Toys production, importation and distribution

Toys must comply with Product Conformity Act,   Safety Requirements for Toys and Procedure for Conformity Attestation of Toys (Government regulation from 03.09.2010), Directive 2009/48/EC on the safety of toys and Directive 88/378/EEC on the approximation of the laws of the Member States concerning the safety of toys attached requirements.

According to § 3 of Government Regulation no 57  from 03.09.2010 „Safety Requirements for Toys and Procedure for Conformity Attestation of Toys“,  toys may not be placed on the market unless they comply with the essential general safety requirements 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.  According to § 6 (1), a conformity mark (CE marking) shall be affixed to toys accordance with the procedure set out in this Regulation before being placed on the market. By affixing or having affixed CE marking to toys, to an affixed label or to the packaging, the manufacturer announces that the product complies with all the requirements stated in the abovementioned legislative texts.

According to § 8 of Government Regulation no 57  from 03.09.2010 „Safety Requirements for Toys and Procedure for Conformity Attestation of Toys“, the manufacturer may, in order to ensure that the toy complies with the requirements:

  1. design and manufacture the toy according to the harmonised standards covering all the safety requirements for the toy;
    Standards concerning toy safety can be found on the website of  Estonian Centre for Standardisation.
    More information on European harmonised standards on toys can be found here.
  2. submit the toy to EC-type examination.
    EC-type examination is a part of 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 regulations set out in the Regulation.

The manufacturer should submit the toy to EC-type examination 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.

A conformity assessment body means a body that performs conformity assessment activities, including calibration, testing, certification and inspection.
Accredited product certification bodies in Estonia can be found the the website of Estonian Accreditation Centre.

All notified bodies that carry out conformity assessment of toys concerning safety can be found here.

According to the Directive 2009/48/EC on the safety of toys, obligations of manufacturers, authorised representatives, importers and distributors of toys are as follows:

Obligations of manufacturers

‘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.

  1. 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.
  2. 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.
  3. 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.
  4. 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 non-conforming toys and toy recalls, and shall keep distributors informed of any such monitoring.
  5. 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.
  6. 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.
  7. 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.
  8. 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 non-compliance and of any corrective measures taken.
  9. 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.

Obligations of Authorised Representatives

‘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.

  1. A manufacturer may, by a written mandate, appoint an authorised representative.

  2. 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.

  3. 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:

  • 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;
  • 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;
  • cooperate with the competent national authorities, at their request, on any action taken to eliminate the risks posed by toys covered by the mandate.

 

 

Obligations of importers

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

  1. Importers shall place only compliant toys on the Community market.

  2. 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 set out in Article 10 and Annex II, 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.

  3. 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.

  4. 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.

  5. Importers shall ensure that, while a toy is under their responsibility, storage or transport conditions do not jeopardise its compliance with the requirements. 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.

  6. 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.

  7. 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.

  8. 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.

Obligations of distributors

‘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.

  1. 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 following requirements:
    • 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 have indicated 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 have indicated 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.
    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.

  2. 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.
  3. 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.
  4. 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. 

REACH (Regulation on Registration, Evaluation, Authorisation and Restriction of Chemicals) Regulation may also apply for the manufacturers and importers of products, therefore it is important to take the requirements of the Regulation into consideration. It may be necessary to notify and/or to register the chemicals found in the products. More information about REACH  can be found here and about national helpdesks can be found on ECHA webpage.

 
Viimati uuendatud:  reede, 27 september 2013 14:18