European Communities (Non-Automatic Weighing Instruments) Regulations, 1992.
Statutory Instruments
Source: Statutory Instruments

num: 1
paragraphs: Citation and commencement.
num: 2
paragraphs: Interpretation.
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paragraphs: Derogation and repeal.
num: 4
paragraphs: Scope of application.
num: 5
paragraphs: Placing on the market and putting into service.
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paragraphs: Offences and penalties.
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paragraphs: Essential requirements.
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paragraphs: Standards.
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paragraphs: Divergence of standard from essential requirements.
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paragraphs: Safeguard clauses.
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paragraphs: Conformity to essential requirements.
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paragraphs: EC type examination.
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paragraphs: EC declaration of type conformity.
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paragraphs: Quality system approval.
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paragraphs: Surveillance of quality system.
num: 16
paragraphs: EC verification.
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paragraphs: EC unit verification.
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paragraphs: Common provisions — place of verification and gravity issue.
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paragraphs: Conformity with other Directives.
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paragraphs: Notified bodies.
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paragraphs: EC mark and inscriptions.
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paragraphs: Review.
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paragraphs: In-service inspection.
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paragraphs: Inspectors.
S.I. No. 424 of 1992.
EUROPEAN COMMUNITIES (NON-AUTOMATIC WEIGHING INSTRUMENTS) REGULATIONS, 1992.
I, PÃ?DRAIG FLYNN, Minister for Industry and Commerce, in exercise of the powers conferred on me by section 3 of the European Communities Act, 1972 (No. 27 of 1972), and for the purpose of giving effect to Council Directive No. 90/384/EEC1 of 20 June, 1990 hereby make the following Regulations:
1 O.J. No. L189, 20.7.90, p.1.
1 Citation and commencement.
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paragraphs: (1) These Regulations may be cited as the European Communities (Non-Automatic Weighing Instruments) Regulations, 1992.
(2) These Regulations shall come into operation on the 1st day of January, 1993.
2 Interpretation.
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paragraphs: (1) In these Regulations—
"the Commission" means the Commission of the European Communities;
"the Directive" means Council Directive 90/384/EEC of 20 June, 1990*;
*O.J. No. L189/1,20.7.90.
"weighing instrument" means a measuring instrument serving to determine the mass of a body by using the action of gravity on that body. A weighing instrument may also serve to determine other mass-related magnitudes, quantities, parameters or characteristics;
"instrument" means a non-automatic weighing instrument;
"non-automatic weighing instrument" means a weighing instrument requiring the intervention of an operator during weighing;
"relevant national standard" means a national standard of any Member State applicable to non-automatic weighing instrument implementing the harmonised standards whose
reference numbers have been published in accordance with Article 5 (2) of the Directive;
"examination and tests" means the appropriate examinations and tests described in the relevant national standard or such equivalent tests;
"notified body" means a body designated by the Minister for Industry and Commerce and notified to the other Member States and the Commission in accordance with Article 9 of the Directive or a body similarly designated by another Member State;
"inspector" has the meaning assigned to it by Regulation 24;
"the Minister" means the Minister for Industry and Commerce;
"Member State" means a Member State of the European Communities;
"inscriptions" means the relevant data as described in Annex IV of the Directive;
"sticker" means that described in paragraph 1.1(b) of Annex IV of the Directive, except as provided for in Regulation 23;
"EC mark of conformity" means the mark specified in Article 10 of the Directive;
"manufacturer" means a manufacturer of non-automatic weighing instruments;
"authorised representative" means a representative established within the European Communities authorised in writing by the manufacturer;
"place on the market" and cognate words, shall be construed in accordance with Regulation 5;
(2) In these Regulations, a reference by number to a Regulation is to the appropriate Regulation of these Regulations.
3 Derogation and repeal.
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paragraphs: (1) By way of derogation from Regulation 1, it shall be permitted during a period of ten years from 1 January, 1993 to place on the market and also to put into service instruments which conform to the rules in force prior to that date. Such instruments shall continue to be subject to such rules only.
(2) Except to the extent of paragraph 1, Council Directive 73/360/EEC2 is repealed as from 1 January, 1993.
2 O.J. No. L335, 5.12.73, p.1.
4 Scope of application.
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paragraphs: A distinction is made in these Regulations between two categories of instrument use:
( a ) (i) determination of mass for commercial transactions;
(ii) determination of mass for the calculation of a toll, tariff, tax, bonus, penalty, remuneration, indemnity or similar type of payment;
(iii) determination of mass for the application of laws or regulations except use of instruments by the Weights and Measures Service of the State in the application of weights and measures laws and regulations; expert opinion given in court proceedings;
(iv) determination of mass in the practice of medicine for weighing patients for the purposes of monitoring, diagnosis and medical treatment;
(v) determination of mass for making up medicines on prescription in a pharmacy and determination of mass in analyses carried out in medical and pharmaceutical laboratories;
(vi) determination of price on the basis of mass for the purposes of direct sales to the public and the making up of packages prepacked other than those made up in predetermined constant quantities in accordance with the Quantity Control Act, 1980;
( b ) all applications other than those listed in paragraph (a).
5 Placing on the market and putting into service.
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paragraphs: (1) Only instruments which meet the requirements of these Regulations that apply to them may be
( a ) placed on the market,
( b ) put into service for the uses referred to in Regulation 4(a).
(2) Any person who places on the market or causes to be placed on the market or who causes to be offered for sale, whether by lease, rental or other type of agreement, any instrument which does not meet the requirements of these Regulations shall be guilty of an offence.
(3) Any person who places in service or causes to be placed in service or uses for any of the applications referred to in Regulation 4 (a), any instrument which does not meet the requirements of these Regulations that apply to it shall be guilty of an offence.
(4) In these Regulations "places on the market" means—
( a ) import,
( b ) sell (whether by wholesale or retail),
( c ) offer or expose for such sale,
( d ) distribute free of charge, or
( e ) supply by a manufacturer for any of those purposes,
and cognate words shall be construed accordingly.
6 Offences and penalties.
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paragraphs: (1) An person guilty of an offence under these Regulations shall be liable, on summary conviction, to a fine not exceeding £1,000 or, in the case of an individual, to imprisonment for a term not exceeding twelve months or to both such fine and such imprisonment and the instruments concerned shall be liable to be forfeited.
(2) Where the commission by any person of an offence under Regulation 5.2, 5.3, 10.3, 19.2, 21.2 or 23.8 is due to the act or default of some other person, that other person shall also be guilty of the offence and may be charged with and convicted of the offence whether or not proceedings are taken against the first mentioned person.
(3) Where an offence, committed by a body corporate, is proved to have been committed with the consent of, or to be attributable to any neglect on the part of, any director, manager, secretary or other similar officer of the body corporate or any person purporting to act in any such capacity, he as well as the body corporate shall be deemed guilty of the offence.
(4) Where the affairs of a body corporate are managed by its members paragraph (3) shall apply in relation to the acts and defaults of a member in connection with his functions of management as if he were a director of the body corporate.
(5) Notwithstanding section 10 (4) of the Petty Sessions (Ireland) Act, 1851, proceedings for an offence under these Regulations may be instituted at any time within one year from the date on which the offence was committed.
(6) Proceedings for an offence under these Regulations may be brought and prosecuted by an inspector as described in Regulation 24.
(7) Details of prosecutions taken under paragraph (6) shall be notified to the Minister.
7 Essential requirements.
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paragraphs: (1) Instruments which are put into use for applications referred to in Regulation 4 (a) must satisfy the essential requirements set out in Annex I of the Directive.
(2) If an instrument includes or is connected to devices which are not used for applications listed in Regulation 4 (a), the devices shall not be subject to the essential requirements referred in paragraph (1).
8 National standards.
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paragraphs: (1) Instruments which comply with the national standards implementing the harmonised standards that meet the essential requirements shall be presumed to conform with the essential requirements referred to in Annex I of the Directive.
(2) The references of the national standards referred to in paragraph (1) shall be published in Iris OifigiÃºil.
9 Divergence of standards from essential requirements.
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paragraphs: (1) Where after receiving a report from the appropriate notified body, the Minister considers that the harmonised standards referred to in Regulation 8, do not fully meet the essential requirements referred to in Annex 1 of the Directive, he shall bring the matter before the Standing Committee set up under Council Directive 83/189/EEC(3), giving his reasons for doing so.
3 O.J. No. L109, 26.4.83, p.8.
(2) In the light of the Committee's opinion, the Commission shall inform the Member States whether or not it is necessary to withdraw those standards from the publications referred to in Regulation 8.
10 Safeguard clauses.
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paragraphs: (1) If it appears to an inspector that two or more instruments of an approved type bearing the EC mark of conformity referred to in Regulations 13, 16 and 17 do not meet the requirements of these Regulations when properly installed and used for the purposes for which they are intended, he shall notify the Minister thereof.
(2) Where the Minister agrees with the opinion of the inspector, he may by direction in writing given to the person or persons who is placing or has placed such instruments on the market or in service, prohibit him from placing or continuing to place on the market or put into service such instruments, impose restrictions on his so doing or require him to take all practical steps to withdraw from the market or from service, as the case may be, any such instruments already placed by him on the market or in service and such person or persons shall comply with the direction.
(3) A person who places the EC mark of conformity on an instrument which does not comply with the requirements of the Directive that apply to it, shall be guilty of an offence under these Regulations. The Minister shall notify such offences to the Commission and the other Member States.
(4) Where the Minister decides to give a direction under paragraph (2), he shall immediately inform the Commission indicating why he intends to issue the direction and in particular whether non-compliance is due to:
( a ) failure to meet the essential requirements referred to in Regulation 7 where the instruments do not meet the standards referred to in Regulation 8;
( b ) incorrect application of the standards referred to in Regulation 8;
( c ) shortcomings in the standards referred to in Regulation 8 themselves.
(5) The Minister may, on receipt of the Commission's opinion, withdraw a direction given by him under paragraph (2).
11 Conformity to essential requirements.
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paragraphs: (1) An instrument shall satisfy the essential requirements only if, as selected by the applicant, either procedure (a) or (b) is followed—
( a ) an EC type-approval certificate has been issued in respect of the instrument by a notified body and is in force and one of the following conditions are satisfied—
(i) an EC declaration of type conformity has been made, and an EC mark of conformity, inscriptions and sticker have been affixed to the instrument, by the manufacturer, in accordance with Regulation 13 or under the law of another Member State;
(ii) an EC verification has been carried out by a notified body and the instrument bears the EC mark of conformity, inscriptions and sticker which have been affixed in accordance with Regulation 16 or under the law of another Member State;
( b ) an EC unit verification has been carried out by a notified body and the instrument bears the EC mark of conformity, inscriptions and sticker which have been affixed in accordance with Regulation 17 or under the law of another Member State.
(2) EC type examination as specified in paragraph (1) (a) shall not be compulsory for instruments which do not use electronic devices and whose load-measuring device does not use a spring to balance the load.
(3) The documents and correspondence relating to the procedures referred to in paragraph (1) shall, so far as the procedures are carried out in the State, be drafted in the English language or a language accepted by the notified body.
12 EC type examination.
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paragraphs: (1) An application for EC type examination shall be made in writing to the relevant notified body in the State by the manufacturer or his authorised representative and shall include:
( a ) the name and address of the manufacturer and, if the application is lodged by the authorised representative, his name and address,
( b ) a written declaration that the application has not been lodged with any other notified body, and
( c ) so far as relevant for assessment, the design documentation specified in Annex III of the Directive.
(2) The applicant shall, when requested by the notified body, make available an instrument, representative of the production envisaged, hereinafter referred called "type".
(3) On receipt of an application under paragraph (1) the notified body shall:
( a ) examine the design documentation and verify that the type has been manufactured in accordance with that documentation;
( b ) agree with the applicant on the location where examinations and tests shall be carried out;
( c ) perform or have performed the appropriate examinations and tests to check whether—
(i) the solutions adopted by the manufacturer meet the essential requirements where the standards referred to in Regulation 8 have not been applied, or
(ii) where the relevant standards have been applied that these have been applied effectively, thereby assuring conformity with the essential requirements.
(4) Where after carrying out the functions under paragraph (3), the type is considered as meeting the provisions of these Regulations, the notified body shall issue an EC type-approval certificate to the applicant. The certificate shall contain the conclusions of the examination, conditions (if any) for its validity, the necessary data for identification of the approved instrument and, if relevant, a description of its functioning. All the relevant technical elements such as drawings and layouts shall be annexed to the EC type-approval certificate.
(5) Subject to any restrictions imposed under paragraph (6) the certificate shall have a validity period of 10 years from the date of its issue, and may be renewed for subsequent periods of 10 years each.
(6) Where new techniques are employed or other fundamental changes to the design of the instrument are made, an EC type-approval certificate may be granted for a specified period, and—
( a ) the initial period for which the certificate is granted shall be restricted to a period of two years; and
( b ) one extension for a period of three years may be granted.
(7) The applicant shall keep the notified body that has issued the EC type-approval certificate informed of any modifications to the approved type.
(8) Where an EC type-approval certificate has been granted under paragraph (4) and modifications or additions to the approved type influencing conformity with the essential requirements of these regulations are proposed, the manufacturer, or his authorised representative, shall make written application to the same notified body for approval of the modifications or additions to the approved type.
(9) On an application under paragraph (8), the notified body shall carry out an examination of the approved type with the modifications or additions proposed and if satisfied that the type complies with the provision of the Directive that apply to it, shall approve the modifications or additions and issue an addition to the original EC type-approval certificate.
(10) ( a ) The notified body shall periodically make available to the Minister and to other Member States a list of:
(i) applications received for EC type-examination,
(ii) EC type-approval certificates issued,
(iii) applications for type-approval certificates refused,
(iv) additions and amendments relating to documents already issued,
and, on request, shall send to the Minsiter or the notified bodies of other Member States a copy of any EC type-approval certificate together with any Annexes to it that have issued.
( b ) The notified body shall inform the Minsiter and all other Member States forthwith of withdrawals of EC type-approval certificates.
13 EC declaration of type conformity.
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paragraphs: (1) A manufacturer who has opted for the EC declaration of type conformonity procedure referred to in Regulation 11.1 (a) (i) and who has implemented an approved quality system which is subject to surveillance as described in Regulation 15 may, after carrying out the appropriate examinations and tests declare that the instruments concerned are, where applicable, in conformity with the type as described in the EC type-approval certificate and satisfy the requirements of these Regulations that apply to them.
(2) ( a ) The manufacturer shall affix the EC mark of conformity to each instrument together with the sticker and inscriptions provided for in Annex IV of the Directive.
( b ) The EC mark shall be accompanied by the identification code of the notified body responsible for EC surveillance as described in Regulation 15.
14 Quality system approval.
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paragraphs: (1) In order to carry out EC declaration of type conformity a manufacturer shall first lodge an application in writing for approval of his quality system with the relevant notified body.
The application shall include an undertaking:
( a ) to carry out the obligations arising from the approved quality system,
( b ) to maintain the approved quality system to ensure its continuing suitability and effectiveness.
(2) The manufacturer shall make available to the notified body all relevant information including in particular the quality system's documentation and the design documentation of the instruments.
(3) On application made to it under paragraph (1), the notified body shall examine and evaluate the quality system to determine whether it satisfied the requiements referred to in paragraph 2.3.2 of Annex II of the Directive. It shall presume conformity with these requirements in respect of quality systems that implement the relevant national standard.
(4) ( a ) After carrying out its obligations under paragraph (3), the notified body shall inform the Minister and the other notified bodies of its decision.
( b ) Where the notified body is satisfied that the system meets the requirements referred to in paragraph 2.3.2 of Annex II of the Directive, it shall grant to the manufacturer an approval of the quality system.
( c ) The notification of approval to the manufacturer shall include the conclusions of the examination and evaluation carried out by the notified body.
(5) Where the notified body, after carrying out its obligations under paragraph (3), refuses to grant an approval of the quality system it shall in writing, inform the manufacturer and the Minister of its decision and the grounds for its decision.
(6) The manufacturer or his authorised representative shall keep the notified body that has approved the quality system informed of any updating of the quality system in relation to changes brought about by, for example, new technologies and new quality concepts.
(7) If a notified body withdraws approval of a quality system, it shall so inform the Minister and the other notified bodies.
15 Surveillance of quality system.
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paragraphs: (1) Where a manufacturer has made an EC declaration of type conformity under Regulation 13 (1), the notified body to whom the manufacturer made an application for approval of the quality system shall carry out EC surveillance, and in particular
( a ) shall periodically carry out audits in order to ensure that the manufacturer is maintaining and applying the quality system and provide the manufacturer with an audit report, and