S.I. No. 14 of 2011 European Communities (Safety of Toys) Regulations 2011
Source: Iris Oifigiúl 2011-01-21

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paragraphs: (1) These Regulations may be cited as the European Communities (Safety of Toys) Regulations 2011.
(2) These Regulations come into operation on 20 July 2011.
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paragraphs: (1) The European Communities (Safety of Toys) Regulations 1990 ( S.I. No. 32 of 1990 ) (“1990 Regulations”), other than Regulation 4 in so far as that Regulation relates to Article 2(1) and Part 3 of Annex II of Council Directive 88/378/EEC of 3 May 19882 (“Directive 88/378/EEC”), are revoked with effect from 20 July 2011.
(2) The said Regulation 4, in so far as it so relates, is revoked with effect from 20 July 2013.
(3) References in any other instrument to the Regulations revoked under paragraphs (1) and (2) shall be construed as references to these Regulations, as appropriate.
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paragraphs: (1) These Regulations apply to toys which are placed on the market on or after 20 July 2011.
(2) These Regulations do not apply to the following toys:
(a) playground equipment intended for public use;
(b) automatic playing machines, whether coin-operated or not, intended for public use;
(c) toy vehicles equipped with combustion engines;
(d) toy steam engines; and
(e) slings and catapults.
(3) Nothing in these Regulations shall impede the making available on the market of toys which are in accordance with the 1990 Regulations and which were placed on the market before 20 July 2011.
(4) In addition to the requirement of paragraph 3, nothing in these Regulations shall impede the making available on the market of toys which are in accordance with the requirements of these Regulations, except those set out in Part III of Annex II, provided that such toys meet the requirements set out in Part 3 of Section 2 of Annex II to Directive 88/378/EEC and were placed on the market before 20 July 2013.
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paragraphs: (1) In these Regulations, save where the context otherwise requires—
(2) A word or expression which is used in these Regulations and is also used in the Toy Safety Directive has, unless the contrary intention appears, the same meaning in these Regulations as it has in that Directive.
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paragraphs: The definition of “relevant statutory provisions” in section 2 of the Consumer Protection Act 2007 (as amended by Regulation 18(3) of the European Communities (Names and Labelling of Textile Products) Regulations 2010 ( S.I. No. 485 of 2010 )) is amended by substituting for paragraphs (e) and (f) the following:
“(e) this Act and any instrument made under this Act for the time being in force,
(f) the European Communities (Names and Labelling of Textile Products) Regulations 2010 ( S.I. No. 485 of 2010 ), and
(g) the European Communities (Safety of Toys) Regulations 2011;”.
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paragraphs: The Agency, for the purposes of these Regulations, is both the market surveillance authority and the competent authority in the State.
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paragraphs: (1) A manufacturer shall, before placing a toy on the market, comply with Regulation 21.
(2) When placing a toy on the market, a manufacturer shall—
(a) ensure that it has been designed and manufactured in accordance with the requirements set out in the essential safety requirements,
(b) draw up the required technical documentation in accordance with Regulation 24 and carry out or have carried out the applicable conformity assessment procedure in accordance with Regulation 20,
(c) where compliance of a toy with the applicable requirements has been demonstrated by that procedure, draw up an EC declaration of conformity, and affix the CE marking as provided for in these Regulations,
(d) 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,
(e) 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,
(f) when deemed appropriate with regard to the risks presented by a toy, 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 keep distributors informed of any such monitoring,
(g) ensure that his, her or its 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,
(h) indicate his, her or its name, registered trade name or registered trade mark and the address at which he, she or it 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, and
(i) ensure that the toy is accompanied by instructions and safety information in English.
(3) A manufacturer who considers or has reason to believe that a toy which he, she or it has 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, the manufacturer shall immediately inform the competent authorities of the Member States in which he, she or it made the toy available to that effect, giving details, in particular, of the non-compliance and of any corrective measures taken.
(4) A manufacturer shall, further to a reasoned request from the competent authority, provide that authority with all the information and documentation necessary to demonstrate the conformity of the toy, in English. He, she or it shall cooperate with that authority, at its request, as regards any action taken to eliminate the risks posed by a toy which he, she or it has placed on the market.
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paragraphs: (1) A manufacturer may, by a written mandate, appoint an authorised representative.
(2) The obligations laid down in Regulation 7(2) 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:
(a) keep the EC declaration of conformity and the technical documentation at the disposal of national surveillance authorities for a period of 10 years from the date when the toy was placed on the market;
(b) further to a reasoned request from a competent authority in a Member State, provide that authority with all the information and documentation necessary to demonstrate the conformity of a toy;
(c) cooperate with each such competent authority, at its request, on any action taken to eliminate the risks posed by a toy covered by the mandate.
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paragraphs: (1) An importer shall place only a toy which is compliant on the market.
(2) Before placing a toy on the market, an importer shall ensure that—
(a) the appropriate conformity assessment procedure has been carried out by the manufacturer,
(b) the manufacturer has drawn up the technical documentation, that the toy bears the required conformity marking and is accompanied by the required documents, and that the manufacturer has complied with the requirements set out in Regulation 7(2)(g) and (h),
(c) the toy is accompanied by instructions and safety information in English, and
(d) while the toy is under his, her or its responsibility, storage or transport conditions do not jeopardise its compliance with the requirements set out in the essential safety requirements.
(3) Where an importer considers or has reason to believe that a toy is not in conformity with the requirements set out in the essential safety requirements, he, she or 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 competent authority to that effect.
(4) An importer shall indicate his, her or its name, registered trade name or registered trade mark, and the address at which he, she or it can be contacted, on the toy or, where that is not possible, on its packaging or in a document accompanying the toy.
(5) When deemed appropriate with regard to the risks presented by a toy placed on the market by him, her or it, an importer 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) An importer who considers or has reason to believe that a toy placed on the market by him, her or it 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, the importer shall immediately inform the competent authority, giving details, in particular, of the non-compliance and of any corrective measures taken.
(7) An importer shall, for a period of 10 years after a toy has been placed on the market by him, her or it, 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) An importer shall, further to a reasoned request from the competent authority—
(a) provide, in English, that authority with all the information and documentation necessary to demonstrate the conformity of the toy, and
(b) cooperate with that authority, at its request, on any action taken to eliminate the risks posed by toys which he, she or it has placed on the market.
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paragraphs: (1) When making a toy available on the market, a distributor shall act with due care in relation to the applicable requirements.
(2) Before making a toy available on the market, a distributor 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 each Member State in which the toy is to be made available on the market (and in the case of the State, in English), and that the manufacturer and the importer have complied with the requirements set out in Regulation 7(2)(g) and (h) and Regulation 9(4).
(3) Where a distributor considers or has reason to believe that a toy is not in conformity with the requirements set out in the essential safety requirements, he, she or 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 competent authority, to that effect.
(4) A distributor shall ensure that, while a toy is under his, her or its responsibility, storage or transport conditions do not jeopardise its compliance with the requirements set out in the essential safety requirements.
(5) A distributor who considers or has reason to believe that a toy which he, she or it has 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, the distributor shall immediately inform the competent authority to that effect, giving details, in particular, of the non-compliance and of any corrective measures taken.
(6) A distributor shall, further to a reasoned request from a competent authority, provide that authority with all the information and documentation necessary to demonstrate the conformity of the toy. He, she or it shall cooperate with that authority, at its request, as regards any action taken to eliminate the risks posed by a toy which he, she or it has made available on the market.
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paragraphs: (1) An importer or distributor shall be considered a manufacturer for the purposes of these Regulations, and be subject to the obligations of the manufacturer under Regulation 7, where he, she or it places a toy on the market under his, her or 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.
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paragraphs: (1) An economic operator shall, on request, identify the following to the market surveillance authorities:
(a) each economic operator who has supplied him, her or it with a toy;
(b) each economic operator to whom he, she or it has supplied a toy.
(2) An economic operator shall ensure that he, she or it is able to present the information referred to in paragraph (1) for a period of—
(a)10 years after the toy has been placed on the market, in the case of the manufacturer, and
(b)10 years after he, she or it has been supplied with the toy, in the case of other economic operators.
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paragraphs: (1) 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. The ability of the users and, where appropriate, their supervisors shall be taken into account, in particular, in the case of toys which are intended for use by children under 36 months or by other specified age groups. Labels affixed in accordance with Regulation 14(4), (5) and (6) and instructions for use which accompany toys shall draw the attention of users or their supervisors to the inherent hazards and risks of harm involved in using the toys, and to the ways of avoiding such hazards and risks.
(2) Toys placed on the market in the State shall comply with the essential safety requirements during their foreseeable and normal period of use.
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paragraphs: (1) Where appropriate for safe use, warnings made for the purposes of Regulation 13(1) shall specify appropriate user limitations in accordance with Part A of Annex V.
(2) As regards the categories of toy listed in Part B of Annex V, the warnings set out therein shall be used. The warnings set out in points 2 to 10 of Part B of Annex V shall be used as worded therein.
(3) Toys shall not bear one or more of the specific warnings set out in Part B of Annex V where that warning conflicts with the intended use of the toy, as determined by virtue of its function, dimension and characteristics.
(4) A manufacturer shall mark the warnings in a clearly visible, easily legible and understandable and accurate 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 in English and 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 minimum and maximum ages for users and the other applicable warnings set out in Annex V, 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.
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paragraphs: Nothing in these Regulations shall impede the making available on the market in the State of a toy which complies with the Toy Safety Directive.
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paragraphs: A toy which is in conformity with harmonised standards or parts thereof, the references of which have been published in the Official Journal of the European Union, shall be presumed to be in conformity with the requirements covered by those standards or parts thereof set out in the essential safety requirements.
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paragraphs: (1) An EC declaration of conformity shall state that the fulfilment of the requirements set out in the essential safety requirements has been demonstrated.
(2) An EC declaration of conformity shall contain the elements specified in Annex III and the relevant modules set out in Annex II to Decision No 768/2008/EC of the European Parliament and of the Council of 9 July 20084 (“Decision No 768/2008/EC”) and shall be continuously updated. It shall be structured as set out in Annex III. It shall be translated into English when being placed on the market in the State.
(3) By drawing up an EC declaration of conformity, a manufacturer assumes responsibility for the compliance of the toy to which it relates.
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paragraphs: All toys made available on the market shall bear the CE marking, as subject to the general principles set out in Article 30. Toys bearing the CE marking shall be presumed to comply with the Toy Safety Directive. Toys not bearing a CE marking or which do not otherwise comply with these Regulations may be shown and used at trade fairs and exhibitions, provided that they are accompanied by a sign which clearly indicates that they do not comply with these Regulations and that they will not be made available on the market unless they are brought into conformity.
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paragraphs: (1) The CE marking shall be affixed visibly, legibly and indelibly to a toy, to an affixed label or to the packaging. In the case of a small toy and a toy consisting of small parts, the CE marking may alternatively be affixed to a label or an accompanying leaflet. Where, in the case of a toy sold in a 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.
(2) Where the CE marking is not visible from outside the packaging, if any, it shall as a minimum be affixed to the packaging.
(3) The CE marking shall be affixed before the toy is placed on the market. It may be followed by a pictogram or any other mark indicating a special risk or use.
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paragraphs: (1) For the purposes of these Regulations, EC type-examination is the procedure whereby a notified body ascertains and certifies that a representative model of a toy satisfies the provisions of these Regulations.
(2) Before placing a toy on the market, manufacturers shall use the conformity assessment procedures referred to in paragraphs 3 and 4 to demonstrate that the toy complies with the essential safety requirements.
(3) If the manufacturer has applied harmonised standards, which have been published in the Official Journal of the European Union, covering all relevant safety requirements for the toy, he, she or it shall use the internal production control procedure set out in Module A of Annex II to Decision No. 768/2008/EC.
(4) In the following cases, a toy shall be submitted to EC-type examination together with the conformity to type procedure set out in Module C of Annex II to Decision No. 768/2008/EC:
(a) 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;
(b) where the harmonised standards referred to in subparagraph (a) exist but the manufacturer has not applied them or has applied them only in part;
(c) where one or more of the harmonised standards specified in subparagraph (a) has been published with a restriction;
(d) where the manufacturer considers that the nature, design, construction or purpose of the toy necessitate third party verification.
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paragraphs: A manufacturer 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.
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paragraphs: (1) An 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. EC-type examination shall be carried out in the manner specified in the second indent of point 2 of that Module.
(2) An application under paragraph (1) shall be made in writing and shall contain such information and be supported by such documents as the notified body may reasonably require, including—
(a) a description of the toy, and
(b) the name and address of the manufacturer or his, her or its authorised representative or representatives, and the place of manufacture of the toy.
(3) When a notified body carries out the EC-type examination, it shall evaluate, if necessary together with the manufacturer, an analysis of the hazards the toy may present, in accordance with Regulation 21.
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paragraphs: (1) The EC-type examination certificate shall include a reference to the Toy Safety Directive, a colour image, a clear description of the toy, including its dimensions, and a list of the tests performed, together with a reference to the relevant test report.
(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. The maximum period between reviews shall be five years.
(3) The EC-type examination certificate shall be withdrawn if the toy fails to comply with the essential safety requirements.
(4) Notified bodies shall withdraw EC-type examination certificates which are no longer valid.
(5) Notified bodies shall not grant an EC-type examination certificate for a toy in respect of which a certificate has been refused or withdrawn.
(6) The technical documentation and correspondence relating to the EC-type examination procedures shall be drawn up in English.
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paragraphs: (1) The technical documentation referred to in Regulation 7(2) shall contain all relevant data or details of the means used by a manufacturer to ensure that a toy complies with the essential safety requirements. It shall, in particular, contain the documents listed in Annex IV.
(2) The technical documentation shall be drawn up in English.
(3) Following a reasoned request from the market surveillance authority of a Member State, a manufacturer shall provide a translation of the relevant parts of the technical documentation into the language of that Member State within thirty days of receipt of the request. In cases of serious and immediate risk, a shorter deadline may be set.
(4) If a manufacturer does not comply with the requirements of paragraphs (1), (2) and (3), the market surveillance authority may require the manufacturer to have a test performed by a notified body at the manufacturer’s own expense within a specified period of time in order to verify compliance with the harmonised standards and essential safety requirements.
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paragraphs: (1) The Minister shall act as a notifying authority in the State, with the authority to designate notified bodies.