Food contact materials: Regulation (EC) No 1935/2004 for importers

Regulation (EC) No 1935/2004 applies to all materials and articles intended to come into contact with food. Kitchen utensils, tableware, storage containers, packaging. Its Article 3 sets out the inertness principle: the material must not release constituents in a quantity capable of endangering health, changing the composition of the food, or altering its taste, smell or appearance.

The scope is broad and goes well beyond plastics: ceramics, glass, metal, wood, paper, rubber, textiles. Two obligations sit on top of this. Article 16 requires a declaration of compliance for materials covered by harmonised rules and for active and intelligent materials. Article 17 requires traceability, from the factory through to the distributor. Key point to remember: food contact materials carry no CE marking. No logo proves compliance. It is the documents that prove it.

The framework regulation sets the objective, the implementing rules set the limits. For plastics, Regulation (EU) No 10/2011 sets out a positive list: only authorised monomers and additives may be used, and many are capped by specific migration limits. It also sets the overall migration limit: 10 mg per square decimetre as a general rule, and 60 mg per kilogram of liquid food. Food simulants, water, acid, ethanol, oil, reproduce the actual use of the product.

Ceramics fall under Directive 84/500/EEC, which caps lead and cadmium migration depending on the type of use. Melamine articles coming from China are also subject to Regulation (EU) No 284/2011: every shipment must be accompanied by a compliant declaration and test report, and customs checks are stepped up. Other national requirements come on top, such as Germany's LFGB and the BfR recommendations. A client selling into Germany may ask for these in addition to the EU texts.

The declaration of compliance commits the manufacturer in writing to the material's compliance. For plastics it is mandatory and its content is defined: identity and address of the operators, description of the materials, confirmation of compliance with the applicable rules, substances concerned, date. It travels along the chain, from the pellet processor through to the importer placing the product on the market.

In China, many factories send a generic letter: headed paper, the phrase food grade, no article name, no date, no material reference. Such a document is worthless. A useful declaration carries the exact name of the factory or processor, describes the article precisely, cites the version of the lists used and bears a signature. Demand one for every material in the product, including coatings and printing inks. A compliant polypropylene body does not make up for a handle or a coating left out of the declaration.

The declaration is verified through testing, and the plan works in three stages. First, list the product's materials and their known risks: overall migration for a plastic, lead and cadmium for ceramics, formaldehyde and melamine for melamine tableware. Next, fix the timing: tests on the pre-production sample, then a check on the mass-production run, since a batch can change pellet or subcontractor without notice. Finally, have the tests carried out by an accredited independent laboratory, on samples drawn from actual production, not on pieces prepared by the factory.

Retest whenever the material, pellet supplier or process changes: a product compliant on the first container may no longer be so on the third. Keep test reports together with the declarations and your commercial file. Together they serve to answer a professional client, a customs check or a health alert. An old test, carried out on a different article or in a different factory, proves nothing for your shipment.

Tableware concentrates most of the difficulties. Melamine articles are the first concerned: Regulation (EU) No 284/2011 requires precise accompanying documents for every shipment from China, and whole shipments are regularly held at customs for lack of a valid test report. Many manufacturers also advise against microwave use on this material, which must appear on the product sheet and the packaging.

The other recurring pitfalls look similar. The glass-and-fork symbol applied without a file to back it up: it proves nothing. The FDA certificate presented as European proof: it says nothing about EU law. Articles designed for the Chinese market, compliant with GB 4806 standards, that do not meet EU limits. Full sets where only the main material is declared, while wooden handles, non-stick coatings, printing and seals stay out of the file. Every part in contact with food matters.

This work happens before the order, not after the shipment arrives. Write the materials into the brief, part by part. Demand named declarations at the same time as the quote, not on delivery. Schedule testing at sample approval stage, then a check on the mass-production run. Keep dated reports and declarations for several years, together with your commercial file.

This documentary chain answers the traceability required by Article 17 and covers you in the event of a customs check or a market check. It also informs supplier selection: a factory that refuses to name its materials or send a recent test discredits itself. The lowest price does not make up for a blocked batch or a market withdrawal.

The documents to gather before any order:

The brief with the materials, part by part

A named and dated declaration of compliance for each material

Test reports on samples from the mass-production run

Identification of the actual factory, including subcontractors

The dates and versions of each document, archived for several years

Sorva is a sourcing and brokerage house. Our Chinese-speaking team in Guangzhou asks factories these questions in their own language, from the first quote: full list of materials, named and dated declarations of compliance, laboratory test reports on production samples. We build these requirements into the brief, check every document before the order, and on melamine shipments we prepare with the factory the documents required under Regulation (EU) No 284/2011. Where your file requires it, our regulatory compliance review and pre-shipment inspection complete the setup.

In most cases you pay no fees: you open a file with us, we negotiate the goods on your behalf, and we take a commission on the ex-factory value.