EU Requirements: EU Regulation (EC) No 1935/2004 (the “EU FCM Regulation”) sets out general requirements that all Food Contact Materials sold in the EU need to comply with. Separate EU legislation sets additional requirements for specific materials in contact with food, such as Regulation (EU) No 10/2011 on plastic materials, or Directive 84/500/EEC for ceramics. If specific EU rules on materials do not exist, there might be complementary Member States’ national legislation. The EU FCM regulation needs to be applied in conjunction with Regulation (EC) No 2023/2006 on Good Manufacturing Practice (GMP), which sets general and detailed rules on applying GMP during the manufacture of Food Contact Materials.
If you sell Food Contact Materials covered by the EU FCM Regulation, you must ensure that they comply with the GMP as well as any other substance-specific requirements, such as for ceramics, regenerated cellulose film, metal, or plastics.
It is your responsibility to comply with the EU requirements if you are selling food contact materials in the EU. You must also comply with any applicable national laws and regulations in Member States, which complement the EU FCM Regulation and with other national requirements in the countries in which you sell these products.
Please see below for further information about EU requirements.
UK Requirements: Until the end of the Brexit transition period (December 31, 2020), the EU FCM Regulation sets out general requirements that all Food Contact Materials sold in the UK need to comply with. Separate EU legislation sets additional requirements for specific materials in contact with food, such as Regulation (EU) No 10/2011 on plastic materials, or Directive 84/500/EEC for ceramics. If specific EU rules on materials do not exist, there might be complementary UK legislation. The EU FCM regulation needs to be applied in conjunction with Regulation (EC) No 2023/2006 on Good Manufacturing Practice (GMP), which sets general and detailed rules on applying GMP during the manufacture of Food Contact Materials.
After the end of the Brexit transition period (December 31, 2020), an amended version of Regulation (EC) No 1935/2004 and Regulation (EU) No 10/2011 will apply to all Food Contact Materials as a result of the Materials and Articles in Contact with Food (Amendment) (EU Exit) Regulations 2019/704 (“the UK Regulation on FCM”). Different rules apply to goods you sell in:
We have noted below where there will be relevant changes in the UK requirements following the Brexit transition period.
It is your responsibility to comply with the UK requirements if you are selling food contact materials in the UK. If you also sell such products on Amazon EU website(s), then you must also comply with the EU FCM Regulation and with other national requirements in the countries in which you sell these products.
Please see below for further information about UK requirements.
This material is for informational purposes and you should not take it as a substitute for legal advice. We encourage you to consult your legal counsel for any concerns about the laws and regulations relating to your product. This material only reflects the position at the date of writing and requirements in the EU and the UK may change – particularly in light of the developing position with Brexit. You should refer to current UK Brexit guidance about your products (where available) to learn more about changes that may affect you following the end of the transition period.
The FCM Regulation applies to materials and articles, including active and intelligent Food Contact Materials, which:
Composition
Food Contact Materials and articles must be manufactured in accordance with good manufacturing practice so that, under normal or foreseeable conditions of use, they do not transfer or release their constituents into food at levels harmful to human health or change food composition, taste, or odor in an unacceptable way.
Annex 1 of the EU FCM Regulation also outline a list of 17 groups of materials and articles for which specific measures should be adopted. These specific measures may include:
There are EU specific measures on materials, including:
There are EU specific measures on substances, including:
Any active materials and articles must not cause changes in the composition, taste, or odor of food, for instance by masking the spoilage of food, which could mislead consumers. Intelligent materials and articles shall not give information about the condition of the food that could mislead consumers.
Documentation
A Declaration of Compliance must accompany Food Contact Materials for which there are specific requirements. These specific requirements are currently covered in the following legislation:
National measures might also require additional Food Contact Materials to require Declarations of Compliance.
Labeling and information
Labeling, advertising, and presentation of materials or articles shall not mislead consumers.
Materials and articles, which are not yet in contact with food when offered for supply or sale, should be accompanied by the following information. This can be either on the materials/articles, on their packaging, or on labels affixed to the materials or their packaging:
This information must be clearly visible, legible, and indelible, and in the case requirements 1, 2 and 5, in a language easily understood as determined by Member States, such as the official national language.
Traceability
Materials and articles sold in the EU should be identifiable by an appropriate system which allows for traceability by way of labeling or relevant document or information.
Business operators are required to have systems and procedures in place to enable the identification of businesses from which, and to which, materials, articles, substances or products covered by the EU requirements for food contact materials have been supplied.
Producers and distributors will also have obligations under the General Product Safety Directive (GPSD). Please refer to the information on the GPSD available on this page.
We strongly encourage you to visit the European Commission’s website for more information on the EU requirements in the EU for Food Contact Materials:
The UK Regulation on FCM applies to all products sold in the UK, but the provisions apply differently to Great Britain (England, Scotland and Wales, GB) and Northern Ireland. You can read more about the position in Northern Ireland (NI) below.
The FCM Regulation applies to materials and articles, including active and intelligent Food Contact Materials, which:
Examples include packaging and containers, kitchen equipment, cutlery, dishes, and coffee makers.
There are some exclusions including antiques, covering or coating materials (for example: materials covering cheese rinds, prepared meat products or fruits, which form part of the food and might be consumed with this food) and fixed public or private water supply equipment.
Composition
Food Contact Materials and articles must be manufactured in accordance with good manufacturing practice so that, under normal or foreseeable conditions of use, they do not transfer or release their constituents into food at levels harmful to human health or change food composition, taste, or odor in an unacceptable way.
Annex 1 of the UK Regulation on FCM also outline a list of 17 groups of materials and articles for which specific measures should be adopted. These specific measures may include:
Materials, articles and substances with specific measures include those in the table below:
Material, Article or Substance | Before the end of the Brexit transition period | After the end of the Brexit transition period |
---|---|---|
Active and intelligent materials | Regulation (EC) 450/2009 | An amended version of Regulation (EC) 450/2009, by way of the UK Materials and Articles in Contact with Food (Amendment) (EU Exit) Regulations 2019 |
Plastic materials | Regulation (EU) 10/2011 | An amended version of Regulation (EU) 10/2011, by way of the UK Materials and Articles in Contact with Food (Amendment) (EU Exit) Regulations 2019 |
Recycled plastic materials | Regulation (EC) 282/2008 | An amended version of Regulation (EC) 282/2008, by way of the UK Materials and Articles in Contact with Food (Amendment) (EU Exit) Regulations 2019 |
Ceramics |
Materials and Articles in Contact with Food (England) Regulations 2012/2619 Materials and Articles in Contact with Food (Wales) Regulations 2012/2705 Materials and Articles in Contact with Food (Scotland) Regulations 2012 /318 Materials and Articles in Contact with Food Regulations (Northern Ireland) 2012/384 (together, the “UK Materials and Articles Regulations”) |
The UK Materials and Articles Regulations |
Regenerated cellulose films | The UK Materials and Articles Regulations | The UK Materials and Articles Regulations |
Certain epoxy derivatives | Regulation (EC) 1895/2005 | An amended version of Regulation (EC) 1895/2005, by way of the UK Materials and Articles in Contact with Food (Amendment) (EU Exit) Regulations 2019 |
N-nitrosamines and N-nitrosable substances from rubber teats and soothers | N-nitrosamines and N-nitrosatable Substances in Elastomer or Rubber Teats and Dummies (Safety) Regulations 1995/1012 | N-nitrosamines and N-nitrosatable Substances in Elastomer or Rubber Teats and Dummies (Safety) Regulations 1995/1012 |
Kitchenware made from melamine or polyamide originating or consigned from China or Hong Kong | Regulation (EU) 284/2011 | An amended version of Regulation (EU) 284/2011, by way of the UK Food and Feed Imports (Amendment) (EU Exit) Regulations 2019 |
Any active materials and articles must not cause changes in the composition, taste, or odor of food, for instance by masking the spoilage of food, which could mislead consumers. Intelligent materials and articles shall not give information about the condition of the food that could mislead consumers.
Documentation
A Declaration of Compliance must accompany Food Contact Materials for which there are specific requirements. These specific requirements are currently covered in the legislation for active and intelligent materials, plastic materials, recycled plastic materials, ceramics and regenerated cellulose film as outlined in the table above.
Labeling
Labeling, advertising, and presentation of materials or articles shall not mislead consumers.
Materials and articles, which are not yet in contact with food when offered for supply or sale, should be accompanied by the following information. This can be either on the materials/articles, on their packaging, or on labels affixed to the materials or their packaging:
The purpose of such information is to enable food business operators who use these materials and articles to comply with:
This information must be clearly visible, legible, and indelible, and in the case requirements 1, 2 and 5, in a language easily understood by purchasers, which in the case of the UK would be English.
Traceability
Materials and articles sold in the UK should be identifiable by an appropriate system which allows for traceability by way of labeling or relevant document or information.
Business operators are required to have systems and procedures in place to enable the identification of businesses from which, and to which, materials, articles, substances or products covered by the UK requirements for food contact materials have been supplied.
Producers and distributors will also have obligations under the UK’s General Product Safety Regulations 2005/1803 (GPSR). Please refer to the information on the GPSR available on this page.
Please note that different rules will apply in NI from January 1, 2021 as a result of the Northern Ireland Protocol. In particular:
The UK Government has released guidance on selling products in GB and NI after Brexit. This guidance provides information for producers and distributors regarding compliance requirements from January 1, 2021, including on:
We encourage you to review this guidance (linked below), alongside any other specific UK Government guidance that applies to your product. You should consult your legal counsel if you have questions about how the laws and regulations apply to your products from January 1, 2021.
GB:
NI:
We strongly encourage you to review the following UK Government guidance for more information on the UK requirements for Food Contact Materials: https://www.food.gov.uk/business-guidance/food-contact-materials
We also encourage you to visit Business Companion website, which contains guidance on UK product compliance rules: https://www.businesscompanion.info/en/quick-guides/food-and-drink/food-contact-materials