legislation-profile

Plastic Materials and Articles Regulation

Commission Regulation (EU) No 10/2011 of 14 January 2011 on plastic materials and articles intended to come into contact with food (Text with EEA relevance)

Scope

This Regulation is a specific measure within the meaning of Article 5 of Regulation 1935/2004. It establishes specific requirements for the manufacture and marketing of plastic materials and articles: (a) intended to come into contact with food; or (b) already in contact with food; or (c ) which can reasonably be expected to come into contact with food. This regulation shall apply to materials and articles which are placed on the EU market and fall under the following categories: (a) materials and articles and parts thereof consisting exclusively of plastics; (b) plastic multi-layer materials and articles held together by adhesives of by other means; (c) materials and articles referred to in points a) and/or b) that are printed and/or covered by a coating; (d) plastic layers or plastic coatings, forming gaskets in caps and closures, that together with those caps and closures compose a set of two or more layers of different types of materials; (e) plastic layers in multi-material multi-layer materials and articles. This regulation shall be without prejudice to the EU or national provisions applicable to printing inks, adhesives or coatings.

Exemptions

This regulation shall not apply to the following materials and articles: (a) ion exchange resins (b) rubber (c) silicones

Regulatory activities

Yes, declaration of compliance

Relevant product types

Yes

Reference documents

No

Obligations based on CLP hazard class

No

Obligations based on properties of concerns

No

EU-level occupational exposure limits

No

EU-level emission limit values

No provision

Substance-centric data source(s) at the EU level

No

Industry submission system in place

No

Format for industry submission

No

Owner

DG SANTE; EFSA

Update process

DG SANTE; EFSA

Amendments

Commission Implementing Regulation (EU) No 321/2011 of 1 April 2011 amending Regulation (EU) No 10/2011 as regards the restriction of use of Bisphenol A in plastic infant feeding bottles Commission Regulation (EU) No 1282/2011 of 28 November 2011 amending and correcting Commission Regulation (EU) No 10/2011 on plastic materials and articles intended to come into contact with food Commission Regulation (EU) No 1183/2012 of 30 November 2012 amending and correcting Regulation (EU) No 10/2011 on plastic materials and articles intended to come into contact with food Corrigendum to Commission Regulation (EU) No 1183/2012 of 30 November 2012 amending and correcting Regulation (EU) No 10/2011 on plastic materials and articles intended to come into contact with food Commission Regulation (EU) No 202/2014 of 3 March 2014 amending Regulation (EU) No 10/2011 on plastic materials and articles intended to come into contact with food Commission Regulation (EU) No 865/2014 of 8 August 2014 correcting the Spanish version of Regulation (EU) No 10/2011 on plastic materials and articles intended to come into contact with food Commission Regulation (EU) 2015/174 of 5 February 2015 amending and correcting Regulation (EU) No 10/2011 on plastic materials and articles intended to come into contact with food Commission Regulation (EU) 2016/1416 of 24 August 2016 amending and correcting Regulation (EU) No 10/2011 on plastic materials and articles intended to come into contact with food Commission Regulation (EU) 2017/752 of 28 April 2017 amending and correcting Regulation (EU) No 10/2011 on plastic materials and articles intended to come into contact with food Commission Regulation (EU) 2018/79 of 18 January 2018 amending Regulation (EU) No 10/2011 on plastic materials and articles intended to come into contact with food Commission Regulation (EU) 2018/213 of 12 February 2018 on the use of bisphenol A in varnishes and coatings intended to come into contact with food and amending Regulation (EU) No 10/2011 as regards the use of that substance in plastic food contact materials Commission Regulation (EU) 2018/831 of 5 June 2018 amending Regulation (EU) No 10/2011 on plastic materials and articles intended to come into contact with food Commission Regulation (EU) 2019/37 of 10 January 2019 amending and correcting Regulation (EU) No 10/2011 on plastic materials and articles intended to come into contact with food Commission Regulation (EU) 2019/988 of 17 June 2019 correcting the French language version of Regulation (EU) No 10/2011 on plastic materials and articles intended to come into contact with food Commission Regulation (EU) 2019/1338 of 8 August 2019 amending Regulation (EU) No 10/2011 on plastic materials and articles intended to come into contact with food Commission Regulation (EU) 2020/1245 of 2 September 2020 amending and correcting Regulation (EU) No 10/2011 on plastic materials and articles intended to come into contact with food Commission Regulation (EU) 2023/1442 of 11 July 2023 amending Annex I to Regulation (EU) No 10/2011 on plastic materials and articles intended to come into contact with food, as regards changes to substance authorisations and addition of new substances Commission Regulation (EU) 2023/1627 of 10 August 2023 amending Annex I to Regulation (EU) No 10/2011 as regards the authorisation of the substance bis(2-ethylhexyl)cyclohexane-1,4-dicarboxylate (FCM No 1079)