PART 2REGULATED NON-AUTOMATIC WEIGHING INSTRUMENTS – OBLIGATIONS OF ECONOMIC OPERATORS
CHAPTER 1OBLIGATIONS OF MANUFACTURERS AND PERSONS TO BE TREATED AS MANUFACTURERS
Introductory5.
(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 instruments6.
F1(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 F2a declaration of conformity; and
F5(2)
For a period of F6seven 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 instruments6.
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 records7.
A manufacturer must keep the technical documentation and the F7EU 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 requirements8.
(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 F8designated 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 requirements8.
(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.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 instruments10.
(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 F9clear, legible and in easily understandable English.
Manufacturers to mark contact details on regulated non-automatic weighing instruments10.
(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 Northern Ireland, they must be in English.
Documentation to accompany regulated non-automatic weighing instruments11.
(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.
F10(2)
. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
(3)
Such instructions and information and any labelling relating to a regulated non-automatic weighing instrument must be F11clear, legible and in easily understandable English.
Documentation to accompany regulated non-automatic weighing instruments11.
(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 Northern 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 requirements12.
(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 F12authority 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 requirements12.
(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 relevant 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 authority13.
(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 manufacturers14.
(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 F13EU 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 2OBLIGATIONS OF IMPORTERS
Introductory15.
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 F14United Kingdom.
Introductory15.
This Chapter applies to the placing on the market of a regulated non-automatic weighing instrument that is imported into Northern Ireland from a country outside the relevant market.
Ensuring compliance of regulated non-automatic weighing instruments16.
(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 F15UK 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 instruments16.
(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 risk17.
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 instruments18.
(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.
F16(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 F17seven 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 F18clear, legible and in easily understandable English.
Requirements to mark importers' details on regulated non-automatic weighing instruments18.
(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 Northern Ireland, they must be in English.
Importers' duty to ensure that regulated non-automatic weighing instruments are accompanied by relevant documentation.19.
(1)
An importer must ensure that regulated non-automatic weighing instruments imported by the importer are accompanied by instructions and information F19which are clear, legible and in easily understandable English.
F20(2)
. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Importers' duty to ensure that regulated non-automatic weighing instruments are accompanied by relevant documentation.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 Northern Ireland, the instructions and information referred to in paragraph (1) must be in English.
Duty of importers to ensure proper conditions of storage and transport20.
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.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 requirements22.
(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 F21EU declaration of conformity23.
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 F22EU 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 authority24.
(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 3OBLIGATIONS OF DISTRIBUTORS
Introductory25.
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 care26.
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 obligations27.
(1)
The distributor must verify that the regulated non-automatic weighing instrument bears the F23UK marking and the M marking.
(2)
The distributor must verify that the regulated non-automatic weighing instrument, it is accompanied by instructions and information F24which are clear, legible and in easily understandable English.
F25(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 obligations27.
(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 Northern 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.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 transport29.
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 requirements30.
(1)
This regulation applies where a distributor considers, or has reason to believe, that a regulated non-automatic weighing instrument F26made 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 authority31.
(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 4IDENTIFICATION 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).
F27Obligations which are met by complying with obligations in the Directive32A.
(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)
F28except 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.
F27Conformity assessment procedure obligations that are met by complying with the Directive32B.
(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.
F29Further use of UK marking32C.
(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.
F27Qualifying Northern Ireland Goods32D.
(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.
F30(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.