Explanatory Memorandum to COM(2008)9 - Safety of toys - Main contents
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This page contains a limited version of this dossier in the EU Monitor.
| dossier | COM(2008)9 - Safety of toys. |
|---|---|
| source | COM(2008)9  |
| date | 25-01-2008 |
The revision of Directive 88/378/EEC of 3 May 1988 on the approximation of the laws of the Member States concerning the safety of toys i (TSD) was announced in the Communication from the Commission to the Council, the European Parliament, the European Economic and Social Committee and the Committee of the Regions - Updating and simplifying the Community acquis. i
Directive 88/378/EEC was adopted in the context of the achievement of the Internal Market. The proliferation of different safety provisions across the Member States had led to barriers to trade and marketing. This went hand in hand with the recognition that a proliferation of different national safety regimes across the EU did not necessarily afford consumers in the EU, especially children, with effective protection against hazards arising from toys. The Directive was the first EC Directive applying the New Approach method – introduced in 1985 – to mass market consumer goods. The key New Approach concept consisted in laying down in the legislation the essential safety related requirements, leaving the technical specifications of products meeting the essential requirements in harmonised standards. Since 1988, the Directive has been amended only once in respect of the CE marking i.
Whilst the TSD has in general proven successful in providing safe products and eliminating trade barriers between the Member States, a number of deficiencies have been identified over time, which have triggered the need to assess the existing legal framework.
A thorough revision of the TSD seems appropriate, with a view to:
- Updating and completing the existing provisions to address safety issues that were unknown at the time of the TSD adoption;
- Improving the implementation and enforcement of the TSD throughout the European Union;
- Clarifying the scope and concepts of the Directive;
- Ensuring consistency with the general measures that have been tabled in the general legislative framework for the marketing of goods i.
The proposal is a central element to ensure the free movement of toys within the European Union and contributes to the protection of the consumer by providing at the same time a uniform level of toy safety across the EU.
The objectives pursued by the revision are in line with the EU´s strategy for jobs and growth and also fit into the Community policy of better regulation and simplification. The overall goal is to improve the quality and efficiency of the toys safety regulations and to simplify the current legislation for both economic operators and market surveillance authorities.
Consultation of interested parties
The revision has been under consideration since 2003 and has been the subject of a wide ranging consultation, namely in the framework of the Expert Group on toys safety with the Member States authorities and other stakeholders like industry, consumer- and standardisation organisations.
A public consultation was organised in May 2007 to invite all interested parties to send their observations on those questions which have been identified as potential objects for changes in the Expert Group discussions. The results of the public consultation are published at ec.europa.eu/enterprise/toys/public_consultation . More than 1500 replies were received: 91 percent responded as an individual and 9 percent on behalf of an organisation, institution or enterprise.
The public consultation confirmed the need to revise the Directive and, in particular, to improve its enforcement and implementation and to clarify its scope and concepts. There was also an agreement to update the essential safety requirements on certain hazards. Although the vast majority of reactions came from respondents qualifying themselves as individuals, because of the nature and or the focus of the comments it could be assumed that a part of these individual replies originates from individuals who are to various degrees involved in the toys business (distributors, retailers, company managers, etc.).
Three studies have been established by independent consultants for the purposes of this revision: one general impact assessment study as well one specific impact assessment study on the revision of the chemical requirements as well as a specific study on certain chemicals used in toys to provide elements for the revision of the chemicals requirements of the Directive. The studies are available at: ec.europa.eu.enterprise/toys/index_en.
Five options for a revision have been identified:
- Repealing of Directive 88/378/EEC;
- No Commission action, i.e. maintaining the status quo;
- Non-regulatory approach; guidance documents; recommendations;
- A new Directive based on the “Old Approach”;
- A revised Directive to the extent necessary to ensure that safe toys can circulate in the EU internal market.
The fifth option was identified as the preferred option because it seems adequate and proportionate to cope with the identified problems without requiring a fundamental change of the system that has proved workable. Option 5 keeps an adequate balance between on the one hand new (compliance and administrative) costs for the industry concerned and on the other hand benefits for children’s health and safety.
Within the option to adapt the Directive to the extent necessary, a number of sub-options with various degrees of stringency have been identified and assessed in detail:
- To enhance safety requirements for toys
- New provisions on the chemical requirements;
- More stringent requirements on warnings;
- Changes to the requirements concerning the choking risk;
- Clarifying the suffocation risk;
- Clarifying the criteria of essential safety requirements;
- Special requirements for toys in food;
- To improve the enforcement and efficiency of the Directive
- Changes to the technical file as regards information on chemicals;
- Changes to the CE marking and traceability information;
- Changes to the conformity assessment procedures.
The Commission has carried out a detailed impact assessment listed in the Work Programme.
Contents
- LEGAL ELEMENTS OF THE PROPOSAL
- budgetary implications
- General context
- Consistency with other policies and objectives of the Union
- CONSULATION OF INTERESTED PARTIES AND IMPACT ASSESSMENT
- Collection and use of expertise
- Impact assessment
- Main elements of the revision
- Warnings
- Choking and suffocation risks
- Toys in food
- Definition of the general safety requirement
- More efficient and coherent enforcement of the Directive
- Information on chemicals in the technical file
- CE marking and its affixing
- Safety assessmen t
- Alignment to the general legislative framework on the marketing of products
- Clarifying scope and concepts of the Directive
- Legal basis
- Subsidiarity principle
- Proportionality
- additional information
- European Economic Area
Enhanced safety requirements
Chemical substances used in toys
The revision focuses on enhanced safety requirements for toys, namely with regard to the use of chemicals in toys. The revision also aims at updating requirements on electrical properties and in physical and mechanical areas, as chocking risks and suffocation.
As regards chemicals in toys, the Directive foresees that toys must comply with Community’s general chemicals legislation, including Regulation EC No 1907/2006 (REACH).
Main novelty of the revision is the introduction of specific rules on CMR (carcinogenic, mutagenic, or toxic for reproduction) in toys. The proposal foresees that toys and components of toys or micro-structurally distinct parts of toys that are accessible to children shall not contain CMR of categories 1, 2 and 3 i. This ban applies to CMR with a concentration above 0,1%, with the exception of some CMR substances for which a lower concentration is already foreseen in existing legislation. The proposal, however, provides for a possibility of granting an exemption from this ban, if the substance has been evaluated by the relevant Scientific Committee and found acceptable for use in toys, while for CMR 1 and 2 no suitable alternative substances must be available at the same time.
It is in important to note that REACH imposes a duty on suppliers of articles containing substances, in particular CMRs 1 or 2, to communicate sufficient information to allow safe use of the article. These provisions are unaffected by the revision of the toys directive and so will continue to apply to toys
The Directive prohibits the use or requires the labelling of certain allergenic substances and certain fragrances. This approach also follows the regime of Directive 76/768/EEC on cosmetic products.
In order to take into account new scientific knowledge, the Directive provides for an update of certain chemical substances to be used in toys and raises the limit values for these substances. The proposal replaces the reference to bioavailability (i.e. the soluble extract having toxicological significance) with “migration” in line with the Standard EN 71-3.
According to the existing Directive toys must be accompanied by clearly legible warnings in order to reduce inherent risks of their use. The revision foresees to complement these provisions by requiring that warnings specify, where appropriate for safe use, user limitations such as minimum and maximum ages for users or the ability of the user of toys or maximum or minimum weight of the users as well as the need to ensure that the toy is used under adult supervision. It is furthermore proposed to require warnings at the point of sale specifying minimum and maximum ages for users. The new measures are meant to improve their effectiveness in the prevention of accident. More detailed practical instructions on warnings will be established in a guidance document to be drawn up together with the various stakeholders and Member States authorities taking into account developments of scientific and technical knowledge.
The risk of choking, that is the risk of inhalation of small parts, is currently regulated in respect of toys intended for children under 36 months. The revised Directive foresees to extend the provisions to those toys that are intended to be put in the mouth, such as toy instruments, even when destined to children above 36 months.
The suffocation risk, defined as an external airway obstruction of the mouth and nose, is already covered by the current Directive. The proposed new measures provide for extending the definition in question to internal airway obstruction, to deal with the risk presented by new toys such as those with suction cups. The suffocation risk shall be covered in case of all toys and not only for those intended for children under 36 months.
Under the current Directive there are no specific provisions for toys in food. These products need to respect the general requirements of the Directive for small parts and for warnings. It is appropriate to proceed to an assessment of the hazard inherent in toys in food on the basis of the precautionary principle i. The Directive foresees the new requirement that i) toys should be marketed in a package separating them from the food items they are attached to, ii) the packaging itself should not present any choking hazard (namely that it passes the safety ‘small parts cylinder test’) and iii) to ban toys that are firmly coupled with foodstuffs in such a way that prior consumption of the food item is necessary to access to the toy itself.
The current safety requirements have created problems of interpretation, in particular because the general safety requirement refers to the obligation to cover “foreseeable” use of a toy taking into account the “normal behaviour of children”, which may result in a narrow consideration of safety issues.
Clarifying the general safety requirement is essential because it is the only legal basis for taking dangerous toys out of the market in cases were a new risk is discovered, that is, a risk which has previously not been known and which is therefore, not covered by specific standards. A recent example of such risk which was previously not known and which is not yet covered by standards is the risk presented by certain powerful magnets.
It is, therefore, foreseen to refer in the general safety requirement to 'behaviour' of children to ensure that the often unpredictable behaviour of children is taken into account when designing toys with a view to achieve greater safety benefits.
Reinforcement of the Member States market surveillance measures
The proposal reinforces in Chapter VI the market surveillance obligations of the Member States under the General Product Safety Directive 2001/95/EC by granting certain specific powers to the market surveillance authorities (right of access to the premises of economic operators, right to request information from Notified bodies, right to give instructions to the Notified bodies, right to obtain mutual assistance from other Member States). It also foresees an obligation for the Member States to ensure a cooperation of their market surveillance authorities and those of the other Member States and between their own authorities and the Commission and the relevant Community Agencies.
The proposal contains an update of the documentation which toy manufacturers and importers have to keep available for inspection by the market surveillance. It has been assessed which information besides a detailed description of the design and manufacture of the toy should be kept in the technical documentation. It is proposed that the technical file needs to contain information on components and materials used in toys.
The Directive takes into account the detailed rules on the CE-marking foreseen in the general legislative framework for the marketing of products.
In addition, the revision retains the provision of the existing Directive that the CE marking shall be marked either on the toy or the packaging or in case of small toys on a label or accompanying leaflet. It adds one novelty: the CE marking shall always be affixed on the packaging if the marking on the toy is not visible from outside the packaging. This provision which adds more visibility to the CE-marking is foreseen to facilitate market surveillance.
A new obligation will be introduced to perform an analysis of the hazards that the toy may present, and to make it available - as part of the toy’s technical file - to the market surveillance authorities for inspection. This new provision is designed to provide a reliable and systematic basis for the analysis of risk, which industry already performs as part of the process involved in the design and marketing of new products, with a view to evaluating their soundness and ensuring conformity with the essential safety requirements.
On 14 February 2007, the Commission adopted its proposals for a Council and European Parliament Regulation and Decision for the marketing of goods i. The proposal for Regulation sets the requirements for accreditation and market surveillance relating to the marketing of products. The proposed Decision on a common framework for the marketing of products sets standard Articles to be used in future New Approach Directives.
According to the Commission proposal, the requirements of the Regulation for accreditation of conformity assessment bodies and the rules on market surveillance will apply also to the accreditation in the toys sector and to the market surveillance of toys at external frontiers. In order to ensure consistency with other sectoral product legislation, the revised Directive contains the following horizontal provisions of the above mentioned Decision: definitions, general obligations for economic operators, presumption of conformity, formal objection against harmonised standards, rules for the CE marking, requirements for conformity assessment bodies and the notification procedures as well as the provisions concerning procedures dealing with products presenting a risk. The conformity assessment procedures available to the manufacturer are also be set by reference to the proposed horizontal Decision. Experience has shown that the two procedures (internal production control and EC type-examination combined with the conformity to type procedure) available under Directive 88/378/EEC and the conditions of their use are appropriate for the toy sector and should therefore be maintained.
In order to facilitate the application of the Directive by manufacturers and national authorities the scope of the Directive is clarified, by completing the list of products which are not within its scope, in particular as regards certain new products, such as videogames and peripherals. In addition to adopting the harmonised definitions laid down in the proposed standard Articles, it is appropriate to foresee certain new definitions specific to the toys sector: Functional toy, activity toy, trampoline, hazard, risk, harm, suffocation and design speed.
The proposal also aims at clarifying the relationship between the Toys Directive and the General Product Safety Directive. The General Product Safety Directive applies in accordance with its Article 1 i to toys in so far as there are no specific provisions with the same objective in the Toys Directive. For the sake of clarity and legal certainty the toys proposal enumerates the Articles of the Directive 2001/95/EC that apply to toys.
The proposal is based on Article 95 of the EC-Treaty.
Directive 88 /378/EEC is a total harmonisation directive adopted on the basis of Article 95 of the Treaty with the objective of the establishment and functioning of the internal market for toys. National legislation cannot impose additional provisions on the safety of toys which would require the modification of the product or affect the conditions for its placing on the market. Therefore, the revision of provisions of Directive 88/378/EEC is, as far as the safety requirements for toys or the conditions of their placing on the market are concerned, within the exclusive competence of the Community. The application of the principle of subsidiarity within the meaning of Article 5, second paragraph, of the EC-Treaty does not arise.
It is important to note that the revision aims at clarifying the scope of products covered by the Directive, but not at extending or changing it otherwise. Therefore the issue of subsidiarity within the meaning of Article 5, second paragraph, of the EC-Treaty does not arise in this respect either.
The respect of the subsidiarity principle, therefore, only arises with regard to the other areas of the revision, namely with regard to the improvement of effective enforcement of the Directive. Experience has shown that coherent and effective enforcement and market surveillance has not been sufficiently achieved by Member States acting alone. As a consequence, the issue of setting some mandatory common minimum requirements arises. As a result of the proposal, this activity would remain within the authority of the national authorities but some general EU-wide requirements would be introduced to ensure equal treatment, a level playing field for economic operators, and a similar level of protection for the citizens in all the Member States.
In accordance with the principle of proportionality, the proposed modifications do not go beyond what is necessary to achieve the objectives set. In order to protect the benefits of the single market in the toys sector, any changes to the existing directive have to be dealt with at the Community level. If Member States acted on their own, there would be a proliferation of safety requirements which would hamper and undermine the achievements of the single market, and very likely lead to confusion for consumers and producers alike. The consequences could be higher prices for consumers, as producers would have to revert to abiding by member state specific requirements, while there would be a lack of clarity regarding the safety of toys bought in another Member State.
All modifications of the Directive do not impose unnecessary burden and costs on industry, especially on small and medium sized enterprises, or administrations. A number of options concern the improvement of clarity of the existing Directive without introducing significant new requirements with cost implication. Where modifications have more significant impacts, the analysis of the impacts of the option serves to provide the most proportionate response to the problems identified.
The proposal foresees establishment of a Regulatory committee. Budgetary implications are discussed in the legislative financial statement annexed to this proposal.
Repeal of existing legislation
The adoption of the proposal will lead to repeal of Directive 88/378/EEC on the safety of toys.
The proposal concerns the EEA and should therefore extended to the European Economic Area.