The Toys (Safety) Regulations 2011

• Citation: S.I. 2011/1881
• Sections: 205

Section 1 Citation and commencement

(1) These Regulations may be cited as the Toys (Safety) Regulations 2011.

(2) These Regulations come into force on 19th August 2011.

Section 2 Revocation, saving and amendment

(1) The Toys (Safety) Regulations 1995 (“ the 1995 Regulations ”) and the Toys (Safety) (Amendment) Regulations 2010 are revoked.

(2) The 1995 Regulations, as amended, continue to apply, subject to the modifications in paragraph (2A) as if they had not been revoked, to a toy placed on the market before these Regulations come into force.

(2A) The modifications referred to in paragraph (2) are—

(a) that references to “the Community” are to be read as including the United Kingdom; and

(b) paragraph (5) of regulation 9 is to be read as if “, the Commission of the Communities, the other member States and other approved bodies” were omitted.

(3) The Pencils and Graphic Instruments (Safety) Regulations 1998 are amended as follows.

(4) In regulation 1, insert after paragraph (2)—

(3) These Regulations do not apply to any article to which the Toys (Safety) Regulations 2011 apply.

Section 2A Transitional provision in relation to EU Exit

(1) In this regulation—

“ pre-exit period ” means the period beginning with 19th August 2011 and ending immediately before IP completion day;

“ product ” means a toy to which these Regulations apply.

(2) Subject to paragraphs (3) and (4), where a product was made available on the market during the pre-exit period, despite the amendments made by Schedule 15 to the Product Safety and Metrology etc. (Amendment etc.) (EU Exit) Regulations 2019 , any obligation or prohibition to which a person was subject under these Regulations as they had effect immediately before IP completion day, continues to have effect as it did immediately before IP completion day, in relation to that product.

(3) Paragraph (2) does not apply to—

(a) any obligation of any enforcement authority to inform the European Commission or the member States of any matter; or

(b) any obligation to take action outside of the United Kingdom in respect of that product.

(4) Where an EC-type examination was issued in relation to a product to which paragraph (2) applies references to “Type examination” in regulations 22 and 45 are to be read as referring to an EC-type examination referred to in regulation 44 as it had effect immediately before IP completion day.

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(7) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

Section 3 Interpretation

In these Regulations—

“ the 1987 Act ” means the Consumer Protection Act 1987;

“ the Directive ” means Directive 2009/48/EC of the European Parliament and of the Council of 18th June 2009 on the safety of toys;

“ the GP SR ” means the General Product Safety Regulations 2005 ;

“ approved body requirements ” has the meaning given to it in regulation 40A;

“ authorised representative ” means a person who has been appointed in accordance with regulation 25(1);

...

“ conformity assessment ” means the process demonstrating whether specified requirements relating to a toy have been fulfilled;

“ conformity assessment activities ” means activities relating to conformity assessment, including calibration, testing, certification and inspection;

“ designated standard ” has the meaning given to it in regulation 3A;

“ distributor ” means any person who—

is in the supply chain for a toy, other than the manufacturer or the importer; and

makes the toy available on the market;

“ economic operator ” means a manufacturer, an authorised representative, an importer or a distributor;

“ enforcement authority ” has the same meaning as in section 45(1) of the 1987 Act;

“ essential safety requirements ” has the meaning given in regulation 5;

“ harm ” means physical injury or any other damage to health, including long-term health effects;

...

“ hazard ” means a potential source of harm;

“ importer ” means a person who—

is established in the United Kingdom and places a toy from a country outside of the United Kingdom on the market; or

is established in Northern Ireland and places a toy on the market that has been supplied to them for distribution, consumption or use in the course of a commercial activity, whether in return for payment or free of charge, from an EEA state;

“ 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;

“ make available on the market ” means supply in the course of a commercial activity (whether in return for payment or free of charge) for distribution, consumption or use on the EU market, and related expressions shall be construed accordingly;

“ manufacturer ” means a person who—

manufactures a toy or has a toy designed or manufactured; and

markets that toy under that person's name or trademark;

“ Module ” means a Module set out in Schedule 6 and Module A, B or C is to be construed accordingly;

“ notified body designation ” has the meaning given in regulation 40;

“ place on the market ” means make a toy available on the EU market for the first time, and related expressions shall be construed accordingly;

“ recall ” means take any measure aimed at achieving the return of a toy that has already been made available to the end user;

“ risk ” means the probable rate of occurrence of a hazard causing harm and the degree of severity of the harm;

“ supply ” includes offering to supply, agreeing to supply, exposing for supply and possessing for supply;

“ toy ” has the meaning given in regulation 4;

“ UK notified body ” has the meaning given in regulation 40;

“ withdraw ” means take any measure aimed at preventing a toy in the supply chain from being made available on the market.

Section 3A Designated standard

(1) Subject to paragraphs (6) and (7) in these Regulations a “ designated standard ” means a technical specification which is—

(a) adopted by a recognised standardisation body or an international standardising body , for repeated or continuous application, with which compliance is not compulsory; and

(b) designated by the Secretary of State by publishing the reference to the standard and maintaining that publication in a manner the Secretary of State considers appropriate;

(2) For the purposes of subparagraph (a), a “ technical specification ” means a document that prescribes technical requirements to be fulfilled by a product, process, service or system and which lays down one of more of the following—

(a) the characteristics required of a product including—

(i) levels of quality, performance, interoperability, environmental protection, health, safety or dimensions, and

(ii) the requirements applicable to the product as regards the name under which the product is sold, terminology, symbols, testing and test methods, packaging, marking or labelling and conformity assessment procedures; or

(b) production methods and processes relating to the products, where these have an effect on their characteristics;

(3) For the purposes of this regulation a “ recognised standardisation body ” means any one of the following organisations—

(a) the European Committee for Standardisation (CEN);

(b) the European Committee for Electrotechnical Standardisation (Cenelec);

(c) the European Telecommunications Standards Institute (ETSI);

(d) the British Standards Institution (BSI);

(3A) In this regulation “ international standardising body ” has the same meaning as it has for the purposes of the Agreement on Technical Barriers to Trade, part of Annex 1A to the agreement establishing the World Trade Organisation signed at Marrakesh on 15 April 1994 (as modified from time to time).

(4) When considering whether the manner of publication of a reference in accordance with paragraph (1)(b), the Secretary of State must have regard to whether the publication will draw the standard to the attention of any person who may have an interest in the standard;

(5) Before publishing the reference to a technical specification adopted by the British Standards Institution, the Secretary of State must have regard to whether the technical specification is consistent with such technical specifications adopted by the other recognised standardisation organisations; or by international standardising bodies as the Secretary of State considers to be relevant.

(6) The Secretary of State may remove from publication the reference to a standard which has been published in accordance with paragraph (1)(b).

(7) Where the Secretary of State removes the reference to a standard from publication, that standard is no longer a designated standard.

(8) In this regulation a reference to a “ product ” is a reference to a toy to which these Regulations apply

(9) The Secretary of State may by regulations amend paragraph (3) to reflect any changes in the name or structure of the recognised standardisation bodies.

(10) Regulations made under paragraph (9) are to be made by statutory instrument.

(11) A statutory instrument containing regulations made under paragraph (9) is subject to annulment in pursuance of a resolution of either House of Parliament.

Section 3B Annexes to EU legislation as Schedules

(1) Schedules 1, 2, 4 and 5 reproduce provisions of the Annexes I, II, IV and V (respectively) to the Directive with amendments to correct deficiencies in assimilated law.

(2) A reference to a provision of Schedules 1, 2, 4, 5 is a reference to the equivalent provision of the relevant Annex to the Directive as set out in the relevant Schedule.

(3) Schedule 6 reproduces provisions of Annex II to Decision No 768/2008/EC of the European Parliament and of the Council of 9 July 2008 on a common framework for the marketing of products, and repealing Council Decision 93/465/EEC (“Decision No 768/2008/EC ”) which are relevant to these Regulations, as it has effect immediately before IP completion day, with amendments to correct deficiencies in assimilated law.

(4) A reference to a provision of Schedule 6 is a reference to the equivalent provision of Annex II of Decision No 768/2008/EC as set out in that Schedule.

Section 4 Toys to which these Regulations apply

(1) These Regulations apply to toys placed on the market on or after 19th August 2011.

(2) Toys are products designed or intended (whether or not exclusively) for use in play by children under 14 years old.

(3) These Regulations do not apply to—

(a) playground equipment intended for public use;

(b) automatic playing machines intended for public use, whether coin operated or not;

(c) toy vehicles equipped with combustion engines;

(d) toy steam engines;

(e) slings and catapults;

(f) products listed in Schedule 1 , as amended from time to time.

Section 5 Essential safety requirements

(1) The essential safety requirements in respect of a toy are—

(a) the general safety requirement set out in paragraphs (2) to (5); and

(b) the particular safety requirements set out in Schedule 2 , so far as relevant.

(2) Toys, including the chemicals they contain, must 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 must 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.

(4) Information as to the matters mentioned in paragraph (5), aimed at users of the toy or their supervisors, must be preceded by the word “Warning” or “Warnings” and must be marked in English in a clearly visible, easily legible, understandable and accurate manner on—

(a) the toy, a label affixed to the toy, or the toy's packaging; and

(b) any instructions for use which accompany the toy.

(5) The matters are—

(a) the inherent hazards and risks of harm involved in using the toy; and

(b) the ways of avoiding such hazards and risks.

Section 6 Particular safety requirements for toys placed on the market before 20th July 2013

Where a toy is placed on the market before 20th July 2013, the particular safety requirements in respect of chemical properties are those in paragraph 3 of Part II of Annex II to Council Directive 88/378/ EEC on the approximation of the laws of the Member States concerning the safety of toys , and not those in Part III of Annex II to the Directive.

Section 7 Presumption of conformity

(1) A toy which conforms with designated standards shall be presumed to comply with the essential safety requirements to the extent that those requirements are covered by those standards.

(2) The presumption set out in paragraph (1) is rebuttable.

Section 8 Exception for trade fairs or exhibitions

(1) A toy which does not bear the UK marking, or in relation to which any other requirement of these Regulations is not complied with, may be shown or used at a trade fair or exhibition.

(2) Such a toy must be accompanied by a sign which indicates clearly that—

(a) the toy does not comply with these Regulations ; and

(b) the toy will not be made available in the United Kingdom before being brought into conformity with these Regulations .

Section 9 Parts 1 and 2 are safety regulations within the meaning of the 1987 Act

Parts 1 and 2 of these Regulations are for all purposes safety regulations within the meaning of the 1987 Act.

Section 10 Prohibitions on placing toys on the market

(1) A manufacturer must not place a toy on the market unless it will comply with the essential safety requirements during its foreseeable and normal period of use.

(2) A manufacturer must not place a toy on the market without having complied with—

(a) regulation 11 (design and manufacture of toys in accordance with essential safety requirements);

(b) regulation 12 (safety assessment);

(c) regulation 13 (applicable conformity assessment procedures);

(d) regulations 15 ( ... declaration of conformity and UK marking);

(e) regulation 17(1) to (3) (drawing up of technical documentation);

(f) regulation 19 (information identifying toy and manufacturer);

(g) regulation 20 (instructions for use, safety information and warnings); and

(h) regulation 21 (compliance procedures for series production).

Section 11 Design and manufacture of toys in accordance with essential safety requirements

The manufacturer must ensure that the toy has been designed and manufactured to comply with the essential safety requirements during its foreseeable and normal period of use.

Section 12 Safety assessment

The manufacturer must 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.

Section 13 Applicable conformity assessment procedures

(1) The manufacturer must follow the applicable conformity assessment procedure to demonstrate that the toy will comply with the essential safety requirements during the toy's foreseeable and normal period of use.

(2) If the manufacturer has applied designated standards covering all the essential safety requirements, the manufacturer must use the internal production control procedure set out in Module A.

(3) In each of the following cases, the toy must be submitted to Type examination in accordance with the following provisions of these Regulations, together with the conformity to type procedure set out in Module C—

(a) where designated standards covering all the essential safety requirements for the toy do not exist;

(b) where the designated standards referred to in sub-paragraph (a) exist but the manufacturer has not applied them or has applied them only in part;

(c) where one or more of the designated standards referred to in sub-paragraph (a) has been published with a restriction;

(d) when the manufacturer considers that the nature, design, construction or purpose of the toy necessitates third party verification.

Section 14 Application for Type examination

An application for Type examination to be performed in relation to a toy must—

(a) be made to an approved body;

(b) be made in accordance with Module B;

(c) include a description of the toy;

(d) indicate the address at which the toy has been or will be manufactured; and

(e) ... be accompanied by such fee as may be required by the body in accordance with regulation 50 (charging of fees by approved body).

Section 15 Declaration of conformity and UK marking

Where it has been demonstrated by performance of the applicable conformity assessment procedure that a toy will comply with the essential safety requirements during its foreseeable and normal period of use, the manufacturer must—

(a) draw up a declaration of conformity in accordance with regulation 16(1) to (4); and

(b) affix a UK marking in relation to the toy in accordance with regulation 18.

Section 15A UK(NI) indication

(1) Where the CE marking is affixed on the basis of an assessment or a certificate issued by a UK notified body, a UK(NI) indication must be affixed in relation to the toy, in accordance with this regulation.

(2) The UK(NI) indication must be affixed—

(a) visibly, legibly and indelibly; and

(b) before a toy is placed on the market in Northern Ireland.

(3) The UK(NI) indication must be affixed wherever the CE marking is affixed, in accordance with regulation 18.

(4) The UK(NI) indication must be affixed by—

(a) the manufacturer; or

(b) the manufacturer's authorised representative who has been appointed by the manufacturer in accordance with regulation 25(1) to affix the UK(NI) indication on the manufacturer's behalf.

(5) When placing a toy on the market in Northern Ireland, an importer must ensure that the manufacturer has complied with their obligations under this regulation.

Section 15B Register of UK notified bodies

(1) The Secretary of State must ensure that—

(a) each UK notified body is assigned an identification number; and

(b) there is a register of—

(i) UK notified bodies;

(ii) their notified body identification number;

(iii) the activities for which they have been notified;

(iv) any restrictions on those activities.

(2) The Secretary of State must ensure that the register referred to in paragraph (1) is maintained and made publicly available.

(3) The Secretary of State may authorise the United Kingdom Accreditation Service to compile and maintain the register in accordance with paragraph (1)(b).

Section 16

(1) The ... declaration of conformity must state that it has been demonstrated that the essential safety requirements have been satisfied in relation to the toy.

(2) The ... declaration of conformity must also—

(a) include the information, and follow the structure, set out in Schedule 3 ; and

(b) include any information required to be included by any Module which was followed in relation to the toy.

(3) The ... declaration of conformity may contain further information.

(4) The manufacturer must keep up to date the ... declaration of conformity drawn up in relation to a toy.

(5) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

(6) By drawing up the ... declaration of conformity, the manufacturer assumes responsibility for the compliance of the toy.

Section 17 Technical documentation and correspondence relating to Type examination

(1) The manufacturer must draw up technical documentation which contains all relevant information about the means used by the manufacturer to ensure that a toy will comply with the essential safety requirements during its foreseeable and normal period of use.

(2) The technical documentation must be drawn up in English.

(3) The technical documentation must include the information and documents listed in Schedule 4 (technical documentation).

(4) Any correspondence relating to the Type examination of a toy must be drawn up in English.

(5) The manufacturer must keep the technical documentation for a toy (including the ... declaration of conformity) for a period of 10 years after the day on which the toy was placed on the market.

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(9) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

(10) If a manufacturer fails to comply with any of the manufacturer's obligations under paragraphs (1), (2) or (3) , an enforcement authority may request the manufacturer to ensure that an approved body performs such tests as the approved body identifies, within such period as the approved body may specify, to verify that the toy will comply with the essential safety requirements during its foreseeable and normal period of use, and that the toy complies with any designated standard applicable to the toy.

(11) The manufacturer must comply with the request (at the manufacturer's own expense).

Section 18 Toys to bear UK marking

(1) The manufacturer must affix a UK marking in relation to a toy.

(2) The UK marking must be affixed visibly, legibly and indelibly.

(3) The UK marking must be affixed to—

(a) the toy;

(b) a label affixed to the toy; or

(c) the toy's packaging.

(3A) For a period of seven years beginning with IP completion day, the manufacturer may, in place of affixing the UK marking in accordance with paragraph (3) affix the UK marking to a document accompanying the toy.

(4) Where the toy is small or consists of small parts, the manufacturer may, in place of affixing the UK marking in accordance with paragraph (3), affix the UK marking to—

(a) a label which is not affixed to the toy; or

(b) a leaflet which accompanies the toy.

(5) The manufacturer may (in place of affixing the UK marking in accordance with paragraphs (3) or (4)) affix the CE marking to a counter display where —

(a) the toy is sold in the counter display;

(b) it is not possible to affix the UK marking in accordance with paragraph (3) or (4); and

(c) the counter display was originally used as packaging for the toy.

(6) Where the toy is inside packaging the UK marking must—

(a) be affixed to the packaging (whether or not it is also affixed elsewhere); or

(b) be otherwise visible from outside the packaging.

(7) The UK marking may be followed by a pictogram or by any other mark indicating a special risk or use.

(8) Any toy which bears the UK marking shall be presumed to comply with all the provisions of these Regulations.

(9) The presumption set out in paragraph (8) is rebuttable.

Section 19 Information identifying toy and manufacturer

(1) The manufacturer must ensure that the required information is marked—

(a) on the toy; or

(b) where the size or nature of the toy precludes the information from being marked on the toy—

(i) on the toy's packaging; or

(ii) in a document accompanying the toy.

(2) The required information is—

(a) a type, batch, serial or model number or other information enabling the toy to be identified;

(b) the manufacturer's name, registered trade name or registered trademark; and

(c) a single address at which the manufacturer can be contacted.

Section 20 Instructions for use, safety information and warnings

(1) The manufacturer must ensure that a toy is accompanied by such instructions for use and safety information as is appropriate.

(2) In particular, the manufacturer must ensure that the following provisions of this regulation are complied with.

(3) Where it is appropriate in order to ensure the safe use of a toy, any information provided as to hazards and risks and avoiding them required by regulation 5(5) must include the specification of appropriate user limitations in accordance with Part A of Schedule 5 (general warnings).

(4) Where a toy falls within a category listed in Part B of Schedule 5 , the toy must be accompanied by any warning and other information which is required to accompany that category of toy.

(5) But a toy must not be accompanied by a warning set out in Part B where that warning would conflict with the intended use of the toy, as determined by virtue of its function, dimension and characteristics.

(6) The wording of a warning which is required by any of points 2 to 10 of Part B to accompany a category of toy must be replicated without alteration.

(7) A warning, instructions or other information required to accompany a toy must be marked in English in a clearly visible, easily legible, understandable and accurate manner on—

(a) the toy;

(b) a label affixed to the toy; or

(c) the toy's packaging and, if appropriate, on any instructions for use which accompany the toy.

(8) Any warning or warnings accompanying a toy in accordance with this regulation must be preceded by the word “Warning” or “Warnings”.

(9) A warning which determines the decision to purchase a toy (such as a warning specifying the minimum or maximum age for users) must also be clearly visible to the consumer before the purchase (whether by appearing on the consumer packaging for the toy or elsewhere), including in cases where the purchase is made on-line.

(10) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

Section 21 Compliance procedures for series production

(1) A manufacturer of toys which are manufactured by means of series production must ensure that procedures are in place to ensure that any toy so manufactured will comply with the essential safety requirements during its foreseeable and normal period of use.

(2) In doing so, the manufacturer must take into account—

(a) any change in the design or characteristics of the toy; and

(b) any change which has been made to any of the designated standards referred to in the ... declaration of conformity drawn up in relation to the toy.

Section 22 Submission of Type examination certificate for review

A Type examination certificate issued in relation to a toy must be submitted by the manufacturer to an approved body for review if—

(a) any change is made to—

(i) the manufacturing process for the toy;

(ii) any raw material used in the toy; or

(iii) any component of the toy;

(b) 5 years have elapsed since the certificate was issued without it having being reviewed by an approved body;

(c) 5 years have elapsed since the certificate was last reviewed by an approved body without it having being reviewed again by an approved body; or

(d) the manufacturer is of the view that a review of the certificate is necessary for any other reason.

Section 23 Monitoring of toys

(1) The manufacturer must take such of the following actions in relation to a toy as the manufacturer considers appropriate for the purpose of protecting the health and safety of consumers, taking into account any risk presented by the toy.

(2) The actions are—

(a) carrying out sample testing of marketed toys;

(b) investigating any complaint made in relation to the toy;

(c) keeping a register of—

(i) any such complaints;

(ii) any toy in relation to which any provision of these Regulations has not been complied with; and

(iii) any toy which has been recalled; and

(d) keeping distributors informed of any action taken by the manufacturer in accordance with sub-paragraph (a), (b) or (c).

Section 24 Non-compliant toys and toys presenting a risk

(1) Where a manufacturer has placed a toy on the market and has reason to believe that any provision of these Regulations has not in fact been complied with by the manufacturer in relation to the toy, the manufacturer must immediately—

(a) take the corrective measures which are necessary to ensure that the provision is complied with in relation to the toy, or withdraw or recall the toy, if appropriate; and

(b) where the toy presents a risk, provide the relevant enforcement authority with information about the following matters.

(2) The matters are—

(a) the risk presented by the toy;

(b) the non-compliance in question; and

(c) any corrective measures taken in accordance with paragraph (1)(a).

(3) An enforcement authority may request a manufacturer who has placed a toy on the market to cooperate with it in relation to any action taken or to be taken to eliminate any risk posed by the toy.

(4) The request must be accompanied by the reasons for making the request

(5) The manufacturer must comply with the request .

Section 25 Manufacturer's authorised representative

(1) A manufacturer may, by a written mandate, appoint a person established in the United Kingdom as the manufacturer's authorised representative to act on the manufacturer's behalf in relation to specified tasks in relation to a toy.

(2) The mandate must allow the authorised representative to do at least the following—

(a) perform the manufacturer's obligations under regulations 17(5) and (9) (duties to keep technical documentation and comply with a request by an enforcement authority for a copy ... of technical documentation); and

(b) perform the manufacturer's obligations under regulation 24(5) (duty to comply with a request in relation to action taken to eliminate risks posed by a toy).

(3) An authorised representative may not be appointed to perform the manufacturer's obligations under regulation 11 (duty to design and manufacture toy in accordance with essential safety requirements) or regulation 17(1) (duty to draw up technical documentation).

(4) An authorised representative must perform each obligation under these Regulations that the representative is appointed by the mandate to perform.

(5) A manufacturer who has appointed an authorised representative to perform on the manufacturer's behalf an obligation under these Regulations remains responsible for the proper performance of that obligation.

Section 26 Prohibitions on placing toys on the market

(1) An importer must not place a toy on the market unless it will comply with the essential safety requirements during its foreseeable and normal period of use.

(2) An importer must not place a toy on the market unless—

(a) the importer has ensured that the manufacturer has done all of the following in relation to the toy—

(i) followed the applicable conformity assessment procedure in accordance with regulation 13;

(ii) drawn up the technical documentation in accordance with regulation 17;

(iii) affixed the UK marking in accordance with regulation 18;

(iv) complied with regulation 19 (information identifying toy and manufacturer);

(v) complied with regulation 20 (instructions for use, safety information and warnings); and

(b) the importer has complied with both of the following—

(i) regulation 27 (information identifying importer);

(ii) regulation 28 (storage or transport of toys).

Section 27 Information identifying importer

(1) An importer must ensure that the following information is marked on the toy—

(a) the importer's name, registered trade name or registered trade mark; and

(b) the address at which the importer can be contacted.

(2) Paragraph (1) does not apply where—

(a) either—

(i) the size or nature of the toy precludes the information from being marked on the toy;

(ii) the importer would have to open the toy's packaging in order to mark the information on the toy; or

(iii) the importer imported the toy from an EEA state or Switzerland and places it on the market within the period of seven years beginning with IP completion day; and

(b) the importer ensures that the information referred to in paragraph (1) is set out on the toy's packaging or in a document accompanying the toy.

Section 28 Storage or transport of toys

An importer must ensure that, while a toy is under the importer's responsibility, the conditions in which it is stored or transported will not jeopardise the toy's compliance with the essential safety requirements during its foreseeable and normal period of use.

Section 29 Monitoring of toys

(1) An importer must take such of the following actions in relation to a toy as the importer considers appropriate for the purpose of protecting the health and safety of consumers, taking into account any risk presented by the toy.

(2) The actions are—

(a) carrying out sample testing of marketed toys;

(b) investigating any complaint made in relation to the toy;

(c) keeping a register of—

(i) any such complaints;

(ii) any toy in relation to which any provision of these Regulations has not been complied with; and

(iii) any toy which has been recalled; and

(d) keeping distributors informed of any action taken by the importer in accordance with sub-paragraph (a), (b) or (c).

Section 30 Non-compliant toys and toys presenting a risk

(1) Paragraph (2) applies if an importer has reason to believe that a toy which the importer was intending to place on the market—

(a) will not comply with the essential safety requirements during its foreseeable and normal period of use; and

(b) presents a risk.

(2) The importer must inform the manufacturer and the relevant enforcement authority of the risk presented by the toy.

(3) An importer who has placed a toy on the market and has reason to believe that any provision of these Regulations has not been complied with in relation to the toy must immediately—

(a) take the corrective measures which are necessary to ensure that the provision is complied with in relation to the toy, or withdraw or recall the toy, if appropriate; and

(b) where the toy presents a risk, provide the relevant enforcement authority with information about the following matters.

(4) The matters are—

(a) the risk presented by the toy;

(b) the non-compliance in question; and

(c) any corrective measures taken in accordance with paragraph (1)(a).

(5) An enforcement authority may request an importer who has placed a toy on the market to cooperate with it in relation to any action taken or to be taken to eliminate any risk posed by the toy.

(6) The importer must comply with the request.

Section 31 Duties to retain and provide information

(1) An importer must, for a period of 10 years after the day on which the toy is placed on the market—

(a) keep a copy of the EC declaration of conformity; and

(b) ensure that the technical documentation can be made available to an enforcement authority on request by the authority.

(2) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

(3) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

(4) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

Section 32 Duty in certain circumstances to comply with manufacturers' duties in place of importers' duties

(1) This regulation applies where an importer—

(a) places a toy on the market under the importer's name or trademark; or

(b) modifies a toy already placed on the market in such a way that compliance with the essential safety requirements may be affected.

(2) The importer must comply with all of the duties imposed by these Regulations on a manufacturer and in such a case, a reference to the manufacturer in these Regulations is to be taken as being a reference to the importer.

(3) Such an importer is not required to comply with the duties imposed by these Regulations on importers.

Section 33 Duty to act with due care and prohibitions on making toys available on the market

(1) A distributor must act with due care in relation to the compliance of a toy which the distributor intends to make available on the market with the provisions of these Regulations.

(2) A distributor must not make a toy available on the market if the distributor has reason to believe that the toy will not comply with the essential safety requirements during its foreseeable and normal period of use.

(3) A distributor must not make a toy available on the market unless the distributor has—

(a) verified that the manufacturer has done all of the following things in relation to the toy—

(i) affixed the UK marking in accordance with regulation 18;

(ii) complied with regulation 19 (information identifying toy and manufacturer); and

(iii) complied with regulation 20 (instructions for use, safety information and warnings);

(b) verified that any importer has complied with regulation 27 (information identifying importer) in relation to the toy; and

(c) complied with regulation 34 (storage or transport of toys) in relation to the toy.

Section 34 Storage or transport of toys under distributor's responsibility

A distributor must ensure that, while a toy is under the distributor's responsibility, the conditions in which it is stored or transported will not jeopardise the toy's compliance with the essential safety requirements during its foreseeable and normal period of use.

Section 35 Non-compliant toys and toys presenting a risk

(1) Paragraph (2) applies if a distributor has reason to believe that a toy which the distributor was intending to make available on the market—

(a) will not comply with the essential safety requirements during its foreseeable and normal period of use; and

(b) presents a risk.

(2) The distributor must inform the following of the risk presented by the toy—

(a) the importer (if there is one);

(b) the manufacturer (if there is no importer); and

(c) the relevant enforcement authority.

(3) A distributor who has made a toy available on the market and has reason to believe that any provision of these Regulations has not been complied with in relation to the toy must immediately—

(a) take the corrective measures which are necessary to ensure that the provision is complied with in relation to the toy, or withdraw or recall the toy, if appropriate; and

(b) where the toy presents a risk, provide the relevant enforcement authority with information about the following matters.

(4) The matters are—

(a) the risk presented by the toy;

(b) the non-compliance in question; and

(c) any corrective measures taken in relation to the toy in accordance with paragraph (3)(a).

(5) An enforcement authority may request a distributor who has made a toy available on the market to cooperate with it in relation to any action taken or to be taken to eliminate any risk posed by the toy.

(6) The request must be accompanied by the reasons for making the request.

(7) The distributor must comply with the request.

Section 36 Duty to provide information

. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

Section 37 Duty in certain circumstances to comply with manufacturers' duties in place of distributors' duties

(1) This regulation applies where a distributor—

(a) places a toy on the market under the distributor's name or trademark; or

(b) modifies a toy already placed on the market in such a way that compliance with the essential safety requirements may be affected.

(2) The distributor must comply with all of the duties imposed by these Regulations on a manufacturer, and in such a case, a reference to the manufacturer in these Regulations is to be taken as being a reference to the distributor.

(3) Such a distributor is not required to comply with the duties imposed by these Regulations on distributors.

Section 38 Identification of economic operators to enforcement authorities

(1) An enforcement authority may, before the end of the period specified in paragraph (3), request an economic operator to identify to the authority, within such period as the authority may specify—

(a) any other economic operator who has supplied it with a toy; and

(b) any other economic operator to whom it has supplied a toy.

(2) The economic operator must comply with the request.

(3) The period is—

(a) where the request is made to a manufacturer, 10 years after the day on which the toy was placed on the market;

(b) where the request is made to any other economic operator, 10 years after the day on which the economic operator was supplied with the toy.

Section 39 Protection of UK marking

(1) A person must not affix a UK marking in relation to a toy unless—

(a) the person is—

(i) the manufacturer; or

(ii) an authorised representative of the manufacturer who has been appointed by the manufacturer ... to affix the UK marking on the manufacturer's behalf; and

(b) it has been demonstrated by performance of the applicable conformity assessment procedure that the toy will comply with the essential safety requirements during its foreseeable and normal period of use.

(2) A person must not affix any marking in relation to a toy which—

(a) is not a UK marking; but

(b) purports to attest that the toy satisfies the essential safety requirements.

(3) A person must not affix in relation to a toy any marking, sign or inscription which is likely to mislead any other person as to the meaning or form of the UK marking affixed in relation to the toy.

(4) Any other marking may be affixed in relation to a toy provided that the visibility, legibility and meaning of the UK marking is not thereby impaired.

Section 39A Obligations which are met by complying with obligations in the Directive

(1) In this regulation—

(a) any reference to an Article or an Annex is a reference to an Article of or an Annex to the Directive;

(b) “ CE marking ” has the meaning given to it in Article 3(16);

(c) “ harmonised standard ” has the meaning given to it in Article 3(8);

(2) Subject to paragraphs (6) and (7) paragraph (3) applies where, before placing a toy on the ... market, a manufacturer—

(a) ensures that the toy has been designed and manufactured in accordance with the requirements set out in—

(i) in Article 10 (essential safety requirements); and

(ii) Annex II (particular safety requirements);

(b) carries out the safety assessment in accordance with Article 18;

(c) ensures that the relevant conformity assessment procedure has been carried out in accordance with Article 19;

(d) in cases where the manufacturer considers that Article 19(3) applies, ensures that the provisions of Article 20 are complied with;

(e) draws up the technical documentation in accordance with Article 21(1);

(f) ensures that the technical documentation and other records and correspondence relating to the conformity assessment procedures are prepared in or translated into English;

(g) affixes the CE marking in accordance with Articles 16 and 17;

(h) draws up an EC declaration of conformity, in accordance with Article 15; and

(i) ensures that the EC declaration of conformity is prepared in or translated into English.

(3) Where this paragraph applies—

(a) the requirements of regulations 10 to 15, 16(1) to (2), 17(1) to (4) and 18, are to be treated as being satisfied;

(b) regulations 16(4) to (5), 17(5) and (10), 21, 22, 39 and 44 are to be read subject to the modifications in paragraph (10);

(c) regulations 42 to 44 do not apply; and

(d) regulation 52 does not apply.

(4) Subject to paragraphs (6) and (7), paragraph (5) applies, where before placing a toy on the market, the importer ensures that—

(a) the relevant conformity assessment procedure that applies to that toy has been carried out in accordance with Article 19;

(b) the manufacturer has drawn up the technical documentation in accordance with Article 21(1); and

(c) the toy bears the CE marking affixed in accordance with Articles 16 and 17.

(5) Where this paragraph applies—

(a) the requirements in regulation 26(a)(i) to (iii) are to be treated as being satisfied; and

(b) regulations 26(1), 28 and 30 to 32 are to be read subject to the modifications in paragraph (10).

(6) This paragraph applies where there is no designated standard or part of a designated standard which corresponds exactly to a harmonised standard or part of a harmonised standard.

(7) Where paragraph (6) applies paragraphs (2)(c) and (4)(a) are to be treated as requiring the manufacturer to carry out the conformity assessment procedure referred to in Article 19(3).

(8) Paragraph (9) applies where before making a toy available on the market, a distributor ensures that the manufacturer has affixed the CE marking in accordance with Articles 16 and 17.

(9) Where this paragraph applies—

(a) regulation 33(3)(a)(i) is to be treated as being satisfied;

(b) regulation 33(2), 34, 35 and 37 are to be read subject to the modifications in paragraph (10).

(10) The modifications referred to in paragraphs (3)(b), (5)(b) and (9)(b) are that—

(a) any reference to “declaration of conformity” is to be read as a reference to the EC declaration of conformity;

(b) any reference to “UK marking” is to be read as a reference to the CE marking;

(c) any reference to “essential safety requirements” is to be read as a reference to the requirements set out in—

(i) in Article 10 (essential safety requirements); and

(ii) Annex II (particular safety requirements);

(d) any reference to “designated standard” is to be read as a reference to a harmonised standard;

(e) any reference to “applicable conformity assessment procedure” is to be read as a reference to the applicable conformity assessment procedures referred to in Article 19;

(f) any reference to “ technical documentation ” is a reference to the technical documentation referred to in Article 21(1);

(g) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

(h) any reference to “ Type examination ” is a reference to “EC-type examination”.

Section 39B Power to amend Schedules 1, 2 and 5

(1) The Secretary of State may by regulations amend the provision of the Schedules referred to in paragraph (2) where the Secretary of State considers it necessary to do so in order to take technical progress and scientific developments into account.

(2) The provisions referred to in paragraph (1) are—

(a) any provision in Schedule 1;

(b) points 11 and 13 of Part 3 of Schedule 2; and

(c) any provision of Schedule 5.

(3) The power to make regulations made under paragraph (1) includes power—

(a) to make different provisions for different cases; and

(b) to make such supplemental, consequential and transitional provisions as the Secretary of State considers appropriate.

(4) Regulations made under this regulation are to be made by statutory instrument subject to annulment in pursuance of a resolution of either House of Parliament.

Section 39C Power to amend Appendix C to Schedule 2

(1) The Secretary of State may by regulations amend Appendix C to Schedule 2 to add specific 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.

(2) Regulations made under paragraph (1) may—

(a) make different provisions for different cases; and

(b) make such supplemental, consequential and transitional provisions as the Secretary of State considers appropriate.

(3) Regulations made under this regulation are to be made by statutory instrument subject to annulment in pursuance of a resolution of either House of Parliament.

Section 39D Powers to amend Appendix A to Schedule 2

(1) Where the conditions set out in paragraph (3)(a) and (b) are met, the Secretary of State may by regulations amend Appendix A to Schedule 2 to allow substances or mixtures classified as carcinogenic, mutagenic or toxic for reproduction of the categories laid down in Section 4 of Appendix B of Schedule 2 to be used in toys, in components of toys or micro-structurally distinct parts of toys.

(2) Where the conditions set out in paragraphs (3)(a), (b) and (c) are met, the Secretary of State may by regulations amend Appendix A to Schedule 2 to allow substances or mixtures classified as carcinogenic, mutagenic or toxic for reproduction of the categories laid down Section 3 of Appendix B of Schedule 2 to be used in toys, in components of toys or micro-structurally distinct parts of toys.

(3) The conditions referred to in paragraphs (1) and (2) are—

(a) the Secretary of State considers that there is sufficient scientific evidence to demonstrate that the use of substances or mixtures that are classified as carcinogenic, mutagenic or toxic for reproduction of the categories laid down in Section 5 of Appendix B to Schedule 2 are safe for use in toys, particularly in view of exposure;

(b) the substance or mixture is not prohibited for use in consumer articles by Regulation (EC) 1907/2006 of the European Parliament and of the Council of 18 December 2006 concerning the Registration, Evaluation, Authorisation and Restriction of Chemicals (REACH) establishing a European Chemicals Agency, amending Directive 1 9999/45/EC and repealing Council Regulation (EEC) No 793/93 and Commission Regulation (EC) No 1488/94 as well as Council Directive 76/769/EEC and Commission Directives 91/155/EEC , 93/105/EC and 2000/21/EC .

(c) there are no suitable alternative substances or mixtures available, as documented in an analysis of alternatives; and

(4) Regulations made under paragraph (1) or (2) may—

(a) make different provisions for different cases; and

(b) make such supplemental, consequential and transitional provisions as the Secretary of State considers appropriate.

(5) Regulations made under this regulation are to be made by statutory instrument subject to annulment in pursuance of a resolution of either House of Parliament.

(6) The Secretary of State must—

(a) carry out a review of regulations made under paragraph (1) or (2);

(b) set out the conclusions of the review in a report; and

(c) publish the report.

(7) A review to which paragraph (6) refers must be made—

(a) as soon as any safety concerns arise; and

(b) at intervals not exceeding five years beginning with the date regulations made under paragraph (1) or (2) come into force.

Section 39E Duty of the Secretary of State to evaluate use of hazardous substances

(1) The Secretary of State must—

(a) evaluate the occurrence of hazardous substances of materials in toys;

(b) set out the conclusions of the evaluation in a report; and

(c) publish the report.

(2) During the evaluation the Secretary of State must consult—

(a) any enforcement authority which is not the Secretary of State; and

(b) any person that the Secretary of State considers appropriate.

(3) The first report must be published before the end of the period of five years beginning on IP completion day.

(4) Subsequent reports are to be published at intervals not exceeding five years.

Section 39AA Further use of UK marking

(1) In this regulation—

(a) any reference to an Article or an Annex is a reference to an Article of or an Annex to the Directive;

(b) “ harmonised standard ” has the meaning given to it in Article 3(8).

(2) Subject to paragraphs (4) and (5), paragraph (3) applies where, before placing a toy on the market, a manufacturer—

(a) ensures that the toy has been designed and manufactured in accordance with the requirements set out in—

(i) Article 10 (essential safety requirements); and

(ii) Annex II (particular safety requirements);

(b) carries out the safety assessment in accordance with Article 18;

(c) ensures that the relevant conformity assessment procedure has been carried out in accordance with Article 19;

(d) in cases where the manufacturer considers that Article 19(3) applies, ensures that the provisions of Article 20 are complied with;

(e) draws up the technical documentation in accordance with Article 21(1); and

(f) ensures that the technical documentation and other records and correspondence relating to the conformity assessment procedure are prepared in or translated into English.

(3) Where this paragraph applies—

(a) the requirements of regulations 10(1) and (2)(a) to (c) and (e), 11, 12, 13, and 17(1) to (4) are to be treated as being satisfied;

(b) regulations 14 and 42 to 44 do not apply;

(c) regulations 15, 16, 17(5), 21, 25, 26, 28, 30 to 37, 39(1), 47 and 52 apply subject to the modifications in paragraph (6);

(d) regulations 22 and 45 and Schedule 3 apply subject to the modifications in paragraphs (6) and (7).

(4) This paragraph applies where there is no designated standard or part of a designated standard which corresponds exactly to a harmonised standard or part of a harmonised standard.

(5) Where paragraph (4) applies paragraph (2)(c) is treated as requiring the manufacturer to carry out the conformity assessment procedures referred to in Article 19(3).

(6) The modifications referred to in paragraph (3)(c) and (d) are that—

(a) any reference to “essential safety requirements” is to be read as a reference to the requirements set out in—

(i) Article 10 (essential safety requirements); and

(ii) Annex II (particular safety requirements);

(b) any reference to “designated standard” is to be read as a reference to a harmonised standard;

(c) any reference to “applicable conformity assessment procedure” is to be read as a reference to the applicable conformity assessment procedure referred to in Article 19;

(d) any reference to “technical documentation” is to be read as a reference to the technical documentation referred to in Article 21(1);

(e) any reference to “approved body” is to be read as a reference to the conformity assessment body that undertook any conformity assessment procedure set out in Article 19.

(7) The modifications referred to in paragraph (3)(d) are that—

(a) in regulations 22 and 45 any reference to “Type examination certificate” is to be read as a reference to any certificate issued pursuant to the conformity assessment procedure set out in Article 20;

(b) in Schedule 3 the reference to “enactments” is to be read as including a reference to the Directive.