Toys must comply with
Safety Requirements for Toys and Procedure for Conformity Attestation of Toys (Government regulation from 03.09.2010) attached requirements.
Directive
2009/48/EC of the European Parliament and of the Council of June 18, 2009 on the safety of toys.
Council Directive
88/378/EEC of May 3, 1988 on the approximation of the laws of the Member States concerning the safety of toys.
In regulation “Safety Requirements for Toys and Procedure for Conformity Attestation of Toys” in accordance with §3: toys that are placed on the market should comply with the general safety requirement and particular safety requirements are concerned, in Annex II (
2009/48/EC).
Toys made available on the market shall bear the CE marking. With the CE marking on the toy, the manufacturer declares that the toy is in conformity with all applicable requirements and that the manufacturer takes full responsibility therefore.
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.
Before placing a toy on the market, manufacturers shall use the conformity assessment procedures.
If the manufacturer has applied harmonised standards, the reference number of which has been published in the Official Journal of the European Union, covering all relevant safety requirements for the toy, it shall use the internal production control procedure set out in Module A of Annex II to Decision No 768/2008/EC.
Toy safety standards can be found on the website of the
Estonian Centre for Standardisation.
More information about harmonised standards can be found
here.
In the following cases, the toy shall be submitted to EC-type examination:
- where harmonised standards, the reference number of which has been published in the Official Journal of the European Union, covering all relevant safety requirements for the toy, do not exist;
- where the harmonised standards referred to in point (a) exist but the manufacturer has not applied them or has applied them only in part;
- where one or more of the harmonised standards referred to in point (a) has been published with a restriction;
- when the manufacturer considers that the nature, design, construction or purpose of the toy necessitate third party verification.
EC type-examination is part of the conformity assessment procedure, where conformity assessment body shall assess the technical design of the toy and verifies and certifies that it meets the stated requirements.
Conformity assessment body makes conformity assessment procedures, including calibration, testing, certification or inspection.
Accredited product certification bodies in Estonia can be found on the website of the
Estonian Accreditation Centre.
All notified bodies, which carry out conformity assessment of toy safety, can be found
here.
Manufacturer means any natural or legal person who manufactures a toy or has a toy designed or manufactured, and has placed that toy on the markets under his name or trademark.
- When placing their toys on the market, manufacturers shall ensure that they have been designed and manufactured in accordance with the requirements set out in Article 10 and Annex II.
- Manufacturers shall draw up the required technical documentation and carry out or have carried out the applicable conformity assessment procedure.
Where compliance of a toy with the applicable requirements has been demonstrated by that procedure, manufacturers shall draw up an EC declaration of conformity.- Manufacturers shall keep the technical documentation and the EC declaration of conformity for a period of 10 years after the toy has been placed on the market.
- Manufacturers shall ensure that procedures are in place for series production to remain in conformity. Changes in toy design or characteristics and changes in the harmonised standards by reference to which conformity of a toy is declared shall be adequately taken into account.
When deemed appropriate with regard to the risks presented by a toy, manufacturers shall, to protect the health and safety of consumers, carry out sample testing of marketed toys, investigate, and, if necessary, keep a register of complaints, of nonconforming toys and toy recalls, and shall keep distributors informed of any such monitoring. - Manufacturers shall ensure that their toys bear a type, batch, serial or model number or other element allowing their identification, or, where the size or nature of the toy does not allow it, that the required information is provided on the packaging or in a document accompanying the toy.
- Manufacturers shall indicate their name, registered trade name or registered trade mark and the address at which they can be contacted on the toy or, where that is not possible, on its packaging or in a document accompanying the toy. The address shall indicate a single point at which the manufacturer can be contacted.
- Manufacturers shall ensure that the toy is accompanied by instructions and safety information in a language or languages easily understood by consumers, as determined by the Member State concerned.
- Manufacturers who consider or have reason to believe that a toy which they have placed on the market is not in conformity with the relevant Community harmonisation legislation shall immediately take the corrective measures necessary to bring that toy into conformity, to withdraw it or recall it, if appropriate. Furthermore, where the toy presents a risk, manufactures shall immediately inform the competent national authorities of the Member States in which they made the toy available to that effect, giving details, in particular, of the noncompliance and of any corrective measures taken.
- Manufacturers shall, further to a reasoned request from a competent national authority, provide that authority with all the information and documentation necessary to demonstrate the conformity of the toy, in a language easily understood by that authority. They shall cooperate with that authority, at its request, as regards any action taken to eliminate the risks posed by toys which they have placed on the market.
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.
- A manufacturer may, by a written mandate, appoint an authorised representative.
- The obligations laid down in Article 4(1) and the drawing up of technical documentation shall not form part of the authorised representative’s mandate.
- An authorised representative shall perform the tasks specified in the mandate received from the manufacturer. The mandate shall allow the authorised representative to do at least the following:
(a) keep the EC declaration of conformity and the technical documentation at the disposal of national surveillance authorities for a period of 10 years after the toy has been placed on the market;
(b) further to a reasoned request from a competent national authority, provide that authority with all the information and documentation necessary to demonstrate the
conformity of a toy;
(c) cooperate with the competent national authorities, at their request, on any action taken to eliminate the risks posed by toys covered by the mandate.
Importer means any natural or legal person established within the Community who places a toy from a third country on the Community market.
- Importers shall place only compliant toys on the Community market.
- Before placing a toy on the market, importers shall ensure that the appropriate conformity assessment procedure has been carried out by the manufacturer.
They shall ensure that the manufacturer has drawn up the technical documentation, that the toy bears the required conformity marking and is accompanied by the required documents.
Where an importer considers or has reason to believe that a toy is not in conformity with the requirements, it shall not place the toy on the market until the toy has been brought into conformity. Furthermore, where the toy presents a risk, the importer shall inform the manufacturer and the market surveillance authorities to that effect. - Importers shall indicate their name, registered trade name or registered trade mark and the address at which they can be contacted on the toy or, where that is not possible, on its packaging or in a document accompanying the toy.
- Importers shall ensure that the toy is accompanied by instructions and safety information in a language or languages easily understood by consumers, as determined by the Member State concerned.
- Importers shall ensure that, while a toy is under their responsibility, storage or transport conditions do not jeopardise its compliance with the requirements set out in Article 10 and Annex II.
- When deemed appropriate with regard to the risks presented by a toy, importers shall, to protect the health and safety of consumers, carry out sample testing of marketed toys, investigate, and, if necessary, keep a register of complaints, of non-conforming toys and toy recalls, and shall keep distributors informed of such monitoring.
- Importers who consider or have reason to believe that a toy which they have placed on the market is not in conformity with the relevant Community harmonisation legislation shall immediately take the corrective measures necessary to bring that toy into conformity, to withdraw it or recall it, if appropriate. Furthermore, where the toy presents a risk, importers shall immediately inform the competent national authorities of the Member States in which they made the toy available to that effect, giving details, in particular, of the non-compliance and of any corrective measures taken.
- Importers shall, for a period of 10 years after the toy has been placed on the market, keep a copy of the EC declaration of conformity at the disposal of the market surveillance authorities and ensure that the technical documentation can be made available to those authorities, upon request.
- Importers shall, further to a reasoned request from a competent national authority, provide that authority with all the information and documentation necessary to demonstrate the conformity of the toy in a language easily understood by that authority. They shall cooperate with that authority, at its request, on any action taken to eliminate the risks posed by toys which they have placed on the market.
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.
- When making a toy available on the market, distributors shall act with due care in relation to the applicable requirements.
- Before making a toy available on the market, distributors shall verify that the toy bears the required conformity marking, that it is accompanied by the required documents and by instructions and safety information in a language or languages easily understood by consumers in the Member State in which the toy is to be made available on the market., and that the manufacturer and the importer have complied with the requirements set out in Article 4(5) and (6) and Article 6(3).
Where a distributor considers or has reason to believe that a toy is not in conformity with the requirements set out in Article 10 and Annex II, it shall not make the toy available on the market until the toy has been brought into conformity. Furthermore, where the toy presents a risk, the distributor shall inform the manufacturer or the importer, as well as the market surveillance authorities, to that effect. - Distributors shall ensure that, while a toy is under their responsibility, storage or transport conditions do not jeopardise its compliance with the requirements set out in Article 10 and Annex II.
- Distributors who consider or have reason to believe that a toy which they have made available on the market is not in conformity with the relevant Community harmonisation legislation shall make sure that the corrective measures necessary to bring that toy into conformity, to withdraw it or recall it, if appropriate, are taken. Furthermore, where the toy presents a risk, distributors shall immediately inform the competent national authorities of the Member States in which they made the toy available to that effect, giving details, in particular, of the non-compliance and of any corrective measures taken.
- Distributors shall, further to a reasoned request from a competent national authority, provide that authority with all the information and documentation necessary to demonstrate the conformity of the toy. They shall cooperate with that authority, at its request, as regards any action taken to eliminate the risks posed by toys which they have made available on the market.
Cases in which obligations of manufacturers apply to importers and distributors
An importer or distributor shall be considered a manufacturer for the purposes of this Directive and be subject to the obligations of the manufacturer under Article 4 where it places a toy on the market under its name or trademark or modifies a toy already placed on the market in such a way that compliance with the applicable requirements may be affected.