Safety Requirements for Toys and Procedure for Conformity Attestation of Toys1
Passed 03.09.2010 Annex 57
The Regulation is established on the basis of subsection 5 (4) of the Product Conformity Act and clause 1 (1) 1) and subsection 1 (2) of the Government of the Republic Regulation No. 123 „Granting of Authorisation for the Establishment of Requirements and a Conformity Assessment Procedure for Products and for the Designation of a Market Supervisory Authority“ of 26 August 2010.
Chapter 1 GENERAL PROVISIONS
§ 1. Scope of application
(1) This Regulation applies to products intended, whether or not exclusively, for use in play by children under 14 years of age (hereinafter toy).
(2) The following are not considered as toys:
1) decorative items used at parties and celebrations;
2) items intended for collectors, if the product or its packaging bears a visible and legible note that the product is intended for collectors at the age of 14 years or older;
3) sports equipment, including roller skates and skateboards intended for children with the body weight of more than 20 kg;
4) bicycles with the maximum saddle height of more than 435 mm, measured vertically from the ground to the upper surface of the saddle when the saddle is in the horizontal position and its pipe has been adjusted to its lower end position;
5) scooters and other means of transport intended for sports or for traffic on public roads or on tracks intended for such means of transport;
6) electric drive vehicles intended for use on public roads or tracks or on the adjoining pavements;
7) diving equipment for use in deep water and equipment for teaching children to swim, such as swim boards and swimming aids;
8) puzzles with more than 500 pieces;
9) compressed gas guns and pistols, except water guns and water pistols, and bows with the length of more than 120 cm;
10) fireworks, including percussion caps not intended for playing;
11) products and games in which pointed flying items are used, such as sets of darts with metallic points;
12) educating functional toys, such as cooking ranges, irons and other functional products operated at a nominal voltage exceeding 24 volts, intended for use only in a teaching context under the supervision of an adult;
13) products intended for use in schools and in other educational institutions under the supervision of an adult in a teaching context, such as science equipment;
14) electronic equipment, such as personal computers and game consoles used with interactive software and peripheral devices, except if this electronic equipment or peripheral device has been developed and intended for children and if this equipment does not have independent use value for playing, such as special personal computers, keyboards, joysticks and steering wheels;
15) interactive software intended for entertainment and playing, such as computer games, and their data media, such as compact discs;
16) babies’ dummies;
17) lighting fixtures attractive for children;
18) transformers for toys;
19) fashion jewellery for children, which are not intended for playing.
(3) This Regulation does not apply to the following toys:
1) playground equipment intended for public use;
2) automatic playing machines intended for public use;
3) toy vehicles equipped with combustion engines;
4) toy steam engines;
5) slings, catapults and other projectile devices.
§ 2. Definitions
In addition to the definitions set out in the Product Conformity Act, the terms are used as follows in this Regulation:
1) EC-type examination – the part of a conformity assessment procedure in which a conformity assessment body examines the technical design of a toy and verifies and attests that the technical design of the product meets the requirements of this Regulation;
2) harm – physical injury or any other damage to health, including long-term health effects;
3) hazard – a potential source of harm;
4) risk – the probable rate of occurrence of a hazard causing harm and the degree of severity of the harm.
Chapter 2 REQUIREMENTS FOR TOYS AND THE ACCOMPANYING LABELLING
§ 3. Essential safety requirements
(1) Toys may not be placed on the market unless they comply with the essential general safety requirements set out in this subsections (2) to (3) of this section and with the particular safety requirements provided in Annex II to the Directive 2009/48/EC of the European Parliament and of the Council on the safety of toys (OJ L 170, 30.06.2009, p. 1–37) (hereinafter Directive 2009/48/EC).
(2) Toys, including the chemicals they contain, shall not jeopardise the safety or health of users or third parties when they are used as intended or in a foreseeable way, bearing in mind the behaviour of children.
(3) The ability of the users and, where appropriate, their supervisors shall be taken into account in designing toys, in particular, in the case of toys which are intended for use by children under 36 months or by other specified age groups.
(4) Labels affixed in accordance with subsections 5 (2) to 5 (5) of this Regulation and instructions for use which accompany toys shall draw the attention of the child or its supervisor to the inherent hazards and risks of harm involved in the manner of using the toys, and to the ways of avoiding such hazards and risks.
(5) Toys placed on the market shall comply with the safety requirements set out in this section during their foreseeable and normal period of use.
§ 4. Presumption of conformity
Toys which are in conformity with harmonised standards or parts thereof, shall be presumed to be in conformity with the requirements covered by those standards or parts thereof set out in section 3 of this Regulation and Annex II to Directive 2009/48/EC.
§ 5. Warnings
(1) Considering the potential hazards related to a toy and the age group for whom the toy is intended, toys shall be accompanied with warnings, such as those specifying the minimum and maximum ages for users and, where appropriate, the abilities of the user, the minimum or maximum weight of the user and the need to ensure that the toy is used only under adult supervision.
(2) On toys listed in Part B of Annex V of Directive 2009/48/EC the warnings listed in that part shall be used, using the warnings set out in clauses 2) to 10) in the wording presented in these clauses.
(3) Toys shall not bear the warnings referred to in subsection (2) of this section if they conflict with the intended use of the toy, as determined by virtue of its function, dimensions and characteristics.
(4) The warnings shall be marked in a clearly visible, easily legible and understandable manner on the toy, on an affixed label or on the packaging and, if appropriate, on the instructions for use which accompany the toy. Small toys which are sold without packaging shall have appropriate warnings affixed to them.
(5) The warnings shall be preceded by the words "warning" or "warnings", as the case may be.
(6) Warnings which determine the decision to purchase the toy, such as those specifying the maximum and minimum ages for users, shall appear on the consumer packaging or be otherwise clearly visible to the consumer before the purchase, including in cases where the purchase is made on-line.
(7) The information mentioned in this section shall be given in Estonian. In the event of a marking being in a foreign language, information in Estonian covering the full extent of the original text shall be affixed in compliance with the requirements.
§ 6. Conformity mark
(1) Before being placed on the market, a conformity mark (EC marking) shall be affixed to toys accordance with the procedure set out in this Regulation, taking into account the general requirements provided in Article 30 of Regulation (EC) of the European Parliament and of the Council setting out the requirements for accreditation and market surveillance relating to the marketing of products and repealing Regulation (EEC) No 339/93 (OJ L 218, 13.08.2008, p. 30–47).
(2) The CE marking shall be affixed visibly, legibly and indelibly to the toy, to an affixed label or to the packaging.
(3) In the case of small toys and toys consisting of small parts, the CE marking may alternatively be affixed to a label or an accompanying leaflet. Where, in the case of toys sold in counter displays, that is not technically possible, and on condition that the counter display was originally used as packaging for the toy, the CE marking may be affixed to the counter display.
(4) Where the CE marking is not visible from outside the packaging, if any, it shall as a minimum be affixed to the packaging.
(5) The CE marking may be followed by a pictogram or any other mark indicating a special risk or use. Any other marking may be affixed to the product provided that the visibility, legibility and meaning of the CE marking is not thereby impaired.
Chapter 3 ATTESTATION OF CONFORMITY
Division 1 Conformity assessment
§ 7. Safety assessments
Manufacturers shall, before placing a toy on the market, carry out an analysis of the chemical, physical, mechanical, electrical, flammability, hygiene and radioactivity hazards that the toy may present, as well as an assessment of the potential exposure to such hazards.
§ 8. Selection of the conformity assessment procedure
(1) In order to ensure that the toy complies with the requirements, the manufacturer may:
1) design and manufacture the toy according to the harmonised standards covering all the safety requirements for the toy;
2) submit the toy to EC-type examination.
(2) The manufacturer should submit the toy to EC-type examination according to the EC-type examination presented in Module C of Annex II of the Decision No 768/2008/EC of the European Parliament and of the Council on a common framework for the marketing of products, and repealing Council Decision 93/465/EEC (OJ L 218, 13.08.2008, p. 82–128) (hereinafter Decision 768/2008/EC) if:
1) there are no harmonised standards covering all the safety requirements for the toy;
2) the harmonised standards mentioned in subsection (1) of this section exist but the manufacturer has not applied them or have applied them only partly;
3) the harmonised standards mentioned in subsection (1) of this section or some of them have been published with a restriction;
4) the manufacturer considers that the nature, design, construction or purpose of the toy necessitates third party verification.
§ 9. EC-type examination
(1) Application for EC-type examination, performance of that examination and issue of the EC-type examination certificate shall be carried out in accordance with the procedures set out in Module B of Annex II to Decision No 768/2008/EC, taking into account the specifications provided for in this Regulation.
(2) The application for an EC-type examination shall include a description of the toy and an indication of the place of manufacture, including the address.
(3) When a conformity assessment body carries out the EC-type examination, it shall evaluate (if necessary together with the manufacturer) the assessment of the hazards that the toy may present carried out in accordance with section 7 of this Regulation.
(4) The technical documentation and correspondence relating to the EC-type examination procedures shall be drawn up in a language understandable to the conformity assessment body.
Division 2 Documentation related to attestation of conformity
§ 10. Technical documentation
(1) The technical documentation prepared by the manufacturer shall contain data or details of the means used by the manufacturer to ensure that toys comply with the requirements set out in this Regulation. The technical documentation shall, in particular, contain the following information:
1) a detailed description of the design and manufacture, including a list of components and materials used in the toy as well as the safety data sheets on chemicals used;
2) the safety assessment carried out in accordance with section 7 of this Regulation;
3) a description of the conformity assessment procedure followed;
4) a copy of the EC declaration of conformity;
5) the addresses of the places of manufacture and storage;
6) copies of documents that the manufacturer has submitted to a conformity assessment body;
7) test reports and description of the means whereby the manufacturer ensured conformity of production with the harmonised standards;
8) a copy of the EC-type examination certificate, a description of the means whereby the manufacturer ensured conformity of the production with the product type as described in the EC-type examination certificate, and copies of the documents that the manufacturer submitted to the conformity assessment body, if the manufacturer submitted the toy to EC-type examination mentioned in subsection 8 (2) of this Regulation and followed the conformity to type procedure referred to therein.
(2) The technical documentation shall be drawn up in one of the official languages of the EU, subject to the requirement set out in subsection 9 (4) of this Regulation.
(3) Following a reasoned request from the market surveillance authority, the manufacturer shall provide a translation of the technical documentation into Estonian. The market surveillance authority may fix a deadline for receipt of such translation of the technical documentation, which shall not be less than 30 days, unless a shorter deadline is justified to prevent serious and immediate risks.
(4) If the manufacturer does not comply with the requirements of subsections (1), (2) and (3) of this section, the market surveillance authority may require it to have a test performed by a conformity assessment body at its own expense within a specified period in order to verify compliance with the harmonised standards and essential safety requirements.
§ 11. EC declaration of conformity
(1) The EC declaration of conformity shall have the model structure set out in Annex III to this Directive 2009/48/EC.
(2) The EC declaration of conformity shall as a minimum contain the elements specified in Annex III to this Directive and the relevant modules set out in Annex II to Decision No 768/2008/EC and shall be continuously updated.
§ 12. EC-type examination certificate
(1) The EC-type examination certificate shall include a reference to Directive 2009/48/EC, a colour image and a clear description of the toy, including its dimensions, and a list of the tests performed, together with a reference to the relevant test reports.
(2) The EC-type examination certificate shall be reviewed whenever necessary, in particular in case of a change to the manufacturing process, the raw materials or the components of the toy, and, in any case, every five years.
(3) The EC-type examination certificate shall be withdrawn if the toy fails to comply with the requirements set out in this Regulation.
(4) A conformity assessment body shall not grant an EC-type examination certificate for a toy in respect of which a certificate has been refused or withdrawn.
§ 13. Instructions to the conformity assessment body
(1) Market surveillance authorities may request a conformity assessment body to provide information relating to any EC-type examination certificate which that body has issued or withdrawn, or which relates to any refusal to issue such a certificate, including the test reports and technical documentation.
(2) If a market surveillance authority finds that a toy is not in conformity with the requirements set out in this Regulation, it shall, where appropriate, instruct the conformity assessment body to withdraw the EC-type examination certificate in respect of that toy.
(3) Where necessary, and in particular in the case of a change to the manufacturing process, the raw materials or the components of the toys, the market surveillance authority may instruct the conformity assessment body to review the EC-type examination certificate.
Chapter 4 SUPERVISION
§ 14. Market surveillance authorities
Supervision over the compliance with the requirements established in this Regulation shall be performed by the Consumer Protection Board and the Health Board according to the procedure established in the Product Conformity Act.
§ 15. Precautionary principle
When market surveillance authorities take market surveillance measures, they shall take due account of the precautionary principle.
Chapter 5 IMPLEMENTING PROVISIONS
§ 16. Entry into force of Regulation
This Regulation enters into force on 1 October 2010.
§ 17. Transitional period
(1) Toys which comply with the requirements established in Directive 88/378/EEC on the approximation of the laws of the Member States concerning the safety of toys (OJ L 187, 16.07.1988, p. 1–13) (hereinafter Directive 88/378/EEC) may be placed on the market until 20 July 2011.
(2) Toys which conform to the requirements of this Regulation but do not conform to the requirements for chemical properties established in Part III of Annex II of Directive 2009/48/EC referred to in subsection 3 (1) of this Regulation may be placed on the market until 20 July 2013, provided that the toys comply with the requirements established in Part III of Annex II of Directive 88/378/EEC.
1Directive 2009/48/EC of the European Parliament and of the Council on the safety of toys (OJ L 170, 30.06.2009, p. 1–37)