EU Toy Safety Directive 2009/48/EC (TSD)
The Toy Safety Directive 2009/48/EC and its amendments, expert group on toy safety, reports, and evaluations.
Guidance documents to assist manufacturers, importers, distributors, and public authorities in the interpretation and application of the Toy Safety Directive.
Toys contribute to child development and play is an essential part of growing up. However, toys have to be safe for children to play with. Ensuring that toys marketed in the EU do not put children at risk is a priority. EU legislation aims to ensure that toys meet safety requirements that are amongst the strictest in the world, especially in relation to the use of chemicals in toys.
The Toy Safety Directive 2009/48/EC
The Toy Safety Directive 2009/48/EC and its amendments, expert group on toy safety, reports, and evaluations. The directive lays down the safety criteria that toys must meet before they can be marketed in the EU. Toys must also comply with any other EU legislation applicable to them.
- general risks: the health and safety of children, as well as other people such as parents or caregivers
- particular risks: physical and mechanical, flammability, chemical, electrical, hygiene and radioactivity risks
The Toy Safety Directive 2009/48/EC replaced the former Directive 88/378/EEC. It adapted the legal framework to technological developments and previously unknown safety issues. The application and enforcement are aligned with the so-called ‘new legislative framework‘.
The new Directive had to be transposed by the EU countries into their national legislation by 20 January 2011 and has applied since 20 July 2011. The chemical safety requirements have applied since 20 July 2013.
Stricter requirements for chemical substances
There are 2 possible conformity assessments allowing toys to be sold in the EU. The manufacturer has to demonstrate the compliance of a toy by
- Eself-verification by using the European harmonised standards.
- third party verification through a notified body
All toys sold in the EU must carry a CE marking. This is the manufacturer’s declaration that the toy satisfies the essential safety requirements. More on placing toys on the EU market.
Placing toys on the EU market
Compared to the former Directive 88/378/EEC, the Toy Safety Directive 2009/48/EC puts in place stricter requirements for chemicals.
- Chemicals that are susceptible to cause cancer, change genetic information, harm fertility or harm an unborn child (so-called CMR substances) are no longer allowed in the accessible parts of toys beyond the concentration limits set in the Regulation on Classification, Labelling and Packaging of substances and mixtures, or unless they are considered safe following a rigorous scientific evaluation.
- 19 so-called ‘heavy elements’ like mercury and cadmium are not allowed in toy parts accessible to children beyond the limits laid down in Toy Safety Directive 2009/48/EC
- 55 allergenic fragrances have been banned. However, some of them, and another 11, may be used in certain toys provided that they are indicated on the label and comply with additional requirements.
Harmonised European standards
The Toy Safety Directive does not specify the technical detail of toy safety requirements. The technical details are developed by the European Standardisation Organisations (CEN, CENELEC).
Safety Requirements: EN 71 Testing
The directive defines safety requirements that toys must comply with, covering aspects such as mechanical and physical properties, flammability, chemical composition, and specific hazards. These requirements aim to prevent potential risks and hazards associated with toys.
EN 71 consists of a series of standards that cover different aspects of toy safety.
- EN 71-1: Mechanical and Physical Properties: This standard sets requirements for the mechanical and physical properties of toys, such as size, shape, strength, and durability.
- EN 71-2: Flammability: This standard establishes criteria for the flammability of toys, ensuring that they do not present a fire hazard.
- EN 71-3: Migration of Certain Elements: This standard limits the migration of certain potentially harmful elements, such as heavy metals (lead, cadmium, mercury) and certain organic compounds, from toys into children’s bodies.
- EN 71-4: Experimental Sets for Chemistry and Related Activities: This standard focuses on the safety requirements for experimental sets and chemistry-related toys, ensuring that children can safely engage in scientific experiments.
- EN 71-5: Chemical Toys (Sets) Other Than Experimental Sets: This standard addresses the safety requirements for chemical toys and sets, which involve the use of chemicals in a controlled manner.
- EN 71-6: Certain Phthalate Esters in Toys and Childcare Articles: This standard restricts the use of certain phthalates, which are chemical additives used in plastic toys, due to their potential health risks.
- EN 71-7: Finger Paints – Requirements and Test Methods: This standard sets requirements and test methods for finger paints to ensure their safety for children.
CE Marking
Toys that meet the essential safety requirements of the directive are marked with the CE mark. The CE marking indicates that the toy has undergone the necessary testing and assessment procedures and meets the legal requirements for sale within the EU.
Age Appropriateness
The directive emphasizes the importance of age-appropriate toys. It requires clear labeling on toys indicating the recommended age range and any specific warnings or precautions for safe use.
Market Surveillance
The directive establishes mechanisms for market surveillance to ensure that toys available in the EU market comply with the safety requirements. It places responsibilities on manufacturers, importers, and distributors to verify and maintain compliance with the directive.
Notification and Documentation
Notification and Documentation: Manufacturers and their authorized representatives are required to provide a declaration of conformity, technical documentation, and records of tests and assessments to demonstrate compliance with the directive. This information must be made available to the competent authorities upon request.
The general provisions of the EU Toy Safety Directive define what constitutes a toy, outline technical documentation requirements, establish production control and more. Chemical requirements of the EU Toy Safety Directive, which include restrictions on toxic elements, certain fragrances and use of CMR chemicals, were effective July 20, 2013.