S.I. No. 230/2017 - European Union (Equipment and Protective Systems Intended for Use in Potentially Explosive Atmospheres) Regulations 2017

ARRANGEMENT OF REGULATIONS

PART 1 CITATION, INTERPRETATION

1.

2.

3.

4.

5.

6.

PART 2 OBLIGATIONS OF ECONOMIC OPERATORS

7.

8.

9.

10.

11.

12.

PART 3 CONFORMITY OF PRODUCTS

13.

14.

15.

16.

17.

PART 4 NOTIFICATION OF CONFORMITY ASSESSMENT BODIES

18.

19.

20.

21.

22.

23.

24.

25.

PART 5 MARKET SURVEILLANCE, SAFEGUARD PROCEDURE

26.

27.

28.

29.

30.

PART 6 POWERS OF THE MARKET SURVEILLANCE AUTHORITY

31.

32.

33.

34.

35.

36.

37.

38.

39.

40.

41.

PART 7 OFFENCES AND PENALTIES

42.

43.

44.

45.

PART 8 MISCELLANEOUS

46.

47.

48.

49.

50.

51.

52.

SCHEDULE 1 Text of Annex I to the Directive

Criteria determining the classification of equipment-groups into categories.

SCHEDULE 2 Text of Annex II to the Directive

Essential health and safety requirements relating to the design and construction of equipment and protective systems intended for use in potentially explosive atmospheres.

SCHEDULE 3 Text of Annex III to the Directive

Module B: EU-type examination.

SCHEDULE 4 Text of Annex IV to the Directive

Module D: Conformity to type based on quality assurance of the production process.

SCHEDULE 5 Text of Annex V to the Directive

Module F: Conformity to type based on product verification.

SCHEDULE 6 Text of Annex VI to the Directive

Module C1: Conformity to type based on internal production control plus supervised product testing.

SCHEDULE 7 Text of Annex VII to the Directive

Module E: Conformity to type based on product quality assurance.

SCHEDULE 8 Text of Annex VIII to the Directive

Module A: Internal production control.

SCHEDULE 9 Text of Annex IX to the Directive

Module G: Conformity based on unit verification.

SCHEDULE 10 Text of Annex X to the Directive

EU declaration of conformity.

SCHEDULE 11 Text of Annex XII to the Directive

Correlation Table.

S.I. No. 230 of 2017

EUROPEAN UNION (EQUIPMENT AND PROTECTIVE SYSTEMS INTENDED FOR USE IN POTENTIALLY EXPLOSIVE ATMOSPHERES) REGULATIONS 2017

Notice of the making of this Statutory Instrument was published in

“Iris Oifigiúil” of 2nd June, 2017.

I, MARY MITCHELL O’CONNOR, Minister for Jobs, Enterprise and Innovation, in exercise of the powers conferred on me by section 3 of the European Communities Act, 1972 (No. 27 of 1972) (as amended by section 2 of the European Communities Act 2007 (No. 18 of 2007) and for the purpose of giving effect to Directive 2014/34/EU of the European Parliament and of the Council of 26 February 2014¹ and of giving further effect to Regulation (EC) No. 765/2008 of the European Parliament and of the Council of 9 July 2008² , hereby make the following regulations:

PART 1 CITATION, INTERPRETATION

Citation

Interpretation

“accreditation” has the meaning assigned to it in point 10 of Article 2 of Regulation (EC) No 765/2008;

“Act of 2005” means the Safety, Health and Welfare at Work Act 2005 (No. 10 of 2005);

“authorised representative” means any natural or legal person established within the European Economic Area who has received a written mandate from a manufacturer to act on its behalf in relation to specified tasks;

“CE marking” means a marking by which the manufacturer indicates that the product other than a component is in conformity with the applicable requirements set out in Union harmonisation legislation providing for its affixing;

“Companies Acts” means the Companies Act 2014 (No. 38 of 2014) or, as the context may require, the legislation repealed by s. 4 of the Companies Act 2014 ;

“competent authority” means—

• (a) in the State, the market surveillance authority, or

• (b) in another Member State, any authority or body to whom functions have been assigned as a competent authority or a market surveillance authority, for the purposes of the Directive;

“components” means any item essential to the safe functioning of equipment and protective systems but with no autonomous function;

“conformity assessment” means the process demonstrating whether the essential health and safety requirements of the Directive or these Regulations relating to a product have been fulfilled;

“conformity assessment body” means a body that performs conformity assessment activities including calibration, testing, certification and inspection;

“contravention notice” means the notice provided for in Regulation 34;

“Coroners Acts 1962 and 2005” means the Coroners Act 1962 (No. 9 of 1962) as amended by the Coroners (Amendment) Act 2005 (No. 33 of 2005);

“Directive” means Directive 2014/34/EU of the European Parliament and of the Council of 26 February 2014;

“Directive 94/9/EC” means Directive 94/9/EC of the European Parliament and of the Council of 23 March 1994³ ;

“distributor” means any natural or legal person in the supply chain, other than the manufacturer or the importer, who makes a product available on the market;

“economic operator” means a manufacturer, authorised representative, importer or distributor;

“equipment” means machines, apparatus, fixed or mobile devices, control components and instrumentation thereof and detection or prevention systems which, separately or jointly, are intended for the generation, transfer, storage, measurement, control and conversion of energy or the processing of material and which are capable of causing an explosion through their own potential sources of ignition;

“equipment category” means the classification of equipment, within each equipment-group, specified in Annex I to the Directive the text of which is set out in Schedule 1 to these Regulations, determining the requisite level of protection to be ensured;

“equipment-group I” means equipment intended for use in underground parts of mines, and in those parts of surface installations of such mines, liable to be endangered by firedamp and/or combustible dust, comprising equipment categories M 1 and M 2 as set out in set out in Annex I to the Directive, the text of which is set out in Schedule 1 to these Regulations;

“equipment-group II” means equipment intended for use in other places liable to be endangered by explosive atmospheres, comprising equipment categories 1, 2 and 3 as set out set out in Annex I to the Directive, the text of which is set out in Schedule 1 to these Regulations;

“EU declaration of conformity” means a declaration of conformity drawn up in accordance with Regulation 15;

“explosive atmosphere” means a mixture with air, under atmospheric conditions, of flammable substances in the form of gases, vapours, mists or dusts in which, after ignition has occurred, combustion spreads to the entire unburned mixture;

“harmonised standard” has the meaning assigned to it in point (c) of Point 1 of Article 2 of Regulation (EU) No 1025/2012 of the European Parliament and of the Council of 25 October 2012⁴ ;

“importer” means any natural or legal person established within the European Economic Area who places a product from a third country on the market of the European Economic Area;

“information notice” means the notice provided for in Regulation 39;

“inspector” has the meaning assigned to it in Regulation 31(2);

“intended use” means the use of a product prescribed by the manufacturer by assigning the equipment to a particular equipment-group and category or by providing all the information which is required for the safe functioning of a protective system, device or component;

“Irish National Accreditation Board” means the national body with responsibility for the accreditation of laboratories, certification bodies and inspection bodies, and notified to the European Commission as being the sole accreditation body for Ireland in line with Regulation (EC) No 765/2008;

“making available on the market” means any supply of a product for distribution, consumption or use on the market of the European Economic Area in the course of a commercial activity, whether in return for payment or free of charge;

“manufacturer” means any natural or legal person who manufactures a product or has a product designed or manufactured, and markets that product under his name or trademark or uses it for his own purposes;

“market surveillance authority” means the authority designated as a market surveillance authority under Regulation 3;

“means of transport” means vehicles and their trailers intended solely for transporting passengers by air or by road, rail or water networks, as well as means of transport in so far as such means are designed for transporting goods by air, by public road or rail networks or by water but does not include vehicles intended for use in a potentially explosive atmosphere;

“Member State” means a state which is a contracting party to the Agreement on the European Economic Area signed in Oporto on 2 May 1992;

“Minister” means the Minister for Jobs, Enterprise and Innovation;

“notified body” means—

• (a) in the State, a conformity assessment body notified by the notifying authority pursuant to Regulation 18, and

• (b) in another Member State, a conformity assessment body notified by the relevant notifying authority pursuant to the Directive;

“notifying authority” means the authority designated as the notifying authority in the State under Regulation 3 and in another Member State the authority designated as notifying authority pursuant to the Directive;

“Official Journal” means the Official Journal of the European Union;

“person in charge” means, in relation to a place—

• (a) the person under whose direction and control the activities at that place are being conducted, or

• (b) the person whom the inspector has reasonable grounds for believing is in control of that place;

“placing on the market” means the first making available of a product on the market of the European Economic Area;

“premises of an economic operator” means any premises owned or being used by an economic operator;

“potentially explosive atmosphere” means an atmosphere which could become explosive due to local and operational conditions;

“product” means the items specified in Regulation 4(1)(a), (b) or (c);

“protective systems” means devices other than components of equipment which are intended to halt incipient explosions immediately or to limit the effective range of an explosion and which are separately made available on the market for use as autonomous systems;

“prohibition notice” means the notice provided for in Regulation 36;

“putting into service” means the first use of a product by its user;

“recall” means any measure aimed at achieving the return of a product that has already been made available to the end-user;

“Regulation (EC) No. 765/2008” means Regulation (EC) No. 765/2008 of the European Parliament and of the Council of 9 July 2008 setting out the requirements for accreditation and market surveillance relating to the marketing of products and repealing Regulation (EEC) No. 996/93;

“Regulations of 1999” means the European Communities (Equipment and Protective Systems Intended for use in Potentially Explosive Atmospheres) Regulations ( S.I. No. 83 of 1999 );

“technical specification” means a document that prescribes technical requirements to be fulfilled by a product;

“Union harmonisation legislation” means any European Union legislation harmonising the conditions for the marketing of products;

“withdrawal” means any measure aimed at preventing a product in the supply chain from being made available on the market.

• (2) A word or expression which is used in these Regulations and which is also used in the Directive has, unless the context otherwise requires, the same meaning in these Regulations as it has in the Directive.

• (3) References to the repealed Directive 94/9/EC shall be construed in existing laws, regulations and administrative provisions of the State as references to the Directive and shall be read in accordance with the correlation table in Annex XII, the text of which is set out in Schedule 11 to these Regulations.

Designation

• (a) the Health and Safety Authority is designated as the market surveillance authority, and

• (b) the Minister is designated as the notifying authority.

Application

• (a) equipment and protective systems intended for use in potentially explosive atmospheres,

• (b) safety devices, controlling devices and regulating devices intended for use outside potentially explosive atmospheres but required for, or contributing to the safe functioning of equipment and protective systems with respect to the risks of explosion,

• (c) components intended to be incorporated into equipment and protective systems referred to in subparagraph (a).

• (2) These Regulations do not apply to—

• (a) medical devices intended for use in a medical environment,

• (b) equipment and protective systems where the explosion hazard results exclusively from the presence of explosive substances or unstable chemical substances,

• (c) equipment intended for use in domestic and non-commercial environments where potentially explosive atmospheres may only rarely be created, solely as a result of the accidental leakage of fuel gas,

• (d) personal protective equipment covered by Council Directive (89/686/EEC) of 21 December 1989⁵ on the approximation of the laws of the Member States relating to personal protective equipment,

• (e) seagoing vessels and mobile offshore units together with equipment on board such vessels or units,

• (f) means of transport,

• (g) the equipment covered by point (b) of Article 346(1) of the Treaty on the Functioning of the European Union.

Making available on the market and putting into service

• (2) Paragraph (1) shall not prevent a person from showing a product which does not comply with the Directive or these Regulations at a trade fair, exhibition or demonstration, provided that—

• (a) a visible sign clearly indicates that the product does not comply with the Directive or these Regulations and that it is not for sale until it has been brought into conformity, and

• (b) adequate safety measures are taken during demonstrations to ensure the protection of persons.

Essential health and safety requirements

PART 2 OBLIGATIONS OF ECONOMIC OPERATORS

Obligations of manufacturers

• (a) ensure that the product placed on the market by the manufacturer or used for the manufacturer’s own purposes, has been designed and manufactured in accordance with the essential health and safety requirements set out in Annex II to the Directive, the text of which is set out in Schedule 2 to these Regulations,

• (b) draw up the technical documentation referred to in Annexes III to IX to the Directive, the text of which is set out in Schedules 3 to 9 to these Regulations and carry out the relevant conformity assessment procedure referred to in Regulation 14 or have it carried out,

• (c) in a case where compliance of a product, other than a component, with the applicable requirements has been demonstrated by the conformity assessment procedure carried out under paragraph (b)—

• (i) draw up an EU declaration of conformity in accordance with Regulation 15,

• (ii) ensure that the EU declaration of conformity accompanies each product, save that where a large number of products are delivered to a single user, the batch or consignment concerned may be accompanied by a single copy of the declaration,

• (iii) affix a CE marking to the product in accordance with Regulation 17,

• (d) in a case where compliance of a component with the applicable requirements has been demonstrated by the relevant conformity assessment procedure under paragraph (b)—

• (i) draw up a written attestation of conformity as referred to in Regulation 14(3),

• (ii) ensure that each component is accompanied by a copy of the attestation of conformity, save that where a large number of components are delivered to a single user, the batch or consignment concerned may be accompanied by a single copy of the attestation,

• (e) retain the technical documentation and the EU declaration of conformity or, where applicable, the attestation of conformity for 10 years after the product has been placed on the market,

• (f) ensure that procedures are in place for series production to remain in conformity with the Directive or these Regulations and that changes in a product design and characteristics and changes in the harmonised standards referred to in Regulation 13 or in other technical specifications by reference to which conformity of a product is declared, are adequately taken into account,

• (g) in a case where it is deemed appropriate by the market surveillance authority with regard to the risks presented by a product and in order to protect the health and safety of end-users—

• (i) carry out sample testing of products made available on the market,

• (ii) investigate, and, if necessary, keep a register of complaints, of non-conforming products and product recalls, and

• (iii) keep distributors informed of any such monitoring,

• (h) ensure that products which it has placed on the market bear a type, batch or serial number or other element allowing their identification, or, where the size or nature of the product does not allow it, that the required information is provided on its packaging or in a document accompanying the product,

• (i) ensure that products, other than components, which the manufacturer has placed on the market bear the specific marking of explosion protection and, where applicable, the other markings and information referred to in paragraph 1.0.5 of Annex II, the text of which is set out in Schedule 2 to these Regulations,

• (j) indicate on the product in a language easily understood by end-users and the competent authorities, the manufacturer’s name, registered trade name or registered trade mark and the postal address at which they can be contacted, which address shall indicate a single point of contact or, where that is not possible to do so on the product, on its packaging or in a document accompanying the product,

• (k) ensure that the product is accompanied by instructions and safety information in a language which can be easily understood by end-users and that such instructions and safety information, as well as any labelling, are clear, understandable and intelligible,

• (l) in the case of a product which a manufacturer has placed on the market and which the manufacturer considers or has reason to believe is not in conformity with the Directive or these Regulations—

• (i) immediately take the corrective measures necessary to bring that product into conformity, to withdraw it or recall it if appropriate, and

• (ii) where the product presents a risk, immediately inform the competent authorities of the Member States in which the manufacturer made the product available on the market, giving details, in particular, of the non-compliance and of any corrective measures taken,

and

• (m) further to a reasoned request from a competent authority in respect of a product which the manufacturer has made available on the market—

• (i) provide it with all the information and documentation in paper or electronic form necessary to demonstrate the conformity of the product with the Directive or these Regulations, in a language which can be easily understood by that authority, and

• (ii) co-operate with that authority, at its request, on any action taken to eliminate the risks posed by products placed on the market by the manufacturer.

Authorised Representatives

• (2) The obligations laid down in Regulation 7(a) and the obligation to draw up technical documentation referred to in Regulation 7(b) shall not form part of the mandate of an authorised representative appointed under paragraph (1).

• (3) An authorised representative appointed under paragraph (1) shall perform the tasks specified in the mandate received from the manufacturer which shall, at least, allow the authorised representative to—

• (a) keep the EU declaration of conformity or, where applicable, the attestation of conformity and the technical documentation at the disposal of competent authorities for 10 years after the product has been placed on the market,

• (b) further to a reasoned request from a competent authority, provide that authority with all the information and documentation necessary to demonstrate the conformity of a product, and

• (c) cooperate with a competent authority, at its request, on any action taken to eliminate the risks posed by products covered by the authorised representative’s mandate.

Obligations of importers

• (2) An importer shall—

• (a) before placing a product on the market, ensure that—

• (i) the appropriate conformity assessment procedure referred to in Regulation 14 has been carried out by the manufacturer,

• (ii) the manufacturer has drawn up the technical documentation,

• (iii) the items referred to in Regulation 4(1)(a) and (b) bear the CE marking, and, are accompanied by the EU declaration of conformity and the required documents,

• (iv) the items referred to in Regulation 4(1)(c) are accompanied by the attestation of conformity and by the required documents, and

• (v) the manufacturer has complied with the requirements set out in Regulations 7(h), 7(i) and 7(j),

• (b) in a case where the importer considers or has reason to believe that a product is not in conformity with the essential health and safety requirements set out in Annex II to the Directive, the text of which is set out in Schedule 2 to these Regulations—

• (i) not place the product on the market until it has been brought into conformity, and

• (ii) where the product presents a risk, inform the manufacturer and the competent authorities of the Member States to that effect,

• (c) indicate on the product, in a language which can be easily understood by end-users and competent authorities, or where it is not possible to do so on the product, in a document accompanying it, the importer’s name, registered trade name or registered trade mark and the postal address at which the importer can be contacted,

• (d) ensure that the product is accompanied by instructions and safety information in a language which can be easily understood by the end-users,

• (e) ensure that, while a product is under the importer’s responsibility, its storage or transport conditions do not jeopardise its compliance with the essential health and safety requirements set out in Annex II, the text of which is set out in Schedule 2 to these Regulations,

• (f) in a case where it is deemed appropriate by the market surveillance authority, with regard to the risks presented by a product and in order to protect the health and safety of end-users, the importer shall—

• (i) carry out sample testing of products made available on the market,

• (ii) investigate, and, if necessary, keep a register of complaints, of non-conforming products and product recalls, and

• (iii) keep distributors informed of any such monitoring,

• (g) in a case where an importer considers or has reason to believe that a product which the importer has placed on the market is not in conformity with the Directive or these Regulations—

• (i) immediately take the corrective measures necessary to bring that product into conformity, to withdraw it or recall it if appropriate, and

• (ii) where the product presents a risk, immediately inform the competent authorities of the Member States in which the importer made the product available on the market to that effect, giving details, in particular, of the non-compliance and of any corrective measures taken,

• (h) for 10 years after the product has been placed on the market by the importer—

• (i) keep a copy of the EU declaration of conformity or, where applicable, of the attestation of conformity at the disposal of competent authorities, and

• (ii) ensure that the technical documentation can be made available to those authorities, upon request,

and

• (i) further to a reasoned request from a competent authority in respect of a product which the importer has made available on the market—

• (i) provide it with all the information and documentation in paper or electronic form necessary to demonstrate the conformity of a product, in a language which can be easily understood by that authority, and

• (ii) cooperate with that authority, at its request, on any action taken to eliminate the risks posed by the product which the importer has placed on the market.

Obligations of distributors

• (a) act with due care in relation to the requirements of the Directive or these Regulations when making a product available on the market,

• (b) before making a product available on the market, verify that—

• (i) the product bears the CE marking, where applicable,

• (ii) where applicable, that it is accompanied by the EU declaration of conformity or the attestation of conformity and the required documents,

• (iii) the product is accompanied by instructions and safety information, in a language which can be easily understood by the end-users in the Member State in which the product is to be made available on the market, and

• (iv) the manufacturer and the importer have complied with the requirements set out in Regulations 7(h), 7(i), 7(j) and 7(k) and Regulation 9(2)(c) respectively.

• (c) in a case where a distributor considers or has reason to believe that a product is not in conformity with the essential health and safety requirements set out in Annex II to the Directive, the text of which is set out in Schedule 2 to these Regulations—

• (i) not make the product available on the market until it has been brought into conformity, and

• (ii) where the product presents a risk, inform the manufacturer or the importer to that effect as well as the competent authorities of the Member States,

• (d) ensure that, while a product is under the distributor’s responsibility, its storage or transport conditions do not jeopardise its compliance with the essential health and safety requirements set out in Annex II to the Directive, the text of which is set out in Schedule 2 to these Regulations,

• (e) in a case where the distributor considers, or has reason to believe, that a product which the distributor has made available on the market is not in conformity with the Directive or these Regulations—

• (i) make sure that the corrective measures necessary to bring that product into conformity, to withdraw it or recall it, if appropriate, are taken, and

• (ii) where that product presents a risk, immediately inform the competent authorities of the Member States in which the distributor made the product available on the market to that effect, giving details, in particular, of the non-compliance and of any corrective measures taken,

and

• (f) further to a reasoned request from a competent authority in respect of a product which the distributor has made available on the market—

• (i) provide it with all the information and documentation, in paper or electronic form, necessary to demonstrate the conformity of the product, and

• (ii) cooperate with that authority, at its request, on any action taken to eliminate the risks posed by the product.

Cases in which obligations of manufacturers apply to importers and distributors

• (a) places a product on the market under the importer’s or distributor’s name or trademark, or

• (b) modifies a product already placed on the market in such a way that compliance with the Directive or these Regulations may be affected.

Identification of economic operators

• (a) on request, identify to a competent authority any economic operator—

• (i) who has supplied the first named economic operator with a product, or

• (ii) to whom the first named economic operator has supplied a product, and

• (b) be able to present the information referred to in paragraph (a) for 10 years after the first named economic operator has been supplied with, or has supplied the product.

PART 3 CONFORMITY OF PRODUCTS

Presumption of conformity on the basis of harmonised standards

Conformity assessment procedures

• (a) for equipment-groups I and II, equipment-categories M 1 and 1, the EU-type examination set out in Annex III to the Directive, the text of which is set out in Schedule 3 to these Regulations, in conjunction with either of the following—

• (i) conformity to type based on quality assurance of the production process set out in Annex IV to the Directive, the text of which is set out in Schedule 4 to these Regulations, or

• (ii) conformity to type based on product verification set out in Annex V to the Directive, the text of which is set out in Schedule 5 to these Regulations,

• (b) for equipment-groups I and II, equipment categories M 2 and 2—

• (i) in the case of internal combustion engines and electrical equipment in these groups and categories, the EU-type examination set out in Annex III to the Directive, the text of which is set out in Schedule 3 to these Regulations, in conjunction with either—

— conformity to type based on internal production control plus supervised product testing set out in Annex VI to the Directive, the text of which is set out in Schedule 6 to these Regulations, or

— conformity to type based on product quality assurance set out in Annex VII to the Directive, the text of which is set out in Schedule 7 to these Regulations,

• (ii) in the case of other equipment in these groups and categories, internal production control set out in Annex VIII to the Directive, the text of which is set out in Schedule 8 to these Regulations and the communication of the technical documentation provided for in point 2 of that Annex and Schedule, to a notified body, which shall acknowledge receipt of it as soon as possible and shall retain it,

• (c) for equipment-group II, equipment category 3, internal production control set out in Annex VIII to the Directive, the text of which is set out in Schedule 8 to these Regulations, and

• (d) for equipment-groups I and II, in addition to the procedures referred to in subparagraphs (a), (b) and (c) of this paragraph, conformity based on unit verification set out in Annex IX to the Directive, the text of which is set out in Schedule 9 to these Regulations may also be followed.

• (2) The procedure referred to in subparagraph (a) or (d) of paragraph (1) shall be used for conformity assessment of protective systems.

• (3) The procedures referred to in paragraph (1) shall be applied in respect of components with the exception of the affixing of the CE marking and the drawing up of the EU declaration of conformity and a written attestation of conformity shall be issued by the manufacturer, declaring the conformity of the components with the applicable provisions of the Directive and stating their characteristics and how they must be incorporated into equipment or protective systems to assist compliance with the essential health and safety requirements set out in Annex II to the Directive, the text of which is set out in Schedule 2 to these Regulations applicable to finished equipment or protective systems.

• (4) With regard to the safety aspects referred to in paragraph 1.2.7 of Annex II to the Directive, the text of which is set out in Schedule 2 to these Regulations, in addition to the conformity assessment procedures referred to in paragraphs (1) and (2), the procedure referred to in Annex VIII to the Directive, the text of which is set out in Schedule 8 may also be followed.

• (5) By derogation from paragraphs (1), (2) and (4), the market surveillance authority may, on a duly justified request in writing, authorise the placing on the market and putting into service of products other than components in respect of which the procedures referred to in paragraphs (1), (2) and (4) have not been applied and the use of which is in the interests of protection.

• (6) Documents and correspondence relating to the conformity assessment procedures referred to in paragraphs (1) to (4) shall be drawn up in a language determined by the Member State concerned.

EU declaration of conformity

• (a) state that the fulfilment of the essential health and safety requirements set out in Annex II to the Directive, the text of which is set out in Schedule 2 to these Regulations has been demonstrated,

• (b) have the model structure set out in Annex X to the Directive, the text of which is set out in Schedule 10 to these Regulations,

• (c) contain the elements specified in the relevant conformity assessment procedures set out in Annexes III to IX to the Directive, the text of which is set out in Schedules 3 to 9 to these Regulations,

• (d) be continuously updated, and

• (e) be translated into the language or languages required by the Member State in which the product is placed or made available on the market.

• (2) Where a product is subject to more than one European Union act requiring an EU declaration of conformity, a single EU declaration of conformity shall be drawn up in respect of all such European Union acts and that declaration shall contain the identification of the European Union acts concerned, including their publication references.

• (3) By drawing up the EU declaration of conformity, the manufacturer shall assume responsibility for the compliance of the product with the requirements laid down in the Directive or these Regulations.

General principles of the CE marking

Rules and conditions for affixing the CE Marking and other markings

• (2) Where it is not possible or not warranted on account of the nature of the product to affix the CE marking in accordance with paragraph (1), before the product is placed on the market, the CE marking shall be affixed to—

• (a) the packaging, and

• (b) the accompanying documents.

• (3) Where a notified body is involved in the production control phase, the CE marking shall be followed by the identification number of that notified body which shall be affixed—

• (a) by the notified body itself, or

• (b) under the instructions of the notified body, by the manufacturer or his authorised representative.

• (4) The CE marking and, where applicable, the identification number of the notified body shall be followed by the specific marking of explosion protection [image omitted], the symbols of the equipment-group and category and, where applicable, the other markings and information referred to in paragraph 1.0.5 of Annex II to the Directive, the text of which is set out in Schedule 2 to these Regulations.

• (5) The CE marking and the markings, symbols and information referred to in paragraph (4) and, where applicable, the identification number of the notified body, may be followed by any other mark indicating a special risk or use.

• (6) Products that are designed for a particular explosive atmosphere shall be marked accordingly.

• (7) A person shall not affix a CE marking—

• (a) in a manner that is in contravention of the Directive or these Regulations, to a product which conforms with these Regulations, or

• (b) to a product which does not conform with the Directive or these Regulations.

PART 4 NOTIFICATION OF CONFORMITY ASSESSMENT BODIES

Notified bodies

• (2) Only conformity assessment bodies which have been notified to the European Commission and other Member States in accordance with the Directive and these Regulations and against whom no objections are raised by the European Commission or the other Member States within the time periods set down under Article 25(5) of the Directive, shall be notified bodies for the purposes of the Directive and these Regulations.

Applications for notification by conformity assessment bodies

• (2) Without prejudice to paragraph (1), where a conformity assessment body demonstrates its conformity with the criteria laid down in the relevant harmonised standards or parts thereof the references of which have been published in the Official Journal, it shall be presumed to comply with the requirements set down in Article 21 of the Directive insofar as the applicable harmonised standards cover those requirements.

• (3) A conformity assessment body seeking to become a notified body shall submit to the notifying authority an application, which application shall be in accordance with Article 24 of the Directive and shall be accompanied by the appropriate fee as may be prescribed by the notifying authority.

Notification of conformity assessment bodies

• (a) has made an application to it in accordance with Article 24 of the Directive, and

• (b) meets the requirements set out in Article 21 of the Directive.

• (2) Notifications by the notifying authority under paragraph (1) shall be made in accordance with the notification procedure set down in Article 25 (2), (3) and (4) of the Directive.

• (3) The notifying authority shall notify the European Commission and the other Member States of any subsequent relevant changes to the notification.

• (4) The assessment and monitoring referred to in Article 18(1) and (2) shall be carried out by the Irish National Accreditation Board within the meaning of and in accordance with Regulation (EC) No. 765/2008.

Changes to notifications

• (2) In the event of restriction, suspension or withdrawal of notification, the notifying authority shall immediately inform the European Commission and the other Member States of the restriction, suspension or withdrawal of same.

• (3) In the event of restriction, suspension or withdrawal of notification or where the notified body has ceased its activity, the notifying authority shall take appropriate steps to ensure that the files of that notified body are either processed by another notified body or kept available for the responsible notifying and competent authorities at their request.

• (4) The notifying authority shall inform the notified body concerned of its decision and allow that body an opportunity to make representations to it.

• (5) The notifying authority shall establish one panel per appeal (“appeal panel”) for the purposes of considering appeals under this Regulation. An appeal panel shall consist of at least 3 but not more than 5 persons appointed by the notifying authority, one of whom shall be designated by the notifying authority to be chairperson of the panel. An appeal panel shall not consist of any person who decided or was involved in the decision to restrict, suspend or withdraw the relevant notification pertaining to a notified body. An appeal panel shall establish its own procedure.

• (6) Where the notifying authority decides to restrict, suspend or withdraw notification pertaining to a notified body, the latter may, within 14 days of the notification under paragraph (4), appeal to an appeal panel against the restriction, suspension or withdrawal, as the case may be. The notification pertaining to a notified body stands restricted, suspended or withdrawn, as the case may be, from the date of the notification of the decision under paragraph (4), unless the appeal panel, upon an application to it, decides otherwise, pending the outcome of the appeal. On hearing the appeal the appeal panel may confirm the decision, vary it or allow the appeal and shall notify the appellant of its decision. The decision of the appeal panel is final except that an appeal lies to the High Court on application to it on a specified point of law. Such an application does not affect the decision of the appeal panel and its operation.

• (7) All expenses reasonably incurred by the notifying authority in relation to an appeal before an appeal panel or the High Court shall be borne by the appellant where the appeal panel or the court confirms or confirms with a variation the decisions of the notifying authority. The notifying authority may recover these expenses as a simple contract debt in a court of competent jurisdiction.

Subsidiaries of and subcontracting by notified bodies

Operational obligations of notified bodies

• (a) carry out conformity assessments in accordance with the conformity assessment procedures provided for in Annexes III to VII and Annex IX to the Directive, the text of which is set out in Schedules 3 to 7 and Schedule 9 of these Regulations,

• (b) ensure that conformity assessments are carried out in a proportionate manner, avoiding unnecessary burdens for economic operators,

• (c) perform its activities taking due account of the size of an undertaking, the sector in which it operates, its structure, the degree of complexity of the product technology in question and the mass or serial nature of the production process,

• (d) in a case where it finds that the essential health and safety requirements set out in Annex II to the Directive, the text of which is set out in Schedule 2 to these Regulations, or corresponding harmonised standards or other technical specifications have not been met by a manufacturer, require that manufacturer to take appropriate corrective measures and shall not issue a certificate of conformity,

• (e) in a case where, in the course of the monitoring of conformity following the issue of a certificate, the notified body finds that a product no longer complies, require the manufacturer to take appropriate corrective measures and suspend or withdraw the certificate if necessary,

• (f) in a case where corrective measures under paragraph (e) are not taken by the manufacturer or do not have the required effect, restrict, suspend or withdraw any certificates, as appropriate,

• (g) inform the manufacturer in question where a decision to restrict, suspend or withdraw any certificate is taken under paragraph (f), and

• (h) participate in the sectoral group of notified bodies established in accordance with Article 33 of the Directive.

• (2) In carrying out its functions under paragraph 1(b) and 1(c) of this Regulation, a notified body shall nevertheless respect the degree of rigour and the level of protection required for the compliance of the product with the Directive or these Regulations.

Appeal against decisions of notified bodies

• (2) An appeal panel shall consist of at least 3 but not more than 5 persons appointed by the notifying authority, one of whom shall be designated by the notifying authority to be chairperson of the panel. An appeal panel shall not consist of any person who decided or was involved in the decision to restrict, suspend or withdraw the relevant certificate. An appeal panel shall establish its own procedure.

• (3) Where a notified body decides to restrict, suspend or withdraw a certificate held by a manufacturer, the latter may, within 14 days of the notification of a decision under Regulation 23(g) appeal to an appeal panel against the restriction, suspension or withdrawal, as the case may be. The certification held by the manufacturer stands restricted, suspended or withdrawn, as the case may be, from the date of notification of the decision under Regulation 23(g), unless the appeal panel, upon an application to it, decides otherwise, pending the outcome of the appeal. On hearing the appeal the appeal panel may confirm the decision, vary it or allow the appeal and shall notify the appellant of its decision. The decision of the appeal panel is final except that an appeal lies to the High Court on application to it on a specified point of law. Such an application does not affect the decision of the appeal panel and its operation.

Information obligation on notified bodies

• (a) inform the notifying authority of the matters referred to in Article 31(a), (b), (c) and (d) of the Directive,

• (b) provide other bodies notified under the Directive or these Regulations carrying out similar conformity assessment activities covering the same products with relevant information on issues relating to negative conformity assessment results,

• (c) on request, provide other bodies notified under the Directive or these Regulations carrying out similar conformity assessment activities covering the same products with relevant information on issues relating to positive conformity assessment results.

PART 5 MARKET SURVEILLANCE, SAFEGUARD PROCEDURE

Market surveillance

Procedure for dealing with products presenting a risk at national level

• (2) The relevant economic operator shall cooperate with the market surveillance authority as deemed necessary by it in carrying out an evaluation under paragraph (1).

• (3) Where, in the course of the evaluation referred to in paragraph (1), the market surveillance authority finds that the product does not comply with the requirements laid down in the Directive or these Regulations, it shall—

• (a) without delay require the relevant economic operator to take all appropriate corrective actions to bring the product into compliance with those requirements, to withdraw the product from the market, or to recall it within a reasonable period commensurate with the nature of the risk, as the authority prescribes,

• (b) inform the notified body who carried out the conformity assessment procedure on the product of the product’s non-compliance, and

• (c) apply the provisions of Article 21 of Regulation (EC) No 765/2008 to the measures referred to in paragraph 3(a) of this Regulation.

• (4) Where the market surveillance authority considers that non-compliance is not restricted to the State, it shall inform the European Commission and the other Member States of the results of the evaluation and of the actions which it has required the economic operator to take.

• (5) The relevant economic operator shall ensure that all appropriate corrective action is taken in respect of all the products concerned that it has made available on the market throughout the European Economic Area.

• (6) Where the relevant economic operator does not take adequate corrective action within the period referred to in paragraph (3)(a) of this Regulation, the market surveillance authority shall, without delay, take all appropriate provisional measures to prohibit or restrict the product from being made available on the market in the State, to withdraw the product from that market or to recall it.

• (7) The market surveillance authority shall inform the European Commission and the other Member States, without delay, of any measures taken under paragraph (6), and shall—

• (a) include all available details, in particular the data necessary for the identification of the non-compliant product, the origin of the product, the nature of the non-compliance alleged and the risk involved, the nature and duration of the measures taken in the State and the arguments put forward by the relevant economic operator, and

• (b) in particular, indicate whether the non-compliance is due to either—

• (i) the failure of the product to meet requirements relating to the health or safety of persons or, to the protection of domestic animals or property, or

• (ii) shortcomings in the harmonised standards referred to in Regulation 13 conferring a presumption of conformity.

• (8) Where another Member State has initiated the procedure under Article 35 of the Directive, the market surveillance authority shall, without delay, inform the European Commission and the other Member States—

• (a) of any measures adopted and of any additional information at its disposal relating to the non-compliance of the product concerned, or

• (b) of its objections, in the event of disagreement with the adopted measure of the other Member State.

• (9) Where, within three months of receipt of the information referred to in paragraph (7), no objection has been raised by either a Member State or the European Commission in respect of a provisional measure taken by the market surveillance authority, that measure shall be deemed to be justified.

• (10) The market surveillance authority shall ensure that appropriate restrictive measures, such as withdrawal of the product from the market, are taken in respect of the product concerned without delay.

Safeguard procedure

• (2) Where a national measure taken by a Member State under Article 35 of the Directive is considered unjustified by the European Commission in accordance with the procedure in Article 36(1) of the Directive, the market surveillance authority shall withdraw that measure.

Compliant products which present a risk

• (a) require the relevant economic operator to take all appropriate measures to ensure that the product concerned, when placed on the market, no longer presents that risk, to withdraw the product from the market or to recall it within a reasonable period, commensurate with the nature of the risk, as it may prescribe and,

• (b) immediately inform the European Commission and the other Member States, of all available details and in particular of—

• (i) the data necessary for the identification of the product concerned,

• (ii) the origin and the supply chain of the product,

• (iii) the nature of the risk involved, and

• (iv) the nature and the duration of the national measures taken.

• (2) An economic operator shall ensure that the corrective action required under paragraph (1) is taken in respect of all products concerned that the operator has placed or made available on the market throughout the European Economic Area.

Formal non-compliance

• (a) the CE marking has been affixed in violation of Article 30 of Regulation (EC) No 765/2008 or of Article 16 of the Directive or Regulation 17 of these Regulations,

• (b) the CE marking, when required, has not been affixed,

• (c) the specific marking of explosion protection [image omitted], the symbols of the equipment-group and category and, where applicable, the other markings and information have been affixed in violation of point 1.0.5 of Annex II to the Directive, the text of which is set out in Schedule 2 of these Regulations or have not been affixed,

• (d) the identification number of the notified body, where that body is involved in the production control phase, has been affixed in violation of Article 16 of the Directive or Regulation 17 of these Regulations, or has not been affixed,

• (e) the EU declaration of conformity or the attestation of conformity, as appropriate, does not accompany the product,

• (f) the EU declaration of conformity or, where required, the attestation of conformity has not been drawn up correctly,

• (g) the technical documentation is either not available or not complete,

• (h) the information referred to in Articles 6(7) or 8(3) of the Directive or Regulation 7(j) or Regulation 9(2)(c) of these Regulations is absent, false or incomplete, or

• (i) any other administrative requirement provided for in Articles 6 or 8 of the Directive or Regulation 7 or Regulation 9 of these Regulations is not fulfilled.

• (2) Where the non-compliance referred to in paragraph 1 persists, the market surveillance authority shall take all appropriate measures to restrict or prohibit the product from being made available on the market or shall ensure that it is recalled or withdrawn from the market.

PART 6 POWERS OF THE MARKET SURVEILLANCE AUTHORITY

General

• (2) A person who for the time being stands appointed as an inspector under section 62 of the Act of 2005 shall be an inspector for the purpose of the Directive and these Regulations.

• (3) An inspector shall, when exercising any power conferred on him or her by these Regulations, if requested to do so by any person affected, produce the certificate of authorisation or a copy of it furnished to him or her under section 62(2) of the Act of 2005 together with a form of personal identification.

Powers of inspectors

• (a) subject to paragraph (4), at any time enter—

• (i) the premises of an economic operator, or

• (ii) any other place or premises where entry on same is necessary to ensure that the objectives of the Directive are achieved;

• (b) inquire into, search, examine and inspect—

• (i) any place referred to in paragraph 1(a),

• (ii) any activity, installation, process, procedure, matter or thing at or in that place, and

• (iii) any product or any record relating to such product, to ascertain whether the Directive or these Regulations have been or are being complied with and, for that purpose, take with him or her and use any equipment or materials he or she consider necessary;

• (c) require that that place and anything at or in it be left undisturbed for so long as is reasonably necessary for the purposes of any search, examination, investigation, inspection or inquiry under the Directive or these Regulations;

• (d) require the person in charge to produce to the inspector—

• (i) any product or partly completed product which is in the possession or under the control of such person, and

• (ii) any records, and in the case of such information in a non-legible form, to reproduce it in a legible form, and to give to the inspector such information as the inspector may reasonably require in relation to any entries in those records;

• (e) inspect and take copies of or extracts from any such records or any electronic information system at that place, including in the case of information in a non-legible form, copies of or extracts from such information in a permanent legible form or require that such copies be provided;

• (f) require a person at or in that place by whom or on whose behalf a computer is or has been used to produce or store records or any person having control of, or otherwise concerned with the operation of the computer, to afford the inspector access thereto and all reasonable assistance as the inspector may require;

• (g) remove from that place and retain the records (including documents stored in a non-legible form) and copies taken and detain the records for such period as the inspector reasonably considers to be necessary for further examination or until the conclusion of any legal proceedings;

• (h) require that records at or in that place be maintained for such period as may be reasonable;

• (i) require the person in charge to give the inspector such information as the inspector may reasonably require for the purposes of any search, examination, investigation, inspection or inquiry under these Regulations;

• (j) require the person in charge to give the inspector such assistance and facilities within the person’s power or control as are reasonably necessary to enable the inspector to exercise any of his or her powers under these Regulations;

• (k) require by notice, at a time and place specified in the notice, any person (including the person in charge) to give the inspector any information that the inspector may reasonably require in relation to the place, any product, equipment, item, activity, installation or procedure at or in the place, and to produce to the inspector any records that are under that person’s power or control;

• (l) examine any person whom the inspector reasonably believes to be able to give to the inspector information relevant to any search, examination, investigation, inspection or inquiry under these Regulations and require the person to answer such questions as the inspector may ask relative to the search, examination, investigation, inspection or inquiry and to sign a declaration of the truth of the answers;

• (m) require that any procedure be followed for the purposes of any search, examination, investigation, inspection or inquiry under these Regulations;

• (n) take any measurements or photographs or make any tape, electrical or other recordings that the inspector considers necessary for the purposes of any search, examination, investigation, inspection or inquiry under these Regulations;

• (o) take samples of air, soil, water or waste at or near that place;

• (p) where appropriate, install, use and maintain at that place monitoring instruments, systems and seals for the purposes of the Directive or these Regulations;

• (q) at that place, or at any other location, carry out, or have carried out, such testing, examination or analysis of any item or product found at that place, as he or she reasonably considers to be necessary, and for that purpose—

• (i) require the person in charge to supply to the inspector without charge any product, equipment or item, or samples thereof, or

• (ii) remove, or have removed, to another location, any product, equipment or item, or samples thereof;

• (r) cause any product found at that place in respect of which there has been or there appears to the inspector to have been a contravention of the Directive or these Regulations, to be subjected to any testing, examination or analysis in accordance with subparagraph (q) (but not so as to damage or destroy it unless necessary for the purposes of the Directive or these Regulations) and where an inspector proposes to exercise the power conferred by this subparagraph in the case of any such product found at any place, he or she shall, if so requested by the person in charge, cause anything that is to be done by virtue of that power to be done in the presence of that person, save that the person in charge is responsible for his or her own costs in attending at the exercise of the inspector’s powers and cannot unreasonably delay the inspector in the exercise of those powers;

• (s) remove and retain for such period as is necessary any product, equipment or item found at that place for all or any of the following purposes:

• (i) to examine or arrange for the examination, testing or analysis of the product, equipment or item;

• (ii) to ensure that it is not tampered with before the examination of it under subparagraph (i) is completed;

• (iii) to ensure that it is available for use as evidence in any proceedings;

• (t) where necessary—

• (i) require the disposal or destruction of any product in respect of which there has been or there appears to the inspector to have been a contravention of the Directive or these Regulations at the expense of the person in charge, or remove that product and arrange for it to be disposed or destroyed of at the expense of the person in charge, and

• (ii) require that such disposal or destruction shall be—

• (I) such as will prevent the product from being used or placed on the market, and

• (II) in compliance with requirements under the Waste Management Acts 1996 to 2003;

• (u) require the recall or removal from the market of a product by the person who has placed or made available that product on the market, where it appears to the inspector that, in relation to that product, the Directive or these Regulations have been contravened.

• (2) Where a product is found at a place, and an inquiry is made by an inspector in the course of a search, examination, investigation or inspection as to the identity of the person who supplied that product, the person in charge shall give the inspector the name and address of the supplier from whom the product was purchased or otherwise obtained.

• (3) Before exercising any of the powers conferred by subparagraphs (q) to (t) of paragraph (1), an inspector shall, in so far as it is practicable, consult such persons as appear to him or her to be appropriate for the purpose of ascertaining what dangers, if any, there may be in doing what he or she proposes to do under those subparagraphs.

• (4) An inspector shall not enter a dwelling other than—

• (a) with the consent of the occupier, or

• (b) in accordance with a warrant of the District Court issued under paragraph (7) authorising such entry.

• (5) The market surveillance authority may authorise such and so many other persons as it considers appropriate to accompany an inspector in the performance of his or her functions.

• (6) Where an inspector in the exercise of his or her powers under this Regulation is prevented from entering any place or premises specified in Regulation 32(1)(a), an application may be made to the District Court for a warrant under paragraph (7) authorising such entry.

• (7) Without prejudice to the powers conferred on an inspector by or under any other provision of this Regulation, if a judge of the District Court is satisfied by information on oath of an inspector that there are reasonable grounds for believing that—

• (a) there is any product, equipment or item at any place or premises any records (including documents stored in a non-legible form) or information, relating to a place, premises or to a product, that the inspector requires to inspect for the purposes of the Directive or these Regulations, held at any place or premises, or

• (b) there is, or such an inspection is likely to disclose, evidence of a contravention of the Directive or these Regulations,

the judge may issue a warrant authorising an inspector, accompanied by such other inspectors or such other competent persons as may be appropriate or members of the Garda Síochána as may be necessary, at any time or times, within one month from the date of issue of the warrant, on production of the warrant if requested, to enter that place or premises, if necessary by the use of reasonable force, and perform the functions conferred on an inspector by or under these Regulations.

• (8) Where an inspector has reasonable grounds for apprehending any serious obstruction in the performance of his or her functions or otherwise considers it necessary, he or she may be accompanied by a member or members of the Garda Síochána and by any other person or persons authorised by the market surveillance authority, when performing any functions conferred on him or her by or under these Regulations.

• (9) Where an inspector, upon reasonable grounds, believes that a person has committed an offence under these Regulations he or she may require that person to provide him or her with the person’s name and the address at which the person ordinarily resides.