UK Statutory Instrument
2016
United Kingdom
The Non-automatic Weighing Instruments Regulations 2016
These Regulations implement Directive 2014/31/EU of the European Parliament and of the Council of 26th February 2014 on the harmonisation of the laws of Member States relating to the making available on the market of non-automatic weighing instruments. These Regulations replace and revoke the Non-automatic Weighing Instruments Regulations 2000 and the Non-automatic Weighing Instruments (Amendment) Regulations 2008. Non-automatic weighing instruments are defined as instruments which require the intervention of an operator to determine mass and other things related to mass by the use of gravity. The Regulations impose requirements in relation to the manufacture of non-automatic weighing instruments which are used for determining mass for:commercial transactions;the determination of the amount of certain payments such as tolls or taxes;the purposes of court proceedings and legal requirements;the weighing of patients for medical purposes;making up medicines and other medical and pharmaceutical laboratory purposes;direct sales to the public and the making up of pre-packages. Show full description Show less
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What's here
1 practical guide
Relevant guidance
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Supporting — topic alignment
1 guidesWhat this Act requires
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Schedules
Browse 207 other Schedules — structural / supplementary
The number of the EU-type examination certificate, where appropriate.
The manufacturer's name, registered trade name or registered trade mark....
The accuracy class, enclosed in an oval or in two...
Maximum capacity, in the form “Max …..”.
Minimum capacity, in the form “Min …..”.
Verification scale interval in the form “e =…..”
Type, batch and serial number
When applicable the following: (a) for instruments consisting of separate...
The requirements of points 1.2 to 1.5 of Schedule 8...
Conformity assessment must be carried out in a proportionate manner,...
Conformity assessment bodies must perform their activities taking due account...
Where an approved body finds that the essential requirements have...
Where in the course of the monitoring of conformity following...
Where corrective measured are not taken or do not have...
Where a person is aggrieved at a decision taken by...
Approved bodies must inform the Secretary of State of the...
Approved bodies must provide other bodies approved under these Regulations...
Notified bodies must— (a) when requested by the Secretary of...
(1) A conformity assessment body must have legal personality and...
A conformity assessment body must have the means necessary to...
The personnel responsible for carrying out conformity assessment tasks must...
Conformity assessment bodies, their top-level management and the personal responsible...
The remuneration of the top-level management and personnel responsible for...
A conformity assessment body must satisfy the Secretary of State...
The personnel of a conformity assessment body must observe professional...
Conformity assessment bodies must participate in, or ensure that their...
A conformity assessment body must be a third party body...
A body belonging to a business association or professional federation...
A conformity assessment body, its top level management and the...
A conformity assessment body, its top level management and the...
Conformity assessment bodies must ensure that the activities of their...
Conformity assessment bodies and their personnel must carry out the...
A conformity assessment body must be capable of carrying out...
At all times and for each conformity assessment procedure and...
Restrictions on use of instruments for trade
Manner of erection of regulated non-automatic weighing instruments
Regulated non-automatic weighing instruments marked with temperature range
Regulated non-automatic weighing instruments marked with manner of use
Regulated non-automatic weighing instruments fitted with printing devices
Load receptors
Operation of regulated non-automatic weighing instrument
Regulated non-automatic weighing instruments to be set to zero or to be balanced before use
Introduction
Procedure
Appeals
Interest and recovery
Units of mass The units of mass used shall be...
Printing of weighing results and other weight values Printed results...
Levelling When appropriate, instruments shall be fitted with a levelling...
Zeroing Instruments may be equipped with zeroing devices. The operation...
Tare devices and preset tare devices The instruments may have...
Instruments for direct sales to the public, with a maximum...
Price labelling instruments Price labelling instruments shall meet the requirements...
Accuracy classes
The following accuracy classes have been defined—
Scale intervals
The actual scale interval (d) and the verification scale interval...
For all instruments other than those with auxiliary indicating devices—...
For instruments with auxiliary indicating devices the following conditions apply—...
Classification
Instruments with one weighing range Instruments equipped with an auxiliary...
Instruments with multiple weighing ranges Multiple weighing ranges are permitted,...
Multi-interval instruments
Instruments with one weighing range may have several partial weighing...
Each partial weighing range i of multi-interval instruments is defined...
The partial weighing ranges are classified according to Table 2....
Accuracy
On implementation of the procedures laid down in regulation 36,...
The maximum permissible errors in service are twice the maximum...
Weighing results of an instrument shall be repeatable, and shall...
The instrument shall react to small variations in the load....
Influence quantities and time
Instruments of classes II, III and IIII, liable to be...
The instruments shall meet the metrological requirements within the temperature...
Instruments operated from a mains power supply shall meet the...
Electronic instruments, except those in class I and in class...
Loading an instrument in class II, III or IIII for...
Under other conditions the instruments shall either continue to function...
General requirements
Design and construction of the instruments shall be such that...
When exposed to disturbances, electronic instruments shall not display the...
The requirements of points 8.1 and 8.2 shall be met...
When external equipment is connected to an electronic instrument through...
The instruments shall have no characteristics likely to facilitate fraudulent...
Instruments shall be designed to permit ready execution of the...
Indication of weighing results and other weight values The indication...
Module B: type examination
type examination is the part of a conformity assessment procedure...
The manufacturer's authorised representative may lodge the application referred to...
type examination may be carried out in any of the...
The manufacturer shall lodge an application for type examination with...
The approved body shall— For the instrument—
examine the technical documentation and supporting evidence to assess the...
verify that the specimen(s) have been manufactured in conformity with...
carry out appropriate examinations and tests, or have them carried...
carry out appropriate examinations and tests, or have them carried...
agree with the manufacturer on a location where the examinations...
The approved body shall draw up an evaluation report that...
Where the type meets the requirements of these Regulations, that...
The approved body shall keep itself apprised of any changes...
Each approved body shall inform the Secretary of State concerning...
The manufacturer shall keep a copy of the type examination...
Module D: Conformity to type based on quality assurance of...
Conformity to type based on quality assurance of the production...
Manufacturing The manufacturer shall operate an approved quality system for...
Quality system
The manufacturer shall lodge an application for assessment of his...
The quality system shall ensure that the instruments are in...
The approved body shall assess the quality system to determine...
The manufacturer shall undertake to fulfil the obligations arising out...
The manufacturer shall keep the approved body that has approved...
Surveillance under the responsibility of the approved body
The purpose of surveillance is to make sure that the...
The manufacturer shall, for assessment purposes, allow the approved body...
The approved body shall carry out periodic audits to make...
In addition, the approved body may pay unexpected visits to...
Conformity marking and declaration of conformity
The manufacturer shall affix the UK marking and the M...
The manufacturer shall draw up a written declaration of conformity...
The manufacturer shall, for a period ending 10 years after...
Each approved body shall inform the Secretary of State of...
Authorised representative The manufacturer's obligations set out in points 2.3.1,...
Module D1: Quality assurance of the production process
Quality assurance of the production process is the conformity assessment...
Authorised representative The manufacturer's obligations set out in points 3.3,...
Technical documentation The manufacturer shall establish the technical documentation. The...
The manufacturer shall keep the technical documentation at the disposal...
Manufacturing The manufacturer shall operate an approved quality system for...
Quality system
The manufacturer shall lodge an application for assessment of his...
The quality system shall ensure compliance of the instruments with...
The approved body shall assess the quality system to determine...
The manufacturer shall undertake to fulfil the obligations arising out...
The manufacturer shall keep the approved body that has approved...
Surveillance under the responsibility of the approved body
The purpose of surveillance is to make sure that the...
The manufacturer shall, for assessment purposes, allow the approved body...
The approved body shall carry out periodic audits to make...
In addition, the approved body may pay unexpected visits to...
Conformity marking and declaration of conformity
The manufacturer shall affix the UK marking and the M...
The manufacturer shall draw up a written declaration of conformity...
The manufacturer shall, for a period ending 10 years after...
Each approved body shall inform the Secretary of State of...
Module F: Conformity to type based on product verification
Conformity to type based on product verification is the part...
Manufacturing The manufacturer shall take all measures necessary so that...
Verification An approved body chosen by the manufacturer shall carry...
Verification of conformity by examination and testing of every instrument...
All instruments shall be individually examined and appropriate tests set...
The approved body shall issue a certificate of conformity in...
Conformity marking and declaration of conformity
The manufacturer shall affix the UK marking and the M...
The manufacturer shall draw up a written declaration of conformity...
If the approved body agrees and under its responsibility, the...
Authorised representative The manufacturer's obligations may be fulfilled by his...
Module F1: Conformity based on product verification
Conformity based on product verification is the conformity assessment procedure...
Technical documentation
The manufacturer shall establish the technical documentation. The documentation shall...
The manufacturer shall keep the technical documentation at the disposal...
Manufacturing The manufacturer shall take all measures necessary so that...
Verification An approved body chosen by the manufacturer shall carry...
Verification of conformity by examination and testing of every instrument...
All instruments shall be individually examined and appropriate tests, set...
The approved body shall issue a certificate of conformity in...
Conformity marking and declaration of conformity
The manufacturer shall affix the UK marking and the M...
The manufacturer shall draw up a written declaration of conformity...
If the approved body agrees and under its responsibility, the...
Authorised representative The manufacturer's obligations may be fulfilled by his...
Module G: Conformity based on unit verification
Conformity based on unit verification is the conformity assessment procedure...
Technical documentation
The manufacturer shall establish the technical documentation and make it...
The manufacturer shall keep the technical documentation at the disposal...
Manufacturing The manufacturer shall take all measures necessary so that...
Verification An approved body chosen by the manufacturer shall carry...
Conformity marking and declaration of conformity
The manufacturer shall affix the UK marking and the M...
The manufacturer shall draw up a written declaration of conformity...
Authorised representative The manufacturer's obligations set out in points 6.2.2...
Common provisions
The conformity assessment according to Module D, D1, F, F1...
If the instrument's performance is sensitive to gravity variations the...
Where a manufacturer has opted for execution in two stages...
The party which has carried out the first stage of...
A manufacturer who has opted for Module D or D1...
The UK marking and the M metrology marking shall be...
Instruments intended to be used for the applications listed in...
Those instruments shall bear visibly, legibly and indelibly the following...
Those instruments shall have adequate facilities for the affixing of...
Where a data plate is used it shall be possible...
The inscriptions Max, Min, e, and d, shall also be...
Each load measuring device which is connected or can be...
Instruments not intended to be used for the applications listed...
Restrictive use symbol referred to in regulation 9(3). The restrictive...
Instrument model/Instrument (product, type, batch or serial number):
Name and address of the manufacturer and, where applicable, his...
This declaration of conformity is issued under the sole responsibility...
Object of the declaration (identification of instrument allowing traceability; it...
The object of the declaration described above is in conformity...
References to the relevant designated standards used or references to...
The approved body … (name, number) performed … (description of...
Additional information: — Signed for and on behalf of: —...
Disqualification mark
Re-qualification mark
Browse 85 other sections — procedural / definitional / commencement
Citation commencement and extent
Interpretation
Designated standard
Application of these Regulations
Revocations and transitional and consequential provisions
Transitional provision in relation to EU Exit
Introductory
Manufacturers' responsibilities – design, conformity assessment and marking of regulated non-automatic weighing instruments
Manufacturers' obligations in respect of records
Manufacturers' obligations to ensure continuing conformity with the essential requirements
Manufacturers' obligations in relation to the marking of regulated non-automatic weighing instruments with serial numbers etc.
Manufacturers to mark contact details on regulated non-automatic weighing instruments
Documentation to accompany regulated non-automatic weighing instruments
Action to be taken where regulated non-automatic weighing instruments placed on the market are not in conformity with the essential requirements
Provision of information to the competent authority
Use of authorised representatives by manufacturers
Introductory
Ensuring compliance of regulated non-automatic weighing instruments
Importers duty to notify manufacturer and market surveillance authorities of non-compliant regulated non-automatic weighing instruments that present a risk
Requirements to mark importers' details on regulated non-automatic weighing instruments
Importers' duty to ensure that regulated non-automatic weighing instruments are accompanied by relevant documentation.
Duty of importers to ensure proper conditions of storage and transport
Duties of importers with regard to monitoring etc.
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
Requirement for importer to keep copy of EU declaration of conformity
Provision of information to a competent authority
Introductory
Distributors – duty to act with due care
Distributors – verification obligations
Distributors not to make non-conforming non-automatic weighing instruments available on the market etc.
Duty of distributors to ensure proper conditions of storage and transport
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
Provision of information to the competent authority
(1) Economic operators must, on request, identify to the market...
Obligations which are met by complying with obligations in the Directive
Conformity assessment procedure obligations that are met by complying with the Directive
Further use of UK marking
Qualifying Northern Ireland Goods
Introductory
Methods of establishing conformity with the essential requirements
Presumptions of conformity of regulated non-automatic weighing instruments
Conformity assessment procedures
Subsidiaries and contractors
Fees
Application of Chapter
Form and contents of ... declaration of conformity etc.
Regulated instruments that require more than one declaration of conformity
Responsibility of manufacturer that draws up declaration of conformity
Conformity with ... requirements to be indicated by the UK marking
Prohibition on improper use of UK marking and the M marking
Rules and conditions for affixing the UK marking and the M marking etc.
UK(NI) indication
Register of notified bodies established in the United Kingdom
(1) This regulation applies to a non-automatic weighing instrument which...
Approved bodies
Approval of conformity assessment bodies
Presumption of conformity of approved bodies
Monitoring
Restriction, suspension or withdrawal of approval
Subsidiaries and contractors
Register of approved bodies
UK national accreditation body
No person shall put into service a regulated non-automatic weighing...
Schedule 4 applies to the use for trade of regulated...
The market surveillance authority
Regulated non-automatic weighing instruments presenting a risk
EU safeguard procedure
Compliant regulated non-automatic weighing instruments which present a risk
Provisions as to directions under regulations 58 and 60
Competent authorities and enforcement proceedings
Compliance notice procedure
Enforcement notice procedure
Review of decisions of a competent authorities
Offence of failing to comply with an enforcement notice
Disqualification
Re-qualification
Testing of regulated non-automatic weighing instruments
Unsuitable use of regulated non-automatic weighing instruments
Unauthorised application of authorised marks
Offences by economic operators etc.
Penalties for offences
Defence of due diligence
Liability of persons other than the principal offender
Service of documents etc.
Review
Enforcement and responsible bodies
The regulators that administer or enforce this legislation.
Office for Product Safety and Standards
Product safety regulator responsible for ensuring consumer products are safe. Enforces product safety regulations, UKCA marking requirements, and works with market surveillance …
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