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Directive 2009/48/EC of the European Parliament and of the Council of 18 June 2009 on the safety of toys (Text with EEA relevance)Text with EEA relevance

Directive 2009/48/EC of the European Parliament and of the Council of 18 June 2009 on the safety of toys (Text with EEA relevance)Text with EEA relevance

CHAPTER I GENERAL PROVISIONS

Article 1 Subject-matter

This Directive lays down rules on the safety of toys and on their free movement in the Community.

Article 2 Scope

1.

This Directive shall apply to products designed or intended, whether or not exclusively, for use in play by children under 14 years of age (hereinafter referred to as toys).

The products listed in Annex I shall not be considered as toys within the meaning of this Directive.

2.

This Directive shall not apply to the following toys:

  1. playground equipment intended for public use;

  2. automatic playing machines, whether coin operated or not, intended for public use;

  3. toy vehicles equipped with combustion engines;

  4. toy steam engines; and

  5. slings and catapults.

Article 3 Definitions

For the purposes of this Directive the following definitions shall apply:

  1. ‘making available on the market’ means any supply of a toy for distribution, consumption or use on the Community market in the course of a commercial activity, whether in return for payment or free of charge;

  2. ‘placing on the market’ means the first making available of a toy on the Community market;

  3. ‘manufacturer’ means any natural or legal person who manufactures a toy or has a toy designed or manufactured, and markets that toy under his name or trademark;

  4. ‘authorised representative’ means any natural or legal person established within the Community who has received a written mandate from a manufacturer to act on his behalf in relation to specified tasks;

  5. ‘importer’ means any natural or legal person established within the Community who places a toy from a third country on the Community market;

  6. ‘distributor’ means any natural or legal person in the supply chain, other than the manufacturer or the importer, who makes a toy available on the market;

  7. ‘economic operators’ means the manufacturer, the authorised representative, the importer and the distributor;

  8. ‘harmonised standard’ means a standard adopted by one of the European standardisation bodies listed in Annex I to Directive 98/34/EC on the basis of a request made by the Commission in accordance with Article 6 of that Directive;

  9. ‘Community harmonisation legislation’ means any Community legislation harmonising the conditions for the marketing of products;

  10. ‘accreditation’ shall have the meaning assigned to it by Regulation (EC) No 765/2008;

  11. ‘conformity assessment’ means the process demonstrating whether specified requirements relating to a toy have been fulfilled;

  12. ‘conformity assessment body’ means a body that performs conformity assessment activities, including calibration, testing, certification and inspection;

  13. ‘recall’ means any measure aimed at achieving the return of a toy that has already been made available to the end user;

  14. ‘withdrawal’ means any measure aimed at preventing a toy in the supply chain from being made available on the market;

  15. ‘market surveillance’ means the activities carried out and measures taken by public authorities to ensure that toys comply with the applicable requirements set out in Community harmonisation legislation and do not endanger health, safety or any other aspect of public interest protection;

  16. ‘CE marking’ means a marking by which the manufacturer indicates that the toy is in conformity with the applicable requirements set out in Community harmonisation legislation providing for its affixing;

  17. ‘functional product’ means a product which performs and is used in the same way as a product, appliance or installation intended for use by adults, and which may be a scale model of such product, appliance or installation;

  18. ‘functional toy’ means a toy which performs and is used in the same way as a product, appliance or installation intended for use by adults, and which may be a scale model of such product, appliance or installation;

  19. ‘aquatic toy’ means a toy intended for use in shallow water which is capable of carrying or supporting a child on the water;

  20. ‘design speed’ means representative potential operating speed that is determined by the design of the toy;

  21. ‘activity toy’ means a toy for domestic use in which the support structure remains stationary while the activity is taking place and which is intended for the performance by a child of any of the following activities: climbing, jumping, swinging, sliding, rocking, spinning, crawling and creeping, or any combination thereof;

  22. ‘chemical toy’ means a toy intended for the direct handling of chemical substances and mixtures and which is used in a manner appropriate to a given age-group and under the supervision of an adult;

  23. ‘olfactory board game’ means a toy the purpose of which is to assist a child to learn to recognise different odours or flavours;

  24. ‘cosmetic kit’ means a toy the purpose of which is to assist a child to learn to make products such as fragrances, soaps, creams, shampoos, bath foams, glosses, lipsticks, other make-up, tooth-paste and conditioners;

  25. ‘gustative game’ means a toy the purpose of which is to allow children to make sweets or dishes which involve the use of food ingredients such as sweets, liquids, powders and aromas;

  26. ‘harm’ means physical injury or any other damage to health, including long-term health effects;

  27. ‘hazard’ means a potential source of harm;

  28. ‘risk’ means the probable rate of occurrence of a hazard causing harm and the degree of severity of the harm;

  29. ‘intended for use by’ means that a parent or supervisor shall reasonably be able to assume by virtue of the functions, dimensions and characteristics of a toy that it is intended for use by children of the stated age group.

CHAPTER II OBLIGATIONS OF ECONOMIC OPERATORS

Article 4 Obligations of manufacturers

Article 5 Authorised representatives

Article 6 Obligations of importers

Article 7 Obligations of distributors

Article 8 Cases in which obligations of manufacturers apply to importers and distributors

Article 9 Identification of economic operators

CHAPTER III CONFORMITY OF TOYS

Article 10 Essential safety requirements

Article 11 Warnings

Article 12 Free movement

Article 13 Presumption of conformity

Article 14 Formal objection to a harmonised standard

Article 15 EC declaration of conformity

Article 16 General principles of the CE marking

Article 17 Rules and conditions for affixing the CE marking

CHAPTER IV CONFORMITY ASSESSMENT

Article 18 Safety assessments

Article 19 Applicable conformity assessment procedures

Article 20 EC-type examination

Article 21 Technical documentation

CHAPTER V NOTIFICATION OF CONFORMITY ASSESSMENT BODIES

Article 22 Notification

Article 23 Notifying authorities

Article 24 Requirements relating to notifying authorities

Article 25 Information obligation of notifying authorities

Article 26 Requirements relating to notified bodies

Article 27 Presumption of conformity

Article 28 Formal objection to a harmonised standard

Article 29 Subsidiaries of and subcontracting by notified bodies

Article 30 Application for notification

Article 31 Notification procedure

Article 32 Identification numbers and lists of notified bodies

Article 33 Changes to notifications

Article 34 Challenge to the competence of notified bodies

Article 35 Operational obligations of notified bodies

Article 36 Information obligation of notified bodies

Article 37 Exchange of experience

Article 38 Coordination of notified bodies

CHAPTER VI OBLIGATIONS AND POWERS OF MEMBER STATES

Article 39 Precautionary principle

Article 40 General obligation to organise market surveillance

Article 41 Instructions to the notified body

Article 42 Procedure for dealing with toys presenting a risk at national level

Article 43 Community safeguard procedure

Article 44 Exchange of information — Community Rapid Information Exchange System

Article 45 Formal non-compliance

CHAPTER VII COMMITTEE PROCEDURES

Article 46 Amendments and implementing measures

Article 47 Committee procedure

CHAPTER VIII SPECIFIC ADMINISTRATIVE PROVISIONS

Article 48 Reporting

Article 49 Transparency and confidentiality

Article 50 Motivation of measures

Article 51 Penalties

CHAPTER IX FINAL AND TRANSITIONAL PROVISIONS

Article 52 Application of Directives 85/374/EEC and 2001/95/EC

Article 53 Transitional periods

Article 54 Transposition

Article 55 Repeal

Article 56 Entry into force

Article 57 Addressees

ANNEX I

ANNEX II

Appendix A

Appendix B

Appendix CSpecific limit values for chemicals used in toys intended for use by children under 36 months or in other toys intended to be placed in the mouth adopted in accordance with Article 46(2)

ANNEX III

ANNEX IV

ANNEX V