EUROPEAN PARLIAMENT RESOLUTION ON THE PROPOSAL FOR A EUROPEAN REGULATION ON THE SAFETY OF TOYS
On 13 March 2024, the European Parliament adopted at first reading a legislative resolution on the proposal for a regulation of the European Parliament and of the Council on the safety of toys and repealing Directive 2009/48/EC.
This proposal for a regulation aims to strengthen the rules on the safety and free movement of toys within the EU internal market, taking account of the European precautionary principle.
The new requirements set out in this proposal are as follows:
- Require manufacturers to draw up a “digital product passport” providing all the information on the conformity of toys, in particular – all the safety requirements and standards applicable to the toy concerned, in order to facilitate conformity assessment and checks by the authorities of the EU Member States. This passport will replace the EU declaration of conformity. The European Commission and national authorities will be required to provide full assistance to SMEs in this process.
- Extending the ban on carcinogenic and mutagenic substances in toys to endocrine disruptors, chemicals affecting the respiratory system and also perfluorinated and polyfluorinated alkaline substances (PFAS).
- Digital toys with artificial intelligence (AI) will have to comply with the future regulation of the European Parliament and of the Council laying down harmonised rules on artificial intelligence (proposal stage – adopted at first reading by the European Parliament). Under the AI legislation, AI-enabled toys are classified as high-risk toys. This means that these toys will have to comply with safety, security and privacy standards from the design stage, and be subject to third-party assessments, risk management, transparency and human supervision. Manufacturers will have to take account of the risks to children’s cognitive development and mental health when using this type of toy.
- Before any toy is placed on the market, manufacturers will have to continue to carry out an evaluation to prove that the product complies with the essential safety requirements.
- The draft regulation on toys stipulates that from now on this assessment will have to include at least the following steps: a) cover all chemical, physical, mechanical, electrical, flammability, hygiene and radioactivity hazards and potential exposure to these hazards; b) with regard to chemical hazards, take into account possible exposure to individual chemical substances and any known additional hazards resulting from combined exposure to the different chemical substances present in the toy, taking into account the obligations under Regulation (EC) No 1907/2006 and the conditions set out therein; c) be updated as and when additional data is provided. The draft regulation also specifies that the safety assessment must be included in the technical documentation. This is an innovation that does not currently exist in the Toys Directive.
In the Toy Safety Directive (Article 21), the supervisory authority gives the manufacturer 30 days to submit the technical documentation and translation. The draft regulation provides for different deadlines: 15 working days for the technical documentation and 30 working days for the translation.
As part of the applicable conformity procedures, the Toys Directive (Article 19) allows the manufacturer to apply harmonised standards covering the relevant safety requirements for toys. The draft regulation on toy safety specifies that these are the relevant safety requirements for the toy identified in the conformity assessment, now extended to the above-mentioned stages (see above).
Under the proposed Toy Safety Regulation, the manufacturer will no longer be able to use the internal control procedure Module A (Annex II) of Decision 768/2008 of 9 July 2008 on a common framework for the marketing of products, but the one mentioned in Part 1 of Annex IV of the draft regulation.
In Part I of Annex IV of the draft regulation on toy safety, the module only concerns internal control of manufacturing. There is no longer any mention of supervised product testing. Furthermore, according to the draft, part 4 of the module concerning “product checks” is deleted.
Part 5 of the module has been extended to include the digital passport, in addition to the requirements for CE marking. The draft stipulates that, from now on, the manufacturer must not only affix the CE marking but also draw up the digital product passport for the identified toy and ensure that it remains available, along with the technical documentation, for ten years after it has been placed on the market.
In addition, manufacturers will now be able to provide consumers with a QR code for online access to safety information, as a supplement to the warnings on toys (label and packaging).
On 15 May 2024, the Council of the European Union adopted its position on the proposed Toy Safety Regulation in a negotiating mandate.
According to the mandate, toy manufacturers’ obligations will have to be brought more into line with those set out in the General Product Safety Regulation:
- Manufacturers will have to ensure the presence of warnings in one or more languages easily understood by consumers and other end-users, the determination of which is left to the Member States.
- Manufacturers will have an obligation to inform other economic operators in the distribution chain as soon as any product conformity problem arises. This obligation extends to toy importers, who will have to inform the manufacturer and the market surveillance authorities if they suspect a risk for a toy.
- Toys offered on online market platforms that do not comply with the Toy Safety Regulation will be considered as illegal content for the purposes of the Digital Services Regulation.
- The Council defines the “digital product passport” as a toy-specific dataset which contains the information referred to in Annex VI of the draft Regulation and which is accessible electronically via a data carrier.
- The Council introduces new requirements into Annex III of the proposal for a Regulation on the safety of toys, concerning the requirements for the minimum size, visibility and legibility of warnings visible to the general public (pictogram of at least 10 mm on a yellow background with a black triangle and a black exclamation mark).
- The regulation on toy safety will have to take account of the provisions of the CLP regulation (Classification, Labelling and Packaging), in particular by limiting the ban on toys to CMR substances (Carcinogenic, Mutagenic and Reprotoxic substances) that have been subject to harmonised classification.
- The Council also clarifies the labelling of certain allergenic fragrances in toys.
The Council of the EU will begin negotiations with the new European Parliament as soon as the MEPs have taken office and adopted their position on the Council’s negotiating mandate.
