In 2009 the European Union ("EU") adopted the Toy Safety Directive ("TSD"), which replaced the former 1988 directive on the safety of toys (88/378/EEC), as part of the EU’s initiative to create a single market that ensures a uniform standard of toy safety within the Member States. The TSD outlined various provisions (including, in particular, stricter concentration limits for chemical substances in the accessible parts of toys) which Member States had to implement by July 2011 and July 2013 (the later as to the chemical safety requirements).
Since then, several adaptations to the TSD have been implemented as a result of new scientific findings and advanced technology uncovering previously unknown safety issues, as well as a shift in mindset of European citizens, especially when it comes to sustainability. These developments have forced the European Commission ("EC") to continuously adapt the directive in order to keep up with the constantly evolving toy industry (e.g. electronical toys). For further information please check our previous articles in which we covered the constant progress of the TSD and its modifications.
In its latest evaluation of the TSD, the EC found once again several shortcomings in the current regulation’s provisions that could compromise the health and safety of children, especially with regard to chemicals that are carcinogenic, mutagenic or reprotoxic (the “CRM” chemicals). The EC also noted other deficiencies in the current TSD, including weak market surveillance, as well as insufficient transposition of the TSD into national law by Member States.
Following the publication of its impact assessment (downloadable here), the EC started an initiative to further strengthen the TSD with particular focus on the protection of children from hazardous chemicals and sustainability, as outlined in the EU’s Chemical Strategy for Sustainability. The idea is (following the current trend with other European legislation) to replace the TSD with a Toy Safety Regulation, which will ensure a timely and simultaneous application of the toy safety rules consistently in all Member States (a binding effect from the outset without the need of individual implementation by the Member States).
Latest EC assessment and initiative
The latest initiative aims to tackle, amongst others, the following issues:
- The lack of sufficient regulation of chemical risks in the former TSD to ensure the protection of children: according to the EC, a generic and uniform approach to risk management of hazardous substances is missing – the use of most hazardous substances should generally be banned and only limited exemptions under clearly defined conditions should be permitted;
- Insufficiencies in the current prohibition of CRM chemicals in toys, which provides for derogations that, according to the EC, appear to allow for their presence in concentrations that are too high to ensure effective protection of children;
- The currently limited application of limit values for chemicals in toys for children only under 36 months and only in toys that are intended to be put in the mouth. However, the same hazardous chemicals can present a risk regardless of the age of the child or the intended use of the toys which should be reflected;
- New risks related to internet-connected toys or toys including artificial intelligence, in particular in relation to personal data and privacy protection, have recently emerged and are not adequately addressed in the current TSD; and
- Lack of both a consistent application of the requirements of the TSD across all Member States and effectiveness in enforcement of compliance: according to the EC, market surveillance is challenged by difficulties in obtaining the safety documentation of toys, or when trying to identify economic operators in online sales.
The EC is aiming to strengthen the TSD in order to further improve child protection against unsafe toys and keep non-compliant toys off the market. The key proposals include the following:
- Extending a general risk assessment approach (currently only for CRMs) to other more hazardous substances such as endocrine disruptors or other persistent and bioaccumulate substances, as well as revising the derogations of the general prohibitions of CMRs;
- Setting chemical limit values for all toys and not only for those intended for children under 36 months;
- Establishing a new “positive list” for substances such as preservatives and colorants that can be used by manufacturers for reference;
- Establishing specific requirements for the labelling of chemical compositions of toys including by way of digital labelling;
Addressing risks in internet-connected toys including artificial intelligence (as long as not covered in other EU legislation such as the Radio Equipment Directive ("RED") and General Data Protection Regulation ("GDPR"); and
Improving Member States’ reporting obligations on unsafe toys and the application of toy safety rules.
Requiring the preparation of a digital product passport containing selected manufacturer compliance documentation which could serve as, or replace, the current EU declaration of conformity, to speed up enforcement and thus better ensure a level playing field;
Following from above, the EC has initiated a Public Consultation to get opinions on the targeted revision of the TSD. Between 2 March 2022 and 25 May 2022 the general public is able and encouraged to take part in the ongoing EU-wide assessment. Citizens, manufacturers, importers, distributors and other businesses, including Small and Medium Enterprise ("SMEs"), are encouraged to share their experiences and provide suggestions on ways to improve the current legislative framework in order to make toys more safe for children whilst ensuring a quality standard for sellers and buyers of the internal market.
The TSD was implemented in the UK by way of the Toys (Safety) Regulations 2011, which was retained post Brexit by the Product Safety and Metrology etc. (Amendment etc.) (EU Exit) Regulations 2019 (“the 2011 Regulations”). It is unclear if the UK regulators will follow the EC and seek to implement similar amendments to the UK Toy Regulations, and, potentially, to the relevant toy safety standards. However, the expectations remain that the UK will continue to match the overall levels of regulatory rigour adopted by the EU, noting that the details of the individual requirements may be different.
Summary and Outlook
The EC has made it its goal to introduce a new legislative proposal to improve the current TSD by the fourth quarter of 2022.
The feedback received from the Public Consultation will be summarized in a report which will outline how the input has been taken into account.
The general feedback received so far appears to be largely in favor of the EC’s proposed amendments to the TSD, in particular the proposed changes to the chemical composition requirements and the harmonisation of toy safety standards that would result from the transposition of the TSD to a Regulation.
For further questions, or if you would like to take part in the survey you can contact a member of our team, who would be happy to assist you in providing feedback to the EC’s consultation, or alternatively, you can find the link to the consultation here.
Authored by Christiane Alpers, Valerie Kenyon, Nicole Böck, Sebastian Graeler, Melissa Vanzant-Birch and Lorena Baltazar.