the customer should provide relevant intended-use information to the supplier, such as food type, contact conditions and processing requirements.

This avoids duplicated work, reduces uncertainty and helps compliance be concluded as early as possible in the manufacturing chain.

Who Must Provide a DoC or Adequate Information?

The exact obligation depends on the product type and the role of the business operator. The table below summarizes the main expectations.

A company may have more than one role. For example, an importer may also be a distributor. A food business may also become a manufacturer if it performs operations that affect the formulation or final article.

This is why companies should map their real activities, not only their job title in the supply chain.

What Should a Plastic FCM DoC Include?

A DoC for plastic materials and articles should be clear, specific and connected to the actual product or product family it covers.

Key information normally includes:

• Identity and address of the business operator issuing the declaration
• Identity and address of the manufacturer or importer
• Identity of the material, article, intermediate product or substance
• Date of the declaration
• Confirmation of compliance with applicable EU requirements
• Information on substances with restrictions or specifications
• Information on substances also restricted in food, such as dual-use additives
• Specifications for intended use, including food type, time, temperature and surface-area-to-volume ratio
• Functional barrier information where relevant

The DoC should not be vague or misleading. It should identify the product clearly and explain the conditions under which compliance has been assessed.

Where one DoC covers a product family, the covered products should be clearly identified. Differences that may affect reportable substances should also be managed carefully.

Adequate Information for Inks, Adhesives and Coatings

The EU Plastics Regulation does not create a harmonised EU DoC requirement for non-plastic intermediates such as printing inks, coatings and adhesives.

However, these materials may become part of a plastic food contact article. They may also contain substances with migration limits or restrictions relevant to the final plastic material.

For this reason, suppliers of inks, adhesives and coatings are recommended to provide Adequate Information to their customers.

This information helps the manufacturer of the final plastic article assess whether restricted substances, degradation products or other relevant substances could affect compliance.

Adequate Information may include:

• Identity of the supplier responsible for the information
• Identity of the non-plastic intermediate material
• Date of the document
• Confirmation that the material supports compliance with relevant Framework Regulation requirements when used correctly
• Information on substances with restrictions
• Relevant migration limits or use restrictions
• Dual-use additive information where applicable
• Information needed by downstream users to perform risk assessment

For businesses using inks, coatings or adhesives in plastic food contact applications, requesting and managing Adequate Information is a critical step.

Supporting Documents: The Evidence Behind the DoC

A DoC is supported by technical evidence. These supporting documents are not usually passed along the supply chain, but they must be kept by the business operator and made available to competent authorities when requested.

Supporting documents may include:

• Supplier Declarations of Compliance
• Migration test results
• Composition and formulation information
• Toxicological information
• Risk assessments for intentionally added and non-intentionally added substances
• Evidence of compliance with specific migration limits and overall migration limits
• Quality assurance and quality control documentation
• Traceability records

The DoC is therefore the visible declaration, while supporting documents are the evidence base behind it.

A strong compliance system must manage both.

The Link Between DoC, GMP, Traceability and Labelling

Plastic food contact compliance is not limited to one declaration. It is connected to broader regulatory expectations, including Good Manufacturing Practice, traceability and safe-use communication.

Companies should ensure that:

• Materials are manufactured under controlled quality systems.
• Starting materials are selected according to defined specifications.
• Processes are performed according to established instructions.
• Products are traceable through suppliers and customers.
• Safe and appropriate use instructions are provided where needed.
• Labelling and product information do not mislead customers or consumers.

This is especially important where the final use involves specific time, temperature or food-type restrictions.

For example, a plastic material may be suitable for dry food at room temperature but not for fatty food, hot filling or long-term storage. If this information is not communicated clearly, the downstream user may apply the material incorrectly.

Special Attention: Multi-Material Multilayer Articles

Multi-material multilayer articles, also known as MMML, can create additional compliance complexity.

In these products, the final article may contain plastic and non-plastic layers. Under the Plastics Regulation, the DoC focuses on the plastic layers rather than the full multi-material structure.

However, national legislation may require additional information for non-plastic layers or the full article.

Companies working with multilayer packaging should therefore confirm:

• Which layers are plastic and which are non-plastic
• Whether a functional barrier is used
• Whether substances behind the barrier meet the relevant requirements
• Whether migration is not detectable where required
• Whether national requirements apply in the target market

This is an area where strong documentation and supplier communication are essential.

Practical Plastic FCM DoC Checklist

Use this checklist to review your plastic food contact compliance process.

Common Compliance Gaps to Avoid

Many companies have a DoC process, but still struggle with quality and consistency.

Common gaps include:

• Using generic declarations that do not match the actual product
• Missing use conditions such as food type, time or temperature
• Not requesting Adequate Information for inks, coatings or adhesives
• Treating supplier DoCs as final proof without reviewing their content
• Failing to update declarations after regulatory or formulation changes
• Keeping supporting documents in disconnected folders or email chains
• Not mapping obligations for importers and distributors
• Overlooking national requirements for non-plastic materials or multilayer articles

The best approach is to build a structured process that connects supplier engagement, regulatory requirements, product data and supporting evidence.

How ComplyMarket Can Support Plastic FCM Compliance

Managing plastic food contact compliance manually can be difficult, especially for companies with many suppliers, materials, formulations and customer requirements.

ComplyMarket supports companies by helping them move from scattered documents and manual follow-ups to a more structured digital compliance workflow.

With ComplyMarket, businesses can support plastic FCM compliance by:

• Mapping applicable regulatory requirements by product, material, supplier and market
• Collecting supplier Declarations of Compliance and Adequate Information in a structured way
• Managing supplier engagement and follow-up activities
• Tracking substances, restrictions and material information across the supply chain
• Organising supporting documents for audits and authority requests
• Improving traceability and documentation quality
• Identifying missing or incomplete supplier data
• Supporting risk-based compliance decisions through material and supplier assessment
• Reducing manual spreadsheet work and strengthening internal compliance control

For manufacturers, importers, distributors and food contact material users, this creates a more reliable way to manage compliance information and prepare for customer or regulatory requests.

Plastic food contact compliance is not just about having a declaration. It is about having the right data, from the right supplier, connected to the right product and supported by the right evidence.

ComplyMarket helps companies build that level of confidence.

Conclusion

The EU plastic food contact supply chain depends on clear, accurate and timely compliance information. The Declaration of Compliance is the central document, but it must be supported by supplier data, technical evidence, traceability, GMP controls and clear use instructions.

Companies that manage this information proactively can reduce compliance risk, respond faster to customer requests and strengthen trust across the supply chain.

For businesses handling plastic food contact materials, now is the right time to review DoC quality, supplier communication and supporting documentation processes.

A well-managed DoC process is not only a regulatory requirement. It is a competitive advantage in a market where transparency, safety and compliance are increasingly expected.