Food Contact Materials Regulations in the European Union: An Overview (2023)

All food contact products sold in the European Union are subject to the EU Food Contact Material Framework Regulation (EC) No 1935/2004, and other material-specific FCM regulations. In this article, we explain what importers and Amazon sellers must know about substance restrictions, material-specific regulations, certification, lab testing, and risks.

Mentioned Products

  • Lunchboxes
  • Electronic kitchen appliances
  • Drinkware
  • Stainless steel bottles
  • Cutlery
  • Bowls
  • Jugs
  • Tableware

Content Overview

  • Food Contact Materials Regulations in the European Union: An Overview (1)

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EU Regulation (EC) 1935/2004 (Framework Regulation)

According to the definition given by the European Food Safety Authority, FCMs refer to any materials and articles intended to come into contact with food and drinks.

The Regulation (EC) 1935/2004 enacted by European Commission requires that all FCMs manufactured, imported and sold in the EU market should be compliant to the Framework Regulation.

A wide range of materials including plastics, elastomer, ceramics, paper, and metal that could be used to make food contact articles should adhere to this regulation and such materials should not:

  • Release their constituents into food at levels harmful to human health
  • Change food composition, taste, and odor
  • Bring about changes in the taste or odor of the food

Product Traceability

Product traceability allows consumers to trace all processes of the product, from the procurement of raw materials to production, consumption, and disposal.

Traceability information should also be printed or engraved upon the product along with the FCM mark, beneath is the example of traceability information:

  • SKU
  • Manufacturing date
  • Production facility
  • Country code

Example: SKU-EF-76-CN

(Video) Food Contact Materials Regulations in the European Union

FCM lab testing

The European Commission had enacted extensive standards for FCM lab-test methods based on different parameters of the products, such as the material, quality, color, hardness degree, and more. Also, different regulations and EN standards might apply to different materials and products such as paper and board, plastics, cookware, tableware, and more.

To check whether your FCM products are compliant with the EU FCMs regulations, simply contact a third-party testing company, such as SGS, Bureau Veritas, QIMA, and Intertek for material analysis.

Testing costs

The costs of the FCM lab-tests generally range from $200-$300 for each item or food contact material. Different companies charge different rates depending on the materials, weights colors of the products, and also the testing packages you select for. To get further information on this topic, you can contact a lab-testing company such as QIMA, Bureau Veritas, or TUV.

Food Contact Materials Regulations in the European Union: An Overview (2)

Plastic Materials: Regulation (EU) 10/2011

Importers should pay special attention to the following requirements before importing food contact material products that are made of plastics to the EU.

Commission Regulation (EU) 10/2011 intends to regulate the standards for food contact materials that are made of plastic, which includes the following scope:

  • Mono-layers and multi-layers plastics
  • Multi-material plastics
  • Coated or printed plastics

This regulation requires that only substances that are authorized may be used to manufacture food contact plastic materials and articles. According to the official legal document of the EU, the Union list contains:

  • Monomers
  • Some additives
  • Some polymer production aids
  • Microbial fermentation macromolecules

Importers should also provide eligible material migration test reports to relevant parties upon import.

Declaration of Compliance (DoC)

Business operators shall provide a DoC (Declaration of Compliance) for plastic food contact materials. The purpose of the Declaration of Compliance is to inform the customers about standards, test results, product specifications, importer profile, and other relevant information of the FCM products.

Importers or manufacturers must self-issue a DoC, and this document includes the following information:

  • Company
  • Address
  • Product name
  • Date
  • List of EU FCM regulations and standards
  • Types of food or beverage the FCM product is made for
  • Information about storage, time and temperature

Click here to download a DoC template provided by the Food Safety Authority of Ireland.

Bisphenol A in Plastic Infant Feeding Bottles: Regulation (EU) 321/2011

This regulation amends Regulation (EU) 10/2011 for the specific case of the restrictions of Bisphenol A (BPA) in polycarbonate infant feeding bottles.

Click here to learn more about this specific regulation.

Recycled Plastic Materials: Regulation (EC) 282/2008

Commission Regulation (EC) 282/2008, which is also known as the Recycling Regulation establishes the specific rules for food contact materials that are made from recycled plastic materials.

This regulation mandates that food contact material products that are made from recycled plastics are only allowed to be sold in the market if they are manufactured from plastics that conform to the recycling procedures approved by the EU.

Declaration of Compliance (DoC)

For recycled plastic FCM, a Declaration of Compliance is needed.

Ceramics: Directive 2005/31/EC

Directive 2005/31/EC was implemented for the purpose of reducing the risk of ceramic products that are intended to come into contact with foodstuffs of releasing harmful levels of cadmium and lead when entering the EU market.

(Video) [Webinar] Understanding the EU Legislation on Food Contact Materials

Before importing ceramic food contact products to any of the member states of the European Union, manufacturers and importers should provide documentation demonstrating compliance with the migration limits, such as test reports for heavy-metal concentration.

Declaration of Compliance (DoC)

For ceramic, as for plastic FCM, a Declaration of Compliance is needed.

Regenerated Cellulose Film: Directive 2007/42/EC

Directive 2007/42/EC sets forth requirements and standards to materials and articles made of regenerated cellulose film intended to come into contact with food.

In particular, it requires that only authorized substances are allowed to be used to make regenerated cellulose films. In addition, printed surfaces of regenerated cellulose film shall not come into contact with foodstuffs.

Below are some authorized substances allowed to be used in the manufacturing process of regenerated cellulose film:

  • Sodium propionate
  • Amylose
  • Natural edible starches and flours
  • Ethanediol
  • Polyethylene oxide
  • Glycerol

Below are some examples of restricted substances:

  • Free formaldehyde
  • Residual Solvents
  • Toluene
  • Monoethylene glycol and dihydroxy diethyl ether

Declaration of Compliance (DoC)

For regenerated cellulose film, a Declaration of Compliance is needed only if it’s not clear whether the product is intended to come into contact with foodstuffs or not.

Active and Intelligent Materials: Regulation (EC) No 450/2009

Regulation (EC) 450/2009 regulates the use of active and intelligent materials and articles sold within the European market. Active materials and articles are intended to maintain the condition of packaged food.

The list of active and intelligent materials are evaluated and assessed by EFSA (European Food Safety Authority) before their inclusion into a positive list. Only authorized and approved substances from the list are allowed to be in the use of active and intelligent materials. The list covers monomers, starting substances, additives, and polymer processing aids.

Here are some examples of substances from the positive list:

  • Albumin
  • Acetylacetic acid, salts
  • Cotton fibers
  • Glass fibers
  • Glass micro balls
  • Taurine, salts

Declaration of Compliance (DoC)

A declaration of compliance is needed also for these kinds of materials.

Products Originating or Consigned from China or Hong Kong: Regulation (EU) 284/2011

Regulation (EU) 284/2011 was implemented in all the member states of the European Union, for the purpose of avoiding certain kinds of plastic kitchenware imported from Mainland China or Hong Kong to the European market, which reportedly contained a higher level of polyamide or melamine.

This regulation requires that plastic kitchenware/tableware originating from or consigned in China and Hong Kong shall be imported into the European market, only if the importer provides a declaration and a laboratory report confirming that the related products are compliant with limits on the release of harmful chemicals such as formaldehyde or primary aromatic amines.

Legislations on Specific Substances

1. Regulation (EU) 2018/213 restricts bisphenol A in FCM coatings

2. Regulation 1895/2005/EC regulates epoxy derivatives used on FCM

3. Directive 93/11/EEC restricts the migration of N-nitrosamines and N-nitrosatable from rubber FMC

(Video) Overview of the evaluation and revision of EU FCM legislation

Regulation (EC) 2023/2006 (GMP)

In order to ensure the quality and compliance of the products sold in the market, the EU requires that manufacturers implement a sound and approved system during the manufacturing process of products, from material sourcing to production, quality control, which is the general principle of Good Manufacturing Practice.

GMP requires that:

1. Materials are pre-selected and procured;

2. The production and quality assurance process is carried out according to pre-established instructions;

3. Quality control and verification system is established;

4. Utilize good and proper production facilities during the manufacturing process.

In practice, this requires that you create a file that includes your quality control processes, lab testing processes, order documents, product specifications, company certificates (e.g. ISO 9001) and other relevant documents.

Covered materials

The GMP covers 17 kinds of materials, including ceramics, glass, metal, plastics, and wood.

You can learn more, including the full list of covered products, by reading the regulation.

Food Contact Material Symbol

Food Contact Materials Regulations in the European Union: An Overview (3)

FCM products sold in the EU market must contain the glass/fork symbol (as shown above), or the text “for food contact” unless:

a. it is obvious that the product is designed as FCM (ie. a fork), or

b. the products are sold with food as containers (ie. a take-away carton)

National European FCM Regulations

Several European countries implement domestic FCM regulations, below are some of the regional regulations for FCM products.

LFGB (Germany)

LFGB is the German abbreviation for the Food and Commodities Act, which is considered the most important food safety management act for Germany. LFGB is the guiding act for Germany’s hygiene regulations and regulates the food and food-related products’ safety standards in the country.

All the foodstuffs and food-related products are required to pass the corresponding tests and be compliant with LFGB in order to be put in the German market.

Generally speaking, LFGB is stricter than other European Food Contact Regulations, such as 1935/2004/EC.

Restricted substances

(Video) Phthalate Regulations in the European Union

A wide range of substances and materials are regulated by LFGB, such as

  • Polymers
  • Silicon
  • Paper

Check the comprehensive overview of LFGB restricted substances on this page.

LFGB lab testing

In order to verify the compliance of your FCM products, hire a reputable lab-testing company such as TUV, SGS or Bureau Veritas and perform an assessment for your products.

Testing Process

The LFGB testing process includes the following steps:

  • Initial testing of samples and materials
  • Odor and taste transfer of sensory evaluation
  • Heavy metals detection
  • Testing of transferred or volatile organic compounds
  • Test for chemical hazards

Learn More

You can learn more about LFGB on the official website of the German BfR.

DGCCRF (France)

DGCCRF is the French abbreviation for the French General Directorate for Competition Policy, Consumer Affairs, and Fraud Control, which regulates and controls products within the French market at all levels, including production, import, and distribution. Regulating foodstuffs and food-related products is one of the main focuses of DGCCRF.

DGCCRF issued a series of documents in 2016, which set requirements for food contact materials made from inorganic material such as metal, ceramic, plastic, paper, wood or glass, organic materials made from synthetic fibers and organic materials made from plant fibers.

Restricted substances

The following substances are restricted to be used in most articles:

  • Aluminum
  • Cobalt
  • Arsenic

DGCCRF lab testing

In order to check the compliance of your FCM products, you can contact an accredited lab-testing company to perform an assessment.

Compliance Risks

Food contact products and materials manufactured outside the EU are not exclusively made to comply with European Union FCM regulations. Here are some compliance risk scenarios:

  • Plastic lunchboxes containing excessive amounts of BPA
  • Wooden coatings or paints containing phthalates
  • Bamboo melamine composites containing excessive amounts of toxic chemicals
  • Stainless steel drink bottles containing excessive amounts of lead and cadmium

Importing non-compliant food contact materials can result in fines and a forced recall. It’s therefore essential to only work with suppliers that have a certain degree of ‘substance control’ – meaning that they have the capability to procure or produce compliant materials. This cannot be taken for granted when sourcing products in China, Vietnam and elsewhere in Asia.

The only way to assess a supplier’s capability to produce compliant FCM products is by assessing their existing compliance track record. In other words, do they have a number of existing EU FCM test report proving that they have made compliant products in the past? If no, then they are less likely to have the capability to manufacture a compliant product.

That said, third-party lab testing is ultimately required when importing and selling food contact products in the EU. You cannot use existing test reports provided by the supplier to prove that your imported product is compliant.

Other Regulations

Food contact products are also subject to general consumer product regulations. Here’s are some product regulations that, depending on the product, may apply:

(Video) Packaging Materials Regulations in the European Union

  • REACH
  • General Product Safety Directive (GPSD)
  • Directive 94/62/EC on Packaging and Packaging Waste
  • Low Voltage Directive
  • EMC Directive
  • RoHS

Related Articles

Here is a list of articles that cover several types of food contact materials in detail:

  • Stainless Steel Cookware Regulations in the European Union
  • Wood and Bamboo Product Regulations in the European Union
  • Plastic Kitchen Products Regulations in the European Union

FAQs

What are the EU regulations on food? ›

The principal aim of retained EU law Regulation (EC) 178/2002, 'General Food Law' is to protect human health and consumer's interest in relation to food. It applies to all stages of production, processing and distribution of food and feed with some exceptions. Food businesses must comply with food and feed safety law.

What materials are safe for food contact? ›

While it's always important to follow specific guidelines related to food storage, temperature and recycling, the following plastics are generally very safe for food contact.
  • High-Density Polyethylene (HDPE) ...
  • Low-Density Polyethylene (LDPE) ...
  • Polycarbonate (PC) ...
  • Polyethylene Terephthalate (PET) ...
  • Polypropylene (PP)

What are food grade materials? ›

“Food grade material” means material made of substances which are safe and suitable for their intended use, which shall not change in the composition of the food and transfer harmful or toxic substances into food it is holding.

Who regulates food packaging in Australia? ›

How is food packaging regulated? In Australia and New Zealand, manufacturers are required by the Food Standards Code to ensure food in contact with packaging is safe. Standard 1.4.

Who regulates food safety in the EU? ›

EFSA was established in February 2002, is based in Parma, Italy, and for 2021 it has a budget of €118.6 million, and a total staff of 542. The work of EFSA covers all matters with a direct or indirect impact on food and feed safety, including animal health and welfare, plant protection and plant health and nutrition.

How many allergens are in EU food regulations? ›

The 14 allergens which must be declared are recognised, across Europe, as the most common ingredients or processing aids causing food allergies and intolerances.

Is PVC safe for food contact? ›

Is PVC Food Safe? When the right type of PVC is used (uPVC or Rigid PVC), it is perfectly safe for use in gardening, aquaponics, drinking water systems, or other systems where it will come into contact with food or beverages.

What is the safest plastic for food? ›

Top 5 FDA-approved food-grade plastics
  • Acrylonitrile Butadiene Styrene (ABS) ABS is an amorphous plastic created by combining acrylonitrile, butadiene, and styrene polymers. ...
  • High-Density Polyethylene (HDPE) ...
  • Polyetheretherketone (PEEK) ...
  • Acrylic (PMMA) ...
  • Polypropylene (PP) ...
  • Serving up food-grade plastics with Fast Radius.
23 Jun 2021

Which of the following is a necessary characteristic of acceptable food contact surfaces? ›

Typically, food contact surfaces require ultra-smooth surface finishes that are devoid of pores or crevices that might attract fallen food particles, lending to bacterial growth.

What are the best materials for food contact equipment? ›

Stainless steel is generally the most preferred and most commonly used material in the design, construction and fabrication of food processing equip- ment and is specified in the 3-A Sanitary Standards (1) as well as in other com- monly used food processing equipment standards throughout the world (20).

What is the difference between food grade and food safe? ›

In short, food grade means that the material is suitable to come into direct contact with food. And food safe means that the food grade material and finished product is suitable for it's intended use and will not create a food safety hazard.

What are the types of food packaging materials? ›

Materials that have traditionally been used in food packaging include glass, metals (aluminum, foils and laminates, tinplate, and tin-free steel), paper and paperboards, and plastics. Moreover, a wider variety of plastics have been introduced in both rigid and flexible forms.

Why are the food regulations important? ›

Food regulations serve as checks and balances on the food industry to prevent malpractices like adulteration and mismeasuring as well as the consequences of cutting corners. Specific regulations are needed at every step of production to make the process foolproof.

What are the legal requirements for packaging? ›

The Section 2(l) of The Legal Metrology Act, 2009 defines a “pre-packaged commodity” as follows: “Pre-packaged commodity” means a commodity which without the purchaser being present is placed in a package of whatever nature, whether sealed or not, so that the product contained therein has a pre-determined quality.

Why is food safety important EU? ›

The EU's food safety policy covers food from farm to fork. It is designed to guarantee safe, nutritious food and animal feed, high standards of animal health and welfare and plant protection, as well as clear information on the origin, content, labelling and use of food.

What country has the best food regulations? ›

Finland was named the top country for food security in 2020, ahead of Ireland and the Netherlands.

Are EU food standards vs US? ›

Overall, US and EU policy for food labels are rather similar. The major differences involve the labeling of additives and GMOs. The FDA mandates that additives are listed by their common name, rather than with a European e-number; if a product label contains an e-number, it will not be allowed into the country.

What are the 14 allergens Recognised by the EU food information? ›

The 14 allergens are: celery, cereals containing gluten (such as barley and oats), crustaceans (such as prawns, crabs and lobsters), eggs, fish, lupin, milk, molluscs (such as mussels and oysters), mustard, peanuts, sesame, soybeans, sulphur dioxide and sulphites (if the sulphur dioxide and sulphites are at a ...

What is the main purpose of allergy regulations? ›

Congress passed this law to make it easier for consumers who are allergic to foods and their caregivers to identify and avoid foods that contain major food allergens. The FDA enforces the provisions of this law in most packaged food products.

When did the EU food information for consumers regulations come into force? ›

The Food Information Regulations and EU Food Information for Consumer Regulations (EU FIC) The Food Labelling Regulations 1996 have been replaced by the EU Food Information Regulation 1169/2001 (FIR). This legislation came into force on 13 December 2011.

Why PVC is not used in food packaging? ›

“It has been decided to restrict the use of PVC in food packaging starting the [second half of] this year in order to reduce the risk of harm to the environment and also public health caused by this material,”​ the EPA stated via a public statement.

What type of PVC is food grade? ›

PVC that doesn't have plasticizers is called Rigid PVC or uPVC. The uPVC is Food safe PVC and does not have any BPA (bisphenol) or phthalates, making it safe for aquaponics and other gardening methods.

Which plastics are food grade? ›

Common Uses of Food Grade Plastic Types

Polyethylene terephthalate, PET or PETE (Code 1): single-serving beverage bottles (e.g., soft drinks, sports drinks, water, etc.) condiment bottles (e.g., salad dressing, ketchup, oil, etc.), vitamin bottles, peanut butter jars.

Are old Tupperware containers safe to use? ›

BPA, as well as arsenic, lead, cadmium, and mercury, are dangerous substances for humans, so if you've been using vintage Tupperware, the best thing you can do is not use them anymore. Plastic not only harms the environment but has also directly harmed humans for years.

Is Tupperware plastic safe? ›

Tupperware containers without decorations are said to be safe as they don't contain arsenic and lead. However, colorful Tupperware containers may contain harmful chemicals such as cadmium which destroys kidneys, bones, and lungs, and also mercury which alters immune and digestive systems, including other vital organs.

Is Tupperware BPA free? ›

In its continuous search for the best materials for use in its products, Tupperware has found other materials with improved performance characteristics that have been approved by regulators to be BPA free to replace polycarbonate.

How often should food contact surfaces be cleaned? ›

At least every 4 hours for any potentially hazardous foods. than 40 °F or greater than 135 °F the food contact surfaces of equipment and utensils may be cleaned less frequently than 4 hours, but at least every 24 hours or when containers are empty.

How do you clean and sanitize food contact surfaces? ›

The Seven-Step Approach to Cleaning and Sanitizing
  1. Remove Debris. Using a lint-free cloth or wipe, physically remove soil deposits off of food contact surfaces. ...
  2. Rinse All Residues. ...
  3. Apply Detergent and a Good Scrubbing. ...
  4. Give a Thorough Rinse. ...
  5. Take a Closer Look. ...
  6. Sanitize or Disinfect. ...
  7. Dry.

How are food contact surfaces handled between uses? ›

Manually wash, rinse, and sanitize them, or run them through a dishwashing machine. o Wash and rinse all other food-contact surfaces that you cannot remove; then wipe or spray them with a properly prepared chemical sanitizing solution.

What foods Cannot be taken into the EU? ›

You cannot take the following with you into the EU : meat or products containing meat. milk or dairy products.
...
Taking meat and dairy products into the EU
  • powdered infant milk.
  • infant food.
  • special food for the dietary management of a diagnosed disease, disorder or medical condition.
  • pet food required for medical reasons.

Are EU food standards vs US? ›

Overall, US and EU policy for food labels are rather similar. The major differences involve the labeling of additives and GMOs. The FDA mandates that additives are listed by their common name, rather than with a European e-number; if a product label contains an e-number, it will not be allowed into the country.

What is EU Labelling guidelines? ›

The label must be legible, firmly secured, and accessible, and the manufacturer or the authorized representative established in the European Union is responsible for supplying the label and for the accuracy of the information contained therein. Only the information provided in the Directive needs to be supplied.

What does the food information regulations 2014 cover? ›

The Food Information Regulations 2014 (FIR) and Regulation (EU) No 1169/2011 control how food businesses must legally give information to their customers about the food they produce, sell and serve and the way this information is provided.

Can I take chocolate to the EU? ›

*Confectionery, chocolate or cakes (including Christmas cake, Simnel cake or cakes containing nuts) are permitted from any country as long as they are for your personal consumption and do not contain fresh cream or high levels of dairy products.

Can I take coffee into the EU? ›

You can no longer take products of animal origin, such as any food or drink contain meat or dairy, or plants and plant products into the EU in your luggage, vehicle, or person. There are certain exemptions to this rule for quantities of powdered infant milk, infant food, confectionary, specialised foods and pet feed.

Can I take a ham sandwich to France? ›

The following items are all prohibited: All meat and dairy products (no bacon, cheese, ham sandwiches, etc.!) No products containing animal-derived products, including milk (so no suet puddings, custard, sweets or cakes containing gelatine, and even chocolate – as it contains milk). Plants and fresh-cut flowers.

What country has the best food regulations? ›

Finland was named the top country for food security in 2020, ahead of Ireland and the Netherlands.

What country has the most strict food regulations? ›

Which Countries Have the Highest Food Standards?
  • United States (tied with the UK)
  • United Kingdom (tied with the US)
  • Netherlands.
  • Australia.
  • Switzerland.
  • Finland.
  • Canada.
  • France.
12 May 2020

Which is the most food secure country in the world? ›

Key findings of the Global Food Security Index 2021

Ireland, Austria, the UK, Finland, Switzerland, the Netherlands, Canada, Japan, France, and the US shared the top 10 ranks with the overall GFS score in the range of 77.8 and 80 points on the index.

What are the mandatory labeling requirements? ›

These include the Product Name/ Name of the Food, Use of Brand Name and/or Trademark, Complete List of Ingredients, Net Contents and Drained Weight, Name and Address of Manufacturer, Repacker, Packer, Importer, Trader and Distributor, Lot Identification, Storage Condition, Expiry or Expiration Date), Food Allergen ...

What information is required on food labels? ›

Nutrition labels must display the amount of energy (calories and kilojoules) and the amount of fat, saturated fat, carbohydrates, sugars, proteins and salt (all expressed in grams) present in 100g (or 100 ml) of the food.

What needs to be done if your product is going to the EU? ›

satisfy any traceability requirements: preserve the technical documentation and the EU declaration of conformity (for 10 years after the product is placed on the market or for the period specified for that product under EU law) give the product a type, batch or serial number for identification.

What does the food information regulations apply to? ›

These new regulations apply to all food businesses supplying food to the public and caterers, including retail premises, manufacturers, restaurants, delicatessens, bakeries, sandwich bars, supermarkets, caterers, take-aways, buffets, and home caterers.

How many allergens are listed in the 2014 regulations? ›

The fourteen allergens (Annex II allergens)

The 14 allergens listed in Annex II (as amended by Commission Delegated Regulation (EU) No. 78/2014) are recognised as the most common ingredients or processing aids causing food allergies and intolerances.

When did food information regulations start? ›

The Food Information Regulations 2014 (FIR) are the domestic regulations that establish the enforcement measures for Regulation (EU) No 1169/2011 on the provision of food information to consumers (EU FIC).

Videos

1. Bisphenol A (BPA) Regulations in the European Union
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2. 01 Overview of EU Legislative Framework on Food Safety Animal Health and Plant Health
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3. European Food Contact Regulatory Updates | Dr Alistair Irvine | Smithers
(Smithers)
4. Formaldehyde Regulations in the European Union
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5. EU Declaration of Compliance (DoC) for Food Contact Materials
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6. Heavy Metals Regulations in the European Union
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