Chemical Regulations in the European Union: An Overview

Practically all consumer products sold in the European Union are subject to regulations governing the use of heavy metals, chemicals, and other substances. Specific bans and restrictions on substances like lead and phthalates apply to essentially all consumer products – including textiles, childcare items, toys, cosmetics, and kitchenware.

Despite bans and restrictions, some products sold in the EU continue to contain high concentrations of restricted chemicals.

In this article, we list some of the most important EU regulations that cover substances in consumer products. We also explain how you can check if a product contains regulated or prohibited substances.

REACH

The REACH Regulation sets restrictions and reporting requirements for consumer products sold in the EU. Here are examples of substances that are restricted by REACH:

• Lead
• Mercury
• Nickel
• Cadmium
• Phthalates

Certain product categories, such as childcare products and clothing, are subjected to specific substance restrictions. Many companies outside the EU don’t have documentation that proves if the materials are compliant.

How can I meet the requirements of the REACH Regulation?

The product must not contain substances above the set limits to comply with REACH. Testing companies can help you test your product’s materials to verify if these contain restricted substances above the set limits.

RoHS Directive

The RoHS Directive sets maximum concentration values for heavy metals, flame retardants, and phthalates in electronic equipment. We list those substances and their restrictions below:

• Lead – 0.1%
• Mercury – 0.1%
• Cadmium – 0.01%
• Hexavalent Chromium – 0.1%
• Polybrominated biphenyls (PBB) – 0.1%
• Polybrominated diphenyl ethers (PBDE) – 0.1%
• Di(2-ethylhexyl) phthalate (DEHP) – 0.1%
• Butyl benzyl phthalate (BBP) – 0.1%
• Dibutyl phthalate (DBP) – 0.1%
• Diisobutyl phthalate (DIBP) – 0.1%

This means that individual components or other materials in electronic products should not contain the listed substances at levels exceeding established concentration limits.

How can I meet the requirements of the RoHS Directive?

As mentioned previously, the components should not contain substances in concentrations exceeding established limits.

The RoHS directive also sets requirements concerning CE marking, Declaration of Conformity, user instructions, traceability information, and technical documentation. Hence, it’s not only a matter of ensuring compliance with the substance limits.

Toy Safety Directive

Toys must meet the requirements of the Toy Safety Directive, which prohibits the use of certain types of allergenic fragrances. It also requires adherence to specific migration limits for the use of heavy metals and other chemicals.

In practice, many brands must comply with the requirements within EN 71-3: Migration of Certain Elements, which is a harmonised standard under the Toy Safety Directive.

How can I meet the requirements of the Toy Safety Directive?

Lab testing is often necessary to prove that substance concentration levels or migration limits do not exceed those specified under EN 71-3 and the directive as a whole.

Additionally, you should ensure that your toys carry a CE marking and a traceability label and are accompanied by documents such as a Declaration of Conformity, user instructions, and technical documentation.

Food Contact Materials Regulations

Substances in products such as kitchenware and food packaging generally should not migrate to the food they come into contact with. While some requirements for food contact materials (FCM) broadly apply to all materials, other FCM regulations apply only to specific materials.

What differentiates these regulations is, generally speaking, that there are stricter requirements for substance migration during heating or other conditions. For example, substances in a lunchbox or cutlery should not migrate (above set limits) to the food they come into contact with.

The specific requirements often ​​depend on the type of material. For example, plastics or ceramics are subject to specific substance and migration limits. Additionally, various guidance documents exist regarding the usage of metals and silicone, among other materials.

Overview

a. EU Food Contact Materials Framework Regulation (EC) 1935/2004

b. Plastic FCM Regulation (EU) 10/2011

c. Recycled Plastic FCM Regulation (EU) 2022/1616

d. Use of Bisphenol A in Varnishes and Coatings Regulation (EU) 2018/213

e. Ceramics Directive 84/500/EEC

f. Regenerated Cellulose Film Directive 2007/42/EC

g. Active and Intelligent FCM Regulation (EC) No 450/2009

h. Polyamide and Melamine Plastic Kitchenware from China or Hong Kong SAR (China) Regulation (EU) No 284/2011

i. Epoxy Derivatives Restriction Regulation (EC) 1895/2005

j. Teats and Soothers Directive (93/11/EEC)

k. Good Manufacturing Practice for FCM Regulation (EC) No 2023/2006

How can I meet the requirements in the FCM regulations?

In most cases, it is necessary to have your FCM lab tested to prove it complies with the relevant regulations. Testing labs can also help you determine which tests apply to your food contact materials. You should also comply with requirements concerning labelling and documentation, such as a Declaration of Compliance.

Cosmetic Products Regulation

The Cosmetic Products Regulation (EC) 1223/2009 prohibits or restricts the use of certain substances in cosmetic products. Annex II provides a list of prohibited substances.

Examples

• Lead
• Cadmium
• Phthalates (e.g., BBP)
• Nonylphenol and nonylphenol ethoxylate
• Octamethylcyclotetrasiloxane (D4) and decamethylcyclopentasiloxane (D5)

How can I meet the requirements of the Cosmetic Products Regulation?

You should have your cosmetic products tested to ensure that they do not contain prohibited substances or substances in concentrations exceeding established limits. You should also comply with labelling and documentation requirements.

Batteries Regulation

The EU’s new Batteries Regulation replaces the Batteries Directive, and restricts the use of certain substances in batteries:

• Mercury – 0.0005% by weight in batteries
• Cadmium – 0.002% by weight in portable batteries
• Lead – 0.01% by weight in portable batteries

How can I meet the requirements in the Batteries Regulation?

You should ensure your batteries comply with relevant substance requirements. You should also adhere to requirements such as those regarding CE marking, labelling, user instructions, technical documentation, and lab testing.

Classification, Labelling and Packaging (CLP) Regulation

The CLP Regulation classifies and regulates mixtures and substances that might be dangerous to human health and the environment. You can find the list of regulated substances in the Classification and Labelling (C&L) Inventory.

Examples

• Methyldioctylamine
• Tetrabutylammonium nitrite
• Benzene-1,3-dicarbonitrile

How can I meet the requirements in the CLP Regulation?

You should adhere to the relevant requirements, such as those regarding classification, documentation, labelling, and packaging.

Persistent Organic Pollutants (POPs) Regulation

The Persistent Organic Pollutants (POPs) Regulation restricts chemical compounds that do not degrade easily. We list below a few examples prohibited substances from Annex I:

• DDT
• Mirex
• Chlordecone

Release reduction provisions

Here are a few substances subject to release reduction provisions, as listed in Annex III:

• Polychlorinated biphenyls
• Hexachlorobenzene
• Polychlorinated napthalenes

Waste management provisions

We also list below a few substances subject to waste management provisions and their concentration limits, as listed in Annex IV:

• Endosulfan – 50 mg/kg
• Perfluorooctane sulfonic acid (PFOS) – 50 mg/kg
• Hexabromocyclododecane – 500 mg/kg

You should ensure your products do not contain prohibited or regulated substances above their concentration limits.

How can I meet the requirements in the POPs Regulation?

You can meet the requirements in the POPs regulation by having your products tested to ensure they don’t contain any substances prohibited or restricted by this regulation. Additionally, there are labelling requirements for products that contain some substances (e.g. decaBDE).

FAQ

Are importers responsible for ensuring that their products meet relevant substance requirements?

Yes. In practice, importers are responsible for ensuring that the products they place on the market meet the relevant requirements. Selling products that contain levels of prohibited substances, or have levels above set limit values, can lead to sales bans and fines.

How do I know which substances my product contains?

You can theoretically request that your supplier attach test reports to your products. In practice, however, you can only do this with larger suppliers. If you order from smaller factories in Asia, they might not be able to provide relevant test reports or other data regarding the substances and materials in your products.

As such, you often need to have the finished products (or at least material samples) lab tested to verify compliance with all applicable substance regulations.

How much does chemical testing cost?

The cost of substance tests usually depends on factors such as:

• Number of unique materials
• Number of colours
• Number of tests relevant to the material in question

The more materials or colour variations your product contains, the more you may need to pay for testing. Note that some materials and substances may also necessitate extensive testing.

Examples

• Bib (1 colour): USD 1400
• Bib (6 colours): USD 4500

Is lab testing mandatory for products?

Product testing is not always mandatory. However, you must ensure that your product does not contain substances that either exceed maximum concentration values or are prohibited.

This means that you should normally have your product tested to prove compliance with applicable requirements unless the factory can provide you with relevant documentation for all materials and components.

Why do products sold in the EU contain high levels of prohibited substances?

There is often no chemical information available for products and materials manufactured outside the EU. Thus, you might not be able to receive test reports from a garment manufacturer in Vietnam or India, for instance. This doesn’t always mean that the product contains restricted chemicals above the limits – but it might be the case.

The EU have stricter consumer product chemical regulations than other countries and markets. Further, most products made outside the EU are not specifically made for the European market,  – and may therefore not be made to comply.

Additionally, many companies in the EU might not be aware of the substance requirements relevant to the types of products they sell. They might assume that their manufacturers already comply with relevant regulations and then proceed to order products without having them tested or having test reports verified.

B2C cross-border e-commerce is another factor. Consumers in the EU can buy products directly from countries all over the world – many of which are not made to comply with EU substance restrictions. It is not possible for the customs authorities to check each inbound shipment.

If you order products from a non-EU country, you shouldn’t assume that they already comply with relevant EU requirements.

What can I do to reduce the risk of importing products that contain restricted substances?

It is essential that you make a supplier in, for example, China or India aware of the EU chemical regulations that your products must comply with. Further, compliance must also be verified.

This is the procedure we normally follow:

1. Verify if the supplier has pre-existing test reports that indicate a compliance track record.

2. Inform the supplier of the exact chemical regulations to which the product and materials must be compliant.

3. Inform them that lab testing will be arranged to verify compliance – before the full payment is settled.

4. Ask if the supplier is confident in their ability to manufacture products in compliance with the relevant chemical regulations – suppliers are often up front if that is not the case.