Food contact materials regulation: rules, declaration of compliance and symbol

TUESDAY, 10 NOVEMBER 2026

Regulation 1935/2004, plastics and the 10 mg/dm² limit, declaration of compliance, the glass and fork symbol, checks on Chinese melamine and the bisphenol A ban: the guide for importers of articles meant for food, with an example on 4,000 lunch boxes.

The food contact materials regulation covers every object meant to touch food and drink: water bottles, mugs, cutlery, containers, films and wrapping paper. Anyone importing them into the EU must show that they do not release harmful substances into food, with a written declaration of compliance, correct labelling and a traceability system.

For companies selling promotional items or housewares made in Asia this is an everyday matter: a branded water bottle or a set of lunch boxes is a food contact material in every sense, and the importer established in the Union can become responsible for its compliance. This guide sets out the European and Italian rules, the specific checks on goods from China and a worked example with figures.

Food contact materials regulation: what it covers and the rule that applies to all

The definition comes from Regulation (EC) 1935/2004, the European framework regulation. It covers materials and articles intended to come into contact with food, including water: plates, glasses, pans, bottles, kitchen utensils, packaging and labels that touch the product.

The basic rule is Article 3. Materials must be manufactured in line with good manufacturing practice 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 spoil its taste and smell. The same article bans labelling or advertising that misleads consumers.

The rules to know: from the framework regulation to material-specific measures

Regulation 1935/2004 sets the common principles; alongside it are specific measures for individual materials. The main ones for consumer goods importers are these:

• Regulation (EC) 2023/2006 on good manufacturing practice, which applies to every stage of production of food contact materials;
• Regulation (EU) 10/2011 on plastics, the most detailed measure, with the list of authorised substances and the migration limits;
• Regulation (EU) 2024/3190 on bisphenol A and other hazardous bisphenols, in force since 20 January 2025;
• Regulation (EU) 284/2011 on polyamide and melamine kitchenware originating in or consigned from China and Hong Kong;
• in Italy, the ministerial decree of 21 March 1973 and Presidential Decree 777/1982 for national rules, and Legislative Decree 29/2017 for penalties.

For materials with no specific European measure, such as many metals, glass or paper, national rules still apply, and in Italy the reference is the 1973 decree with its updates. That is why, before ordering, it is worth asking the supplier what each part that touches food is made of, gaskets and lids included.

Plastics: overall migration and specific limits

For plastics, Regulation 10/2011 sets two kinds of limit, checked with laboratory tests on food simulants, liquids that mimic the behaviour of aqueous, acidic, alcoholic or fatty foods.

The overall migration limit is 10 milligrams of released substances per square decimetre of contact surface. For articles intended for food for infants and young children the limit is 60 milligrams per kilo of simulant. Specific migration limits apply instead to the individual substances listed in Annex I of the regulation; for those without their own limit a generic value of 60 milligrams per kilo of food applies.

There is also a less known constraint: only substances on the Union list may be used as additives and fillers. That is why plastic tableware with bamboo powder is illegal. Ground bamboo is not on the list, and in 2021 the European Commission and Member States launched an enforcement plan after numerous alerts in the RASFF system; at the end of that year the Italian Ministry of Health declared these articles illegal, as the bamboo powder is mixed with melamine-formaldehyde resins. Natural bamboo objects without resin are a different matter.

The declaration of compliance: who signs it and what it must contain

Article 16 of Regulation 1935/2004 requires materials covered by specific measures to come with a written declaration of compliance with the applicable rules, backed by documentation to be shown to the authorities on request. For plastics, Article 15 of Regulation 10/2011 makes it mandatory at all marketing stages other than retail, with the content set out in Annex IV, and requires it to be renewed when changes in composition or production alter migration.

In Italy, the Ministry of Health note of 11 October 2011 clarifies a decisive point for importers: the declaration normally comes from the manufacturer, but for imported products it can also be issued by the importer established in the Union, which then becomes responsible for compliance and must hold the supporting documentation. In practice, a declaration from a Chinese supplier without recent laboratory test reports, covering that material and that use, does not protect the importer.

Labelling and the glass and fork symbol

Article 15 of Regulation 1935/2004 sets out what must accompany a food contact material sold empty, that is not yet in contact with food:

• the words "for food contact", or a specific indication of use such as "wine bottle", or the glass and fork symbol;
• where needed, instructions for safe use, for example "not suitable for microwave" or "dry food only";
• name and address of the manufacturer, processor or seller responsible, established in the Union;
• identification ensuring traceability, such as a batch or order code.

The wording is not required for articles that by their nature are clearly meant for food, such as a fork. The information must be conspicuous, legible and indelible, and at retail it must be in a language easily understood by buyers: in Italy, Italian. Article 17 completes the picture: every operator must know who supplied the materials and to whom they were supplied, and show it to the authorities on request.

Melamine and polyamide kitchenware from China: border checks

For two materials widely used in kitchen items and promotional gadgets, imports from China and Hong Kong follow their own rules, set by Regulation (EU) 284/2011 after cases of primary aromatic amines released by polyamide and formaldehyde released by melamine. Each consignment is subject to these obligations:

• a declaration for each consignment, backed by a laboratory report, confirming compliance with the limits on primary aromatic amines and formaldehyde;
• for formaldehyde from melamine, a maximum release of 15 milligrams per kilo of food or simulant;
• notification to the authority at the point of entry at least two working days before the consignment arrives;
• documentary checks on all consignments within two working days of arrival and laboratory analysis of 10% of consignments, chosen unpredictably.

If the analysis finds non-compliance, the authority immediately informs the Commission through the RASFF alert system. For importers of spatulas, ladles, plates or bowls in these materials, the check must be built into delivery times: the goods can move on only with the authority's approval and stay under its control until the test results are in.

Bisphenol A: the ban in force since 2025

Regulation (EU) 2024/3190, adopted by the Commission on 19 December 2024, has banned since 20 January 2025 the use of bisphenol A and other hazardous bisphenols in many food contact materials: plastics, varnishes and coatings, printing inks, adhesives, rubbers, silicones and ion-exchange resins. It therefore also covers reusable bottles, water coolers and kitchen utensils, not just cans.

The general transition period ended on 20 July 2026: until then, articles compliant with the previous rules could still be placed on the market, while longer deadlines remain for some special cases, such as certain single-use packaging and professional equipment. For an order of polycarbonate bottles or containers with internal coatings, the declaration of compliance must now take the new ban into account.

In Italy: notifying establishments and penalties

Legislative Decree 29/2017 makes the European rules on food contact materials enforceable in Italy. Article 6 requires operators to notify the competent local health authority of the establishments where they carry out the activities governed by the good manufacturing practice regulation; it is worth checking with the local health authority whether the company's import and storage activity falls under the obligation.

Penalties are administrative and rise with the seriousness of the breach. The highest, up to 80,000 euros, applies to anyone who produces, places on the market or uses materials that release substances into food in quantities that endanger human health. Beyond the fine, a non-compliant consignment usually means withdrawal or blocking of the goods, often at a cost higher than the penalty.

A worked example: 4,000 melamine lunch boxes

The example is hypothetical, with rounded figures. An Italian promotional goods company orders 4,000 branded melamine lunch boxes in China at 2.10 euros each, for 8,400 euros of goods. Before shipment it has an accredited laboratory run overall migration and formaldehyde release tests, at a hypothetical cost of 900 euros: about 0.23 euros per piece, 10.7% of the value of the goods.

With the test report in hand, the importer fills in the declaration required by Regulation 284/2011, notifies the port of the arrival at least two working days in advance, prepares the declaration of compliance for its own customers and prints on the box the glass and fork symbol, the company address and the batch code. If the consignment fell within the 10% selected for analysis, delivery would take longer, but documentation prepared in advance reduces the risk of the 4,000 lunch boxes being held. Without prior testing, a result above 15 milligrams per kilo of formaldehyde would mean losing the whole order.

Food contact materials in brief: the pre-order checklist

Before confirming an order of articles intended for food, it is worth checking these points:

• the material of every part in contact with food and, for plastics, that additives and fillers are on the Union list, with no bamboo powder;
• recent test reports with overall migration within 10 milligrams per square decimetre and the specific limits for the substances used;
• the absence of bisphenol A and of the other bisphenols banned since 20 January 2025;
• for melamine and polyamide from China, the declaration per consignment, the laboratory report and notification two working days before arrival;
• a label in the local language with symbol or wording, instructions for use, the address of the party responsible in the Union and a batch code.

With La Merce, an order of water bottles or lunch boxes starts with migration test reports requested from the supplier before production, so the declaration of compliance and the notification required for Chinese melamine are ready before the goods reach port.

Let's talk about your productprojectconceptgoalbrandproductprojectconceptgoalbrandproductprojectconceptgoalbrandproduct