Statutory Instrument 2006 No. 1258

The Measuring Instruments (Automatic Gravimetric Filling Instruments) Regulations 2006

(The document as of February, 2008)

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STATUTORY INSTRUMENTS

2006 No. 1258

WEIGHTS AND MEASURES

The Measuring Instruments (Automatic Gravimetric Filling Instruments) Regulations 2006

	Made	28th April 2006
	Laid before Parliament	5th May 2006
	Coming into force
	Regulations 1, 2, 7, 9 and 10 and Part 1 of Schedule 2	30th May 2006
	Remaining regulations	30th October 2006

CONTENTS

PART I
PRELIMINARY

1.	Citation and commencement

2.	Interpretation

3.	Application

PART II
PLACING ON THE MARKET AND PUTTING INTO USE OF AUTOMATIC GRAVIMETRIC FILLING INSTRUMENTS

4.	Requirements for placing on the market and putting into use

5.	Compliance with the essential requirements

6.	Conformity assessment procedures

7.	Designation of United Kingdom notified bodies

8.	Functions of notified bodies

9.	Provisions supplemental to regulation 7

10.	Variation and termination of designations

11.

Fees

12.	Marking and identification requirements

13.	Conformity with other directives

PART III
USE FOR TRADE OF AUTOMATIC GRAVIMETRIC FILLING INSTRUMENTS

14.	Requirements for use for trade

15.	Manner of use

16.	Automatic gravimetric filling instruments to be set to zero

17.	Manner of erection and installation

PART IV
ENFORCEMENT

18.	Enforcement authority

19.	Compliance notice procedure

20.	Immediate enforcement action

21.	Review by the Secretary of State

22.	Disqualification

23.	Re-qualification

24.	Testing of automatic gravimetric filling instruments

25.	Unauthorised application of authorised marks

26.	Powers of entry and inspection

27.	Obstruction of enforcement officer

28.	Penalties for offences

29.	Defence of due diligence

30.	Liability of persons other than the principal offender

PART V
MISCELLANEOUS AND SUPPLEMENTAL

31.	Service of documents

32.	Savings for certain privileges

33.	The Electromagnetic Compatibility Regulations 2005

34.	Adaptation for Northern Ireland

SCHEDULE 1—

ESSENTIAL REQUIREMENTS

SCHEDULE 2—

NOTIFIED BODIES

PART 1—

NOTIFIED BODY CRITERIA

PART 2—

FUNCTIONS

SCHEDULE 3—

TECHNICAL DOCUMENTATION

SCHEDULE 4—

MARKING AND INSCRIPTIONS

SCHEDULE 5—

REQUIREMENTS FOR USE FOR TRADE

PART 1—

ACCURACY CLASSES

PART 2—

MAXIMUM PERMISSIBLE ERRORS

SCHEDULE 6—

ADAPTATIONS FOR NORTHERN IRELAND

The Secretary of State is a Minister designated[1] for the purposes of section 2(2) of the European Communities Act 1972[2] in relation to, and for purposes ancillary to, the regulation of specifications, construction, placing on the market and use of articles, instruments, containers or other equipment intended for weighing, measuring or testing.

    The Secretary of State makes the following Regulations under the powers conferred on him by section 2(2) of that Act and, in relation to Part III of the Regulations, under the powers conferred on him by sections 15(1) and 86(1) of the Weights and Measures Act 1985[3].



PART I
PRELIMINARY
Citation and commencement
    1.—(1) These Regulations may be cited as the Measuring Instruments (Automatic Gravimetric Filling Instruments) Regulations 2006.

    (2) This regulation, regulations 2, 7, 9 and 10 and Part 1 of Schedule 2 shall come into force on 30th May 2006.

    (3) The remaining regulations shall come into force on 30th October 2006.

Interpretation
    2.—(1) In these Regulations—

"accuracy class" means the classification of an automatic gravimetric filling instrument determined in accordance with—

(a) the provisions of regulation 14 in the case of an automatic gravimetric filling instrument when put into use for trade; and

(b) paragraph 16 of Schedule 1 in the case of an automatic gravimetric filling instrument when placed on the market or put into use,

but the accuracy class in respect of that automatic gravimetric filling instrument shall not be of a higher level of precision than the reference value for accuracy class in respect of that instrument;

"authorised representative" means a person who is established in a member State and is authorised by a manufacturer, in writing, to act on his behalf;

"automatic gravimetric filling instrument" means an automatic weighing instrument that fills containers with a predetermined and virtually constant mass of product from bulk;

"automatic weighing instrument" means an instrument that determines the mass of a product without the intervention of an operator and follows a predetermined programme of automatic processes characteristic of the instrument intended to determine the mass of a body by using the action of gravity on that body;

"CE marking" means the CE marking referred to in regulation 12;

"the Commission" means the European Commission;

"compliance notice" means a notice served in accordance with regulation 19(2);

"conformity assessment procedure" means any procedure referred to in regulation 6;

"the Directive" means Directive 2004/22/EC of the European Parliament and of the Council of 31st March 2004 on measuring instruments[4];

"disqualification sticker" means a sticker the design of which is published by the Secretary of State and which is affixed to an automatic gravimetric filling instrument in accordance with regulation 22;

"enforcement authority" means any person who is, pursuant to regulation 18, authorised to enforce these Regulations;

"enforcement notice" means a notice served in accordance with regulation 20(2);

"enforcement officer" means—

(a) an inspector; or

(b) a person appointed by the Secretary of State to act on his behalf to enforce Part II of these Regulations;

"essential requirements" means the requirements set out in Schedule 1;

"harmonised standard" means a technical specification adopted by the European Committee for Standardisation (CEN), the European Committee for Electrotechnical Standardisation (CENELEC) or the European Telecommunications Standards Institute (ETSI) or jointly by two or all of these organisations, at the request of the Commission pursuant to Directive 98/34/EC of the European Parliament and of the Council of 22nd June 1998 laying down a procedure for the provision of information in the field of technical standards and regulations and of rules on Information Society Services[5], as amended by Directive 98/48/EC[6], and prepared in accordance with the General Guidelines agreed between the Commission and one or more of CEN, CENELEC and ETSI;

"in writing" includes text that is—

(a) transmitted by electronic means;

(b) received in legible form; and

(c) capable of being used for subsequent reference;

"load receptor" means a part of an automatic gravimetric filling instrument on which loads are placed for the purpose of their being weighed;

"M marking" means the M marking referred to in regulation 12;

"manufacturer" means a person responsible for the conformity of an automatic gravimetric filling instrument with these Regulations with a view to either placing it on the market under his own name or putting it into use for his own purposes, or both;

"maximum capacity" means the maximum discrete load which the automatic gravimetric filling instrument is authorised to weigh and that can be weighed automatically on a load receptor;

"maximum permissible error" means, in the case of an automatic gravimetric filling instrument—

(a) when it is placed on the market or put into use, the limit of error determined in accordance with paragraph 17 of Schedule 1; and

(b) when it is in use for trade, the limit of error determined in accordance with paragraph 1 of Part 2 of Schedule 5;

"minimum capacity" means the minimum discrete load which the automatic gravimetric filling instrument is authorised to weigh and that can be weighed automatically on a load receptor;

"normative document" means a document containing technical specifications adopted by the Organisation Internationale de Métrologie Légale, subject to the procedure stipulated in Article 16.1, the reference of which is published by the Commission in the Official Journal of the European Union pursuant to Article 16.1(b);

"notified body" means—

(a) the Secretary of State; or

(b) a United Kingdom notified body; and

(c) for the purposes of regulations 4(1)(c), 20(1)(b), 22(1)(c) and 25(6), a person designated by another member State,

who has been notified to the Commission and the other member States pursuant to Article 11.1;

"notified body criteria" means the criteria set out in Part 1 of Schedule 2;

"place on the market" means making available for the first time in a member State an automatic gravimetric filling instrument intended for an end user, whether for reward or free of charge;

"put into use" means the first use of an automatic gravimetric filling instrument intended for the end user for the purposes for which it was intended;

"reference value for accuracy class" means the value for accuracy class of an automatic gravimetric filling instrument determined by static testing of the weighing unit during influence quality testing prior to a certificate of approval being issued;

"relevant national standard" means a standard applicable to an automatic gravimetric filling instrument—

(a) implementing a harmonised standard that has been published in the Official Journal of the European Union C series; and

(b) the reference of which is published—


(i) in the United Kingdom by the Secretary of State; or

(ii) in another member State by the competent authority pursuant to the third sub-paragraph of Article 13.1;

"relevant normative document" means a normative document applicable to an automatic gravimetric filling instrument, the reference of which is published—

(a) in the United Kingdom by the Secretary of State; or

(b) in another member State by the competent authority pursuant to the third sub-paragraph of Article 13.2;

"re-qualification sticker" means a sticker the design of which is published by the Secretary of State and which is affixed to an automatic gravimetric filling instrument in accordance with regulation 23;

"United Kingdom notified body" means a person designated under regulation 7; and

"weighing unit" means a device which provides information on the mass of the load being weighed by the automatic gravimetric filling instrument.

    (2) Other expressions used in these Regulations have the same meanings as in the Weights and Measures Act 1985.

    (3) In these Regulations, a reference to a member State includes Norway, Iceland and Liechtenstein[7].

    (4) References in these Regulations to an Article, Annex or a part of an Annex are references to an Article, Annex or a part of an Annex to the Directive.

Application
    3.—(1) Subject to paragraphs (2) and (3), these Regulations apply to an automatic gravimetric filling instrument which is—

(a) for use for trade; and

(b) first placed on the market or put into use on or after 30th October 2006.

    (2) These Regulations do not apply to an automatic gravimetric filling instrument—

(a) in respect of which a certificate of approval has been granted before 30th October 2006 and is in force; and

(b) which is first passed as fit for use for trade and stamped under the the Weights and Measures Regulations 1963[8]; the Weighing Equipment (Filling and Discontinuous Totalising Automatic Weighing Machines) Regulations 1986[9]; or the Weighing Equipment (Automatic Gravimetric Filling Instruments) Regulations 2000[10].

    (3) These Regulations do not apply to an automatic gravimetric filling instrument which is not compliant with the essential requirements and which is displayed or presented at a trade fair, exhibition or demonstration, if a sign displayed visibly on or near the instrument clearly indicates that the instrument—

(a) is not compliant with those requirements; and

(b) cannot be acquired or used until it is made compliant with those requirements by the manufacturer.

PART II
PLACING ON THE MARKET AND PUTTING INTO USE OF AUTOMATIC GRAVIMETRIC FILLING INSTRUMENTS
Requirements for placing on the market and putting into use
    4.—(1) No person shall place on the market or put into use an automatic gravimetric filling instrument unless the following requirements, or the corresponding requirements of the Directive as implemented under the law of another member State, are met—

(a) the instrument is compliant with the essential requirements;

(b) the manufacturer has demonstrated its compliance with the essential requirements in accordance with regulation 5; and

(c) the instrument has affixed to it the CE marking, the M marking and the identification number of the notified body which carried out the conformity assessment procedure in respect of the instrument.

    (2) A person who fails to comply with the requirements of paragraph (1) shall be guilty of an offence and any automatic gravimetric filling instrument to which the offence relates shall be liable to be forfeited.

Compliance with the essential requirements
    5.—(1) A manufacturer may demonstrate that an automatic gravimetric filling instrument is compliant with the essential requirements by—

(a) using any technical solution that is compliant with the essential requirements;

(b) correctly applying solutions set out in the relevant national standard; or

(c) correctly applying solutions set out in the relevant normative document,

and selecting and following one of the conformity assessment procedures.

    (2) An automatic gravimetric filling instrument which is compliant with the relevant national standard or relevant normative document shall be presumed to be compliant with the essential requirements.

    (3) Where the automatic gravimetric filling instrument is compliant only in part with the relevant national standard or relevant normative document, it shall be presumed to be compliant only with that part of the essential requirements which corresponds to the element of the relevant national standard or relevant normative document with which the instrument is compliant.

    (4) Where an automatic gravimetric filling instrument includes or is connected to a device which is not used for trade—

(a) that device shall not be subject to the essential requirements; and

(b) the instrument may be considered to be compliant with the essential requirements notwithstanding that the compliance of that device with the essential requirements has not been established.

Conformity assessment procedures
    6.—(1) The conformity assessment procedures are the procedures as follows—

(a) for mechanical systems—


(i) B and D;

(ii) B and E;

(iii) B and F;

(iv) D1;

(v) F1;

(vi) G; or

(vii) H1;



(b) for electromechanical instruments—



(i) B and D;

(ii) B and E;

(iii) B and F;

(iv) G; or

(v) H1; and



(c) for electronic systems or systems containing software—



(i) B and D;

(ii) B and F;

(iii) G; or

(iv) H1.

    (2) The manufacturer or his authorised representative shall provide to the notified body carrying out the relevant conformity assessment procedure the technical documentation set out in Schedule 3.

    (3) In this regulation—

(a) "B" means type examination, set out in Annex B;

(b) "D" means declaration of conformity to type based on quality assurance of the production process, set out in Annex D;

(c) "D1" means declaration of conformity based on quality assurance of the production process, set out in Annex D1;

(d) "E" means declaration of conformity to type based on quality assurance of final product inspection and testing, set out in Annex E;

(e) "F" means declaration of conformity to type based on product verification, set out in Annex F;

(f) "F1" means declaration of conformity based on product verification, set out in Annex F1;

(g) "G" means declaration of conformity based on unit verification, set out in Annex G; and

(h) "H1" means declaration of conformity based on full quality assurance plus design examination, set out in Annex H1.

Designation of United Kingdom notified bodies
    7.—(1) The Secretary of State may, on the application of a person, designate that person to be a United Kingdom notified body.

    (2) The Secretary of State shall not make a designation under paragraph (1) unless he is satisfied that the person meets the notified body criteria.

    (3) A person who meets the criteria laid down in a national standard shall be presumed to meet that part of the notified body criteria which corresponds to the criteria in the national standard.

    (4) A designation under paragraph (1)—

(a) shall be in writing;

(b) may be made subject to such conditions as may be specified in the designation, which may include conditions which—


(i) are to apply upon or following termination of the designation;

(ii) require the use of test equipment for the purpose of conformity assessment appropriate to the automatic gravimetric filling instrument being assessed; and

(iii) limit the description of any automatic gravimetric filling instrument for which the person is designated;



(c) subject to regulation 10, may last for such period as may be specified in the designation;

(d) shall specify the conformity assessment procedures and specific tasks (which may be framed by reference to any circumstances) which the person has been designated to carry out; and

(e) may include a requirement to publish from time to time the scale of fees which the person charges pursuant to regulation 11 or such information about the basis of calculation of such fees as may be specified.

    (5) In exercising the power conferred on him by paragraph (1), the Secretary of State may (in addition to the matters of which he is required to satisfy himself pursuant to paragraph (2)) have regard to any matter appearing to him to be relevant.

    (6) For the purposes of paragraph (3), "national standard" means a standard applicable to the designation of notified bodies—

(a) implementing a harmonised standard that has been published in the Official Journal of the European Union; and

(b) the reference of which is published—


(i) in the United Kingdom by the Secretary of State; or

(ii) in another member State by the competent authority pursuant to Article 11.2.

Functions of notified bodies
    8.A notified body shall carry out the functions set out in Part 2 of Schedule 2.

Provisions supplemental to regulation 7
    9.—(1) The Secretary of State shall, from time to time, publish a list of notified bodies indicating, in the case of each United Kingdom notified body, the description of any automatic gravimetric filling instrument in respect of which that notified body is designated; and such a list may include information concerning any condition to which the designation of any United Kingdom notified body is subject.

    (2) The Secretary of State shall, from time to time, carry out an inspection of each United Kingdom notified body with a view to verifying that it—

(a) meets the notified body criteria;

(b) complies with any condition to which its designation is subject; and

(c) complies with these Regulations,

but, unless it appears to him that there are circumstances which make it necessary or expedient to do so, he shall not carry out an inspection within two years from the date of designation under regulation 7, or of any later inspection under this paragraph.

Variation and termination of designations
    10.—(1) The Secretary of State may vary a designation made under regulation 7 if—

(a) the United Kingdom notified body so requests; or

(b) it appears to him necessary or expedient to do so.

    (2) The Secretary of State may terminate a designation made under regulation 7—

(a) on the expiry of 90 days' notice in writing at the request of the United Kingdom notified body;

(b) if it appears to him that any condition of the designation is not complied with; or

(c) if in his opinion the United Kingdom notified body ceases to satisfy the notified body criteria.

    (3) Where the Secretary of State is minded to—

(a) vary a designation pursuant to paragraph (1)(b); or

(b) terminate a designation pursuant to paragraph (2)(b) or (c),

he shall—

(i) give notice in writing to the United Kingdom notified body of his reasons; and

(ii) give that notified body the opportunity to make representations within a period of 21 days from the date of that notice and consider any representations made to him within that period.

    (4) If a designation is terminated under paragraph (2), the Secretary of State may—

(a) give such directions (either to the United Kingdom notified body the subject of the termination or to another United Kingdom notified body) for the purposes of making arrangements for the determination of outstanding applications as he considers appropriate; and

(b) notwithstanding sub-paragraph (a), authorise another United Kingdom notified body to take over the functions of the United Kingdom notified body the subject of the termination in respect of such cases as he may specify.

Fees
    11.—(1) A United Kingdom notified body may charge such 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) shall not exceed the following—

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

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


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

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

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

    (4) Where any fees payable to a United Kingdom notified body pursuant to this regulation remain unpaid 28 days after either the work has been completed or payment of the fees has been requested in writing, whichever is the later, that 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.

Marking and identification requirements
    12.—(1) Where an automatic gravimetric filling instrument is compliant with the essential requirements—

(a) the manufacturer shall affix the CE marking and the M marking to the instrument; and

(b) the notified body which carries out the conformity assessment procedure in respect of that instrument shall affix its identification number to the instrument, or may agree that the manufacturer shall do so on its behalf.

    (2) Any other marking may be affixed to the automatic gravimetric filling instrument provided that the visibility and legibility of the CE marking, the M marking and the identification number of the notified body are not reduced.

    (3) For the purposes of paragraph (1)—

(a) the CE marking means the symbol "CE", which shall be compliant with the requirements of paragraphs 1, 4 and 5 of Schedule 4;

(b) the M marking means the capital letter "M" which shall be compliant with the requirements of paragraphs 2, 4 and 5 of Schedule 4; and

(c) the identification number of the notified body shall be compliant with the requirements of paragraphs 3, 4 and 5 of Schedule 4.

Conformity with other directives
    13.—(1) Where an automatic gravimetric filling instrument falls within the scope of other directives which provide for the affixing of the CE marking, the affixing of the CE marking under these Regulations shall indicate that the instrument is also presumed to be compliant with the requirements of those other directives.

    (2) Where paragraph (1) applies, the publication reference of such other directives in the Official Journal of the European Union must be given in the documents, notices or instructions required to accompany the automatic gravimetric filling instrument.

PART III
USE FOR TRADE OF AUTOMATIC GRAVIMETRIC FILLING INSTRUMENTS
Requirements for use for trade
    14.No person shall use for trade an automatic gravimetric filling instrument unless—

(a) it is compliant with the essential requirements other than the provisions relating to maximum permissible errors referred to in paragraph 17 of Schedule 1;

(b) the requirements of regulations 15 and 16 are complied with;

(c) it has been erected and installed in accordance with the requirements of regulation 17;

(d) the instrument operates within the limits of maximum permissible error set out in Table 2 in Part 2 of Schedule 5;

(e) subject to paragraph (f), where test fills are required, these limits are determined on the basis of consecutive fills; and

(f) in the case of an instrument of the description and maximum capacity set out, respectively, in columns 1 and 2 of Table 1 in Part 1 of Schedule 5, it is within the accuracy class specified for that instrument in column 3 or within an accuracy class of a higher level of precision than the specified class.

Manner of use
    15.—(1) Where an automatic gravimetric filling instrument is marked with a temperature range, it shall not be used for trade in temperatures outside that range.

    (2) Where an automatic gravimetric filling instrument bears a mark which signifies the manner and purpose of use, it shall not be used for trade in a manner or for a purpose which does not accord with that marking.

    (3) An automatic gravimetric filling instrument shall only be used for trade for the purpose of weighing material the value of which, expressed in units of measurement of mass, is neither less than the value of the minimum capacity nor more than the value of the maximum capacity.

    (4) An automatic gravimetric filling instrument shall not be used for trade in circumstances—

(a) in which it may be prevented from operating consistently or accurately; or

(b) which are likely prematurely to degrade its metrological characteristics.

Automatic gravimetric filling instruments to be set to zero
    16.—(1) Subject to paragraph (2), a person shall not use an automatic gravimetric filling instrument for trade unless it is properly balanced or set to zero immediately prior to use.

    (2) Paragraph (1) shall not apply in the case of an instrument if it is designed so as not to balance when unloaded.

Manner of erection and installation
    17.—(1) Every automatic gravimetric filling instrument shall be so positioned as to facilitate cleaning and testing.

    (2) If any special equipment for an automatic gravimetric filling instrument, as referred to in paragraph 9(5) of Schedule 1 is not a permanent fixture of the instrument, it shall be kept in the vicinity of the instrument.

PART IV
ENFORCEMENT
Enforcement authority
    18.—(1) It shall be the duty of every local weights and measures authority to enforce these Regulations within its area.

    (2) The Secretary of State may enforce Part II of these Regulations and for that purpose may appoint any person to act on his behalf.

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

    (4) Nothing in these Regulations shall authorise an enforcement authority to bring proceedings in Scotland for an offence.

Compliance notice procedure
    19.—(1) Where an enforcement authority establishes that, in the case of an automatic gravimetric filling instrument that has been placed on the market or put into use, the CE marking or the M marking has, or both have, been affixed unduly, the following provisions of this regulation shall have effect.

    (2) The enforcement authority shall serve a compliance notice on the manufacturer or his authorised representative which shall—

(a) be in writing;

(b) describe the automatic gravimetric filling instrument to which it relates in a manner sufficient to identify that instrument;

(c) state that the enforcement authority is of the opinion that the CE marking or the M marking has, or both have, been affixed unduly to the automatic gravimetric filling instrument and give reasons for its opinion;

(d) require the person on whom the notice is served to end the infringement under conditions specified in the notice;

(e) specify the date, being not less than 21 days from the date of the notice, by which the infringement must be ended; and

(f) warn that person that, where the non-conformity continues beyond the date specified in sub-paragraph (e), the enforcement authority may take further action under regulation 20 in respect of that automatic gravimetric filling instrument.

    (3) For the purposes of paragraph (1)—

(a) the CE marking shall be considered to have been affixed unduly if it is not compliant with the requirements of regulation 12(3)(a); and

(b) the M marking shall be considered to have been affixed unduly if it is not compliant with the requirements of regulation 12(3)(b).

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

Immediate enforcement action
    20.—(1) Where an enforcement authority has reasonable grounds for considering that—

(a) the manufacturer or his authorised representative has failed to comply with a compliance notice;

(b) an automatic gravimetric filling instrument, which is placed on the market or put into use, does not bear one or more of the CE marking, the M marking and the identification number of the notified body which carried out the conformity assessment procedure in respect of that instrument; or

(c) an automatic gravimetric filling instrument which bears the marking and identification requirements referred to in sub-paragraph (b) does not meet the essential requirements when placed on the market, or properly installed and put into use in accordance with the manufacturer's instructions,

the following provisions of this regulation shall have effect.

    (2) The enforcement authority shall serve an enforcement notice on the manufacturer or his authorised representative which shall—

(a) be in writing;

(b) describe the automatic gravimetric filling instrument to which it relates in a manner sufficient to identify that instrument;

(c) specify, with reasons, the respects in which, in the opinion of the enforcement authority, the requirements of these Regulations have not been complied with;

(d) specify the date, being not less than 21 days from the date of the notice, by which the person to whom the notice is given is required to comply with it; and

(e) inform that person of the judicial remedies available to him and of the time limits to which those remedies are subject.

    (3) A notice under paragraph (2) may—

(a) require the automatic gravimetric filling instrument to be withdrawn from the market; or

(b) prohibit or restrict the placing on the market or putting into use of the automatic gravimetric filling instrument; and

(c) specify that unless steps are taken which ensure—


(i) that the automatic gravimetric filling instrument is compliant with the requirements of these Regulations; or

(ii) that the manufacturer or his authorised representative acts as required under sub-paragraph (a) or (b),



any certificate or notification, issued by a notified body in accordance with the relevant conformity assessment procedure applicable to the automatic gravimetric filling instrument that the instrument satisfies the essential requirements, may be withdrawn by that notified body.

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

    (5) In the case of a certificate or notification referred to in paragraph (3)—

(a) which is granted by a United Kingdom notified body, if the Secretary of State is of the opinion that consideration ought to be given to whether the certificate or notification should be withdrawn, he shall inform that notified body of that fact; and

(b) which is granted under the law of another member State, if the Secretary of State is of the opinion that consideration ought to be given to whether the certificate or notification should be withdrawn, he shall inform the relevant competent authority of that fact.

Review by the Secretary of State
    21.—(1) Where a person is aggrieved by a compliance notice or an enforcement notice served by an enforcement authority other than the Secretary of State, that person may apply to the Secretary of State to review such notice.

    (2) An application under paragraph (1) shall—

(a) be in writing;

(b) state the grounds on which the application is made; and

(c) be sent to the Secretary of State within 21 days from the date of the notice referred to in paragraph (1).

    (3) The Secretary of State may—

(a) hold an inquiry in connection with the notice which is the subject of his review; and

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

    (4) The Secretary of State shall, within a reasonable time, inform the aggrieved person and the enforcement authority referred to in paragraph (1) in writing of his decision whether to uphold the notice served by that authority, together with reasons for his decision.

    (5) Where the Secretary of State does not uphold any notice referred to in paragraph (1), he shall give instructions for the withdrawal of that notice.

Disqualification
    22.—(1) If it appears to an inspector that an automatic gravimetric filling instrument which bears—

(a) the CE marking;

(b) the M marking; and

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

is used for trade in circumstances where—

(i) the instrument is no longer compliant with one or more of the requirements of regulation 14; or

(ii) by reason of any adjustment, alteration, addition, repair or replacement it is likely that the instrument has ceased to be compliant with one or more of the requirements of regulation 14,



the inspector may affix a disqualification sticker to the automatic gravimetric filling instrument.

    (2) Where one or more of the markings and identification requirements referred to in paragraph (1) is not affixed to an automatic gravimetric filling instrument, the inspector may affix a disqualification sticker to the instrument.

    (3) Where it appears to the inspector that the nature or degree of non-compliance of the automatic gravimetric filling instrument under paragraph (1) is not such that a disqualification sticker should be immediately affixed to it, he may give to any person in possession of the instrument a notice requiring that person to rectify the non-compliance before the expiry of a stated period not less than 14 days and not exceeding 28 days from the date of the notice.

    (4) If a notice given under paragraph (3) is not complied with, the inspector shall affix a disqualification sticker to the automatic gravimetric filling instrument.

    (5) A disqualification sticker which is affixed to an automatic gravimetric filling instrument shall be affixed in such a position that it is clearly visible when the instrument is in its regular operating position.

    (6) A person shall be guilty of an offence if he uses for trade an automatic gravimetric filling instrument to which there is affixed a disqualification sticker, unless a re-qualification sticker has been affixed to the instrument in accordance with regulation 23.

Re-qualification
    23.—(1) Where—

(a) a disqualification sticker has been affixed to an automatic gravimetric filling instrument in accordance with regulation 22(1), 22(2) or 22(4);

(b) a notice has been served under regulation 22(3); or

(c) the automatic gravimetric filling instrument is intended to be used for trade in the circumstances referred to in regulation 22(1)(i) or (ii) or 22(2) but a disqualification sticker has not been affixed to the instrument,

a person requiring a re-qualification sticker to be affixed to the instrument shall submit it, in such manner as may be directed, to an inspector or approved verifier and provide such assistance as the inspector or approved verifier may reasonably require.

    (2) An inspector or approved verifier may affix a re-qualification sticker to that automatic gravimetric filling instrument if satisfied that the instrument is compliant with—

(a) the essential requirements; and

(b) the requirements of regulation 14(b), (c) (e) and (f).

    (3) For the purposes of being satisfied that a re-qualification sticker may be affixed to an automatic gravimetric filling instrument, an inspector or approved verifier may take such steps as he considers appropriate, including testing the instrument by means of such test equipment as he considers appropriate and suitable for the purpose.

    (4) There may be charged in respect of any steps taken under paragraph (3)—

(a) by an inspector, such reasonable fees as the local weights and measures authority may determine; and

(b) by an approved verifier, such reasonable fees as he may determine,

having regard to the character and extent of the work done or to be done.

    (5) The inspector or approved verifier shall keep a record of any test carried out under paragraph (3).

    (6) Where a re-qualification sticker is affixed to an automatic gravimetric filling instrument pursuant to paragraph (2), it shall be affixed in such a position that it obliterates as far as possible any disqualification sticker.

Testing of automatic gravimetric filling instruments
    24.Where an inspector considers that a test of an automatic gravimetric filling instrument is necessary, otherwise than for the purposes of regulation 23(3), he may require the person who has control of the instrument, or whom he has reasonable cause to believe has control of it, to provide to him such equipment, materials, qualified personnel or other assistance as the inspector may reasonably require.

Unauthorised application of authorised marks
    25.—(1) Subject to paragraph (2), a person shall be guilty of an offence if, in the case of an automatic gravimetric filling instrument, he—

(a) affixes an authorised mark to the instrument otherwise than in accordance with these Regulations;

(b) alters or defaces an authorised mark affixed to the instrument;

(c) removes an authorised mark affixed to the instrument; or

(d) affixes any other marking to the instrument which is likely to deceive any person as to the meaning or form, or both, of an authorised mark.

    (2) Where the alteration or defacement of an authorised mark is occasioned solely—

(a) in the course of the adjustment or repair of an automatic gravimetric filling instrument by a person regularly engaged in the business of repair of such instruments, or by his authorised agent; or

(b) by an enforcement officer or approved verifier in the carrying out of any of his functions under these Regulations,

that person or his authorised agent, enforcement officer or approved verifier shall not be guilty of an offence under paragraph (1)(b).

    (3) A person shall be guilty of an offence if he places on the market, puts into use or uses for trade an automatic gravimetric filling instrument—

(a) which, to his knowledge, bears—


(i) an authorised mark affixed otherwise than in accordance with these Regulations;

(ii) an authorised mark that has been altered or defaced otherwise than in the circumstances referred to in paragraph (2); or

(iii) any marking which is likely to deceive any person as to the meaning or form, or both, of an authorised mark; or



(b) from which, to his knowledge, an authorised mark has been removed.

    (4) An automatic gravimetric filling instrument in respect of which an offence under this regulation has been committed and any implement used in the commissioning of the offence shall be liable to be forfeited.

    (5) A reference in this regulation to other provisions of these Regulations includes a reference to corresponding provisions under the laws of other member States.

    (6) In this regulation, "authorised mark" means the CE marking, the M marking, the identification number of the notified body which carried out the conformity assessment procedure in respect of the automatic gravimetric filling instrument, disqualification sticker or re-qualification sticker.

Powers of entry and inspection
    26.—(1) Subject to the production if so requested of his credentials, an enforcement officer may for the purposes of these Regulations, at all reasonable times—

(a) inspect and test any automatic gravimetric filling instrument in such manner as he considers appropriate;

(b) inspect and take copies of any document relating to an automatic gravimetric filling instrument; and

(c) enter any premises at which he has reasonable cause to believe there to be an automatic gravimetric filling instrument, not being premises used only as a private dwelling house.

    (2) Subject to the production if so requested of his credentials, an enforcement officer may, at any time, seize and detain—

(a) an automatic gravimetric filling instrument which he has reasonable cause to believe is liable to be forfeited under these Regulations; and

(b) any document or goods which he has reason to believe may be required as evidence in proceedings for an offence under these Regulations.

    (3) If a justice of the peace, on written information on oath—

(a) is satisfied that there are reasonable grounds to believe that any automatic gravimetric filling instrument or document as is mentioned in paragraph (1) or (2) is on any premises, or that an offence under these Regulations has been, is being or is about to be committed on any premises; and

(b) is also satisfied either that—


(i) admission to the premises has been or is likely to be refused, and that notice of intention to apply for a warrant has been given to the occupier; or

(ii) an application for admission, or the giving of such a notice would defeat the object of the entry, or that the case is one of urgency, or that the premises are unoccupied or the occupier is temporarily absent,

the justice may by warrant under his hand, which shall continue in force for a period of one month, authorise the enforcement officer to enter the premises, if need be by force.

    (4) In the application of paragraph (3) to Scotland, "justice of the peace" includes a sheriff and references to written information on oath shall be construed as references to evidence on oath.

    (5) An enforcement officer entering any premises by virtue of this regulation may take such other persons and such equipment as may appear to him necessary, and on leaving such premises which he has entered by virtue of a warrant under paragraph (3), being premises which are unoccupied or the occupier of which is temporarily absent, he shall leave them as effectively secured against a trespasser as he found them.

    (6) If an enforcement officer or other person who enters any work-place by virtue of this regulation discloses to any person any information obtained by him in the work-place with regard to any secret manufacturing process or trade secret, he shall, unless the disclosure was made in the performance of his duty, be guilty of an offence.

    (7) It shall not be an offence under paragraph (6) for a person to disclose information in circumstances where—


(a) the person from whom the information was received has consented to its disclosure; or

(b) the information is disclosed more than 50 years after it was received.



    (8) Nothing in this regulation shall authorise any person to stop any vehicle on a highway.

    (9) In this regulation, "credentials" means evidence of appointment or designation as an enforcement officer.

Obstruction of enforcement officer
    27.—(1) A person shall be guilty of an offence if he—



(a) wilfully obstructs an enforcement officer in the execution of any of his functions under these Regulations; or

(b) without reasonable cause fails to give that officer any assistance or information which the officer has reasonably required of him for the purpose of the performance by the enforcement authority of its functions under these Regulations.



    (2) A person shall be guilty of an offence if, in giving an enforcement officer such information as is mentioned in paragraph (1)(b), that person gives any information which he knows to be false.

Penalties for offences
    28.A person guilty of an offence under Part II or Part IV shall be liable, on summary conviction, to a fine not exceeding level 5 on the standard scale.

Defence of due diligence
    29.—(1) Subject to the following provisions of this regulation, in proceedings against a person for an offence under these Regulations, it shall be a defence for that person to show that he took all reasonable steps and exercised all due diligence to avoid committing the offence.

    (2) Where, in proceedings against a person for such an offence, the defence provided by paragraph (1) involves an allegation that the commission of the offence was due to—



(a) the act or default of another; or

(b) reliance on information given by another,



that person shall not, without the leave of the court, be entitled to rely on the defence, unless, not less than seven clear days before the hearing of the proceedings (or, in Scotland, the trial diet), he has served a notice in accordance with paragraph (3) on the person bringing the proceedings.

    (3) A notice under this regulation shall give such information identifying or assisting in the identification of the person who committed the act or default or gave the information as is in the possession of the person serving the notice at the time he serves it.

    (4) A person shall not be entitled to rely on the defence provided by paragraph (1) by reason of his reliance on information supplied by another, unless he shows it was reasonable in all the circumstances for him to have relied on the information, having regard in particular to—



(a) the steps which he took, and those which might reasonably have been taken, for the purpose of verifying the information; and

(b) whether he had any reason to disbelieve the information.



Liability of persons other than the principal offender
    30.—(1) Where the commission by a person of an offence under these Regulations is due to the act or default of another person in the course of any business of his, that other person shall be guilty of the offence and may be proceeded against and punished, whether or not proceedings are taken against the first person.

    (2) Where a body corporate commits an offence and it is proved that the offence was committed—



(a) with the consent or connivance of an officer of the body corporate; or

(b) as a result of the negligence of an officer of the body corporate,



the officer, as well as the body corporate, shall be guilty of the offence.

    (3) In paragraph (2), a reference to an officer of a body corporate includes a reference to—



(a) a director, manager, secretary or other similar officer of the body corporate;

(b) a person purporting to act as a director, manager, secretary or other similar officer; and

(c) if the affairs of the body corporate are managed by its members, a member.



    (4) In this regulation, references to a "body corporate" include references to a partnership in Scotland, and in relation to such partnership, any reference to a director, manager, secretary or other similar officer of a body corporate is a reference to a partner.





PART V
MISCELLANEOUS AND SUPPLEMENTAL
Service of documents
    31.—(1) Any document required or authorised by these Regulations to be served on a person may be so served—


(a) by delivering it to him or by leaving it at his proper address or by sending it by post to him at that address;

(b) if the person is a body corporate, by serving it in accordance with sub-paragraph (a) on the secretary or clerk of that body corporate; or

(c) if the person is a partnership, by serving it in accordance with sub-paragraph (a) on a partner or on a person having control or management of the partnership business.



    (2) For the purposes of paragraph (1), and for the purposes of section 7 of the Interpretation Act 1978[11] (which relates to the service of documents by post) in its application to that paragraph, the proper address of any person on whom a document is to be served in accordance with these Regulations shall be his last known address except that—



(a) in the case of service on a body corporate or its secretary or clerk, it shall be the address of the registered or principal office of the body corporate; and

(b) in the case of service on a partnership or a partner or a person having the control or management of a partnership business, it shall be the principal office of the partnership,



and for the purposes of this paragraph the principal office of a company registered outside the United Kingdom or of a partnership carrying on business outside the United Kingdom is its principal office within the United Kingdom.

Savings for certain privileges
    32.—(1) Nothing in these Regulations shall be taken as requiring a person to produce any documents or records if he would be entitled to refuse to produce those documents or records in any proceedings in any court on the grounds that they are the subject of legal professional privilege or, in Scotland, that they contain a confidential communication made by or to an advocate or solicitor in that capacity, or as authorising a person to take possession of any documents or records which are in the possession of a person who would be so entitled.

    (2) Nothing in these Regulations shall be construed as requiring a person to answer any question or give any information if to do so would incriminate that person or that person's spouse or civil partner.

    (3) Sub-section (1) of section 14 of the Civil Evidence Act 1968[12] (which relates to the privilege against self-incrimination) shall apply to the right conferred by paragraph (2) as it applies to the right described in sub-section (1) of that section; but this paragraph does not extend to Scotland.

The Electromagnetic Compatibility Regulations 2005
    33.The Electromagnetic Compatibility Regulations 2005[13] shall be amended as follows—

After regulation 29 there shall be inserted a new regulation 29A—



"The Measuring Instruments Directive
    29A.—(1) These Regulations do not apply to a measuring instrument or sub-assembly covered by Directive 2004/22/EC of the European Parliament and of the Council on measuring instruments[14] which bear the—


(a) CE marking;

(b) M marking; and

(c) identification number of the notified body responsible for carrying out the conformity assessment of the instrument or sub-assembly



in accordance with the requirements of that Directive, as regards the immunity of such instrument or sub-assembly.

    (2) For the purposes of this regulation, "measuring instrument" and "sub-assembly" have the meanings defined in that Directive.".



Adaptation for Northern Ireland
    34.In their application to Northern Ireland, these Regulations shall have effect subject to Schedule 6.


Barry Gardiner
Parliamentary Under Secretary of State for Competitiveness Department of Trade and Industry

28th April 2006





SCHEDULE 1Regulations2(1), 14(1), and 17(2)


ESSENTIAL REQUIREMENTS

    1.The essential requirements are the relevant requirements relating to automatic gravimetric filling instruments contained in Annex I and MI-006 set out in this Schedule.

Definitions
    2.In these Regulations—


"climatic environments" means the conditions in which automatic gravimetric filling instruments may be used;
"critical change value" means the value at which the change in the measurement result is considered undesirable;
"disturbance" means an influence quantity having a value within the limits specified in the appropriate requirement but outside the specified rated operating conditions of the automatic gravimetric filling instrument. An influence quantity is a disturbance if for that influence quantity the rated operating conditions are not specified;
"influence quantity" means a quantity that is not the measurand but that affects the result of measurement;
"measurand" means the particular quantity subject to measurement; and
"rated operating conditions" means the values for the measurand and influence quantities making up the normal working conditions of an automatic gravimetric filling instrument.

Allowable Errors
    3.—(1) Under rated operating conditions and in the absence of a disturbance, the error of measurement shall not exceed the maximum permissible error (MPE) value as set out in paragraph 17.

    (2) Unless stated otherwise, MPE is expressed as a bilateral value of the deviation from the true measurement value.

    (3) Under rated operating conditions and in the presence of a disturbance, the performance requirement shall be as set out in paragraph 18(2).

    (4) Where the automatic gravimetric filling instrument is intended to be used in a specified permanent continuous electromagnetic field the permitted performance during the radiated electromagnetic field-amplitude modulated test shall be within MPE.

    (5) The manufacturer shall specify the climatic and electromagnetic environments in which the automatic gravimetric filling instrument is intended to be used, power supply and other influence quantities likely to affect its accuracy, taking account of the requirements in this Schedule.



(a) Climatic environments—


    The manufacturer shall specify the temperature range. The minimum temperature range is 30°C and shall be within the upper temperature limit of 70°C and the lower temperature limit of -40°C. The manufacturer shall indicate whether the automatic gravimetric filling instrument is designed for condensing or non-condensing humidity as well as the intended location for the instrument, i.e. open or closed.



(b) Electromagnetic environments—



(i) Electromagnetic environments are classified into classes E1, E2 or E3 as follows—

    E1 This class applies to automatic gravimetric filling instruments used in locations with electromagnetic disturbances corresponding to those likely to be found in residential, commercial and light industrial buildings.

    E2 This class applies to automatic gravimetric filling instruments used in locations with electromagnetic disturbances corresponding to those likely to be found in other industrial buildings.

    E3 This class applies to automatic gravimetric filling instruments supplied by the battery of a vehicle. Such instruments shall comply with the requirements of E2 and the following additional requirements—


(aa) voltage reductions caused by energising the starter-motor circuits of internal combustion engines;

(bb) load dump transients occurring in the event of a discharged battery being disconnected while the engine is running.



(ii) The following influence quantities shall be considered in relation with electromagnetic environments—



(aa) voltage interruptions;

(bb) short voltage reductions;

(cc) voltage transients on supply lines and/or signal lines;

(dd) electrostatic discharges;

(ee) radio frequency electromagnetic fields;

(ff) conducted radio frequency electromagnetic fields on supply lines and/or signal lines;

(gg) surges on supply lines and/or signal lines.



    (6) Other influence quantities to be considered, where appropriate, are—



(a) voltage variation;

(b) mains frequency variation;

(c) power frequency magnetic fields;

(d) any other quantity likely to influence in a significant way the accuracy of the automatic gravimetric filling instrument.



    (7) When carrying out the tests as envisaged in these Regulations, the following paragraphs apply—



(a) Basic rules for testing and the determination of errors—


(i) Essential requirements specified in sub-paragraphs (1) to (4) shall be verified for each relevant influence quantity. These essential requirements apply when each influence quantity is applied and its effect evaluated separately, all other influence quantities being kept relatively constant at their reference value.

(ii) Metrological tests shall be carried out during or after the application of the influence quantity, whichever condition corresponds to the normal operational status of the automatic gravimetric filling instrument when that influence quantity is likely to occur.



(b) Ambient humidity—



(i) According to the climatic operating environment in which the automatic gravimetric filling instrument is intended to be used either the damp heat-steady state (non-condensing) or damp heat cyclic (condensing) test may be appropriate.

(ii) The damp heat cyclic test is appropriate where condensation is important or when penetration of vapour will be accelerated by the effect of breathing. In conditions where non-condensing humidity is a factor the damp-heat steady state is appropriate.



Reproducibility
    4.The application of the same measurand in a different location or by a different user, all other conditions being the same, shall result in the close agreement of successive measurements. The difference between the measurement results shall be small when compared with the MPE.

Repeatability
    5.The application of the same measurand under the same conditions of measurement shall result in the close agreement of successive measurements. The difference between the measurement results shall be small when compared with the MPE.

Discrimination and Sensitivity
    6.An automatic gravimetric filling instrument shall be sufficiently sensitive and the discrimination threshold shall be sufficiently low for the intended measurement task.

Durability
    7.An automatic gravimetric filling instrument shall be designed to maintain an adequate stability of its metrological characteristics over a period of time estimated by the manufacturer, provided that it is properly installed, maintained and used according to the manufacturer's instruction when in the environmental conditions for which it is intended.

Reliability
    8.An automatic gravimetric filling instrument shall be designed to reduce as far as possible the effect of a defect that would lead to an inaccurate measurement result, unless the presence of such a defect is obvious.

Suitability
    9.—(1) An automatic gravimetric filling instrument shall have no feature likely to facilitate fraudulent use, whereas possibilities for unintentional misuse shall be minimal.

    (2) An automatic gravimetric filling instrument shall be suitable for its intended use taking account of the practical working conditions and shall not require unreasonable demands of the user in order to obtain a correct measurement result.

    (3) Where an automatic gravimetric filling instrument is designed for the measurement of values of the measurand that are constant over time, the instrument shall be insensitive to small fluctuations of the value of the measurand, or shall take appropriate action.

    (4) An automatic gravimetric filling instrument shall be robust and its materials of construction shall be suitable for the conditions in which it is intended to be used.

    (5) An automatic gravimetric filling instrument shall be designed so as to allow the control of the measuring tasks after the instrument has been placed on the market and put into use. If necessary, special equipment or software for this control shall be part of the instrument. The test procedure shall be described in the operation manual.

    (6) When an automatic gravimetric filling instrument has associated software which provides other functions besides the measuring function, the software that is critical for the metrological characteristics shall be identifiable and shall not be inadmissibly influenced by the associated software.

    (7) Means shall be provided to limit the effects of tilt, loading and rate of operation such that MPEs are not exceeded in normal operation.

    (8) Adequate material handling facilities shall be provided to enable the automatic gravimetric filling instrument to respect the MPEs during normal operation.

    (9) Any operator control interface shall be clear and effective.

    (10) The integrity of the display (where present) shall be verifiable by the operator.

    (11) Adequate zero setting capability shall be provided to enable the automatic gravimetric filling instrument to respect the MPEs during normal operation.

    (12) Any result outside the measurement range shall be identified as such, where a printout is possible.

Protection against corruption
    10.—(1) The metrological characteristics of an automatic gravimetric filling instrument shall not be influenced in any inadmissible way by the connection to it of another device, by any feature of the connected device itself or by any remote device that communicates with the instrument.

    (2) A hardware component that is critical for metrological characteristics shall be designed so that it can be secured. Security measures foreseen shall provide for evidence of an intervention.

    (3) Software that is critical for metrological characteristics shall be identified as such and shall be secured.

    (4) Software identification shall be easily provided by the automatic gravimetric filling instrument.

    (5) Evidence of a software intervention shall be available for a reasonable period of time.

    (6) Measurement data, software that is critical for measurement characteristics and metrologically important parameters stored or transmitted shall be adequately protected against accidental or intentional corruption.

Information to be borne by and to accompany the automatic gravimetric filling instrument
    11.—(1) An automatic gravimetric filling instrument shall bear the following inscriptions—



(a) manufacturer's mark or name;

(b) information in respect of its accuracy,



plus, when applicable:



(c) information in respect of the conditions of use;

(d) measuring capacity;

(e) measuring range;

(f) identity marking;

(g) number of the EC-type examination certificate or the EC design examination certificate;

(h) information whether or not additional devices providing metrological results comply with these Regulations.



    (2) The automatic gravimetric filling instrument shall be accompanied by information on its operation, unless the simplicity of the instrument makes this unnecessary. Information shall be easily understandable and shall include where relevant—



(a) rated operating conditions;

(b) electromagnetic environment classes;

(c) the upper and lower temperature limit, whether condensation is possible or not, open or closed location;

(d) instructions for installation, maintenance, repairs, permissible adjustments;

(e) instructions for correct operation and any special conditions of use; and

(f) conditions for compatibility with interfaces or measuring instruments.



    (3) Groups of identical automatic gravimetric filling instruments used in the same location do not necessarily require individual instruction manuals.

    (4) The scale interval for a measured value shall be in the form 1 x 10ⁿ, 2 x 10ⁿ or 5 x 10ⁿ, where n is any integer or zero. The unit of measurement or its symbol shall be shown close to the numerical value.

    (5) The units of measurement used and their symbols shall be in accordance with the provisions of Community legislation on units of measurement and their symbols.

    (6) All marks and inscriptions required under any requirement shall be clear, non-erasable, unambiguous and non-transferable.

Indication of result
    12.—(1) Indication of the result shall be by means of a display or hard copy.

    (2) The indication of any result shall be clear and unambiguous and accompanied by such marks and inscriptions necessary to inform the user of the significance of the result. Easy reading of the presented result shall be permitted under normal conditions of use. Additional indications may be shown provided they cannot be confused with the metrologically controlled indications.

    (3) In the case of hard copy the print or record shall also be easily legible and non-erasable.

Further processing of data to conclude the trading transaction
    13.—(1) An automatic gravimetric filling instrument shall record by a durable means the measurement result accompanied by information to identify the particular transaction, when—



(a) the measurement is non-repeatable; and

(b) the automatic gravimetric filling instrument is normally intended for use in the absence of one of the trading parties.



    (2) Additionally, a durable proof of the measurement result and the information to identify the transaction shall be available on request at the time the measurement is concluded.

Conformity evaluation
    14.An automatic gravimetric filling instrument shall be designed so as to allow ready evaluation of its conformity with the appropriate requirements of these Regulations.

Rated Operating Conditions
    15.The manufacturer shall specify the rated operating conditions for the automatic gravimetric filling instrument as follows—



(a) for the measurand—

    the measuring range in terms of its maximum and minimum capacity.

(b) for the electrical supply influence quantities—


(i) in case of AC voltage supply: the nominal AC voltage supply, or the AC voltage limits;

(ii) in case of DC voltage supply: the nominal and minimum DC voltage supply, or the DC voltage limits.



(c) for the mechanical quantities—

    for automatic gravimetric filling instruments which are used under special mechanical strain, e.g. instruments incorporated into vehicles, the manufacturer shall define the mechanical conditions of use.

(d) for other influence quantities (if applicable)—



(i) the rate(s) of operation;

(ii) the characteristics of the product(s) to be weighed.



Accuracy classes
    16.—(1) The manufacturer shall specify both the reference accuracy class Ref(x) and the operational accuracy class(es) X(x).

    (2) An automatic gravimetric filling instrument type is designated a reference accuracy class, Ref(x), corresponding to the best possible accuracy for instruments of the type. After installation, individual automatic gravimetric filling instruments are designated for one or more operational accuracy classes, X(x), having taken account of the specific products to be weighed. The class designation factor (x) shall be ≤ 2, and in the form 1 x 10^k, 2 x 10^k or 5 x 10^k where k is a negative whole number or zero.

    (3) The reference accuracy class, Ref(x) is applicable for static loads.

    (4) For the operational accuracy class X(x), X is a regime relating accuracy to load weight and (x) is a multiplier for the limits of error specified for class X(1) in paragraph 17(2).

MPE
    17.—(1) Static weighing error



(a) For static loads under rated operating conditions, the MPE for reference accuracy class Ref(x), shall be 0.312 of the maximum permissible deviation of each fill from the average: as specified in the following Table; multiplied by the class designation factor (x).

(b) For automatic gravimetric filling instruments where the fill may be made up from more than one load (e.g. cumulative or selective combination weighers) the MPE for static loads shall be the accuracy required for the fill as specified in sub-paragraph (2) (i.e. not the sum of the maximum permissible deviation for the individual loads).



    (2) Deviation from average fill


Table


Value of the mass of the fills (m) in grams	Maximum permissible deviation of each fill from the average for class X(1)
m ≤ 50	7.2%
50 < m ≤ 100	3.6 grams
100 < m ≤ 200	3.6 %
200 < m ≤ 300	7.2 grams
300 < m ≤ 500	2.4 %
500 < m ≤ 1 000	12 grams
1 000 < m ≤ 10 000	1.2 %
10 000 < m ≤ 15 000	120 grams
15 000 < m	0.8 %
Note: The calculated deviation of each fill from the average may be adjusted to take account of the effect of material particle size


    (3) Error relative to pre-set value (setting errors)

For automatic gravimetric filling instruments where it is possible to pre-set a fill weight; the maximum difference between the pre-set value and the average mass of the fills shall not exceed 0.312 of the maximum permissible deviation of each fill from the average, as specified in the Table above.

Performance Under Influence Factor and Electromagnetic Disturbance
    18.—(1) The MPE due to influence factors shall be as specified in paragraph 17(1)

    (2) The critical change value due to a disturbance is a change of the static weight indication equal to the MPE as specified in paragraph 17(1) calculated for the rated minimum fill, or a change that would give equivalent effect on the fill in the case of automatic gravimetric filling instruments where the fill consists of multiple loads. The calculated critical change value shall be rounded to the next higher scale interval (d).

    (3) The manufacturer shall specify the value of the rated minimum fill.



SCHEDULE 2Regulations 2(1) and 8


NOTIFIED BODIES



PART 1
NOTIFIED BODY CRITERIA
    1.The body, its director and staff involved in conformity assessment tasks shall not be the designer, manufacturer, supplier, installer or user of the automatic gravimetric filling instrument that they inspect, nor the authorised representative of any of them. In addition, they may not be directly involved in the design, manufacture, marketing or maintenance of the automatic gravimetric filling instrument, nor represent the parties engaged in these activities. The preceding criterion does not, however, preclude in any way the possibility of exchanges of technical information between the manufacturer and the body for the purposes of conformity assessment.

    2.The body, its director and staff involved in conformity assessment tasks shall be free from all pressures and inducements, in particular financial inducements, that might influence their judgement or the results of their conformity assessment, especially from persons or groups of persons with an interest in the results of the assessments.

    3.The conformity assessment shall be carried out with the highest degree of professional integrity and requisite competence in the field of metrology. Should the body sub-contract specific tasks, it shall first ensure that the sub-contractor meets the requirements of these Regulations, and in particular of this Schedule. The body shall keep the relevant documents assessing the sub-contractor's qualifications and the work carried out by him under these Regulations at the disposal of the Secretary of State.

    4.The body shall be capable of carrying out all the conformity assessment tasks for which it has been designated, whether those tasks are carried out by the body itself or on its behalf and under its responsibility. It shall have at its disposal the necessary staff and shall have access to the necessary facilities for carrying out in a proper manner the technical and administrative tasks entailed in conformity assessment.

    5.The body's staff shall have—


(a) sound technical and vocational training, covering all conformity assessment tasks for which the body was designated;

(b) satisfactory knowledge of the rules governing the tasks which it carries out, and adequate experience of such tasks; and

(c) the requisite ability to draw up the certificates, records and reports demonstrating that the tasks have been carried out.



    6.The impartiality of the body, its director and staff shall be guaranteed. The remuneration of the body shall not depend on the results of the tasks it carries out. The remuneration of the body's director and staff shall not depend on the number of tasks carried out or on the results of such tasks.

    7.The body shall satisfy the Secretary of State that it has adequate civil liability insurance.

    8.The body's director and staff shall be bound to observe professional secrecy with regard to all information obtained in the performance of their duties pursuant to these Regulations, except vis-à-vis the Secretary of State.





PART 2
FUNCTIONS
Assessment of applications for certificates or notifications
    9.—(1) Subject to paragraph 10, a notified body shall assess an application made by a manufacturer for the issue of—


(a) a certificate of conformity;

(b) a design or type examination certificate; or

(c) a notification of approval of the manufacturer's quality system,



in accordance with the Annex applicable to the relevant conformity assessment procedure in respect of an automatic gravimetric filling instrument.

    (2) In determining such an application, the notified body—



(a) shall have regard to the actual or usual environment of the automatic gravimetric filling instrument; and

(b) may have regard to any other standard or other technical criteria appearing to it to be relevant.



    (3) Where, in the opinion of the notified body, the automatic gravimetric filling instrument to which an application relates is compliant with the essential requirements, it shall issue a certificate or notification in accordance with requirements of paragraph 12.

    (4) Where, in the opinion of the notified body, the automatic gravimetric filling instrument to which an application relates is not compliant with the essential requirements, it shall issue a notice to the applicant in accordance with paragraph 15.

    (5) Where a certificate or notification under sub-paragraph (3) is issued by a United Kingdom notified body, it shall send a copy to the Secretary of State.

Limitations on duties to exercise functions
    10.—(1) A notified body shall not accept an application for a certificate or notification in respect of an automatic gravimetric filling instrument unless the application—



(a) is in writing, in English or another language acceptable to that notified body;

(b) is accompanied by all relevant documentation, in which all writing is in English or another language acceptable to that notified body; and

(c) includes particulars of which applicable standards the manufacturer has applied or proposes to apply in respect of the instrument.



    (2) A notified body shall not be required to determine an application for a certificate or notification where the manufacturer has not—



(a) granted the notified body access to an automatic gravimetric filling instrument to which the application relates or the production facilities for the instrument (including, where applicable, the production facilities envisaged in relation to a representative instrument) to the extent that the notified body reasonably requests; and

(b) made available to the notified body such information as it may reasonably require to determine the application.



    (3) A notified body shall not be required to carry out the functions referred to in regulation 7(4) (d) if—



(a) the person making the application has not submitted with the application the amount of the fee which the notified body requires to be submitted with the application pursuant to regulation 11; or

(b) the notified body reasonably believes that, having regard to the number of applications made to it pursuant to its designation which are outstanding, it will be unable to commence the required work within three months of receiving the application.



Contractors
    11.—(1) A notified body may, in exercising its functions—



(a) arrange for some other person to carry out any test, assessment or inspection on its behalf; or

(b) require the applicant to satisfy another person with respect to any matter at the applicant's expense.



    (2) But nothing in sub-paragraph (1) authorises a notified body to rely on the opinion of another person with regard to whether an automatic gravimetric filling instrument is compliant with any of the essential requirements.

    (3) Nothing in these Regulations shall preclude a person referred to in sub-paragraph (1)(a) or (1)(b) from charging any fee in respect of any work undertaken by him in pursuance of those sub-paragraphs.

Form of certificates and notifications
    12.A certificate or notification issued by a notified body shall be in writing and, in addition to the requirements provided for in the relevant conformity assessment procedure, shall—



(a) be in English;

(b) give the name and address—


(i) of the applicant;

(ii) where the applicant is not the manufacturer, of the manufacturer;



(c) be signed by or on behalf of the notified body and give the identification number of the notified body;

(d) bear—



(i) the date of issue; and

(ii) the number of the certificate or notification;



(e) give particulars of the relevant automatic gravimetric filling instrument (where applicable, in relation to each variant) to which it relates sufficient to identify it, and shall state whether the instrument to which it relates is a single item or a representative, or if it covers a number of variants of that instrument; and

(f) certify that the automatic gravimetric filling instrument to which it relates is compliant with the essential requirements.



Conditions in certificates or notifications
    13.—(1) A certificate or notification may be unconditional or may be subject to such conditions as the notified body considers appropriate.

    (2) Such conditions may include—



(a) a limitation on the environment for which the automatic gravimetric filling instrument is stated to be suitable; or

(b) a requirement that the automatic gravimetric filling instrument is only to be installed at a specific site.



    (3) The conditions imposed pursuant to sub-paragraph (1) may be varied in accordance with paragraph 15 by the notified body which issued the certificate or notification and such variation may include the imposition of new conditions or the removal of conditions.

Withdrawal of certificates or notifications
    14.The notified body which issued the certificate or notification shall withdraw that certificate or notification in accordance with paragraph 15, if it appears that the automatic gravimetric filling instrument to which it relates is not compliant with the essential requirements.

Procedure where a notified body is minded to refuse to give, or to vary or withdraw a certificate or notification
    15.—(1) Where a notified body is minded to—



(a) refuse to issue a certificate or notification;

(b) vary a certificate or notification (other than at the request of the person to whom it was given); or

(c) withdraw a certificate or notification,



it shall give the applicant, or the person to whom the certificate or notification was given, a notice in writing—



(i) giving reasons for the refusal, variation or withdrawal;

(ii) specifying the date on which the refusal, variation or withdrawal is to take effect; and

(iii) giving the applicant or person the opportunity to make representations within 21 days from the date of the notice and stating that the notified body shall consider any representations made to it within that period by that applicant or person.



    (2) Where a notified body, having considered representations made to it under sub-paragraph (1), remains of the opinion that—



(a) an application for a certificate or notification should be refused; or

(b) a certificate or notification should be varied or withdrawn,



it shall inform the applicant, or the person to whom the certificate or notification was given, of that decision in writing and give that applicant or person information about the judicial remedies available to him.

    (3) Where a notice is given under sub-paragraph (1) by a United Kingdom notified body, it shall send a copy to the Secretary of State.





SCHEDULE 3Regulation 6(2)


TECHNICAL DOCUMENTATION

    1.The technical documentation shall render the design, manufacture and operation of the automatic gravimetric filling instrument intelligible and shall permit an assessment of its conformity with the appropriate requirements of these Regulations.

    2.The technical documentation shall be sufficiently detailed to ensure—


(a) the definition of the metrological characteristics;

(b) the reproducibility of the metrological performances of produced automatic gravimetric filling instruments when properly adjusted using appropriate intended means; and

(c) the integrity of the automatic gravimetric filling instrument.



    3.The technical documentation shall include insofar as relevant for assessment and identification of the type and/or automatic gravimetric filling instrument—



(a) a general description of the instrument;

(b) conceptual design and manufacturing drawings and plans of components and circuits;

(c) manufacturing procedures to ensure consistent production;

(d) if applicable, a description of the electronic devices with drawings, diagrams, flow diagrams of the logic and general software information explaining their characteristics and operation;

(e) descriptions and explanations necessary for the understanding of sub-paragraphs (b), (c) and (d), including the operation of the instrument;

(f) a list of the relevant national standards and/or relevant normative documents, applied in full or in part;

(g) descriptions of the solutions adopted to meet the essential requirements where the relevant national standards and/or relevant normative documents have not been applied;

(h) results of design calculations and examinations;

(i) the appropriate test results, where necessary, to demonstrate that the type and/or instrument is compliant with the requirements of these Regulations under declared rated operating conditions and under specified environmental disturbances; and

(j) the EC-type examination certificates or EC design examination certificates in respect of instruments containing parts identical to those in the design.



    4.The manufacturer shall specify where seals and markings have been applied.

    5.The manufacturer shall indicate the conditions for compatibility with interfaces, where relevant.





SCHEDULE 4Regulation 12(3)


MARKING AND INSCRIPTIONS

    1.The CE marking consists of the symbol "CE" according to the design laid down in paragraph I.B(d) of the Annex to Decision 93/465/EEC[15]. The CE marking shall be at least 5 mm high.

    2.The M marking consists of the capital letter "M" and the last two digits of the year of its affixing, surrounded by a rectangle. The height of the rectangle shall be equal to the height of the CE marking. The M marking shall immediately follow the CE marking.

    3.The identification number of the notified body concerned shall follow the CE marking and the M marking.

    4.When an automatic gravimetric filling instrument consists of a set of devices operating together, the markings shall be affixed on the instrument's main device.

    5.The CE marking and the M marking shall be indelible. The identification number of the notified body concerned shall be indelible or self-destructive upon removal. All markings shall be clearly visible or easily accessible.



SCHEDULE 5Regulations 2(1) and 14(1)


REQUIREMENTS FOR USE FOR TRADE



PART 1
ACCURACY CLASSES

Table 1Accuracy classes for automatic gravimetric filling instruments for use for trade


Description of use of filling instrument	Maximum capacity of filling instrument	Accuracy class
(1)	(2)	(3)
For use for weighing potato crisps and similar products commonly known as "snack foods"	Any capacity	X2
For use for weighing solid fuel	110 kg or less	X(1)
For use for weighing vegetable produce	55 kg or less	X(1)
For weighing waste	Any capacity	X(1)
For use for weighing materials not described in any of the above	Less than 5 kg 5 kg or more	X(1) X(0.5)


For the purpose of this Table, "waste" shall be construed in accordance with section 75 of the Environmental Protection Act 1990[16], but "waste" shall include any waste disposed of for reprocessing or recycling purposes and shall not include any radioactive waste as defined in section 2 of the Radioactive Substances Act 1993[17].



PART 2
MAXIMUM PERMISSIBLE ERRORS
Maximum permissible error value for instruments in use for trade
    1.—(1) The automatic gravimetric filling instrument shall have a specified accuracy class X(x) for which the maximum permissible error value of each fill from the average shall be equal to the limits specified in Table 2, multiplied by the class designation factor (x).

    (2) (x) shall be 1 x 10^k, 2 x 10^k, 5 x 10^k , k being a positive or negative whole number or zero.


Table 2


Value of the mass of the fills (m) in grams	Maximum permissible deviation of each fill from the average for class X(1)
	In use
m< = 50	9%
50 < m < = 100	4.5grams
100 < m < = 200	4.5%
200 < m < = 300	9 grams
300 < m < = 500	3%
500 < m < = 1000	15 grams
1000 < m < = 10 000	1.5%
10 000 < m < = 15 000	150 grams
15 000 < m	1%


    (3) For in-service testing, when the reference particle mass exceeds 0.1 of the maximum permissible in-service deviation, the values derived from Table 2 shall be increased by 1.5 times the value of the reference particle mass. However, the maximum value of the maximum permissible deviation shall not exceed (x) x 9% .

Note: Particle mass correction is not applicable to limits which are derived from Table 2, e.g. influence quality tests, zero setting.

Note: Table 2 is illustrative of the maximum permissible deviation where the class designation factor is 1.



SCHEDULE 6Regulation 34


ADAPTATIONS FOR NORTHERN IRELAND

    1.In regulation 2(2), the reference to the Weights and Measures Act 1985[18] shall be construed as a reference to the Weights and Measures (Northern Ireland) Order 1981[19].

    2.Part III does not apply to Northern Ireland.

    3.In regulation 18—


(a) for paragraph (1), substitute the following paragraph—


    "(1) The Department of Enterprise, Trade and Investment shall enforce these Regulations in Northern Ireland."; and


(b) for paragraph (3), substitute the following paragraph—


    "(3) No proceedings for an offence under these Regulations shall be instituted in Northern Ireland except by or on behalf of the Department of Enterprise, Trade and Investment or the Director of Public Prosecutions for Northern Ireland.".



    4.In regulation 26—



(a) the reference in paragraph (3) to written information on oath shall be construed as a reference to a complaint on oath; and

(b) for paragraph (9), substitute the following paragraph—


    "(9) In this regulation, "credentials" in relation to an enforcement officer, means an authenticated document showing that he is authorised to act to exercise the powers conferred on him by this regulation.".



    5.In regulation 32(3) the reference to sub-section (1) of section 14 of the Civil Evidence Act 1968 shall be construed as a reference to sub-section (1) of section 10 of the Civil Evidence Act (Northern Ireland) 1971[20].




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EXPLANATORY NOTE

(This note is not part of the Regulations)

These Regulations implement Directive 2004/22/EC of the European Parliament and of the Council on measuring instruments (OJ No. L135, 30.4.04, p.1) ("the Directive") in relation to the class of automatic gravimetric filling instruments within the category of automatic weighing instruments covered by the Directive.

Part I provides that these Regulations apply, with certain exceptions, to automatic gravimetric filling instruments for use for trade which are first placed on the market or put into use on or after the 30th October 2006.

Part II deals with the requirements for placing on the market and putting into use. These are that automatic gravimetric filling instruments are compliant with the essential requirements, that the manufacturer has demonstrated such compliance with the essential requirements and that the instruments have the CE marking, the M marking and the identification number of the relevant notified body affixed to them (regulation 4(1)). It is an offence under regulation 4(2) to place on the market and put into use an automatic gravimetric filling instrument without complying with the requirements of regulation 4(1). The essential requirements are set out in Schedule 1. Compliance with the essential requirements can be demonstrated in accordance with the provisions in regulation 5. Regulation 6 sets out the different conformity assessment procedures available to a manufacturer to demonstrate compliance. The technical documentation required is set out in Schedule 3.

Regulations 7 to 11 and Schedule 2 contain provisions relating to the eligibility and designation of persons as notified bodies and with the administrative procedures relating to their appointment, functions and fees. Requirements relating to the marking of automatic gravimetric filling instruments are set out in regulation 12 and Schedule 4. Regulation 13 provides for a presumption of conformity of an automatic gravimetric filling instrument with other applicable directives conferred by the CE marking.

Part III of these Regulations deals with requirements relating to the use for trade of automatic gravimetric filling instruments (Regulations 14 to 17 and Schedule 5) pursuant to section 15(1) of the Weights and Measures Act 1985. Failure to comply with these requirements is an offence under section 15(3) of that Act.

Part IV deals with enforcement of these Regulations. Regulation 18 provides that the Regulations shall be enforced by every local weights and measures authority within its area; the Secretary of State may act as an enforcement authority in relation to Part II and for that purpose may appoint any person to act on his behalf. Regulation 19 (compliance notice procedure) and regulation 20 (immediate enforcement action) confer powers on the enforcement authorities to take action in respect of non-compliant automatic gravimetric filling instruments. Regulation 21 permits a review by the Secretary of State of notices issued by other enforcement authorities under regulations 19 and 20. Regulation 22 provides for disqualification of automatic gravimetric filling instruments and it is an offence to use an instrument which has been disqualified unless it has been re-qualified in accordance with regulation 23. Regulation 24 provides for the testing of an automatic gravimetric filling instrument by an inspector for purposes otherwise than for re-qualification.

Regulations 25 details the offences relating to the unauthorised application of authorised marks. Regulation 26 provides powers of entry and inspection for enforcement officers. Regulation 27 provides for offences relating to the obstruction of an enforcement officer. A person guilty of an offence under Part II or Part IV is liable on summary conviction to a fine not exceeding level 5 on the standard scale (which is currently £5,000) (regulation 28). A defence of due diligence in relation to any offence under these Regulations is provided for in regulation 29 and the liability of persons other than the principal offender is set out in regulation 30.

Part V (regulations 31 to 34) deals with miscellaneous matters including the application of the Regulations to Northern Ireland to the extent set out in Schedule 6 (regulation 34). Regulation 33 is a consequential amendment to the Electromagnetic Compatibility Regulations 2005 (S.I. 2005/281) to provide that the immunity requirements of those Regulations do not apply to certain measuring instruments and sub-assemblies which bear the marking and identification requirements specified in these Regulations.

These Regulations have been notified to the European Commission and the other member States in accordance with Directive 98/34/EC of the European Parliament and of the Council (OJ No. L204, 21.7.98, p.37), as amended by Directive 98/48/EC of the European Parliament and of the Council (OJ No. L217, 5.8.98, p.18).

A Regulatory Impact Assessment (RIA) in respect of these Regulations is available and a copy can be obtained from the National Weights and Measures Laboratory (NWML), Stanton Avenue, Teddington, Middlesex TW11 OJZ or from its website at www.nwml.gov.uk. As these Regulations transpose the Directive, a transposition note (TN) setting out how the Government has transposed the Directive into United Kingdom law has been prepared. Copies of the RIA and TN are available from NWML as above. Copies of these documents have been placed in the libraries of both Houses of Parliament.



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Notes:

[1]S.I. 1975/427.back

[2]1972 c.68.back

[3]1985 c.72.back

[4]OJ No. L135, 30.4.04, p.1.back

[5]OJ No. L204, 21.7.98, p.37.back

[6]OJ No. L217, 5.8.98, p.18.back

[7]The application of the Directive was extended to the European Economic Area by Decision No. 31/205 (OJ No. L198, 28.7.05, p.20).back

[8]S.I. 1963/1710, as amended by S.I. 1970/1370, S.I. 1972/767, S.I. 1974/1326, S.I. 1977/1932, S.I. 1978/484, S.I. 1979/1612, S.I. 1980/1070, S.I. 1980/1079, S.I. 1983/914, S.I. 1984/1446, S.I. 1985/1532, S.I 1986/1320, S.I. 1986/1682, S.I. 1988/120, S.I. 1988/876, S.I. 1994/1259, S.I. 1995/735, S.I. 2000/388, S.I. 2001/599, S.I. 2001/1208, S.I. 2003/2454 and S.I. 2003/2761.back

[9]S.I. 1986/1320 as amended by S.I. 1994/1851, S.I. 1996/797, S.I. 2000/387, S.I. 2001/85, S.I. 2003/214.back

[10]S.I. 2000/388 as amended by SI 2003/214 and SI 2006/659back

[11]1978 c.30.back

[12]1968 c.64.back

[13]SI 2005/281.back

[14]OJ No.L135, 30.4.04, p.1.back

[15]OJ No. L220, 30.8.93, p.23.back

[16]1990 c. 43.back

[17]1993 c.12.back

[18]1985 c.72.back

[19]S.I. 1981/231 (N.I. 10) and see S.I. 1982/846 (N.I. 11) and 1999/283 (N.I. 1).back

[20]1971 c.36)back

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