Upcoming Toys Safety Regulation

Shaking up the market for toys
There will be a new regulation on the safety of toys. On July 28 2023, the European Commission published a proposal.

The proposal aims to decrease the number of unsafe toys sold in the EU by extending the ban on harmful chemicals and strengthening testing on safety, security, and privacy. The rules also respond to several new challenges introduced by digital (smart) toys and online shopping. The existing Directive is replaced a directly applicable Regulation.

This proposal will be voted on in rounds by the European Parliament and the Council and is expected to be largely approved in the foreseeable future. New chemical requirements and the introduction of the digital product passport will pose a huge challenge for the toy industry.

On 13 March 2024, the European Parliament approved its position in favour of the safety rules drafted for toys.

The first trilogue on the proposed Regulation on Toy Safety was held on 20 November 2024 during which Commission, Parliament and the Council presented their mandates and priorities. The Rapporteur, Ms Marion Walsmann (EPP) reported back to IMCO Members on the proceedings during the committee meeting of 3 December.

Transition period

For the most part, there is a transition period of 30 months after the final version of the Toy Safety Regulation has been published. Deviations are under discussion including the unusual proposal that would affect toys already being marketed before the end of the transition period.

Harmful chemical substances

An important part of the changes is the introduction of much stricter rules on chemicals. This caused great concern in the toy industry, which fears that the stricter rules will put many toy manufacturers out of business.

The Toy Safety Regulation extends and simplifies the requirements for chemicals. There is more alignment with existing chemicals regulations such as REACH. Generic restrictions of harmful substances are no longer limited to substances which are carcinogenic, mutagenic or toxic for reproduction (CMR) but will also apply to endocrine disruptors (EDR), respiratory sensitisers and substances toxic to a specific organ (STOT).
The possibilities for a derogation will be limited and are assessed by the European Chemicals Agency (ECHA).

The proposed changes on chemicals are in line with the so-called Chemicals Strategy for Sustainability (CSS). The strategy is part of the EU’s zero pollution ambition, which is an important goal of the European Green Deal. The chemicals strategy protects citizens and the environment better. It bans the most harmful chemicals in consumer products such as toys, childcare articles, food contact materials, cosmetics, detergents, furniture, and textiles. Enforcement is also an issue, there are still too many non-compliant or unsafe toys on the EU market. The impact assessment report proposes several policy options, the preferred solution is a combination of policy options 1b and 2b:

• Policy option 1b empowers the Commission to add and amend limit values for chemicals in any toy. It extends generic bans to other harmful chemicals in toys, but still allows (few) derogations.
• Policy Option 2b requires compliance documentation to be present in the digital product passport -> under the Ecodesign for Sustainable Products Regulation (ESPR), and requires this product passport to be presented at customs. This option does not demand third-party conformity assessment to: (i) toys for children under the age of 3; (ii) toys to be put in the mouth; and (iii) toys which are chemical mixtures as is proposed in options 2a and 2c.

Even with the ‘baseline’ option of no policy change specific restrictions on harmful chemicals for children under 3 years of age will still be introduced.

More substances
The appendix with conditions for chemicals in toys has more strict migration limits for aluminium, chromium-VI, nitrosamines and nitrosable substances. It adds limits for formaldehyde and aniline. It extended the list of restricted allergenic fragrances and of substances with specific labelling requirements. New scientific knowledge may revise existing limit values where necessary.

Good manufacturing practice
In order to ensure toy safety any change to the manufacturing process, the raw materials or the components of the toy should be reviewed and documented. Even traces of prohibited substances should be (technologically) avoided with good manufacturing practices.

This means that the toy manufacturer must know all the chemical details for each material present in the final toy. That is:

• How is the material made or processed?
• Which raw materials have been used for making of a material?
• Is the material contaminated with harmful chemicals?

Impact on costs
It is expected that the number of banned substances increases with 10 - 30%. This results in 5% of toy models no longer possible, that is around 300 million Euro worth of products. And another 6% of toy models needs adaptation. More complex and sensitive testing is required, testing costs may increase with 3.000 Euro per model.

Digital Product Passport
The Ecodesign for Sustainable Products Regulation (ESPR) introduces a digital product passport (DPP).
The passport provides information on the compliance of products to authorities, supply chain ‘actors’ and consumers.
The Toy Safety Regulation refers to ESPR for the general requirements and principles. In addition it defines to information requirements for toys to be mentioned in the digital product passport. Direct access to the digital product passport is enabled through a ‘data carrier’, such as a QR-code, that shall be affixed to the toy.

The Ecodesign for Sustainable Products Regulation (ESPR) introduces a digital product passport (DPP). The passport provides information on the compliance of products to authorities, supply chain ‘actors’ and consumers. The Toy Safety Regulation refers to ESPR for the general requirements and principles. In addition it defines to information requirements for toys to be mentioned in the digital product passport. The draft Toy Safety Regulation extends the use of the Digital Product Passport beyond ecodesign and also covers safety and compliance information. Direct access to the digital product passport is enabled through a ‘data carrier’, such as a QR-code, that shall be affixed to the toy.
The product passport replaces the EU declaration of conformity (for toys).

The digital product passport for toys shall contain the following information:

• Traceability; unique product identifier, name and address of the manufacturer, unique operator identifier, identification of toy, colour image, commodity code;
• References to all Union legislation and harmonised standards used;
• Notified body name and number, conformity assessment procedure, certificate reference (where applicable)
• The CE marking;
• List of allergenic fragrances that are present in the toy (if any)
• Any substance of concern that is present in the toy (if any)

Safety information, warnings and instructions of use may be included in the product passport.

Electronic address
Communication with consumers will be enhanced by the indication of a website or email address in addition to the postal address. The mention of an electronic address is an obligation for manufacturers and importers. The same address obligation is in the GPSR (EU) 2023/988, which entered into force on 13 December 2024.

Pictogram for warning
The present Toy Safety Directive requires that warnings are preceded by the word ‘Warning’.
The word shall be translated into all languages.
A new generic pictogram may be used instead of the word(s) and simplifies this requirement.

Slings and catapults
Slings and catapults are no longer mentioned in the list of excluded products. Therefore, slings and catapults intended for children need to comply with the requirements of the Toy Safety Regulation.

Link to the Toys Safety training: https://www.productip.com/toy-safety-training