PART 1U.K.INTRODUCTORY

Citation commencement and extentU.K.

1.—(1) These Regulations may be cited as the Non-automatic Weighing Instruments Regulations 2016.

(2) These Regulations come into force on 28th December 2016.

(3) These Regulations extend to Northern Ireland except for Part 7.

InterpretationE+W+S

2.—(1) In these Regulations—

F1...

F2...

[F3“approved body” has the meaning given to it in regulation 47 (approved bodies);]

“authorised representative” means any person established [F4in the United Kingdom] who has received a written mandate from a manufacturer to act on the manufacturer's behalf in relation to specified tasks;

F5...

“commencement date” means the date referred to in regulation 1(2);

F6...

“competent authority” means a person who is, pursuant to regulation 62 (competent authorities and enforcement proceedings), authorised to enforce these Regulations;

“compliance notice” means a notice served in accordance with regulation 63(2);

“conformity assessment” means the process demonstrating whether the essential requirements relating to a regulated non-automatic weighing instrument have been met;

“conformity assessment body” means a body that performs conformity assessment activities including calibration, testing, certification and inspection;

[F7“conformity assessment procedure” means a procedure referred to in regulation 36;]

[F7“declaration of conformity” means a declaration of conformity required to be drawn up in accordance with Chapter 2 of Part 3;]

[F7“designated standard” has the meaning given to it in regulation 2A;]

“the Directive” means Directive 2014/31/EU of the European Parliament and of the Council of 26th February 2014 on the harmonisation of the laws of the Member States relating to the making available on the market of non-automatic weighing instruments M5 and references to the Directive (or a specific provision of it) are references to the Directive (or that provision) [F8(as it has effect immediately before IP completion day)];

[F9“disqualification mark” means a marking in the form set out in paragraph 1 of Schedule A1;]

“distributor” means any person in the supply chain, other than a manufacturer or an importer, who makes a non-automatic weighing instrument available on the market;

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

“enforcement notice” means a notice served in accordance with regulation 64(2);

“enforcement officer” means—

“essential requirements” means, in relation to a regulated non-automatic weighing instrument (or a class of that instrument), the requirements specified as being applicable in relation to that regulated non-automatic weighing instrument (or that class of instrument) in [F10Schedule 6] ;

F11...

F12...

F13...

[F14“importer” means a person who—

“in writing” includes text that is—

“M marking” means a marking applied to a regulated non-automatic weighing instrument which consists of the capital letter ‘M’ and the last two digits of the year of its affixing surrounded by a rectangle, the height of which is equal to that of the [F15UK] marking applied to that instrument;

“make available on the market” means any supply of a non-automatic weighing instrument for distribution or use on the [F16market of Great Britain] in the course of a commercial activity, whether in return for payment or free of charge and related expressions are to be construed accordingly;

“manufacturer” means any person who—

“market surveillance authority” means the Secretary of State acting in the capacity of market surveillance authority pursuant to the designation made by regulation 57 (the market surveillance authority), and, where the context requires, a market surveillance authority in another EEA state;

F17...

“non-automatic weighing instrument” means a weighing instrument that—

“notified body” means a conformity assessment body that has been notified to the Commission in accordance with Part 5 and includes, where the context so requires, a notified body designated as such in another EEA state in accordance with the Directive;

F18...

F19...

“place on the market” means the first making available of a non-automatic weighing instrument on the market [F20of Great Britain] and related expressions are to be construed accordingly;

“RAMS” means Regulation (EC) 765/2008 of the European Parliament and of the Council setting out the requirements for accreditation and market surveillance relating to the marketing of products and repealing Regulation (EEC) No 339/93 M6 (as amended from time to time);

“recall” means any measure aimed at achieving the return of a regulated non-automatic weighing instrument that has already been made available to the end-user and related expressions are to be construed accordingly;

“regulated non-automatic weighing instrument” means a non-automatic weighing instrument which is intended to be used to perform one of the functions referred to in regulation 3(2);

“relevant economic operator” means, in relation to a non-automatic weighing instrument, an economic operator with obligations in respect of that non-automatic weighing instrument under Part 2;

[F21“re-qualification mark” means a marking in the form set out in paragraph 2 of Schedule A1;]

“technical documentation” means the documentation which meets the requirements of [F22Schedule 7];

“technical specification” means a document that prescribes technical requirements to be fulfilled by a regulated non-automatic weighing instrument;

[F23“Type-examination certificate” means a type-examination certificate issued by an approved body in accordance with Module B of Schedule 7;]

[F23“UK marking” means the marking in the form set out in Annex 2 of RAMS;]

[F23“UK national accreditation body” means the body appointed by the Secretary of State in accordance with Article 4 of RAMS;]

F24...

“United Kingdom Accreditation Service” means the company limited by guarantee incorporated in England and Wales under number 3076190;

“weights and measures authority” means a local weights and measures authority within the meaning set out in section 69 of the Weights and Measures Act 1985;

“withdraw” when used in relation to a regulated non-automatic weighing instrument means taking any measure aimed at preventing an instrument in the supply chain from being made available on the market and related expressions are to be construed accordingly.

[F25(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.]

F26(2) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

(3) Other expressions used in these Regulations have in relation to the application of these Regulations to—

(a)Great Britain, the same meanings as in the Weights and Measures Act 1985 M7; and

(b)Northern Ireland, the same meanings as in the Weights and Measures (Northern Ireland) Order 1981 M8.

InterpretationN.I.

2.—(1) In these Regulations—

“accreditation” means accreditation as defined in point 10 of Article 2 of RAMS;

“accreditation certificate” means a certificate, issued by the United Kingdom Accreditation Service or a national accreditation body as defined in point 11 of Article 2 of RAMS in another [F171relevant] state, attesting that a conformity assessment body meets the notified body requirements;

“authorised representative” means any person established within the [F172relevant market] who has received a written mandate from a manufacturer to act on the manufacturer's behalf in relation to specified tasks;

“CE marking” means a marking which takes the form set out in Annex II of RAMS;

“commencement date” means the date referred to in regulation 1(2);

“Commission” means the Commission of the European Union:

“competent authority” means a person who is, pursuant to regulation 62 (competent authorities and enforcement proceedings), authorised to enforce these Regulations;

“compliance notice” means a notice served in accordance with regulation 63(2);

“conformity assessment” means the process demonstrating whether the essential requirements relating to a regulated non-automatic weighing instrument have been met;

“conformity assessment body” means a body that performs conformity assessment activities including calibration, testing, certification and inspection;

“the Directive” means Directive 2014/31/EU of the European Parliament and of the Council of 26th February 2014 on the harmonisation of the laws of the Member States relating to the making available on the market of non-automatic weighing instruments F173 and references to the Directive (or a specific provision of it) are references to the Directive (or that provision) as from time to time amended;

[F9“disqualification mark” means a marking in the form set out in paragraph 1 of Schedule A1;]

“distributor” means any person in the supply chain, other than a manufacturer or an importer, who makes a non-automatic weighing instrument available on the market;

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

“enforcement notice” means a notice served in accordance with regulation 64(2);

“enforcement officer” means—

“essential requirements” means, in relation to a regulated non-automatic weighing instrument (or a class of that instrument), the requirements specified as being applicable in relation to that regulated non-automatic weighing instrument (or that class of instrument) in Annex I to the Directive;

“EU declaration of conformity” means a declaration of conformity required to be drawn up in accordance with Chapter 2 of Part 3;

“EU-type examination certificate” means an EU-type examination certificate issued by a notified body in accordance with Module B of Annex II to the Directive;

“harmonised standard” has the meaning set out in point 1(c) of Article 2 of Regulation (EU) No. 1025/2012 of the European Parliament and of the Council on European standardisation F174 (as amended from time to time);

“importer” means any person who—

“in writing” includes text that is—

“M marking” means a marking applied to a regulated non-automatic weighing instrument which consists of the capital letter ‘M’ and the last two digits of the year of its affixing surrounded by a rectangle, the height of which is equal to that of the CE marking applied to that instrument;

“make available on the market” means any supply of a non-automatic weighing instrument for distribution or use on the [F177relevant market] in the course of a commercial activity, whether in return for payment or free of charge and related expressions are to be construed accordingly;

“manufacturer” means any person who—

“market surveillance authority” means the Secretary of State acting in the capacity of market surveillance authority pursuant to the designation made by regulation 57 (the market surveillance authority), and, where the context requires, a market surveillance authority in another [F178relevant] state;

“national accreditation body” means the national accreditation body as defined in point 11 of Article 2 of RAMS;

[F179“NI Protocol obligation” means any obligation created or arising by or under the Protocol on Ireland/ Northern Ireland in the EU withdrawal agreement, whether or not an obligation to which section 7A(2) of the European Union (Withdrawal) Act 2018 applies;]

“non-automatic weighing instrument” means a weighing instrument that—

“notified body” means a conformity assessment body that has been notified to the Commission in accordance with Part 5 and includes, where the context so requires, a notified body designated as such in another [F180relevant] state in accordance with the Directive;

“notified body requirements” means the requirements set out in Schedule 3 (requirements related to notified bodies)

“notifying authority” means the notifying authority within the meaning of regulation 48 (the notifying authority);

“place on the market” means the first making available of a non-automatic weighing instrument on the [F181relevant market] and related expressions are to be construed accordingly;

“RAMS” means Regulation (EC) 765/2008 of the European Parliament and of the Council setting out the requirements for accreditation and market surveillance relating to the marketing of products and repealing Regulation (EEC) No 339/93 F182 (as amended from time to time);

“recall” means any measure aimed at achieving the return of a regulated non-automatic weighing instrument that has already been made available to the end-user and related expressions are to be construed accordingly;

“regulated non-automatic weighing instrument” means a non-automatic weighing instrument which is intended to be used to perform one of the functions referred to in regulation 3(2);

“relevant economic operator” means, in relation to a non-automatic weighing instrument, an economic operator with obligations in respect of that non-automatic weighing instrument under Part 2;

[F183“relevant market” means—

[F183“relevant state” means—

[F21“re-qualification mark” means a marking in the form set out in paragraph 2 of Schedule A1;]

“technical documentation” means the documentation which meets the requirements of Annex II to the Directive;

“technical specification” means a document that prescribes technical requirements to be fulfilled by a regulated non-automatic weighing instrument;

[F184“UK(NI) indication” means the marking in the form set out in Schedule 1 to the Product Safety and Metrology etc. (Amendment etc.) (UK(NI) Indication) (EU Exit) Regulations 2020;]

“Union harmonisation legislation” means any European Union legislation harmonising the conditions for the marketing of products;

“United Kingdom Accreditation Service” means the company limited by guarantee incorporated in England and Wales under number 3076190;

“weights and measures authority” means a local weights and measures authority within the meaning set out in section 69 of the Weights and Measures Act 1985;

“withdraw” when used in relation to a regulated non-automatic weighing instrument means taking any measure aimed at preventing an instrument in the supply chain from being made available on the market and related expressions are to be construed accordingly.

(2) A non-automatic weighing instrument that meets the requirements of the Directive by virtue of the laws of another [F185relevant] state is to be treated as meeting the requirements of these Regulations (except any requirement of these Regulations for anything to be written in English) and references to a non-automatic weighing instruments being in conformity with these Regulations are to be construed accordingly.

(3) Other expressions used in these Regulations have in relation to the application of these Regulations to—

(a)Great Britain, the same meanings as in the Weights and Measures Act 1985 F186; and

(b)Northern Ireland, the same meanings as in the Weights and Measures (Northern Ireland) Order 1981 F187.

[F27Designated standardE+W+S

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 [F28or an international standardising body], for repeated or continuous application, with which compliance is not compulsory; and

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

(2) For the purposes of 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).

[F29(3A) In this regulation “international standardising body” has the same meaning as it has for the purposes of the Agreement on Technical Barriers to Trade, part of Annex 1A to the agreement establishing the World Trade Organisation signed at Marrakesh on 15 April 1994 (as modified from time to time).]

(4) When considering whether the manner of publication of a reference 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 [F30such] technical specifications adopted by the other recognised standardisation bodies [F31or by international standardising bodies as the Secretary of State considers to be relevant.]

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

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

(8) 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.]

Application of these RegulationsU.K.

3.—(1) Subject to regulation 4 (revocations and transitional and consequential provisions), these Regulations apply to non-automatic weighing instruments.

(2) These Regulations, except Part 4, apply to an instrument (referred to in these Regulations as a “regulated non-automatic weighing instrument”) for use for any of the following purposes—

(a)the determination of mass for commercial transactions;

(b)the determination of mass for the calculation of a toll, tariff, tax, bonus, penalty, remuneration, indemnity or similar type of payment;

(c)the determination of mass for the application of laws or regulations or for an expert opinion given in court proceedings;

(d)the determination of mass in the practice of medicine for weighing patients for the purposes of monitoring, diagnosis and medical treatment;

(e)the determination of mass for making up medicines on prescription in a pharmacy and determination of mass in analyses carried out in medical and pharmaceutical laboratories; and

(f)the determination of price on the basis of mass for the purposes of direct sales to the public and the making up of prepackages.

(3) Part 4 applies to a non-automatic weighing instrument that is not a regulated instrument.

Revocations and transitional and consequential provisionsU.K.

4.—(1) The Non-automatic Weighing Instruments Regulations 2000 M9 and the Non-automatic Weighing Instruments (Amendment) Regulations 2008 M10 are revoked.

(2) In this regulation, “the former law” means the Regulations referred to in paragraph (1) [F32subject to the modifications made in paragraph (3A)].

(3) This paragraph applies to a regulated non-automatic weighing instrument placed on the market before the commencement date which was required by any provision of the former law to meet the essential requirements.

[F33(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).]

(4) A regulated non-automatic weighing instrument to which paragraph (3) applies which meets the requirements of the former law applicable to it is to be treated as meeting the requirements of these Regulations.

(5) Where a regulated non-automatic weighing instrument to which paragraph (3) applies does not meet the requirements of the former law, these Regulations apply to that instrument as they apply to a regulated instrument placed on the market or put into service after the commencement date which does not comply with the requirements of these Regulations.

(6) Part 7 (use for trade of regulated non-automatic weighing instruments for the purposes listed in regulation 3(2)) applies to regulated non-automatic weighing instruments to which paragraph (3) applies as it applies to a regulated instrument placed on the market or put into service after the commencement date.

(7) A certificate granted under any provision of the former law has effect as if granted under the corresponding provision of these Regulations.

(8) In the list in paragraph 10 in Schedule 5 to the Consumer Rights Act 2015 M11, insert at the appropriate place the following entry—

“regulation 62 of the Non-automatic Weighing Instruments Regulations 2016 (S.I. 2016/1152)”.

(9) In the table in paragraph 11 of Schedule 5 to the Consumer Rights Act 2015, omit the entry relating to the Non-automatic Weighing Instruments Regulations 2000.

(10) An application to be a recognised as a notified body which is made before the commencement date is to be treated as having been made under these Regulations if it meets the requirements of these Regulations.

(11) Except in a case where paragraph (10) applies, a requirement of these Regulations (“the relevant requirement”) is to be treated as having been satisfied by anything done on or after 20th April 2016 but before the commencement date where that thing—

(a)was done for the purposes of complying with a requirement of the Directive; and

(b)if it had been done on or after the commencement date it would have met the relevant requirement.

[F34 Transitional provision in relation to EU ExitE+W+S

4A.—(1) In this regulation—

(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 F35, 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.]

[F36(5) Where paragraph (6) applies to a regulated non-automatic weighing instrument, regulations 67 and 68 have effect subject to the modifications in paragraph (7).

(6) This paragraph applies to a regulated non-automatic weighing instrument that has been placed on the market—

(a)during the pre-exit period; or

(b)pursuant to Article 41 of the EU withdrawal agreement.

(7) The modifications referred to in paragraph (5) are that—

(a)the reference in regulation 67(1)(a) to “UK marking” is to be read as a reference to the CE marking within the meaning of Article 2(19) of the Directive;

(b)the reference in regulation 67(1)(b) to “M marking” is to be read as a reference to the supplementary metrology marking as described in Article 16(2) of the Directive;

(c)the reference in regulation 67(1)(c) to “approved body” is to be read as a reference to the body that undertook any conformity assessment procedure in accordance with Article 13 of the Directive;

(d)the references in regulations 67(2)(b) and 68(4)(b) to “type examination certificate” are to be read as references to an EU-type examination certificate, issued in accordance with the conformity assessment procedure set out in point 1 of Annex II to the Directive, known as “Module B”.

[F37(8) Subject to paragraph (9), where before 11pm on 31st December 2024—

(a)a non-automatic weighing instrument has not been placed on the market or put into service; and

(b)a manufacturer has taken any action under the conformity assessment procedure that applies to that product in accordance with Article 13 of the Directive

that action has effect as if it had been done under the applicable conformity assessment procedure referred to in regulation 36.

(9) Paragraph (8) does not apply—

(a)after the expiry of the validity of any certificate issued pursuant to the applicable conformity assessment procedure; and

(b)in any event, after 31st December 2027.]]

PART 2U.K.REGULATED NON-AUTOMATIC WEIGHING INSTRUMENTS – OBLIGATIONS OF ECONOMIC OPERATORS

CHAPTER 1U.K.OBLIGATIONS OF MANUFACTURERS AND PERSONS TO BE TREATED AS MANUFACTURERS

IntroductoryU.K.

5.—(1) This Chapter applies in relation to the placing on the market of a regulated non-automatic weighing instrument by a manufacturer.

(2) The obligations in this Chapter also apply to an importer or distributor who—

(a)places a regulated non-automatic weighing instrument on the market under the name or trade mark of that importer or distributor; or

(b)modifies a regulated non-automatic weighing instrument already placed on the market in such a way that compliance with these Regulations may be affected,

and the expression “manufacturer” is to be construed accordingly.

Manufacturers' responsibilities – design, conformity assessment and marking of regulated non-automatic weighing instrumentsE+W+S

6.—[F38(1)] A manufacturer must not place on the market a regulated non-automatic weighing instrument unless the manufacturer has—

(a)designed and manufactured the instrument in accordance with the essential requirements;

(b)drawn up technical documentation in relation to the instrument;

(c)carried out (or procured the carrying out of) the relevant conformity assessment procedure which has demonstrated compliance of the instrument with the applicable requirements;

(d)drawn up [F39a] declaration of conformity; and

(e)affixed to the instrument [F40or where paragraph (2) applies, in respect of the UK marking, to a label affixed to a product or to a document accompanying the product] —

(i)the [F41UK] marking; and

(ii)the M marking.

[F42(2) For a period of [F43seven years] 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.]

Manufacturers' responsibilities – design, conformity assessment and marking of regulated non-automatic weighing instrumentsN.I.

6.  A manufacturer must not place on the market a regulated non-automatic weighing instrument unless the manufacturer has—

(a)designed and manufactured the instrument in accordance with the essential requirements;

(b)drawn up technical documentation in relation to the instrument;

(c)carried out (or procured the carrying out of) the relevant conformity assessment procedure which has demonstrated compliance of the instrument with the applicable requirements;

(d)drawn up an EU declaration of conformity; and

(e)affixed to the instrument—

(i)the CE marking; and

(ii)the M marking.

Manufacturers' obligations in respect of recordsU.K.

7.  A manufacturer must keep the technical documentation and the [F44EU] declaration of conformity for a period of 10 years beginning with the day after the day on which the regulated non-automatic weighing instrument to which it relates has been placed on the market.

Manufacturers' obligations to ensure continuing conformity with the essential requirementsE+W+S

8.—(1) Manufacturers must have procedures in place for series production of regulated non-automatic weighing instruments by them to ensure that instruments so manufactured continue to meet the essential requirements.

(2) These procedures must adequately take into account changes in—

(a)regulated non-automatic weighing instrument design or characteristics; and

(b)changes in the [F45designated] standards or in other technical specifications by reference to which the conformity of the regulated non-automatic weighing instrument is declared.

(3) When deemed appropriate with regard to the risks presented by the use of a regulated non-automatic weighing instrument, a manufacturer must—

(a)carry out sample testing of regulated non-automatic weighing instruments made available by the manufacturer on the market;

(b)investigate complaints about regulated non-automatic weighing instruments made available by the manufacturer on the market;

(c)if necessary, keep a register of—

(i)such complaints;

(ii)non-conforming regulated non-automatic weighing instruments; and

(iii)regulated non-automatic weighing instrument recalls; and

(d)keep distributors informed of any monitoring action the manufacturer has undertaken.

Manufacturers' obligations to ensure continuing conformity with the essential requirementsN.I.

8.—(1) Manufacturers must have procedures in place for series production of regulated non-automatic weighing instruments by them to ensure that instruments so manufactured continue to meet the essential requirements.

(2) These procedures must adequately take into account changes in—

(a)regulated non-automatic weighing instrument design or characteristics; and

(b)changes in the harmonised standards or in other technical specifications by reference to which the conformity of the regulated non-automatic weighing instrument is declared.

(3) When deemed appropriate with regard to the risks presented by the use of a regulated non-automatic weighing instrument, a manufacturer must—

(a)carry out sample testing of regulated non-automatic weighing instruments made available by the manufacturer on the market;

(b)investigate complaints about regulated non-automatic weighing instruments made available by the manufacturer on the market;

(c)if necessary, keep a register of—

(i)such complaints;

(ii)non-conforming regulated non-automatic weighing instruments; and

(iii)regulated non-automatic weighing instrument recalls; and

(d)keep distributors informed of any monitoring action the manufacturer has undertaken.

Manufacturers' obligations in relation to the marking of regulated non-automatic weighing instruments with serial numbers etc.U.K.

9.—(1) A manufacturer must ensure that a regulated non-automatic weighing instrument, which that manufacturer has placed on the market, bears a type, batch, serial number or other element allowing identification of the instrument.

(2) A manufacturer must ensure that a regulated non-automatic weighing instrument is marked with the information specified in Schedule 1 (information to be marked on regulated non-automatic weighing instruments) and in the manner required by that Schedule.

(3) Where a regulated non-automatic measuring instruments includes or is attached to devices which are not used or intended to be used for any of the purposes listed in regulation 3(2), the manufacturer must affix to those devices a symbol constituted by a capital letter (M) printed in black on a red background at least 25mm x 25mm square with two intersecting diagonals forming a cross.

(4) The symbol referred to in paragraph (3) must be affixed in a clearly visible and indelible form.

Manufacturers to mark contact details on regulated non-automatic weighing instrumentsE+W+S

10.—(1) A manufacturer must indicate on every regulated non-automatic weighing instruments manufactured by that manufacturer, the manufacturer's name, registered trade name or registered trade mark and the postal address at which the manufacturer can be contacted.

(2) The address required by these Regulations must indicate a single point at which the manufacturer can be contacted.

(3) The contact details required by this regulation must be [F46clear, legible and in easily understandable] English.

Manufacturers to mark contact details on regulated non-automatic weighing instrumentsN.I.

10.—(1) A manufacturer must indicate on every regulated non-automatic weighing instruments manufactured by that manufacturer, the manufacturer's name, registered trade name or registered trade mark and the postal address at which the manufacturer can be contacted.

(2) The address required by these Regulations must indicate a single point at which the manufacturer can be contacted.

(3) The contact details required by this regulation must be in a language that is easily understood by end-users and market surveillance authorities and in the case of regulated non-automatic weighing instruments made available in [F188Northern Ireland], they must be in English.

Documentation to accompany regulated non-automatic weighing instrumentsE+W+S

11.—(1) A manufacturer must ensure that regulated non-automatic weighing instruments manufactured by that manufacturer are accompanied by instructions and information easily understood by end-users.

F47(2) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

(3) Such instructions and information and any labelling relating to a regulated non-automatic weighing instrument must be [F48clear, legible and in easily understandable English].

Documentation to accompany regulated non-automatic weighing instrumentsN.I.

11.—(1) A manufacturer must ensure that regulated non-automatic weighing instruments manufactured by that manufacturer are accompanied by instructions and information easily understood by end-users.

(2) Where end-users are in [F189Northern Ireland], those instructions and information must be in English.

(3) Such instructions and information and any labelling relating to a regulated non-automatic weighing instrument must be clear, understandable and intelligible.

Action to be taken where regulated non-automatic weighing instruments placed on the market are not in conformity with the essential requirementsE+W+S

12.—(1) This regulation applies where a manufacturer considers or has reason to believe that a regulated non-automatic weighing instrument placed on the market by that manufacturer is not in conformity with the requirements of these Regulations.

(2) The manufacturer must immediately take the corrective measures necessary to bring the regulated non-automatic weighing instrument into conformity, or withdraw or recall it, if appropriate.

(3) Where the regulated non-automatic weighing instrument presents a risk, the manufacturer must immediately inform the competent [F49authority] to that effect giving details, in particular, of the non-compliance and of any corrective measures taken.

Action to be taken where regulated non-automatic weighing instruments placed on the market are not in conformity with the essential requirementsN.I.

12.—(1) This regulation applies where a manufacturer considers or has reason to believe that a regulated non-automatic weighing instrument placed on the market by that manufacturer is not in conformity with the requirements of these Regulations.

(2) The manufacturer must immediately take the corrective measures necessary to bring the regulated non-automatic weighing instrument into conformity, or withdraw or recall it, if appropriate.

(3) Where the regulated non-automatic weighing instrument presents a risk, the manufacturer must immediately inform the competent national authorities of the [F190relevant] states in which the instrument has been made available on the market to that effect giving details, in particular, of the non-compliance and of any corrective measures taken.

Provision of information to the competent authorityU.K.

13.—(1) A manufacturer must, further to a reasoned request from a competent authority, provide that authority, with all the information and documentation in paper or electronic form necessary to demonstrate the conformity of a regulated non-automatic weighing instrument manufactured by that manufacturer with the requirements of these Regulations.

(2) Information and documentation supplied to a competent authority pursuant to this regulation must be supplied in English.

(3) A manufacturer must co-operate with a competent authority, at the request of that authority, on any action to eliminate the risks posed by regulated non-automatic weighing instruments that the manufacturer has placed on the market.

Use of authorised representatives by manufacturersU.K.

14.—(1) A manufacturer may, by written mandate, appoint an authorised representative to discharge the responsibilities of that manufacturer under these Regulations in relation to the placing on the market of a regulated non-automatic weighing instrument.

(2) The authorised representative does not have the power to discharge the manufacturer's obligations under regulations 6(a) and 6(b).

(3) The authorised representative must be treated as authorised to—

(a)keep the [F50EU] declaration of conformity and the technical documentation at the disposal of the market surveillance authority for 10 years beginning with the day after the day on which a regulated non-automatic weighing instrument has been placed on the market;

(b)provide a competent authority further to a reasoned request from that authority with all the information and documentation necessary to demonstrate the conformity of a regulated non-automatic weighing instrument; and

(c)co-operate with a competent authority, at its request, on any action taken to eliminate the risks posed by regulated non-automatic weighing instruments covered by its mandate.

CHAPTER 2U.K.OBLIGATIONS OF IMPORTERS

IntroductoryE+W+S

15.  This Chapter applies to the placing on the market of a regulated non-automatic weighing instrument that is imported into the United Kingdom from a country outside the [F51United Kingdom].

IntroductoryN.I.

15.  This Chapter applies to the placing on the market of a regulated non-automatic weighing instrument that is imported into [F191Northern Ireland] from a country outside the [F192relevant market].

Ensuring compliance of regulated non-automatic weighing instrumentsE+W+S

16.—(1) An importer must only place compliant regulated non-automatic weighing instruments on the market.

(2) An importer must ensure that—

(a)the appropriate conformity assessment procedure has been carried out by the manufacturer of the regulated non-automatic weighing instrument (or by the importer where the importer is to be regarded as the manufacturer by virtue of regulation 5(2);

(b)the manufacturer has drawn up the technical documentation (or that the importer has done so where the importer is treated as the manufacturer by virtue of regulation 5(2);

(c)the regulated non-automatic weighing instrument bears the [F52UK] marking and the M marking;

(d)the manufacturer (or the importer where he is treated as the manufacturer under regulation 5(2)) has complied with the requirements of regulations 9 (manufacturers' obligations in relation to the marking of regulated non-automatic weighing instruments with serial numbers etc.) and 10 (manufacturers to mark contact details on regulated non-automatic weighing instruments).

Ensuring compliance of regulated non-automatic weighing instrumentsN.I.

16.—(1) An importer must only place compliant regulated non-automatic weighing instruments on the market.

(2) An importer must ensure that—

(a)the appropriate conformity assessment procedure has been carried out by the manufacturer of the regulated non-automatic weighing instrument (or by the importer where the importer is to be regarded as the manufacturer by virtue of regulation 5(2);

(b)the manufacturer has drawn up the technical documentation (or that the importer has done so where the importer is treated as the manufacturer by virtue of regulation 5(2);

(c)the regulated non-automatic weighing instrument bears the CE marking and the M marking;

(d)the manufacturer (or the importer where he is treated as the manufacturer under regulation 5(2)) has complied with the requirements of regulations 9 (manufacturers' obligations in relation to the marking of regulated non-automatic weighing instruments with serial numbers etc.) and 10 (manufacturers to mark contact details on regulated non-automatic weighing instruments).

Importers duty to notify manufacturer and market surveillance authorities of non-compliant regulated non-automatic weighing instruments that present a riskU.K.

17.  Where an importer considers, or has reason to believe, that the regulated non-automatic weighing instrument is not in conformity with the essential requirements and presents a risk, the importer must inform the manufacturer and the market surveillance authority.

Requirements to mark importers' details on regulated non-automatic weighing instrumentsE+W+S

18.—(1) An importer must indicate on any regulated non-automatic weighing instrument imported by that importer, the importer's name, registered trade name or trademark, and the postal address at which the importer can be contacted.

[F53(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 [F54seven years] 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.]

(3) The contact details required by this regulation must be [F55clear, legible and in easily understandable] English.

Requirements to mark importers' details on regulated non-automatic weighing instrumentsN.I.

18.—(1) An importer must indicate on any regulated non-automatic weighing instrument imported by that importer, the importer's name, registered trade name or trademark, and the postal address at which the importer can be contacted.

(2) Where this would require the packaging to be opened, those indications may be given on the packaging and in a document accompanying the instrument.

(3) The contact details required by this regulation must be in a language that is easily understood by end-users and market surveillance authorities, and in the case of regulated non-automatic weighing instruments made available in [F193Northern Ireland], they must be in English.

Importers' duty to ensure that regulated non-automatic weighing instruments are accompanied by relevant documentation.E+W+S

19.—(1) An importer must ensure that regulated non-automatic weighing instruments imported by the importer are accompanied by instructions and information [F56which are clear, legible and in easily understandable English].

F57(2) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

Importers' duty to ensure that regulated non-automatic weighing instruments are accompanied by relevant documentation.N.I.

19.—(1) An importer must ensure that regulated non-automatic weighing instruments imported by the importer are accompanied by instructions and information in a language easily understood by end users

(2) Where end users are in [F194Northern Ireland], the instructions and information referred to in paragraph (1) must be in English.

Duty of importers to ensure proper conditions of storage and transportU.K.

20.  An importer must, in respect of regulated non-automatic weighing instruments under the importer's responsibility, ensure that the conditions of their storage or transport are not such as to jeopardise their continuing compliance with the essential requirements.

Duties of importers with regard to monitoring etc.U.K.

21.—(1) When deemed appropriate with regard to the performance of a regulated non-automatic weighing instrument imported by an importer, the importer must—

(a)carry out a sample testing of regulated non-automatic weighing instruments made available on the market by the importer;

(b)investigate complaints about regulated non-automatic weighing instruments imported by them; and

(c)if necessary, keep a register of—

(i)such complaints;

(ii)non-conforming regulated non-automatic weighing instruments;

(iii)regulated non-automatic weighing instrument recalls; and

(d)where the importer is not also the distributor of the regulated non-automatic weighing instrument, keep distributors, to whom he has supplied an instrument, informed of any monitoring undertaken by that importer.

Action to be taken by importers where regulated non-automatic weighing instruments placed on the market by them are not in conformity with essential requirementsU.K.

22.—(1) This regulation applies where an importer considers, or has reason to believe, that a regulated non-automatic weighing instrument placed on the market by the importer is not in conformity with the requirements of these Regulations.

(2) Where this regulation applies, the importer must immediately take the corrective measures necessary to bring the regulated non-automatic weighing instrument into conformity, or withdraw or recall it, if appropriate.

(3) Where the non-automatic weighing instrument presents a risk, the importer must immediately inform the competent authority to that effect, giving details, in particular, of the non-compliance of the instrument and of the corrective measures taken by that importer.

Requirement for importer to keep copy of [F58EU] declaration of conformityU.K.

23.  The importer must, for a period of 10 years beginning with the day after the day on which the regulated non-automatic weighing instrument is placed on the market, keep a copy of the [F59EU] declaration of conformity at the disposal of the market surveillance authorities and ensure that the technical documentation can be made available to those authorities upon request.

Provision of information to a competent authorityU.K.

24.—(1) The importer must, further to a reasoned request from a competent authority, provide the competent authority with all the information and documentation in paper or electronic form necessary to demonstrate the conformity of the regulated non-automatic weighing instrument with the requirements of these Regulations.

(2) Information and documentation supplied to a competent authority pursuant to this regulation must be supplied in English.

(3) An importer must co-operate with a competent authority, at its request, as regards any action to eliminate the risks posed by any regulated non-automatic weighing instrument that the importer has placed on the market.

CHAPTER 3U.K.OBLIGATIONS OF DISTRIBUTORS

IntroductoryU.K.

25.  This Chapter applies in relation to the making available on the market of a regulated non-automatic weighing instrument by a distributor.

Distributors – duty to act with due careU.K.

26.  Before making the regulated non-automatic instrument available on the market, the distributor must act with due care in relation to the requirements of these Regulations.

Distributors – verification obligationsE+W+S

27.—(1) The distributor must verify that the regulated non-automatic weighing instrument bears the [F60UK] marking and the M marking.

(2) The distributor must verify that the regulated non-automatic weighing instrument, it is accompanied by instructions and information [F61which are clear, legible and in easily understandable English].

F62(3) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

(4) The distributor must verify that the manufacturer and the importer have complied with the requirements set out in regulation 9 (manufacturers' obligations in relation to the marking of regulated non-automatic weighing instruments with serial numbers etc.), regulation 10 (manufacturers to mark contact details on regulated non-automatic weighing instruments) and regulation 18 (requirements to mark importers' details on regulated non-automatic weighing instruments).

Distributors – verification obligationsN.I.

27.—(1) The distributor must verify that the regulated non-automatic weighing instrument bears the CE marking and the M marking.

(2) The distributor must verify that the regulated non-automatic weighing instrument, it is accompanied by instructions and information easily understood by end users.

(3) Instructions and information supplied in accordance with this regulation must be in a language that is easily understood by end users and where those users are in [F195Northern Ireland] must be in English.

(4) The distributor must verify that the manufacturer and the importer have complied with the requirements set out in regulation 9 (manufacturers' obligations in relation to the marking of regulated non-automatic weighing instruments with serial numbers etc.), regulation 10 (manufacturers to mark contact details on regulated non-automatic weighing instruments) and regulation 18 (requirements to mark importers' details on regulated non-automatic weighing instruments).

Distributors not to make non-conforming non-automatic weighing instruments available on the market etc.U.K.

28.—(1) This regulation applies where a distributor considers, or has reason to believe, that a regulated non-automatic weighing instrument is not in conformity with the essential requirements.

(2) Where this regulation applies, the distributor must not make the regulated non-automatic weighing instrument available on the market until it has been brought into conformity.

(3) Where the regulated non-automatic weighing instrument presents a risk, the distributor must immediately inform—

(a)the manufacturer;

(b)the importer (where the distributor is not also the manufacturer or importer); and

(c)the market surveillance authority,

to that effect, giving details, in particular, of the non-compliance of the instrument and of the corrective measures taken by that distributor.

Duty of distributors to ensure proper conditions of storage and transportU.K.

29.  A distributor must, in respect of regulated non-automatic weighing instruments under that distributor's responsibility, ensure that the conditions of their storage or transport are not such as to jeopardise their continuing compliance with the essential requirements.

Action to be taken by distributors where regulated non-automatic weighing instruments placed on the market by them are not in conformity with essential requirementsU.K.

30.—(1) This regulation applies where a distributor considers, or has reason to believe, that a regulated non-automatic weighing instrument [F63made available] on the market by that distributor is not in conformity with the requirements of these Regulations.

(2) Where this regulation applies, the distributor must immediately take the corrective measures necessary to bring the regulated non-automatic weighing instrument into conformity, or withdraw or recall it, if appropriate.

(3) Where the regulated non-automatic weighing instrument presents a risk, the distributor must immediately inform the competent authority to that effect, giving details, in particular, of the non-compliance of the instrument and of the corrective measures taken by that distributor.

Provision of information to the competent authorityU.K.

31.—(1) The distributor must, further to a reasoned request from a competent authority, provide that authority with all the information and documentation in paper or electronic form necessary to demonstrate the conformity of the regulated non-automatic weighing instrument with the requirements of these Regulations.

(2) Information and documentation supplied to a competent authority pursuant to this regulation must be supplied in English.

(3) A distributor must co-operate with a competent authority, at its request, as regards any action to eliminate the risks posed by any regulated non-automatic weighing instrument that the distributor has placed on the market.

CHAPTER 4U.K.IDENTIFICATION OF ECONOMIC OPERATORS

32.—(1) Economic operators must, on request, identify to the market surveillance authorities—

(a)any economic operator who has supplied them with a regulated non-automatic weighing instrument; and

(b)any economic operator to whom they have supplied a regulated non-automatic weighing instrument.

(2) Economic operators must be able to present the information referred to in paragraph (1) for 10 years beginning with the day on which they have been supplied with the regulated non-automatic weighing instrument and for 10 years beginning with the day after the day on which they have supplied the instrument.

(3) The Secretary of State may impose a monetary penalty on an economic operator who fails to comply with an obligation imposed by this regulation.

(4) Schedule 5 has effect in relation to the imposition of a monetary penalty under paragraph (3).

[F64Obligations which are met by complying with obligations in the DirectiveE+W+S

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)[F65except in relation to regulation 68,] 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.]

[F64Conformity assessment procedure obligations that are met by complying with the DirectiveE+W+S

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.]

[F64Expiry of regulations 32A and 32BE+W+S

32C.—(1) Subject to [F66paragraphs (2) and (6)], regulation 32A ceases to have effect at the end of the period of [F67four years] 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 [F68paragraphs (4) and (6)], regulation 32B ceases to have effect at the end of the period of [F69four years] 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).

[F70(6) regulations 67 and 68 continue to have effect in relation to any non-automatic weighing instrument—

(a)placed on the market pursuant to 32A; or

(b)in relation to which a manufacturer has undertaken a conformity assessment procedure in accordance with regulation 32B,

as if regulations 32A or 32B had not expired.]

Qualifying Northern Ireland GoodsU.K.

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.

[F71(3A) After a non-automatic weighing instrument has been placed on the market pursuant to this regulation, regulations 67 and 68 are to be read in relation to that instrument subject to the following modifications—

(a)the reference in regulation 67(1)(a) to “UK marking” is to be read as a reference to the CE marking, within the meaning of regulation 2(1) as it applies in Northern Ireland;

(b)the reference in regulation 67(1)(b) to “M marking”, is to be read as a reference to the M Marking as defined in regulation 2(1), as it applies in Northern Ireland;

(c)the reference in regulation 67(1)(c) to “approved body” is to be read as a reference to a “notified body” as defined in regulation 2(1), as it applies in Northern Ireland;

(d)the references in regulations 67(2)(a) and 68(4)(a) to “essential requirements” are to be read as the essential requirements within the meaning of that term in regulation 2(1), as it applies in Northern Ireland; and

(e)the references in regulations 67(2)(b) and 68(4)(b) to “type examination certificate” is to be read as a reference to an EU-type examination certificate as defined in regulation 2(1), as it applies in Northern Ireland.]

(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.]

PART 3U.K.CONFORMITY OF REGULATED NON-AUTOMATIC WEIGHING INSTRUMENTS

CHAPTER 1U.K.ESTABLISHING COMPLIANCE WITH THE ESSENTIAL REQUIREMENTS

IntroductoryU.K.

33.  This Chapter applies for the purposes of establishing whether a regulated non-automatic weighing instrument complies with the essential requirements.

Methods of establishing conformity with the essential requirementsE+W+S

34.  Conformity with the essential requirements may be established in relation to a regulated non-automatic weighing instrument—

(a)through conformity with [F72designated] standards (or parts of those standards) covering the essential requirements F73...; or

(b)through the use by the manufacturer of any other technical solution that complies with the essential requirements.

Methods of establishing conformity with the essential requirementsN.I.

34.  Conformity with the essential requirements may be established in relation to a regulated non-automatic weighing instrument—

(a)through conformity with harmonised standards (or parts of those standards) covering the essential requirements where the harmonised standards have been published in the Official Journal of the European Union; or

(b)through the use by the manufacturer of any other technical solution that complies with the essential requirements.

Presumptions of conformity of regulated non-automatic weighing instrumentsE+W+S

35.  Regulated non-automatic weighing instruments which are in conformity with [F74designated] standards (or parts of those standards) shall be presumed to be in conformity with the essential requirements covered by those standards (or parts of those standards).

Presumptions of conformity of regulated non-automatic weighing instrumentsN.I.

35.  Regulated non-automatic weighing instruments which are in conformity with harmonised standards (or parts of those standards) shall be presumed to be in conformity with the essential requirements covered by those standards (or parts of those standards).

Conformity assessment proceduresE+W+S

36.—(1) The conformity of regulated non-automatic weighing instruments to the essential requirements may, subject to paragraph (2), be established by either of the following conformity assessment procedures as selected by the manufacturer—

(a)Module B as set out in point 1 of [F75Schedule 7] followed by either—

(i)Module D as set out in point 2 of [F76Schedule 7]; or

(ii)Module F as set out in point 4 of [F77Schedule 7]; or

(b)Module G as set out in point 6 of [F78Schedule 7].

(2) Module B is compulsory for instruments—

(a)which use electronic devices; and

(b)the load measuring device of which uses a spring to balance the load.

(3) Where an instrument is not submitted to Module B, either of the following modules must be applied—

(a)Module D1 as set out in point 3 of [F79Schedule 7]; or

(b)Module F1 as set out in point 5 of [F80Schedule 7].

(4) [F81An approved] body must carry out the conformity assessment procedure selected by the manufacturer in accordance with the requirements of Schedule 2.

(5) The documents and correspondence relating to the conformity assessment procedures referred to in this regulation, and which are carried out in the United Kingdom, must be drawn up in English.

(6) In this regulation a reference to a module other than Module B includes the common provisions as set out in point 7 of [F82Schedule 7].

Conformity assessment proceduresN.I.

36.—(1) The conformity of regulated non-automatic weighing instruments to the essential requirements may, subject to paragraph (2), be established by either of the following conformity assessment procedures as selected by the manufacturer—

(a)Module B as set out in point 1 of Annex II to the Directive followed by either—

(i)Module D as set out in point 2 of Annex II; or

(ii)Module F as set out in point 4 of Annex II; or

(b)Module G as set out in point 6 of Annex II.

(2) Module B is compulsory for instruments—

(a)which use electronic devices; and

(b)the load measuring device of which uses a spring to balance the load.

(3) Where an instrument is not submitted to Module B, either of the following modules must be applied—

(a)Module D1 as set out in point 3 of Annex II; or

(b)Module F1 as set out in point 5 of Annex II.

(4) A notified body must carry out the conformity assessment procedure selected by the manufacturer in accordance with the requirements of Schedule 2.

(5) The documents and correspondence relating to the conformity assessment procedures referred to in this regulation, and which are carried out in the United Kingdom, must be drawn up in English.

(6) In this regulation a reference to a module other than Module B includes the common provisions as set out in point 7 of Annex II to the Directive.

[F83Subsidiaries and contractorsU.K.

37.—(1) This regulation applies where—

(a)a notified body subcontracts specific conformity assessment activities, or

(b)has such activities carried out by a subsidiary.

(2) The activities are only to be treated as having been carried out by a notified body for the purposes of regulation 36 (conformity assessment procedures) where the conditions in paragraphs (3) and (4) are met.

(3) The notified body must—

(a)ensure that the subcontractor or subsidiary meets the notified body requirements; and

(b)inform the Secretary of State accordingly.

(4) The notified body must have obtained the agreement of the client to the use of a subcontractor or subsidiary.

(5) Where a notified body subcontracts specific conformity assessment activities, or has such activities carried out by a subsidiary, the notified body must for a period of at least 10 years beginning on the day after the activities are carried out, keep at the disposal of the Secretary of State the documentation concerning—

(a)the assessment of the qualifications of the subcontractor or the subsidiary; and

(b)the conformity assessment activities carried out by the subcontractor or subsidiary.

(6) When monitoring a notified body in accordance with regulation 52 (monitoring), the Secretary of State must treat the notified body as responsible for the tasks performed by a subcontractor or subsidiary, wherever the subcontractor or subsidiary is established.]

FeesE+W+S

38.—(1) [F84An approved] body may charge fees in connection with, or incidental to, the carrying out of conformity assessment procedures or specific tasks as it may determine.

(2) The fees referred to in paragraph (1) must not exceed the following—

(a)the costs incurred or to be incurred by the [F85approved] body in performing the relevant function; and

(b)an amount on account of profit which is reasonable in the circumstances having regard to—

(i)the character and extent of the work done or to be done by that notified body on behalf of the applicant; and

(ii)the commercial rate normally charged on account of profit for that work or similar work.

(3) The power in paragraph (1) includes the power to require payment of fees or a reasonable estimate of such fees in advance of carrying out the work requested by the applicant.

(4) Where any fees payable to [F84an approved] body pursuant to this regulation remain unpaid 28 days after either the work has been requested or payment of the fees has been requested in writing, whichever is the later, the notified body may by 14 days' notice in writing provide that, unless the fees are paid before the expiry of the notice, the certificate or notification appropriate to the relevant conformity assessment procedure may be suspended until payment of the fees has been received.

(5) This regulation does not apply to the Secretary of State.

FeesN.I.

38.—(1) A United Kingdom notified body may charge fees in connection with, or incidental to, the carrying out of conformity assessment procedures or specific tasks as it may determine.

(2) The fees referred to in paragraph (1) must not exceed the following—

(a)the costs incurred or to be incurred by the United Kingdom notified body in performing the relevant function; and

(b)an amount on account of profit which is reasonable in the circumstances having regard to—

(i)the character and extent of the work done or to be done by that notified body on behalf of the applicant; and

(ii)the commercial rate normally charged on account of profit for that work or similar work.

(3) The power in paragraph (1) includes the power to require payment of fees or a reasonable estimate of such fees in advance of carrying out the work requested by the applicant.

(4) Where any fees payable to a United Kingdom notified body pursuant to this regulation remain unpaid 28 days after either the work has been requested or payment of the fees has been requested in writing, whichever is the later, the notified body may by 14 days' notice in writing provide that, unless the fees are paid before the expiry of the notice, the certificate or notification appropriate to the relevant conformity assessment procedure may be suspended until payment of the fees has been received.

(5) This regulation does not apply to the Secretary of State.

CHAPTER 2U.K.REQUIREMENTS RELATING TO [F86EU] DECLARATIONS OF CONFORMITY

Application of ChapterU.K.

39.  This Chapter applies in relation to [F87EU] declarations of conformity made in relation to a regulated non-automatic weighing instrument for the purposes of these Regulations.

Form and contents of F88... declaration of conformity etc.E+W+S

40.—(1) The F89... declaration of conformity must—

(a)state that the fulfilment of the essential requirements has been demonstrated in relation to the regulated non-automatic weighing instrument;

(b)have the model structure set out in [F90Schedule 9]; and

(c)contain the elements specified in the relevant modules set out in [F91Schedule 7] and must be updated when appropriate.

(2) Where a regulated non-automatic weighing instrument is placed or made available on the market in the United Kingdom, the F92... declaration of conformity in relation to the instrument must be in English.

Form and contents of EU declaration of conformity etc.N.I.

40.—(1) The EU declaration of conformity must—

(a)state that the fulfilment of the essential requirements has been demonstrated in relation to the regulated non-automatic weighing instrument;

(b)have the model structure set out in Annex IV to the Directive; and

(c)contain the elements specified in the relevant modules set out in Annex II to the Directive and must be updated when appropriate.

(2) Where a regulated non-automatic weighing instrument is placed or made available on the market in [F196Northern Ireland], the EU declaration of conformity in relation to the instrument must be in English.

Regulated instruments that require more than one declaration of conformityE+W+S

[F9341.  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.]

Regulated instruments that require more than one declaration of conformityN.I.

41.—(1) This regulation applies where a regulated non-automatic weighing instrument is subject to [F197an NI Protocol obligation] for an EU declaration of conformity otherwise than by virtue of these Regulations.

(2) Where this regulation applies, a single EU declaration of conformity must be drawn up covering all applicable requirements which identifies the [F198relevant] Union acts concerned including their publication references.

Responsibility of manufacturer that draws up declaration of conformityE+W+S

42.  A manufacturer, who draws up [F94a] declaration of conformity in relation to a regulated non-automatic weighing instrument, is responsible for compliance of that instrument with the requirements of these Regulations.

Responsibility of manufacturer that draws up declaration of conformityN.I.

42.  A manufacturer, who draws up an EU declaration of conformity in relation to a regulated non-automatic weighing instrument, is responsible for compliance of that instrument with the requirements of these Regulations.

CHAPTER 3U.K.CONFORMITY MARKING

Conformity with F95... requirements to be indicated by the [F96UK] markingE+W+S

43.  The conformity of a regulated non-automatic weighing instrument with the requirements of these Regulations must be indicated by the presence on it of the [F97UK] marking and the M marking.

Conformity with Directive requirements to be indicated by the CE markingN.I.

43.  The conformity of a regulated non-automatic weighing instrument with the requirements of these Regulations must be indicated by the presence on it of the CE marking and the M marking.

[F98Prohibition on improper use of UK marking and the M markingE+W+S

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.]

General principles relating to the M markingN.I.

44.  The general principles set out in article 30 of RAMS apply to the M marking with such modifications as are necessary in the circumstances.

Rules and conditions for affixing the [F99UK] marking and the M marking etc.E+W+S

45.—(1) The [F100UK] marking and M marking (“the markings”) must be affixed to a regulated non-automatic weighing instrument in accordance with the provisions of this regulation.

(2) The markings must be affixed visibly, legibly and indelibly to the regulated non-automatic weighing instrument [F101, 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].

(3) The markings must be affixed before the regulated non-automatic weighing instrument is placed on the market.

(4) The M marking must immediately follow the [F102UK] marking.

(5) The markings must immediately be followed by the identification of the [F103approved] body where that body is involved in the production control phase as set out in [F104Schedule 7].

(6) The identification number of the [F105approved] body which carried out the conformity assessment procedure must be affixed by the body itself, or under its instructions by the manufacturer or the manufacturer's authorised representative.

(7) The markings and the identification number of the [F106approved] body may be followed by any other mark indicating a special risk or use.

Rules and conditions for affixing the CE marking and the M marking etc.N.I.

45.—(1) The CE marking and M marking (“the markings”) must be affixed to a regulated non-automatic weighing instrument in accordance with the provisions of this regulation.

(2) The markings must be affixed visibly, legibly and indelibly to the regulated non-automatic weighing instrument or its data plate.

(3) The markings must be affixed before the regulated non-automatic weighing instrument is placed on the market.

(4) The M marking must immediately follow the CE marking.

(5) The markings must immediately be followed by the identification of the notified body where that body is involved in the production control phase as set out in Annex II to the Directive.

(6) The identification number of the notified body which carried out the conformity assessment procedure must be affixed by the body itself, or under its instructions by the manufacturer or the manufacturer's authorised representative.

(7) The markings and the identification number of the notified body may be followed by any other mark indicating a special risk or use.

[F107UK(NI) indicationN.I.

45A.—(1) Where the CE marking is affixed on the basis of an assessment or a certificate issued by a notified body established in the United Kingdom, a UK(NI) indication must be affixed in relation to the regulated non-automatic weighing instrument, in accordance with this regulation.

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

(a)visibly, legibly and indelibly; and

(b)before the regulated non-automatic weighing instrument is placed on the market in Northern Ireland.

(3) The UK(NI) indication must accompany the CE marking, wherever that is affixed in accordance with regulation 45.

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

(a)the manufacturer; or

(b)the manufacturer's authorised representative.

(5) When placing a regulated non-automatic weighing instrument on the market in Northern Ireland, an importer must ensure that the manufacturer has complied with their obligations under this regulation.]

[F107Register of notified bodies established in the United KingdomN.I.

45B.—(1) The Secretary of State must ensure that—

(a)each notified body established in the United Kingdom is assigned an identification number; and

(b)there is a register of—

(i)notified bodies established in the United Kingdom;

(ii)their notified body identification number;

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

(iv)any restrictions on those activities.

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

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

PART 4U.K.REQUIREMENTS FOR NON-REGULATED NON-AUTOMATIC WEIGHING INSTRUMENTS

46.—(1) This regulation applies to a non-automatic weighing instrument which is not a regulated non-automatic weighing instrument.

(2) A manufacturer must not place on the market a non-automatic weighing instrument to which this regulation applies unless it is marked legibly and indelibly with the following information—

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

(b)the maximum capacity of the instrument, in the form “Max…..”.

(c)the postal address at which they can be contacted, indicating a single point of contact.

(3) Before placing on the market a non-automatic weighing instrument to which this regulation applies, an importer must ensure that—

(a)the manufacturer has marked the instrument in the manner referred to in paragraph (2) with the information referred to in that paragraph;

(b)the importer has indicated on the instrument their name or registered trade mark and the postal address at which they can be contacted.

(4) Where compliance with paragraph (3)(b) would require the packaging to be opened, the information required by that paragraph may be given on the packaging and in a document accompanying the non-automatic weighing instrument.

(5) Before making available on the market a non-automatic weighing instrument to which this regulation applies, a distributor must verify that—

(a)the manufacturer has marked the instrument in the manner referred to in paragraph (2) with the information referred to in that paragraph;

(b)the importer of the instrument has complied with paragraph (3).

PART 5U.K.[F108NOTIFICATION OF CONFORMITY ASSESSMENT BODIES] [F108APPROVAL OF CONFORMITY ASSESSMENT BODIES]

[F108Approved bodiesE+W+S

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—

“approved body requirements” means the requirements set out in Schedule 3.]

IntroductoryN.I.

47.—(1) This Part applies to the notification to the Commission and other [F199relevant] states of the bodies authorised to carry out conformity assessment procedures in the United Kingdom in relation to regulated non-automatic weighing instruments.

(2) For the purposes of this Part, a notified body is a conformity assessment body—

(a)which has been notified to the Commission and to other [F199relevant] states in accordance with the Directive; and

(b)in respect of which no objections [F200, other than an immaterial objection,] are raised by the Commission or other [F199relevant] states—

(i)within 2 weeks of a notification, where an accreditation certificate is used; or

(ii)within 2 months of a notification, where accreditation is not [F201used;]

[F202(c)in sub-paragraph (b), an “immaterial objection” is an objection on the grounds that—

(i)the conformity assessment body is established in the United Kingdom; or

(ii)the accreditation certificate was issued by the United Kingdom Accreditation Service.]

(3) Paragraph (2) has effect subject to regulation 54 (changes to notifications).

[F108Approval of conformity assessment bodiesE+W+S

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.]

The notifying authorityN.I.

48.—(1) The notifying authority for the purposes of these Regulations is the Secretary of State.

(2) The functions of the notifying authority are—

(a)to assess whether applicants for recognition as conformity assessment bodies meet the requirements for recognition as such;

(b)where an assessment that a body is qualified to act as a conformity assessment body is made, to notify the Commission of that fact; and

(c)to carry out such monitoring of bodies notified to the Commission to ensure continuing compliance with the requirements of these Regulations.

(3) The notifying authority may delegate the performance of its functions to a body that meets the requirements of Articles 20(3) and 21 of the Directive but in the event of such a delegation the notifying authority remains fully responsible for the performance of those functions.

(4) The notifying authority must supply such information as the Commission may request in relation to a body notified by it.

[F108Presumption of conformity of approved bodiesE+W+S

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.]

NotificationN.I.

49.—(1) The Secretary of State may notify to the Commission and the other [F203relevant] states only those conformity assessment bodies that qualify for notification.

(2) A conformity assessment body qualifies for notification if the first and the second conditions below are met.

(3) The first condition is that the conformity assessment body makes an application to the Secretary of State for notification and that application is accompanied by—

(a)a description of—

(i)the conformity assessment activities that the conformity assessment body intends to carry out;

(ii)the conformity assessment module for which the conformity assessment body claims to be competent; and

(iii)the regulated non-automatic weighing instrument in respect of which the conformity assessment body claims to be competent; and

(b)an accreditation certificate or the documentary evidence necessary for the Secretary of State to verify, recognise and regularly monitor the conformity assessment body's compliance with the notified body requirements.

(4) The second condition is that the Secretary of State is satisfied that the conformity assessment body meets the requirements of Schedule 3 (“the notified body requirements”).

(5) For the purposes of paragraph (4), the Secretary of State may accept an accreditation certificate, provided in accordance with paragraph (3)(b), as sufficient evidence that the conformity assessment body meets the notified body requirements.

(6) When deciding whether to notify a conformity assessment body that qualifies for notification to the Commission and the other [F204relevant states], 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) The Secretary of State must inform the Commission of the United Kingdom's procedures for the assessment and notification of conformity assessment bodies, and any changes to those procedures.

[F108MonitoringE+W+S

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.]

Presumption of conformity of notified bodiesN.I.

50.—(1) Where a conformity assessment body demonstrates its conformity with the criteria laid down in a harmonised standard (or part of such a standard), the reference of which has been published in the Official Journal of the European Union, the Secretary of State is to presume that the conformity assessment body meets the notified body requirements covered by that standard (or part of that standard).

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

[F108Restriction, suspension or withdrawal of approvalE+W+S

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).]

Contents of notificationN.I.

51.  A notification under regulation 49 (notification) must include—

(a)details of—

(i)the conformity assessment activities in respect of which the conformity assessment body has made its application for notification;

(ii)the conformity assessment module in respect of which the conformity assessment body has made its application for notification;

(iii)the regulated non-automatic weighing instrument in respect of which the conformity assessment body has made its application for notification; and

(b)either or both of the following—

(i)an accreditation certificate; or

(ii)documentary evidence which attests to—

(aa)the conformity assessment body's competence; and

(bb)the arrangements in place to ensure that the conformity assessment body will be monitored regularly and will continue to meet the notified body requirements.

[F108Subsidiaries and contractorsE+W+S

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 F109.]

MonitoringN.I.

52.—(1) The Secretary of State must monitor each notified body with a view to verifying that the notified body—

(a)continues to meet the notified body requirements;

(b)meets any conditions set in accordance with regulation 49(6)(b) ; and

(c)carries out its functions in accordance with these Regulations.

(2) The Secretary of State must inform the Commission of the United Kingdom's procedures for the monitoring of notified bodies, and any changes to those procedures.

[F108Register of approved bodiesE+W+S

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.]

Delegation to the United Kingdom Accreditation ServiceN.I.

53.—(1) The Secretary of State may authorise the United Kingdom Accreditation Service to carry out the following activities on behalf of the Secretary of State—

(a)assessing whether a conformity assessment body meets the notified body requirements; and

(b)monitoring notified bodies.

(2) Where the Secretary of State authorises the United Kingdom Accreditation Service pursuant to paragraph (1), the Secretary of State remains fully responsible for anything done pursuant to that authorisation.

[F108UK national accreditation bodyE+W+S

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.]

Changes to notificationsN.I.

54.—(1) Where the Secretary of State determines that a notified body no longer meets a notified body requirement, or that it is failing to fulfil any of its obligations under these Regulations other than conditions set in accordance with regulation 49(6)(b), the Secretary of State must restrict, suspend or withdraw the body's status as a notified body under regulation 49 (notification).

(2) With the consent of a notified body, or where the Secretary of State determines that a notified body no longer meets a condition set in accordance with regulation 49(6)(b), the Secretary of State may restrict, suspend or withdraw the body's status as a notified body under regulation 49 (notification).

(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 that the Secretary of State intends to take such action and the reasons for taking such action; and

(b)give the notified body an opportunity to make representations within a reasonable period from the date of that notice and consider any such representations.

(5) Where the Secretary of State takes action under paragraph (1) or (2), the Secretary of State must immediately inform the Commission and the other [F205relevant] states.

(6) Where the Secretary of State has taken action in respect of a notified body under paragraph (1) or (2), or where a notified body has ceased its activity, the body must—

(a)on the request of the Secretary of State, transfer its files to another notified body or to the Secretary of State; or

(b)in the absence of a request under sub-paragraph (a), ensure that its files are kept available for the Secretary of State and each enforcing authority for such period as the Secretary of State may specify.

(7) The Secretary of State may impose a monetary penalty on a United Kingdom notified body that fails to comply with any requirement imposed by or under paragraph (6).

(8) Schedule 5 has effect in relation to monetary penalties imposed under paragraph (7).

PART 6U.K.PUTTING INTO SERVICE OF REGULATED NON-AUTOMATIC WEIGHING INSTRUMENTS FOR THE PURPOSES LISTED IN REGULATION 3(2)

55.  No person shall put into service a regulated non-automatic weighing instrument for any of the uses listed in regulation 3(2) or have such an instrument in his possession for such use unless prior to placing the instrument on the market it has been established by the application of the appropriate conformity assessment procedure that the essential requirements are met in relation to the instrument.

PART 7E+W+SUSE FOR TRADE OF REGULATED NON-AUTOMATIC WEIGHING INSTRUMENTS IN GREAT BRITAIN

56.  Schedule 4 applies to the use for trade of regulated non-automatic weighing instruments in Great Britain.

PART 8U.K.MARKET SURVEILLANCE AND ENFORCEMENT

CHAPTER 1U.K.MARKET SURVEILLANCE

The market surveillance authorityU.K.

57.  The Secretary of State is the market surveillance authority for the purposes of these Regulations and RAMS.

Regulated non-automatic weighing instruments presenting a riskE+W+S

58.—(1) This regulation applies where the market surveillance authority has sufficient reason to believe that a regulated non-automatic weighing instrument presents a risk in relation to any of the purposes set out in regulation 3(2).

(2) Where this regulation applies the market surveillance authority must carry out an evaluation of the regulated non-automatic weighing instrument covering all relevant requirements of these Regulations which apply to that instrument.

(3) The relevant economic operators in relation to the non-automatic weighing instrument must co-operate as necessary with the market surveillance authority for that purpose.

(4) Where, in the course of the evaluation referred to in paragraph (2), the market surveillance authority finds that that the regulated non-automatic weighing instrument does not comply with the essential requirements applicable to it, it must without delay issue a direction which requires the relevant economic operator to—

(a)take all appropriate corrective actions;

(b)withdraw the regulated non-automatic weighing instrument from the market; or

(c)recall it within a reasonable period commensurate with the nature of the risk.

(5) Where the market surveillance authority acts under paragraph (4) it must without delay inform the [F110approved] body that carried out the conformity assessment procedure in respect of the regulated non-automatic weighing instrument of—

(a)the respect in which the regulated non-automatic weighing instrument is not in conformity with the requirements of these Regulations; and

(b)the actions that the authority is requiring the relevant economic operator to take.

F111(6) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

(7) The economic operator must ensure that all appropriate corrective action is taken in respect of all the regulated non-automatic weighing instruments concerned that it has made available [F112in the United Kingdom].

(8) Where the relevant economic operator does not take adequate corrective action within a reasonable period, the market surveillance authority must take all provisional measures to prohibit or restrict the regulated non-automatic weighing instrument being made available on the market, to withdraw the instrument from that market or to recall it.

(9) Where the market surveillance authority takes measures under paragraph (8), the market surveillance authority must notify the [F113Secretary of State] of those measures without delay.

(10) A notification under paragraph (9) must include all available details, in particular—

(a)the data necessary for the identification of the non-compliant regulated measuring instrument;

(b)the origin of the instrument;

(c)the nature of the non-compliance alleged and the risk involved;

(d)the nature and duration of the measures taken;

(e)the arguments put forward by the relevant economic operator; and

(f)whether the non-compliance is due to either of the following—

(i)failure of the regulated measuring instrument to meet the requirements relating to a risk; or

(ii)shortcomings in the [F114designated] standards referred to in regulation 34(a).

Regulated non-automatic weighing instruments presenting a riskN.I.

58.—(1) This regulation applies where the market surveillance authority has sufficient reason to believe that a regulated non-automatic weighing instrument presents a risk in relation to any of the purposes set out in regulation 3(2).

(2) Where this regulation applies the market surveillance authority must carry out an evaluation of the regulated non-automatic weighing instrument covering all relevant requirements of these Regulations which apply to that instrument.

(3) The relevant economic operators in relation to the non-automatic weighing instrument must co-operate as necessary with the market surveillance authority for that purpose.

(4) Where, in the course of the evaluation referred to in paragraph (2), the market surveillance authority finds that that the regulated non-automatic weighing instrument does not comply with the essential requirements applicable to it, it must without delay issue a direction which requires the relevant economic operator to—

(a)take all appropriate corrective actions;

(b)withdraw the regulated non-automatic weighing instrument from the market [F206in Northern Ireland]; or

(c)recall it within a reasonable period commensurate with the nature of the risk.

(5) Where the market surveillance authority acts under paragraph (4) it must without delay inform the notified body that carried out the conformity assessment procedure in respect of the regulated non-automatic weighing instrument of—

(a)the respect in which the regulated non-automatic weighing instrument is not in conformity with the requirements of these Regulations; and

(b)the actions that the authority is requiring the relevant economic operator to take.

(6) [F207Subject to paragraph (6A),] where the market surveillance authority considers that non-compliance is not restricted to [F208Northern Ireland], it must inform the Commission and the other [F209relevant] states of the results of the evaluation and of the actions which they have required the economic operator to take.

[F210(6A) Paragraph (6) does not require the Secretary of State to inform the Commission or the other relevant states where the non-compliance extends only to any of England or Wales or Scotland.]

(7) The economic operator must ensure that all appropriate corrective action is taken in respect of all the regulated non-automatic weighing instruments concerned that it has made available on the market throughout [F211Northern Ireland].

(8) Where the relevant economic operator does not take adequate corrective action within a reasonable period, the market surveillance authority must take all provisional measures to prohibit or restrict the regulated non-automatic weighing instrument being made available on the market [F212in Northern Ireland], to withdraw the instrument from that market or to recall it.

(9) Where the market surveillance authority takes measures under paragraph (8), the market surveillance authority must notify the Commission and the other [F213relevant] states of those measures without delay.

(10) A notification under paragraph (9) must include all available details, in particular—

(a)the data necessary for the identification of the non-compliant regulated measuring instrument;

(b)the origin of the instrument;

(c)the nature of the non-compliance alleged and the risk involved;

(d)the nature and duration of the measures taken;

(e)the arguments put forward by the relevant economic operator; and

(f)whether the non-compliance is due to either of the following—

(i)failure of the regulated measuring instrument to meet the requirements relating to a risk; or

(ii)shortcomings in the harmonised standards referred to in regulation 34(a).

[F115EU safeguard procedureU.K.

59.—(1) Where another [F116relevant] state has initiated the procedure under Article 37 of the Directive, the market surveillance authority must without delay, inform the Commission and the other [F116relevant] states of—

(a)any measures taken by competent authority in respect of the regulated non-automatic weighing instrument;

(b)any additional information which the market surveillance authority has at its disposal relating to the lack of conformity of the regulated non-automatic weighing [F117instrument.]

F118(c). . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

(2) Where a measure taken by another [F119relevant] state in respect of a regulated non-automatic weighing instrument is considered justified under Article 37(7) of the Directive, the market surveillance authority must ensure that appropriate measures to withdraw the instrument are taken in respect of the regulated non-automatic weighing instrument without delay.

(3) If, pursuant to Article 38 of the Directive, the Commission considers a direction given pursuant to regulation 58(4) is unjustified, the market surveillance authority must forthwith withdraw it and notify other competent authorities and economic operators affected accordingly.]

Compliant regulated non-automatic weighing instruments which present a riskE+W+S

60.—(1) This regulation applies where, having carried out an evaluation under regulation 58 (regulated non-automatic weighing instruments presenting a risk), the market surveillance authority finds that although a regulated non-automatic weighing instrument is in compliance with the requirements of these Regulations, it presents a risk in relation to its use in relation to any activity referred to in regulation 3(2).

(2) Where this regulation applies, the market surveillance authority must issue a direction requiring the economic operator to—

(a)take all appropriate measures to ensure that the non-automatic weighing instrument concerned, when placed on the market, no longer presents that risk;

(b)withdraw the non-automatic weighing instrument from the market; or

(c)recall it within a reasonable period, commensurate with the nature of the risk as it may prescribe.

(3) Where this regulation applies, the market surveillance authority must immediately inform the [F120Secretary of State] of all available details including—

(a)the data necessary for the identification of the regulated non-automatic weighing instrument concerned;

(b)the origin and supply chain of the regulated non-automatic weighing instrument;

(c)the nature of the risk involved; and

(d)the nature and duration of the national measures taken.

Compliant regulated non-automatic weighing instruments which present a riskN.I.

60.—(1) This regulation applies where, having carried out an evaluation under regulation 58 (regulated non-automatic weighing instruments presenting a risk), the market surveillance authority finds that although a regulated non-automatic weighing instrument is in compliance with the requirements of these Regulations, it presents a risk in relation to its use in relation to any activity referred to in regulation 3(2).

(2) Where this regulation applies, the market surveillance authority must issue a direction requiring the economic operator to—

(a)take all appropriate measures to ensure that the non-automatic weighing instrument concerned, when placed on the market [F214in Northern Ireland], no longer presents that risk;

(b)withdraw the non-automatic weighing instrument from the market [F215in Northern Ireland]; or

(c)recall it within a reasonable period, commensurate with the nature of the risk as it may prescribe.

(3) Where this regulation applies, the market surveillance authority must immediately inform the Commission and the other [F216relevant] states of all available details including—

(a)the data necessary for the identification of the regulated non-automatic weighing instrument concerned;

(b)the origin and supply chain of the regulated non-automatic weighing instrument;

(c)the nature of the risk involved; and

(d)the nature and duration of the national measures taken.

Provisions as to directions under regulations 58 and 60U.K.

61.—(1) This regulation applies in relation to directions given under regulations 58 (regulated non-automatic weighing instruments presenting a risk) and 60 (compliant regulated non-automatic weighing instruments which present a risk).

(2) A direction must—

(a)be in writing;

(b)describe the regulated non-automatic weighing instrument to which it relates in a manner sufficient to identify that instrument;

(c)specify the risk identified by the market surveillance authority; and

(d)specify the steps that the economic operator must take (including the time period within which they must be taken).

(3) The Secretary of State may impose a monetary penalty on an economic operator who fails to comply with a direction given under regulation 58 or 60.

(4) Schedule 5 has effect in relation to monetary penalties imposed under paragraph (3).

CHAPTER 2U.K.ENFORCEMENT PROCEDURES

Competent authorities and enforcement proceedingsU.K.

62.—(1) In Great Britain, it is the duty of every local weights and measures authority to enforce these Regulations within its area.

(2) In Northern Ireland, it is the duty of the Department for the Economy to enforce these Regulations (other than Part 7).

(3) The Secretary of State—

(a)must enforce these Regulations when required to do so in the capacity of the market surveillance authority; and

(b)may otherwise than in the capacity of market surveillance authority enforce these Regulations and for that purpose may appoint any person to act on his behalf.

(4) No proceedings for an offence under these Regulations may be instituted in England and Wales except by or on behalf of a competent authority.

(5) Nothing in these Regulations authorises a competent authority to bring proceedings in Scotland for an offence.

(6) No proceedings shall be instituted in Northern Ireland for an offence under these Regulations in respect of a regulated non-automatic weighing instrument except—

(a)by or on behalf of a competent authority which has responsibility for enforcing these Regulations in respect of that regulated non-automatic weighing instrument; or

(b)the Director of Public Prosecutions for Northern Ireland.

Compliance notice procedureE+W+S

63.—(1) This regulation applies where a competent authority has reasonable grounds for considering that one or more of the following breaches applies in relation to a regulated non-automatic weighing instrument that has been placed on the market—

(a)the [F121UK] marking or the M marking has been affixed in violation of [F122regulation 44 or regulation 45];

(b)the [F123UK] marking or the M marking has not been affixed;

(c)the identification number of the [F124approved] body, where the body is involved in the production control phase has—

(i)been affixed otherwise than in accordance with the requirements of these Regulations; or

(ii)not been affixed;

(d)the F125... declaration of conformity has not been drawn up correctly;

(e)the technical documentation is either not available or is not complete;

(f)the information referred to in regulation 10 (manufacturers to mark contact details on regulated non-automatic weighing instruments) or regulation 18 (requirements to mark importers' details on regulated non-automatic weighing instruments) is absent, false or incomplete; or

(g)any other failure—

(i)by a manufacturer to comply with the requirements of Chapter 1 of Part 2; or

(ii)by an importer to comply with the requirements of Chapter 2 of Part 2.

(2) The competent authority may serve a notice in writing (“a compliance notice”) on the economic operator it considers is responsible for the breach which must—

(a)describe the regulated non-automatic weighing instrument to which it relates in a manner sufficient to identify that instrument;

(b)specify which of the circumstances in paragraph (1) applies in relation to the regulated non-automatic weighing instrument;

(c)require the economic operator on whom the notice is served to take steps specified in the notice to remedy the matters referred to in sub-paragraph (b);

(d)specify the date, being not less than 21 days from the date of the notice, by which the steps specified in it must be taken; and

(e)warn that person that, where the non-conformity continues beyond the date specified in sub-paragraph (d), the competent authority may take further action under regulation 64 (enforcement notice procedure) in respect of that regulated non-automatic weighing instrument.

(3) Where a compliance notice is served by a competent authority other than the Secretary of State, it must, at the same time as it serves that notice, send a copy to the Secretary of State.

Compliance notice procedureN.I.

63.—(1) This regulation applies where a competent authority has reasonable grounds for considering that one or more of the following breaches applies in relation to a regulated non-automatic weighing instrument that has been placed on the market—

(a)the CE marking or the M marking has been affixed in violation of Article 30 of the RAMS Regulation or the requirements of these Regulations;

(b)the CE marking or the M marking has not been affixed;

(c)the identification number of the notified body, where the body is involved in the production control phase has—

(i)been affixed otherwise than in accordance with the requirements of these Regulations; or

(ii)not been affixed;

[F217(ca)the UK(NI) indication—

(i)has not been affixed, in contravention of regulation 45A; or

(ii)has been affixed other than in accordance with regulation 45A;]

(d)the EU declaration of conformity has not been drawn up correctly;

(e)the technical documentation is either not available or is not complete;

(f)the information referred to in regulation 10 (manufacturers to mark contact details on regulated non-automatic weighing instruments) or regulation 18 (requirements to mark importers' details on regulated non-automatic weighing instruments) is absent, false or incomplete; or

(g)any other failure—

(i)by a manufacturer to comply with the requirements of Chapter 1 of Part 2; or

(ii)by an importer to comply with the requirements of Chapter 2 of Part 2.

(2) The competent authority may serve a notice in writing (“a compliance notice”) on the economic operator it considers is responsible for the breach which must—

(a)describe the regulated non-automatic weighing instrument to which it relates in a manner sufficient to identify that instrument;

(b)specify which of the circumstances in paragraph (1) applies in relation to the regulated non-automatic weighing instrument;

(c)require the economic operator on whom the notice is served to take steps specified in the notice to remedy the matters referred to in sub-paragraph (b);

(d)specify the date, being not less than 21 days from the date of the notice, by which the steps specified in it must be taken; and

(e)warn that person that, where the non-conformity continues beyond the date specified in sub-paragraph (d), the competent authority may take further action under regulation 64 (enforcement notice procedure) in respect of that regulated non-automatic weighing instrument.

(3) Where a compliance notice is served by a competent authority other than the Secretary of State, it must, at the same time as it serves that notice, send a copy to the Secretary of State.

Enforcement notice procedureE+W+S

64.—(1) This regulation applies where a competent authority has reasonable grounds for considering that an economic operator on whom a compliance notice has been served by the competent authority has failed to comply with that notice.

(2) The competent authority may serve a notice (“an enforcement notice”) on the economic operator which must—

(a)be in writing;

(b)describe the regulated non-automatic weighing instrument to which it relates in a manner sufficient to identify that instrument;

(c)specify, with reasons, the respects in which, in the opinion of the competent authority, the compliance notice has not been complied with;

(d)specify the steps that the economic operator must take to comply with the compliance notice; and

(e)specify the date, being not less than 21 days from the date of the notice, by which the economic operator is required to take the steps specified in it.

(3) An enforcement notice may impose either or both of the following requirements where appropriate—

(a)that the regulated non-automatic weighing instrument is to be withdrawn from the market unless the steps referred to in paragraph (2)(d) are taken; or

(b)that the placing on the market or making available on the market of the regulated non-automatic weighing instrument is to be prohibited or restricted unless the steps referred to in paragraph (2)(d) are taken.

(4) Where an enforcement notice is served by an competent authority other than the Secretary of State, it must at the same time as it serves that notice send a copy of the notice to the Secretary of State.

(5) If the Secretary of State is of the opinion that consideration ought to be given as to whether a certificate or notification which is granted by [F126an approved] body should be withdrawn, the Secretary of State must inform [F127that approved] body of that fact.

F128(6) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

Enforcement notice procedureN.I.

64.—(1) This regulation applies where a competent authority has reasonable grounds for considering that an economic operator on whom a compliance notice has been served by the competent authority has failed to comply with that notice.

(2) The competent authority may serve a notice (“an enforcement notice”) on the economic operator which must—

(a)be in writing;

(b)describe the regulated non-automatic weighing instrument to which it relates in a manner sufficient to identify that instrument;

(c)specify, with reasons, the respects in which, in the opinion of the competent authority, the compliance notice has not been complied with;

(d)specify the steps that the economic operator must take to comply with the compliance notice; and

(e)specify the date, being not less than 21 days from the date of the notice, by which the economic operator is required to take the steps specified in it.

(3) An enforcement notice may impose either or both of the following requirements where appropriate—

(a)that the regulated non-automatic weighing instrument is to be withdrawn from the market [F218in Northern Ireland] unless the steps referred to in paragraph (2)(d) are taken; or

(b)that the placing on the market or making available on the market of the regulated non-automatic weighing instrument is to be prohibited or restricted unless the steps referred to in paragraph (2)(d) are taken.

(4) Where an enforcement notice is served by an competent authority other than the Secretary of State, it must at the same time as it serves that notice send a copy of the notice to the Secretary of State.

(5) If the Secretary of State is of the opinion that consideration ought to be given as to whether a certificate or notification which is granted by a United Kingdom notified body should be withdrawn, the Secretary of State must inform that notified body of that fact.

F219(6) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

Review of decisions of a competent authoritiesU.K.

65.—(1) Where a notice is served under regulation 63 (compliance notice procedure) or 64 (enforcement notice procedure) by a competent authority other than the Secretary of State, an economic operator who is aggrieved by the decision to serve that notice may, in accordance with paragraphs (2) and (3) apply to the Secretary of State to review the decision and on such application the Secretary of State may—

(a)hold an inquiry in connection with the decision; and

(b)appoint an assessor for the purposes of assisting him with his review or any such inquiry.

(2) An application for a review of a decision under paragraph (1) must be made by notice in writing to the Secretary of State before the end of the period of 21 days beginning with the day on which the notice is served on the economic operator by the competent authority under regulation 63 or 64

(3) A notice of application for review under this regulation must state the grounds on which the application is made.

(4) The Secretary of State must, within a reasonable time, inform the economic operator and the authority referred to in paragraph (1) in writing of the Secretary of State's decision whether to uphold the decision of that authority and—

(a)in a case where the Secretary of State upholds that decision, must also state the grounds for the Secretary of State's decision; and

(b)in a case where the Secretary of State does not uphold that decision, may—

(i)where the review relates to regulation 63, give instructions for the withdrawal of the notice given under paragraph (2) of that regulation; or

(ii)where the review relates to regulation 64, give instructions for the withdrawal of the notice given under paragraph (2) of that regulation.

Offence of failing to comply with an enforcement noticeU.K.

66.—(1) This paragraph applies where an enforcement notice has been served pursuant to regulation 64 (enforcement notice procedure) on an economic operator by a competent authority other than the Secretary of State and either—

(a)the time for making an application for a review pursuant to regulation 65 (review of decisions of competent authorities) has expired without such an application having been made; or

(b)an application has been made by the economic operator and determined without an instruction for the withdrawal of the notice being given and a period of 21 days has elapsed beginning with the day after notice of the outcome of the review has been served on the economic operator.

(2) Where this paragraph (1) applies, if the economic operator on whom the [F129enforcement notice] has been served, fails to comply with the requirements of that notice, that economic operator is guilty of an offence.

(3) An economic operator that fails to comply with an enforcement notice served on the economic operator by the Secretary of State is guilty of an offence.

DisqualificationE+W+S

67.—(1) Where the circumstances in paragraph (2) apply, an inspector may affix a disqualification mark to a regulated non-automatic weighing instrument which bears the—

(a)[F130UK] marking;

(b)M marking; and

(c)identification number of the [F131approved] body which carried out the conformity assessment procedure in respect of the instrument

(2) The circumstances referred to in paragraph (1) are that the instrument is used for any of the purposes listed in regulation 3(2) in circumstances where—

(a)the instrument does not conform to the essential requirements;

(b)the instrument does not conform to any F132...type examination certificate issued in relation to it;

(c)by reason of any adjustment, alteration, addition, repair or replacement it is likely that the instrument has ceased to be compliant with the essential requirements; or

(d)any requirements applicable to the instrument by virtue of Part 7 are not met.

(3) Where one or more of the markings and identification requirements referred to in paragraph (1) is not affixed to a regulated non-automatic weighing instrument, the inspector may affix a disqualification mark to the instrument.

(4) Where it appears to the inspector that the nature or degree of non-compliance of the regulated non-automatic weighing instrument under paragraph (1) is not such that a disqualification mark should be immediately affixed to it, the inspector may give to any person in possession of the instrument a notice requiring the person to ensure that the instrument is made to comply with the essential requirements before the expiry of 21 days from the date of the notice or such longer period as may be specified in the notice.

(5) If a notice given under paragraph (4) is not complied with, the inspector must affix a disqualification mark to the regulated non-automatic weighing instrument.

(6) Any disqualification mark which is affixed to a regulated non-automatic weighing instrument under this regulation must be affixed in such a position that it is clearly visible when the instrument is in its regular operating position.

[F133(6A) A disqualification mark may be affixed to a regulated non-automatic weighing instrument by affixing to the instrument a label which clearly, legibly and indelibly bears the disqualification mark.]

(7) A person is guilty of an offence if that person uses for any of the purposes mentioned in regulation 3(2) a regulated non-automatic weighing instrument to which there is affixed a disqualification mark, unless a re-qualification mark has been affixed to it in accordance with regulation 68 (re-qualification).

DisqualificationN.I.

67.—(1) Where the circumstances in paragraph (2) apply, an inspector may affix a disqualification mark to a regulated non-automatic weighing instrument which bears the—

(a)CE marking;

(b)M marking; and

(c)identification number of the notified body which carried out the conformity assessment procedure in respect of the instrument

(2) The circumstances referred to in paragraph (1) are that the instrument is used for any of the purposes listed in regulation 3(2) in circumstances where—

(a)the instrument does not conform to the essential requirements;

(b)the instrument does not conform to any EU-type examination certificate issued in relation to it;

(c)by reason of any adjustment, alteration, addition, repair or replacement it is likely that the instrument has ceased to be compliant with the essential requirements; or

(d)any requirements applicable to the instrument by virtue of Part 7 are not met.

(3) Where one or more of the markings and identification requirements referred to in paragraph (1) is not affixed to a regulated non-automatic weighing instrument, the inspector may affix a disqualification mark to the instrument.

(4) Where it appears to the inspector that the nature or degree of non-compliance of the regulated non-automatic weighing instrument under paragraph (1) is not such that a disqualification mark should be immediately affixed to it, the inspector may give to any person in possession of the instrument a notice requiring the person to ensure that the instrument is made to comply with the essential requirements before the expiry of 21 days from the date of the notice or such longer period as may be specified in the notice.

(5) If a notice given under paragraph (4) is not complied with, the inspector must affix a disqualification mark to the regulated non-automatic weighing instrument.

(6) Any disqualification mark which is affixed to a regulated non-automatic weighing instrument under this regulation must be affixed in such a position that it is clearly visible when the instrument is in its regular operating position.

[F133(6A) A disqualification mark may be affixed to a regulated non-automatic weighing instrument by affixing to the instrument a label which clearly, legibly and indelibly bears the disqualification mark.]

(7) A person is guilty of an offence if that person uses for any of the purposes mentioned in regulation 3(2) a regulated non-automatic weighing instrument to which there is affixed a disqualification mark, unless a re-qualification mark has been affixed to it in accordance with regulation 68 (re-qualification).

Re-qualificationE+W+S

68.—(1) This regulation applies where—

(a)a disqualification mark has been affixed to a regulated non-automatic weighing instrument in accordance with regulation 67 (disqualification);

(b)a notice has been served under regulation 67(4); or

(c)a regulated non-automatic weighing instrument intended to be used for any of the purposes mentioned in regulation 3(2) in the circumstances referred to in [F134regulation 67(2) or 67(3)] but a disqualification mark has not been affixed to the instrument.

(2) A person requiring a re-qualification mark to be affixed to the regulated non-automatic weighing instrument must submit it, in such manner as may be directed, to a re-qualification authority and provide such assistance as the requalification authority may reasonably require.

(3) For the purposes of this regulation, a requalification authority is—

(a)an inspector;

(b)an approved verifier;

(c)[F135an] approved F136... body for module F or F1 in [F137Schedule 7]; or

(d)a manufacturer whose quality system has been approved by a UK [F138approved] body under module D or D1 of [F139Schedule 7] for the purposes of re-qualification.

(4) A requalification authority may affix a re-qualification mark to that regulated non-automatic weighing instrument if satisfied that the instrument is compliant with—

(a)the essential requirements;

(b)any F140...type examination certificate which applies to it; and

(c)where it is intended that the instrument is to be used for trade any requirements applicable to that instrument by virtue of Schedule 4.

(5) For the purposes of being satisfied that a re-qualification mark may be affixed to a regulated non-automatic weighing instrument, a requalification authority may take such steps as the requalification authority considers appropriate, including testing the instrument by means of such test equipment as the requalification authority considers appropriate and suitable for the purpose.

(6) There may be charged in respect of any steps taken under paragraph (5) such fees as are reasonable in the circumstances.

(7) The requalification authority must keep a record of any test carried out under paragraph (5).

(8) Where a re-qualification mark is affixed to a regulated non-automatic weighing instrument pursuant to paragraph (4), it must be affixed in such a position that it obliterates as far as possible any disqualification mark.

[F141(9) Where a re-qualification mark is affixed to a regulated non-automatic weighing instrument pursuant to paragraph (4), it must be accompanied by—