The Product Safety and Metrology etc. (Amendment etc.) (EU Exit) Regulations 2019

• (c) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

• (d) omit the definition of “CE marking”;

• (e) before the definition of “distributor” insert—

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

• (f) omit the definition of “harmonised standard”;

• (g) for the definition of “importer” substitute—

“importer” means a person who— (a) is established in the United Kingdom and places a toy from a country outside of the United Kingdom on the market; or (b) 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;

• (h) in the definition of “make available on the market” for “EU market” substitute “market of Great Britain”;

• (i) for the definition of “Module” substitute—

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

• (j) omit the definition of “notified body designation”;

• (k) in the definition of “place on the market” for “EU market” substitute “market of Great Britain”;

• (l) after the definition of “place on the market” insert—

“RAMS” means Regulation (EC) No 765/2008 of the European Parliament and of the Council setting out the requirements for accreditation and market surveillance relating to the marketing of products and repealing Regulation (EEC) No 339/93;

• (m) after the definition of “toy” insert—

“UK marking” means the marking in the form set out in Annex 2 of RAMS; “UK national accreditation body” means the body appointed by the Secretary of State in accordance with Article 4 of RAMS;

• (n) omit the definition of “UK notified body”.

Insertion of Regulations 3A and 3B

5

After regulation 3, insert—

(3A) (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, 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); (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 technical specifications adopted by the other recognised standardisation organisations; (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. (3B) (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 retained EU 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 retained EU 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.

Amendment to regulation 4

6

In regulation 4 (toys to which these Regulations apply) in paragraph (3)(f) for “Annex I to the Directive” substitute “ Schedule 1 ”.

Amendment to regulation 5

7

In regulation 5(1)(b) (essential safety requirement) for “Annex II to the Directive (as amended from time to time)” substitute “ Schedule 2 ”.

Omission of regulation 6

8

Regulation 6 (toys placed on the market before 20th July 2013) is omitted.

Amendment to regulation 7

9

In regulation 7 (presumption of conformity) for “harmonised” substitute “ designated ”.

Amendment to regulation 8

10

In regulation 8 (exception for trade fairs or exhibitions)—

• (a) in paragraph (1) for “CE” substitute “ UK ”;

• (b) in paragraph (2) in both places in which it occurs for “the Directive” substitute “ these Regulations ”;

• (c) in paragraph (2)(b) for “EU” substitute “ United Kingdom ”.

Amendment to regulation 10

11

In regulation 10 (prohibitions on placing toys on the market) in paragraph (2)(d)—

• (a) omit “EC”;

• (b) for “CE” substitute “ UK ”.

Amendment to regulation 13

12

In regulation 13 (applicable conformity assessment procedures)—

• (a) in paragraphs (2) and (3)(a) to (c) for “harmonised” substitute “ designated ”;

• (b) in paragraph (3) for “EC-type” substitute “ Type ”.

Amendment to regulation 14

13

In regulation 14 (application for EC-type examination)—

• (a) in the heading and in the regulation for “EC-type” substitute “ Type ”

• (b) in paragraph (a) for “a notified” substitute “ an approved ”;

• (c) in paragraph (e)—

• (i) omit the words beginning with “if” and ending with “UK notified body,”;

• (ii) for “by UK notified” substitute “ by approved ”.

Amendment to regulation 15

14

In regulation 15 (EC declaration of conformity and CE marking)—

• (a) in the heading—

• (i) for “EC declaration” substitute “ Declaration ”; and

• (ii) for “CE” substitute “ UK ”;

• (b) in paragraph (a) for “an EC” substitute “ a ”;

• (c) in paragraph (b) for “CE” substitute “ UK ”.

Amendment to regulation 16

15

In regulation 16—

• (a) omit “EC” in each place in which it occurs;

• (b) in paragraph 2(a) for “Annex III to the Directive” substitute “ Schedule 3 ”;

• (c) omit paragraph (5).

Amendment to regulation 17

16

In regulation 17 (technical documentation and correspondence)—

• (a) in the heading for “EC-type” substitute “ Type ”;

• (b) for paragraph (2) substitute—

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

• (c) in paragraph (3) for “Annex IV of the Directive” substitute “ Schedule 4 ”;

• (d) for paragraph (4) substitute—

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

• (e) in paragraph (5) omit “EC”;

• (f) in paragraph (10)—

• (i) for “a notified” substitute “ an approved ”;

• (ii) for “the notified” substitute “ the approved ” in both places in which it occurs;

• (iii) for “harmonised” substitute “ designated ”.

Amendment to regulation 18

17

In regulation 18 (Toys to bear CE marking)—

• (a) in the heading and in each place in which it occurs for “CE” substitute “ UK ”;

• (b) after paragraph (3) insert—

(3A) For a period of 24 months 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.

Amendment to regulation 20

18

In regulation 20 (instructions for use, safety information and warnings)—

• (a) omit paragraph (10);

• (b) in each place in which it occurs for “Annex V to the Directive” substitute “ Schedule 5 ”.

Amendment to regulation 21

19

In regulation 21(2)(b) (compliance procedures for series production)—

• (a) for “harmonised” substitute “ designated ”;

• (b) omit “EC”.

Amendment to regulation 22

20

In regulation 22 (submission of EC-type examination certificate for review)—

• (a) in the heading for “EC-type” substitute “ Type ”;

• (b) for “An EC-type” substitute “ A Type ”;

• (c) for “a notified” in each place in which it occurs substitute “ an approved ”.

Amendment to regulation 25

21

In regulation 25 (manufacturer's authorised representative)—

• (a) in paragraph (1) for “within the EU” substitute “ in the United Kingdom ”;

• (b) in paragraph (2)(a) omit “or translation”.

Amendment to regulation 26

22

Regulation 26 (prohibitions on placing toys on the market) in paragraph 2(a)(iii) for “CE” substitute “ UK ”.

Amendment to regulation 27

23

In regulation 27 (information identifying importer) for paragraph (2) substitute—

(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 24 months 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.

Amendment to regulation 31

24

In regulation 31 (duties to retain and provide information) omit “EC”.

Amendment to regulation 33

25

In regulation 33 (duty to act with due care and prohibitions) in paragraph (3)(a)(i) for “CE” substitute “ UK ”.

Amendment to regulation 39

26

In regulation 39 (protection of CE marking)—

• (a) in the heading and in each place in which it occurs for “CE” substitute “ UK ”;

• (b) in paragraph (1)(a)(ii) omit “in accordance with regulation 25(1)”.

Insertion of regulation 39A and Part 2A

27

After regulation 39 insert—

(39A) (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 UK 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) any reference to “authorised representative” is a reference to a person appointed in accordance with Article 5; and (h) any reference to “Type examination” is a reference to “EC-type examination”. (39AA) (1) Subject to paragraph (2), regulation 39A ceases to have effect at the end of the period of 12 months beginning with IP completion day. (2) Notwithstanding the expiry of regulation 39A— (a) any toy which was placed on the market pursuant to regulation 39A may continue to be made available on the market on or after the expiry of regulation 39A; (b) any obligation to which a person was subject under regulation 39A in respect of a toy placed on the market pursuant to regulation 39A continues to have effect after the expiry of regulation 39A, in respect of that toy. (39AB) (1) Where paragraph (2) applies— (a) a toy is to be treated as being in conformity with the essential safety requirements; and (b) each relevant economic operator is to be treated as having complied or as complying with the obligations imposed on them under Part 2. (2) This paragraph applies where— (a) a toy is— (i) in conformity with the essential safety requirements, within the meaning of regulation 3 as it applies in Northern Ireland; and (ii) qualifying Northern Ireland goods; (b) each relevant economic operator has complied or is complying with the obligations imposed on them under Part 2, as that Part applies in Northern Ireland; and (c) an importer has complied with the obligations set out in paragraph (3). (3) The obligations referred to in paragraph (2)(c) are that, before placing the toy on the market, the importer— (a) complies with regulation 27; (b) ensures that— (i) the applicable conformity assessment procedure has been carried out; (ii) the manufacturer has drawn up the technical documentation; and (iii) the toy bears the CE marking. (4) In this regulation— - “applicable conformity assessment procedure” means the conformity assessment procedure applicable to the toy under regulation 15, as it applies in Northern Ireland; - “CE marking” has the meaning given to it in regulation 3, as it applies in Northern Ireland; - “qualifying Northern Ireland goods” has the meaning given to it in regulations made under section 8C(6) of the European Union (Withdrawal) Act 2018; - “technical documentation” means the technical documentation that a manufacturer has to draw up in accordance with regulation 17, as it applies in Northern Ireland. (39B) (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. (39C) (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. (39D) (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 19999/45/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. (39E) (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.

Substitution of Part 3

28

For Part 3, substitute—

(40A) (1) An approved body is a conformity assessment body which— (a) has been approved by the Secretary of State pursuant to the procedure set out in regulation 40B (approval of conformity assessment bodies); or (b) immediately before IP completion day was a UK notified body in respect of which the Secretary of State has taken no action under regulation 41(4) as it had effect immediately before IP completion day to suspend or withdraw the body's status as a UK notified body. (2) Paragraph (1) has effect subject to regulation 40E (restriction, suspension or withdrawal of approval). (3) In this Part— - “UK notified body” means a body— 1. which the Secretary of State had before IP completion day notified to the European Commission and the member States of the European Union, in accordance with Article 31 of the Directive; and 2. in respect of which no objections had been raised, as referred to in regulation 40(2), as it had effect immediately before IP completion day; - “approved body requirements” means the requirements set out in Schedule 7. (40B) (1) The Secretary of State may approve only those conformity assessment bodies that qualify for approval. (2) A conformity assessment body qualifies for approval if the first and second conditions below are met. (3) The first condition is that the conformity assessment body has applied to the Secretary of State to become an approved body and that application is accompanied by— (a) a description of— (i) the conformity assessment activities that the conformity assessment body intends to carry out; (ii) the conformity assessment module in respect of which the conformity assessment body claims to be competent; (iii) the category of toys in respect of which the conformity assessment body claims to be competent; and (b) either— (i) an accreditation certificate; or (ii) the documentary evidence necessary for the Secretary of State to verify, recognise and regularly monitor the conformity assessment body's compliance with the approved body requirements. (4) The second condition is that the Secretary of State is satisfied that the conformity assessment body meets the approved body requirements. (5) For the purposes of paragraph (4), the Secretary of State may accept an accreditation certificate, provided in accordance with paragraph (3)(b), as sufficient evidence that the conformity assessment body meets the approved body requirements. (6) When deciding whether to approve a conformity assessment body that qualifies for approval, the Secretary of State may— (a) have regard to any other matter which appears to the Secretary of State to be relevant; and (b) set conditions that the conformity assessment body must meet. (7) For the purposes of this regulation “accreditation certificate” means a certificate issued by the UK national accreditation body attesting that a conformity assessment body meets the approved body requirements. (40C) (1) Where a conformity assessment body demonstrates its conformity with the criteria laid down in a designated standard (or part of such standard), the Secretary of State is to presume that the conformity assessment body meets the approved body requirements covered by that standard (or that part of that standard). (2) The presumption in paragraph (1) is rebuttable. (40D) The Secretary of State must monitor each approved body with a view to verifying that the body— (a) continues to meet the approved body requirements; (b) meets any conditions set— (i) in accordance with regulation 40B(6)(b); or (ii) by the Secretary of State before IP completion day in that body's capacity as a UK notified body; and (c) carries out its functions in accordance with these Regulations. (40E) (1) Where the Secretary of State determines that an approved body— (a) no longer meets an approved body requirement; or (b) is failing to fulfil its obligations under these Regulations, other than a condition referred to in regulation 40D(b), the Secretary of State must restrict, suspend or withdraw the body's status as an approved body under regulation 40A (approved bodies). (2) Where the Secretary of State determines that an approved body no longer meets a condition referred to in regulation 40D(b), the Secretary of State may restrict, suspend or withdraw the body's status as an approved body under regulation 40A. (3) In deciding what action is required under paragraph (1) or (2), the Secretary of State must have regard to the seriousness of the non-compliance. (4) Before taking action under paragraph (1) or (2), the Secretary of State must— (a) give notice in writing to the approved body of the proposed action and the reasons for it; (b) give the approved body an opportunity to make representations to the Secretary of State regarding the proposed action within a reasonable period from the date of the notice; and (c) consider any such representations made by the approved body. (5) Where the Secretary of State has taken action in respect of an approved body under paragraph (1) or (2), or where an approved body has ceased its activity, the approved body must, at the request of the Secretary of State— (a) transfer its files relating to the activities it has undertaken as an approved body to another approved body or to the Secretary of State; or (b) keep its files relating to the activities it has undertaken as an approved body available for the Secretary of State and other enforcement authorities for a period of 10 years from the date they were created. (6) The activities undertaken as an approved body referred to in paragraph (5) include any activities that the body has undertaken as a UK notified body. (40F) (1) Subject to the terms of its appointment and to regulation 44, an approved body must carry out the conformity assessment activities and modules— (a) in respect of which the body's approval was given under regulation 40B; or (b) in respect of which body's notification as a notified body was made. (2) Where an approved body carries out a conformity assessment procedure, it must do so in accordance with Schedule 6. (40G) (1) An approved body may subcontract specific conformity assessment activities, or use a subsidiary to carry out such activities provided— (a) the body is satisfied that the subcontractor or subsidiary meets the approved body requirements; (b) the body has informed the Secretary of State that it is satisfied that the subcontractor or subsidiary meets those requirements; and (c) the economic operator for whom the activities are to be carried out has consented to the activities being carried out by that person. (2) The approved body which subcontracts specific conformity assessment activities or uses a subsidiary to carry out such activities remains responsible for the proper performance of those activities (irrespective of where the subcontractor or subsidiary is established). (3) Where an approved body subcontracts, or uses a subsidiary to carry out, a specific conformity assessment activity, the approved body must, for a period of 10 years beginning on the day on which the activity is first carried out, keep available for inspection by the Secretary of State all relevant documentation concerning— (a) the assessment of the qualifications of the subcontractor or the subsidiary; and (b) the conformity assessment activity carried out by the subcontractor or subsidiary. (4) In this regulation “subsidiary” has the meaning given to it in section 1159 of the Companies Act 2006 . (40H) (1) The Secretary of State must— (a) assign an approved body identification number to each approved body; and (b) compile and maintain a register of— (i) approved bodies; (ii) their approved body identification numbers; (iii) the activities for which they have been approved; and (iv) any restrictions on those activities. (2) The register referred to in paragraph (1) must be made publicly available. (41) The Secretary of State may authorise the UK national accreditation body to carry out the following activities on behalf of the Secretary of State— (a) assessing whether a conformity assessment body meets the approved body requirements; (b) monitoring approved bodies in accordance with regulation 40D; and (c) compiling and maintaining the register of approved bodies, in accordance with regulation 40H.

Amendment to Part 4

29

In the heading of Part 4 (Functions of UK Authorised Bodies) for “UK Notified” substitute “ Approved ”.

Amendment to regulation 42

30

In regulation 42 (duty to perform EC-type examinations)—

• (a) in the heading and in paragraph (1) in both places in which it occurs for “EC-type” substitute “ Type ”;

• (b) in paragraph (1) for “A UK notified” substitute “ An approved ”;

• (c) in paragraph (2) for “a UK notified” substitute “ an approved ”;

• (d) in paragraph (2)(d)—

• (i) for “designation” substitute “ approval ”;

• (ii) for “notified” substitute “ approved ”.

Amendment to regulation 43

31

In regulation 43 (performance of EC-type examinations)—

• (a) in the heading and in paragraph (2) for “EC-type” substitute “ Type ”;

• (b) in paragraph (1)—

• (i) for “A UK notified” substitute “ An approved ”;

• (ii) for “an EC-type” substitute “ a Type ”.

Amendment of regulation 44

32

In regulation 44 (issue and content of EC-type examination certificate)—

• (a) in the heading and in paragraph (2)(d) for “EC-type” substitute “ Type ”;

• (b) in each place in which it occurs for “an EC-type” substitute “ a Type ”;

• (c) in paragraphs (1) and (3) for “A UK notified” substitute “ An approved ”;

• (d) in paragraph (2)(a) for “the Directive” substitute “ these Regulations ”;

• (e) in paragraph (3)(b) for “notified” substitute “ approved ”;

• (f) in paragraph (3)(c) for “a notified” substitute “ an approved ”;

• (g) in paragraphs (4), (5) and (6) for “a UK notified body” substitute “ an approved body ”.

Amendment of regulation 45

33

In regulation 45 (action after issue of EC-type examination certificate)—

• (a) in the heading and in paragraphs (2)(a)(ii), (3) and (3)(a) for “EC-type” substitute “ Type ”;

• (b) in paragraph (1)(a) and (4) for “an EC-type” substitute “ a Type ”;

• (c) in paragraph (1)(b) for “a UK notified” substitute “ an approved ”;

• (d) for “the UK notified” in each place in which it occurs substitute “ the approved ”.

Amendment to regulation 46

34

In regulation 46 (provision of information by UK notified bodies)—

• (a) in the heading—

• (i) for “UK notified” substitute “ approved ”;

• (ii) for “other notified” substitute “ other approved ”;

• (b) for “A UK notified” substitute “ An approved ”;

• (c) for “other notified” substitute “ other approved ”.

Amendment of regulation 47

35

In regulation 47 (instructions to UK notified bodies)—

• (a) in the heading, in paragraph (3) and paragraph (7) for “UK notified” substitute “ approved ”;

• (b) in the title for “EC-type” substitute “ Type ”;

• (c) for “a notified” in each place in which it occurs substitute “ an approved ”;

• (d) for “a UK notified” in each place in which it occurs substitute “ an approved ”;

• (e) for “an EC-type” in each place in which it occurs substitute “ a Type ”.

Omission of regulations 48 and 49

36

Regulations 48 (participation by UK notified bodies) and 49 (subcontracting by a UK notified body) are omitted.

Amendment to regulation 50

37

In regulation 50 (charging of fees by UK notified body)—

• (a) in the heading for “UK notified” substitute “ approved ”;

• (b) for “A UK notified” in both places in which it occurs substitute “ An approved ”.

Amendment to regulation 51

38

In regulation 51 (provision of information by UK notified bodies)—

• (a) in the heading and in paragraph (3) for “UK notified” substitute “ approved ”;

• (b) for “a UK notified” in both places in which it occurs substitute “ an approved ”;

• (c) for “an EC-type” in both places in which it occurs substitute “ a Type ”;

• (d) for “designation” in each place in which it occurs substitute “ approval ”;

• (e) in paragraph (2)(c) for the words beginning with “paragraphs” and ending in “bodies)” substitute “ the approved body requirements ”.

Amendment to regulation 52

39

In regulation 52 (enforcement action in cases of formal non-compliance)—

• (a) for “CE” in both places in which it occurs substitute “ UK ”;

• (b) for “an EC” in both places in which it occurs substitute “ a ”.

Amendment to regulation 53

40

In regulation 53 (enforcement action in cases of toys presenting a risk) omit paragraph (5).

Amendment to regulation 54

41

In regulation 54 (notification of enforcement action)—

• (a) for paragraph (1) substitute—

(1) Where a person or an enforcing authority is not the Secretary of State and it has taken action under regulation 53, it must notify the Secretary of State of— (a) the results of the evaluation; and (b) the corrective actions which it requires the relevant economic operator to take.

• (b) in paragraph (2) for “notified” substitute “ approved ”.

Amendment to regulation 55

42

In regulation 55 omit paragraph (4).

Insertion of Schedules

43

At the end of the Regulations insert—

SCHEDULE 1 (1) Products listed in paragraphs 2 to 20 are not to be considered as toys. (2) Decorative objects for festivities and celebrations. (3) Products for collectors, provided that the product or its packaging bears a visible and legible indication that it is intended for collectors of 14 years of age and aboveExamples of this category are— (a) detailed and faithful scale models; (b) kits for the assembly of detailed scale models; (c) folk dolls and decorative dolls and other similar articles; (d) historical replicas of toys; and (e) reproductions of real fire arms. (4) Sports equipment, including roller skates, inline skates, and skateboards intended for children with a body mass of more than 20 kg. (5) Bicycles with a maximum saddle height of more than 435 mm, measured as the vertical distance from the ground to the top of the seat surface, with the seat in a horizontal position and with the seat pillar set to the minimum insertion mark. (6) Scooters and other means of transport designed for sport or which are intended to be used for travel on public roads or public pathways. (7) Electrically driven vehicles which are intended to be used for travel on public roads, public pathways, or the pavement thereof. (8) Aquatic equipment intended to be used in deep water, and swimming learning devices for children, such as swim seats and swimming aids. (9) Puzzles with more than 500 pieces. (10) Guns and pistols using compressed gas, with the exception of water guns and water pistols, and bows for archery over 120 cm long. (11) Fireworks, including percussion caps which are not specifically designed for toys. (12) Products and games using sharp-pointed missiles, such as sets of darts with metallic points. (13) Functional educational products, such as electric ovens, irons or other functional products operated at a nominal voltage exceeding 24 volts which are sold exclusively for teaching purposes under adult supervision. (14) Products intended for use for educational purposes in schools and other pedagogical contexts under the surveillance of an adult instructor, such as science equipment. (15) Electronic equipment, such as personal computers and game consoles, used to access interactive software and their associated peripherals, unless the electronic equipment or the associated peripherals are specifically designed for and targeted at children and have a play value on their own, such as specially designed personal computers, key boards, joy sticks or steering wheels. (16) Interactive software, intended for leisure and entertainment, such as computer games, and their storage media, such as compact disks. (17) Babies' soothers. (18) Child-appealing luminaires. (19) Electrical transformers for toys. (20) Fashion accessories for children which are not for use in play. SCHEDULE 2 (1) Toys and their parts and, in the case of fixed toys, their anchorages, must have the requisite mechanical strength and, where appropriate, stability to withstand the stresses to which they are subjected during use without breaking or becoming liable to distortion at the risk of causing physical injury. (2) Accessible edges, protrusions, cords, cables and fastenings on toys must be designed and manufactured in such a way that the risks of physical injury from contact with them are reduced as far as possible. (3) Toys must be designed and manufactured in such a way as not to present any risk or only the minimum risk inherent to their use which could be caused by the movement of their parts. (4) (a) Toys and their parts must not present a risk of strangulation. (b) Toys and their parts must not present a risk of asphyxiation by closing off the flow of air as a result of airway obstruction external to the mouth and nose. (c) Toys and their parts must be of such dimensions as to not present a risk of asphyxiation by closing off the flow of air as a result of internal airway obstruction by objects wedged in the mouth or pharynx or lodged over the entrance to the lower airways. (d) Toys, which are clearly intended for use by children under 36 months, and their component parts and any of their detachable parts must be of such dimensions as to prevent their being swallowed or inhaled. This also applies to other toys which are intended to be put in the mouth, and to their component parts and any of their detachable parts. (e) The packaging in which toys are contained for retail sale must not present a risk of strangulation or asphyxiation caused by airway obstruction external to the mouth and nose. (f) Toys contained within food or co-mingled with food must have their own packaging. This packaging, as it is supplied, must be of such dimensions as to prevent its being swallowed and/or inhaled. (g) Toy packaging, as referred to in points (e) and (f), which is spherical, egg-shaped or ellipsoidal, and any detachable parts of this or of cylindrical toy packaging with rounded ends, must be of such dimensions as to prevent it from causing airway obstruction by being wedged in the mouth or pharynx or lodged over the entrance to the lower airways. (h) Toys firmly attached to a food product at the moment of consumption, in such a way that the food product needs to be consumed in order to get direct access to the toy, are prohibited. Parts of toys otherwise directly attached to a food product must fulfil the requirements set out in points (c) and (d). (5) Aquatic toys must be designed and manufactured so as to reduce as far as possible, taking into account the recommended use of the toy, any risk of loss of buoyancy of the toy and loss of support afforded to the child. (6) Toys which it is possible to get inside and which thereby constitute an enclosed space for occupants must have a means of exit which the intended user can open easily from the inside. (7) Toys conferring mobility on their users must, as far as possible, incorporate a braking system which is suited to the type of toy and is commensurate with the kinetic energy generated by it. Such a system must be easy for the user to operate without risk of ejection or physical injury for the user or for third parties. The maximum design speed of electrically driven ride-on toys must be limited so as to minimise the risk of injury. (8) The form and composition of projectiles and the kinetic energy they may generate when fired from a toy designed for that purpose must be such that, taking into account the nature of the toy, there is no risk of physical injury to the user or to third parties. (9) Toys must be manufactured so as to ensure that: (a) the maximum and minimum temperature of any accessible surfaces does not cause injury when touched; and (b) liquids and gases contained within the toy do not reach temperatures or pressures which are such that their escape from the toy, other than for reasons essential to the proper functioning of the toy, might cause burns, scalds or other physical injury. (10) Toys which are designed to emit a sound must be designed and manufactured in such a way in terms of the maximum values for impulse noise and continuous noise that the sound from them is not able to impair children's hearing. (11) Activity toys must be manufactured so as to reduce the risk of crushing or trapping of body parts or trapping of clothing and of falls, impacts and drowning as far as possible. In particular, any surface of such a toy accessible for one or more children to play on must be designed to bear their load. (1) Toys must not constitute a dangerous flammable element in the child's environment. They must therefore be composed of materials which fulfil one or more of the following conditions: (a) they do not burn if directly exposed to a flame or spark or other potential source of fire; (b) they are not readily flammable (the flame goes out as soon as the fire cause disappears); (c) if they do ignite, they burn slowly and present a low rate of spread of the flame; (d) irrespective of the toy's chemical composition, they are designed so as to mechanically delay the combustion process. Such combustible materials must not constitute a risk of ignition for other materials used in the toy. (2) Toys which, for reasons essential to their functioning, contain substances or mixtures that meet the classification criteria laid down in Section 1 of Appendix B, in particular materials and equipment for chemistry experiments, model assembly, plastic or ceramic moulding, enamelling, photography or similar activities, must not contain, as such, substances or mixtures which may become flammable due to the loss of non-flammable volatile components. (3) Toys other than toy percussion caps must not be explosive or contain elements or substances likely to explode when used as intended or in a foreseeable way, bearing in mind the behaviour of children. (4) Toys and, in particular, chemical games and toys, must not contain as such substances or mixtures: (a) which, when mixed together, may explode through chemical reaction or through heating; (b) which may explode when mixed with oxidizing substances; or (c) which contain volatile components which are flammable in air and liable to form a flammable or explosive vapour/air mixture. (1) Toys must be designed and manufactured in such a way that there are no risks of adverse effects on human health due to exposure to the chemical substances or mixtures of which the toys are composed or which they contain when the toys are used as intended or in a foreseeable way, bearing in mind the behaviour of children. (2) Toys that are themselves substances or mixtures must comply also with Regulation (EC) No 1272/2008 of the European Parliament and of the Council of 16 December 2008 on classification, labelling and packaging of substances and mixtures, as applicable, relating to the classification, packaging and labelling of certain substances and mixtures (“Regulation 1272/2008”). (3) Without prejudice to the restrictions referred to in the second paragraph of point 1, substances that are classified as carcinogenic, mutagenic or toxic for reproduction (CMR) of category 1A, 1B or 2 under Regulation 1272/2008 must not be used in toys, in components of toys or in micro-structurally distinct parts of toys. (4) By way of derogation from point 3, substances or mixtures classified as CMR of the categories laid down in Section 3 of Appendix B may be used in toys, in components of toys or micro-structurally distinct parts of toys provided that one or more of the following conditions is met: (a) these substances and mixtures are contained in individual concentrations equal to or smaller than the relevant concentrations established in the Community legal acts referred to in Section 2 of Appendix B for the classification of mixtures containing these substances; (b) these substances and mixtures are inaccessible to children in any form, including inhalation, when the toy is used as intended or in a foreseeable way, bearing in mind the behaviour of children; (c) regulations have been made under regulation 39D. (5) By way of derogation from point 3, substances or mixtures classified as CMR of the categories laid down in Section 4 of Appendix B may be used in toys, in components of toys or micro-structurally distinct parts of toys provided that one of the following conditions is met: (a) these substances and mixtures are contained in individual concentrations equal to or smaller than the relevant concentrations established in the Community legal acts referred to in Section 2 of Appendix B for the classification of mixtures containing these substances; (b) these substances and mixtures are inaccessible to children in any form, including inhalation, when the toy is used as intended or in a foreseeable way, bearing in mind the behaviour of children; or (c) regulations have been made under regulation 39D. (6) Points 3, 4 and 5 do not apply to nickel in stainless steel. (7) Points 3, 4 and 5 do not apply to materials that comply with the specific limit values set out in Appendix C. (8) Without prejudice to the application of points 3 and 4, nitrosamines and nitrosable substances are be prohibited for use in toys intended for use by children under 36 months or in other toys intended to be placed in the mouth if the migration of the substances is equal to or higher than 0,05 mg/kg for nitrosamines and 1 mg/kg for nitrosable substances. (9) Not applicable. (10) Cosmetic toys, such as play cosmetics for dolls, must comply with the compositional and labelling requirements laid down in Regulation (EC) 1223/2009 of the European Parliament and of the Council of 30 November 2009 on cosmetic products. (11) Toys must not contain the following allergenic fragrances:

No	Name of the allergenic fragrance	CAS number
(1)	Alanroot oil (Inula helenium)	97676-35-2
(2)	Allylisothiocyanate	57-06-7
(3)	Benzyl cyanide	140-29-4
(4)	4 tert-Butylphenol	98-54-4
(5)	Chenopodium oil	8006-99-3
(6)	Cyclamen alcohol	4756-19-8
(7)	Diethyl maleate	141-05-9
(8)	Dihydrocoumarin	119-84-6
(9)	2,4-Dihydroxy-3-methylbenzaldehyde	6248-20-0
(10)	3,7-Dimethyl-2-octen-1-ol (6,7-Dihydrogeraniol)	40607-48-5
(11)	4,6-Dimethyl-8-tert-butylcoumarin	17874-34-9
(12)	Dimethyl citraconate	617-54-9
(13)	7,11-Dimethyl-4.6,10-dodecatrien-3-one	26651-96-7
(14)	6,10-Dimethyl-3.5,9-undecatrien-2-one	141-10-6
(15)	Diphenylamine	122-39-4
(16)	Ethyl acrylate	140-88-5
(17)	Fig leaf, fresh and preparations	68916-52-9
(18)	trans-2-Heptenal	18829-55-5
(19)	trans-2-Hexenal diethyl acetal	67746-30-9
(20)	trans-2-Hexenal dimethyl acetal	18318-83-7
(21)	Hydroabietyl alcohol	13393-93-6
(22)	4-Ethoxy-phenol	622-62-8
(23)	6-lsopropyl-2-decahydronaphthalenol	34131-99-2
(24)	7-Methoxycoumarin	531-59-9
(25)	4-Methoxyphenol	150-76-5
(26)	4-(p-Methoxyphenyl)-3-butene-2-one	943-88-4
(27)	1-(p-Methoxyphenyl)-1-penten-3-one	104-27-8
(28)	Methyl trans-2-butenoate	623-43-8
(29)	6-Methylcoumarin	92-48-8
(30)	7-Methylcoumarin	2445-83-2
(31)	5-Methyl-2,3-hexanedione	13706-86-0
(32)	Costus root oil (Saussurea lappa Clarke)	8023-88-9
(33)	7-Ethoxy-4-methylcoumarin	87-05-8
(34)	Hexahydrocoumarin	700-82-3
(35)	Peru balsam, crude (Exudation of Myroxylon pereirae (Royle) Klotzsch)	8007-00-9
(36)	2-Pentylidene-cyclohexanone	25677-40-1
(37)	3.6,10-Trimethyl-3.5,9-undecatrien-2-one	1117-41-5
(38)	Verbena oil (Lippia citriodora Kunth)	8024-12-2
(39)	Musk ambrette (4-tert-Butyl-3-methoxy-2,6-dinitrotoluene)	83-66-9
(40)	4-Phenyl-3-buten-2-one	122-57-6
(41)	Amyl cinnamal	122-40-7
(42)	Amylcinnamyl alcohol	101-85-9
(43)	Benzyl alcohol	100-51-6
(44)	Benzyl salicylate	118-58-1
(45)	Cinnamyl alcohol	104-54-1
(46)	Cinnamal	104-55-2
(47)	Citral	5392-40-5
(48)	Coumarin	91-64-5
(49)	Eugenol	97-53-0
(50)	Geraniol	106-24-1
(51)	Hydroxy-citronellal	107-75-5
(52)	Hydroxy-methylpentylcyclohexenecarboxaldehyde	31906-04-4
(53)	Isoeugenol	97-54-1
(54)	Oakmoss extracts	90028-68-5
(55)	Treemoss extracts	90028-67-4

However, the presence of traces of these fragrances is allowed provided that such presence is technically unavoidable under good manufacturing practice and does not exceed 100 mg/kg.
In addition, the names of the following allergenic fragrances must be listed on the toy, on an affixed label, on the packaging or in an accompanying leaflet, if added to a toy, as such, at concentrations exceeding 100 mg/kg in the toy or components thereof:

No	Name of the allergenic fragrance	CAS number
(1)	Anisyl alcohol	105-13-5
(2)	Benzyl benzoate	120-51-4
(3)	Benzyl cinnamate	103-41-3
(4)	Citronellol	106-22-9
(5)	Farnesol	4602-84-0
(6)	Hexyl cinnamaldehyde	101-86-0
(7)	Lilial	80-54-6
(8)	d-Limonene	5989-27-5
(9)	Linalool	78-70-6
(10)	Methyl heptine carbonate	111-12-6
(11)	3-methyl-4-(2.6,6-trimethyl-2-cyclohexen-1-yl)-3-buten-2-one	127-51-5

(12) The use of the fragrances set out in points 41 to 55 of the list set out in the first paragraph of point 11 and of the fragrances set out in points 1 to 11 of the list set out in the third paragraph of that point are allowed in olfactory board games, cosmetic kits and gustative games, provided that (i) those fragrances are clearly labelled on the packaging, and the packaging contains the warning set out in point 10 of Part B of Annex V; (ii) if applicable, the resulting products made by the child in accordance with the instructions comply with the requirements of Regulation (EC) No 1223/2009 of the European Parliament and of the Council of 30 November 2009 on cosmetic products; and (iii) if applicable, those fragrances comply with the relevant legislation on food. Such olfactory board games, cosmetic kits and gustative games must not be used by children under 36 months and must comply with point 1 of Part B of Schedule 5. (13) Without prejudice to points 3, 4 and 5, the following migration limits, from toys or components of toys, must not be exceeded:

Element	mg/kg	mg/kg	mg/kg
Element	in dry, brittle, powder-like or pliable toy material	in liquid or sticky toy material	in scraped-off toy material
Aluminium	5 625	1 406	70 000
Antimony	45	11,3	560
Arsenic	3,8	0,9	47
Barium	1 500	375	18 570
Boron	1 200	300	15 000
Cadmium	1,3	0,3	17
Chromium (III)	37,5	9,4	460
Chromium (VI)	0,02	0,005	0,053
Cobalt	10,5	2,6	130
Copper	622,5	156	7 700
Lead	2,0	0,5	23
Manganese	1 200	300	15 000
Mercury	7,5	1,9	94
Nickel	75	18,8	930
Selenium	37,5	9,4	460
Strontium	4 500	1 125	56 000
Tin	15 000	3 750	180 000
Organic tin	0,9	0,2	12
Zinc	3 750	938	46 000

These limit values do not apply to toys or components of toys which, due to their accessibility, function, volume or mass, clearly exclude any hazard due to sucking, licking, swallowing or prolonged contact with skin when used as intended or in a foreseeable way, bearing in mind the behaviour of children.

(1) Toys must not be powered by electricity of a nominal voltage exceeding 24 volts direct current (DC) or the equivalent alternating current (AC) voltage, and their accessible parts must not exceed 24 volts DC or the equivalent AC voltage. Internal voltages must not exceed 24 volts DC or the equivalent AC voltage unless it is ensured that the voltage and the current combination generated do not lead to any risk or harmful electric shock, even when the toy is broken. (2) Parts of toys which are connected to, or liable to come into contact with, a source of electricity capable of causing electric shock, together with the cables or other conductors through which electricity is conveyed to such parts, must be properly insulated and mechanically protected so as to prevent the risk of such shock. (3) Electric toys must be designed and manufactured in such a way as to ensure that the maximum temperatures reached by all directly accessible surfaces are not such as to cause burns when touched. (4) Under foreseeable fault conditions, toys must provide protection against electrical hazards arising from an electrical power source. (5) Electric toys must provide adequate protection against fire hazards. (6) Electric toys must be designed and manufactured in such a way that electric, magnetic and electromagnetic fields and other radiations generated by the equipment are limited to the extent necessary for the operation of the toy and must operate at a safe level in compliance with the generally acknowledged state of the art, taking account of specific Community measures. (7) Toys which have an electronic control system must be designed and manufactured in such a way that the toy operates safely even when the electronic system starts malfunctioning or fails due to failure of the system itself or an outside factor. (8) Toys must be designed and manufactured in such a way that they do not present any health hazards or risk of injury to eyes or skin from lasers, light-emitting diodes (LEDs) or any other type of radiation. (9) The electrical transformer of a toy must not be an integral part of the toy. (1) Toys must be designed and manufactured in such a way as to meet hygiene and cleanliness requirements in order to avoid any risk of infection, sickness or contamination. (2) A toy intended for use by children under 36 months must be designed and manufactured in such a way that it can be cleaned. A textile toy must, to this end, be washable, except if it contains a mechanism that may be damaged if soak washed. The toy must fulfil the safety requirements also after having been cleaned in accordance with this point and the manufacturer's instructions. Toys must comply with all retained EU law that was adopted for the purposes of implementing Chapter 3 of Euratom.

Substance	Classification	Permitted use
Nickel	CMR 2	In toys and toy components made of stainless steel.In toy components which are intended to conduct an electric current

(A1) In this Appendix— “Regulation (EC) No 1272/2008” means Regulation (EC) 1272/2008 of the European Parliament and of the Council of 16th December 2008 on classifications, labelling and packaging of substances and mixtures, amending and repealing Directives 67/548/EEC and 1999/45/EC and amending Regulation (EC) 1907/2006. (1) Criteria for classifying substances and mixtures for the purposes of point 2 of Part 2 The substance or mixture fulfils the criteria for any of the following hazard classes or categories set out in Annex I to Regulation (EC) 1272/2008: (a) hazard classes 2.1 to 2.4, 2.6 and 2.7, 2.8 types A and B, 2.9, 2.10, 2.12, 2.13 categories 1 and 2, 2.14 categories 1 and 2, 2.15 types A to F; (b) hazard classes 3.1 to 3.6, 3.7 adverse effects on sexual function and fertility or on development, 3.8 effects other than narcotic effects, 3.9 and 3.10; (c) hazard class 4.1; (d) hazard class 5.1. (2) Enactments governing the use of certain substances for the purposes of points 4(a) and 5(a) of Part 3 The relevant concentrations for the classification of mixtures containing the substances are those established in accordance with Regulation (EC) No 1272/2008. (3) Categories of substances and mixtures classified as carcinogenic, mutagenic or toxic for reproduction (CMR) for the purposes of point 4 of Part 3. Substances Point 4 of Part 3 concerns substances classified as CMR category 1A and 1B under Regulation (EC) No 1272/2008. Mixtures Point 4 of Part 3 concerns mixtures classified as CMR category 1A and 1B under Regulation (EC) No 1272/2008. (4) Categories of substances and mixtures classified as carcinogenic, mutagenic or toxic for reproduction (CMR) for the purposes of point 5 of Part III Substances Point 5 of Part 3 concerns substances classified as CMR category 2 under Regulation (EC) No 1272/2008. Mixtures Point 5 of Part 3 concerns mixtures classified as CMR category 2 under Regulation (EC) No 1272/2008. (5) Categories of substances and mixtures classified as carcinogenic, mutagenic or toxic for reproduction (CMR) for the purposes of regulation 39D(3)(a). Substances Regulation 39D(3)(a) concerns substances classified as CMR category 1A, 1B and 2 under Regulation (EC) No 1272/2008. Mixtures Regulation 39D(3)(a) concerns mixtures classified as CMR category 1A, 1B and 2 under Regulation (EC) No 1272/2008. Specific limit 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 adopted by the Secretary of State.

Substance	CAS No	Limit value
TCEP	115-96-8	5 mg/kg (content limit)
TCPP	13674-84-5	5 mg/kg (content limit)
TDCP	13674-87-8	5 mg/kg (content limit)
Bisphenol A	80-05-7	0,04 mg/l (migration limit) in accordance with the methods laid down in EN 71-10:2005 and EN 71-11:2005.
Formamide	75-12-7	20μg/m³ (emission limit) after a maximum of 28 days from commencement of the emission testing of foam toy materials containing more than 200 mg/kg (cut-off limit based on content)
1,2-benzisothiazol-3(2H)-one	2634-33-5	5 mg/kg (content limit) in aqueous toy materials, in accordance with the methods laid down in EN 71-10:2005 and EN 71-11:2005
Reaction mass of: 5-chloro-2- methyl-4-isothiazolin-3-one (EC no. 247-500-7) and 2-methyl-2H -isothiazol-3-one (EC no. 220-239-6) (3:1)	55965-84-9	1 mg/kg (content limit) in aqueous toy materials
5-Chloro-2-methyl-isothiazolin-3(2H)-one	26172-55-4	0,75 mg/kg (content limit) in aqueous toy materials
2-methylisothiazolin-3(2H)-one	2682-20-4	0,25 mg/kg (content limit) in aqueous toy materials
Phenol	108-95-2	5mg/l (migration limit) in polymeric materials in accordance with the methods laid down in EN 71-10:2005 and EN 71-11:200510mg/kg (content limit) as a preservative in accordance with the methods laid down in EN 71-10: 2005 and EN 71-11:2005.