Scope:

Evaluation of Directive 2009/48/EC of the European Parliament and of the Council on the safety of toys

Evaluation findings:

Toys have to be safe when children play with them. The Toy Safety Directive lays down rules to make toys safe, including when they are exposed to children’s sometimes ‘unforeseeable’ behaviour. At the same time, the Directive ensures the successful functioning of the internal market for toys, worth almost EUR 20 billion a year. The toy industry is dynamic and innovative: around one third of the toys on the market each year have new features or are newly developed.

The Directive is more effective than its predecessor regarding protecting children from chemicals in toys. This is due to a higher number of restrictions on specific (groups of) dangerous chemicals. However, the Directive’s effectiveness as regards the protection of children is limited in the following aspects that require urgent attention:

– Under the Directive, specific limit values for chemicals can only be set for toys for children under 36 months of age and toys that are intended to be placed in the mouth, instead of for all toys.

– The Directive makes it possible to derogate from the prohibition on using chemicals that are carcinogenic, mutagenic or toxic for reproduction (CMR). In particular, CMR chemicals may be present in toys if they do not exceed certain concentrations, which are set in a separate piece of legislation and which are useful to classify chemical mixtures as dangerous. The concentrations allowed however appear to be too high and can still pose a risk to children.

– The Directive sets limit values for carcinogenic nitrosamines and nitrosatable substances (that may convert into nitrosamines). However, a Commission Decision of 2012 has recognised that these limit values are too high and can still pose a risk to children.

– The Directive provides labelling requirements for specific allergenic substances in certain ‘experimental’ toy sets. However, these requirements cannot be easily updated when the related lists of allergenic substances are being updated.

For risks other than those related to chemicals, the Directive appears to be sufficiently effective.

The Directive’s effectiveness as regards the enforcement of its rules appears to be only partially satisfactory. The Directive only provides for a general obligation for Member States to carry out market surveillance, however detailed (and binding) EU-wide market surveillance rules have recently been set in the Regulation on market surveillance and compliance of products.

The Directive's effectiveness as regards the free movement of toys was analysed by looking at the intra-EU trade of toys and its evolution over the years, as well as stakeholder feedback. The figures on intra-EU export of toys covered by the Toy Safety Directive, and in particular on the remarkable increase since 2012/2013, suggest that applying the Directive and all its requirements since mid-2013 did not hamper growth in this area.

The Directive could be more effective if it were converted into a Regulation, as this would free up staff in Member States working on transposing the repeated amendments of the Directive into national legislation. Moreover, since the Directive provides for maximum harmonisation of the provisions on toys, it leaves no room for Member States to deviate and could thus appear to be a ‘de facto regulation’.

The requirement that all toys be safe in order to protect children – which is one of the two key objectives of the Toy Safety Directive – is undoubtedly still relevant, in particular in light of the weekly notifications on dangerous toys in the EU's safety gate RAPEX. Member States and stakeholders also confirmed this requirement as relevant. The Toy Safety Directive is, therefore, still a relevant policy measure for ensuring the safety of toys, in that it requires that all toys placed on the EU market comply with its safety provisions. However, there have been doubts about the speed with which the Toy Safety Directive is being adapted to technical and scientific developments.

The requirement that toys move freely in the EU market – the second key objective of the Toy Safety Directive – is equally relevant, as confirmed by a very large majority of Member States and stakeholders. Harmonising national requirements is crucial in order to eliminate any possible barriers that would stem from different regulatory systems in the Member States, and to ensure a level playing field for all toys placed in the EU market.

In terms of toy safety and the creation of a large internal market for safe toys, the current evaluation has confirmed the EU added value of the Toy Safety Directive. In particular, without the Directive, Member States could set diverging limit values for chemicals, which would be to the detriment of the internal market. All categories of stakeholders highly appreciated the existence of the same safety requirements across the EU, and companies valued the creation of a large market for toys and the simplification of trade as major achievements. Possibly diverging national rules were not considered as being more beneficial. Notified bodies in particular agreed that the Directive contributes to streamlining testing and standards, and public authorities welcomed the harmonisation of testing and standards and the opportunity to work together with authorities from other Member States.

Therefore, the Directive clearly provides EU added value by harmonising the rules on toy safety and facilitating the free movement of safe toys in the internal market.

Estimated savings and benefits

Complying with the Toy Safety Directive when it became applicable reportedly caused one-off costs to economic operators, in particular manufacturers, due to the many new requirements. These one-off costs were reported to be between 1% and 3% of turnover. The ongoing costs for producing toys are considered to be higher than under the previous Directive, since there are now more requirements to be met.

On the other hand, costs did not prevent several hundred companies from entering the market, increasing the total number of companies by some 10% between 2013 and 2017. – To note that 99% of the companies in the toy sector are SMEs.

Furthermore, the Toy Safety Directive does not appear to have hindered the cost competitiveness of the toy industry. Profits dropped in 2009, probably due to the financial crisis of 2008 and perhaps also due to companies internalising some of the one-off costs. However the EU toy industry recovered during the following years, its turnover growing steadily since 2009 by a total of 16% and its profits being almost 15% higher in 2017 than in 2008.

Furthermore, manufacturers are only exceptionally required to request the intervention of a third party (a 'notified body'), namely when producing novel toys that have hazardous features not covered by the existing toy safety standards, the references of which have been published in the Official Journal.

Whereas the costs related to the Toy Safety Directive have been quantified to a certain extent, it does not appear possible to quantify the benefits due to missing data. Nevertheless, stakeholders see benefits in the Directive’s detailed provisions, whether regarding the definition of ‘toy’ or the roles of economic operators, because they ensure legal certainty and a level playing field.

In addition, although it is not possible to provide a quantitative balance of benefits and costs, some 50% of the companies and business associations that took part in the 2018 public consultation considered the benefits of the Toy Safety Directive to outweigh the costs, sometimes even by far; a further 20% of participating companies considered the costs proportionate to the benefits. Public authorities, consumer organisations and notified bodies responded that the benefits outweigh the costs even by 60% to 80% (or outweigh them by far).

The Toy Safety Directive is, therefore, still a relevant policy measure for ensuring the safety of toys, in that it requires that all toys placed on the EU market comply with its safety provisions.