FCM - Regulation (EC) No 1935/2004

What FCM is and why it matters

The Food Contact Materials framework — formally Regulation (EC) No 1935/2004 on materials and articles intended to come into contact with food — is the EU’s overarching law for anything that touches food along the supply chain. If you make, import or sell packaging, kitchenware, processing equipment, cutlery, bottles, coatings or any other article meant to meet food, this regulation almost certainly applies to you. It sets the baseline principle that food contact materials must not endanger human health or harm the food, and it acts as the umbrella under which more detailed, material-specific rules sit.

FCM matters because it establishes the general safety principle that governs every food contact material, whether or not a specific measure exists for that material. Plastics have their own detailed rules, ceramics have theirs, but a wooden board, a paper wrapper or a silicone mould without a dedicated EU measure still has to satisfy the framework. For a brand owner that means Regulation 1935/2004 is the rule that catches everything: it is the foundation that the Declaration of Compliance, traceability and Good Manufacturing Practice obligations all build on.

📄 Official text: Regulation (EC) No 1935/2004 on materials and articles intended to come into contact with food — on EUR-Lex →

Who FCM applies to

FCM applies across the supply chain rather than to a single actor. The duties scale with your role, but every business handling a food contact material is covered:

Manufacturers — anyone who produces materials or articles intended to come into contact with food, including converters, packaging producers and makers of kitchen utensils and processing equipment. They carry the heaviest obligations, including compliance work under Good Manufacturing Practice and issuing the Declaration of Compliance.
Importers — businesses bringing food contact materials from outside the EU into the Union market. They must ensure the products satisfy the framework and any specific measures, and that the supporting documentation exists.
Processors and converters — operators at intermediate stages who transform a material (for example printing, coating or laminating) must pass on the compliance information that the next operator needs.
Fillers, packers and retailers — businesses further down the chain who place packaged food on the market rely on the documentation upstream and must keep traceability records of who supplied the materials.

The Regulation covers materials and articles in their finished state that are intended to come into contact with food, are already in contact with food, or can reasonably be expected to come into contact with food or transfer their constituents to food under normal use. Annex I lists the material groups that may be subject to specific measures, from plastics and ceramics to paper, rubber and active and intelligent materials.

Key dates and timeline

2004 — Regulation (EC) No 1935/2004 was adopted, replacing the earlier framework Directive 89/109/EEC and modernising the EU approach to food contact materials.
The Regulation is directly applicable in all Member States, so it does not require national transposition. Because it is a framework, it works together with specific measures adopted over time for individual materials.
Regulation (EC) No 2023/2006 on Good Manufacturing Practice has applied alongside the framework since 2008, setting the GMP rules referenced by Article 3.
Material-specific measures continue to evolve under the framework: Regulation (EU) No 10/2011 governs plastics and is amended regularly, while older measures such as Directive 84/500/EEC govern ceramics. Operators must track the specific measure relevant to each material they use.

Core requirements

The general safety principle

At the heart of FCM is the general requirement in Article 3: materials and articles must be manufactured so that, under normal or foreseeable conditions of use, they do not transfer their constituents to food in quantities that could endanger human health, bring about an unacceptable change in the composition of the food, or deteriorate its taste, smell or appearance. This principle applies to every food contact material regardless of what it is made from, and it is the legal anchor for migration limits and testing in the specific measures.

Specific measures per material

The framework is deliberately layered. For materials listed in Annex I — such as plastics, ceramics, regenerated cellulose film, and active and intelligent materials — the EU adopts specific measures that translate the general principle into concrete rules: positive lists of authorised substances, migration limits, purity criteria and testing methods. Plastics are governed by Regulation (EU) No 10/2011, including its Union list of authorised monomers and additives and its overall and specific migration limits. Ceramics fall under Directive 84/500/EEC, which sets limits for the release of lead and cadmium. Where no specific EU measure exists for a material, the framework still applies and Member States may maintain national provisions.

Good Manufacturing Practice

Article 3 is backed by Good Manufacturing Practice (GMP), set out in Regulation (EC) No 2023/2006. GMP requires that food contact materials be manufactured under a quality assurance system, with quality control and appropriate documentation, so that the finished article consistently meets the rules and is fit for its intended use. Printing inks, coatings and adhesives are explicitly within scope, and the regulation requires controls so that any substance from a non-food-contact side, such as the printed outer layer of packaging, does not migrate through to the food.

The Declaration of Compliance

For materials covered by a specific measure, business operators must provide a written Declaration of Compliance (DoC) stating that the material or article complies with the rules applicable to it. The DoC accompanies the product at the marketing stages other than retail and gives the downstream operator the information needed to verify compliance and carry out their own checks — for example the identity of the material, any restrictions on use, and confirmation that migration limits are met. Supporting documentation demonstrating that compliance must be available to the competent authorities on request.

Labelling and the symbol

Materials and articles not yet in contact with food when placed on the market must carry appropriate labelling: the words “for food contact”, a specific indication of their use (such as “coffee machine” or “wine bottle”), or the glass-and-fork symbol reproduced in Annex II. Where the intended use is obvious from the nature of the article, this indication is not required. Materials must also carry the name or trade name and address of the manufacturer, processor or seller responsible for placing them on the market, and instructions for safe and appropriate use where needed.

Traceability

The framework requires traceability of materials and articles at all stages to facilitate control, the recall of defective products, consumer information and the attribution of responsibility. Operators must have systems and procedures in place to identify the businesses from which and to which materials, articles or substances were supplied, and this information must be made available to the competent authorities on demand. Products placed on the market must be identifiable through appropriate systems such as labelling or relevant documentation.

Obligations by role

Manufacturers — apply GMP, meet the general safety principle and any specific measure, issue the Declaration of Compliance and supporting documentation, label correctly and keep traceability records.
Importers — verify that products meet the framework and the relevant specific measures, ensure the DoC and documentation exist, and add the required identification.
Processors and converters — maintain GMP for their stage, pass on accurate compliance information, and keep traceability up and down the chain.
Fillers and retailers — keep records of suppliers, rely on and retain the DoC, and stop using materials they have reason to believe are non-compliant.

Enforcement

Each Member State designates competent authorities to enforce the FCM framework through official controls and market surveillance. In Denmark, the Danish Veterinary and Food Administration (Fødevarestyrelsen) is responsible for food contact materials, carrying out inspections and sampling and acting where products fail to meet the rules.

Authorities can require corrective action, restrict or prohibit the marketing of non-compliant materials, and order withdrawals or recalls. Where a food contact material is found to pose a risk to health, the EU’s Rapid Alert System for Food and Feed (RASFF) allows the problem to be shared across the Union so action can follow in other markets. Consequences for non-compliance are set at national level and can include sales bans, recalls, fines and reputational damage. The qualitative reality for a brand is that a migration failure or a missing Declaration of Compliance can halt sales and trigger a recall across multiple markets quickly.

Getting compliant

Identify which material group each of your products falls into and which specific measure applies (plastics 10/2011, ceramics 84/500/EEC, or framework-only).
Confirm your products meet the Article 3 general safety principle and any migration limits and positive lists in the relevant specific measure.
Implement Good Manufacturing Practice under Regulation 2023/2006, including controls on inks, coatings and adhesives.
Issue a written Declaration of Compliance and compile the supporting documentation demonstrating compliance.
Apply correct labelling — “for food contact”, the intended use, or the glass-and-fork symbol — plus the responsible operator’s name and address.
Put traceability systems in place to identify suppliers and customers one step up and one step down.

How Conphora helps

Conphora monitors the FCM framework and the material-specific measures beneath it, mapping your products against the right rules and flagging gaps in the Declaration of Compliance, GMP, labelling and traceability before they become enforcement problems. The platform helps you generate and keep the right documentation, and alerts you when a specific measure such as the plastics Union list changes so your compliance stays current.

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Sources and further reading

This guide is for general information and is not legal advice.

Last updated: 12 June 2026