An overview of the draft EU Toy Safety Regulation

The EU presented the draft Toy Safety Regulation on 28 July 2023. The aim is to replace the current Directive 2009/48/EC on the safety of toys and to address shortcomings in the existing legislation against the desired high level of protection for children, including, according to the European Commission, in particular in relation to harmful chemicals. In 2022, alerts on toys were at the top of the EU's "Safety Gate" portal, the EU's rapid alert system for dangerous non-food products.

Scope of application

The draft EU Toy Safety Regulation applies to all toys, ie products designed or intended to be used for play by children under the age of 14, in line with Directive 2009/48/EC; it adds only slings and catapults. However, it does not apply to the 23 product categories listed in Annex I, including: 

• playgrounds for public use
• collectors' items
• sports equipment, including inline skates and skateboards, for children with a body weight of more than 20 kg
• bicycles with a maximum saddle height > 435 mm
• scooters and other means of transport (whether or not electrically powered) intended for use as sports equipment or for travel on public roads or paths
• water sports equipment intended for use in deep water and flotation devices for children, such as swimming seats and flotation devices
• puzzles with more than 500 pieces
• functional educational products such as cookers, irons and other functional products with a rated voltage > 24 volts
• electronic devices such as personal computers and game consoles, unless specifically designed for children
• lights that could be mistaken by children for toys
• fashion accessories for children not intended for play.

The European Commission may further specify the scope through implementing acts.

Tighter product safety requirements

The draft contributes to the protection of children from harmful substances by extending existing requirements and tightening up limit values. In addition to the protection of mental health and safety, the general safety requirement is extended to include psychological and mental health, as well as children's wellbeing and cognitive development.

The ban on the use of carcinogenic, mutagenic and reprotoxic (CMR) substances is also extended to include a ban on endocrine disrupters, inhalation allergens and specific organotoxic substances in order to address particular risks to children's endocrine and respiratory systems. At the same time, the draft provides for the possibility of derogations from the ban on the use of certain substances, to be examined on application by the European Chemicals Agency (ECHA).

In order to effectively protect children over 36 months, the limit values for certain substances already contained in the previous Toy Safety Directive will apply to all toys, regardless of their targeted age. Manufacturers must carry out a safety assessment of the toy to demonstrate that their product complies with the essential safety requirements (Article 21 ff.; previously Article 18 ff. of the Toy Safety Directive), whereby the possible combined exposure to several chemical substances must now also be taken into account with regard to chemical hazards.

Warnings and CE marking

There are also noteworthy changes relating to the design of toys. Manufacturers must now affix a CE marking to the toy, to a label attached to the toy or to the packaging of the toy. If the CE marking is not visible on the outside of the packaged toy, it must also appear on the product packaging. After the CE marking, the manufacturer must affix a general warning to the toy (Article 6) with appropriate use restrictions - the word "Warning" or “Warnings”, which was previously required, can now be replaced by the word "caution" or the following pictogram (see Article 11(2) Toy Safety Directive versus Articles  11(2) and 16 of the Toy Regulation):

Introduction of the digital product passport

In order to prevent the marketing of non-compliant toys, the draft relies on increased market surveillance. Infuture, every manufacturer will have to provide a product passport on a data carrier (Article 17) with toy information for the respective toy, which declares the conformity of the toy with the product requirements of the Toy Safety Regulation and in this respect replaces the EU Declaration of Conformity (Article 5 Decision No. 768/2008/EC). For example, in addition to a unique product identifier (product code), information on the manufacturer, the customs tariff number and the CE marking must be provided, as well as a list of all EU legislation with which the toy complies and all substances of concern and fragrances contained in the toy (Annex VI).

To ensure that market surveillance authorities, customs authorities and other economic operators have direct access to the information on the toy, the product passport will be kept in a centralised register at the Commission for ten years after the toy has been placed on the market.

Extended identification of manufacturers and importers

In addition to their name and postal address, manufacturers and importers will have to indicate their email address on the toy or on the packaging or documents accompanying the toy.

Manufacturers must also make publicly available a telephone number, email address, dedicated section of their website or other communication channel through which consumers can submit safety-related complaints and inform manufacturers of accidents or safety problems related to the toy. Importers must check compliance and, if there is no publicly available communication channel, must establish one themselves.

The role of the General Product Safety Regulation

Among other things, the draft of the new Toy Regulation lacks provisions on distance and online sales. However, the new general EU product safety law (the General Product Safety Regulation 2023/988 (GPSR) (overview here in German) applies in addition - in particular the provisions on online sales in Chapter IV, on the Safety Gate rapid alert system and the Safety Business Gateway in Chapter VI, and on the right to information and redress in Chapter VIII. This is accompanied by the following obligations and innovations:

• Economic operators are obliged to inform the competent market surveillance authorities of any accidents they become aware of in relation to toys made available (Article 20 GPSR).
• Economic operators are obliged to offer compensation measures such as free repairs or replacements when carrying out product recalls - regardless of the age of the recalled toy.
• Recalls and similar measures are subject to stricter requirements, eg recalls using potentially trivialising wording such as "voluntary", "precautionary", "in rare situations" etc. are prohibited under Article 36 of the GPSR.

Getting ready for compliance

The draft EU Toy Safety Regulation introduces many innovations - in particular stricter safety requirements and the introduction of a digital product passport. In view of the time it will take to implement compliance procedures for the new rules, affected economic operators in the toy industry, in particular manufacturers and importers, should familiarise themselves with the obligations involved, even though they have not yet entered into force. Once agreed, the Regulation will come into force 20 days after publication in the Official Journal and will apply (subject to transitional provisions) to toys already on the market.