EU legislation on Food Contacts with Plastic Materials
Plastic Materials
The main EU-specific measure on plastic food contact materials is Commission Regulation (EU) No 10/2011. It lays down rules on the composition of plastic food contact materials and establishes a Union List of substances authorised for use in their manufacture. The Regulation also sets restrictions on those substances and defines the compliance requirements for plastic materials and articles intended to come into contact with food. (EUR-Lex)
As the Regulation is amended regularly, the consolidated version of Regulation (EU) No 10/2011 is useful for reference, but it is not legally binding in itself and may not yet reflect the very latest amendments. (EUR-Lex)
A key safety mechanism is the use of migration limits, which define the maximum amount of substances permitted to migrate from the plastic into food. For substances on the Union List, the Regulation sets Specific Migration Limits (SMLs), established on the basis of toxicological assessment. In addition, the total migration of all substances together must not exceed the Overall Migration Limit (OML) of 60 mg/kg of food or 10 mg/dm² of contact material. (EUR-Lex)
The Regulation also sets detailed migration testing rules. Although testing in actual food prevails, migration is normally assessed using food simulants that represent categories of food, under standardised time and temperature conditions corresponding to the intended use and maximum shelf life of the packaged product. (EUR-Lex)
To ensure safety, quality and traceability across the supply chain, businesses must communicate adequate composition data through the manufacturing chain by means of a Declaration of Compliance (DoC). This declaration must be supported by documentation showing why the plastic food contact material is safe and compliant, and that documentation must be made available to enforcement authorities on request. This requirement also links to the manufacturer’s obligations under Commission Regulation (EC) No 2023/2006 on good manufacturing practice. (EUR-Lex)
Recent and relevant amendments to Regulation (EU) No 10/2011
The most recent amendments include:
Other important amending acts include:
Commission Regulation (EU) 2023/1627, Commission Regulation (EU) 2023/1442, Commission Regulation (EU) 2020/1245, Commission Regulation (EU) 2019/37, Commission Regulation (EU) 2019/1338, Commission Regulation (EU) 2018/831, Commission Regulation (EU) 2018/213, Commission Regulation (EU) 2018/79, Commission Regulation (EU) 2017/752, Commission Regulation (EU) 2016/1416, Commission Regulation (EU) 2015/174, Commission Regulation (EU) 202/2014, Commission Regulation (EU) 1183/2012, Corrigendum to Regulation (EU) 1183/2012, Commission Regulation (EU) 1282/2011, and Commission Regulation (EU) 321/2011 restricting the use of BPA in plastic infant feeding bottles. (EUR-Lex)
As the Regulation is amended regularly, the consolidated version of Regulation (EU) No 10/2011 is useful for reference, but it is not legally binding in itself and may not yet reflect the very latest amendments. (EUR-Lex)
A key safety mechanism is the use of migration limits, which define the maximum amount of substances permitted to migrate from the plastic into food. For substances on the Union List, the Regulation sets Specific Migration Limits (SMLs), established on the basis of toxicological assessment. In addition, the total migration of all substances together must not exceed the Overall Migration Limit (OML) of 60 mg/kg of food or 10 mg/dm² of contact material. (EUR-Lex)
The Regulation also sets detailed migration testing rules. Although testing in actual food prevails, migration is normally assessed using food simulants that represent categories of food, under standardised time and temperature conditions corresponding to the intended use and maximum shelf life of the packaged product. (EUR-Lex)
To ensure safety, quality and traceability across the supply chain, businesses must communicate adequate composition data through the manufacturing chain by means of a Declaration of Compliance (DoC). This declaration must be supported by documentation showing why the plastic food contact material is safe and compliant, and that documentation must be made available to enforcement authorities on request. This requirement also links to the manufacturer’s obligations under Commission Regulation (EC) No 2023/2006 on good manufacturing practice. (EUR-Lex)
Recent and relevant amendments to Regulation (EU) No 10/2011
The most recent amendments include:
- Commission Regulation (EU) 2026/245 amending Annex I as regards the authorisation or conditions of use of several substances. (EUR-Lex)
- Commission Regulation (EU) 2025/2240 on transitional measures for plastic materials and articles manufactured with salicylic acid or untreated wood flour or fibres. (EUR-Lex)
- Commission Regulation (EU) 2025/351 amending Regulations (EU) No 10/2011, (EU) 2022/1616 and (EC) No 2023/2006 on quality control and manufacturing of plastic food contact materials. (EUR-Lex)
- Commission Regulation (EU) 2024/3190 concerning the use of bisphenol A (BPA) and other bisphenols and bisphenol derivatives in certain food contact materials. (EUR-Lex)
Other important amending acts include:
Commission Regulation (EU) 2023/1627, Commission Regulation (EU) 2023/1442, Commission Regulation (EU) 2020/1245, Commission Regulation (EU) 2019/37, Commission Regulation (EU) 2019/1338, Commission Regulation (EU) 2018/831, Commission Regulation (EU) 2018/213, Commission Regulation (EU) 2018/79, Commission Regulation (EU) 2017/752, Commission Regulation (EU) 2016/1416, Commission Regulation (EU) 2015/174, Commission Regulation (EU) 202/2014, Commission Regulation (EU) 1183/2012, Corrigendum to Regulation (EU) 1183/2012, Commission Regulation (EU) 1282/2011, and Commission Regulation (EU) 321/2011 restricting the use of BPA in plastic infant feeding bottles. (EUR-Lex)