The purpose of the Toys Safety Directive is twofold: ensuring that proper rules are in place to make toys safe when they are exposed to children and making sure that the internal market for toys functions successfully. Since its adoption, the Toys Safety Directive has been adapted 12 times, usually resulting in stricter limitations regarding chemicals that are present in toys. The European Commission has published its summary of the assessment of the functioning of the Toys Safety Directive.
Since the updated definition of ‘toy’ and the higher number of restrictions for chemicals, the effectiveness of the Directive appears to have improved. The standards that are referenced in the Official Journal also prove to be effective in maintaining children’s safety. Regarding the internal market, all stakeholders highly rated the Directive’s effectiveness, with some deviations in interpretation and national legislation to be resolved. Concerning EU-wide trade, the Directive successfully enables the free movement of toys on the European market.
However, the effectiveness of the Directive is still flawed when it comes to the following topics:
- Limit values on chemicals: The Directive states that these values are only applicable for toys for children younger than 36 months, and for toys intended to be put in the mouth;
- The prohibition of CMR chemicals (carcinogenic, mutagenic or toxic for reproduction) as a rule, while derogations tolerate them, if these are presented in concentrations too high to provide effective protection under the current scientific knowledge;
- The limit values for nitrosamines (which can be carcinogenic) and nitrosatable substances are too high;
- Labelling requirements for specific allergenic fragrances cannot be easily updated when the lists of allergenic fragrances are amended;
- The general obligation to execute market surveillance is limited to a few tens of thousands per year, although the market consists of billions of toys. An improvement for this surveillance gap can be found in the Regulation of Market Surveillance and Compliance of Products.
The Toys Safety Directive scores high on efficiency, as it provides a correct balance between costs and benefits. Additional costs were generated by a higher number of requirements in comparison with the preceding Directive, however the number of toy-manufacturing companies has increased by around 10% over the last 8 years. Given the lack of data on key indicators and decisions to move production to low-wage countries, it is difficult to assess the quantitative benefits of the Directive. Better harmonization of data collection and monitoring of toy safety could allow more meaningful analyses of the data. Quality-wise, the benefits can be found in ensuring the level playing field and legal certainty, which outweigh the costs.
The Toys Safety Directive lacks coverage of internet-connected toys, as it mainly focuses on the protection of physical health and safety. Children’s privacy and security in internet-connected toys is however covered by the Radio Equipment Directive.
The Toys Safety Directive is a maximum harmonization directive, which means national law may not exceed the terms of the legislation, which clearly offers added value to the Directive. This is
apparent from the harmonizing effect on health and safety requirements for toys and the coherent market it creates in the EU.
The evaluation by the EC has proved that the safety requirements of the Directive still play a crucial role in restricting dangerous toys from the EU market before they can affect the health of children. However, its effectiveness remains limited in certain areas, such as limit values for CMR chemicals and carcinogenic nitrosamines and nitrosatable substances.
Regulatory Affairs department
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- Obelis Group. (2021). Toy safety: the EU moves to protect children from potentially allergenic fragrances in toys. Retrieved on 02/06/2021 from Toy safety: the EU new Directives | Obelis Group
- European Commission. (2020). Staff working document on the evaluation of the Toy Safety Directive – Executive summary. Retrieved on 02/06/2021 from DocsRoom – European Commission (europa.eu)
- UL. (2020). EU Releases Evaluation of The Toy Safety Directive 2009/48/EC. Retrieved on 02/06/2021 from EU Releases Evaluation of The Toy Safety Directive 2009/48/EC | UL
- European Commission. (2018). Evaluation roadmap. Retrieved on 02/06/2021 from Evaluation of the Toy Safety Directive (europa.eu)