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

Type Statutory-Instrument

Publication 2019-03-27

Last updated 2020-12-31

State In force

Department King's Printer of Acts of Parliament

Source legislation.gov.uk

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SCHEDULE 3A (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 that apply to it. (2) Type examination shall be carried out with the examination of a specimen, representative of the production envisaged, of the complete product (production type). (3) The manufacturer shall lodge an application for Type examination with a single approved body of his choice. The application shall include: (a) the name and address of the manufacturer and, if the application is lodged by the authorised representative, his name and address as well, (b) a written declaration that the same application has not been lodged with any other approved body, (c) the technical documentation. The technical documentation shall make it possible to assess the product's conformity with the applicable requirements of these Regulations and shall include an adequate analysis and assessment of the risk(s). The technical documentation shall specify the applicable requirements and cover, as far as relevant for the assessment, the design, manufacture and operation of the product. The technical documentation shall contain at least the following elements: (i) a general description of the product, (ii) conceptual design and manufacturing drawings and schemes of components, sub-assemblies, circuits, etc., (iii) descriptions and explanations necessary for the understanding of those drawings and schemes and the operation of the product, (iv) a list of the designated standards applied in full or in part and, where those designated standards have not been applied, descriptions of the solutions adopted to meet the essential health and safety requirements of these Regulations, including a list of other relevant technical specifications applied. In the event of partly applied designated standards, the technical documentation shall specify the parts which have been applied, (v) results of design calculations made, examinations carried out, etc., and (vi) test reports, (d) the specimens representative of the production envisaged. The approved body may request further specimens if needed for carrying out the test programme. (4) The approved body shall: (4) examine the technical documentation, 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, as well as the elements which have been designed in accordance with other relevant technical specifications; (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, 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 have not been applied, the solutions adopted by the manufacturer applying other relevant technical specifications meet the corresponding essential health and safety requirements of these Regulations; (4) agree with the manufacturer on a location where the examinations and tests will be carried out. (5) The approved body shall draw up an evaluation report that records the activities undertaken in accordance with paragraph 4 and their outcomes. Without prejudice to its obligations vis-à-vis the Secretary of State, the approved body shall 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 these Regulations that apply to the product concerned, the approved body shall issue a Type examination certificate to the manufacturer. That certificate shall 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 Type examination certificate may have one or more annexes attached. The Type examination certificate and its annexes shall 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 shall refuse to issue a Type examination certificate and shall inform the applicant accordingly, giving detailed reasons for its refusal. (7) The approved body shall 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 these Regulations and shall determine whether such changes require further investigation. If so, the approved body shall inform the manufacturer accordingly. The manufacturer shall 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 health and safety requirements of these Regulations or the conditions for validity of that certificate. Such modifications shall require additional approval in the form of an addition to the original Type examination certificate. (8) Each approved body shall inform the Secretary of State concerning the Type examination certificates and/or any additions thereto which it has issued or withdrawn, and shall, periodically or upon request, make available to the Secretary of State the list of such certificates and/or any additions thereto refused, suspended or otherwise restricted. Each approved body shall 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 such certificates and/or additions thereto which it has issued. The Health and Safety Executive for Northern Ireland may, on request, obtain a copy of the Type examination certificates and/or additions thereto. On request, The Health and Safety Executive for Northern Ireland may obtain a copy of the technical documentation and the results of the examinations carried out by the approved body. The approved body shall 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 that certificate. (9) The manufacturer shall 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 paragraph 3 and fulfil the obligations set out in paragraphs 7 and 9, provided that they are specified in the mandate. (1) Conformity to type based on quality assurance of the production process is the part of a conformity assessment procedure whereby the manufacturer fulfils the obligations laid down in paragraphs 2 and 5, and ensures and declares on his sole responsibility that the products concerned are in conformity with the type described in the Type examination certificate and satisfy the requirements of these Regulations that apply to them. (2) The manufacturer shall operate an approved quality system for production, final product inspection and testing of the products concerned as specified in paragraph 3 and shall be subject to surveillance as specified in paragraph 4. (3) (3) The manufacturer shall lodge an application for assessment of his quality system with the approved body of his choice, for the products concerned. The application shall include: (a) the name and address of the manufacturer and, if the application is lodged by the authorised representative, his name and address as well, (b) a written declaration that the same application has not been lodged with any other approved body, (c) all relevant information for the product category envisaged, (d) the documentation concerning the quality system, (e) the technical documentation of the approved type and a copy of the Type examination certificate. (3) The quality system shall ensure that the products are in conformity with the type described in the Type examination certificate and comply with the requirements of these Regulations that apply to them. All the elements, requirements and provisions adopted by the manufacturer shall be documented in a systematic and orderly manner in the form of written policies, procedures and instructions. The quality system documentation shall permit a consistent interpretation of the quality programmes, plans, manuals and records. It shall, in particular, contain an adequate description of: (a) the quality objectives and the organisational structure, responsibilities and powers of the management with regard to product quality, (b) the corresponding manufacturing, quality control and quality assurance techniques, processes and systematic actions that will be used, (c) the examinations and tests that will be carried out before, during and after manufacture, and the frequency with which they will be carried out, (d) the quality records, such as inspection reports and test data, calibration data, qualification reports on the personnel concerned, etc., and (e) the means of monitoring the achievement of the required product quality and the effective operation of the quality system. (3) The approved body shall assess the quality system to determine whether it satisfies the requirements referred to in paragraph 3.2. It shall presume conformity with those requirements in respect of the elements of the quality system that comply with the corresponding specifications of the relevant designated standard. In addition to experience in quality management systems, the auditing team shall have at least one member with experience of evaluation in the relevant product field and product technology concerned, and knowledge of the applicable requirements of these Regulations. The audit shall include an assessment visit to the manufacturer's premises. The auditing team shall review the technical documentation referred to in paragraph 3.1(e) to verify the manufacturer's ability to identify the relevant requirements of these Regulations and to carry out the necessary examinations with a view to ensuring compliance of the product with those requirements. The decision shall be notified to the manufacturer. The notification shall contain the conclusions of the audit and the reasoned assessment decision. (3) The manufacturer shall undertake to fulfil the obligations arising out of the quality system as approved and to maintain it so that it remains adequate and efficient. (3) The manufacturer shall keep the approved body that has approved the quality system informed of any intended change to the quality system. The approved body shall evaluate any proposed changes and decide whether the modified quality system will continue to satisfy the requirements referred to in paragraph 3.2 or whether a reassessment is necessary. It shall notify the manufacturer of its decision. The notification shall contain the conclusions of the examination and the reasoned assessment decision. (4) (4) The purpose of surveillance is to make sure that the manufacturer duly fulfils the obligations arising out of the approved quality system. (4) The manufacturer shall, for assessment purposes, allow the approved body access to the manufacture, inspection, testing and storage sites and shall provide it with all necessary information, in particular: (a) the quality system documentation, (b) the quality records, such as inspection reports and test data, calibration data, qualification reports on the personnel concerned, etc. (4) The approved body shall carry out periodic audits to make sure that the manufacturer maintains and applies the quality system and shall provide the manufacturer with an audit report. (4) In addition, the approved body may pay unexpected visits to the manufacturer. During such visits the approved body may, if necessary, carry out product tests, or have them carried out, in order to verify that the quality system is functioning correctly. The approved body shall provide the manufacturer with a visit report and, if tests have been carried out, with a test report. (5) (5) The manufacturer shall affix the UK marking and, under the responsibility of the approved body referred to in paragraph 3.1, the latter's identification number to each individual product other than a component that is in conformity with the type described in the Type examination certificate and satisfies the applicable requirements of these Regulations. (5) The manufacturer shall draw up a written declaration of conformity for each product model, other than a component and keep it at the disposal of the national authorities for 10 years after the product other than a component has been placed on the market. The declaration of conformity shall identify such product model for which it has been drawn up. A copy of the declaration of conformity shall accompany every product, other than a component. (5) The manufacturer shall draw up a written attestation of conformity for each component model and keep it at the disposal of the national authorities for 10 years after the component has been placed on the market. The attestation of conformity shall identify the component model for which it has been drawn up. A copy of the attestation of conformity shall accompany every component. (6) The manufacturer shall, for a period ending 10 years after the product has been placed on the market, keep at the disposal of the national authorities: (a) the documentation referred to in paragraph 3.1, (b) the information relating to the change referred to in paragraph 3.5, as approved, (c) the decisions and reports of the approved body referred to in paragraphs 3.5, 4.3 and 4.4. (7) Each approved body shall inform the Secretary of State of quality system approvals issued or withdrawn, and shall, periodically or upon request, make available to the Secretary of State the list of quality system approvals refused, suspended or otherwise restricted. Each approved body shall inform the other approved bodies of quality system approvals which it has refused, suspended, withdrawn or otherwise restricted, and, upon request, of quality system approvals which it has issued. (8) The manufacturer's obligations set out in paragraphs 3.1, 3.5, 5 and 6 may be fulfilled by his authorised representative, on his behalf and under his responsibility, provided that they are specified in the mandate. (1) Conformity to type based on product verification is the part of a conformity assessment procedure whereby the manufacturer fulfils the obligations laid down in paragraphs 2 and 5 and ensures and declares on his sole responsibility that the products concerned, which have been subject to the provisions of paragraph 3, are in conformity with the type described in the Type examination certificate and satisfy the requirements of these Regulations that apply to them. (2) The manufacturer shall 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 that apply to them. (3) An approved body chosen by the manufacturer shall carry out appropriate examinations and tests in order to check the conformity of the products with the approved type described in the Type examination certificate and with the appropriate requirements of these Regulations. The examinations and tests to check the conformity of the products with the appropriate requirements shall be carried out by examination and testing of every product as specified in paragraph 4. (4) (4) All products shall be individually examined, and appropriate tests set out in the relevant designated standard(s) and/or equivalent tests set out in other relevant technical specifications, shall be carried out in order to verify conformity with the approved type described in the Type examination certificate and with the appropriate requirements of these Regulations. In the absence of such a designated standard, the approved body concerned shall decide on the appropriate tests to be carried out. (4) The approved body shall issue a certificate of conformity in respect of the examinations and tests carried out and shall affix its identification number to each approved product or have it affixed under its responsibility. The manufacturer shall keep the certificates of conformity available for inspection by the national authorities for 10 years after the product has been placed on the market. (5) (5) The manufacturer shall affix the UK marking and, under the responsibility of the approved body referred to in paragraph 3, the latter's identification number to each individual product other than a component that is in conformity with the approved type described in the Type examination certificate and satisfies the applicable requirements of these Regulations. (5) The manufacturer shall draw up a written declaration of conformity for each product model other than a component and keep it at the disposal of the national authorities, for 10 years after the product, other than a component, has been placed on the market. The declaration of conformity shall identify such product model for which it has been drawn up. A copy of the declaration of conformity shall accompany every product other than a component. (5) The manufacturer shall draw up a written attestation of conformity for each component model and keep it at the disposal of the national authorities for 10 years after the component has been placed on the market. The attestation of conformity shall identify the component model for which it has been drawn up. A copy of the attestation of conformity shall accompany every component. If the approved body referred to in paragraph 3 agrees and under its responsibility, the manufacturer may also affix the approved body's identification number to the products other than components. (6) If the approved body agrees and under its responsibility, the manufacturer may affix the approved body's identification number to the products during the manufacturing process. (7) The manufacturer's obligations may be fulfilled by his authorised representative, on his behalf and under his responsibility, provided that they are specified in the mandate. An authorised representative may not fulfil the manufacturer's obligations set out in paragraph 2. (1) Conformity to type based on internal production control plus supervised product testing is the part of a conformity assessment procedure whereby the manufacturer fulfils the obligations laid down in paragraphs 2, 3 and 4, and ensures and declares on his sole responsibility that the products concerned are in conformity with the type described in the Type examination certificate and satisfy the requirements of these Regulations that apply to them. (2) The manufacturer shall take all measures necessary so that the manufacturing process and its monitoring ensure conformity of the manufactured products with the type described in the Type examination certificate and with the requirements of these Regulations that apply to them. (3) For each individual product manufactured one or more tests on one or more specific aspects of the product shall be carried out by the manufacturer or on his behalf, in order to verify conformity with the type described in the Type examination certificate and with the corresponding requirements of these Regulations. The tests shall be carried out under the responsibility of an approved body, chosen by the manufacturer. The manufacturer shall, under the responsibility of the approved body, affix the approved body's identification number during the manufacturing process. (4) (4) The manufacturer shall affix the UK marking to each individual product other than a component that is in conformity with the type described in the Type examination certificate and satisfies the applicable requirements of these Regulations. (4) The manufacturer shall draw up a written declaration of conformity for a product model other than a component and keep it at the disposal of the national authorities for 10 years after the product, other than a component has been placed on the market. The declaration of conformity shall identify such product model for which it has been drawn up. A copy of the declaration of conformity shall accompany every product, other than a component. (4) The manufacturer shall draw up a written attestation of conformity for each component model and keep it at the disposal of the national authorities for 10 years after the component has been placed on the market. The attestation of conformity shall identify the component model for which it has been drawn up. A copy of the attestation of conformity shall accompany every component. (5) The manufacturer's obligations set out in paragraph 4 may be fulfilled by his authorised representative, on his behalf and under his responsibility, provided that they are specified in the mandate. (1) Conformity to type based on product quality assurance is that part of a conformity assessment procedure whereby the manufacturer fulfils the obligations laid down in paragraphs 2 and 5 and ensures and declares on his sole responsibility that the products concerned are in conformity with the type described in the Type examination certificate and satisfy the requirements of these Regulations that apply to them. (2) The manufacturer shall operate an approved quality system for final product inspection and testing of the products concerned as specified in paragraph 3 and shall be subject to surveillance as specified in paragraph 4. (3) (3) The manufacturer shall lodge an application for assessment of his quality system with the approved body of his choice, for the products concerned. The application shall include: (a) the name and address of the manufacturer and, if the application is lodged by the authorised representative, his name and address as well (b) a written declaration that the same application has not been lodged with any other approved body, (c) all relevant information for the product category envisaged, (d) the documentation concerning the quality system, and (e) the technical documentation of the approved type and a copy of the Type examination certificate. (3) The quality system shall ensure compliance of the products with the type described in the Type examination certificate and with the applicable requirements of these Regulations. All the elements, requirements and provisions adopted by the manufacturer shall be documented in a systematic and orderly manner in the form of written policies, procedures and instructions. The quality system documentation shall permit a consistent interpretation of the quality programmes, plans, manuals and records. It shall, in particular, contain an adequate description of: (a) the quality objectives and the organisational structure, responsibilities and powers of the management with regard to product quality, (b) the examinations and tests that will be carried out after manufacture, (c) the quality records, such as inspection reports and test data, calibration data, qualification reports on the personnel concerned, etc., (d) the means of monitoring the effective operation of the quality system. (3) The approved body shall assess the quality system to determine whether it satisfies the requirements referred to in paragraph 3.2. It shall presume conformity with those requirements in respect of the elements of the quality system that comply with the corresponding specifications of the relevant designated standard. In addition to experience in quality management systems, the auditing team shall have at least one member with experience of evaluation in the relevant product field and product technology concerned, and knowledge of the applicable requirements of these Regulations. The audit shall include an assessment visit to the manufacturer's premises. The auditing team shall review the technical documentation referred to in paragraph 3.1(e) in order to verify the manufacturer's ability to identify the relevant requirements of these Regulations and to carry out the necessary examinations with a view to ensuring compliance of the product with those requirements. The decision shall be notified to the manufacturer. The notification shall contain the conclusions of the audit and the reasoned assessment decision. (3) The manufacturer shall undertake to fulfil the obligations arising out of the quality system as approved and to maintain it so that it remains adequate and efficient. (3) The manufacturer shall keep the approved body that has approved the quality system informed of any intended change to the quality system. The approved body shall evaluate any proposed changes and decide whether the modified quality system will continue to satisfy the requirements referred to in paragraph 3.2 or whether a reassessment is necessary. It shall notify the manufacturer of its decision. The notification shall contain the conclusions of the examination and the reasoned assessment decision. (4) (4) The purpose of surveillance is to make sure that the manufacturer duly fulfils the obligations arising out of the approved quality system. (4) The manufacturer shall, for assessment purposes, allow the approved body access to the manufacture, inspection, testing and storage sites and shall provide it with all necessary information, in particular: (a) the quality system documentation, (b) the quality records, such as inspection reports and test data, calibration data, qualification reports on the personnel concerned, etc. (4) The approved body shall carry out periodic audits to make sure that the manufacturer maintains and applies the quality system and shall provide the manufacturer with an audit report. (4) In addition, the approved body may pay unexpected visits to the manufacturer. During such visits the approved body may, if necessary, carry out product tests, or have them carried out, in order to verify that the quality system is functioning correctly. The approved body shall provide the manufacturer with a visit report and, if tests have been carried out, with a test report. (5) (5) The manufacturer shall affix the UK marking and, under the responsibility of the approved body referred to in paragraph 3.1, the latter's identification number to each individual product other than a component that is in conformity with the type described in the Type examination certificate and satisfies the applicable requirements of these Regulations. (5) The manufacturer shall draw up a written declaration of conformity for each product model, other than a component and keep it at the disposal of the national authorities for 10 years after the product other than a component has been placed on the market. The declaration of conformity shall identify such product model for which it has been drawn up. A copy of the declaration of conformity shall accompany every product other than a component. (5) The manufacturer shall draw up a written attestation of conformity for each component model and keep it at the disposal of the national authorities for 10 years after the component has been placed on the market. The attestation of conformity shall identify the component model for which it has been drawn up. A copy of the attestation of conformity shall accompany every component. (6) The manufacturer shall, for a period ending 10 years after the product has been placed on the market, keep at the disposal of the national authorities: (a) the documentation referred to in paragraph 3.1, (b) the information relating to the change referred to in paragraph 3.5, as approved, (c) the decisions and reports of the approved body referred to in paragraphs 3.5, 4.3 and 4.4. (7) Each approved body shall inform the Secretary of State of quality system approvals issued or withdrawn, and shall, periodically or upon request, make available to the Secretary of State the list of quality system approvals refused, suspended or otherwise restricted. Each approved body shall inform the other approved bodies of quality system approvals which it has refused, suspended or withdrawn, and, upon request, of quality system approvals which it has issued. (8) The manufacturer's obligations set out in paragraphs 3.1, 3.5, 5 and 6 may be fulfilled by his authorised representative, on his behalf and under his responsibility, provided that they are specified in the mandate. (1) Internal production control is the conformity assessment procedure whereby the manufacturer fulfils the obligations laid down in paragraphs 2, 3 and 4, and ensures and declares on his sole responsibility that the products concerned satisfy the requirements of these Regulations that apply to them. (2) The manufacturer shall establish the technical documentation. The documentation shall make it possible to assess the product's conformity to the relevant requirements and shall include an adequate analysis and assessment of the risk(s). The technical documentation shall specify the applicable requirements and cover, as far as relevant for the assessment, the design, manufacture and operation of the product. The technical documentation shall contain at least the following elements: (a) a general description of the product, (b) conceptual design and manufacturing drawings and schemes of components, sub-assemblies, circuits, etc. (c) descriptions and explanations necessary for the understanding of those drawings and schemes and the operation of the product, (d) a list of the designated standards applied in full or in part and, where those designated standards have not been applied, descriptions of the solutions adopted to meet the essential health and safety requirements of these Regulations, including a list of other relevant technical specifications applied. In the event of partly applied designated standards, the technical documentation shall specify the parts which have been applied, (e) results of design calculations made, examinations carried out, etc., and (f) test reports. (3) The manufacturer shall 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 paragraph 2 and with the requirements of these Regulations that apply to them. (4) (4) The manufacturer shall affix the UK marking to each individual product other than a component that satisfies the applicable requirements of these Regulations. (4) The manufacturer shall draw up a written declaration of conformity for a product model other than a component and keep it together with the technical documentation at the disposal of the national authorities for 10 years after the product, other than a component, has been placed on the market. The declaration of conformity shall identify such product model for which it has been drawn up. A copy of the declaration of conformity shall accompany every product other than a component. (4) The manufacturer shall draw up a written attestation of conformity for each component model and keep it together with the technical documentation at the disposal of the national authorities for 10 years after the component has been placed on the market. The attestation of conformity shall identify the component for which it has been drawn up. A copy of the attestation of conformity shall accompany every component. (5) The manufacturer's obligations set out in paragraph 4 may be fulfilled by his authorised representative, on his behalf and under his responsibility, provided that they are specified in the mandate. (1) Conformity based on unit verification is the conformity assessment procedure whereby the manufacturer fulfils the obligations laid down in paragraphs 2, 3 and 5, and ensures and declares on his sole responsibility that the product concerned, which has been subject to the provisions of paragraph 4, is in conformity with the requirements of these Regulations that apply to it. (2) (2) The manufacturer shall establish the technical documentation and make it available to the approved body referred to in paragraph 4. The documentation shall make it possible to assess the product's conformity with the relevant requirements and shall include an adequate analysis and assessment of the risk(s). The technical documentation shall specify the applicable requirements and cover, as far as relevant for the assessment, the design, manufacture and operation of the product. The technical documentation shall contain at least the following elements: (a) a general description of the product, (b) conceptual design and manufacturing drawings and schemes of components, sub-assemblies, circuits, etc., (c) descriptions and explanations necessary for the understanding of those drawings and schemes and the operation of the product, (d) a list of the designated standards applied in full or in part and, where those designated standards have not been applied, descriptions of the solutions adopted to meet the essential health and safety requirements of these Regulations, including a list of other relevant technical specifications applied. In the event of partly applied designated standards, the technical documentation shall specify the parts which have been applied, (e) results of design calculations made, examinations carried out, etc., and (f) test reports. (2) The manufacturer shall keep the technical documentation at the disposal of the relevant national authorities for 10 years after the product has been placed on the market. (3) The manufacturer shall take all measures necessary so that the manufacturing process and its monitoring ensure conformity of the manufactured product with the applicable requirements of these Regulations. (4) An approved body chosen by the manufacturer shall carry out appropriate examinations and tests, set out in the relevant designated standards and/or equivalent tests set out in other relevant technical specifications, to check the conformity of the product with the applicable requirements of these Regulations, or have them carried out. In the absence of such a designated standard the approved body concerned shall decide on the appropriate tests to be carried out. The approved body shall issue a certificate of conformity in respect of the examinations and tests carried out and shall affix its identification number to the approved product, or have it affixed under its responsibility. The manufacturer shall keep the certificates of conformity at the disposal of the national authorities for 10 years after the product has been placed on the market. (5) (5) The manufacturer shall affix the UK marking and, under the responsibility of the approved body referred to in paragraph 4, the latter's identification number to each product other than a component that satisfies the applicable requirements of these Regulations. (5) The manufacturer shall draw up a written declaration of conformity and keep it at the disposal of the national authorities for 10 years after the product, other than a component has been placed on the market. The declaration of conformity shall identify such product for which it has been drawn up. A copy of the declaration of conformity shall accompany every product, other than a component. (5) The manufacturer shall draw up a written attestation of conformity and keep it at the disposal of the national authorities for 10 years after the component has been placed on the market. The attestation of conformity shall identify the component for which it has been drawn up. A copy of the attestation of conformity shall accompany every component. (6) The manufacturer's obligations set out in paragraphs 2.2 and 5 may be fulfilled by his authorised representative, on his behalf and under his responsibility, provided that they are specified in the mandate.

Amendment to Schedule 6

41

Schedule 6 (EU Declaration of Conformity) is amended as follows—

(a) omit “EU” from the heading;

(b) in paragraph 5, for “Union harmonisation legislation” substitute “ statutory requirements ”;

(d) in paragraph 7, for “notified” substitute “ approved ”.

SCHEDULE 26 — Amendment of the Non-automatic Weighing Instruments Regulations 2016

Introduction

1

The Non-automatic Weighing Instruments Regulations 2016 are amended in accordance with paragraphs 2 to 45.

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”;

“approved body” has the meaning given to it in regulation 47 (approved bodies);

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

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

(f) omit the definition of “Commission”;

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

“conformity assessment procedure” means a procedure referred to in regulation 36;”; “declaration of conformity” means a declaration of conformity required to be drawn up in accordance with Chapter 2 of Part 3;”; “designated standard” has the meaning given to it in regulation 2A;

(h) in the definition of “the Directive” for “as from time to time amended;” substitute “ (as it has effect immediately before IP completion day) ” ...;

(ha) in the definition of “essential requirements” for “Annex I to the Directive” substitute “ Schedule 6 ”;

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

(j) omit the definition of “EU-type examination certificate”

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

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

“importer” means a person who— (a) is established in the United Kingdom and places a non-automatic weighing instrument from a country outside of the United Kingdom on the market; or (b) is established in Northern Ireland and places a non-automatic weighing instrument 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 “M marking” for “CE” substitute “ UK ”;

(n) in the definition of “make available on the market” for “European Economic Area market” substitute “market of Great Britain”;

(o) omit the definition of “national accreditation body”;

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

(q) omit the definition of “notifying authority”;

(r) in the definition of “place on the market” for “in the European Economic Area” substitute “of Great Britain”;

(s) in the definition of “technical documentation” for “Annex II to the Directive” substitute Schedule 7;

(t) after the definition of “technical specification” insert—

“Type-examination certificate” means a type-examination certificate issued by an approved body in accordance with Module B of Schedule 7; “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;

(u) omit the definition of “Union harmonisation legislation”.

(3) After paragraph (1) insert—

(1A) Schedules 6 to 8 reproduce the provisions of Annexes I to III to the Directive (respectively) with amendments to correct deficiencies in retained EU law. (1B) A reference to any provision of Schedules 6 to 8 is a reference to the equivalent provision of the relevant Annex to the Directive as set out in the relevant Schedule.

(4) Omit paragraph (2).

Insertion of regulation 2A

3

After regulation 2 insert—

(2A) (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 paragraph (1), a “technical specification” means a document that prescribes technical requirements to be fulfilled by a non-automatic weighing instrument, process, service or system and which lays down one or more of the following— (a) the characteristics required of a non-automatic weighing instrument, including— (i) levels of quality, performance, interoperability, environmental protection, health, safety or dimensions, and (ii) the requirements applicable to the non-automatic weighing instrument as regards the name under which the measuring instrument is sold, terminology, symbols, testing and test methods, packaging, marking or labelling and conformity assessment procedures; and (b) production methods and processes relating to the non-automatic weighing instrument, where these have an effect on the characteristics of the non-automatic weighing instrument. (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 persons 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 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) The Secretary of State may by regulations amend paragraph (3) to reflect any changes in the name or structure of the recognised standardisation bodies. (9) Regulations made under paragraph (8) are to be made by statutory instrument. (10) A statutory instrument containing regulations made under paragraph (8) is subject to annulment in pursuance of a resolution of either House of Parliament.

Amendment to regulation 4

4

Regulation 4 (revocations and transitional and consequential provisions) is amended as follows—

(a) in paragraph (2) after “in paragraph (1)” insert “ subject to the modifications made in paragraph (3A) ”;

(b) after paragraph (3) insert—

(3A) The modifications referred to in paragraph (2) are as follows— (a) in the Non-automatic Weighing Instruments Regulations 2000 and the Non-automatic Weighing Instruments (Amendment) Regulations 2008— (i) any reference to “the Community” is to be read as including the United Kingdom; (ii) references to “member State” is to be read as including the United Kingdom; (b) in the Non-automatic Weighing Instruments Regulations 2000— (i) omit regulation 10(14); (ii) in regulations 25(6)(a)(i) and 25(7)(a) for “; and” substitute “ . ”; and (iii) omit regulations 25(6)(a)(ii), 25(6)(b) and 25(7)(b).

Transitional provision in relation to EU Exit

5

After regulation 4 insert—

(4A) (1) In this regulation— “pre-exit period” means the period beginning with the commencement date and ending immediately before IP completion day. (2) Subject to paragraph (3), where a non-automatic weighing instrument was made available on the market during the pre-exit period, despite the amendments made by Schedule 26 to 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 non-automatic weighing instrument. (3) Paragraph (2) does not apply to— (a) any obligation of any competent authority to inform the European Commission or Member States of any matter; or (b) any obligation to take action outside of the United Kingdom in respect of that non-automatic weighing instrument. (4) Where during the pre-exit period— (a) a non-automatic weighing instrument has not been placed on the market; and (b) a manufacturer has taken any action under regulation 36 as it had effect immediately before IP completion day in relation to that non-automatic weighing instrument, that action has effect as if it had been done under regulation 36 as it had effect on and after IP completion day.

Amendment to regulation 6

6

In regulation 6 (manufacturer's responsibilities - design, conformity assessment and marking of regulated non-automatic weighing instruments)—

(a) the existing provision is renumbered paragraph (1);

(b) in paragraph (1)(d) (as so renumbered) for “an EU” substitute “ a ”;

(i) after “instrument” insert “ or where paragraph (2) applies, in respect of the UK marking, to a label affixed to a product or to a document accompanying the product ”;

(ii) for “CE” substitute “ UK ”;

(d) after the renumbered paragraph (1) insert—

(2) For a period of 24 months beginning with IP completion day, the UK marking may be affixed to— (a) a label affixed to the instrument; or (b) to a document accompanying the instrument.

Amendment to regulation 7

7

In regulation 7 (manufacturers' obligations in respect of records) omit “EU”.

Amendment to regulation 8

8

In regulation 8 (manufacturers' obligations to ensure continuing conformity with essential requirements) in paragraph (2)(b) for “harmonised” substitute “ designated ”.

Amendment to regulation 10

9

In regulation 10 (manufacturers to mark contact details on regulated non-automatic weighing instruments) in paragraph (3) for “in a language” to “be in”, substitute “ clear, legible and in easily understandable ”.

Amendment to regulation 11

10

In regulation 11 (documentation to accompany regulated non-automatic weighing instruments)—

(a) omit paragraph (2);

(b) in paragraph (3) for “clear, understandable and intelligible” substitute “ clear, legible and in easily understandable English ”.

Amendment to regulation 12

11

In regulation 12 (action to be taken where regulated non-automatic weighing instruments placed on the market are not in conformity with the essential requirements) in paragraph (3) for “national” to “market” substitute “ authority ”.

Amendment to regulation 14

12

In regulation 14 (use of authorised representatives by manufacturers) in paragraph (3)(a) omit “EU”.

Amendment to regulation 15

13

In regulation 15 (introductory) for “European Economic Area” substitute “ United Kingdom ”.

Amendment to regulation 16

14

In regulation 16 (ensuring compliance of regulated non-automatic weighing instruments) in paragraph (2)(c) for “CE” substitute “ UK ”.

Amendment to regulation 18

15

In regulation 18 (requirements to mark importers' details on regulated non-automatic weighing instruments) —

(a) for paragraph (2) substitute—

(2) Paragraph (1) does not apply where— (a) either— (i) the importer would have to open the packaging in order to indicate the information on the instrument; or (ii) the importer has imported the instrument 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) before placing the instrument on the market, the importer sets out the information referred to in paragraph (1)— (i) where sub-paragraph (a)(i) applies, on the packaging and in a document accompanying the instrument; (ii) where sub-paragraph (a)(ii) applies, in a document accompanying the instrument.

(b) in paragraph (3) for “in a language” to “be in” substitute “ clear, legible and in easily understandable ”.

Amendment to regulation 19

16

In regulation 19 (importers' duty to ensure that regulated non-automatic weighing instruments are accompanied by relevant documentation)—

(a) in paragraph (1) for “in a language easily understood by end users” substitute “ which are clear, legible and in easily understandable English ”; and

(b) omit paragraph (2).

Amendment to regulation 23

17

In regulation 23 (requirement for importer to keep copy of EU declaration of conformity) and in the heading to that regulation, omit “EU”.

Amendment to regulation 27

18

Regulation 27 (distributors-verification obligations) is amended as follows—

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

(b) in paragraph (2) for “easily understood by end users” substitute “ which are clear, legible and in easily understandable English ”; and

Insertion of regulation 32A

19

After regulation 32 insert—

(32A) (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(19); (c) “Module B” means the conformity assessment procedure set out in point 1 of Annex II; (d) “EU-type examination certificate” means an EU-type examination certificate issued in accordance with Module B; (e) “harmonised standard” has the meaning given to it in Article 2(11). (2) Paragraph (3) applies where, before placing a non-automatic weighing instrument on the market, the manufacturer— (a) ensures that the non-automatic weighing instrument has been designed and manufactured in accordance with the essential requirements set out in Annex I; (b) ensures that the relevant conformity assessment procedures that apply to that non-automatic weighing instrument in accordance with Article 13 have been carried out; (c) draws up the technical documentation referred to in Annex II; (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 the CE marking and the supplementary metrology marking, in accordance with Articles 16 and 17(1) to (5); (f) affixes the inscriptions provided for in points 1 or 2 of Annex III in accordance with Article 6(5); (g) affixes where required in accordance with Article 6(5) the restrictive use symbol as provided for in Article 18 and in point 3 of Annex III; (h) draws up an EU declaration of conformity, in accordance with Article 14; and (i) ensures that the EU declaration of conformity is prepared in or translated into English. (3) Where this paragraph applies— (a) the requirements of regulations 6, 9(3) and (4), 41 and 45(2) are to be treated as being satisfied; (b) regulations 7, 8(2), 44, 63(1)(a) to (e), 67, 68 and 71 apply subject to the modifications in paragraph (8); and (c) Regulations 34 to 36 do not apply. (4) Paragraph (5) applies where, before placing a regulated non-automatic weighing instrument on the market, the importer ensures that— (a) the relevant conformity assessment procedure referred to in Article 13 has been carried out; (b) the manufacturer has drawn up the technical documentation referred to in Annex II; and (c) the non-automatic weighing instrument bears the CE marking and supplementary metrology marking in accordance with Articles 16 and 17(1) to (5). (5) Where this paragraph applies— (a) the requirements of regulation 16(2)(a) to (c) are to be treated as being satisfied; and (b) regulations 23, 63(1)(a) to (e), 67 and 68 apply subject to the modifications in paragraph (8). (6) Paragraph (7) applies where, before making a regulated non-automatic weighing instrument available on the market, a distributor ensures that the non-automatic weighing instrument bears the CE marking and the inscriptions referred to in point 1 of Annex III. (7) Where this paragraph applies— (a) regulation 27(1) is to be treated as being satisfied; and (b) regulations 28(1), 28(2), 29, 63(1)(a), 63(1)(b), 67, 68 and 71 apply subject to the modifications in paragraph (8). (8) The modifications referred to in sub-paragraphs (3)(b), (5)(b) and (7)(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 “designated standard” is to be read as a reference to a harmonised standard; (d) any reference to “relevant conformity assessment procedure” is to be read as a reference to the relevant conformity assessment procedures referred to in Article 13; (e) any reference to “technical documentation” is to be read as a reference to the technical documentation referred to in Annex II; (f) any reference to “type examination certificate” is to be read as a reference to an EU-type examination certificate; (g) any reference to “M marking” is to be read as a reference to the supplementary metrology marking; (h) any reference to “approved body” is to be read as a reference to the body that undertook any conformity assessment procedure in accordance with Article 13; (i) any reference to “authorised mark” includes the CE marking and the supplementary metrology marking. (32B) (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) “EU-type examination certificate” means an EU-type examination certificate issued in accordance with the conformity assessment procedure set out in point 1 of Annex II (Module B); (c) any reference to “the first stage of the conformity assessment procedure” is a reference to one or both of the following— (i) all examinations and tests which are not gravity dependent and which are included in the conformity assessment procedures set out in points 2 to 5 of Annex II; (ii) the examinations and tests included in the conformity assessment procedures set out in points 2 to 5 of Annex II that may be carried out at the manufacturer's works or any other location where— (aa) the transport of the instrument to its place of use requires dismantling of the instrument; or (bb) the putting into service of the instrument in its place of use requires assembly of the instrument or other technical installation work that is likely to affect the instrument's performance. (2) Paragraph (3) applies where, prior to the manufacture of a non-automatic weighing instrument the manufacturer has ensured that the conformity assessment procedure as set out in point 1 of Annex II (Module B) has been carried out. (3) Where this paragraph applies— (a) the reference in regulation 36(a) to “Module B as set out in point 1 of Schedule 7” is to be read as a reference to the conformity assessment procedure as set out in point 1 of Annex II (Module B); and (b) regulations 6(b) and (c), 7, 16(2)(a) and (b), 63(1)(e), 67(2)(b), 68(4)(b) and paragraph 1 of Schedule 1 apply subject to the modifications in paragraph (6). (4) Paragraph (5) applies where— (a) in accordance with point 7.1 of Annex II, the procedures set out in points 2 to 5 of that Annex may be carried out in two stages; and (b) the first stage of the conformity assessment procedure is carried out in accordance with any of the following points of Annex II— (i) point 2 (Module D); (ii) point 3 (Module D1); (iii) point 4 (Module F); or (iv) point 5 (Module F1). (5) Where this paragraph applies— (a) the reference in regulation 36(1)(a)(i) to “Module D as set out in point of Schedule 7” is to be read as including the first stage of the conformity assessment procedure as set out in point 2 of Annex II (Module D); (b) the reference in regulation 36(1)(a)(ii) to “Module F as set out in point 4 of Schedule 7” is to be read as including the first stage of the conformity assessment procedure as set out in point 4 of Annex II (Module F); (c) the reference in regulation 36(3)(a) to “Module D1 as set out in point 3 of Schedule 7” is to be read as including the first stage of the conformity assessment procedure as set out in point 3 of Annex II (Module D1); (d) the reference in regulation 36(3)(b) to “Module F1 as set out in point 5 of Schedule 7” is to be read as including the first stage of the conformity assessment procedure as set out in point 5 of Annex II (Module F1); (e) regulations 6(b) and (c), 7, 16(2)(a) and (b), 45(6) and (7), 63(1)(c) and (e) and 67(1)(c) apply subject to the modifications in paragraph (6). (6) The modifications referred to in paragraphs (3)(b) and (5)(e) are that— (a) any reference to “relevant conformity assessment procedure” is to be read as including— (i) where paragraph (3) applies, the conformity assessment procedure set out in point 1 of Annex II; (ii) where paragraph (5) applies, the relevant first stage conformity assessment procedure; (b) any reference to “type examination” is to be read as a reference to the EU-Type examination certificate; (c) any reference to “technical documentation” is to be read as including the technical documentation required by points 1 to 5 of Annex II (as applicable); (d) any reference to “approved body” is to be read as including the body which undertook the first stage conformity assessment procedure. (32C) (1) Subject to paragraph (2), regulation 32A ceases to have effect at the end of the period of 12 months beginning with IP completion day. (2) Notwithstanding the expiry of regulation 32A— (a) any non-automatic weighing instrument which was placed on the market pursuant to regulation 32A may continue to be made available on the market on or after the expiry of regulation 32A; (b) any obligation to which a person was subject under regulation 32A in respect of any non-automatic weighing instrument placed on the market pursuant to regulation 32A continues to have effect after the expiry of regulation 32A, in respect of that instrument. (3) Subject to paragraph (4), regulation 32B 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 32B in relation to a non-automatic weighing instrument prior to the expiry of regulation 32B, regulation 32B continues to apply in respect of that instrument 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” has the meaning given to it in regulation 32B(1)(b). (32D) (1) Where paragraph (2) applies— (a) a non-automatic weighing instrument is to be treated as being in conformity with the essential 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 non-automatic weighing instrument is— (i) in conformity with the essential requirements, within the meaning of that term in regulation 2, 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 non-automatic weighing instrument on the market, the importer— (a) complies with regulation 18; (b) ensures that— (i) the relevant conformity assessment procedure has been carried out in accordance with Part 3, as that Part applies in Northern Ireland; (ii) the manufacturer has drawn up the technical documentation; and (iii) the non-automatic weighing instrument bears the CE marking. (4) In this regulation— - “CE marking” has the meaning given to it in regulation 2(1), 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” has the meaning given to it in regulation 2(1), as it applies in Northern Ireland.

Amendment to regulation 34

20

In regulation 34 (methods of establishing conformity with the essential requirements)—

(a) in sub-paragraph (a) for “harmonised” the first time it appears, substitute “ designated ”; and

(b) omit from “where” to “European Union”.

Amendment to regulation 35

21

In regulation 35 (presumptions of conformity of regulated non-automatic weighing instruments) for “harmonised” substitute “ designated ”.

Amendment to regulation 36

22

In regulation 36 (conformity assessment procedures)—

(a) in paragraphs (1)(a) and (6) for “Annex II to the Directive” substitute “ Schedule 7 ”;

(b) in paragraphs (1)(a)(i), (1)(a)(ii), (1)(b), (3)(a) and (3)(b) for “Annex II” substitute “ Schedule 7 ”;

Amendment to regulation 37

23

Omit regulation 37 (subsidiaries and contractors).

Amendment to regulation 38

24

In regulation 38 (fees)—

(a) for “a United Kingdom notified”, substitute “ an approved ” in both places in which it occurs;

(b) In sub-paragraph (2)(a), for “United Kingdom notified” substitute “ approved ”.

Amendment to regulation 39

25

In regulation 39 (application of Chapter) and in the heading to Chapter 2 omit “EU” in both places in which it occurs.

Amendment to regulation 40

26

In regulation 40 (form and contents of EU declaration of conformity etc.)—

(a) in paragraph (1) and in the heading omit “EU”;

(b) in paragraph (1)(b) for “Annex IV to the Directive” substitute Schedule 9;

(d) in paragraph (2) omit “EU”.

Amendment to regulation 41

27

For regulation 41 (regulated instruments that require more than one declaration of conformity) substitute—

(41) Where a non-automatic weighing instrument is subject to more than one enactment requiring the drawing up of a declaration of conformity, the manufacturer must draw up a single declaration of conformity which identifies each enactment by its title.

Amendment to regulation 42

28

In regulation 42 (responsibility of manufacturer that draws up declaration of conformity) for “an EU” substitute “ a ”.

Amendment to regulation 43

29

In regulation 43 (conformity with Directive requirements to be indicated by the CE marking)—

(a) in the heading omit “Directive”; and

(b) in the regulation and in the heading for “CE” substitute “ UK ”.

Amendment to regulation 44

30

For regulation 44 (general principles relating to the M marking) substitute—

(44) (1) An economic operator must not affix the UK marking or the M marking to a regulated non-automatic weighing instrument unless— (a) that economic operator is the manufacturer of the non-automatic weighing instrument; and (b) the conformity of the non-automatic weighing instrument with the essential requirements has been demonstrated by a conformity assessment procedure. (2) An economic operator must not affix a marking to a regulated non-automatic weighing instrument which is not the UK marking or the M marking but which purports to attest that the non-automatic weighing instrument satisfies the essential requirements. (3) An economic operator must not affix to a regulated non-automatic weighing instrument any other marking if the visibility, legibility and meaning of the UK marking or the M marking would be impaired as a result.

Amendment to regulation 45

31

Regulation 45 (rules and conditions for affixing the CE marking and the M marking etc.) is amended as follows—

(a) in paragraphs (1) and (4) and in the heading for “CE” substitute “ UK ”;

(ab) in paragraph (2) for “or its data plate” substitute “ , its data plate, or where regulation 6(2) applies in respect of the UK marking, to a label affixed to the regulated non-automatic weighing instrument, or to a document accompanying the regulated non-automatic weighing instrument; ”

(b) in paragraph (5) for “Annex II to the Directive” substitute “ Schedule 7 ”; and

Amendment to Part 5

32

For Part 5, substitute—

(47) (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 48 (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 54(1) or (2) as they had effect immediately before IP completion day to suspend or withdraw the body's status as a notified body. (2) Paragraph (1) has effect subject to regulation 51 (restriction, suspension or withdrawal of approval). (3) In this Part— - “notified body” means a body— 1. which the Secretary of State had before IP completion day notified to the European Commission and the member State of the European Union, in accordance with Article 27 of the Directive; and 2. in respect of which no objections had been raised, as referred to in regulation 47(2)(b), as it had effect immediately before IP completion day; - “approved body requirements” means the requirements set out in Schedule 3. (48) (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 class of regulated non-automatic weighing instruments 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)(i), 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. (49) (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. (50) 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 48(6)(b); or (ii) in the case of an approved body which was a notified body immediately before IP completion day, in accordance with regulation 48(6)(b), as it applied immediately before IP completion day; and (c) carries out its functions in accordance with these Regulations. (51) (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 50(b), the Secretary of State must restrict, suspend or withdraw the body's status as an approved body under regulation 48 (approval of conformity assessment bodies). (2) With the consent of an approved body, or where the Secretary of State determines that an approved body no longer meets a condition in accordance with regulation 50(b), the Secretary of State may restrict, suspend or withdraw the body's status as an approved body under regulation 48 (approval of conformity assessment bodies). (3) In deciding what action is required under paragraph (1) or (2), the Secretary of State must have regard to the seriousness of the failure. (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 that 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— (a) on the request of the Secretary of State, transfer its files to another approved body or to the Secretary of State; or (b) in the absence of a request under sub-paragraph (a), ensure that its files relating to the activities it has undertaken as an approved body are kept available for the Secretary of State and competent 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. (7) The Secretary of State may impose a monetary penalty on an approved body that fails to comply with any requirement imposed by or under paragraph (5). (8) Schedule 5 has effect in relation to monetary penalties imposed under paragraph (7). (52) (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 . (53) (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. (54) (1) 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; and (b) monitoring approved bodies in accordance with regulation 50. (2) Where the Secretary of State authorises the UK national accreditation body pursuant to paragraph (1), the Secretary of State remains fully responsible for anything done pursuant to that authorisation.

Amendment to regulation 58

33

Regulation 58 (regulated non-automatic weighing instruments presenting a risk) is amended as follows—

(a) in paragraph (5), for “notified” substitute “ approved ”;

(b) omit paragraph (6);

(d) in paragraph (9) for “Commission and the other EEA States” substitute “ Secretary of State ”; and

(e) in paragraph (10)(f)(ii) for “harmonised” substitute “ designated ”.

Amendment to regulation 59

34

Omit regulation 59 (EU safeguard procedure).

Amendment to regulation 60

35

In regulation 60 (compliant regulated non-automatic weighing instruments which present a risk) in paragraph (3), for “Commission and the other EEA states” substitute “ Secretary of State ”.

Amendment to regulation 63

36

In regulation 63 (compliance notice procedure) in paragraph (1)—

(a) in sub-paragraphs (a) and (b), for “CE” substitute “ UK ” in both places in which it occurs;

(b) in sub-paragraph (a) for “Article 30 of the RAMS Regulation or the requirements of these Regulations” substitute “ regulation 44 or regulation 45 ”;

(d) in sub-paragraph (d) omit “EU”.

Amendment to regulation 64

37

In regulation 64 (enforcement notice procedure)—

(a) in paragraph (5)—

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

(ii) for “that notified” substitute “ that approved ”; and

(b) omit paragraph (6).

Amendment to regulation 67

38

In regulation 67 (disqualification)—

(a) in paragraph (1)—

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

(ii) in sub-paragraph (c) for “notified” substitute “ approved ”; and

(b) in paragraph 2(b) omit “EU-”.

Amendment to regulation 68

39

In regulation 68 (requalification)—

(a) in paragraph (3)(c)—

(i) omit “notified”; and

(ii) for “Annex II to the Directive” substitute “ Schedule 7 ”;

(b) in paragraph (3)(d)—

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

(ii) for “Annex II to the Directive” substitute Schedule 7;

Amendment to regulation 71

40

In regulation 71 (unauthorised application of authorised marks) in paragraph (5)—

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

(b) in sub-paragraph (c) for “notified” substitute “ approved ”.

Amendment to Schedule 1

41

In Schedule 1 (information to be marked on regulated non-automatic weighing instruments)—

(a) in paragraph 1 omit “EU-”; and

(b) in paragraph 9 for “the Annex III to the Directive” substitute “ Schedule 8 ”.

Amendment to Schedule 2

42

In Schedule 2 (operational obligations of notified bodies)—

(a) in paragraphs 3, 4 and 6 for “a notified” substitute “ an approved ”;

(b) in all places in which it occurs (other than the paragraphs referred to in sub-paragraph (a)), including in the heading, for “notified” substitute “ approved ”;

(d) in paragraph 7(b) for “notification” substitute “ approval ”;

(e) in paragraph 8 for “this Directive” substitute “ these Regulations ”; and

(f) omit paragraph 9.

Amendments to Schedule 3

43

In Schedule 3 (requirements related to notified bodies)—

(a) for the heading, substitute— “ SCHEDULE 3 Approved Body requirements ”;

(b) in paragraph 1 for “under the national law of an EEA state” substitute “ in the United Kingdom ”;

(d) in paragraph 9(c) for “a notified” substitute “ an approved ”;

(e) in all places in which it occurs (other than the paragraph referred to in sub-paragraph (d)), including in the heading, for “notified” substitute “ approved ”;

(f) in paragraph 11(c)—

(i) for “Annex I to the Directive” substitute “ Schedule 6 ”;

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

(iii) for “European harmonisation legislation and of national legislation” substitute “ these Regulations ”;

(g) in paragraph 16 for “under the European Union harmonisation legislation” substitute “ by the Secretary of State ”.

Amendments to Schedule 4

44

In Schedule 4 (use for trade of regulated non-automatic weighing instruments in Great Britain) in paragraphs 1(3) and 1(5) for “Annex I to the Directive” substitute “ Schedule 6 ”.

Insertion of Schedule 6

45

After Schedule 5 (monetary penalties) insert—

SCHEDULE 6 Where an instrument includes, or is connected to, more than one indicating or printing device used for the applications listed in sub-paragraphs (a) to (f) of regulation 3(2), those devices which repeat the results of the weighing operation and which cannot influence the correct functioning of the instrument shall not be subject to the essential requirements if the weighing results are printed or recorded correctly and indelibly by a part of the instrument which meets the essential requirements and the results are accessible to both parties concerned by the measurement. However, in the case of instruments used for direct sales to the public, display and printing devices for the vendor and the customer must fulfil the essential requirements. (1) Units of mass The units of mass used shall be the legal units within the meaning of the Weights and Measures Act 1985 relating to units of measurement . Subject to compliance with this condition, the following units are permitted— (a) SI units: kilogram, microgram, milligram, gram, tonne; (b) imperial unit: troy ounce, if weighing precious metals; (c) other non-SI unit: metric carat, if weighing precious stones. For instruments that make use of the imperial unit of mass referred to above, the relevant essential requirements specified below shall be converted to that unit, using simple interpolation. (2) Accuracy classes (2) The following accuracy classes have been defined— (a) I special (b) II high (c) III medium (d) IIII ordinary The specifications of these classes are given in Table 1.

Accuracy classes	Accuracy classes	Accuracy classes	Accuracy classes	Accuracy classes
Class	Verification scale interval (e)	Minimum capacity (Min)	Number of verification scale intervals n = ((Max)/(e))	Number of verification scale intervals n = ((Max)/(e))
		minimum value	minimum value	maximum value
I	0,001 g ≤ e	100 e	50 000
II	0,001 g ≤ e ≤ 0,05 g	20 e	100	100 000
II	0,1 g ≤ e	50 e	5 000	100 000
III	0,1 g ≤ e ≤ 2 g	20 e	100	10 000
III	5 g ≤ e	20 e	500	10 000
IIII	5 g ≤ e	10 e	100	1 000

The minimum capacity is reduced to 5 e for instruments in classes II and III for determining a conveying tariff.
(2) Scale intervals (2) The actual scale interval (d) and the verification scale interval (e) shall be in the form— - 1 x 10k, 2 x 10k, or 5 x 10k mass units, - k being any integer or zero. (2) For all instruments other than those with auxiliary indicating devices— d = e. (2) For instruments with auxiliary indicating devices the following conditions apply— - e = 1 x 10kg; - d < e ≤ 10 d. Those conditions do not apply for instruments of class I with d < 10–4 g, for which e = 10–3 g. (3) Classification (3) Instruments with one weighing range Instruments equipped with an auxiliary indicating device shall belong to class I or class II. For these instruments the minimum capacity lower limits for these two classes are obtained from Table 1 by replacement in column 3 of the verification scale interval (e) by the actual scale interval (d). If d < 10–4 g, the maximum capacity of class I may be less than 50 000 e. (3) Instruments with multiple weighing ranges Multiple weighing ranges are permitted, provided they are clearly indicated on the instrument. Each individual weighing range is classified according to point 3.1. If the weighing ranges fall into different accuracy classes the instrument shall comply with the severest of the requirements that apply for the accuracy classes in which the weighing ranges fall. (3) Multi-interval instruments (3) Instruments with one weighing range may have several partial weighing ranges (multi-interval instruments). Multi-interval instruments shall not be equipped with an auxiliary indicating device. (3) Each partial weighing range i of multi-interval instruments is defined by—

— its verification scale interval ei	with e(i + 1) > ei
— its maximum capacity Maxi	with Maxr = Max
— its minimum capacity Mini	with Mini = Max (i – 1)
	and Min₁ = Min

Where:
- i = 1, 2, …r,
- i = partial weighing range number,
- r = the total number of partial weighing ranges
All capacities are capacities of net load, irrespective of the value of any tare used.
(3) The partial weighing ranges are classified according to Table 2. All partial weighing ranges shall fall into the same accuracy class, that class being the instrument's accuracy class.

Multi-level instruments	Multi-level instruments	Multi-level instruments	Multi-level instruments	Multi-level instruments
i = 1, 2, …r,i = partial weighing range number,r = the total number of partial weighing ranges	i = 1, 2, …r,i = partial weighing range number,r = the total number of partial weighing ranges	i = 1, 2, …r,i = partial weighing range number,r = the total number of partial weighing ranges	i = 1, 2, …r,i = partial weighing range number,r = the total number of partial weighing ranges	i = 1, 2, …r,i = partial weighing range number,r = the total number of partial weighing ranges
Class	Verification scale interval (e)	Minimum capacity (Min)	Number of verification scale intervals	Number of verification scale intervals
		Minimum value	Minimum value n = ((Maxi) / (e(i+1)))	Maximum valuen = ((Maxi) / (ei))
I	0,001 g ≤ ei	100 e1	50 000
II	0,001 g ≤ ei ≤ 0,05 g	20 e1	5 000	100 000
II	0,1 g ≤ ei	50 e1	5 000	100 000
III	0,1 g ≤ ei	20 e1	500	10 000
IIII	5g ≤ ei	10 e1	50	1 000

(4) Accuracy (4) On implementation of the procedures laid down in regulation 36, the error of indication shall not exceed the maximum permissible error of indication as shown in Table 3. In the case of digital indication the error of indication shall be corrected for the rounding error. The maximum permissible errors apply to the net value and tare value for all possible loads, excluding preset tare values.

Maximum permissible errors	Maximum permissible errors	Maximum permissible errors	Maximum permissible errors	Maximum permissible errors
Load	Load	Load	Load	Maximum permissible error
Class I	Class II	Class III	Class IIII	Maximum permissible error
0 ≤ m ≤ 50 000 e	0 ≤ m ≤ 5 000 e	0 ≤ m ≤ 500 e	0 ≤ m ≤ 50 e	± 0,5 e
50 000 e < m ≤ 200 000 e	5 000 e < m ≤ 20 000 e	500 e < m ≤2 000 e	50 e < m ≤ 200 e	± 1,0 e
200 000 e < m	20 000 e < m ≤ 100 000 e	2 000 e < m ≤ 10 000 e	200 e < m ≤1 000 e	± 1,5 e

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