Bisphenol A (BPA) Regulations in the European Union: An Overview

A broad range of products can contain Bisphenol A (BPA), which is used to enhance plastic durability. However, Bisphenol A (BPA) is restricted under various regulations in the EU due to its potential to cause harm to human health.

More specifically, Bisphenol A is restricted in consumer products, food contact materials, and toys in the European Union.

In this guide, we explain how regulations REACH, the Toy Safety Directive, and other regulations, including some national laws, either restrict or relate to Bisphenol A.

What is Bisphenol A?

Bisphenol A, also known as BPA, is an organic chemical mainly used for producing plastics such as polycarbonates and epoxy resins. Since the 1960s, a wide range of products have contained BPA.

The main reason for using BPA is that it enhances crucial properties such as durability and heat resistance for a wide range of plastic products.

BPA-based plastics and coatings are common materials used to manufacture a wide range of products, such as:

• Food contact materials (FCM)
• Toys
• Eyewear
• Accessories

Research into BPA suggests that the substance may cause side effects such as harm and disruption to the human hormonal and reproductive systems.

These effects, for instance, could lead to slow development and damage to the functionality of the brain and reproductive organs of infants. BPA may also negatively impact human fertility and cause skin allergies.

Is Bisphenol A banned in the European Union?

The EU has prohibited the use of BPA in the manufacture of infant feeding bottles and similar products. Additionally, it limits the amount of BPA allowed to leach into food from plastic food contact materials, varnishes and coatings to 0.05 mg/kg.

Further, REACH has restricted the use of BPA in thermal paper to 0.02% by weight since 2020. BPA is also a substance of very high concern (SVHC), which means that there are notification requirements under REACH, for products that contain it.

The Toy Safety Directive specifies that the migration limit of BPA permitted to leach from the following products is 0.04 mg/L:

• Toys for children up to three years of age
• Toys meant for placement in a child’s mouth

Some EU countries have developed their own national regulations related to the restrictions of BPA. For example, France bans the use of BPA in food packaging intended to be used by consumers of all ages. Other EU member states, such as Sweden, Denmark, or Belgium, ban BPA in certain food contact materials intended for young children.

Examples of products and materials that may contain Bisphenol A

Products such as food contact articles, toys, and lenses may contain BPA-based plastics to enhance their resistance, durability, and sustainability.

For example, food packaging products such as tin cans, plastic lunch boxes, and plastic wraps have contained BPA for decades to increase the materials’ durability, shatter resistance, and heat resistance. These characteristics lead to the better preservation performance of the food. The electronics and toy industries also use BPA during manufacturing.

Here are a few examples of product categories that may contain BPA:

• Food packaging
• Plastic toys
• Safety glasses
• Safety helmets
• Reusable plastic FCM
• Optical lenses
• Window glass
• Catheters

As mentioned, BPA is also an important substance in the electronic manufacturing industry. BPA-based polycarbonate plastic is sometimes used as the exterior element of products, such as:

• LED lighting
• Computers
• Cell phones
• Cameras
• Hairdryers
• Power sockets

REACH

REACH is an EU regulation that restricts the use of certain chemical substances in consumer products. The Candidate List of Substances of Very High Concern (SVHC) under REACH includes Bisphenol A under Category 1B because it is toxic for reproduction and has endocrine-disrupting properties.

As such, importers and manufacturers must submit to the ECHA a notification via the SCIP database if the concentration of BPA in their products exceeds 0.1% by weight.

BPA restrictions on thermal paper

The ECHA has added BPA to Annex XVII to REACH, restricting the concentration of BPA in thermal paper to 0.02% by weight.

The main reason for this decision is that cashiers are exposed to BPA as they must often handle a great number of thermal paper receipts. The unborn children of pregnant workers represent the category that is most at risk for BPA exposure.

BPA restriction intention

Germany has proposed to restrict BPA in products to 0.001% by weight in order to reduce the amount of endocrine-disrupting bisphenols released into the environment. This proposal also concerns other types of bisphenols, that is, Bisphenol B, S, F, and AF.

Toy Safety Directive

The Toy Safety Directive sets migration limit values for chemicals used in toys meant for placement in the mouth by children aged 3 and under. The directive specifically requires the BPA migration limit to not exceed 0.04 mg/l (migration limit) per the methods and requirements of the following standards:

a. EN 71-10 – Safety of toys – Organic chemical compounds – Sample preparation and extraction

b. EN 71-11 – Safety of toys – Organic chemical compounds – Methods of analysis

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

This regulation specifies that the migration limit of BPA from coatings or varnishes into food must not exceed 0.05 mg/kg. It also specifies that no BPA migration is allowed from varnishes or coatings used in articles intended for:

• Infant formula and follow-on formula
• Processed cereal-based food
• Special medical food for infants and young children
• Milk-based drinks specifically meant for young children

Finally, this regulation amends the Plastic Food Contact Materials Regulation (EC) 10/2011. See the next section for details.

Plastic Food Contact Materials: Regulation (EC) 10/2011

This regulation was amended by the Use of Bisphenol A in Varnishes and Coatings Regulation (EU) 2018/213 to include the following provisions:

a. The specific migration limit of BPA from plastic food contact materials is set to 0.05 mg/kg; and

b. The usage of BPA is prohibited in the manufacture of:

• Polycarbonate infant feeding bottles
• Polycarbonate drinking cups for infants and young children

Classification, Labelling and Packaging Regulation

The Classification, Labelling and Packaging (CLP) Regulation sets classification, labelling, packaging, and testing requirements for hazardous substances.

This includes BPA (or 4,4′-isopropylidenediphenol) which, according to the C&L Inventory, can be found in polymers used to manufacture products such as food packaging, toys, and electronics, and may cause eye damage and respiratory irritation and is:

• Reprotoxic
• Skin sensitising
• Endocrine disrupting
• Very toxic to aquatic life

Labelling requirements

The CLP Regulation requires substances and mixtures containing BPA to carry harmonised hazard classification and labelling symbols and hazard statements. This is due to the substance’s potential reprotoxic and negative effects on human health and the environment.

Specifically, the packaging label for substances and mixtures containing BPA must include the signal word “Danger!” and the following pictograms, besides the general labelling information listed in Article 17 of the regulation:

• Corrosive
• Serious health hazard
• Health hazard
• Hazardous to the environment

EN 14372 – Child use and care articles – Cutlery and feeding utensils – Safety requirements and tests

EN 14372 sets test methods and safety requirements for the following products:

• Cutlery meant for use by children aged 3 and under
• Feeding utensils meant for use by children aged 3 and under
• Products whose secondary function allows children to use them as feeding utensils

This standard does not apply to:

• Pre-prepared food containers
• Specialist medical-use cutlery and feeding utensils
• Feeding bottles
• Teats
• Spouts
• Cups

According to SAI Global, EN 14372 also covers requirements regarding BPA release.

National BPA Regulations

Other than the above-mentioned regulations enacted by the EU, there are several national regulations concerning the restriction of BPA in consumer products. The following are brief descriptions of regulations implemented in some EU countries.

France

France’s Law No. 2012-1442 bans the manufacture, importation, and placing on the market of packaging, containers, or utensils meant to directly contact food intended for infants and young children.

The law also notes that such packaging containing BPA should include a health warning for:

• Pregnant women
• Breastfeeding women
• Infants
• Young children

Sweden

Sweden’s Regulation SFS 2012:991 forbids the use of BPA in paints and coatings for food packaging in direct contact with food intended to be consumed by children between the ages of 0 and 3.

Denmark

Denmark’s Statutory Order No. 822 bans the use of BPA in materials intended to come in contact with food specifically meant for children under the age of 3.

Belgium

Belgium’s Act of 4 September 2012 prohibits the use of BPA in food containers marketed to children under the age of 3 years.

Austria

Austria’s Federal Law Gazette II No. 327/2011 forbids the use of BPA in manufacturing pacifiers and teething rings for children.

Bisphenol A Lab Testing

Importers and manufacturers must ensure that the BPA levels in their products do not exceed specified migration limits and restrictions by having their products lab tested to prove compliance with various regulatory requirements (e.g., REACH, Toy Safety Directive).

When the products pass lab testing, they receive a test report that proves compliance with the relevant requirements.

Test methods

Here are a few examples of methods used to test products for BPA:

• Liquid chromatography-mass spectrometry (LC-MS)
• High-performance liquid chromatography (HPLC)
• Gas chromatography with mass spectrometry (GC-MS)

Testing companies

We list here a few companies that offer to test products for BPA:

• Intertek
• SGS
• Eurofins
• Bureau Veritas

Compliance Risks

Plastics used to manufacture food contact materials and other plastics may contain excessive amounts of Bisphenol A. Some manufacturers outside the European Union simply don’t have material data confirming whether their materials contain Bisphenol A or not.

It’s therefore essential to assess the supplier’s existing compliance track record – in terms of Bisphenol A test reports issued for previous production runs.

Further, lab testing is also often the only way to verify compliance.