Understanding the EU Declaration of Compliance (DoC) for Food Contact Materials

Overview

The supply chain for food contact materials (FCMs) is often complex, involving chemical manufacturers, intermediate material producers, final product manufacturers, food producers, and ultimately, consumers. To ensure food safety across the entire chain, the EU Regulation (EC) No 1935/2004, Article 16, requires that FCMs covered by specific EU measures must be accompanied by a Declaration of Compliance (DoC) — a key document confirming legal conformity.

What Is a Declaration of Compliance (DoC)?

A Declaration of Compliance (DoC) is a formal written statement confirming that the food contact material or article complies with the relevant EU regulatory requirements.

Why Is the DoC Important?

• It is a mandatory compliance document required for customs clearance and market entry into the EU.
• It helps ensure that the materials used in food-contact products do not endanger human health and meet EU safety and quality standards.
• It provides transparency and traceability throughout the entire supply chain.

Who Is Responsible for Issuing the DoC?

• The DoC may be self-declared by the manufacturer or supplier of the food contact material or article.
• Alternatively, a company may entrust a professional third-party organization to prepare the document in accordance with the applicable legislation.

What Should a DoC Include?

A valid Declaration of Compliance must typically include:

• Company name and address (manufacturer/supplier)
• Type of food contact material or article
• Date of issue
• Statement confirming compliance with all relevant EU regulations and specific measures

When Is a DoC Required?

A DoC is generally required in the following situations:

1. For Materials and Articles Covered by Specific EU Measures

The EU has issued specific measures for several categories of food contact materials. For these materials, a DoC is mandatory:

• Plastic materials – Used in packaging, containers, etc.; safety is critical due to direct food contact.
• Active and intelligent materials – Materials that interact with food or the environment and must meet strict performance and safety criteria.
• Ceramics – Common in kitchenware; lead and cadmium migration are tightly controlled.
• Regenerated cellulose film – Requires compliance due to its contact with food in packaging applications.

2. Supply Chain Information Transmission

Each upstream supplier must provide a DoC to their downstream partners. Manufacturers of final products are responsible for consolidating the compliance information and issuing a comprehensive DoC for the finished material or article.

3. Regulation Updates or New Legal Requirements

If the EU issues new legislation (e.g., bans on substances like BPA), or updates current regulations or EFSA opinions, the existing DoC may need to be reviewed, revised, or reissued to maintain compliance.

Our Professional Services

To help you navigate EU FCM regulations and prepare valid Declarations of Compliance, we offer:

Customized Compliance Solutions

We design personalized compliance plans based on the material composition, intended use, and applicable testing requirements of your products, helping you issue accurate and complete DoCs efficiently.

Expert Legal Interpretation

Our team continuously monitors EU legislation and guidance. We offer in-depth regulatory interpretation tailored to your products, ensuring full alignment with the latest requirements and standards.

Ongoing Compliance Monitoring

Achieving compliance is not a one-time task. We provide continuous regulatory tracking and timely alerts on changes, ensuring your products remain fully compliant during audits, inspections, or product modifications.

Why Choose REACH24H?

With years of experience in regulatory compliance and a dedicated team of specialists, we deliver end-to-end support for your FCM projects — from documentation to testing coordination, risk assessments, and policy updates.

Let us help you enter the EU market confidently and compliantly.

Contact us today to start your Declaration of Compliance process.