Select Committee on European Scrutiny Fortieth Report

1 Safety of toys



+ ADDS 1-2

COM(08) 9

Draft Directive on the safety of toys

Legal baseArticle 95EC; co-decision; QMV
DepartmentBusiness, Enterprise & Regulatory Reform
Basis of considerationSEM of 18 November 2008
Previous Committee ReportHC 16-xv (2007-08), chapter 2 (12 March 2008)
To be discussed in CouncilDecember 2008
Committee's assessmentPolitically important
Committee's decisionFor debate in European Committee


1.1 Council Directive 88/378/EEC[1] seeks to harmonise the safety levels of toys throughout the Member States, and to remove obstacles to the trade within the internal market. It specifies that toys may be placed on the market only if their design and use do not pose a risk to safety and/or health when used as intended (or in a foreseeable way). In particular, Member States must take the steps needed to ensure that toys cannot be placed on the market unless they meet certain safety requirements, with compliance being presumed where they bear the EC mark, granted as a result of the type-examination procedure laid down. However, the Commission says that technological developments have raised new safety issues in this area and given rise to increased consumer concerns, and that it is therefore necessary to revise and enhance existing measures, and, in the interests of clarity, to repeal Directive 88/378/EEC.

The current proposal

1.2 It accordingly put forward, in January 2008, this revised Directive, with the aim of enhancing the level of safety of toys, whilst maintaining the smooth functioning of the internal market. In order to achieve this overall aim, the Commission identified three specific objectives:

  • strengthening, clarifying, modernising and completing the essential safety requirements;
  • improving the understanding, implementation and enforcement of the Directive; and
  • providing clarity and updating the scope, concepts and definitions of the Directive, ensuring that it is in line with the general legislative framework for marketing products within the Community.

1.3 The Commission proposes that these objectives should be achieved by the following measures:

Chemical requirements

The proposal would maintain the safety requirements in the current Directive, but would in addition ban certain allergenic fragrances and require the labelling of 28 other fragrance allergens. It would also ban all substances categorised as carcinogens, mutagens and substances toxic to reproduction (CMRs) in accessible parts of toys unless authorised by comitology procedure in the Directive: and the current reference to the "availability" of certain metals which may be present would be replaced by a reference to their "migration limits".  


The new measures would provide for the mandatory display of minimum/maximum age for users at point of sale, for specific warnings on age or ability, for a minimum/maximum user weight and for the need for the relevant toys to be used under adult supervision.

Choking risks

The Directive currently covers the risk of inhalation of small parts from toys intended for children under 36 months, and this provision would be extended to any toys intended to be put in the mouth, regardless of the age of the child.

Suffocation risks

The Directive currently covers the risk of external airway obstruction of the
mouth and nose, and this would be extended to include internal airway

General safety requirements  

These currently refer to the 'foreseeable' use of a toy taking into account the 'normal' behaviour of children, and, as this has led to problems of interpretation, not least in dealing with previously unforeseen risks, they would instead refer to 'behaviour of children".

Choking as a result of the association of toys and food items  

The current Directive contains no specific provisions for toys in food, and there would be a new requirement that such toys should be marketed in a separate package, which should not itself present a choking hazard: also, toys should not be firmly attached to the food product at moment of consumption, in such a way that the product needs to be consumed in order to get direct access to the toy.

Market surveillance measures

The proposal would reinforce the relationship between the Directive and the General Product Safety Directive (2001/95/EC),[2] particularly in relation to the specific powers for market surveillance authorities and enforcement cooperation between Member States.

Information on chemicals in the technical files

The proposal would require further information on the chemical components and materials used in toys to be included in the technical file used for market surveillance.

CE Marking

The proposal would extend the current CE Marking requirements by requiring the marking to be fixed to the packaging of the toy if the marking on the toy is not visible.

Safety Assessment

Manufacturers and importers etc. would in future be required to perform an analysis of the hazards which the toy may present, and to make this available to market surveillance authorities for inspection as part of the toy's technical file.

Alignment of the Directive with the proposed Council and Parliament Decision on the marketing of goods

The new Directive would be aligned with the provision in the draft Decision[3] which the Commission put forward on 14 February 2007 on the marketing of goods in order to ensure consistency between all New Approach Directives, particularly in areas such as conformity assessment bodies, definitions, routes to conformity and rules for CE Marking.

Scope of the Directive

The proposal aims to complete the list of products which are not within its scope, particularly as regards new products such as videogames and their peripherals. It would also include definitions specific to the sector (such as functional toys, activity toys, hazard, harm, risk etc).

The Government's view

1.4 As we noted in our Report of 12 March 2008, the text reflects discussion in informal Commission working groups, and the Government believes that the revision is sensible. The UK therefore supports the proposal, which it believes will lead to an enhanced level of safety, whilst maintaining the well established and smooth functioning of the market in the UK and within the Community as a whole. It also concludes that individual elements in the proposal should be beneficial, and that any further costs should not, for the most part, be significant.

1.5 At the same time, the Government says that the new approach to the banning of CMRs would lead to substitution of chemicals or in some cases withdrawal of certain toys from the market, and would therefore increase manufacturing costs (and to a lesser extent some administration costs), but that there would be considerable long-term beneficial health effects; that the costs to industry of the revised requirements on warning labels are likely to be lower than would be expected, as many manufacturers already provide these (and that, again the health benefits would be considerable); and that the new provision on the Safety Assessment would lead to some additional costs, which were not evaluated in the Commission's Impact Assessment, but which will be covered in the Impact Assessment being prepared by the UK. He also says that there are no financial costs falling on the Government as a consequence of this proposal.

1.6 We commented that the safety of toys is self-evidently an important topic, and that we therefore thought it right to draw this proposal to the attention of the House. We added that it did not, on the basis of the evidence available, appear likely to give rise to any issues requiring the further consideration of the House, but as the Government had said that it was preparing an Impact Assessment, we felt it would be sensible to defer a final view until we had seen that.

Supplementary Explanatory Memorandum of 18 November 2008

1.7 In his supplementary Explanatory Memorandum of 18 November 2008, the Parliamentary Under-Secretary of State for Trade and Consumer Affairs at the Department for Business, Enterprise and Regulatory Reform (Mr Gareth Thomas) says that the negotiations in Brussels have covered a wide range of options, making it unclear what the final form of the measure will be, particularly as the European Parliament had earlier tabled a large number of amendments. However, he says that a consensus is now emerging, and that, although the outcome is still by no means certain, it appears that overall, the measure adopted will reflect the original Commission proposal fairly closely.

1.8 The Minister has also enclosed a partial Impact Assessment. After pointing out that imports — which would be covered by the proposals — account for a large majority of the toys sold, it says that the UK toy manufacturing industry comprises nearly 700 businesses, almost entirely made up of small and medium-sized enterprises with a total annual turnover of £500 million. The Assessment then seeks to analyse the impact of the proposal, whilst making it clear that the complex nature of the industry and the lack of relevant data make it difficult to arrive at any precise figures.

1.9 Having said that, it suggests that the main costs will arise from the revised requirements for chemicals and CMRs and from the more stringent warning requirements, the former giving rise to increased annual costs of £31.6 million (equivalent to 7.6% of present production costs) and the latter to between £6.6 million and £36.8 million (or between 1.6% and 8.9% of existing costs). The total additional costs would thus be £38-68 million, equivalent to £55,000-98,000 for each business.

1.10 The main benefits would arise from a reduction in the number of toy-related incidents affecting children, especially as a result of the proposed modifications to the chemical safety requirements (though it is suggested that there could in the longer term also be a consequent reduction in the burden on Member States' health systems). The Assessment notes that, when the Commission calculated these benefits for the Community as a whole it did so in terms of so-called disability adjusted life years, and that, if those calculations are attributed in proportion to the UK, they would give rise to annual benefits ranging from £4.7 million to £199 million, according to the assumptions made as to ingestion rates and the level of resultant damage. The Assessment also provides aggregate figures over a 10 year period, showing a net benefit ranging from -£590 million to £1.5 billion, with a best estimate of £303 million.


1.11 Although we said in our earlier Report that this document did not, on the basis of the evidence then available, seem likely to give rise to any issues requiring the further consideration of the House, we are somewhat concerned at the level of costs involved and the range of estimates given, both for these, and more particularly, for the assumed benefits. We note that the figures quoted above are likely to be an over-estimate, and we recognise the difficulty of producing precise figures. We are also conscious of a point made by the Commission in its own Impact Assessment, namely that "it is essential to bear in mind that the main objective is to ensure the health and safety of children... Ensuring that toys do not endanger the health and safety of children necessarily incurs costs to economic operators. These costs are acceptable as long as they are necessary to attain the objective pursued and remain proportionate to the objective."

1.12 However, given the various uncertainties involved, including the extent to which it will prove possible for any additional costs to be passed on to consumers, we find it difficult to say with confidence that the proposal meets the test of proportionality, bearing in mind that the UK toy manufacturing industry is almost entirely made up of small and medium-sized enterprises. We therefore believe that it raises issues which should be considered further in European Committee.

1   OJ No. L 187, 16.7.88, p.1. Back

2   OJ No. L 11, 15.1.02, p.4. Back

3   (28376) 6378/07: see HC 41-xiv (2006-07), chapter 3 (14 March 2007) and HC 16-xiv (2007-08), chapter 5 (5 March 2008). Back

previous page contents next page

House of Commons home page Parliament home page House of Lords home page search page enquiries index

© Parliamentary copyright 2008
Prepared 4 December 2008