Directive 2009/48/EC regulates the safety of toys on the EU market, whether coming from the European Union or not. Over the past years, the Commission evaluated the current toys legislation and pointed out the need to improve children’s protection level. In particular, the evaluation identified risks posed by harmful chemicals and non-compliant toys, especially in online sales.
On 28 July 2023, the Commission published the Toys Safety Regulation Proposal. While the transitional period is stated to be 30 months, the application date is still unknown. The Proposal will now be submitted to the Council and the European Parliament, which will have to negotiate and agree upon the text. The scope of the new Regulation will remain the same as the scope of the current Toys Safety Directive.
EU to address risks of harmful chemicals in toys
The protection of children from harmful chemicals has been one of the main focuses of the Regulation’s impact assessment. In this sense, the proposed Regulation will maintain the current ban on carcinogenic, mutagenic or toxic for reproduction (CMRs) in toys and extend it to endocrine disruptors as well as to chemicals toxic to a specific organ. However, there will be the possibility for derogations where those toys do not pose children at risk and there are no alternatives.
Digital passport among the main changes of the new Toys Safety Regulation
Among the main novelties, the new Regulation introduces a digital product passport, which will replace the current Declaration of Conformity. The digital passport will have the function of declaring compliance with the legislation requirements. Moreover, the passport will be connected to a unique product identifier and be included in the Commission Registry – foreseen by the ESPR Regulation (Ecodesign for Sustainable Products Regulation) – which will enable EU customs to identify the product coming from non-EU countries and prevent non-compliant toys from entering the market.
According to the Proposal, the passport must:
- Declare compliance
- Be up to date and available in the languages required by the EU country of sales
- Correspond to one specific model
- Include unique product identifier of the toy and be accessible through a data carrier
- Contain at last all information listed in Annex VI – Part I and may contain the information listed in Annex VI – Part II
- Be accessible to consumers, end-users, market surveillance authorities, notified bodies, the Commission, and other economic operators
- Fulfil specific and technical requirements
Conformity assessment procedures for toys
Manufacturers must assess their toys’ conformity against the Regulation’s requirements. Both EU and non-EU manufacturers can self-assess their toys if there are harmonised standards covering the requirements of that product. In case there are no harmonised standards, the Commission can establish common specifications for the essential safety requirements.
To demonstrate compliance with the safety requirements, manufacturers must perform a safety assessment. The safety assessment must cover chemical, physical, mechanical, electrical, flammability, hygiene and radioactivity hazards as well as any possible exposure hazards, considering also combined exposure to the different chemicals.
When there is no harmonised standard or common specifications for that product, manufacturers must involve a third-party conformity assessment body. This also applies when the manufacturer considers that the toy requires a third-party verification even if harmonised standards or common specifications exist for their product.
Warnings requirements for toys
Toys must bear warnings that specify appropriate limitations when necessary. The manufacturer should mark either on the labels, packaging, or instructions for use all applicable warnings in a clear and understandable way. A pictogram must indicate any special risks or uses of the product. Some specific warnings might be necessary in case of derogations. Such warnings must include information on specific uses allowed in toys with substances subject to bans (in case there is no derogation).
How to approach the European market
Under the current Toys Directive as well as the future Regulation, all manufacturers must comply with the EU legislation if they want to sell on the EU market. Among other things, manufacturers must have compliant technical documentation, EU labels and IFUs, and have a contact point in the EU for market surveillance activities.
The European authorised representative can support non-EU manufacturers in their compliance process, verifying that their toys are not be stopped at European customs and ensuring smooth market-surveillance obligations.
Check the Library of Documents dedicated to toys for more guidelines and news.
European Commission (2023) Proposal for a Regulation of the European Parliament and of the Council on the safety of toys and repealing Directive 2009/48/EC. Retrieved on 31/07/2023.