Plastic Product Regulations and Safety Standards in the European Union

Plastics and consumer products made of plastics are subject to chemical restrictions, bans, labeling, and lab testing requirements. In this guide, we explain how REACH, RoHS Directive, and many other regulations apply to plastic materials and consumer products.

Further, we also look into plastic food contact materials regulations, and regulations concerning single-use plastics in the European Union.

REACH

REACH restricts (e.g. limits or bans) chemical substances that are deemed toxic or otherwise dangerous. Many of these substances can be commonly found in plastic products, such as phthalates, TBNPA, which is commonly used in polymers production, or MCCP, which is a plasticizer additive often used in plastics.

REACH sets out substance limitations and notification requirements. Importers and manufacturers must verify if their plastic products comply with the regulation before placing them on the market.

Product Scope

REACH covers consumers products, including plastic products such as:

• Plastic bowls
• Plastic toys
• Plastic packages
• Plastic gloves

Restricted Substances

Regulated substances are listed on the Substances of Very High Concern (SVHC) Candidate List or Annex XVII under REACH. For SVHC, a notification to the European Chemicals Agency (ECHA) is required, if a product contains the SVHC in an amount greater than 0.1% by weight.

Conversely, substances listed in Annex XVII are either prohibited or limited (e.g. maximum 0.1% by weight). Substances listed in the SVHC list might be added to Annex XVII at any time.

SVHC

The Candicate List provides the full list of SVHC. Here are some examples of SVHC that might be found in plastic products:

• Diisohexyl phthalate
• Methoxyethyl acetate
• Sodium dichromate

If your product contains any SVHC in an amount greater than 0.1% by weight, you have the following duties:

a. Notify consumers, if they request information concerning the safety of your product

b. Notify the ECHA, by registering and listing the products in the SCIP (Substances of Concern In Products) database, which allows waste operators and consumers to access the following information concerning notified articles:

• Article name
• ID number
• Article category
• Production status
• Safe use instruction (if applicable)

Annex XVII

The Annex XVII includes the substances for which there is a specific restriction or ban. Generally speaking, these are substances that are deemed particularly harmful to the human body.

Here are some substances listed on Annex XVII that might commonly be found in plastic products:

li>BBP (phthalate) < 0.1% by weight
• DEHP (phthalate) < 0.1% by weight
• TBNPA < 0.1% by weight
• MCCP < 0.1% by weight
• Polycyclic Aromatic Hydrocarbons (PAH) < 0.1% by weight

Lab Testing

Most importers and manufacturers do not have the technical expertise to assess if their plastic products contain prohibited substances or excessive amounts of restricted chemical substances. In this case, performing relevant lab testing is the only way to assess product compliance.

For example, a PAH test can help you to determine the PAH content in rubber and plastic products. There are testing companies that can arrange REACH testing for plastic products, including SGS and Intertek.

RoHS Directive

The RoHS Directive restricts certain heavy metals and phthalates in electronic products, including plastic components. This includes, for example, casings and enclosures for electronic products.

Product Scope

If a plastic component is used in electrical equipment, you must ensure that it is RoHS-compliant. Here are some examples:

• Plastic cases
• PVC used to insulate electric wiring
• Circuit board components
• Fire-resistant plastic covers

Restricted Substances

RoHS sets out the limitations for six phthalates, which are known as plasticizers. Here’s an overview:

• PBB < 0.1% by weight
• PBDE < 0.1% by weight
• DEHP < 0.1% by weight
• BBP < 0.1% by weight
• DBP < 0.1% by weight
• DIBP < 0.1% by weight

RoHS also restricts certain heavy metals that might be found in plastic components as listed below:

• Lead (Pb) < 0.1% by weight
• Mercury (Hg) < 0.1% by weight
• Cadmium (Cd) < 0.01% by weight
• Hexavalent chromium (Cr6+) < 0.1% by weight

Documentation

RoHS is a CE directive. Therefore, importers and manufacturers should provide the documents as below:

• Declaration of Conformity
• Technical files
• User instructions
• Test reports

Labeling

RoHS covered products should comply with the CE directives’ labeling requirements as below:

• Product SKU
• Manufacturer contact information
• Warning statements
• CE marking

Lab Testing

RoHS lab testing is the only way to verify if your plastic products are compliant with the RoHS directive. Importers and manufacturers should contact reputable testing companies for the purpose of testing their products.

Toy Safety Directive

The Toy Safety Directive lays down the safety requirements for toys, including mechanical properties, chemical properties, labeling, and lab testing requirements. It also covers plastic toys that are designed or intended for use in play by children under 14 years of age.

Product Scope

The Toy Safety Directive covers plastic toys, such as:

• Remote cars
• Plastic animal toys
• Educational plastic toys

Restricted Substances

The directive restricted certain substances in toy products, including plastic toys and toys containing plastic components. Here are some examples of the restricted substances:

More specifically, the directive requires that toys intended to be used by children under the age of 14 must contain a concentration lower than 0.1% by weight of the above-mentioned phthalates, which include the following:

• DEHP < 0.1% by weight
• BBP < 0.1% by weight
• DBP < 0.1% by weight

For toys intended for children that have less than 3 years, or that are intended to be placed in the mouth, the following migration limits apply:

• N-nitrosamines < 0.05 mg/kg
• N-nitrosatable , 1 mg/kg

Mechanical Properties

The mechanical properties of a plastic toy should comply with the requirements laid down under EN 71-1. For example, a plastic toy might contain small parts that cause choking hazards to children.

More in general, certain mechanical properties can lead to hazards such as suffocation or cut injuries. here we list some mechanical properties that are covered under EN 71-1:

• Small parts
• Sharp edges
• Hinges
• Springs

Documentation

As the Toy Safety Directive is one of the CE directives, plastic toys importers and manufacturers should comply with the documentation requirement as listed below:

• Declaration of Conformity
• Technical files
• User instructions
• EC Type-Examination Certificate (if applicable)
• Test reports

Labeling

The directive sets out the labeling requirements for general toy products, including plastic toys. Here’s an overview of the required labeling information:

• CE marking
• Warning statements
• Product traceability information (e.g. manufacturer contact information and batch ID)

Lab Testing

Plastic toys’ importers or manufacturers should arrange lab testing according to the requirements of the Toy Safety Directive, for example, EN 71-1. There are testing companies such as SGS and TUV that can provide testing services for your plastic toys.

Persistent Organic Pollutant (POP) Regulation

Certain plastic products might contain Persistent Organic Pollutant (POP) for different usages, such as flame retardants. The POP Regulation restricts certain types of POP.

Product Scope

Here are some examples of plastic products that might contain POP:

• Plastic containers
• Plastic beverage bottles
• Product packaging
• Plastic bags

Restricted Substances

Annex I lists restricted POPs under the regulation. Here are some examples of restricted POPs that might be found in plastic products:

• Polychlorinated Biphenyls (PCB) – < 0.005% by weight
• Mirex – < 0.005% by weight
• Hexabromocyclododecane – < 0.1% by weight

Lab Testing

Importers and manufacturers should assess the concentration of restricted POP in their plastic products. Testing companies such as TUV and Intertek can provide POPs testing services.

Regulation (EC) No 1935/2004: EU Food Contact Materials Framework Regulation

Regulation (EC) No 1935/2004 applies to food contact materials (FCM), including plastic products. It sets general safety requirements such as:

• Substance restrictions
• Documentation requirements
• Labeling requirements
• Good Manufacturing Practice (GMP) requirements

While Regulation (EC) No 1935/2004 covers general requirements, specific requirements for different kinds of FCM are listed in different regulations. In the following sections of this guide, we cover the specific regulations that apply to specific plastic products:

• Regulation (EU) 10/2011: Plastic FCM
• Regulation (EC) No 1895/2005: Epoxy Derivatives Restriction
• Regulation (EC) No 282/2008: Recycled Plastic FCM
• Regulation (EU) 2018/213: Bisphenol A in FCMs
• Directive 93/11/EEC: Teats and Soothers
• Regulation (EU) 284/2011: FCM from China or Hong Kong

Substance Restrictions

Article 5 specifies that articles listed in Annex I might be subjected to specific substances restrictions. Annex I includes plastic products, and we list specific substance requirements in the following sections.

Documentation

Article 16 specify that, for some classes of products, including plastic products, importers and manufacturers should draft a Declaration of Compliance, which should include information such as:

• Importer or manufacturer contact information
• Identity of the materials
• Compliance statement
• Specifications on the use of materials
• Date of the declaration and signature

Labeling

Article 15 specifies the information that should be included in the product or packaging label:

• Importer or manufacturer contact information
• Instructions for appropriate use (if necessary)
• The words or symbol of “For Food Contact” (if it is not clear that the product is intended to enter in contact with food)

Regulation (EU) 10/2011: Plastic FCM

Regulation (EU) 10/2011 acts as a comprehensive guideline for plastic food contact material (FCM) products. It covers topics such as general requirements for plastic FCMs, migration limits, and declaration of compliance as specified in Regulation (EC) No 1935/2004.

Product Scope

The regulation is applicable to plastic FCMs, such as:

• Plastic boxes
• Plastic bottles
• Plastic kitchenwares
• Plastic forks

Restricted Substances

The regulation establishes restrictions for substances that might be dangerous for humans. For example, Annex II sets a migration limit in plastic products for substances such as:

• Barium <1mg/kg
• Cobalt <0.05 mg/kg
• Iron <48 mg/kg
• Lithium <0.6mg/kg
• Managanese <0.6mg/kg
• Zinc <25 mg/kg

Lab Testing

FCM importers and manufacturers should arrange relevant lab testing in accordance with Regulation (EU) 10/2011, for example, to confirm the migration limits of restricted substances. Testing companies such as Intertek and SGS can offer testing services.

Regulation (EC) No 1895/2005: Epoxy Derivatives Restriction

Regulation (EC) No 1895/2005 sets out restrictions of epoxy derivatives used in plastic FCMs, such as BADGE, BFDGE and NOGE. It also specifies that a written declaration is needed, according to the declaration of compliance requirements specified in Regulation (EC) No 1935/2004.

Product Scope

The regulation applies to plastic FCMs, such as:

• Plastic containers
• Plastic bottles
• Plastic bowls

Restricted Substances

The regulation sets out the migration limits and prohibitions as below:

• BADGE < 9 mg/kg
• BFDGE – prohibited
• NOGE – prohibited

Lab Testing

Most importers and manufacturers are not capable of assessing the epoxy derivative substances in their FCMs, and they should arrange tests from testing from reputable testing companies.

Regulation (EC) No 282/2008: Recycled Plastic FCM

Regulation (EC) No 282/2008 sets out the requirements for recycled plastic materials and articles, which covers topics such as recycling process, specific labeling requirements, and declaration of compliance requirements as set out in Regulation (EC) No 1935/2004.

Product Scope

The regulation is applicable for plastic FCMs which contain recycled plastic. Here are some examples of the covered products:

• Plastic tablewares
• Plastic bottles
• Plastic food packages

Requirements

The regulation sets out the requirements as below:

a. Recycled plastic materials should only contain recycled plastics that undergo the recycling process authorized in accordance with this regulation

b. The quality assurance system of the recycling process should comply with regulation (EC) No 2023/2006

Labeling

Besides complying with the labeling requirements set out by Regulation (EC) No 1935/2004, which apply to all FCM, recycled plastic products should also comply with the following measures:

a. Importers or manufacturers should indicate on the label if their products contain recycled plastics, for example, “This product contains recycled plastics.”

b. It is voluntary to create a self-declaration to demonstrate that the recycled plastic materials comply with the requirements laid down in ISO 14021 or equivalent

Regulation (EU) 2018/213: Bisphenol A in FCMs

Regulation (EU) 2018/213 sets out the Bisphenol A restrictions in FCMs, which are relevant for most plastic FCMs, and the need for a written declaration, that is the declaration of compliance mentioned in Regulation (EC) No 1935/2004.

Product Scope

BPA is used as a monomer in the production of plastic materials. Here are some examples of FCMs that might contain BPA:

• Plastic lunch boxes
• Plastic containers
• Plastic bottles
• Plastic straws

Restricted Substances

The regulation sets out the requirements for BPA as below:

a. The migration limit of BPA from varnishes or coatings applied to FCMs is 0.05mg/kg

b. BPA from varnishes or coatings is prohibited for FCMs designed for infants and young children

Lab Testing

Importers and manufacturers should perform lab testing to assess the BPA content in their FCM products before placing them in the market.

Directive 93/11/EEC: Teats and Soothers

Directive 93/11/EEC focuses on the release of N-nitrosamines and N-nitrosatable substances from rubber teats and soothers.

Product Scope

The Directive covers most types of teats and soothers, such as:

• Plastic teats
• Plastic soothers
• Rubber teats
• Rubber soothers

Restricted Substances

The Directive sets out the following restrictions for teats and soothers:

• N-nitrosamines <0.01 mg/kg
• N-nitrosatable < 0.1 mg/kg

Lab Testing

Importers and manufacturers should verify if plastic teats and soothers are compliant with this directive. They should contact a reputable testing company to perform relevant N-nitrosamines or N-nitrosatable testing.

Regulation (EU) 284/2011: FCM from China or Hong Kong

Regulation 284/2011 lays down specific provisions relating to imported polyamide and melamine plastic kitchenware from China or Hong Kong, including restricted substances and documentation requirements.

Product Scope

The regulation covers plastic kitchenware imported from Hong Kong or China. Here are some examples of the covered products:

• Plastic spoons
• Plastic chopping boards
• Plastic forks
• Plastic spatulas

Restricted Substances

The regulation provides the substance requirements as below:

a. The detection limit for primary aromatic amines is set to 0.01 mg/kg of food

b. Melamine kitchenware should not release formaldehyde into foods in a quantity exceeding 15 mg/kg of food

Documentation

The regulation states that importers and manufacturers should draft a declaration stating that the products do not release restricted substances above the limits.

Lab Testing

Lab testing reports are necessary for importing polyamide and melamine plastic kitchenware from China or Hong Kong. Importers and manufacturers should arrange lab testing from reputable companies such as Intertek and TUV.

Single-Use Plastics Directive

The Single-Use Plastics Directive applies to a wide range of single-use plastic products, including food containers and straws. It sets out product bans and marking requirements for single-use plastic products.

Product Scope

Here are some examples of the covered products:

• Cups for beverages
• Food containers
• Straws
• Food wrappers
• Balloons

Banned articles

Certain single-use plastic products are prohibited, such as:

• Forks
• Knives
• Spoons
• Chopsticks
• Plates
• Drink stirrers

Labeling

The Directive requires that single-use plastic products listed in Annex Part D should bear a legible and indelible marking on its packaging or on the product. Here are some product examples:

• Sanitary towels
• Tampons
• Tobacco products with filters
• Cups for beverages

The label should include the following elements:

• Waste management options
• Plastic-type in the product
• Harmonized mark
• Recycling information