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

SCHEDULE 3 (1) No (unique identification of the toy(s)) (2) Name and address of the manufacturer or the manufacturer's authorised representative: (3) This declaration of conformity is issued under the sole responsibility of the manufacturer: (4) Object of the declaration (identification of toy allowing traceability). It must include a colour image of sufficient clarity to enable the identification of the toy. (5) The object of the declaration described in point 4 is in conformity with the following enactments: (6) References to the relevant designated standards used, or references to the specifications in relation to which conformity is declared: (7) Where applicable: the approved body … (name, number) … performed … (description of intervention) … and issued the certificate: (8) Additional information: Signed for and on behalf of: (place and date of issue) (name, function) (signature) SCHEDULE 4 The technical documentation referred to in regulation 17(3) must contain so far as relevant for assessment: (a) a detailed description of the design and manufacture, including a list of components and materials used in the toy as well as the safety data sheets on chemicals used, to be obtained from the chemical suppliers; (b) the safety assessment(s) carried out in accordance with regulation 12. (c) a description of the conformity assessment procedure followed; (d) a copy of the declaration of conformity; (e) the addresses of the places of manufacture and storage; (f) copies of documents that the manufacturer has submitted to an approved body, if involved; (g) test reports and description of the means whereby the manufacturer ensured conformity of production with designated standards, if the manufacturer followed the internal production control procedure set out in Module A; and (h) a copy of the Type examination certificate, a description of the means whereby the manufacturer ensured conformity of the production with the product type as described in the Type examination certificate, and copies of the documents that the manufacturer submitted to the approved body, if the manufacturer submitted the toy to Type examination and followed the conformity to type procedure set out in Module C. SCHEDULE 5 The user limitations referred to in regulation 20(3) must include at least the minimum or maximum age of the user and, where appropriate, the abilities of the user, the maximum or minimum weight of the user and the need to ensure that the toy is used only under adult supervision. (1) Toys not intended for use by children under 36 months Toys which might be dangerous for children under 36 months of age must bear a warning such as ‘Not suitable for children under 36 months’ or ‘Not suitable for children under three years’ or a warning in the form of the following graphic: These warnings must be accompanied by a brief indication, which may appear in the instructions for use, of the specific hazard calling for this precaution. This point does not apply to toys which, on account of their function, dimensions, characteristics or properties, or on other cogent grounds, are manifestly unsuitable for children under 36 months. (2) Activity toys Activity toys must bear the following warning:‘Only for domestic use’. Activity toys attached to a crossbeam as well as other activity toys, where appropriate, must be accompanied by instructions drawing attention to the need to carry out checks and maintenance of the main parts (suspensions, fixings, anchorages, etc.) at intervals, and pointing out that, if these checks are not carried out, the toy may cause a fall or overturn. Instructions must also be given as to the correct assembly of the toy, indicating those parts which can present a danger if incorrectly assembled. Specific information regarding a suitable surface on which to place the toy must be given. (3) Functional toys Functional toys must bear the following warning:‘To be used under the direct supervision of an adult’. In addition, these toys must be accompanied by directions giving working instructions as well as the precautions to be taken by the user, with the warning that failure to take these precautions will expose the user to the hazards – to be specified – normally associated with the appliance or product of which the toy is a scale model or imitation. It must also be indicated that the toy must be kept out of the reach of children under a certain age, which must be specified by the manufacturer. (4) Chemical toys Without prejudice to the application of the provisions laid down in applicable enactments on the classification, packaging and labelling of certain substances or mixtures, the instructions for use of toys containing inherently dangerous substances or mixtures must bear a warning of the dangerous nature of these substances or mixtures and an indication of the precautions to be taken by the user in order to avoid hazards associated with them, which must be specified concisely according to the type of toy. The first aid to be given in the event of serious accidents resulting from the use of this type of toy must also be set out. It must also be stated that the toy must be kept out of reach of children under a certain age, which must be specified by the manufacturer. In addition to the instructions provided for in the first subparagraph, chemical toys must bear the following warning on their packaging:‘Not suitable for children under (insert appropriate age) years. For use under adult supervision’. In particular, the following are regarded as chemical toys: chemistry sets, plastic embedding sets, miniature workshops for ceramics, enamelling or photography and similar toys which lead to a chemical reaction or similar substance alteration during use. (5) Skates, roller skates, online skates, skateboards, scooters and toy bicycles for children Where these toys are offered for sale as toys, they must bear the following warning:‘Protective equipment should be worn. Not to be used in traffic’. Moreover, the instructions for use must contain a reminder that the toy must be used with caution, since it requires great skill, so as to avoid falls or collisions causing injury to the user or third parties. Some indication must also be given as to recommended protective equipment (helmets, gloves, knee-pads, elbow-pads, etc.). (6) Aquatic toys Aquatic toys must bear the following warning:‘Only to be used in water in which the child is within its depth and under adult supervision’. (7) Toys in food Toys contained in food or co-mingled with food must bear the following warning:‘Toy inside. Adult supervision recommended’. (8) Imitations of protective masks and helmets Imitations of protective masks and helmets must bear the following warning:‘This toy does not provide protection’. (9) Toys intended to be strung across a cradle, cot or perambulator by means of strings, cords, elastics or straps Toys intended to be strung across a cradle, cot or perambulator by means of strings, cords, elastics or straps must carry the following warning on the packaging, which must also be permanently marked on the toy:‘To prevent possible injury by entanglement, remove this toy when the child starts trying to get up on its hands and knees in a crawling position’. (10) Packaging for fragrances in olfactory board games, cosmetic kits and gustative games Packaging for fragrances in olfactory board games, cosmetic kits and gustative games that contain the fragrances set out in points 41 to 55 of the list set out in the first paragraph of point 11 of Part 3 of Schedule 2 and of the fragrances set out in points 1 to 11 of the list set out in third paragraph of that point must contain the following warning:‘Contains fragrances that may cause allergies’. SCHEDULE 6 (1) Internal production control is the conformity assessment procedure whereby the manufacturer fulfils the obligations laid down in points 2, 3 and 4, and ensures and declares on the manufacturer's sole responsibility that the products concerned satisfy the requirements of the legislative instrument that apply to them. (2) The manufacturer must establish the technical documentation. The documentation must make it possible to assess the product's conformity to the relevant requirements, and must include an adequate analysis and assessment of the risk(s). The technical documentation must specify the applicable requirements and cover, as far as relevant for the assessment, the design, manufacture and operation of the product. The technical documentation must, wherever applicable, contain at least the following elements: - — a general description of the product, - — conceptual design and manufacturing drawings and schemes of components, sub-assemblies, circuits, etc. - — descriptions and explanations necessary for the understanding of those drawings and schemes and the operation of the product, - — a list of the designated standards and/or other relevant technical specifications applied in full or in part, and descriptions of the solutions adopted to meet the essential requirements of the enactments where those designated standards have not been applied. In the event of partly applied designated standards, the technical documentation must specify the parts which have been applied, - — results of design calculations made, examinations carried out, etc., and - — test reports. (3) The manufacturer must take all measures necessary so that the manufacturing process and its monitoring ensure compliance of the manufactured products with the technical documentation referred to in point 2 and with the requirements of the legislative instruments that apply to them. (4) The manufacturer must affix the UK marking to each individual product in accordance with regulation 18. (4) The manufacturer must draw up a written declaration of conformity for a product model and keep it together with the technical documentation at the disposal of the national authorities for 10 years after the product has been placed on the market. The declaration of conformity must identify the product for which it has been drawn up. A copy of the declaration of conformity must be made available to the relevant authorities upon request. (5) The manufacturer's obligations set out in point 4 may be fulfilled by the manufacturer's authorised representative, on the manufacturer's behalf and under the manufacturer's responsibility, provided that they are specified in the mandate. (1) Type examination is the part of a conformity assessment procedure in which an approved body examines the technical design of a product and verifies and attests that the technical design of the product meets the requirements of these Regulations. (2) Type examination may be carried out in either of the following manners: - — examination of a specimen, representative of the production envisaged, of the complete product (production type), - — assessment of the adequacy of the technical design of the product through examination of the technical documentation and supporting evidence referred to in point 3, plus examination of specimens, representative of the production envisaged, of one or more critical parts of the product (combination of production type and design type), - — assessment of the adequacy of the technical design of the product through examination of the technical documentation and supporting evidence referred to in point 3, without examination of a specimen (design type). (3) The manufacturer must lodge an application for Type examination with a single approved body of the manufacturer's choice. The application must include: - — the name and address of the manufacturer and, if the application is lodged by the authorised representative, the name and address of the authorised representative as well, - — a written declaration that the same application has not been lodged with any other approved body, - — the technical documentation. The technical documentation must make it possible to assess the product's conformity with the applicable requirements of these Regulations and must include an adequate analysis and assessment of the risk(s). The technical documentation must specify the applicable requirements and cover, as far as relevant for the assessment, the design, manufacture and operation of the product. The technical documentation must contain, wherever applicable, at least the following elements: - — a general description of the product, - — conceptual design and manufacturing drawings and schemes of components, sub-assemblies, circuits, etc., - — descriptions and explanations necessary for the understanding of those drawings and schemes and the operation of the product, - — a list of the designated standards and/or other relevant technical specifications applied in full or in part, and descriptions of the solutions adopted to meet the essential safety requirements where those designated standards have not been applied. In the event of partly applied designated standards, the technical documentation must specify the parts which have been applied, - — results of design calculations made, examinations carried out, etc., and - — test reports, - — the specimens representative of the production envisaged. The approved body may request further specimens if needed for carrying out the test programme, - — the supporting evidence for the adequacy of the technical design solution. This supporting evidence must mention any documents that have been used, in particular where the relevant designated standards and/or technical specifications have not been applied in full. The supporting evidence must include, where necessary, the results of tests carried out by the appropriate laboratory of the manufacturer, or by another testing laboratory on the manufacturer's behalf and under the manufacturer's responsibility. (4) The approved body must: For the product: (4) examine the technical documentation and supporting evidence to assess the adequacy of the technical design of the product; For the specimen(s): (4) verify that the specimen(s) have been manufactured in conformity with the technical documentation, and identify the elements which have been designed in accordance with the applicable provisions of the relevant designated standards and/or technical specifications, as well as the elements which have been designed without applying the relevant provisions of those standards; (4) carry out appropriate examinations and tests, or have them carried out, to check whether, where the manufacturer has chosen to apply the solutions in the relevant designated standards and/or technical specifications, these have been applied correctly; (4) carry out appropriate examinations and tests, or have them carried out, to check whether, where the solutions in the relevant designated standards and/or technical specifications have not been applied, the solutions adopted by the manufacturer meet the corresponding essential requirements of the legislative instrument; (4) agree with the manufacturer on a location where the examinations and tests will be carried out. (5) The approved body must draw up an evaluation report that records the activities undertaken in accordance with point 4 and their outcomes. Without prejudice to its obligations set out in paragraph 8, the approved body must release the content of that report, in full or in part, only with the agreement of the manufacturer. (6) Where the type meets the requirements of the specific legislative instrument that apply to the product concerned, the approved body must issue a Type examination certificate to the manufacturer. The certificate must contain the name and address of the manufacturer, the conclusions of the examination, the conditions (if any) for its validity and the necessary data for identification of the approved type. The certificate may have one or more annexes attached. The certificate and its annexes must contain all relevant information to allow the conformity of manufactured products with the examined type to be evaluated and to allow for in-service control. Where the type does not satisfy the applicable requirements of these Regulations, the approved body must refuse to issue a Type examination certificate and must inform the applicant accordingly, giving detailed reasons for its refusal. (7) The approved body must keep itself apprised of any changes in the generally acknowledged state of the art which indicate that the approved type may no longer comply with the applicable requirements of the legislative instrument, and must determine whether such changes require further investigation. If so, the approved body must inform the manufacturer accordingly. The manufacturer must inform the approved body that holds the technical documentation relating to the Type examination certificate of all modifications to the approved type that may affect the conformity of the product with the essential safety requirements or the conditions for validity of the certificate. Such modifications must require additional approval in the form of an addition to the original Type examination certificate. (8) Each approved body must inform the Secretary of State concerning the Type examination certificates and/or any additions thereto which it has issued or withdrawn, and must, periodically or upon request, make available to the Secretary of State the list of certificates and/or any additions thereto refused, suspended or otherwise restricted. Each approved body must inform the other approved bodies concerning the Type examination certificates and/or any additions thereto which it has refused, withdrawn, suspended or otherwise restricted, and, upon request, concerning the certificates and/or additions thereto which it has issued. The authorised body must keep a copy of the Type examination certificate, its annexes and additions, as well as the technical file including the documentation submitted by the manufacturer, until the expiry of the validity of the certificate. (9) The manufacturer must keep a copy of the Type examination certificate, its annexes and additions together with the technical documentation at the disposal of the national authorities for 10 years after the product has been placed on the market. (10) The manufacturer's authorised representative may lodge the application referred to in point 3 and fulfil the obligations set out in points 7 and 9, provided that they are specified in the mandate. (1) Conformity to type based on internal production control is the part of a conformity assessment procedure whereby the manufacturer fulfils the obligations laid down in points 2 and 3, and ensures and declares that the products concerned are in conformity with the type described in the type examination certificate and satisfy the requirements of the legislative instrument that apply to them. (2) The manufacturer must take all measures necessary so that the manufacturing process and its monitoring ensure conformity of the manufactured products with the approved type described in the Type examination certificate and with the requirements of these Regulations. (3) The manufacturer must affix the UK marking to each individual product that is in conformity with the type described in the Type examination certificate and satisfies the applicable requirements of these Regulations. (3) The manufacturer must draw up a written declaration of conformity for a product model and keep it at the disposal of the enforcement authorities for 10 years after the product has been placed on the market. The declaration of conformity must identify the product model for which it has been drawn up. A copy of the declaration of conformity must be made available to the enforcement authorities upon request. (4) The manufacturer's obligations set out in point 3 may be fulfilled by the manufacturer's authorised representative, on the manufacturer's behalf and under the manufacturer's responsibility, provided that they are specified in the mandate. SCHEDULE 7 (1) A conformity assessment body must be established in the United Kingdom and must have legal personality. (2) (1) A conformity assessment body must be a third-party body independent of the organisation or the toy it assesses. (2) A body belonging to a business association or professional federation representing undertakings involved in the design, manufacturing, provision, assembly, use or maintenance of toys which it assesses may, on condition that its independence and the absence of any conflict of interest are demonstrated, be considered such a body. (3) (1) A conformity assessment body, its top level management and the personnel responsible for carrying out the conformity assessment activities must not be the designer, manufacturer, supplier, installer, purchaser, owner, user or maintainer of the toys which they assess, not the authorised representative of any of those parties. (2) Sub-paragraph (1) does not preclude the use of assessed toys that are necessary for the operations of the conformity assessment body or the use of such toys for personal purposes. (4) A conformity assessment body, its top level management and the personnel responsible for carrying out the conformity assessment tasks must not be directly involved in the design or manufacture, the marketing, installation, use or maintenance of toys it assesses, or represent parties involved in those activities. (5) A conformity assessment body must not engage in any activity, including consultancy services, that may conflict with their independence of judgement or integrity in relation to conformity assessment activities for which they are approved. (6) Conformity assessment bodies must ensure that the activities of their subsidiaries and subcontractors do not affect the confidentiality, objectivity or impartiality of their conformity assessment activities. (7) Conformity assessment bodies and their personnel must carry out the conformity assessment activities with the highest degree of professional integrity and the requisite technical competence in the specific field and must be free from all pressures and inducements, particularly financial, which might influence their judgement or the results of their conformity assessment activities, especially as regards persons or groups of persons with an interest in the results of those activities. (8) Conformity assessment bodies must be capable of carrying out the conformity assessment tasks assigned to them by the provisions of regulation 14 or by their approval whether those tasks are carried out by the conformity assessment body itself or on its behalf and under its responsibility. (9) At all times and for each conformity assessment procedure and each kind or category of toy in relation to which it has been approved, a conformity assessment body must have at its disposal— (a) personnel with technical knowledge and sufficient and appropriate experience to perform the conformity assessment tasks; (b) descriptions of procedures in accordance with which conformity assessment is carried out ensuring the transparency and ability of reproduction of those procedures. It must have appropriate policies and procedures in place that distinguish between tasks it carries out as an approved body and other activities. (c) procedures for the performance of activities which take due account of the size of an undertaking, the sector in which it operates, its structure, the degree of complexity of the technology of the toy in question and the mass or serial nature of the production process. (10) A conformity assessment body must have the means necessary to perform the technical and administrative tasks connected with the conformity assessment activities in an appropriate manner and must have access to all necessary equipment or facilities. (11) The personnel responsible for carrying out the conformity assessment activities must have— (a) sound technical and vocational training covering all the conformity assessment activities in relation to which the conformity assessment body has been approved; (b) satisfactory knowledge of the requirements of the assessments they carry out and adequate authority to carry out those assessments; (c) appropriate knowledge and understanding of the essential safety requirements; (d) the ability to draw up certificates, records and reports demonstrating that assessments have been carried out. (12) A conformity assessment body must be able to demonstrate the impartiality of their top level management and personnel responsible for assessment. (13) The renumeration of the top level management and personnel responsible for assessment of a conformity assessment body must not depend on the number of assessments carried out or on the results of those assessments. (14) A conformity assessment body must have, and must satisfy the Secretary of State that it has, adequate civil liability insurance in respect of its activities. (15) A conformity assessment body must ensure that its personnel observe professional secrecy with regard to all information obtained in carrying out their tasks in accordance with these Regulations and that proprietary rights are protected. (16) Paragraph 15 does not prevent the personnel from providing information to the Secretary of State or an enforcement authority. (17) A conformity assessment body must participate in, or ensure that its personnel who are responsible for carrying out the conformity assessment activities are informed of, the relevant standardisation activities and the activities of any approved body coordination group established by the Secretary of State and must apply as general guidance the administrative decisions and documents produced as a result of the work of that group.

SCHEDULE 16 — Amendment of the Explosives Regulations 2014

PART 1 — Amendments to the Explosives Regulations 2014

Introduction

1

The Explosives Regulations 2014 are amended in accordance with paragraphs 2 to 35.

Amendment to regulation 2

2

• (1) Regulation 2 (interpretation) is amended as follows.

• (2) In paragraph (1)—

• (a) omit the definition of “accreditation”;

• (b) omit the definition of “accreditation certificate”;

• (c) after the definition of “ammonium nitrate blasting intermediate” insert—

“approved body” has the meaning given to it in regulation 69 (approved bodies);

• (d) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

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

• (f) omit the definition of “competent national authority”;

• (g) after the definition of “conformity assessment body” insert—

“declaration of conformity” means a declaration of conformity required to be drawn up in accordance with regulation 41;

• (h) after the definition of “desensitised explosive” insert—

“designated standard” has the meaning given to it in regulation 2A;

• (i) in the definition of “the Directive” at the end insert “ (as it has effect immediately before IP completion day) ”;

• (j) omit the definition of “EU declaration of conformity”;

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

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

“importer”, in relation to civil explosives, means any person who— (a) is established in the United Kingdom and places a civil explosive from a country outside of the United Kingdom on the market; or (b) is established in Northern Ireland and places a civil explosive 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;

• (m) in the definition of “making available on the market” for “in an EEA state” substitute “of Great Britain”;

• (n) omit the definition of “notified body requirements”;

• (o) in the definition of “place on the market” for “in an EEA state” substitute “of Great Britain”;

• (p) after the definition of “recipient competent authority document” insert—

“relevant authority” means any public authority which has a function under these Regulations or a function under another enactment in relation to the security or traceability of civil explosives;

and

• (q) after the definition of “transfer” 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;

Insertion of regulation 2A

3

After regulation 2 insert—

(2A) (1) Subject to paragraphs (6) and (7), in these Regulations a “designated standard” means 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 paragraph (1), 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 or 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; (b) production methods and processes relating to the product, where these have an effect on the characteristics of the product. (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 is appropriate 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 a 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 bodies. (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 civil explosive. (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.

Amendment to regulation 8

4

• (1) Regulation 8 (authorisation to transfer civil explosives) is amended as follows.

• (2) In paragraph (1) omit “for the place where the transfer will terminate”.

• (3) In paragraph (2) for “relevant authority” substitute “ relevant competent authority ”.

• (4) In paragraph (5), in both places where it appears, for “the area of the EEA States” substitute “ the United Kingdom ”.

• (5) After paragraph (8) insert—

(8A) A recipient competent authority document issued under this regulation may be granted for such period as the competent authority determines and may be revoked by notice in writing by that authority on grounds of safety or security.

• (6) For paragraph (9) substitute—

(9) In this regulation— (a) “competent authority” means the Executive; and (b) “recipient competent authority document” means a document issued in accordance with this regulation by the competent authority; (c) “relevant competent authority” means— (i) in respect of a transfer or part of a transfer which takes place within Great Britain, the Executive; and (ii) in respect of a transfer or part of a transfer which takes place in Northern Ireland, the body which discharges in Northern Ireland similar functions to those discharged by the Executive under these Regulations in relation to Great Britain.

• (7) After paragraph (9) insert—

(10) A transfer document issued under the Directive, which was valid immediately before IP completion day is deemed to be a valid recipient competent authority document for the purposes of this regulation after IP completion day, until such time as it expires or is withdrawn by a relevant competent authority.

Amendment to regulation 34

5

Regulation 34 (Attribution of manufacturing site codes for civil explosives) is amended as follows—

• (a) in paragraph (3)—

• (i) for “that is not an EEA State” substitute “ other than the United Kingdom ”;

• (ii) in sub-paragraph (a) for “an EEA State” substitute “ the United Kingdom ”;

• (iii) in sub-paragraph (b) for “an EEA State” substitute “ the United Kingdom ”;

• (iv) in sub-paragraph (c) after “import of the civil explosives is” omit “either”;

• (v) in sub-paragraph (c) after “Northern Ireland” omit “or an EEA State other than the United Kingdom”;

• (b) in paragraph (4)(b), after “Northern Ireland” omit “or an EEA State other than the United Kingdom”;

• (c) in paragraph (5)—

• (i) in sub-paragraph (a), at the end omit “and”;

• (ii) for sub-paragraph (b) substitute—

(b) the importer must at the time of its application provide the Executive with the details of any site code previously attributed to those explosives; and (c) the Executive must attribute the code (which may be the same as the code previously attributed to the explosives) and inform the importer accordingly.

• (d) for paragraph (6) substitute—

(6) Where this paragraph applies, the manufacturer must apply to the Secretary of State for Northern Ireland for the Secretary of State to attribute a code for the site where the civil explosives are manufactured.

Amendment to regulation 40

6

Regulation 40 (technical documentation and conformity assessment) is amended as follows—

• (a) in paragraph (b)(i)—

• (i) for “66(a)” substitute “ 66(2)(a) ”;

• (ii) for “point 3(c) of Module B of Annex III to the Directive as amended from time to time” substitute “ paragraph 2(2)(c) of Part 1 (Module B) of Schedule 17 ”;

• (b) in paragraph (b)(ii)—

• (i) for “66(b)” substitute “ 66(2)(b) ”;

• (ii) for “point 2 of Module G of Annex III to the Directive as amended from time to time” substitute “ paragraph 46 of Part 6 (Module G) of Schedule 17 ”.

Amendment to regulation 41

7

Regulation 41 (EU declaration of conformity and CE marking) is amended as follows—

• (a) in the heading to that regulation—

• (i) for “EU declaration” substitute “ Declaration ”;

• (ii) for “CE” substitute “ UK ”;

• (b) in paragraph (1)(a) omit “(EU declaration of conformity)”;

• (c) in paragraph (1)(b)—

• (i) for “CE” substitute “ UK ”;

• (ii) omit “(CE Marking)”;

• (d) for paragraph (3) substitute—

(3) Where a civil explosive is subject to more than one enactment requiring a declaration of conformity to be drawn up, the manufacturer must draw up a single declaration of conformity which identifies each enactment by its title.

Amendment to regulation 42

8

In regulation 42 (retention of technical documentation and EU declaration of conformity) and in the heading to that regulation omit “EU”.

Amendment to regulation 43

9

In regulation 43 (compliance procedures for series production), in paragraph (2)(b)—

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

• (b) omit “EU”.

Amendment to regulation 44

10

In regulation 44 (traceability of certain civil explosives excluded from the scope of regulations 33, 34 and 36) for paragraph (4) substitute—

(4) For a civil explosive that is to be made available on the market in Great Britain the contact details referred to in paragraph (1) must be provided in English.

Amendment to regulation 45

11

For regulation 45 (instructions and safety information), substitute—

(45) (1) When placing a civil explosive on the market, a manufacturer must ensure that it is accompanied by instructions and safety information that are clear, legible and in easily understandable English. (2) Any labelling on the civil explosive must be clear, legible and in easily understandable English.

Amendment to regulation 46

12

Regulation 46 (appointment of authorised representative by written mandate) is amended as follows—

• (a) in paragraph (1) after “appoint a person” insert “ established in the United Kingdom ”;

• (b) in paragraph (2)(a) omit “EU”.

Amendment to regulation 48

13

In regulation 48 (requirements which must be satisfied before an importer places a civil explosive on the market), in paragraph (1)(c)(i) for “CE” substitute “ UK ”.

Amendment to regulation 50

14

In regulation 50 (information identifying importer)—

• (a) after paragraph (1) insert—

(1A) Paragraph (1) does not apply where the importer has imported the civil explosive from an EEA state or Switzerland and places it on the market within the period of 24 months beginning with IP completion day, and before placing the civil explosive on the market, the importer sets out the information referred to in paragraph (1) in a document accompanying the civil explosive.

• (b) in paragraph (2) for “the competent national authority in the EEA state in which the civil explosive is to be made available to such end users” substitute “ a relevant authority ”.

Amendment to regulation 51

15

For regulation 51 (instructions and safety information) substitute—

(51) When placing a civil explosive on the market, an importer must ensure that it is accompanied by instructions and safety information that are clear, legible and in easily understandable English.

Amendment to regulation 52

16

In regulation 52 (retention of technical documentation and EU declaration of conformity), in the heading to that regulation and in paragraph (a), omit “EU”.

Amendment to regulation 53

17

In regulation 53 (duty to take action in respect of civil explosives placed on the market which are considered not to be in conformity), in paragraph (2) omit “, and the competent national authorities of any other EEA state in which the manufacturer or importer made the civil explosive available on the market,”.

Amendment to regulation 54

18

In regulation 54 (provision of information and cooperation), for paragraph (1)(b) substitute—

(b) in clear, legible and easily understandable English.

Amendment to regulation 56

19

In regulation 56 (requirements which must be satisfied before a distributor makes a civil explosive available on the market), paragraph (1)(a) is amended as follows—

• (a) in sub-paragraph (i) for “CE” substitute “ UK ”; and

• (b) for sub-paragraph (iii) substitute—

(iii) is accompanied by instructions and safety information that are clear, legible and in easily understandable English;

Amendment to regulation 58

20

In regulation 58 (duty to take action in respect of civil explosives made available on the market which are not in conformity), in paragraph (2) omit “, and the competent national authorities of the other EEA states in which the distributor has made the civil explosive available on the market,”.

Revocation of regulation 62

21

Omit regulation 62 (translation of declaration of conformity).

Amendment to regulation 64

22

In regulation 64 (prohibition on improper use of CE marking) in the heading, and in each place in which it occurs, for “CE” substitute “ UK ”.

Insertion of regulation 64A

23

After regulation 64 insert—

(64A) (1) In this regulation— (a) any reference to an Article or an Annex is a reference to an Article or an Annex of the Directive; (b) “CE marking” has the meaning given to it in Article 2(24); (c) “harmonised standard” has the meaning given to it in Article 2(16). (2) Subject to paragraphs (6) and (7), paragraph (3) applies where, before placing a civil explosive on the market, the manufacturer— (a) ensures that the civil explosive has been designed and manufactured in accordance with the essential safety requirements set out in Annex II; (b) ensures that the relevant conformity assessment procedures that apply to that civil explosive in accordance with Article 20 have been carried out; (c) draws up the technical documentation referred to in Annex III; (d) ensures that the technical documentation and other records and correspondence relating to the conformity assessment procedures are prepared in or translated into English; (e) affixes a CE marking, in accordance with Articles 22 and 23(1) to (5); (f) draws up an EU declaration of conformity, in accordance with Article 21; and (g) ensures that the EU declaration of conformity is prepared in or translated into English. (3) Where this paragraph applies— (a) the requirements of regulations 39, 40, 41(1) and 41(3) are to be treated as being satisfied; (b) regulations 41(2), 42, 43(2), 46(2) and 64 apply subject to the modifications in paragraph (10); and (c) Schedule 12 paragraph 12 does not apply. (4) Subject to paragraphs (6) and (7), paragraph (5) applies where, before placing a civil explosive on the market, the importer ensures that— (a) the relevant conformity assessment procedures that apply to that explosive in accordance with Article 20 have been carried out; (b) the manufacturer has drawn up the technical documentation referred to in Annex III; and (c) the civil explosive bears the CE marking referred to in Article 23. (5) Where this paragraph applies— (a) the requirements of regulation 48(1)(a) to (c) are to be treated as being satisfied; and (b) regulations 47, 49(1), 52 and 60 apply 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 referred to in Article 19. (7) Where paragraph (6) applies paragraphs (2)(b) and (4)(a) are to be treated as requiring the manufacturer to carry out one of the conformity assessment procedures set out in Article 20. (8) Paragraph (9) applies where, before making a civil explosive available on the market, a distributor ensures that the civil explosive bears the CE marking referred to in Article 23. (9) Where this paragraph applies— (a) regulation 56(1)(a)(i) is to be treated as being satisfied; and (b) regulations 57(1) and 60 apply subject to the modifications in paragraph (10). (10) The modifications referred to in sub-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 EU 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 essential safety requirements referred to in Annex II; (d) any reference to “designated standard” is to be read as a reference to a harmonised standard; (e) any reference to “relevant conformity assessment procedure” is to be read as a reference to the relevant conformity assessment procedures referred to in Article 20; (f) any reference to “technical documentation” is a reference to the technical documentation referred to in Annex III. (64B) (1) In this regulation any reference to an Article or an Annex is a reference to an Article or an Annex of the Directive. (2) Paragraph (3) applies where, prior to the manufacture of a civil explosive, the manufacturer ensures that the conformity assessment procedure that applies to that explosive in accordance with Article 20(a) has been carried out. (3) Where this paragraph applies— (a) any reference to “relevant conformity assessment procedure” in regulations 40(a), 41(1), 48(1)(a), 64(1)(b), 67(b) and 68(3) are to be read as including the conformity assessment procedure referred to in Article 20(a) of the Directive; and (b) any reference to “technical documentation” in regulations 40(b), 42, 48(1)(b), 52(b), and in paragraph 12(1)(d) of Part 1 of Schedule 12 and Schedule 17 is to be read as including the technical documentation relating to the design of the civil explosive referred to in Annex III. (64C) (1) Subject to paragraph (2), regulation 64A ceases to have effect at the end of the period of 12 months beginning with IP completion day. (2) Notwithstanding the expiry of regulation 64A— (a) any civil explosive which was placed on the market pursuant to regulation 64A may continue to be made available on the market on or after the expiry of regulation 64A; (b) any obligation to which a person was subject under regulation 64A in respect of a civil explosive placed on the market pursuant to regulation 64A continues to have effect after the expiry of regulation 64A, in respect of that civil explosive. (3) Subject to paragraph (4), regulation 64B ceases to have effect at the end of the period of 12 months beginning with IP completion day. (4) Where a conformity assessment procedure has been completed pursuant to regulation 64B in relation to a civil explosive prior to the expiry of regulation 64B, regulation 64B continues to apply in respect of that civil explosive where— (a) the manufacturer arranges for the EU-Type examination certificate and any annexes to be transferred to an approved body; (b) the approved body referred to in sub-paragraph (a) accepts responsibility for the EU-Type examination certificate; and (c) the approved body issues a Type-examination certificate relying, or relying in part, on any examinations or tests undertaken prior to the issue of the EU-Type examination certificate. (5) In paragraph (4) “EU-Type examination certificate” means a certificate issued after an EU-Type examination has been carried out in accordance with a conformity assessment procedure set out in point 1 of Annex III of the Directive. (64D) (1) In this regulation— - “the 2016 Regulations” means the Making Available on the Market and Supervision of Transfers of Explosives Regulations (Northern Ireland) 2016; - “CE marking” has the meaning given to it in regulation 2(1) of the 2016 Regulations; - “qualifying Northern Ireland goods” has the meaning given to it in regulations made under section 8C(6) of the European Union (Withdrawal) Act 2018; - “relevant conformity assessment procedure” has the meaning given to it in regulation 2(1) of the 2016 Regulations; - “technical documentation” has the meaning given to it in regulation 2(1) of the 2016 Regulations. (2) Where paragraph (3) applies, a civil explosive is to be treated as being in conformity with Part 13 Sub-Part A. (3) This paragraph applies where— (a) a civil explosive— (i) is in conformity with Part 3 Sub-Part A of the 2016 Regulations; (ii) is qualifying Northern Ireland goods; and (b) an importer has met the obligations set out in paragraph (4). (4) The obligations referred to in paragraph (3)(b) are that, before placing the civil explosive on the market, the importer— (a) complies with regulation 50; (b) ensures that— (i) the relevant conformity assessment procedure has been carried out in in relation to the civil explosive; (ii) the manufacturer has drawn up the technical documentation; and (iii) the civil explosive bears the CE marking.

Amendment to regulation 65

24

In regulation 65 (presumption of conformity), paragraph (1) is amended as follows—

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

• (b) omit “the reference to which has been published in the Official Journal of the European Union”.

Amendment to regulation 66

25

For regulation 66 (conformity assessment procedures) substitute—

(66) (1) Assessment of conformity of a civil explosive is carried out by an approved body in accordance with the procedures set out in Schedule 17. (2) For the assessment of conformity of a civil explosive, the manufacturer must follow one of the following procedures set out in Schedule 17— (a) in Part 1 of Schedule 17, Type examination carried out by an approved body (Module B), and, at the choice of the manufacturer, one of the following procedures— (i) in Part 2 of Schedule 17, conformity to type based on internal production control plus supervised product checks at random intervals (Module C2); (ii) in Part 3 of Schedule 17, conformity to type based on quality assurance of the production process (Module D); (iii) in Part 4 of Schedule 17, conformity to type based on product quality assurance (Module E); (iv) in Part 5 of Schedule 17, conformity to type based on product verification (Module F); (b) in Part 6 of Schedule 17, conformity based on unit verification (Module G).

Amendment to regulation 67

26

Regulation 67 (EU declaration of conformity) is amended as follows—

• (a) in the heading for “EU declaration” substitute “ Declaration ”;

• (b) in the opening words omit “EU”;

• (c) in paragraph (b) for “Annex III to the Directive, as amended from time to time,” substitute “ Schedule 17, ”;

• (d) in paragraph (c) for “Annex IV to the Directive, as amended from time to time” substitute “ Schedule 18. ”.

Amendment to regulation 68

27

Regulation 68 (CE Marking) is amended as follows—

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

• (b) for paragraph (1) substitute—

(1) The UK marking must be affixed visibly, legibly and indelibly— (a) to the civil explosive; or (b) where paragraph (1A) applies, to— (i) a label affixed to the civil explosive; or (ii) the accompanying documents.

• (ba) after paragraph (1) insert—

(1A) For a period of 24 months beginning with IP completion day, the UK marking may be affixed to— (a) a label affixed to the civil explosive; or (b) the accompanying documents.

• (c) in paragraph (2)—

• (i) after “Where” insert “ paragraph (1A) does not apply and ”;

• (ii) for “CE” substitute “ UK ” (twice);

• (d) in paragraph (3)—

• (i) for “CE” substitute “ UK ”;

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

• (e) in paragraph (4) for “notified” in each place it appears, substitute “ approved ”;

• (f) in paragraph (5) for “CE” substitute “ UK ”.

Amendment to Part 13, Sub-Part C

28

For Part 13, Sub-Part C (notification of conformity assessment bodies) substitute—

(69) (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 70 (approval of conformity assessment bodies); or (b) immediately before IP completion day was a notified body in respect of which the Secretary of State had taken no action under regulation 75(1) or (2) as they had effect before IP completion day to suspend or withdraw the body's status as a notified body. (2) Paragraph (1) has effect subject to regulation 73 (restriction, suspension or withdrawal of approval). (3) In this Sub-Part— - “notified body” means a body— 1. which the Secretary of State had before IP completion day notified to the European Commission and to the other EEA states, in accordance with Article 24 of the Directive; and 2. in respect of which no objections had been raised, as referred to in regulation 69(1)(b); - “approved body requirements” means the requirements set out in Schedule 15. (70) (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 procedure in respect of which the conformity assessment body claims to be competent; (iii) the civil explosives 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. (71) (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. (72) 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 70(6)(b); or (ii) in the case of an approved body which was a notified body immediately before IP completion day, in accordance with conditions set under regulation 70(6)(b) as it applied immediately before IP completion day; and (c) carries out its functions in accordance with these Regulations. (73) (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 72(b), the Secretary of State must restrict, suspend or withdraw the body's status as an approved body under regulation 69 (approved bodies). (2) Where the Secretary of State determines that an approved body no longer meets a condition referred to in regulation 72(b), the Secretary of State may restrict, suspend or withdraw the body's status as an approved body under regulation 69. (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. (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 market surveillance 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 notified body. (74) (1) Subject to the terms of its appointment, an approved body must carry out the conformity assessment activities and procedures— (a) in respect of which the body's approval was given under regulation 70; or (b) in respect of which the 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 16 (operational obligations of approved bodies). (3) An approved body must make provision for a manufacturer to be able to make an appeal against a refusal by the approved body— (a) to issue a Type examination certificate referred to in Schedule 17 (conformity assessment procedures); or (b) to affix, or cause to be affixed, the body's identification number pursuant to regulation 68 (UK marking). (75) (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 . (76) (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. (77) 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 72; and (c) compiling and maintaining the register of approved bodies, in accordance with regulation 76.

Transitional provision in relation to EU Exit

29

After regulation 82 (savings and transitional provisions) insert—

(82A) (1) In this regulation— - “pre-exit period” means the period beginning with 20th April 2016 and ending immediately before IP completion day; - “product” means a civil explosive to which these Regulations apply. (2) Subject to paragraph (3), where a product was made available on the market during the pre-exit period, despite the amendments made by Schedule 16 of the Product Safety and Metrology etc. (Amendment etc.) (EU Exit) Regulations 2019 , any obligation 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 enforcing authority to inform the European Commission or the member States of any matter; or (b) any obligation to take action outside of the market in respect of that product. (4) Where during the pre-exit period— (a) a product has not been placed on the market; and (b) a manufacturer has taken any action under regulation 40 as it had effect immediately beforeIP completion day in relation to that product that action has effect as if it had been done under regulation 40 as it had effect on and after IP completion day.

Amendment to Schedule 6

30

In Schedule 6 in paragraph 1(a)(ii)(aa) for “the EEA State (place of production or import onto the market of the EEA States)” substitute “ Great Britain, Northern Ireland or the EEA state (place of production or import) ”.

Amendment to Schedule 9

31

In Schedule 9 at the beginning omit “(This Schedule reproduces, with minor modifications, the provisions of Annex II to the Directive)”.

Amendment to Schedule 12

32

Schedule 12 is amended as follows—

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

• (b) omit paragraph 4(c);

• (c) in paragraph 9(2) for “notified body” substitute “ approved body ”;

• (d) omit paragraph 9(4);

• (e) omit paragraph 9(7);

• (f) in paragraph 9(8)—

• (i) for “The notices in sub-paragraphs (6) and (7)” substitute “ The notice in sub-paragraph (6) ”;

• (ii) in sub-paragraph (f)(ii) for “harmonised” substitute “ designated ”;

• (g) in paragraph 9(10) for “competent national authority” substitute “ relevant authority ”;

• (h) omit paragraph 10 (EU safeguarding procedure);

• (i) omit paragraph 11(3);

• (j) in paragraph 11(4) for “The notices referred to in sub-paragraphs (2) and (3)” substitute “ The notice referred to in sub-paragraph (2) ”;

• (k) in paragraph 12—

• (i) in sub-paragraphs (1)(a) and 1(c), for “CE marking” substitute “ UK marking ” in each place it appears;

• (ii) in sub-paragraph (1)(b) for “a notified body” substitute “ an approved body ”;

• (iii) in sub-paragraph (1)(b) for “the notified body” substitute “ the approved body ”; and

• (iv) in sub-paragraph (1)(c) for “EU declaration of conformity” substitute “ declaration of conformity ” in each place it appears.

Amendment to Schedule 15

33

Schedule 15 is amended as follows—

• (a) in the heading, for “Notified” substitute “ Approved ”;

• (b) in paragraph 8 and paragraph 9(b), for “notified” substitute “ approved ”;

• (c) in paragraph 11(c)—

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

• (ii) omit “of the Directive and Part 13”;

• (d) in paragraph 17—

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

• (ii) for “under the Directive” substitute “ by the Secretary of State ”.

Amendment to Schedule 16

34

Schedule 16 is amended as follows—

• (a) in the heading, for “Notified” substitute “ Approved ”;

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

• (c) in paragraph 2, for “A notified” substitute “ An approved ”;

• (d) in paragraph 3, for “A notified” substitute “ An approved ”;

• (e) in paragraph 4, for “A notified” substitute “ An approved ”;

• (f) in paragraph 5—

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

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

• (g) in paragraph 6, for “a notified” substitute “ an approved ”;

• (h) in paragraph 7, for “notified” substitute “ approved ” in both places it appears;

• (i) in paragraph 8, for “a notified” substitute “ an approved ”;

• (j) in paragraph 9, for “notified” substitute “ approved ”;

• (k) in paragraph 10—

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

• (ii) in sub-paragraph (b)—

• (aa) for “notification” in the first place it appears substitute “ approval ”;

• (bb) in the second place it appears omit “(notification)”;

• (iii) in sub-paragraph (d) for “notification” substitute “ approval ”;

• (l) in paragraph 11, for “A notified” substitute “ An approved ”;

• (m) in paragraph 12—

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

• (ii) for “notified under the Directive” substitute “ approved under these Regulations ”;

• (n) in paragraph 13—

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

• (ii) for “any notified body” substitute “ any approved body ”;

• (iii) for “under the Directive” substitute “ by the Secretary of State ”.

Insertion of Schedule 17 and Schedule 18

35

After Schedule 16 insert—