Plastic food contact materials

Draft Commission Regulation amending Regulation (EU) No 10/2011 on plastic materials and articles intended to come into contact with food and amending Regulation (EC) No 2023/2006 on good manufacturing practice for materials and articles intended to come into contact with food as regards recycled plastic and other matters related to quality control and manufacturing of plastic materials and articles intended to come into contact with food.

Draft Annex

Update

The European Commission has published a draft proposal that aims to increase quality control of plastic food contact materials. In particular, it aims to align existing rules on these materials (Regulation 10/2011) with legislation on recycled plastics (Regulation 2022/1616) and biocidal products (Regulation 528/2012). It introduces purity requirements for substances obtained from waste and natural materials, and adds quality control rules on good manufacturing practice.

What is changing?

Regulation 10/2011 sets requirements for plastic materials intended to come into contact with foods. The changes proposed by the Commission include the following.

Reinforcing purity requirements

• High degree of purity: substances used to manufacture plastic materials must be of a “high degree of purity”. The proposal defines “high degree of purity” (new Art. 3a).
• Purity of substances from waste: substances that are manufactured from waste and used to produce plastic materials will also have to comply with purity requirements (new Art. 8).
• Substances of natural origin: specific rules on purity are introduced for substances from biological and mineral sources (new Art. 8).
• Demonstrating purity: documentation that is currently required to demonstrate compliance (Art. 16) must in the future also demonstrate compliance with purity criteria. Competent authorities must be able to take samples of materials to verify purity and composition (new Art. 8).

Increasing information for food businesses

• Currently, manufacturers must provide a written declaration of compliance containing information on substances for which restrictions/specifications are set out in Annexes I and II of Regulation 10/2011. The proposed new rules extend information requirements to include all substances, impurities, and products present in plastic materials. Manufacturers must also give information on the maximum lifespan of plastic materials, and whether those materials have been manufactured from waste materials.
• New labelling rules will require manufacturers of plastic materials to include labelling or instructions on the maximum lifespan, a description of signs of deterioration, instructions on how to slow down deterioration, and instructions on use (new Art. 14a).

Other amendments

• Reprocessed plastic: conditions are set for the use of reprocessed plastic in plastic materials, including migration limits and prohibited constituents (new Art. 10).
• Biocidal products: in addition to those substances authorised for use in plastic materials (Annex I), Regulation 10/2011 currently refers to possible temporary use of other substances (Art. 6(5)). This will be replaced with the possibility to incorporate products with a biocidal function, provided the substances and products are authorised under Regulation 528/2012 for use in plastic food contact materials.
• Migration limits: these limits do not currently apply to plastic layers in multi-layer materials. According to the new proposal, migration limits will apply to these materials where the layer in direct contact with food is a plastic layer (new Art. 14 (4)).
• Good manufacturing practices (GMP): detailed rules are established on GMP for reprocessing and recycling plastics (amendment to Regulation 2023/2006).
• Clarification on plastic layers: Regulation 10/2011 currently refers to “plastic layers”, which has created confusion about whether compositional requirements (Chapter II) also apply to non-plastic layers (adhesives, printing inks, varnishes, and coatings). To clarify that Chapter II does not apply to non-plastic layers, the reference to “plastic layers” is deleted in that Chapter of the new Regulation. The term is still used (in Chapter III) to distinguish between plastic and non-plastic layers in multi-layer materials.
• Clarification of additives: there is sometimes uncertainty about whether solid materials added to plastics should be considered “additives”. The definition of additives will be amended to include these materials (Art. 3).

Why?

The EU aims to reduce risks to consumers associated with substances passing from plastic materials into foods, especially taking into account the increased production of plastic from reprocessed plastics and waste.

Timeline

The new Regulation is expected to enter into force at approximately the end of 2024.

A transition period is foreseen: plastic materials must be in compliance with the new rules 18 months after the Regulation enters into force (approximately mid-2026).

What are the major implications for exporting countries?

Under the proposed rules, manufacturers of food contact materials will have to review whether all substances used in plastic materials, including substances manufactured from waste and substances of natural origin, meet the high degree of purity required by the new Regulation. They will also have to review the information that they provide to food businesses through labelling and in their declaration of compliance.

Recommended Actions

Exporters of food products packaged in plastic should inform their packaging suppliers of upcoming changes to rules on plastic food contact materials.

Background

Regulation 1935/2004 sets out the scope and aims of EU rules on food contact materials. There are specific rules for certain food contact materials, including plastics (Regulation 10/2011), active and intelligent materials (Regulation 450/2009), recycled plastics (Regulation 2022/1616), ceramics (Directive 84/500/EEC), and regenerated cellulose film (Directive 2007/42/EEC).

In response to growing concerns about the potential health impacts of chemicals used in food contact materials, the European Commission has launched a review of current rules (see Food contact materials: Public consultation).

Resources

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