European Commission notifies proposed Toy Safety Regulation to WTO

On 4 October 2023, the European Commission notified its ‘Proposal for a Regulation of the European Parliament and of the Council on the Safety of Toys and Repealing Directive 2009/48/EC’ to the World Trade Organization (WTO). The proposed Regulation will introduce general bans on the most harmful chemicals in toys and will require that a product passport for toys, including information on compliance. Comments will be accepted for 90 days from the date of notification.

Background

In the EU toys are currently regulated by Directive 2009/48/EC on the safety of toys. This Directive sets out the safety requirements that toys must meet in order to be placed on the EU market, whether they are manufactured in the EU or in third countries. This facilitates the free movement of toys within the Single Market.

However it has been found that there is a need for a higher level of protection against possible risks in toys, in particular those posed by harmful chemicals. In addition, the EU’s Chemicals Strategy for Sustainability (CSS) called for better protection of consumers and vulnerable groups from the most harmful chemicals. As a result, the European Commission is proposing new rules to ensure that only safe toys are sold in the EU.

Key points of the proposed Toy Safety Regulation

The new proposed Toy Safety Regulation will build on the existing legislation and update the safety requirements that toys must meet to be marketed in the EU, whether they are manufactured in the EU or elsewhere.

The proposed Regulation will mainly focus on increasing the protection from harmful chemicals but will also strengthen enforcement measures by introducing a Digital Product Passport. Details of the two measures are set out below.

1. Strengthening protection against harmful chemicals: The proposed Regulation will not only maintain the current ban on substances that are carcinogenic, mutagenic or toxic for reproduction (CMRs), but will also ban the use of other harmful chemicals in toys. It targets chemicals that are particularly harmful for children such as endocrine disrupters, or substances toxic to a specific organ including the immune, neurological or respiratory systems. Specifically, the Regulation prohibits the use in toys of substances or mixtures classified in any of the following categories:

• Carcinogenicity, germ cell mutagenicity or reproductive toxicity (CMR): Category 1A, 1B or 2

• Endocrine disruption: Category 1 or 2

• Specific target organ toxicity: Category 1 (either in single exposure or in repeated exposure)

• Respiratory sensitisation: Category 1

Substances within these hazard classes are automatically banned in toys without the need to assess the specific risk they pose to children. 

These chemicals are particularly harmful for children as they can affect their hormones, their cognitive development or health in general. The introduction of  general bans for the most harmful substances as soon as their hazards have been established under the Classification, Labelling and Packaging (CLP) Regulation will ensure that children are protected more quickly from the possible risks of these substances when they are present in toys.

The proposed Regulation will only allow derogations from these general bans only in limited circumstances where the use of these substances in toys does not pose a risk to children and where  no alternatives are available.

The Appendices of the proposed Regulation list substances for which specific conditions such as migration limits are set. For example, nitrosamines and nitrosable substances are prohibited in toys intended for us by children under 36 months or in other toys intended to be placed in the mouth where the migration of those substances is equal to or higher than 0.01 mg/kg for nitrosamines and 0.1 mg/kg for nitrosable substances. They also set limits for, for example, flame retardants, preservatives in water-based toys, and fragrances and list substances subject to specific labelling requirements.

2. Strengthening enforcement: The proposed Regulation will ensure that only safe toys are sold in the EU. All toys will be required to have a Digital Product Passport, containing information on compliance with the proposed Regulation. Importers will have to submit Digital Product Passports for all toys at the EU borders, including for those sold online. In addition, if there are unsafe toys that pose risks not clearly covered by the Regulation, the proposal ensures that the Commission has the power to require that these toys are withdrawn from the market.

The full text of the proposed Regulation can be found here.

Timeline

The proposed Regulation will have to be adopted by the European Parliament and the Council under the ordinary legislative procedure. No precise timetable has yet been set.