Citation commencement and extent
(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.
Interpretation
(1) In these Regulations— ... ... “ 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; ... “ commencement date ” means the date referred to in regulation 1(2); ... “ 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 ; ... ... ... “ 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; ... “ 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; ... ... “ 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; ... “ 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 .
Designated standard
(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.
Application of these Regulations
(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 provisions
(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.
Transitional provision in relation to EU Exit
(1) In this regulation— “ pre-exit period ” means the period beginning with the commencement date and ending immediately before IP completion day. (2) Subject to paragraph (3), where a non-automatic weighing instrument was made available on the market during the pre-exit period, despite the amendments made by Schedule 26 to the Product Safety and Metrology etc. (Amendment etc.) (EU Exit) Regulations 2019 , any obligation to which a person was subject under these Regulations as they had effect immediately before IP completion day, continues to have effect as it did immediately before IP completion day, in relation to that non-automatic weighing instrument. (3) Paragraph (2) does not apply to— (a) any obligation of any competent authority to inform the European Commission or Member States of any matter; or (b) any obligation to take action outside of the United Kingdom in respect of that non-automatic weighing instrument. (4) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . (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”. (8) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . (9) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
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