Requirements for Food Contact Materials

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:

1. Great Britain (England, Scotland and Wales); and
2. Northern Ireland

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.

Which products do the EU requirements for Food Contact Materials apply to?

The FCM Regulation applies to materials and articles, including active and intelligent Food Contact Materials, which:

• Are intended to be brought into contact with food
• Are already in contact with food and were intended for that purpose
• Can reasonably be expected to be brought into contact with food or to transfer their constituents to food under normal or foreseeable conditions of use

What are the key obligations under the EU requirements for Food Contact Materials?

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:

• Lists of substances authorized for use in the manufacturing of materials and articles;
• Lists of authorized substances incorporated in active or intelligent Food Contact Materials and articles or lists of active or intelligent articles and materials and, when necessary, special conditions of use for these substances and/or the materials and articles in which they are incorporated.

There are EU specific measures on materials, including:

• Regulation (EU) No 10/2011 on plastic materials
• Regulation (EC) No 450/2009 on active and intelligent materials
• Regulation (EC) No 282/2008 on recycled plastic materials
• Directive 84/500/EEC for ceramics
• Directive 2007/42/EC for regenerated cellulose film

There are EU specific measures on substances, including:

• Regulation 1895/2005/EC - restricting use of certain epoxy derivatives in Food Contact Materials
• Directive 93/11/EEC - release of N-nitrosamines and N-nitrosatable substances from rubber teats and soothers
• Regulation EU No 284/2011 for kitchenware made of melamine or polyamide originating or consigned from China or Hong Kong

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:

• Regulation (EU) No 10/2011 on plastic materials
• Regulation (EC) No 450/2009 on active and intelligent materials
• Regulation (EC) No 282/2008 on recycled plastic materials
• Directive 84/500/EEC for ceramics
• Directive 2007/42/EC for regenerated cellulose film

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.

• Active and intelligent materials and articles must be adequately labeled, so that they indicate the materials or articles are active and/or intelligent.
• Active and intelligent materials and articles that have already been brought into contact with food must be adequately labeled, so that consumers can identify the non-edible parts.

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 words "for food contact" or a specific indication as to their use (such as a wine bottle), or the symbol contained in Annex II of the EU FCM Regulation , unless it is clearly intended due to its characteristic for it to come into contact with food
• Any special instructions that must be observed for safe and appropriate use
• The name or trade name and, in either case, the address or registered office of the manufacturer, processor, or seller responsible for selling the material or article in the EU, who is established within the EU
• Adequate labeling to ensure the traceability of the material or article.
• In the case of active materials and articles:
  • Information on the permitted use or uses; and
  • Other relevant information (for example: the name and quantity of the substances released by the active component). The purpose of such information is to enable food business operators who use these materials and articles to comply with any other relevant EU provisions, or in their absence, national provisions applicable to food, including provisions on food labeling.

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.

Any other obligations?

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.

Additional Information

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:

• https://ec.europa.eu/food/safety/chemical_safety/food_contact_materials_en
• https://www.efsa.europa.eu/de/topics/topic/food-contact-materials

Where do the UK requirements for Food Contact Materials apply?

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.

Which products do the UK requirements for Food Contact Materials apply to?

The FCM Regulation applies to materials and articles, including active and intelligent Food Contact Materials, which:

• are intended to be brought into contact with food
• are already in contact with food and were intended for that purpose
• can reasonably be expected to be brought into contact with food or to transfer their constituents to food under normal or foreseeable conditions of use

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.

What are the key obligations under the UK requirements for Food Contact Materials?

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:

• Lists of substances authorized for use in the manufacturing of materials and articles;
• Lists of authorized substances incorporated in active or intelligent Food Contact Materials and articles or lists of active or intelligent articles and materials and, when necessary, special conditions of use for these substances and/or the materials and articles in which they are incorporated.

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.

• Active and intelligent materials and articles must be adequately labeled, so that they indicate the materials or articles are active and/or intelligent.
• Active and intelligent materials and articles that have already been brought into contact with food must be adequately labeled, so that consumers can identify the non-edible parts.

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:

1. The words "for food contact" or a specific indication as to their use (such as a wine bottle), or the symbol contained in Annex II of the EU FCM Regulation, unless it is clearly intended due to its characteristic for it to come into contact with food.
2. Any special instructions that must be observed for safe and appropriate use.
3. The name or trade name and, in either case, the address or registered office of the manufacturer, processor, or seller responsible for selling the material or article in the UK, who until the end of the Brexit transition period (December 31, 2020), is established within the EU or, after the end of the Brexit transition period, is established in GB.
4. Adequate labeling to ensure the traceability of the material or article.
5. In the case of active materials and articles:

• Information on the permitted use or uses; and
• Other relevant information (for example: the name and quantity of the substances released by the active component).

The purpose of such information is to enable food business operators who use these materials and articles to comply with:

• until the end of the Brexit transition period (December 31, 2020), any other relevant EU provisions; or
• after the end of the Brexit transition period (December 31, 2020), any retained EU legislation or other domestic UK legislation; and/or
• any other enactment, including the provisions on food labeling.

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.

Any other obligations?

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.

Northern Ireland

Please note that different rules will apply in NI from January 1, 2021 as a result of the Northern Ireland Protocol. In particular:

• You should ensure that products meet EU requirements.
• You are responsible for placing products on the market if you are established in the EU or NI and you sell products from a country outside of the EU and Northern Ireland (including from GB) into NI. Products sold in NI should be marked with details of any EU / NI based entity responsible for placing products on the market.

BREXIT: UK Government Guidance

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:

• whether your legal responsibilities will change as a result of Brexit;
• whether you need to provide GB importer information, and methods for doing this (including transitional arrangements until the end of 2022);
• what documentary evidence is required to show that products have been placed in the UK or EU before the end of the Transition Period; and
• specific rules for selling products in NI.

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:

• Product Safety and Metrology in GB from January 1, 2021
• General Product Safety Regulations - GB

NI:

• Product Safety and Metrology – NI
• General Product Safety Regulations - NI

Additional Information

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