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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 Executive, 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 Executive 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. Great Britain may, on request, obtain a copy of the Type examination certificates and/or additions thereto. On request, Great Britain 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 Executive of quality system approvals issued or withdrawn, and shall, periodically or upon request, make available to the Executive 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. 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. (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) 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 Executive of quality system approvals issued or withdrawn, and shall, periodically or upon request, make available to the Executive 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 33 — Amendment of Regulation (EC) No 765/2008

Introduction

1

Regulation (EC) No 765/2008 of the European Parliament and of the Council of 9 July 2008 setting out the requirements for accreditation and market surveillance relating to the marketing of products and repealing Regulation (EEC) No 339/93 is amended in accordance with paragraphs 2 to 38.

Amendments to Chapter 1

2

In Article 1—

(a) in paragraph 3, for “from third countries”, substitute “ entering the market of Great Britain ”; and

(b) for paragraph 4 substitute—

(4) This Regulation provides the requirements as to the form of the UK marking.

3

In Article 2—

(a) in the text before paragraph 1 omit “shall”;

(b) in paragraphs 1 to 3, 6, 7, 12 to 15 and 17 for “shall mean” substitute “ means ”;

(i) for “Community market” substitute “ market of Great Britain ”;

(ii) at the end, insert “ and related expressions must be construed accordingly ”;

(d) in paragraph 2—

(i) for “Community market” substitute “ market of Great Britain ”;

(ii) at the end, insert “ and related expressions must be construed accordingly ”;

(e) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

(f) for paragraph 5 substitute—

(5) “importer” means any person established in the United Kingdom who places a product from a country outside of the United Kingdom on the market;

(g) omit paragraphs 8 and 9;

(h) for paragraph 10 substitute—

(10) “accreditation” means an attestation by a national accreditation body conveying formal recognition that a conformity assessment body is competent to carry out a specific conformity assessment activity;

(i) for paragraph 11 substitute—

(11) “UK national accreditation body” means the body appointed by the Secretary of State in accordance with Article 4;

(j) omit paragraph 16;

(k) in paragraph 17 for “the relevant Community harmonisation legislation” substitute “ any relevant enactment; ”;

(l) for paragraph 18 substitute—

(18) “market surveillance authority” means an authority responsible for carrying out market surveillance in the United Kingdom;

(m) for paragraph 19 substitute—

(19) “the free circulation procedure” means the procedure set out in Schedule 1 to the Taxation (Cross-border Trade) Act 2018 ;

(n) for paragraph 20 substitute—

(20) “conformity marking” means a marking, such as the UK marking, by which the manufacturer indicates that a product is in conformity with the applicable requirements of any enactment providing for the affixing such a marking;

(o) for paragraph 21 substitute—

(21) “relevant enactment” means any retained EU law , as it applies in Great Britain, derived from an EU instrument harmonising the conditions for the marketing of products in the EU;

(p) after paragraph 21 insert—

(22) “UK marking” means the marking in the form set out in Annex 2.

Amendments to Chapter 2

4

In Article 3 for “shall apply” substitute “ applies ”.

5

For Article 4 substitute—

(1) The Secretary of State must by regulations appoint a single UK national accreditation body. (2) The appointment of the UK national accreditation body under regulation 3 of the Accreditation Regulations 2009 is to be treated on and after IP completion day as having been made in pursuance of the duty on the Secretary of State to appoint a UK national accreditation body set out in paragraph 1. (3) The UK national accreditation body must perform its functions in accordance with the provisions of this Chapter. (4) Regulations made under this Article may— (a) terminate the appointment of a UK national accreditation body; and (b) appoint a different body as the UK national accreditation body where the Secretary of State considers that a UK national accreditation body is not performing its functions in accordance with this Chapter. (5) Regulations made under this Article must establish procedures for the resolution of appeals against accreditation decisions made by the appointed UK national accreditation body. (6) Regulation 5 of the Accreditation Regulations 2009 is to be treated as meeting the requirements of paragraph 5. (7) The UK national accreditation body must operate on a not-for-profit basis. (8) The UK national accreditation body must not— (a) offer or provide any activities or services that are provided by conformity assessment bodies, (b) provide consultancy services; and (c) own shares in, or otherwise have any financial or managerial interest in, a conformity assessment body. (9) The UK national accreditation body must establish and maintain appropriate structures to ensure— (a) consultation on its activities with interested parties; and (b) responses of interested parties to consultation are adequately taken into account. (10) The Secretary of State must ensure that the UK national accreditation body has the appropriate financial and personnel resources for the proper fulfilment of its tasks, including— (a) the fulfilment of special tasks such as activities related to international accreditation cooperation; and (b) activities that are required to support public policy and which are not self-financing. (11) Regulations made under this Article must be made by statutory instrument. (12) Regulations made under this Article may make such transitional, transitory , consequential or saving provision as the Secretary of State considers appropriate. (13) A statutory instrument containing regulations made under this Article is subject to annulment in pursuance of a resolution of either House of Parliament.

6

In Article 5—

(a) in paragraph 1—

(i) for “A national accreditation body shall” substitute “ The UK national accreditation body must ”;

(ii) for “the national accreditation body shall” substitute “ the UK national accreditation body must ”;

(b) omit paragraph 2;

(i) for “National accreditation bodies shall” substitute “ The UK national accreditation body must ”;

(ii) for “they have” substitute “ it has ”;

(d) in paragraph 4—

(i) for “a national accreditation body” substitute “ the UK national accreditation body ”;

(ii) for “that national accreditation body shall” substitute “ the UK national accreditation body must ”;

(e) omit paragraph 5.

7

In Article 6—

(a) in paragraph 1 for “National accreditation bodies shall” substitute “ The UK national accreditation body must ”;

(b) omit paragraphs 2 and 3.

8

Omit Article 7.

9

In Article 8—

(a) in the heading, for “national accreditation bodies” substitute “ the UK national accreditation body ”;

(b) in the words before paragraph 1, for “A national accreditation body shall” substitute “ The UK national accreditation body must ”;

(d) in paragraph 5 for “relevant Community or national legislation” substitute “ any enactment ”.

10

In Article 9—

(a) in paragraph 1—

(i) for “a national accreditation body” substitute “ the UK national accreditation body ”;

(ii) for “Member State concerned shall” substitute “ Secretary of State must ”;

(iii) for “shall ensure” substitute “ must ensure ”;

(iv) omit “, and shall inform the Commission thereof”;

(b) in paragraph 2—

(i) for “Member States shall” substitute “ The Secretary of State must ”;

(ii) for “their national accreditation bodies” substitute “ the UK national accreditation body ”;

(iii) for “they fulfil” substitute “ it fulfils ”;

(d) in paragraph 4—

(i) for “National accreditation bodies shall” substitute “ The UK national accreditation body must ”;

(ii) for “they have” substitute “ it has ”.

11

For Article 10 substitute—

(1) The UK national accreditation body must— (a) ensure that it is evaluated in accordance with the requirements of this Article by a body which is approved by the Secretary of State; (b) set out the results of the evaluation in a report; (c) make that report publicly available; and (d) provide a copy of that report to the Secretary of State. (2) The evaluation referred to in paragraph 1(a) must— (a) be based on evaluation criteria and procedures— (i) agreed between the national accreditation body and the body undertaking the evaluation; and (ii) approved by the Secretary of State; and (b) evaluate whether the UK national accreditation body meets the requirements of Article 8. (3) The procedures referred to in paragraph 2(a) must include provision for appeal by the UK national accreditation body against the results of the evaluation. (4) The report paragraph (1)(c) must include the evaluation criteria and procedures referred to in paragraph (2)(a). (5) The first report under paragraph (1) must be made publicly available before the end of the period of five years beginning on IP completion day. (6) After the first report, reports made under this Article are to be made publicly available at intervals not exceeding five years

12

Omit Articles 11 to 14.

Amendment to Chapter 3

13

After “CHAPTER III”, in the heading—

(a) omit “COMMUNITY” in the first place it occurs;

(b) for “COMMUNITY MARKET” substitute “ MARKET OF GREAT BRITAIN ”.

14

In Article 15—

(a) in paragraphs 1, 2 and 4 before “26”, insert “ 22 and ”;

(b) in paragraphs 1 and 2, for “Community harmonisation legislation”, substitute “ any relevant enactment ”;

(d) in paragraph 2 for “shall apply” substitute “ applies ”;

(e) in paragraph 3—

(i) for “Directive 2001/95/EC” substitute “ the General Product Safety Regulations 2005 ”;

(ii) for “shall” substitute “ does ”;

(f) in paragraph 4 for “shall mean” substitute “ means ”;

(g) in paragraph 5—

(i) for “Community legislation” in the first place it occurs, substitute “ any relevant enactment ”;

(ii) for “Community legislation does” substitute “ enactments do ”.

15

In Article 16—

(a) omit paragraph 1;

(b) in paragraph 2—

(i) after “Market surveillance”, insert “ authorities ”;

(ii) for “shall” substitute “ must ”;

(iii) for “Community harmonisation legislation” substitute “ any relevant enactment ” in both places in which it occurs;

(iv) for “, the Commission and the other Member States”, substitute “ and the Secretary of State ”;

(3) The Secretary of State must ensure that there is a national market surveillance infrastructure and programme so that effective measures may be taken in relation to any product subject to any relevant enactment.

(d) in paragraph 4—

(i) for “shall” in the first place it occurs substitute “ must ”;

(ii) for “Community harmonisation legislation”, substitute “ any relevant enactment ”;

(iii) omit “shall” in the second place it occurs.

16

After Article 16, in the heading, after “SECTION 2” for “Community market” substitute “ Market ”.

17

In Article 17—

(a) omit paragraph 1;

(b) in paragraph 2, for “Member States shall” substitute “ The Secretary of State must take appropriate measures to ”.

18

In Article 18—

(a) in the heading, omit “of the Member States”;

(b) omit paragraph 1;

(i) for “Member States shall” substitute “ The Secretary of State must ”;

(ii) in sub-paragraph (a) for “Community harmonisation legislation” substitute “ any relevant enactment ”;

(d) for paragraph 3, substitute—

(3) The Secretary of State may by regulations make such provision as the Secretary of State considers appropriate to ensure that market surveillance authorities have the powers necessary for the proper performance of their duties. The Secretary of State must entrust market surveillance authorities with the resources and knowledge necessary for the proper performance of their duties. Regulations made under this paragraph must be made by statutory instrument. A statutory instrument containing regulations under this paragraph may not be made unless a draft of the instrument has been laid before, and approved by a resolution of, each House of Parliament.

(e) for paragraph 4, substitute—

(4) Market surveillance authorities must exercise their powers proportionately.

(f) for paragraph 5, substitute—

(5) The Secretary of State must establish, implement and periodically update the United Kingdom's market surveillance programme setting out the principles as to how market surveillance is to be organised and covering the sectors in which market surveillance is conducted in the United Kingdom. The Secretary of State must make this programme available to the public by way of electronic communication and, where appropriate, by other means.

(g) in paragraph 6—

(i) for “Member States” substitute “ The Secretary of State ”;

(ii) for “shall” substitute “ must ” in each place it occurs;

(iii) omit “their”;

(iv) after “activities” insert “ by market surveillance authorities ”; and

(v) omit “be communicated to the other Member States and the Commission and”.

19

In Article 19—

(a) in paragraphs 1, 2, 4 and 5 for “shall” substitute “ must ” in each place it occurs;

(b) in paragraph 2 omit “within their territories”;

(3) Where a market surveillance authority decides to withdraw a product manufactured in the United Kingdom, it must inform the economic operator concerned at the address indicated on the product in question or in the documentation accompanying the product.

(d) for paragraph 5, substitute—

(5) Market surveillance authorities must observe confidentiality where necessary in order to protect commercial secrets or to preserve personal data pursuant to national legislation, subject to the requirements that: (a) information be made public under this Regulation to the fullest extent necessary in order to protect the users in the United Kingdom; (b) the protection of confidentiality shall not prevent the dissemination to market surveillance authorities of information relevant to ensuring the effectiveness of market surveillance activities.

20

In Article 20—

(a) in paragraph 1—

(i) for “Member States shall”, substitute, “Market surveillance authorities must”;

(ii) for “their”, in the second place it occurs, substitute “ the ”; and

(iii) for “Commission” substitute “ Secretary of State ”;

(b) in paragraph 2 for “shall”—

(i) in the first place it occurs substitute “ must ”;

(ii) in the second place it occurs substitute “ does ”.

21

In Article 21—

(a) in paragraph 1—

(i) for “Member States shall”, substitute “ Market surveillance authorities must ”; and

(ii) for “the relevant Community harmonisation legislation”, substitute “ any relevant enactment ”;

(b) in paragraph 2—

(i) for “shall” substitute “ must ” in both places it occurs;

(ii) after “informed of the”, insert “ legal ”; and

(iii) omit “under the law of the Member State concerned”; and

(i) for “shall” substitute “ must ” in each place it occurs;

(ii) for “the relevant Community harmonisation legislation”, substitute “ any of the relevant enactments ”.

(d) in paragraph 4 for “shall” substitute “ must ”.

22

In Article 22—

(a) for the heading and paragraph 1, substitute—

(1) Where a market surveillance authority takes or intends to take a measure in accordance with Article 20 it must immediately notify the Secretary of State of that measure.

(b) in paragraphs 2 and 3 for “shall” substitute “ must ” in each place it occurs;

(i) for “Member States” substitute “ the market surveillance authority ”;

(ii) for “Commission” substitute “ the Secretary of State ”;

(d) in paragraph 3 omit “national”;

(e) in paragraph 4 from “and information” to the end of that paragraph, substitute “ authority must notify the Secretary of State through the database containing information relating to market surveillance and product safety established by regulation 33(A1) of the General Product Safety Regulations 2005 ”.

23

Omit Articles 23 to 25.

24

In Article 26—

(a) in paragraph 1—

(i) omit “, promoting and facilitating access to European systems”;

(ii) omit “The Commission shall, in cooperation with Member States, develop appropriate programmes for that purpose.”

(b) omit paragraph 2.

25

After “SECTION 3”, in the heading—

(a) after “of” insert “ imported ”;

(b) omit “entering the Community market”.

26

In Article 27—

(a) for the heading and paragraph 1, substitute—

(1) The authorities in charge of the control of products entering Great Britain must carry out appropriate checks on the characteristics of products on an adequate scale, in accordance with the principles set out in Article 19(1), before those products are discharged from the free-circulation procedure.

(b) in paragraph 2—

(i) omit “in a Member State”;

(ii) for “shall” substitute “ must ”;

(i) for “shall” substitute “ must ” in both places it occurs;

(ii) for “release of a product for free circulation on the Community market”, substitute “ the discharge of a product from the free-circulation procedure ”; and

(iii) in point (b), for “the relevant Community harmonisation legislation”, substitute “ any relevant enactment ”;

(iv) in point (c), for “the CE”, substitute “ a conformity ”;

(d) in paragraph 4 for “shall” substitute “ must ”;

(e) omit paragraph 5.

27

In Article 28—

(a) in the heading for “Release” substitute “Discharge;

(b) in paragraph 1—

(i) for “release” in each place it occurs substitute “ discharge ”;

(ii) for “shall” substitute “ must ”;

(iii) for “released” substitute “ discharged from the free-circulation procedure ”; and

(i) for “Community harmonisation legislation”, substitute “ any relevant enactment ”; and

(ii) for “shall be released”, substitute “ must be discharged from the free-circulation procedure ”

(iii) for “release” substitute “ discharge ”.

28

In Article 29—

(a) in paragraphs 1 and 2—

(i) for “the market surveillance authorities find” substitute “ a market surveillance authority finds ” in both places it occurs;

(ii) for “they”, substitute “ it ” in both places it occurs;

(b) in paragraph 1—

(i) for “shall” substitute “ must ” in each place it occurs;

(ii) for “release for free circulation”, substitute “ discharge from the free-circulation procedure ”.

(i) for “Community harmonisation legislation”, substitute “ any relevant enactment ”;

(ii) for “shall” substitute “ must ” in both places it occurs;

(iii) for “authorities” substitute “ authority ”;

(iv) for “release the product for free circulation”, substitute “ discharge the product from the free-circulation procedure ”; and

(v) for “release for free circulation”, substitute “ discharge from the free-circulation procedure ”;

(d) in paragraph 3—

(i) for “release for free circulation”, substitute “ the free-circulation procedure ”;

(ii) for “shall” substitute “ must ”;

(e) in paragraph 4 for “Member States'” substitute “ Market surveillance ”;

(f) in paragraph 5 for “shall” substitute “ must ”.

Amendment to Chapter 4

29

For Chapter 4, substitute—

(1) The Secretary of State must publish the form of the UK marking as set out in Annex 2 on the Gov.uk website (https://www.gov.uk) . (2) Annex 2 has effect. (3) Any reference to the UK marking in any enactment is a reference to the UK marking in the form set out in Annex 2 and published in accordance with paragraph 1. (4) A requirement in any enactment to affix the UK marking is a requirement to affix the UK marking in accordance with the requirements in Annex 2. (5) The UK marking must not be affixed to a product unless an enactment provides for its affixing. (6) An economic operator must not affix any other marking, sign or inscription which is likely to mislead any person as to the meaning or form of the UK marking. (7) An economic operator must not affix any other marking if the visibility, legibility and meaning of the UK marking would be impaired as a result. (8) Where the UK marking is affixed to a product in breach of paragraph 4, the UK marking is affixed in a false or misleading manner and Article 27(3)(c) applies.

Omission of Chapter 5

30

Omit Chapter 5.

Amendments to Chapter 6

31

Omit Article 38.

32

Omit Article 40.

33

Omit Article 41.

34

Omit Article 42.

35

In Article 43 omit the words from “references to the repealed Regulation” to the end.

36

Omit Article 44.

37

After Article 44, omit—

(a) the words “This Regulation shall be binding” to the end;

(b) “Done at Strasbourg, 9 July 2008”; and

Omission of Annex 1

38

Omit Annex 1.

Substitution of Annex 2

39

For Annex 2 substitute—

ANNEX 2 (1) The UK marking consists of the initials “UKCA” taking the following form— (2) Where the UK marking is reduced or enlarged, the proportions given in the graduated drawing in paragraph 1 must be respected. (3) Where an enactment does not require specific dimensions, the UK marking must be at least 5 millimetres high.

Introduction

1

Regulation (EC) No 1223/2009 of the European Parliament and of the Council of 30 November on cosmetic products (recast) is amended in accordance with paragraphs 2 to 28.

Amendment of Article 1

2

In Article 1 (scope and objective) omit “internal”.

Amendment of Article 2

3

In Article 2 (definitions), in paragraph 1—

(a) in point (d) (manufacturer)—

(i) omit “natural or legal”;

(ii) for “his” substitute “ their ”;

(b) in point (e) (distributor)—

(i) omit “natural or legal”;

(ii) omit “Community”;

(i) for “Community market” substitute “ market of Great Britain ”;

(ii) at the end insert “ and related expressions are to be construed accordingly ”;

(d) for point (h) (placing on the market) substitute—

(h) placing on the market' means the first making available of a cosmetic product on the market of Great Britain on or after IP completion day and related expressions are to be construed accordingly;

(e) for point (i) (importer) substitute—

(i) “importer” means a person who— (aa) is established in the United Kingdom and places a cosmetic product from a country outside of the United Kingdom on the market; or (bb) is established in Northern Ireland and places a cosmetic product 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;

(f) omit point (j) (harmonised standard);

(g) in point (s) omit the last sentence;

(h) after point (s) insert—

(t) ‘Regulation (EC) No 1272/2008’ means Regulation (EC) 1272/2008 of the European Parliament and of the Council of 16th December 2008 on classifications, labelling and packaging of substances and mixtures, amending and repealing Directives 67/548/EEC and 1999/45/EC and amending Regulation (EC) 1907/2006; (u) ‘EU Regulation (pre-exit)’ means Regulation (EC) No 1223/2009 of the European Parliament and of the Council of 30 November on cosmetic products (recast) , as it has effect immediately before IP completion day; (v) ‘Enforcement Regulations’ means the Cosmetic Products Enforcement Regulations 2013 ; (va) ‘CMR’ means carcinogenic, mutagenic or toxic for reproduction; (w) ‘competent authority’ has the meaning given to it in regulation 4 of the Enforcement Regulations; (x) ‘enforcement authority’ has the meaning given to it in regulation 2(1) of the Enforcement Regulations; (y) ‘finished cosmetic product’ means the cosmetic product in its final formulation, as placed on the market and made available to the end user, or its prototype; (ya) ‘historic animal testing data’ means data from any animal testing that was carried out before the date on which such testing was prohibited in accordance with Article 18 of the EU Regulation (pre-exit); (z) ‘prototype’ means a first model or design that has not been produced in batches, and from which the finished cosmetic product is copied or finally developed; (za) “the transitory period” means the period of 90 days beginning on the day after the day on which IP completion day falls.

(i) for paragraph (3) substitute—

(3) (1) Subject to subparagraphs (6) and (7), in this Regulation a “designated standard” means a technical specification which is— (a) adopted by a recognised standardisation body, for repeated or continuous application, with which compliance is not compulsory; and (b) designated by the Secretary of State by publishing the reference to the standard and maintaining that publication in a manner the Secretary of State considers appropriate. (2) For the purposes of subparagraph (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 cosmetic 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; and (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 subparagraph (1)(b), the Secretary of State must have regard to whether the publication will draw the standard to the attention of any person who may have an interest in the standard. (5) Before publishing the reference to a technical specification adopted by the British Standards Institution, the Secretary of State must have regard to whether the technical specification is consistent with technical specifications adopted by the other recognised standardisation bodies. (6) The Secretary of State may remove from publication the reference to a standard which has been published in accordance with subparagraph (1)(b). (7) Where the Secretary of State removes the reference to a standard from publication, that standard is no longer a designated standard.

Amendment of Article 3

4

In Article 3 (safety), in point (a) for “Directive 87/357/EEC” substitute “ the Food Imitations (Safety) Regulations 1989 ”.

Substitution of Article 4

5

For Article 4 (responsible person) substitute—

(1) A cosmetic product may not be placed on the market unless there is a responsible person established in the United Kingdom in respect of the cosmetic product. (2) Subject to paragraphs 6 and 7, a manufacturer of a cosmetic product is the responsible person in respect of that product where— (a) the manufacturer is established in the United Kingdom; and (b) the cosmetic product— (i) is manufactured in the United Kingdom; and (ii) after manufacture but prior to placing on the market is not exported and imported back into the United Kingdom. (3) Where paragraph 4 applies the manufacturer must ensure that— (a) there is a person established in the United Kingdom designated by written mandate as the responsible person in respect of the cosmetic product; and (b) that person has agreed in writing to be the responsible person in respect of that cosmetic product. (4) This paragraph applies where— (a) a manufacturer of a cosmetic product is established in a country outside the United Kingdom; and (b) the cosmetic product— (i) is manufactured in the United Kingdom; and (ii) after manufacture but prior to placing on the market is not exported and imported back into the United Kingdom. (5) Subject to paragraphs 6 and 7, any importer placing a cosmetic product on the market is the responsible person in respect of that cosmetic product. (6) An importer or a manufacturer established in the United Kingdom may by written mandate designate a person established in the United Kingdom as the responsible person. (7) Where the person designated by the importer or the manufacturer under paragraph 6 accepts the designation in writing, that person is the responsible person. (8) A distributor is the responsible person in respect of a cosmetic product where that distributor— (a) places a product on the market under the distributor's name or trademark; or (b) modifies a product already placed on the market in such a way that compliance with the applicable requirements may be affected.

Amendment of Article 5

6

In Article 5 (obligations of responsible persons)—

(ia) at the beginning of paragraph 1 insert “ Subject to Article 5A ”;

(a) in paragraphs 2 and 3 omit “national”;

(b) in paragraph 2 omit the words from “of the Member States” (in the first place in which it occurs) to “accessible”;

(d) after paragraph 3 insert—

(4) The information and documentation referred to in paragraph 3 must be in English.

Amendment of Article 6

7

In Article 6 (obligations of distributors)—

(a) in paragraph 3—

(i) omit “national”;

(ii) omit “of the Member States in which they made the product available”;

(b) in paragraph 5—

(i) omit “national”;

(ii) omit “, in a language which can be easily understood by that authority”;

(6) The information and documentation referred to in paragraph 5 must be in English

Amendment of Article 8

8

In Article 8 (good manufacturing practice), in paragraph 2—

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

(b) omit “, the references of which have been published in the Official Journal of the European Union”.

Omission of Article 9

9

Omit Article 9 (free movement).

Amendment of Article 10

10

In Article 10 (safety assessment)—

(a) in paragraph 1 omit the words from “The first subparagraph shall” to “referred to in Article 32(2).”;

(b) in paragraph 2 for “a Member State” substitute “ the Secretary of State ”;

(i) for the words from “shall comply with” to “study” substitute “ must comply with the Good Laboratory Practice Regulations 1999 ” ;

(ii) before “international standards” omit “other”;

(iii) for “Commission or the ECHA” substitute “ Secretary of State ”.

Amendment of Article 11

11

In Article 11 (product information file)—

(a) in point (e) for “his” substitute “ their ”;

(b) for paragraph 3 substitute—

(3) The responsible person must make the product information file readily accessible to a competent authority in an electronic or other format at the address notified in accordance with Article 13 as the address at which the product information file is kept.

(4) The information contained in the product information file must be in English

Amendment of Article 12

12

In Article12, in paragraph 2—

(a) omit “In the absence of any applicable Community legislation,”;

(b) for “harmonised” substitute “ designated ”;

Substitution of Article 13

13

For Article 13 (notification) substitute—

(1) Before placing a cosmetic product on the market, the responsible person must submit by electronic means the following information to the Secretary of State— (a) the category of cosmetic product and its name or names, enabling its specific identification; (b) the name of the responsible person; (c) the address at which the product information file in respect of the cosmetic product is kept; (d) the contact details of a natural person to contact in the case of urgency; (e) where applicable, the following information— (i) presence of substances in the form of nanomaterials; (ii) the identification including the chemical name (IUPAC) and other descriptors as specified in point 2 of the Preamble to Annexes 2 to 6 to this Regulation; and (iii) the reasonably foreseeable exposure conditions; (f) the name and the Chemicals Abstracts Service (CAS) or EC number of substances classified as CMR substances of category 1A or 1B under Regulation (EC) No 1272/2008; (g) the frame formulation allowing for prompt and appropriate medical treatment in the event of difficulties. (2) When a cosmetic product is placed on the market, the responsible person must notify to the Secretary of State the original labelling and, where reasonably legible, a photograph of the corresponding packaging (3) Paragraph 4 applies in relation to a cosmetic product where prior to IP completion day— (a) the cosmetic product has been supplied on the market of the United Kingdom or the market of any EEA state for distribution, consumption or use in the course of a commercial activity (whether in return for payment or free of charge); and (b) a responsible person designated under Article 4 of the EU Regulation (pre-exit) has complied with Article 13 of that Regulation in relation to that product. (4) Where this paragraph applies— (a) if the cosmetic product is placed on the market at any time before the expiry of the transitory period, subject to subparagraph (b), paragraphs 1 and 2 are to have effect as if they required the information specified in those paragraphs before the end of the transitory period; (b) paragraph 1 is to be treated as being satisfied in respect of the cosmetic product and paragraph 2 does not apply in respect of that product where— (i) before the expiry of the transitory period, the responsible person for the cosmetic product submits to the Secretary of State by electronic means the information set out in points (a) to (d) and (g) of paragraph 1; and (ii) when submitting that information, the responsible person at the same time gives notice confirming the matters set out in paragraph 3 in relation to the cosmetic product; (c) if at any time a request is made to the responsible person by the Secretary of State in accordance with paragraphs 5 and 6, the responsible person must comply with the request within the period specified in the request. (5) Where the Secretary of State considers it necessary for the purposes of reducing a risk to human health, the Secretary of State may request that a responsible person submits the information referred to in paragraph 1(e) to (f) in relation to a cosmetic product to which paragraph 4 applies. (6) When making a request under paragraph 5 the Secretary of State must specify a period— (a) within which the responsible person must respond; and (b) which is reasonable and commensurate with the nature of the risk presented by the product. (7) The Secretary of State must make the following information available in relation to a cosmetic product to all other competent authorities— (a) the information referred to in paragraph 1(a) to (f); and (b) the information referred to in paragraph 2. (8) Competent authorities may only use the information referred to in paragraph 7 for the purposes of market surveillance, market analysis, evaluation and consumer information in the context of Articles 25 to 27. (9) The Secretary of State must without delay make the following information available to poison centres or similar bodies established in the United Kingdom— (a) the information referred to in paragraph 1; and (b) the information referred to in paragraph 2 (10) Those poison centres and similar bodies may only use that information for the purposes of medical treatment. (11) Where any information provided under this Article in relation to a cosmetic product changes, the responsible person must provide an update by electronic means to the Secretary of State without delay.

Amendment of Article 14

14

In Article 14 (restrictions for substances)—

(a) in paragraph 1(c)(i)—

(i) at the beginning insert “Subject to point (iii);

(ii) omit “except for hair colouring products referred to in paragraph 2”;

(b) after point (c)(ii) insert—

(iii) “point (c)(i) does not apply to hair colouring products;”;

Substitution of Article 15

15

For Article 15 (substances classified as CMR substances) substitute—

(1) A cosmetic product must not contain a substance classified as a CMR substance of category 1A, 1B or 2 under Regulation (EC) No 1272/2008, unless the substance is included in any of Annexes 3 to 6. (2) Where a CMR substance of category 1A or 1B is permitted for use in cosmetic products, specific labelling in order to avoid misuse of the cosmetic product must be provided in accordance with Article 3 of this Regulation, taking into account possible risks linked to the presence of hazardous substances and the routes of exposure.

Substitution of Article 16

16

For Article 16 (nanomaterials) substitute—

(1) The provisions of this Article do not apply to nanomaterials used as colourants, UV-filters or preservatives that are regulated under Article 14. (2) A cosmetic product containing nanomaterials must be notified in accordance with paragraph 3. (3) To meet the requirements of paragraph 2, the information set out in paragraph 4 must be submitted by electronic means— (a) to the Secretary of State; (b) by the responsible person; and (c) at least six months prior to the cosmetic product being placed on the market. (4) The information referred to in paragraph 3 must contain— (a) the identification of the nanomaterial including its chemical name (IUPAC) and other descriptors as specified in point 2 of the Preamble to Annexes 2 to 6 to this Regulation; (b) the specification of the nanomaterial including size of particles and chemical properties; (c) an estimate of the quantity of nanomaterials contained in cosmetic products intended to be placed on the market per year; (d) except where paragraph 13 applies, the toxicological profile of the nanomaterial; (e) the safety data of the nanomaterial relating to the category of cosmetic product, as used in such products; (f) the reasonably foreseeable exposure conditions. (5) Paragraph 6 applies in relation to a cosmetic product containing nanomaterials where prior to IP completion day— (a) the cosmetic product has been supplied on the market of the United Kingdom or the market of any EEA state for distribution, consumption or use in the course of a commercial activity (whether in return for payment or free of charge); and (b) a responsible person designated under Article 4 of the EU Regulation (pre-exit) has complied with Article 16 of that Regulation in relation to that product. (6) Where this paragraph applies— (a) if the cosmetic product containing nanomaterials is placed on the market at any time before the expiry of the transitory period, subject to subparagraph (b) paragraphs 2 and 3 are to have effect as if they required the information specified in paragraph 4 before the end of the transitory period; and (b) paragraphs 2 and 3 are to be treated as being satisfied in respect of the cosmetic product where— (i) before the end of the transitory period, the responsible person for the cosmetic product submits to the Secretary of State by electronic means the information set out in paragraph 4; and (ii) when submitting that information, the responsible person at the same time gives notice confirming the matters set out in paragraph 5 in relation to the cosmetic product; (c) if at any time a request is made to the responsible person by a competent authority in accordance with paragraphs 9 and 10, the responsible person must comply with the request within the period specified in the request. (7) Paragraph 8 applies in relation to a cosmetic product containing nanomaterials where— (a) prior to IP completion day a responsible person designated under Article 4 of the EU Regulation (pre-exit) has complied with the requirements of Article 16 of that Regulation in relation to that product; and (b) the period between the day on which IP completion day falls and the day on which the person designated under Article 4 of the EU Regulation (pre-exit) complied with Article 16 of that Regulation is less than six months. (8) Where this paragraph applies— (a) paragraphs 2 and 3 are to be treated as being satisfied where— (i) a period of 7 months has elapsed between the day on which the responsible person designated under Article 4 of the EU Regulation (pre-exit) complied with Article 16 of that Regulation and the day on which the responsible person places the cosmetic product on the market; (ii) before the expiry of the transitory period, the responsible person for that cosmetic product submits to the Secretary of State the information set out in paragraph 4; and (iii) when submitting that information, the responsible person at the same time gives notice confirming the matters set out in paragraph 7; and (b) if at any time a request is made to the responsible person by a competent authority in accordance with paragraphs 9 and 10, the responsible person must comply with the request within the period specified in the request. (9) Where a competent authority has concerns regarding the safety of a nanomaterial, the competent authority may request that a responsible person submits the following information to the competent authority— (a) which nanomaterials are used in a cosmetic product; and (b) the reasonably foreseeable exposure conditions. (10) When a competent authority makes a request under paragraph 9, the competent authority must specify a period— (a) within which the responsible person must respond; and (b) which is reasonable and commensurate with the nature of the concerns held by the competent authority. (11) Where paragraph 12 applies, the information set out in paragraph 4 may be provided by the person designated in accordance with that paragraph on behalf of the responsible person. (12) This paragraph applies where— (a) the responsible person designates another person by written mandate to meet the notification requirements under this Article in respect of a cosmetic product on that responsible person's behalf (“the designated person”); (b) the designated person accepts the designation in writing; and (c) the responsible person informs the Secretary of State of the name and address of that designated person. (13) The Secretary of State may provide a reference for the toxicological profile and that reference may be provided in the place of the information referred to in paragraph 4(d)

Substitution of Article 18

17

For Article 18 (animal testing) substitute—

(1) Except as provided in paragraph 1A, no cosmetic product may be placed on the market— (a) where the final formulation of the product has been the subject of animal testing in order to meet the requirements of this Regulation; (b) where the ingredients or combinations of ingredients of the product have been the subject of animal testing in order to meet the requirements of this Regulation. (1A) Paragraph 1 does not prevent the use of historic animal testing data in order to meet the requirements of this Regulation. (2) No animal testing of finished cosmetic products may take place in the United Kingdom in order to meet the requirements of this Regulation. (3) No animal testing of ingredients or combinations of ingredients may take place in the United Kingdom in order to meet the requirements of this Regulation.

Amendment of Article 19

18

In Article 19 (labelling)—

(a) in paragraph 1 point (a) for “his” substitute “ their ”;

(b) after point (a) of paragraph 1 insert—

(ab) for a period of two years beginning on the day after the day on which IP completion day falls, point (a) is to be treated as satisfied where the requirements of Article 19(1)(a) of the EU Regulation (pre-exit) are complied with;

(c) in paragraph 4 for the words from “Member” to “rules” substitute “ the requirements of regulation 5(1) and (2) of the Enforcement Regulations apply ”;

(d) in paragraph 5 for the words from “shall be” to “user” substitute “ must meet the requirements of regulation 5(3) of the Enforcement Regulations ”;

(e) in paragraph 6 for “provided for” substitute “ referred to ”.

Amendment of Article 20

19

In Article 20 (product claims)—

(a) for paragraph 2 substitute—

(2) A responsible person must ensure that the wording of any claim in relation to a cosmetic product is in compliance with the common criteria set out in the Annex to Commission Regulation (EU) No 655/2013 of 10th July 2013 laying down common criteria for the justification of claims used in relation to cosmetic products.

(b) in paragraph 3 for “his” substitute “the manufacturer's”.

Amendment of Article 22

20

In Article 22 (in-market control)—

(a) in the first and second paragraphs for “Member States shall” substitute “ enforcement authorities must ”;

(b) for “They shall” substitute “ Enforcement authorities must ”;

The Secretary of State must entrust other enforcement authorities with the resources and knowledge necessary for the proper performance of their duties.

(d) omit the fourth paragraph.

Amendment of Article 23

21

In Article 23 (communication of serious undesirable effects)—

(a) in paragraph 1—

(i) for “competent authority” substitute “ Secretary of State ”;

(ii) omit the words from “of the Member State” to “occurred”;

(b) in point (a) for “him”—

(i) in the first place in which it occurs substitute “ the responsible person or the distributor ”;

(ii) in the second place in which it occurs substitute “ that responsible person or distributor ”'

(d) for paragraph 2 substitute—

(2) The Secretary of State must immediately inform all other competent authorities of any information notified to the Secretary of State under paragraph 1.

(e) for paragraph 3 substitute—

(3) Where a distributor reports serious undesirable effects of a cosmetic product to the Secretary of State, the Secretary of State must immediately inform the responsible person.

(f) for paragraph 4 substitute—

(4) Where end users or health professionals report serious undesirable effects of a cosmetic product to any competent authority that is not the Secretary of State, that competent authority must immediately inform the Secretary of State who must then immediately inform the responsible person. Where end users or health professionals report serious undesirable effects of a cosmetic product to the Secretary of State, the Secretary of State must immediately inform all other competent authorities and the responsible person.

Amendment of Article 24

22

In Article 24 (information on substances)—

(a) for “the competent” substitute “ a competent ”;

(b) omit the words from “of a Member” to “market”;

Amendment of Article 25

23

In regulation 25 (non-compliance by responsible person)—

(a) in paragraph 1 omit “Without prejudice to paragraph 4,”

(b) omit paragraph 2;

(d) omit paragraph 4;

(e) in paragraph 5 omit the subparagraph after point (b);

(f) for paragraph 6 substitute—

(6) In the event of serious risks to human health, a competent authority which has taken measures under paragraph 5 must inform all other competent authorities of the measures taken.

(g) for paragraph 7 substitute—

(7) For the purposes of paragraph 6 the database provided for in regulation 33(A1) of the General Product Safety Regulations 2005 (S.I. 2005/1803) must be used

Amendment to Article 27

24

In Article 27 (safeguard clause)—

(a) in paragraph 1 for “a competent authority” substitute “ an enforcement authority ”

(b) for paragraph 2 substitute—

(2) An enforcement authority which is not the Secretary of State must obtain authorisation from the Secretary of State by requesting the authorisation in accordance with regulation 11 of the Enforcement Regulations prior to taking provisional measures under this Article.

(i) for “Commission shall” substitute “ Secretary of State must ”;

(ii) for “it shall” substitute “ the Secretary of State must ”;

(iii) for the words from “the interested” to “SCCS” substitute “ any person the Secretary of State considers has an interest in the measure ”;

(d) for paragraph 4 substitute—

(4) Where the provisional measures are justified the Secretary of State must give authorisation to the enforcement authority to take those measures.

(e) omit paragraph 5.

Amendment of Article 28

25

In Article 28 (good administrative practice)—

(a) in paragraph 1—

(i) for “him” substitute “ that responsible person ”;

(ii) omit “of the Member State concerned”;

(b) in paragraph 2 for “his” substitute “ their ”.

Omission of Chapter 9

26

Omit Chapter 9.

Substitution of Chapter 10

27

For Chapter 10, substitute—

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

Amendment to Schedule 6

41

SCHEDULE 33 — Amendment of Regulation (EC) No 765/2008

Introduction

1

Amendments to Chapter 1

2

3

Amendments to Chapter 2

4

5

6

7

8

9

10

11

12

Amendment to Chapter 3

13

14

15

16

17

18

19

20

21

22

23

24

25

26

27

28

Amendment to Chapter 4

29

Omission of Chapter 5

30

Amendments to Chapter 6

31

32

33

34

35

36

37

Omission of Annex 1

38

Substitution of Annex 2

39

SCHEDULE 34 — Amendment of Regulation (EC) No 1223/2009 and related amendments

Introduction

1

Amendment of Article 1

2

Amendment of Article 2

3

Amendment of Article 3

4

Substitution of Article 4

5

Amendment of Article 5

6

Amendment of Article 6

7

Amendment of Article 8

8

Omission of Article 9

9

Amendment of Article 10

10

Amendment of Article 11

11

Amendment of Article 12

12

Substitution of Article 13

13

Amendment of Article 14