EU FCMs - legislation and rules on food contact materials
Regulation (EC) No 1935/2004 provides a harmonised legal EU framework. It sets out the general principles of safety and inertness for all Food Contact Materials (FCMs).
Regulation (EC) No 1935/2004 was amended by Regulation (EU) 2019/1381 on the transparency and sustainability of the EU risk assessment in the food chain amended with effect from 27 March 2021.
The resulting and latest consolidated version is available: Regulation (EC) No 1935/2004 (Consolidated).
The principles set out in Regulation (EC) No 1935/2004 require that materials do not:
- – Release their constituents into food at levels harmful to human health
- Change food composition, taste and odour in an unacceptable way
Moreover, the framework provides:
- for special rules on active and intelligent materials (they are by their design not inert)
- powers to enact additional EU measures for specific materials (e.g. for plastics)
- the procedure to perform safety assessments of substances used to manufacture FCMs involving the European Food Safety Authority
- rules on labelling including an indication for use (e.g. as a coffee machine, a wine bottle, or a soup spoon) or by reproducing the appropriate symbol. For more information, please refer to the following document on Symbols for labelling food contact materials.
- for compliance documentation and traceability
Regulation (EC) No 1935/2004 was amended by Regulation (EU) 2019/1381 on the transparency and sustainability of the EU risk assessment in the food chain amended with effect from 27 March 2021.
Further information on the implementation of that Regulation can be found on DG SANTE’s website.
Commission Regulation on Good Manufacturing Practices
Commission Regulation (EC) No 2023/2006 ensures that the manufacturing process is well controlled so that the specifications for FCMs remain in conformity with the legislation:
- premises fit for purpose and staff awareness of critical production stages
- documented quality assurance and quality control systems maintained at the premises, and
- selection of suitable starting materials for the manufacturing process with a view to the safety and inertness of the final articles
Good manufacturing rules apply to all stages in the manufacturing chain of food contact materials, although the production of starting materials is covered by other legislation.
In addition to the general legislation, certain FCMs — ceramic materials, regenerated cellulose film, plastics (including recycled plastic), as well as active and intelligent materials — are covered by specific EU measures.
There are also specific rules on some starting substances used to produce FCMs.
The most comprehensive specific EU measure is Commission Regulation (EU) No 10/2011 on plastic materials and articles. It sets out rules on the composition of plastic FCMs, and establishes a Union List of substances that are permitted for use in the manufacture of plastic FCMs.
The Regulation also specifies restrictions on the use of these substances and sets out rules to determine the compliance of plastic materials and articles.
This Regulation is regularly amended. The consolidated version should be considered as a tool for your convenience but may not contain all the most recent amendments:
The consolidated version however is not legally binding, and a list of specific amendments is given below.
Relation between the present Regulation and earlier Directives.
An important mechanism to ensure the safety of plastic materials is the use of migration limits. These limits specify the maximum amount of substances allowed to migrate to food. For the substances on the Union list the Regulation sets out ‘Specific Migration Limits‘ (SML).
These are established by EFSA on the basis of toxicity data of each specific substance. To ensure the overall quality of the plastic, the overall migration to a food of all substances together may not exceed the Overall Migration Limit (OML) of 60mg/kg food, or 10 mg/dm2 of the contact material.
The Regulation sets out detailed migration testing rules. Although migration testing in the food prevails, migration is usually tested using ‘simulants‘. These simulants are representative for a food category, e.g. Acetic acid 3 % (w/v) is assigned for acidic foods.
The migration testing is done under standardised time/temperature conditions, representative for a certain food use, and covers the maximum shelf life of packed food.
To ensure the safety, quality and compliance of plastic materials, adequate data on the composition of (intermediate) materials has to be communicated via the manufacturing chain, up to but not including the retail stage.
For this purpose a ‘Declaration of Compliance‘ (DoC) needs to be provided. The DoC is based on supporting documentation which documents the reasoning on the safety of a plastic food contact material, and which must be provided to enforcement Authorities on their request. The supporting documentation also provides an important link to the manufacturer’s responsibility under GMP (Commission Regulation (EC) No 2023/2006).
in support of the implementation of the general requirements of Commission Regulation (EU) 10/2011 on plastic food contact materials and articles
in support of the implementation of Commission Regulation (EU) 10/2011 on plastic food contact materials as regards the declaration of compliance
Commission Regulation (EU) 2020/1245, amending and correcting Regulation (EU) No 10/2011 on plastic materials and articles intended to come into contact with food
Commission Regulation (EU) 2019/37, amending and correcting Regulation (EU) No 10/2011 on plastic materials and articles intended to come into contact with food
Commission Regulation (EU) 2018/831, amending Regulation (EU) No 10/2011 on plastic materials and articles intended to come into contact with food
Commission Regulation (EU) 2017/752, 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, amending and correcting Regulation (EU) No 10/2011 on plastic materials and articles intended to come into contact with food
The amendments below only amend Annex I of Commission Regulation (EU) No 10/2011, thus changing the Union list of authorised substances.
Commission Regulation (EU) 2023/1627, 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)
Commission Regulation (EU) 2023/1442 – plastic materials and articles intended for contact with food amending Regulation (EU) No 10/2011
Commission Regulation (EU) 2019/1338 – plastic materials and articles intended to come into contact with food
Commission Regulation (EU) 2018/213 – 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) 2018/79 – plastic materials and articles intended for contact with food amending Regulation (EU) No 10/2011
Commission Regulation (EU) 2015/174 – plastic materials and articles intended for contact with food amending Regulation (EU) No 10/2011
Commission Regulation (EU) 202/2014 – plastic materials and articles intended for contact with food amending Regulation (EU) No 10/2011
Commission Regulation (EU) 1183/2012 – plastic materials and articles intended for contact with food amending Regulation (EU) No 10/2011
Corrigendum to Commission Regulation (EU) 1183/2012 – plastic materials and articles intended for contact with food amending Regulation (EU) No 10/2011.
Commission Regulation (EU) 1282/2011 – plastic materials and articles intended for contact with food amending Regulation (EU) No 10/2011
Commission Regulation (EU) 321/2011 – restricting Bisphenol A use in plastic infant feeding bottles
- Provisional list of additives for use in plastic food contact materials
Active and intelligent materials extend the shelf-life by maintaining or improving the condition of packaged food, by releasing or absorbing substances to or from the food or its surrounding environment.
As a result they are exempted from the general inertness rule in Regulation (EC) No 1935/2004. The specific rules in Commission Regulation (EC) No 450/2009 apply to address their specific purpose, e.g.:
- absorption of substances from food packaging interior such as liquid and oxygen
- release of substances into the food such as preservatives
- indicate expiry of food through labelling that changes colour when maximum shelf life or storage temperature is exceeded
Active materials do not include systems that absorb substances entering from the atmosphere, such as active oxygen barriers.
Commission Regulation (EC) No 450/2009 foresees the establishment of a Union list of substances permitted for the manufacture of active and intelligent materials.
- Register of substances with a valid application for authorisation (Regulation (EC) No 450/2009 – active and intelligent materials and articles)
Commission Regulation (EU) No 10/2011 sets out criteria for the composition of new plastic materials. However after these materials have been used, they do not comply anymore to the plastic Regulation, as they may have been contaminated with other substances. Therefore, a separate Regulation exists to control the recycling processes: Commission Regulation (EU) 2022/1616 on recycled plastic materials and articles intended to come into contact with foods. Further information can be found here.
- Commission Directive 84/500/EEC – approximating EU countries’ laws on ceramic articles intended to come into contact with foods
- Commission Directive 2007/42/EC – materials and articles made of regenerated cellulose film intended to come into contact with foods
Legislation on Specific Substances
- Commission Regulation (EU) 2018/213 – 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 1895/2005/EC – restricting use of certain epoxy derivatives in materials and articles intended to come into contact with food
- Commission Directive 93/11/EEC – release of N-nitrosamines and N-nitrosatable substances from rubber teats and soothers
From 1 July 2011 kitchenware made of melamine or polyamide originating or consigned from China or Hong Kong must comply with the import rules of Commission Regulation (EU) No 284/2011:
- Consignments must be notified to the competent authorities at the entry points at least 2 working days before arrival
- Consignments must have a declaration and a laboratory report on the analysis of primary aromatic amines (for polyamide) and formaldehyde (for melamine).
- Guidance
- EU guidelines for the import of polyamide and melamine kitchenware from China and Hong Kong
- Addendum to the EU Guidelines concerning kitchenware and tableware.
- Technical Guidelines concerning polyamide and melamine kitchenware including sampling and analytical methods
Other documents
- Declaration of compliance under Commission Regulation (EU) No 284/2011 – on import of polyamide and melamine plastic kitchenware from China and Hong Kong – Template
Commission Recommendation (EU) 2019/794 of 15 May 2019 set out a coordinated control plan with a view to establishing the prevalence of certain substances migrating from materials and articles intended to come into contact with food.
Controls done by the Member States took place in 2019 and 2020. Results were presented at the Expert Working Groups on Food Contact Materials; presentations are available via the document library page
In the absence of specific EU measures, EU Member State countries may maintain or adopt their own national provisions on FCMs in accordance with Article 6 of Regulation 1935/2004.
National legislation is in place in the majority of EU Member States, setting out individual rules on different materials and substances. These may differ from one Member State to another.
The European Commission’s Joint Research Centre (JRC) published a study in 2017, which comprehensively describes the situation concerning FCMs, for which there are no specific measures at EU level.
The study provides detailed information on the national measures or other measures in place for these materials at the time of the study.