EU Food Contact Materials

Materials and articles that can come into contact with food during its production, processing, storage, preparation, and serving are regulated as food contact materials (FCMs) in the European Union (EU). This includes direct or indirect contact. FCMs include materials that

are intended to be brought into contact with food;
are already in contact with food; or
can reasonably be brought into contact with food or transfer their constituents to the food under normal or foreseeable use.

In the EU, there is a Framework Regulation—Regulation (EC) No 1935/2004—that sets out the general principles of safety for FCMs. It constitutes safety for the consumer by demanding that that FCMs:

do not release their constituents into food at levels harmful to human health
do not alter food composition in an unacceptable way,
bring about changes in the taste, or odor (organoleptics) of the food.

The Framework Regulation has stipulated 17 groups of materials that require specific measures, however only few of these have actually been implemented EU-wide. Specific EU measures are in place for plastics, processes for recycled plastics, regenerated cellulose film, lead and cadmium in ceramics, and active and intelligent materials and articles.

In the absence of specific EU measures, member states may maintain or adopt their own national provisions on food contact materials.

The European Food Safety Authority (EFSA) evaluates the safety of substances used in FCM. Companies may either submit applications to the national competent authority of a Member State, which forwards the application to EFSA, or submit the application to the EFSA directly. The EFSA also evaluates the safety of the substances continuously and will, when necessary, restrict the use of substances.

A requirement in the Framework Regulation is that food contact materials are produced according to good manufacturing practices (GMP). The GMP Regulation, (EC) 2023/2006, establishes good manufacturing practices for FCMs. Good manufacturing rules apply to all points in the manufacturing chain of food contact materials. The rules are intended to ensure that manufacturing processes are well controlled so that the specifications for FCMs remain in conformity with applicable requirements.

The safety of Food Contact Materials is evaluated by the business operators placing them on the market, and monitored continuously by the competent authorities of the Member States. The European Reference Laboratory for Food Contact Materials (EURL-FCM) maintains scientific knowledge and technical competence on testing methods.

In the EU, information about the composition of FCM materials needs to be communicated through the supply chain via a Declaration of Compliance (DoC). The declarations are intended to provide traceability and transparency throughout the supply chain. The final responsibility lies with the business operator placing the FCM/Packaging on the market. The business operator will use the Declarations to validate the safety of the FCM. Specific DoC requirements exist for plastics, recycled plastics, ceramics, and active and intelligent materials.

The materials available and information provided at the Avery Dennison ADvantage: Complete Compliance site are for informational purposes only and not for the purpose of providing legal advice.

Plastics

Regulation (EU) No 10/2011 addresses FCMs that are plastic materials and articles. It sets out rules on the composition of plastic FCMs, and establishes a list of substances (the Union list) that are permitted for use in the manufacture of plastic FCMs. The Plastics Regulation specifies restrictions on the use of the FCMs and sets out rules to determine the compliance of plastic materials and articles.

Basic requirements of the Plastics Regulation include:

Compositional requirements. Only substances that are authorized (on the Union List) may be intentionally used in the manufacture of plastic materials and articles.
Specific and overall migration limits, and rules for migration testing.
Specific provisions for plastic multi-layer materials and articles and for multi-material multilayers.
Declaration of Compliance (DoC) requirements. A DoC must be available at all market stages other than the retail stage. Supporting documents need to demonstrate the statements of compliance to authorities.
Requirements to assess the risk of Non-Intentionally Added Substances (NIAS).

Plastic packaging can include other substances such as inks, adhesives, and coatings. These are not included in the Union list, but must meet associated conditions if they are on the Union list.

Plastic Materials and Articles

Plastic materials and articles include the following types of products:

plastic intermediate materials (e.g. resins and films for further conversion) and those which already have their final composition, but still require mechanical re-shaping to reach their final article shape, without any modification of the formulation (e.g. thermo-formable sheets and bottle pre-forms);
final plastic food contact materials or articles ready to come into contact with food (e.g. packaging material, food storage container, kitchenware or utensil, and so forth);
finished plastic components of the final food contact material or article which only need to be brought together or assembled, either during packing/filling or before, to make the final article (e.g. bottle and cap, tray and lid, parts of kitchenware or food processing machinery); and
plastic layers inside a finished multi-material multi-layer.

The Plastics Regulation does not apply to:

varnished or unvarnished regenerated cellulose film, covered by Commission Directive 2007/42/EC8;
rubber;
paper and paperboard, whether modified or not by the addition of plastics;
surface coatings obtained from
- paraffin waxes, including synthetic paraffin waxes, and/or micro-crystalline waxes, or
- mixtures of the waxes listed in the previous indent with each other and/or with plastics;
ion-exchange resins; and
silicones.

Plastics manufactured with recycled plastics from mechanical recycling processes are also covered by another regulation—Regulation (EC) No 282/2008. The regulation is intended to control the recycling process for recycled plastic materials and articles intended to come into contact with foods, with the exception of those separated from food by a functional barrier layer.

The Union List

The Union list is intended to contain all substances that are functional constituents of plastic used in the EU for food contact. If a substance in the Union list is used as FCM, it is required to comply with the associated specifications and migration limits, unless it is stated explicitly that the specification or migration limit is not applicable.

The Union list contains monomers and other starting materials used to make polymers—i.e., the “building blocks” are listed, not the finished polymers. The Union list also includes additives that are intended to be present in the final material, such as emulsifiers, fillers, hardening agents, stabilizers, and so forth. It also includes polymer production aids (PPAs) such as flow control agents, pH regulators, solvents, surfactants, and so forth.

New substances can be added to the Union list, which requires submitting an application to a national competent authority, which then forwards the application to the European Food Safety Authority (EFSA). EFSA has 6 months to provide an opinion on a valid application (which may be extended for up to an additional year). Following a favorable EFSA opinion, the European Commission makes a decision on the authorization of the substance, and as appropriate prepares an amendment to the Plastics Regulation to include the substance in the Union list.

There are some types of substances for which the Union list is not complete, meaning that substances other than those listed can be used in plastics. These include certain PPAs, slats, mixtures, additives, and macromolecular structures. There are additional exceptions for substances including aids to polymerization; non-intentionally added substances; colorants; solvents; and monomers, other starting substances, and additives only used in surface coatings, epoxy resins, adhesion promoters, and printing inks.

Migration Limits

The regulation of plastics as FCMs involves migration limits, which specify the maximum amount of substances allowed to migrate to food. For the substances on the Union list, the Plastics Regulation sets out Specific Migration Limits (SML), which EFSA establishes on the basis of toxicity data of each specific substance. The overall migration to a food of all substances together may not exceed the Overall Migration Limit (OML) of 60mg/kg food, or 10 mg/dm2 of the contact material. The Plastics Regulation sets out detailed migration testing rules.

Multi-Layer Materials and Articles

Multi-layer materials and articles are composed of two or more layers. The layers can be held together by adhesives or by other means. The Plastics Regulation applies to plastic layers, even if these layers are bound together with layers of other materials to form a multi-material-multilayer. It only applies to the plastic layers themselves and not to the final article made up by layers of plastic and layers of other materials.

Plastic multi-layer materials or articles are solely made of plastic layers, which are held together by adhesives or by other means, printed or not, covered or not by a coating. The final plastic multi-layer material or article has to comply with the Specific Migration Limits (SMLs) set out for the authorized substances in the Union list. The final plastic multi-layer material or article also has to comply with the Overall Migration Limit (OML), regardless of the layer from which the constituents derive.

Multi-material multi-layer materials or articles are composed of two or more layers of different types of materials, at least one of them being a plastic layer. The final material and article does not need to comply with the SMLs and OML in the Plastics Regulation, as it is composed of different materials for which no harmonized specific measures exist yet at EU level. The plastic layers may only be composed of substances listed in the Union list. The plastic layers on their own do not have to comply with the SMLs and OML set out in the Plastics Regulation, as this migration may not be representative of the migration into food of the final material. (The plastic layers have to comply with the restrictions set out for vinyl chloride monomer as regards residual content and non-detectable migration.)

The plastic layer in direct contact with food always has to comply with the compositional requirements of the Plastics Regulation. A plastic layer behind the plastic layer in contact with food can be manufactured with additives or monomers not included in the Union list or does not need to comply with all restrictions or specifications set out in the Union list if one of the layers separating it from the food works as a functional barrier. This means that a monomer or additive not listed in the Union list can be used in the manufacture of the layer behind the functional barrier if the migration of this substance is not detectable in food with a detection limit of 0.01 mg/kg (10ppb). The functional barrier concept cannot be applied to substances that are mutagenic, carcinogenic or toxic to reproduction or to substances in nanoparticulate form.

Declaration of Compliance

In the EU, information about the composition of FCMs needs to be communicated through the supply chain. The Declaration of Compliance (DoC) is a document delivered by the supplier to the customer at marketing stages up to but excluding the retailer. It confirms to the customer the compliance of the product with the relevant requirements of the Plastics Regulation and the Framework Regulation, and it provides the customer with relevant information necessary to establish or check the compliance of the product with relevant legislation.

Each manufacturer has to declare compliance for the manufacturing steps under his responsibility, e.g., production of a monomer, production of a plastic intermediate, production of an article. The manufacturers of adhesives, printing inks and coatings should provide their customers, if using their products in plastic materials or articles or plastic intermediates, with “adequate” information that allows the manufacturer of the plastic article to issue a DoC.

Annex IV of the Plastics Regulation includes a standard format for the DoC. A DoC can only be issued on the basis of information about the product for which it is issued. This information includes all the compliance work that has been performed by the business operator issuing the DoC and is called the Supporting Documents (Article 16 of the Plastics Regulation). The Supporting Documents are generated and kept by the business operator who is issuing the DoC.

The DoC and the “adequate information” are a confirmation of the “compliance work” performed by the business operator issuing the documents. Compliance work covers a risk assessment, including the assessment of the hazard of substances added, generated or present in the material, together with its potential to migrate into the food. The compliance work necessary is dependent on the position of the business operator in the supply chain and the information that is available to the business operator.

There are also labeling requirements in the Framework Regulation. Materials and articles not yet in contact with food should be, if necessary, be accompanied with special instructions for safe and appropriate use.

The European Commission has issued a guidance document that provides details on many matters related to the DoC including:

DoC and its link to the requirements of the Framework Regulation and Good Manufacturing Practices;
Content of the DoC and “adequate information;”
Principles for what “compliance work” to share at different points in the supply chain and
Roles and obligations of different actors in the supply chain.

ROLE	GOODS	RECEIVE INFO	KEEP SUPPORTING DOCUMENTS	NEXT ACTOR	ISSUE DoC	LABELING ART. 15
Non-plastic Manufacturer	Substance	No	Yes	Manufacturer	Adequate Information	No
Non-plastic Manufacturer	Intermediate	Adequate Information	Yes	Distributor	Adequate Information	No
Plastic Manufacturer	Substance	No	Yes	Manufacturer	Yes	No
Plastic Manufacturer	Intermediate	DoC	Yes	Distributor	Yes	No
Manufacturer	Article	DoC and Adequate Information	Yes	User	Yes	Yes
				Distributor	Yes	Yes
				Retailer + distribution centers	No	Yes
				Consumer	No	Yes
Distributor	Substance	DoC	Yes	Manufacturer	Yes	No
Distributor	Intermediate	DoC	Yes	Distributor	Yes	No
Distributor	Article	DoC	Yes	User	Yes	Yes
Distributor	Article	Labeling	Yes	Retailer + distribution centers	No	Yes
Importer	Substance	Information	Yes	Manufacturer	Yes	Yes
Importer	Intermediate	Information	Yes	Distributor	Yes	Yes
Importer	Article	Information + Labeling	Yes	User	Yes	Yes
				Distributor	Yes	Yes
				Retailer + distribution centers	Yes	Yes
				Retailer + distribution centers	No	Yes
				Consumer	No	Yes
User	Article	DoC + Labeling	Yes	na	na	na
Retailer and their distribution centre	Article	Labeling	Yes	Retailer	No	Yes
Retailer and their distribution centre	Article	Labeling	Yes	Consumer	No	Yes
Consumer		Labeling

Paper and Board

Paper and board are not subject to specific EU legislation for them, but must comply with the requirements of Framework Regulation (EC) no 1935/2004, which states that materials and articles made of paper and board shall be manufactured in compliance with good manufacturing practice so that, under normal or foreseeable conditions of use, they do not transfer their constituents to food in quantities which could:

endanger human health, or
bring about an unacceptable change in the composition of the food, or
bring about a deterioration in the organoleptic characteristics of the food.

National requirements may apply and compliance needs to be demonstrated according to the national regulation of the country where the product will be placed on the market. There are national requirements in countries including but not limited to the Netherlands, France, and Italy.

There are industry guidelines available, such as the guideline from the Confederation of European Paper Industries (CEPI) Guidance for paper and board FCMs. The guidelines provide recommendations for testing and risk assessment to meet European requirements, traceability, declaration of compliance, and other issues.

Active/Intelligent

“Active materials and articles” are materials and articles that are intended to extend the shelf life or to maintain or improve the condition of packaged food. They are designed to deliberately incorporate components that would release or absorb substances into or from the packaged food or the environment surrounding the food. Examples include absorbing or scavenging materials.

“Intelligent materials and articles” are materials and articles that monitor the condition of packaged food or the environment surrounding the food. An example is a time-temperature indicator.

Suppliers of active and intelligent packaging materials on the European market need to make sure that their materials comply with the general European Framework (EC) 1935/2004 and with 450/2009 (EC), which has specific rules for active and intelligent materials and articles intended to come into contact with food. There are requirements related to composition restrictions, labeling, and the Declaration of Compliance (DoC) and supporting documentation.

Additional labeling rules apply to these materials. Non-edible parts shall be labeled with the words ‘Do not eat’ and where technically possible the relevant symbol.

Other Materials

There is a variety of other EU legislation that covers food contact materials and articles.

Regenerated cellulose film. Directive 2007/42/EC covers materials and articles made of regenerated cellulose film that is intended to come into contact with foods. Substances used to manufacture regenerated cellulose film must be on the list of approved substances. Printed surfaces may not come into contact with food stuffs.
Ceramics. Directive 84/500/EEC includes limits on lead and cadmium migration and associated test methods.
Elastomers and rubbers. Directive 93/11/EEC addresses the release of N-nitrosamines and N-nitrosatable substances from pacifiers and related artiles.
Epoxies. Regulation 1895/2005/EC restricting use of certain epoxy derivatives in materials and articles intended to come into contact with food.
Other materials. For many materials such as inks, coatings, rubbers, glass, wood, metals, textiles, and other items, there is no specific EU regulation, but Member States may adopt national regulations.

Like other FCMs, the above materials are subject to Declaration of Compliance (Doc) requirements when intended to come into contact with food.