IE
S.I. No. 83/1999 - European Communities (Equipment and Protective Systems Intended For Use in Potentially Explosive Atmospheres) Regulations, 1999.
Table of Provisions (18)
Statutory Text (18 Articles)
1. This module describes the procedure whereby the manufacturer ensures and declares that the equipment or protective system which has been issued with the certificate referred to in paragraph 2 conforms to the requirements of these Regulations which are applicable to it. The manufacturer or his authorised representative in the Community shall affix the CE marking to the equipment or protective system and draw up a declaration of conformity.
2. The notified body shall examine the individual equipment or protective system and carry out the appropriate tests as set out in the relevant standard referred to in these Regulations, or equivalent tests, to ensure its conformity with the relevant requirements.
The notified body shall affix, or cause to be affixed, its identification number on the approved equipment or protective system and shall draw up a certificate of conformity concerning the tests carried out.
3. The aim of the technical documentation is to enable conformity with the requirements of these Regulations to be assessed and the design, manufacture and operation of the equipment or protective system to be understood.
The documentation shall contain
— a general description of the product;
— conceptual design and manufacturing drawings and layouts of components, sub-assemblies, circuits, etc.;
— descriptions and explanations necessary for the understanding of said drawings and layouts and the operation of the equipment or protective system;
— a list of the standards referred to in these Regulations, applied in full or in part, and descriptions of the solutions adopted to meet the essential requirements of these Regulations where the standards referred to have not been applied;
— results of design calculations made, examinations carried out, etc.;
— test reports.
GIVEN under my Official Seal, this 30th day of March, 1999.
MARY HARNEY,
Minister for Enterprise, Trade and Employment.
EXPLANATORY NOTE.
(This note is not part of the Instrument and does not purport to be a legal interpretation.)
These Regulations implement Council Directive 94/9/EC on the approximation of the laws of the Member States concerning equipment and protective systems intended for use in potentially explosive atmospheres. They apply to equipment, protective systems, devices and components intended for use in potentially explosive atmospheres and going on the market for the first time after the 1st March 1996. The Regulations require compliance with the essential health and safety requirents (Schedule 2) and the affixing of the CE marking. The CE marking can only be affixed if the equipment has undergone the appropriate conformity assessment procedure (Regulation 7) and in respect of which an EC declaration of Conformity has been drawn up.
The aim of the Directive is to remove barriers to trade in the area of equipment and protective systems which are intended for use in potentially explosive atmospheres.
There is a transitional period up to the 30th June 2003 whereby the Regulations do not apply to equipment or a protective system which complies with the health and safety provisions, in respect of it, which were in force in Ireland on 23rd of March 1994. Also, electrical equipment which complies with Directives 76/117/EEC and 79/196/EEC may continue to be marketed until the 30th June 2003.
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OJ No. L100, 19.4.94. p.1.
4. The manufacturer or his authorised representative shall keep a copy of the declaration of conformity with the technical documentation.
5. The manufacturer shall take all measures necessary to ensure that the manufacturing process guarantees compliance of the manufactured equipment with the technical documentation referred to in paragraph 2 and with the requirements of these Regulations applicable to such equipment.
NINTH SCHEDULE
Regulation 7
Module: Unit Verification
6. Each notified body shall forward to the other notified bodies the relevant information concerning the quality system approvals issued and withdrawn.
EIGHTH SCHEDULE
Regulation 7
Module: Internal Control of Production
7. Each notified body shall communicate to the other notified bodies the relevant information concerning the EC-type-examination certificates and additions issued and withdrawn.
8. The other notified bodies may receive copies of the EC-type-examination certificates and their additions or both. The annexes to the certificates shall be kept at the disposal of the other notified bodies.
9. The manufacturer or his authorised representative established in the Community shall keep with the technical documentation copies of EC-type-examination certificates and their additions for a period ending at least 10 years after the last equipment or protective system was manufactured. Where neither the manufacturer nor his authorised representative is established within the Community, the obligation to keep the technical documentation available shall be the responsibility of the person who places the product on the Community market.
FOURTH SCHEDULE
Regulation 7
Module: Production Quality Assurance
10. (1) Requests to a notified body to carry out one or more of the conformity assessment procedures specified in Regulation 7 shall be made in writing and shall be accompanied by the prescribed fee.
(2) Where a notified body is satisfied, following the carrying out of the conformity assessment procedures in respect of which the application was made, that the results of any of the tests or examination conducted by it do not satisfy the requirements of these Regulations it shall inform the applicant in writing stating the reasons and of the right to apply for a review of the decision under Regulation 12.
11. (1) An authorised officer may from time to time carry out an inspection on—
(
a
) equipment, protective system or device on which the CE marking has been placed or in respect of which an EC declaration of conformity has been issued, or
(
b
) a component in respect of which a declaration of conformity with these Regulations has been issued, in accordance with these Regulations, or where appropriate, the law of a Member State,
for the purposes of ascertaining if such equipment, protective system, device or component has been manufactured to conform in all aspects with the requirement of these Regulations.
(2) A responsible person shall, for the purpose of assisting an authorised officer to carry out an inspection in respect of—
(
a
) equipment, a protective system or a device referred to in paragraph (1),
or
(
b
) a component referred to in paragraph (1)
retain, from the date of issue of an EC declaration of conformity for equipment, a protective system or a device referred to in subparagraph (
a
) or a certificate of conformity for a component referred to in subparagraph (
b
) proper records, including documentation specifying the conformity assessment procedures carried out, on the equipment, protective system, device or component concerned and that the conformity assessment procedures have been complied with, and shall when requested to do so by the authorised officer produce them to the authorised officer.
(3) Where an authorised officer is of the opinion that the equipment, protective system, device or component has not been manufactured in conformity with the requirements of these Regulations or that proper records have not been kept in accordance with paragraph (2), he or she shall notify in writing the responsible person of such opinion in accordance with paragraph (5).
(4) If an authorised officer is notified that—
(
a
) equipment, a protective system or a device—
(i) bearing the CE markings, or
(ii) in respect of which an EC declaration of conformity or an EC type examination certificate has been issued, or
(
b
) a component for which a declaration of conformity with these Regulations has been issued, or in respect of which an EC type examination certificate has been issued,
has not been manufactured in conformity with the requirement of these Regulations or that proper records have not been kept in accordance with paragraph (2), the authorised officer may notify in writing the responsible person in accordance with paragraph (5).
(5) An authorised officer shall, when issuing a notification under paragraph (3) or (4) state—
(
a
) the manner in which the equipment, protective system, device or component does not conform with these Regulations, or in which proper records have not been kept.
(
b
) the procedure specified in these Regulations for the purpose of ensuring that—
(i) the equipment, protective system, device or component or any equipment, protective systems, devices or components of the same type, conform, or
(ii) proper records are kept within a specified period and a declaration that if the appropriate procedure is not completed the equipment, protective system, device or component shall not be marketed, or as the case may be, shall be withdrawn from the market,
(
c
) that the equipment, protective system, device or component concerned shall not be put into service nor transported to another Member State, except in order to bring the equipment, protective system, device or component into compliance with these Regulations, and, if appropriate, any EC type examination certificate issued in respect of the equipment, protective system, device or component of the same type will be suspended or withdrawn, and
(
d
) where appropriate, the date on which it is to take effect.
(6) Where an authorised officer decides that equipment, a protective system, device or component—
(
a
) shall not be marketed, shall be withdrawn from the market or shall be prohibited from being put into service, or
(
b
) shall be prohibited from being transported to another Member State,
except in order to bring the equipment, protective system, device or component concerned into compliance with the Regulation, the authorised officer shall give immediate notice in writing to the responsible person specifying the grounds on which such decision has been made in addition to the matters specified in paragraph (5).
(7) In these Regulations “responsible person” means—
(
a
) the manufacturer of equipment, a protective system, a device or a component concerned,
(
b
) the manufacturer's representative, or
(
c
) where the manufacturer is not established in the European Community and—
(i) has not appointed an authorised representative who is also established in the European Community, or
(ii) the representative established in the European Community is not the person who places that equipment, protective system, device or component on the market.
the person who places it on the market in the Community.
12. (1) Any person aggrieved by a decision of a notified body under Regulation 10 may, by notice in writing given to the Authority not later than 14 days after the receipt of notice of that decision, appeal to the Authority against the decision and the Authority, having considered any submissions made to him or her by that person, and any other interested parties and the report of any enquiry held under paragraph (2) in relation to the appeal or of any assessor appointed under paragraph (3) in relation thereto, may uphold, vary or reverse the decision of a notified body.
(2) The Authority may appoint an officer to hold an enquiry in connection with an appeal under this Regulation and to make a report to the Authority on the findings and the result of the enquiry.
(3) The Authority may appoint an assessor to assist and to make a report to the Authority in relation to an appeal under this Regulation or to assist an officer of the Authority in relation to an appeal under this Regulation or to assist an officer of the Authority in relation to an enquiry being held under paragraph (2) of this Regulation.
13. (1) The Minister or the Authority may authorise such and so many officers of the Minister, as the Minister or the Authority thinks fit, to be authorised officers for the purpose of these Regulations.
(2) A person appointed under paragraph (1) shall, on such appointment, be furnished by the Minister or the Authority, as may be appropriate, with a certificate of authorisation of his or her authorisation and when exercising power conferred by these Regulations shall, if requested by any person thereby affected, produce such certificate or an authenticated copy of it to that person for inspection.
(3) An authorised officer for the purpose of these Regulations, may—
(
a
) enter, inspect, examine, and search at all times any structure, premises or other land which he or she has reasonable grounds for believing is being used for or in connection with the manufacture, storage, packing or placing on the market of any equipment, protective systems, components or device,
(
b
) at such structure, premises or other land inspect and take copies of, or extracts from, any books, records in other documents which he or she finds in the course of an inspection, examination or search,
(
c
) require any person whom the authorised officer considers to be in charge of or employed in or on any structure, premises or other land entered by the authorised officer under these Regulations, to—
(i) produce any equipment, protective system, component or device which is in the possession or under the control of such person,
(ii) produce any books, records or other documents which relate to transactions concerning any equipment, protective systems, components or device and which are in the possession or under the control of such person, and
(iii) require any person whom the authorised officer finds on any structure, premises or other land, to furnish such information as the authorised officer may reasonably require for the purposes of these Regulations,
(
d
) make such examination and inquiry as may be necessary to ascertain whether the provisions of these Regulations are being complied with,
(
e
) take possession of and remove from the premises for examination and checking, any equipment, protective systems, component or device, and
(
f
) carry out or cause to have carried out any test which the authorised officer considers to be appropriate in order to establish conformity of equipment, a protective system, device or a component if an EC declaration of conformity has been issued in respect of any equipment, protective systems, or device or a declaration of conformity has been issued in respect of a component and there are reasonable grounds for believing that such equipment, protective system, device or component does not comply with the essential handling and safety requirements.
(4) A person who obstructs or interferes with an authorised officer in the course of exercising a power conferred on such authorised officer by these Regulations or impedes the exercise by the authorised officer of such power or fails or refuses to comply with a request made by, or to answer a question asked by, an authorised officer purport to these Regulations or in purported compliance with such request or in answer to such question gives information to any authorised officer that he or she knows to be false or misleading in a material respect, shall be guilty of an offence.
14. Proceedings for an offence under these Regulations may be brought and be prosecuted by the Minister or the Authority.
15. (1) A person guilty of an offence under these Regulations shall be liable on summary conviction of a fine not exceeding £1,500.
(2) Where an offence under this Act is committed by a body corporate and is proved to have been so committed with the consent, connivance or approval of or to be attributable to any neglect on the part of the person being a director, manager, secretary or other officer of the body corporate, or any other person who was acting or purporting to act in any such capacity, that person as well as the body corporate shall be guilty of an offence and be liable to be proceeded against and punished as if he or she were guilty of the first-mentioned offence.
(3) If the contravention in respect of which a person is convicted of an offence under these Regulations is continued after the conviction, the person shall be guilty of a further offence on every day on which the contravention continues and for each such offence the person shall be liable, on summary conviction, to a find not exceeding £200.
16. (1) All the parties involved in the application of these Regulations shall, subject to paragraph (2), observe confidentiality in respect of all information obtained in the performance of carrying out their tasks under these Regulations.
(2) Paragraph (1) does not affect the obligations of the State and of the notified bodies regarding reciprocal information and the dissemination of warnings.
17. As and from the 1st day of July, 2003—
(
a
) the Regulations of 1981
(
b
) the Regulations of 1986
(
c
) the Regulations of 1991, and
(
d
) the Regulations of 1998
are hereby revoked.
FIRST SCHEDULE
Regulation 2
CE Marking and Other Inscriptions
I, MARY HARNEY, Minister for Enterprise, Trade and Employment, 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 94/9/EC of 23 March, 1994,
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hereby make the following regulations