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 Latest Amendments: 

Commission Regulation (EU) 2024/3190 came into force on 20 January 2025 outlining new requirements on the use of bisphenol A (BPA) and other bisphenols and bisphenol derivatives in plastic FCM as well as coatings and varnishes. The Regulation (EU) 2024/3190 amends regulation (EU) 10/2011 and repeals Regulation (EU) 2018/213. 

Depending on the type of food contact article, products compliant with the previous legislation could continue to be placed on the EU market until 20 July 2026 or, for certain applications such as specific metal packaging and professional food production equipment, until 20 January 2028. In addition, certain single-use articles placed on the market during the transition period may continue to be filled and sealed with food for a further 12 months, and packaged foods may remain on the market until stocks are exhausted. 

Commission Regulation (EU) 2025/351 came into force on 16 March 2025, amending regulations (EU) 10/2011 on plastic Food Contact Materials (FCM), (EU) 2022/1616 on recycled plastic FCM, and (EC) 2023/2006 on Good Manufacturing Practice. The main updates concerning plastic materials and the (EU) 10/2011 are the requirements of high degree of purity, the use of reprocessed plastic and labelling of repeat use articles, to mention a few. 

From 16 September 2026, plastic materials and articles in all stages of the supply chain first placed on the market must comply with the (EU) 10/2011 as amended with the (EU) 2025/351.  

Amending regulations (EU) 2026/245 and (EU) 2026/1380 concern inclusion of newly authorized substances to the Annex I of the regulation (EU) 10/2011 and language correction, respectively. 

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, or bound by adhesives 

• 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 or II of the Regulation may be intentionally used in the manufacture of plastic materials and articles 

• Purity requirements for substances used in manufacture of plastic materials 

• 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 with specific rules for repeat-use articles 

• Risk Assessment Requirements - Assessment of Non-Intentionally Added Substances (NIAS) and their risk, by the manufacturer of plastic food contact materials and articles. 

Our services include: 

• Compliance reviews of supplier documentation (DoCs, etc.) 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 

• Verification of high purity degree of Food Contact Substance 

• Support on developing appropriate documentation and a DoC for food contact materials 

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.