Food Contact Materials Regulations in the European Union: An Overview

Food contact materials usually include products and packaging made to be in contact with food or beverage. This includes a wide range of consumer goods, such as baby bottles, lunch boxes, cookware, and cutlery. Naturally, there are regulations that restrict the usage of certain chemicals and heavy metals in such products.

In this guide you’ll find summaries of EU food contact material regulations, including product scope, labelling requirements, documentation requirements, testing, and more.

EU Food Contact Materials Framework Regulation (EC) 1935/2004

Food contact materials (FCM) refer to any materials and articles intended to come into contact with food. Regulation (EC) 1935/2004 sets safety principles for FCM manufactured, imported, and sold in the EU.

Covered products should not:

a. Release their constituents into food at levels harmful to human health.

b. Change food composition, taste, and odour.

c. Bring about changes in the taste or odour of the food.

Product scope

This regulation covers food contact materials and articles that:

a. Are meant to come into contact with food.

b. Are already in contact with food.

c. Are expected to come into contact with food under normal usage conditions.

The regulation does not cover:

a. Antique articles and materials.

b. Covering or coating materials as food constituents.

c. Fixed public or private water supply equipment.

Requirements

The regulation provides a general framework for FCM so that they do not harm human health or otherwise alter the food’s characteristics. It generally requires:

• Adherence to good manufacturing practice (GMP)
• Declaration of Compliance
• Traceability information
• Lab testing against restricted substances

Annex I of the regulation lists groups of articles and materials that might be covered by the specific measures laid out in Article 5. We list the adopted specific measures in the following sections of this article.

Labelling requirements

Article 15 of the regulation covers labelling requirements for FCM.

Importers and manufacturers are required to sufficiently label their FCM to ensure the products’ traceability. This includes the following information:

• Company name or trade name
• Company address or registered office
• Product identification

They are also required to provide the following information regarding FCM not yet in contact with food when placed on the market:

• The words “for food contact”, or
• A specific indication of the material’s use, or
• The FCM symbol as provided in Annex II

Note that the above information is only necessary for articles for which it is not obvious that they come into contact with food (e.g. it is not necessary for a fork, or a knife).

Additionally, they should specify special instructions for safe and proper use, if necessary.

Finally, further information (e.g. name and quantity of released substances) might be required for active FCM.

Plastic FCM Regulation (EU) 10/2011

This regulation sets documentation and substance restrictions requirements for plastic FCM.

Product scope

The regulation covers the following types of FCM:

a. Exclusively plastic FCM.

b. Plastic multi-layer FCM held together by adhesives or other means.

c. Plastic multi-layer FCM printed or covered by a coating.

d. Plastic layers or coatings forming gaskets in caps and closures.

e. Plastic layers in multi-material multi-layer FCM.

It does not cover ion exchange resins, rubber, or silicones.

Authorised substances

The regulation sets a Union List of authorised substances – found in Annex I – that manufacturers might use in their products. The Union List includes the following types of substances:

a. Monomers (or other starting substances).

b. Additives (excluding colourants).

c. Polymer production aids (excluding solvents).

d. Macromolecules procured from microbial fermentation.

Substance restrictions

The regulation specifies different types of substance restrictions.

General restrictions

Article 10 references Annex II regarding substance restrictions on plastic FCM. Below, we list a few substances from Annex II and their specific migration limits:

• Aluminium – 1 mg/kg of food
• Cadmium – 0.002 mg/kg of food
• Copper – 5 mg/kg of food

Specific migration limits

Article 11 states that plastic FCM should not exceed migration limits provided in Annex I. Here are a few substances from Annex I and their specific migration limits:

• Trialkyl acetic acid – 0.05 mg/kg of food
• Refined paraffinic waxes – 0.05 mg/kg of food
• Vinylidene fluoride – 5 mg/kg of food

Overall migration limits

Article 12 sets out the overall migration limits of plastic FCM to the following:

• 10 mg/dm2 of the food contact surface
• A total of 60 mg/kg of food simulant for infants and young children

Declaration of Compliance

Importers and manufacturers of plastic FCM should provide a Declaration of Compliance. You can find more information in Annex IV of the regulation.

Recycled Plastic FCM Regulation (EU) 2022/1616

This regulation sets requirements concerning the development, usage, and placement in the market of recycled plastic FCM.

Product scope

This regulation covers the following:

a. Plastic FCM that contains recycled plastic.

b. Recycled plastic for use in plastic FCM.

c. Plastic FCM meant for recycling.

Requirements

The regulation sets requirements for the following:

a. Recycled plastic materials and articles.

b. Documentation, instructions, and labelling.

c. Collection and pre-processing.

d. Decontamination of recycled plastic.

e. Post-processing and use of recycled plastic FCM.

f. Operation of recycling schemes.

g. Development of a novel technology for processing recycled plastic.

Declaration of Compliance

Annex III contains templates for two different Declarations of Compliance:

a. PART A – Declaration of compliance to be used by recyclers.

b. PART B – Declaration of compliance to be used by converters if the converted plastic material contains recycled plastic.

Use of Bisphenol A in Varnishes and Coatings Regulation (EU) 2018/213

This regulation is an amendment to Regulation (EU) 10/2011. It sets requirements for using Bisphenol A (BPA) in varnishes and coatings in FCM.

Product scope

The regulation covers varnishes and coatings that are:

a. Manufactured using BPA.

b. Applied to an FCM to improve its performance.

Substance restrictions

According to Article 2 of the regulation, the migration of BPA into food from coatings or varnishes must not exceed 0.05 mg/kg of food.

The regulation also forbids the migration of BPA from varnished or coated products specifically meant for young children into their food (e.g. polycarbonate infant feeding bottles).

Written Declaration

The regulation requires importers and manufacturers of coated or varnished FCM to furnish a written declaration. You can find the details in Annex I.

Ceramics Directive 84/500/EEC

This directive sets requirements for ceramic articles meant to come into contact with food items.

Product scope

The directive covers ceramic articles that may be:

• Glazed
• Enamelled
• Decorated

Substance restrictions

Article 2 of the directive specifies the substance restrictions for the migration of lead and cadmium from ceramic articles. We provide those restrictions in the table below.

Category	Ceramic articles	Lead	Cadmium
Category 1	a. Fillable articles b. Articles that cannot be filled c. Articles with an internal depth not exceeding 25 mm	0.8 mg/dm2	0.07 mg/dm2
Category 2	a. All other fillable articles	4.0 mg/litre	0.3 mg/litre
Category 3	a. Cooking ware b. Packaging and storage vessels with a capacity of more than 3 litres	1.5 mg/litre	0.1 mg/litre

Declaration of Compliance

The directive requires importers and manufacturers of ceramic articles to provide a Declaration of Compliance. You can find more information in Annex III of the directive.

Regenerated Cellulose Film Directive 2007/42/EC

This directive sets forth requirements for materials and articles made of regenerated cellulose film intended to come into contact with food.

In particular, it requires that only authorised substances should be allowed for usage in making regenerated cellulose films. Additionally, printed surfaces of regenerated cellulose film should not come into contact with foodstuffs.

Product scope

This directive covers regenerated cellulose film meant to come into contact with foodstuffs and either:

a. Is a finished product.

b. Forms part of a finished product that contains other materials.

Substance restrictions

The directive provides two lists of substances authorised for use in manufacturing regenerated cellulose film. The first concerns uncoated regenerated cellulose film, and the second covers the coated variety. You can find the details in Annex II.

Labelling requirements

Importers and manufacturers should label their FCM made of regenerated cellulose film accordingly when special usage conditions are necessary.

Written Declaration

Importers and manufacturers need to draft a written declaration only if it’s not clear whether the product is intended to come into contact with foodstuffs or not. You can find information about the written declaration in Article 16(1) of Regulation (EC) No 1935/2004.

Active and Intelligent FCM Regulation (EC) No 450/2009

This regulation sets specific requirements for active and intelligent FCMs meant to come into contact with food.

It mandates that importers and manufacturers ensure that active and intelligent FCMs are acceptable and functional for use. It also sets substance restrictions, labelling and documentation requirements

Product scope

This regulation covers active and intelligent FCM.

Substance restrictions

The regulation restricts the migration of substances from components to food to a maximum of 0.01 mg/kg.

It also claims that you may only use substances on the ‘Community list’ in components of active and intelligent FCM. However, we were unable to find any such ‘Community list’ through our research.

Labelling requirements

Importers and manufacturers should label active and intelligent non-edible FCM, and their parts, with the following:

a. The words “DO NOT EAT”; and

b. The symbol in Annex I, always and where technically feasible.

The above information must be clear, permanent, and printed in a font size of at least 3 mm.

Declaration of Compliance

Annex II of this regulation lists the information that importers and manufacturers must provide in their Declaration of Compliance.

Polyamide and Melamine Plastic Kitchenware from China or Hong Kong Regulation (EU) No 284/2011

This regulation establishes conditions and methods regarding the importation of the following products made in or delivered from China or Hong Kong:

• Polyamide kitchenware
• Melamine plastic kitchenware

It mandates that importers and manufacturers comply with substance restrictions, as well as notification and declaration requirements.

Product scope

This regulation covers polyamide and melamine plastic kitchenware that originates in, or has been consigned from, China or Hong Kong.

Substance restrictions

We list below the substance restrictions for polyamide and melamine plastic kitchenware:

a. Polyamide kitchenware – the sum of primary aromatic amines should not exceed a detection limit of 0.01 mg/kg of food or its simulants.

b. Melamine plastic kitchenware – the quantity of formaldehyde released into food or its simulants should not exceed 15 mg/kg of food.

Notification requirements

The regulation requires importers of covered products to notify the relevant authorities two days before their products from China or Hong Kong arrive in the EU.

Declaration

Businesses can import polyamide and melamine plastic kitchenware into the EU only if they provide the relevant authorities with a completed declaration confirming the products’ compliance with relevant substance restrictions.

The Annex provides a template for this declaration, which should also include a lab test report.

Epoxy Derivatives Restriction Regulation (EC) 1895/2005

This regulation establishes restrictions and prohibitions of certain epoxy derivatives. It also mandates importers and manufacturers to provide a written declaration.

Product scope

This regulation covers FCMs that contain, or are manufactured with, one or more of the following substances:

• ‘BADGE’ and some of its derivatives
• ‘BFDGE’
• ‘NOGE’

Substance restrictions

Article 2 of the regulation restricts the migration limit for the usage of BADGE in the manufacture of FCM. Articles 3 and 4 prohibit the usage of BFDGE and NOGE in the manufacture of FCM.

The regulation has specific migration limits for BADGE and its derivatives. Per Annex I, we list some examples below.

The total migration limit of the following substances must not exceed 9 mg/kg in food or its simulants:

• BADGE [= 2,2-bis(4-hydroxyphenyl)propane bis(2,3-epoxypropyl) ether]
• BADGE.H2O
• BADGE.2H2O

The total migration limit of the following substances must not exceed 1 mg/kg in food or its simulants:

• BADGE.HCl
• BADGE.2HCl
• BADGE.H2O.HCl

Written Declaration

Importers and manufacturers should provide a written declaration with their FCM. You can find more information in Article 5 of the regulation.

Teats and Soothers Directive (93/11/EEC)

This directive restricts the release of N-nitrosamines and N-nitrosatable substances in teats and soothers.

Product scope

This regulation covers the following products:

• Elastomer or rubber teats
• Elastomer or rubber soothers

Substance restrictions

Per Article 2 of the regulation, teats and soothers must not be capable of transferring N-nitrosamine and N-nitrosatable substances to the release-test liquid specified in Annex I:

a. The total release of N-nitrosamines should not exceed 0.01 mg/kg of the parts of the elastomer or rubber teats or soothers.

b. The total release of N-nitrosatable substances should not exceed 0.1 mg/kg of the parts of the elastomer or rubber teats or soothers.

Single-Use Plastics Directive (EU) 2019/904

This directive aims to prevent and reduce the impact of single-use plastics on human health and the environment (inclusive of the aquatic environment).

It mandates that importers and manufacturers comply with product restrictions, marking, and EPR requirements.

Product scope

This directive covers products such as the following:

a. Products made from oxo-degradable plastic.

b. Fishing gear containing plastic.

c. Single-use plastic products listed in the Annex.

Importers and manufacturers should note that in case of conflict with the Packaging and Packaging Waste Directive or the Waste Framework Directive, the requirements of this directive should prevail.

Product restriction requirements

Importers and manufacturers should not place on the market oxo-degradable plastic products, as well as single-use plastic products listed in Part B of the Annex. We list a few examples of such products below:

• Beverage stirrers
• Straws
• Expanded polystyrene cups

Importers and manufacturers should also adhere to the requirements set out in Article 6, and ensure that:

a. Plastic caps and lids remain attached to single-use plastic products listed in Part C of the Annex before placement on the market.

b. Beverage bottles listed in Part F of the Annex contain at least 25% recycled plastic from 2025, and 30% recycled plastic from 2030, onwards.

Extended Product Responsibility (EPR)

The directive mandates that importers and manufacturers of single-use products listed in Parts E of the Annex must comply with the extended producer responsibility (EPR) requirements set by the Packaging and Packaging Waste Directive.

Marking requirements

Article 7 of the directive requires importers and manufacturers to ensure that single-use plastic products listed in Part D of the Annex carry an obvious, readable, and permanent marking on the product or its packaging. Here are a few examples of single-use plastic products:

• Beverage cups
• Pre-wetted personal care wipes
• Sanitary towels (pads)

Annexes I to IV of Regulation (EU) 2020/2151 provide the specifications for the above-mentioned markings. These product-specific markings should inform consumers of the following:

a. Proper waste management options.

b. Improper means of waste disposal to avoid.

c. The presence of plastics in the product.

d. The negative impact of littering or other unacceptable means of waste disposal.

Good Manufacturing Practice for FCM Regulation (EC) No 2023/2006

This regulation requires manufacturers to implement a sound and approved system during the manufacturing process of products.

While the regulation applies to the manufacture, processing, and distribution of FCM, it does not apply to manufacturing starting substances.

Product scope

The regulation covers articles and FCM listed in Annex I of Regulation 1935/2004, such as the following:

• Adhesives
• Ceramics
• Glass
• Plastics
• Regenerated cellulose

Requirements

Article 4 requires that manufacturers carry out their operations per the general rules regarding:

• Quality assurance
• Quality control
• Documentation

Manufacturers should also adhere to the detailed rules on GMP in the Annex.

Specifically, Part B of the Annex requires manufacturers to ensure that their quality system documentation includes a test report outlining items such as the following:

• Analytical protocols
• Scientific evidence
• Test equipment used

Substance restrictions

Per Part A of the Annex, manufacturers should ensure that the process of applying printing inks to the non-food contact side of the FCM does not result in the substances from the printed side migrating to the food-contact side.

They should also ensure that the concentration of printed inks does not result in a violation of the requirements set out in Article 3 of Regulation (EC) 1935/2004.

Guidance Documents and Resolutions

Guidance and other relevant documents might be helpful when it comes to applying the requirements of the regulations (e.g. ensuring that a product doesn’t contain restricted substances above the allowed limits).

For example, in our experience, in certain cases lab testing is carried out based on resolutions and guidance documents. This can happen especially when regulations are more open-ended, or when a standard or substance restriction does not exist for a specific food contact material.

Multi-language versions of brochures and guidance documents

On this page, the European Commission lists several brochures and guidance documents, providing versions in multiple languages such as English, German, French, and more. Here we list the titles of the documents in English language:

a. Brochure “Food Contact Materials”.

b. Union Guidelines on Regulation (EU) No 10/2011 on plastic materials and articles intended to come into contact with food.

c. Declaration to be provided for every consignment of polyamide and melamine plastic kitchenware originating in or consigned from People’s Republic of China and Hong Kong Special Administrative Region, China.

Food contact materials technical guidance documents

The European Union Reference Laboratory for Food Contact Materials (EURL-FCM), which aims at providing assistance to the EU and its member states, lists several FCM technical guidance documents on this page.

Here is a list of the documents that you can find on the above-mentioned page:

a. Testing conditions for kitchenware articles in contact with foodstuffs: Plastics, Metals, Silicone and Rubber.

b. Roundtable Workshop on the Determination of MOAH in Infant Formula (Summary and Minutes).

c. Guidance on sampling, analysis and data reporting for the monitoring of mineral oil hydrocarbons in food and food contact materials.

d. Guidance on characterisation of the composition of plastic multi-layers.

e. Task force on migration modelling (Guidelines, List of substances).

f. Guideline on testing migration of primary aromatic amines from polyamide utensils and for formaldehyde from melamine-based kitchenware in support of Regulation (EU) No 284/2011 on imports from China and Hong-Kong.

g. Calculator for the correction of the experimental specific migration for comparison with the legislative limit.

h. Guidelines on test conditions for kitchenware.

i. Guidelines to evaluate method performance and conduct validation studies of analytical methods for FCM.

Resolution ResAP(2004)5 on silicones used for food contact applications

The Committee of Ministers from the Council of Europe put forth principles in “Resolution ResAP(2004)5 on silicones used for food contact applications”. This includes:

a. Using a certified Quality Assurance System (e.g. ISO 9002).

b. Conduct migration testing according to specific directives (e.g. Directive 97/48/EEC).

c. Provide appropriate labelling.

The Committee recommends EU member states to take these principles into account in their laws and regulations regarding the usage of silicones in food contact applications.

National European FCM Regulations

Several European countries implement domestic FCM regulations. Below, we provide some examples.

LFGB (Germany)

The LFGB is the German abbreviation for the German Food and Feed Code, which is considered the most important food safety management act in Germany. It regulates safety standards for food and food-related products in the country.

Foodstuffs and food-related products are required to pass the corresponding tests and be compliant with the LFGB to be put in the German market.

Generally speaking, the LFGB is considered to be stricter than other EU FCM regulations. It regulates a wide range of substances and materials, such as the following:

• Polymers
• Silicon
• Paper

You can find a comprehensive list of LFGB-restricted substances on this page.

DGCCRF (France)

DGCCRF is the French abbreviation for the French General Directorate for Competition Policy, Consumer Affairs, and Fraud Control, which regulates and controls products within the French market at many levels, including production, import, and distribution. One of DGCCRF’s main focuses is regulating foodstuffs and food-related products.

The DGCCRF sets requirements for FCM made from materials such as the following:

• Metal
• Ceramic
• Plastic
• Paper
• Wood
• Glass
• Organic materials made from synthetic fibres
• Organic materials made from plant fibres

It restricts the usage of the following substances in most articles:

• Aluminium
• Cobalt
• Arsenic

FCM lab testing

Importers and manufacturers should have their products tested, and receive a test report, to prove compliance with FCM regulations requirements (e.g. substance restrictions and migration limits).

Also, different regulations and EN standards might apply to different materials and products such as paper and board, plastics, or active and intelligent materials.

Test methods

Here are some examples of test methods relevant to FCM:

a. Overall migration tests (e.g.EN 1186-1).

b. Lead and cadmium migration tests for ceramic FCM (Directive 84/500/EEC).

c. Plastic constituent and colouring migration tests for regenerated cellulose film (Directive 2007/42/EC).

Lab testing companies

Below, we list a few companies that offer FCM testing against EU regulations and relevant testing methods:

• Eurofins
• Intertek
• SGS
• Bureau Veritas

Compliance Risks

Food contact products and materials manufactured outside the EU are not exclusively made to comply with European Union FCM regulations. Here are some compliance risk scenarios:

a. Plastic lunch boxes containing excessive amounts of BPA.

b. Wooden coatings or paints containing phthalates.

c. Bamboo melamine composites contain excessive amounts of toxic chemicals.

d. Stainless steel drink bottles containing excessive amounts of lead and cadmium.

Importing non-compliant food contact materials can result in fines and a forced recall. It’s therefore essential to only work with suppliers having a certain degree of ‘substance control’ – meaning that they can procure or produce compliant materials. This cannot be taken for granted when sourcing products in China, Vietnam, and elsewhere in Asia.

The only way to assess a supplier’s capability to produce compliant FCM products is by assessing their existing compliance track record. In other words, do they have some existing EU FCM test reports proving that they have made compliant products in the past? If not, then they are less likely to have the capability to manufacture a compliant product.

That said, third-party lab testing is ultimately required when importing and selling food contact products in the EU. You cannot use existing test reports provided by the supplier to prove that your imported product is compliant.