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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.

 

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.
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ROLE

GOODS

RECEIVE INFO

KEEP SUPPORTING DOCUMENTS

NEXT ACTOR

ISSUE DoC

LABELING ART. 15

Non-plastic Manufacturer

Substance

No

Yes

Manufacturer

Adequate Information

No

Intermediate

Adequate Information

Yes

Distributor

Adequate Information

No

Plastic Manufacturer

Substance 

No

Yes

Manufacturer

Yes

No

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

Intermediate

DoC

Yes

Distributor

Yes

No

Distributor

Article

DoC

Yes

User

Yes

Yes

Labeling

Yes

Retailer + distribution centers

No

Yes

Importer

Substance 

Information 

Yes

Manufacturer

Yes

Yes

Intermediate

Information 

Yes

Distributor

Yes

Yes

Importer

Article

Information + Labeling 

Yes

User

Yes

Yes

Distributor

Yes

Yes

Retailer + distribution centers

Yes

Yes

No

Yes

Consumer

No

Yes

User

Article

DoC + Labeling

Yes

na

na

na

Retailer and their distribution centre

Article

Labeling 

Yes

Retailer

No

Yes

Consumer

No

Yes

Consumer

 

Labeling