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(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.
(1) In these Regulations—
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“ approved body ” has the meaning given to it in regulation 47 (approved bodies);
“ authorised representative ” means any person established in the United Kingdom who has received a written mandate from a manufacturer to act on the manufacturer's behalf in relation to specified tasks;
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“ commencement date ” means the date referred to in regulation 1(2);
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“ 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;
“ conformity assessment procedure ” means a procedure referred to in regulation 36;
“ declaration of conformity ” means a declaration of conformity required to be drawn up in accordance with Chapter 2 of Part 3;
“ designated standard ” has the meaning given to it in regulation 2A;
“ 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 and references to the Directive (or a specific provision of it) are references to the Directive (or that provision) ...;
“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—
an inspector; or
a person appointed by the Secretary of State to act on the Secretary of State's behalf to enforce these Regulations;
“ 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 Schedule 6 ;
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“ importer ” means a person who—
is established in the United Kingdom and places a non-automatic weighing instrument from a country outside of the United Kingdom on the market; or
is established in Northern Ireland and places a non-automatic weighing instrument on the market that has been supplied to them for distribution, consumption or use in the course of a commercial activity, whether in return for payment or free of charge, from an EEA state;
“ in writing ” includes text that is—
transmitted by electronic means;
received in legible form; and
capable of being used for subsequent reference.
“ 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 UK 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 market 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—
manufactures a non-automatic weighing instrument or has a non-automatic weighing instrument designed or manufactured and markets that instrument under their name or trademark; or
is to be treated as a manufacturer by virtue of regulation 5(2);
“ 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;
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“ non-automatic weighing instrument ” means a weighing instrument that—
serves to determine the mass of a body by using the action of gravity on that body and which may also serve to determine other mass-related magnitudes, quantities, parameters and characteristics; and
requires the intervention of an operator during weighing;
“ 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;
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“ place on the market ” means the first making available of a non-automatic weighing instrument on the market of 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 (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;
“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 Schedule 7 ;
“ technical specification ” means a document that prescribes technical requirements to be fulfilled by a regulated non-automatic weighing instrument;
“ Type-examination certificate ” means a type-examination certificate issued by an approved body in accordance with Module B of Schedule 7;
“ UK marking ” means the marking in the form set out in Annex 2 of RAMS;
“ UK national accreditation body ” means the body appointed by the Secretary of State in accordance with Article 4 of RAMS;
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“ 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.
(1A) Schedules 6 to 8 reproduce the provisions of Annexes I to III to the Directive (respectively) with amendments to correct deficiencies in assimilated 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.
(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 ; and
(b) Northern Ireland, the same meanings as in the Weights and Measures (Northern Ireland) Order 1981 .
(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 or 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).
(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 such technical specifications adopted by the other recognised standardisation bodies or 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.
(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.
(1) The Non-automatic Weighing Instruments Regulations 2000 and the Non-automatic Weighing Instruments (Amendment) Regulations 2008 are revoked.
(2) In this regulation, “ the former law ” means the Regulations referred to in paragraph (1) subject 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.
(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 , 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.
(1) In this regulation—
“ pre-exit period ” means the period beginning with the commencement date and ending immediately before IP completion day.
(2) Subject to paragraph (3), where a non-automatic weighing instrument was made available on the market during the pre-exit period, despite the amendments made by Schedule 26 to the Product Safety and Metrology etc. (Amendment etc.) (EU Exit) Regulations 2019 , any obligation to which a person was subject under these Regulations as they had effect immediately before IP completion day, continues to have effect as it did immediately before IP completion day, in relation to that non-automatic weighing instrument.
(3) Paragraph (2) does not apply to—
(a) any obligation of any competent authority to inform the European Commission or Member States of any matter; or
(b) any obligation to take action outside of the United Kingdom in respect of that non-automatic weighing instrument.
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(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”.
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(9) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
(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.
(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 a declaration of conformity; and
(e) affixed to the instrument or where paragraph (2) applies, in respect of the UK marking, to a label affixed to a product or to a document accompanying the product —
(i) the UK marking; and
(ii) the M marking.
(2) For a period of seven 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.
A manufacturer must keep the technical documentation and the EU 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.
(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 designated 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.
(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.
(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 clear, legible and in easily understandable English.
(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) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
(3) Such instructions and information and any labelling relating to a regulated non-automatic weighing instrument must be clear, legible and in easily understandable English .
(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 authority to that effect giving details, in particular, of the non-compliance and of any corrective measures taken.
(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.
(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 EU 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.
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 United Kingdom .
(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 UK 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).
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.
(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) 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 seven 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 clear, legible and in easily understandable English.
(1) An importer must ensure that regulated non-automatic weighing instruments imported by the importer are accompanied by instructions and information which are clear, legible and in easily understandable English .
(2) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
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.
(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.
(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.
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 EU 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.
(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.
This Chapter applies in relation to the making available on the market of a regulated non-automatic weighing instrument by a distributor.
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.
(1) The distributor must verify that the regulated non-automatic weighing instrument bears the UK marking and the M marking.
(2) The distributor must verify that the regulated non-automatic weighing instrument, it is accompanied by instructions and information which are clear, legible and in easily understandable English .
(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).
(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.
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.
(1) This regulation applies where a distributor considers, or has reason to believe, that a regulated non-automatic weighing instrument made 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.
(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.
(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).
(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) except 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.
(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.
(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) “ 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, a 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; and
(d) ensures that the technical documentation and other records and correspondence relating to the conformity assessment procedures are prepared in or translated into English.
(3) Where this paragraph applies—
(a) regulation 6(1)(a) to (c) is to be treated as being satisfied;
(b) regulations 34 to 36 and 45(5) and (6) do not apply;
(c) regulations 8, 14, 16(2)(a) and (b), 17, 20, 23, 28, 29, 44, 55, 58(4), 63 and 72 apply subject to the modifications in paragraph (4);
(d) regulation 40 and Schedule 9 apply subject to the modifications in paragraphs (4) and (5);
(e) regulations 41, 45(7), 67, 68 and 71 are to be read subject to the modifications in paragraph (5).
(4) The modifications referred to in paragraph (3)(c) and (d) are that—
(a) any reference to “essential requirements” is to be read as a reference to the essential requirements as set out in Annex I;
(b) any reference to “designated standard” is to be read as a reference to a harmonised standard;
(c) any reference to “conformity assessment procedure” is to be read as a reference to the applicable conformity assessment procedure as set out in Article 13;
(d) any reference to “technical documentation” is to be read as a reference to the technical documentation referred to in Annex II.
(5) The modifications referred to in paragraph (3)(d) and (e) are that—
(a) in regulation 40 the reference to “Schedule 7” is to be read as a reference to Annex II;
(b) in regulation 41 the reference to “enactment” is to be read as including the Directive;
(c) regulation 45(7) is to be read as if the words beginning with “and” and ending with “body” were omitted;
(d) in regulations 67(2)(b) and 68(4)(b) any reference to “type examination certificate” is to be read as a reference 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”;
(e) in regulation 71 and Schedule 9 any reference to “approved body” is to be read as a reference to the conformity assessment body that undertook the relevant conformity assessment procedure in accordance with Article 13;
(f) in Schedule 9 the reference to “relevant UK legislation” is to be read as including the Directive.
(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.
(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.
This Chapter applies for the purposes of establishing whether a regulated non-automatic weighing instrument complies with the essential requirements.
Conformity with the essential requirements may be established in relation to a regulated non-automatic weighing instrument—
(a) through conformity with designated standards (or parts of those standards) covering the essential requirements ...; or
(b) through the use by the manufacturer of any other technical solution that complies with the essential requirements.
Regulated non-automatic weighing instruments which are in conformity with designated 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).
(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 Schedule 7 followed by either—
(i) Module D as set out in point 2 of Schedule 7 ; or
(ii) Module F as set out in point 4 of Schedule 7 ; or
(b) Module G as set out in point 6 of Schedule 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 Schedule 7 ; or
(b) Module F1 as set out in point 5 of Schedule 7 .
(4) An 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 Schedule 7 .
(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.
(1) An 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 approved 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 an 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.
This Chapter applies in relation to EU declarations of conformity made in relation to a regulated non-automatic weighing instrument for the purposes of these Regulations.
(1) The ... 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 Schedule 9 ; and
(c) contain the elements specified in the relevant modules set out in Schedule 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 ... declaration of conformity in relation to the instrument must be in English.
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.
A manufacturer, who draws up a 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.
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 UK marking and the M marking.
(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.
The Non-automatic Weighing Instruments Regulations 2016 (legislation.gov.uk, OGL v3.0). Retrieved via LawPlayer, https://lawplayer.com/uk/act/uksi-2016-1152
Contains public sector information licensed under the Open Government Licence v3.0.
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