Food Contact Plastics Regulation (EU) 10/2011 Solutions

Regulation (EU) 10/2011 sets out safety requirements for plastic materials and articles intended to come into contact with food. This regulation is a specific measure for plastic food contact materials as mentioned in the European Framework Regulation (EU) 1935/2004.

Regulation (EU) 10/2011 replaced Directive 2002/72/EC and its amendments, the Vinyl Chloride Monomer Directive and the specific directives for migration testing.

Regulation (EU) 10/2011 Latest Amendment:

On 02 September 2020, the European Union (EU) published an amendment to the Food Contact Plastics Regulation EU 10/2011. The amendment (EU 2020/1245) came into force on 23 September 2020. Plastic materials and articles placed on the market for the first time before 23 March 2021, can continue to be placed and remain on the market until 23 September 2022 until stocks are depleted. After this date, business operators must comply with the requirements set out in the new amendment.

Regulation 10/2011 Applies To:

• Materials and articles and parts thereof, consisting exclusively of plastics
• Plastic multi-layer materials and articles held together by adhesives
• Materials that can be printed or covered by a coating
• Plastic layers or plastic coatings, forming gaskets in caps and closures
• Plastic layers in multi-material and multi-layer materials and articles  

Key Regulation Inclusions & Requirements:

• Compositional requirements - Only authorised substances that are positive-listed in Annex I of the Regulation may be intentionally used in the manufacture of plastic materials and articles
• Specific provisions for several categories of plastic materials - Caps and closures and multi-layer plastic materials or multi-material multilayers
• Declaration of Compliance (DoC) – A DoC is required at all stages of production and marketing (excluding the retail stage) and it needs to be supported by appropriate underlying documentation.
• Testing requirements - Requirements for testing of overall and specific migration, including comprehensive guidance on selecting simulants and conditions for testing
• Risk Assessment Requirements - Assessment of Non-Intentionally Added Substances (NIAS) and their risk, by the manufacturer of plastic food contact materials and articles.

How Can Intertek Help?

It can be challenging for companies developing and manufacturing plastic food contact materials to be aware of and understand their regulatory obligations. Intertek experts have extensive knowledge and experience with both the regulatory and technical aspects of Regulation (EU) 10/2011 and can assist with your material/product assessments to help you achieve compliance with this regulation.

Our services include:

• Compliance reviews of bill of materials (BOM) and/or material formulations
• Develop and conduct migration testing programs
• NIAS analytical and toxicological safety assessments per Article 19 of the Food Contact Plastics Regulation
• Support on developing appropriate documentation and a DoC for food contact materials
• Provide a technical review of testing strategies to identify and mitigate risk

For substances that are not yet authorised for use in plastic food contact materials, we offer services to support a petition to the European Food Safety Authority (EFSA) for evaluation of a substance to be added to the positive list of Regulation (EU) 10/2011.