The Non-automatic Weighing Instruments Regulations 2016

1. Introductory Text

2. PART 1 INTRODUCTORY

   1. 1. Citation commencement and extent

   2. 2. Interpretation

   3. 2A. Designated standard

   4. 3. Application of these Regulations

   5. 4. Revocations and transitional and consequential provisions

   6. 4A. Transitional provision in relation to EU Exit

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

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

      1. 5. Introductory

      2. 6. Manufacturers' responsibilities – design, conformity assessment and marking of regulated non-automatic weighing instruments

      3. 7. Manufacturers' obligations in respect of records

      4. 8. Manufacturers' obligations to ensure continuing conformity with the essential requirements

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

      6. 10. Manufacturers to mark contact details on regulated non-automatic weighing instruments

      7. 11. Documentation to accompany regulated non-automatic weighing instruments

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

      9. 13. Provision of information to the competent authority

      10. 14. Use of authorised representatives by manufacturers

   2. CHAPTER 2 OBLIGATIONS OF IMPORTERS

      1. 15. Introductory

      2. 16. Ensuring compliance of regulated non-automatic weighing instruments

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

      4. 18. Requirements to mark importers' details on regulated non-automatic weighing instruments

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

      6. 20. Duty of importers to ensure proper conditions of storage and transport

      7. 21. Duties of importers with regard to monitoring etc.

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

      9. 23. Requirement for importer to keep copy of EU declaration of conformity

      10. 24. Provision of information to a competent authority

   3. CHAPTER 3 OBLIGATIONS OF DISTRIBUTORS

      1. 25. Introductory

      2. 26. Distributors – duty to act with due care

      3. 27. Distributors – verification obligations

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

      5. 29. Duty of distributors to ensure proper conditions of storage and transport

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

      7. 31. Provision of information to the competent authority

   4. CHAPTER 4 IDENTIFICATION OF ECONOMIC OPERATORS

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

      2. 32A. Obligations which are met by complying with obligations in the Directive

      3. 32B. Conformity assessment procedure obligations that are met by complying with the Directive

      4. 32C. Further use of UK marking

      5. 32D. Qualifying Northern Ireland Goods

4. PART 3 CONFORMITY OF REGULATED NON-AUTOMATIC WEIGHING INSTRUMENTS

   1. CHAPTER 1 ESTABLISHING COMPLIANCE WITH THE ESSENTIAL REQUIREMENTS

      1. 33. Introductory

      2. 34. Methods of establishing conformity with the essential requirements

      3. 35. Presumptions of conformity of regulated non-automatic weighing instruments

      4. 36. Conformity assessment procedures

      5. 37. Subsidiaries and contractors

      6. 38. Fees

   2. CHAPTER 2 REQUIREMENTS RELATING TO EU DECLARATIONS OF CONFORMITY

      1. 39. Application of Chapter

      2. 40. Form and contents of ... declaration of conformity etc.

      3. 41. Regulated instruments that require more than one declaration of conformity

      4. 42. Responsibility of manufacturer that draws up declaration of conformity

   3. CHAPTER 3 CONFORMITY MARKING

      1. 43. Conformity with ... requirements to be indicated by the UK marking

      2. 44. Prohibition on improper use of UK marking and the M marking

      3. 45. Rules and conditions for affixing the UK marking and the M marking etc.

      4. 45A. UK(NI) indication

      5. 45B. Register of notified bodies established in the United Kingdom

5. PART 4 REQUIREMENTS FOR NON-REGULATED NON-AUTOMATIC WEIGHING INSTRUMENTS

   1. 46. (1) This regulation applies to a non-automatic weighing instrument which...

6. PART 5 APPROVAL OF CONFORMITY ASSESSMENT BODIES

   1. 47. Approved bodies

   2. 48. Approval of conformity assessment bodies

   3. 49. Presumption of conformity of approved bodies

   4. 50. Monitoring

   5. 51. Restriction, suspension or withdrawal of approval

   6. 52. Subsidiaries and contractors

   7. 53. Register of approved bodies

   8. 54. UK national accreditation body

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

   1. 55. No person shall put into service a regulated non-automatic weighing...

8. PART 7 USE FOR TRADE OF REGULATED NON-AUTOMATIC WEIGHING INSTRUMENTS IN GREAT BRITAIN

   1. 56. Schedule 4 applies to the use for trade of regulated...

9. PART 8 MARKET SURVEILLANCE AND ENFORCEMENT

   1. CHAPTER 1 MARKET SURVEILLANCE

      1. 57. The market surveillance authority

      2. 58. Regulated non-automatic weighing instruments presenting a risk

      3. 59. EU safeguard procedure

      4. 60. Compliant regulated non-automatic weighing instruments which present a risk

      5. 61. Provisions as to directions under regulations 58 and 60

   2. CHAPTER 2 ENFORCEMENT PROCEDURES

      1. 62. Competent authorities and enforcement proceedings

      2. 63. Compliance notice procedure

      3. 64. Enforcement notice procedure

      4. 65. Review of decisions of a competent authorities

      5. 66. Offence of failing to comply with an enforcement notice

      6. 67. Disqualification

      7. 68. Re-qualification

      8. 69. Testing of regulated non-automatic weighing instruments

      9. 70. Unsuitable use of regulated non-automatic weighing instruments

10. PART 9 OFFENCES

    1. 71. Unauthorised application of authorised marks

    2. 72. Offences by economic operators etc.

    3. 73. Penalties for offences

    4. 74. Defence of due diligence

    5. 75. Liability of persons other than the principal offender

11. PART 10 MISCELLANEOUS AND SUPPLEMENTAL

    1. 76. Service of documents etc.

    2. 77. Review

12. Signature

13. 1. SCHEDULE A1

       Disqualification and re-qualification marks

       1. 1. Disqualification mark

       2. 2. Re-qualification mark

    2. SCHEDULE 1

       INFORMATION TO BE MARKED ON REGULATED NON-AUTOMATIC WEIGHING INSTRUMENTS

       1. 1. The number of the EU-type examination certificate, where appropriate.

       2. 2. The manufacturer's name, registered trade name or registered trade mark....

       3. 3. The accuracy class, enclosed in an oval or in two...

       4. 4. Maximum capacity, in the form “Max …..”.

       5. 5. Minimum capacity, in the form “Min …..”.

       6. 6. Verification scale interval in the form “e =…..”

       7. 7. Type, batch and serial number

       8. 8. When applicable the following: (a) for instruments consisting of separate...

       9. 9. The requirements of points 1.2 to 1.5 of Schedule 8...

    3. SCHEDULE 2

       OPERATIONAL OBLIGATIONS OF APPROVED BODIES

       1. 1. Conformity assessment must be carried out in a proportionate manner,...

       2. 2. Conformity assessment bodies must perform their activities taking due account...

       3. 3. Where an approved body finds that the essential requirements have...

       4. 4. Where in the course of the monitoring of conformity following...

       5. 5. Where corrective measured are not taken or do not have...

       6. 6. Where a person is aggrieved at a decision taken by...

       7. 7. Approved bodies must inform the Secretary of State of the...

       8. 8. Approved bodies must provide other bodies approved under these Regulations...

       9. 9. Notified bodies must— (a) when requested by the Secretary of...

    4. SCHEDULE 3

       APPROVED BODY REQUIREMENTS

       1. 1. (1) A conformity assessment body must have legal personality and...

       2. 2. A conformity assessment body must be a third party body...

       3. 3. A body belonging to a business association or professional federation...

       4. 4. A conformity assessment body, its top level management and the...

       5. 5. A conformity assessment body, its top level management and the...

       6. 6. Conformity assessment bodies must ensure that the activities of their...

       7. 7. Conformity assessment bodies and their personnel must carry out the...

       8. 8. A conformity assessment body must be capable of carrying out...

       9. 9. At all times and for each conformity assessment procedure and...

       10. 10. A conformity assessment body must have the means necessary to...

       11. 11. The personnel responsible for carrying out conformity assessment tasks must...

       12. 12. Conformity assessment bodies, their top-level management and the personal responsible...

       13. 13. The remuneration of the top-level management and personnel responsible for...

       14. 14. A conformity assessment body must satisfy the Secretary of State...

       15. 15. The personnel of a conformity assessment body must observe professional...

       16. 16. Conformity assessment bodies must participate in, or ensure that their...

    5. SCHEDULE 4

       USE FOR TRADE OF REGULATED NON-AUTOMATIC WEIGHING INSTRUMENTS IN GREAT BRITAIN

       1. 1. Restrictions on use of instruments for trade

       2. 2. Manner of erection of regulated non-automatic weighing instruments

       3. 3. Regulated non-automatic weighing instruments marked with temperature range

       4. 4. Regulated non-automatic weighing instruments marked with manner of use

       5. 5. Regulated non-automatic weighing instruments fitted with printing devices

       6. 6. Load receptors

       7. 7. Operation of regulated non-automatic weighing instrument

       8. 8. Regulated non-automatic weighing instruments to be set to zero or to be balanced before use

    6. SCHEDULE 5

       MONETARY PENALTIES

       1. 1. Introduction

       2. 2. Procedure

       3. 3. Appeals

       4. 4. Interest and recovery

    7. SCHEDULE 6

       (Annex I to the Directive)

       1. ESSENTIAL REQUIREMENTS

          1. The terminology used is that of the International Organisation of Legal Metrology

             1. Preliminary observation

          2. Metrological requirements

             1. 1. Units of mass The units of mass used shall be...

             2. 2. Accuracy classes

             3. 2.1. The following accuracy classes have been defined—

             4. 2.2. Scale intervals

             5. 2.2.1. The actual scale interval (d) and the verification scale interval...

             6. 2.2.2. For all instruments other than those with auxiliary indicating devices—...

             7. 2.2.3. For instruments with auxiliary indicating devices the following conditions apply—...

             8. 3. Classification

             9. 3.1. Instruments with one weighing range Instruments equipped with an auxiliary...

             10. 3.2. Instruments with multiple weighing ranges Multiple weighing ranges are permitted,...

             11. 3.3. Multi-interval instruments

             12. 3.3.1. Instruments with one weighing range may have several partial weighing...

             13. 3.3.2. Each partial weighing range i of multi-interval instruments is defined...

             14. 3.3.3. The partial weighing ranges are classified according to Table 2....

             15. 4. Accuracy

             16. 4.1. On implementation of the procedures laid down in regulation 36,...

             17. 4.2. The maximum permissible errors in service are twice the maximum...

             18. 5. Weighing results of an instrument shall be repeatable, and shall...

             19. 6. The instrument shall react to small variations in the load....

             20. 7. Influence quantities and time

             21. 7.1. Instruments of classes II, III and IIII, liable to be...

             22. 7.2. The instruments shall meet the metrological requirements within the temperature...

             23. 7.3. Instruments operated from a mains power supply shall meet the...

             24. 7.4. Electronic instruments, except those in class I and in class...

             25. 7.5. Loading an instrument in class II, III or IIII for...

             26. 7.6. Under other conditions the instruments shall either continue to function...

          3. Design and construction

             1. 8. General requirements

             2. 8.1. Design and construction of the instruments shall be such that...

             3. 8.2. When exposed to disturbances, electronic instruments shall not display the...

             4. 8.3. The requirements of points 8.1 and 8.2 shall be met...

             5. 8.4. When external equipment is connected to an electronic instrument through...

             6. 8.5. The instruments shall have no characteristics likely to facilitate fraudulent...

             7. 8.6. Instruments shall be designed to permit ready execution of the...

             8. 9. Indication of weighing results and other weight values The indication...

             9. 10. Printing of weighing results and other weight values Printed results...

             10. 11. Levelling When appropriate, instruments shall be fitted with a levelling...

             11. 12. Zeroing Instruments may be equipped with zeroing devices. The operation...

             12. 13. Tare devices and preset tare devices The instruments may have...

             13. 14. Instruments for direct sales to the public, with a maximum...

             14. 15. Price labelling instruments Price labelling instruments shall meet the requirements...

    8. SCHEDULE 7

       (Annex II to the Directive)

       1. CONFORMITY ASSESSMENT PROCEDURES

          1. 1. Module B: type examination

          2. 1.1. type examination is the part of a conformity assessment procedure...

          3. 1.2. type examination may be carried out in any of the...

          4. 1.3. The manufacturer shall lodge an application for type examination with...

          5. 1.4. The approved body shall— For the instrument—

          6. 1.4.1. examine the technical documentation and supporting evidence to assess the...

          7. 1.4.2. verify that the specimen(s) have been manufactured in conformity with...

          8. 1.4.3. carry out appropriate examinations and tests, or have them carried...

          9. 1.4.4. carry out appropriate examinations and tests, or have them carried...

          10. 1.4.5. agree with the manufacturer on a location where the examinations...

          11. 1.5. The approved body shall draw up an evaluation report that...

          12. 1.6. Where the type meets the requirements of these Regulations, that...

          13. 1.7. The approved body shall keep itself apprised of any changes...

          14. 1.8. Each approved body shall inform the Secretary of State concerning...

          15. 1.9. The manufacturer shall keep a copy of the type examination...

          16. 1.10. The manufacturer's authorised representative may lodge the application referred to...

          17. 2. Module D: Conformity to type based on quality assurance of...

          18. 2.1. Conformity to type based on quality assurance of the production...

          19. 2.2. Manufacturing The manufacturer shall operate an approved quality system for...

          20. 2.3. Quality system

          21. 2.3.1. The manufacturer shall lodge an application for assessment of his...

          22. 2.3.2. The quality system shall ensure that the instruments are in...

          23. 2.3.3. The approved body shall assess the quality system to determine...

          24. 2.3.4. The manufacturer shall undertake to fulfil the obligations arising out...

          25. 2.3.5. The manufacturer shall keep the approved body that has approved...

          26. 2.4. Surveillance under the responsibility of the approved body

          27. 2.4.1. The purpose of surveillance is to make sure that the...

          28. 2.4.2. The manufacturer shall, for assessment purposes, allow the approved body...

          29. 2.4.3. The approved body shall carry out periodic audits to make...

          30. 2.4.4. In addition, the approved body may pay unexpected visits to...

          31. 2.5. Conformity marking and declaration of conformity

          32. 2.5.1. The manufacturer shall affix the UK marking and the M...

          33. 2.5.2. The manufacturer shall draw up a written declaration of conformity...

          34. 2.6. The manufacturer shall, for a period ending 10 years after...

          35. 2.7. Each approved body shall inform the Secretary of State of...

          36. 2.8. Authorised representative The manufacturer's obligations set out in points 2.3.1,...

          37. 3. Module D1: Quality assurance of the production process

          38. 3.1. Quality assurance of the production process is the conformity assessment...

          39. 3.2. Technical documentation The manufacturer shall establish the technical documentation. The...

          40. 3.3. The manufacturer shall keep the technical documentation at the disposal...

          41. 3.4. Manufacturing The manufacturer shall operate an approved quality system for...

          42. 3.5. Quality system

          43. 3.5.1. The manufacturer shall lodge an application for assessment of his...

          44. 3.5.2. The quality system shall ensure compliance of the instruments with...

          45. 3.5.3. The approved body shall assess the quality system to determine...

          46. 3.5.4. The manufacturer shall undertake to fulfil the obligations arising out...

          47. 3.5.5. The manufacturer shall keep the approved body that has approved...

          48. 3.6. Surveillance under the responsibility of the approved body

          49. 3.6.1. The purpose of surveillance is to make sure that the...

          50. 3.6.2. The manufacturer shall, for assessment purposes, allow the approved body...

          51. 3.6.3. The approved body shall carry out periodic audits to make...

          52. 3.6.4. In addition, the approved body may pay unexpected visits to...

          53. 3.7. Conformity marking and declaration of conformity

          54. 3.7.1. The manufacturer shall affix the UK marking and the M...

          55. 3.7.2. The manufacturer shall draw up a written declaration of conformity...

          56. 3.8. The manufacturer shall, for a period ending 10 years after...

          57. 3.9. Each approved body shall inform the Secretary of State of...

          58. 3.10. Authorised representative The manufacturer's obligations set out in points 3.3,...

          59. 4. Module F: Conformity to type based on product verification

          60. 4.1. Conformity to type based on product verification is the part...

          61. 4.2. Manufacturing The manufacturer shall take all measures necessary so that...

          62. 4.3. Verification An approved body chosen by the manufacturer shall carry...

          63. 4.4. Verification of conformity by examination and testing of every instrument...

          64. 4.4.1. All instruments shall be individually examined and appropriate tests set...

          65. 4.4.2. The approved body shall issue a certificate of conformity in...

          66. 4.5. Conformity marking and declaration of conformity

          67. 4.5.1. The manufacturer shall affix the UK marking and the M...

          68. 4.5.2. The manufacturer shall draw up a written declaration of conformity...

          69. 4.6. If the approved body agrees and under its responsibility, the...

          70. 4.7. Authorised representative The manufacturer's obligations may be fulfilled by his...

          71. 5. Module F1: Conformity based on product verification

          72. 5.1. Conformity based on product verification is the conformity assessment procedure...

          73. 5.2. Technical documentation

          74. 5.2.1. The manufacturer shall establish the technical documentation. The documentation shall...

          75. 5.2.2. The manufacturer shall keep the technical documentation at the disposal...

          76. 5.3. Manufacturing The manufacturer shall take all measures necessary so that...

          77. 5.4. Verification An approved body chosen by the manufacturer shall carry...

          78. 5.5. Verification of conformity by examination and testing of every instrument...

          79. 5.5.1. All instruments shall be individually examined and appropriate tests, set...

          80. 5.5.2. The approved body shall issue a certificate of conformity in...

          81. 5.6. Conformity marking and declaration of conformity

          82. 5.6.1. The manufacturer shall affix the UK marking and the M...

          83. 5.6.2. The manufacturer shall draw up a written declaration of conformity...

          84. 5.7. If the approved body agrees and under its responsibility, the...

          85. 5.8. Authorised representative The manufacturer's obligations may be fulfilled by his...

          86. 6. Module G: Conformity based on unit verification

          87. 6.1. Conformity based on unit verification is the conformity assessment procedure...

          88. 6.2. Technical documentation

          89. 6.2.1. The manufacturer shall establish the technical documentation and make it...

          90. 6.2.2. The manufacturer shall keep the technical documentation at the disposal...

          91. 6.3. Manufacturing The manufacturer shall take all measures necessary so that...

          92. 6.4. Verification An approved body chosen by the manufacturer shall carry...

          93. 6.5. Conformity marking and declaration of conformity

          94. 6.5.1. The manufacturer shall affix the UK marking and the M...

          95. 6.5.2. The manufacturer shall draw up a written declaration of conformity...

          96. 6.6. Authorised representative The manufacturer's obligations set out in points 6.2.2...

          97. 7. Common provisions

          98. 7.1. The conformity assessment according to Module D, D1, F, F1...

          99. 7.2. If the instrument's performance is sensitive to gravity variations the...

          100. 7.2.1. Where a manufacturer has opted for execution in two stages...

          101. 7.2.2. The party which has carried out the first stage of...

          102. 7.2.3. A manufacturer who has opted for Module D or D1...

          103. 7.2.4. The UK marking and the M metrology marking shall be...

    9. SCHEDULE 8

       (Annex III to the Directive)

       1. INSCRIPTIONS

          1. 1. Instruments intended to be used for the applications listed in...

          2. 1.1. Those instruments shall bear visibly, legibly and indelibly the following...

          3. 1.2. Those instruments shall have adequate facilities for the affixing of...

          4. 1.3. Where a data plate is used it shall be possible...

          5. 1.4. The inscriptions Max, Min, e, and d, shall also be...

          6. 1.5. Each load measuring device which is connected or can be...

          7. 2. Instruments not intended to be used for the applications listed...

          8. 3. Restrictive use symbol referred to in regulation 9(3). The restrictive...

    10. SCHEDULE 9

        DECLARATION OF CONFORMITY (No XXXX)

        1. 1. Instrument model/Instrument (product, type, batch or serial number):

        2. 2. Name and address of the manufacturer and, where applicable, his...

        3. 3. This declaration of conformity is issued under the sole responsibility...

        4. 4. Object of the declaration (identification of instrument allowing traceability; it...

        5. 5. The object of the declaration described above is in conformity...

        6. 6. References to the relevant designated standards used or references to...

        7. 7. The approved body … (name, number) performed … (description of...

        8. 8. Additional information: — Signed for and on behalf of: —...

14. Explanatory Note