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

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

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

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

4. Object of the declaration (identification of product allowing traceability; it may, where necessary for the identification of the product, include an image)

5. The object of the declaration described above is in conformity with the relevant Union harmonisation legislation

6. References to the relevant harmonised standards used or references to the other technical specifications in relation to which conformity is declared

7. Where applicable, the notified body … (name, number) performed … (description of intervention) and issued the certificate

8. Additional information

Signed for and on behalf of

(place and date of issue)

(name, function) (signature)

Regulation 2

SCHEDULE 11

TEXT OF ANNEX XII TO THE DIRECTIVE

CORRELATION TABLE

Directive 94/9/EC

Directive 2014/33/EU

Article 1(1)

Article 1(1)(a)

Article 1(2)

Article 1(1)(b)

—

Article 1(1)(c)

Article 1(3)

Article 2(1) to (9)

—

Article 2(10) to (26)

Article 1(4)

Article 1(2)

Article 2

Article 3

Article 3

Article 4

Article 4

Article 5

Article 5(1), first subparagraph

—

Article 5(1), second subparagraph

Article 12(2)

Article 5(2)

Article 12(1)

Article 5(3)

—

—

Articles 6 to 11

—

—

Article 6(1) and (2)

—

Article 6(3)

Article 39(1) to (4)

—

Article 39(5), first subparagraph

Article 6(4)

Article 39(5), second subparagraph

Article 7

—

Article 8(1) to (6)

Article 13(1) to (6)

Article 8(7)

—

—

Articles 14 and 15

Article 9

—

Article 10(1)

—

Article 10(2)

Article 16(1)

Article 10(3)

—

—

Article 16(2) to (6)

—

Articles 17 to 33

Article 11

—

—

Articles 34 to 38

Articles 12 and 13

—

—

Article 40

—

Article 41(1)

Article 14(1)

—

Article 14(2)

Article 41(2)

Article 14(3)

—

Article 15(1)

Article 42(1)

Article 15(2)

—

—

Article 42(2)

—

Articles 43 and 44

Article 16

Article 45

Annexes I to IX

Annexes I to IX

Annex X

—

Annex XI

—

—

Annex X

—

Annex XI

—

Annex XII

GIVEN under my Official Seal,

26 May 2017.

MARY MITCHELL O’CONNOR,

Minister for Jobs, Enterprise and Innovation.

EXPLANATORY NOTE

(This note is not part of the Instrument and does not purport to be a legal interpretation.)

These Regulations transpose into national legislation the provisions of Directive 2014/34/EU which set out the requirements for the making available on the market and putting into service, as well as the essential health and safety requirements relating to the design and construction of equipment and protective systems intended for use in potentially explosive atmospheres, (known as ATEX). These Regulations also set out the obligations on economic operators in relation to these products and the required conformity assessment procedures for such ATEX products. These Regulations also give further effective to 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. 339/93 and include duties to have proper market surveillance procedures consistent with EU Regulation 765/2008.

These Regulations do not impede the making available on the market of products covered by Directive 94/9/EC which are in conformity with that Directive and which were placed on the market before 20 April 2016.

The Regulations revoke and replace the European Communities (Equipment and Protective Systems Intended for Use in Potentially Explosive Atmospheres) Regulations 1999, (

S.I. No. 83 of 1999

).

1 OJ No. L 96, 29.3.2014, p.309.

2 OJ No. L. 218, 13.8.2008, p.30.

3 OJ No. L 100, 19.4.1994, p.1.

4 OJ No. L 316, 14.11.2012, p.12.

5 OJ No. L 399, 30.12.89, p.18.

6It is optional for the manufacturer to assign a number to the declaration of conformity.

9. The manufacturer shall keep a copy of the EU-type examination certificate, its annexes and additions together with the technical documentation at the disposal of the national authorities for 10 years after the product has been placed on the market.

10. The manufacturer’s authorised representative may lodge the application referred to in point 3 and fulfil the obligations set out in points 7 and 9, provided that they are specified in the mandate.

Regulations 7, 14, 15 and 23

SCHEDULE 4

TEXT OF ANNEX IV TO THE DIRECTIVE

MODULE D: CONFORMITY TO TYPE BASED ON QUALITY ASSURANCE OF THE PRODUCTION PROCESS

11. An importer or distributor shall be considered a manufacturer for the purposes of the Directive or these Regulations, and shall be subject to the obligations of the manufacturer under Regulation 7, where that importer or distributor—

(

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

12. An economic operator shall—

(

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

13. Without prejudice to the powers of the State under Article 35 and 37 of the Directive, a product which is in conformity with harmonised standards or part thereof, the references to which have been published in the Official Journal, shall be presumed to be 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, or parts thereof.

Conformity assessment procedures

14. (1) The procedures to be followed for assessing the conformity of equipment and, where necessary the devices referred to in Regulation 4(1)(

b

) of these Regulations, are—

(

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

15. (1) An EU declaration of conformity for a product other than a component shall—

(

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

16. The CE marking when affixed to a product is subject to the general principles set out in Article 30 of Regulation (EC) No. 765/2008.

Rules and conditions for affixing the CE Marking and other markings

17. (1) Subject to paragraph (2), before the product is placed on the market, the CE marking shall be affixed visibly, legibly and indelibly to the product or to its data plate.

(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

, 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

18. (1) The notifying authority shall notify the European Commission and the other Member States of the conformity assessment bodies authorised under these Regulations to carry out third party conformity assessment tasks.

(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

19. (1) A conformity assessment body seeking to become a notified body shall meet the requirements set down in paragraphs 2 to 11 of Article 21 of the Directive.

(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

20. (1) The notifying authority may only notify a conformity assessment body where that body—

(

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

21. (1) Where the notifying authority has ascertained or has been informed that a notified body no longer meets the requirements laid down in Article 21 of the Directive, or that it is failing to fulfil its obligations under Article 29 or 31 of the Directive or these Regulations, that authority shall restrict, suspend or withdraw notification, as appropriate, depending on the seriousness of the failure to meet those requirements or fulfil those obligations.

(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

22. Where a notified body subcontracts specific tasks connected with conformity assessment or has recourse to a subsidiary, it shall comply with Article 23 of the Directive.

Operational obligations of notified bodies

23. (1) Subject to paragraph (2), a notified body shall—

(

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

24. (1) The notifying authority shall establish one panel per appeal (“appeal panel”) for the purposes of considering appeals against restrictions, suspensions or withdrawals rendered by notified bodies under Regulation.

(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

25. A notified body shall—

(

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

26. The market surveillance authority shall organise and carry out market surveillance of products covered by these Regulations in accordance with Articles 16 to 29 of Regulation (EC) No. 765 of 2008.

Procedure for dealing with products presenting a risk at national level

27. (1) Where the market surveillance authority has sufficient reason to believe that a product covered by these Regulations presents a risk to the health or safety of persons or to domestic animals or property, it shall carry out an evaluation in relation to the product concerned covering all relevant requirements laid down in the Directive or these Regulations.

(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

28. (1) Where a national measure taken by a Member State under Article 35 of the Directive is considered justified by the European Commission in accordance with the procedure in Article 36(1) of the Directive, the market surveillance authority shall take the necessary measures to ensure that the non-compliant product is withdrawn from the market in the State and shall inform the European Commission accordingly.

(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

29. (1) Where, having carried out an evaluation under Regulation 27, the market surveillance authority finds that although a product is in compliance with the Directive or these Regulations, it presents a risk to the health or safety of persons or to domestic animals or to property, it shall—

(

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

30. (1) Without prejudice to Regulation 27, the market surveillance authority shall require the relevant economic operator to put an end to the non-compliance concerned where it finds that—

(

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

, 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

31. (1) The market surveillance authority shall perform its market surveillance duties in accordance with the relevant provisions of Article 34 of the Directive.

(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

32. (1) An inspector shall, for the purposes of these Regulations, have power to do any one or more of the following

(

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.

(10) A statement or admission made by a person pursuant to a requirement under paragraph (1)(i), (

k

) or (

l

) shall not be admissible in proceedings brought against that person for an offence (other than an offence under Regulation 42(4)) relating to a breach of, or failure to comply with, an obligation in the said paragraph (1)(i), (

k

) or (

l

).

Measures entailing refusal or restriction

33. An inspector who finds that—

(

a

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

(

b

) the CE marking, where required, has not been affixed,

(

c

) the specific marking of explosion protection

, 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 to 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 and Regulation 17 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

) 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 9(2)(

c

) 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 9 is not fulfilled,

may issue a direction in writing to the relevant economic operator to put an end to the non-compliance observed within a specified timeframe.

Contravention notice

34. (1) An inspector who is of the opinion that a person—

(

a

) is contravening or has contravened any of the provisions of the Directive or these Regulations, or

(

b

) has failed to comply with a direction under Regulation 33,

may serve a notice on the person who has or may reasonably be presumed to have control of the activity concerned.

(2) A contravention notice shall—

(

a

) state that the inspector is of the opinion referred to in paragraph (1),

(

b

) specify the grounds for the inspector being of the opinion referred to in paragraph (1) and specify the Regulation or Regulations concerned,

(

c

) identify the relevant provision in respect of which that opinion is held,

(

d

) direct the person, where required, to—

(i) remedy the contravention or the matters occasioning that notice,

(ii) cease placing or making available the product on the market or putting it into use,

(iii) remove the product from the market,

(iv) recall the product,

(v) dispose of the product,

(vi) destroy the product where it presents a serious risk,

by a date specified in the notice that shall not be earlier than the end of the period within which an appeal may be made under Regulation 35(1),

(

e

) include information regarding the making of an appeal under Regulations 35(1) and 35(2),

(

f

) include any other requirement that the inspector considers appropriate,

(

g

) state that if the person to whom the notice is addressed fails to take such measures as are specified in the notice within the time period specified in that notice, that person commits an offence, and

(

h

) be signed and dated by the inspector.

(3) A contravention notice may include directions—

(

a

) as to the measures to be taken to remedy any contravention or matter to which the notice relates, or to otherwise comply with the notice, and

(

b

) to bring the notice to the attention of any person who may be affected by it, or to the public generally.

(4) A person on whom a contravention notice has been served who is of the opinion that the contravention notice has been complied with shall confirm in writing to the inspector that the matters referred to in the notice have been so remedied.

(5) Where a person on whom a contravention notice has been served confirms in writing to the inspector in accordance with paragraph (4) that the matters referred to in the contravention notice have been remedied, the inspector shall, on being satisfied that the matters have been so remedied, within one month of receipt of such confirmation, give notice to the person concerned of compliance with the contravention notice.

(6) An inspector may—

(

a

) withdraw or amend a contravention notice at any time, or

(

b

) where no appeal is made or pending under Regulation 35(1) extend the period specified under paragraph (2) (

d

) of this Regulation.

(7) Where there is no appeal under Regulation 35(1), the contravention notice shall take effect on the later of—

(

a

) the end of the period for making an appeal, or

(

b

) the day specified in the notice.

(8) A person shall comply with a contravention notice under this Regulation.

Appeal against contravention notice

35. (1) A person aggrieved by a contravention notice may, within 14 days beginning on the day on which the notice is served on him or her, appeal against the notice to a judge of the District Court in the district court district in which the notice was served in and, in determining the appeal the judge may, if he or she is satisfied that it is reasonable to do so, confirm, vary or cancel the notice.

(2) A person who appeals under paragraph (1) shall at the same time notify the market surveillance authority of the appeal and the grounds for the appeal and the authority shall be entitled to appear, be heard and adduce evidence on the hearing of the appeal.

(3) Where an appeal under paragraph (1) is taken, and the contravention notice is not cancelled, the notice shall take effect on the later of—

(

a

) the day next following the day on which the notice is confirmed on appeal or the appeal is withdrawn, or

(

b

) the day specified in the notice.

(4) Subject to paragraph (5), in the case of a product which the inspector does not consider to present a serious risk requiring rapid intervention as per Article 20 of EU Regulation 765/2008, the intended recipient of a measure referred to in Regulation 34(1) shall have the opportunity to make representations within 10 working days of first being advised of the inspector’s intention, to the market surveillance authority in advance of the measure being taken.

(5) Where, due to the urgency of the measure referred to in Regulation 34(1), as justified in particular by public health, security or safety requirements, it is not possible to give the person concerned the opportunity to make representations in advance of the measure being taken, the market surveillance authority shall give such opportunity, as soon as may be, thereafter.

Prohibition notice

36. (1) A prohibition notice may be served by an inspector—

(

a

) on the person who is or who may reasonably be presumed to be in control of the activity concerned, where that inspector is of the opinion that at any place there is occurring or is likely to occur any activity relating to a product that gives rise to or is likely to give rise to a serious risk requiring rapid intervention, including a serious risk the effects of which are not immediate, or

(

b

) on any person in relation to a product in respect of which a direction under Regulation 33 or a contravention notice has been issued but not complied with.

(2) A prohibition notice shall—

(

a

) state that the inspector is of the opinion referred to in paragraph (1),

(

b

) state the reason for that opinion,

(

c

) specify the activity in respect of which that opinion is held,

(

d

) where in the opinion of the inspector the activity involves a contravention, or likely contravention of any provision of the Directive or these Regulations, specify the provision,

(

e

) prohibit the carrying on of the activity concerned until the matters that give rise or are likely to give rise to the risk are remedied,

(

f

) inform the person concerned that he or she may appeal the prohibition notice to the District Court in accordance with Regulation 37(1),

(

g

) state that if the person to whom the prohibition notice is addressed fails to comply with the notice within the time period specified in the notice, that person commits an offence, and

(

h

) be signed and dated by the inspector.

(3) A prohibition notice may include directions—

(

a

) as to the measures to be taken to remedy any contravention or matter to which the notice relates, or to otherwise comply with the notice, and

(

b

) to bring the notice to the attention of any person who may be affected by it, or to the public generally.

(4) A prohibition notice shall take effect—

(

a

) when the notice is received by the person on whom it is served, or

(

b

) where an appeal is brought against the prohibition notice, on the day immediately following—

(i) the day on which the notice is confirmed on appeal or the appeal is withdrawn, or

(ii) the day specified in the notice,

whichever occurs later.

(5) A person on whom a prohibition notice has been served who is of the opinion that the matters referred to in the prohibition notice have been remedied by the date specified in the notice shall confirm in writing to the inspector that those matters have been so remedied.

(6) Where a person on whom a prohibition notice has been served confirms in writing to the inspector in accordance with paragraph (5) that the matters referred to in the prohibition notice have been remedied, the inspector shall, on being satisfied that the matters have been so remedied, within one month of receipt of such confirmation, give notice to the person concerned of such compliance with the prohibition notice.

(7) An inspector may at any time withdraw a prohibition notice if—

(

a

) the inspector is satisfied that the activity to which the notice relates no longer gives rise to a serious risk to safety or health, or

(

b

) the inspector is satisfied that the notice was issued in error or is incorrect in some material respect.

(8) A person shall comply with a prohibition notice under this Regulation.

Appeal against prohibition notice

37. (1) A person on whom a prohibition notice is served may, within 7 days beginning on the day on which the notice is served on him or her, appeal against the notice to a judge of the District Court in the district court district in which the notice was served and in determining the appeal the judge may, if he or she is satisfied that it is reasonable to do so, confirm, vary or cancel the notice.

(2) Where, on the hearing of an appeal under this Regulation, a prohibition notice is confirmed, notwithstanding Regulation 36(4), the judge by whom the appeal is heard may, on the application of the appellant, suspend the operation of the prohibition notice for such period as in the circumstances of the case the judge considers appropriate.

(3) A person who—

(

a

) brings an appeal under paragraph (1), or

(

b

) applies for the suspension of the operation of a prohibition notice under this Regulation,

shall at the same time notify the market surveillance authority of the appeal or the application, and the grounds for the appeal or application.

(4) In the case of an appeal or any application to suspend the operation of the prohibition notice under this Regulation, the market surveillance authority shall be entitled to appear, be heard and adduce evidence on the hearing of the appeal or application.

(5) The bringing of an appeal against a prohibition notice shall not have the effect of suspending the operation of the notice but the appellant may apply to the court to have the operation of the notice suspended until the appeal is disposed of and, on such application, the court may, if it thinks proper to do so, direct that the operation of the notice be suspended until the appeal is disposed of.

Order of the High Court

38. (1) Where a person contravenes a prohibition notice an inspector may apply ex parte to the High Court for an order prohibiting the continued contravention of the notice.

(2) The High Court may, upon an application under this Regulation, order the person on whom the prohibition notice concerned was served to cease doing such acts as the High Court directs.

Information notice

39. (1) An inspector or the market surveillance authority may, by notice served on a person, require the person to give, within such period and in such form as may be specified in the notice, any information specified in the notice that the inspector or the authority may reasonably require for the proper performance by it of his or her or its functions under the Directive or these Regulations.

(2) Upon the written application of the person on whom the notice is served, the period specified in the information notice may be extended by and at the discretion of—

(i) the market surveillance authority, or

(ii) an inspector.

(3) A person on whom an information notice is served may, within 7 days beginning on the day on which the notice is served on him or her, appeal against the notice to a judge of the District Court in the district court district in which the notice was served and in determining the appeal the judge may, if he or she is satisfied that it is reasonable to do so, confirm, vary or cancel the notice.

(4) A person who appeals under paragraph (3) shall at the same time notify the market surveillance authority of the appeal and the grounds for the appeal and the authority shall be entitled to appear, be heard and adduce evidence on the hearing of the appeal.

(5) Where, on the hearing of an appeal under paragraph (3), an information notice is confirmed or varied, the judge of the District Court by whom the appeal is heard may, on the application of the appellant, suspend the operation of the notice for such period as in the circumstances of the case the judge considers appropriate.

(6) Subject to paragraph (7), a person on whom an information notice is served shall comply with the notice before the later of—

(

a

) the end of the period specified in the notice, or

(

b

) where the period referred to in subparagraph (

a

) is extended under paragraph (2), the end of that extended period.

(7) Where an appeal is brought under this Regulation, and the information notice to which the appeal relates is confirmed or varied or the appeal is withdrawn, the person on whom the notice is served shall comply with the notice before—

(

a

) the day immediately following the day on which the notice is confirmed or varied or the appeal is withdrawn,

(

b

) the end of the period specified in the notice, or

(

c

) where the operation of the notice has been suspended under paragraph (5), the end of the period of suspension,

whichever occurs latest.

Service of notifications

40. (1) Subject to paragraphs (2) and (3), a notice or other document required or authorised to be served on, sent or given to a person shall be addressed to the person concerned by name and may be given to the person in one of the following ways—

(

a

) by delivering it to the person,

(

b

) by leaving it at the address at which the person carries on business or ordinarily resides or, in the case in which an address for service has been furnished, at that address,

(

c

) by sending it by post in a prepaid registered letter to the address at which the person carries on business or ordinarily resides or, in a case in which an address for service has been furnished, to that address,

(

d

) if the person concerned has agreed to service of notices by means of an electronic communication (within the meaning assigned by

section 2

of the

Electronic Commerce Act 2000

), service by such means, provided that there is a facility for confirming receipt of electronic communication and that such receipt has been confirmed,

(

e

) if the address at which the person ordinarily resides cannot be ascertained by reasonable enquiry and the compliance notice relates to a premises, by delivering it to the premises or by affixing it in a conspicuous position on or near the premises, or

(

f

) by any other means that may be prescribed.

(2) Where a notice or other document required or authorised to be served on, sent or given to a person is to be given to a person who is the owner or occupier of land or property and the name of the person cannot be ascertained by reasonable inquiry, it may be addressed to the person by using the words “the owner” or, as the case may require, “the occupier”.

(3) For the purposes of this Regulation, a company within the meaning of the Companies Acts shall be deemed to be ordinarily resident at its registered office, and every other body corporate and every unincorporated body shall be deemed to be ordinarily resident at its principal office or place of business.

Sharing information on the application of the Directive

41. (1) The market surveillance authority may provide information to any European Union information network, the European Commission or a competent authority of another Member State for the purpose of sharing information related to the application of the Directive.

(2) The market surveillance authority may, in the interest of the protection of safety, take such measures as it considers appropriate to bring to the attention of the public, any matter of concern arising from the requirements of these Regulations.

PART 7

OFFENCES AND PENALTIES

Offences

42. (1) A person who contravenes a provision or requirement of Regulation 5, 7, 8(3), 9, 10, 12, 27(2), 27(5) or 29(2) commits an offence.

(2) A person who contravenes a requirement of Regulation 32, 33, 34, 36 or 39, or a notice issued or measure taken thereunder commits an offence.

(3) A person who, in relation to the CE marking or any document required for the purposes of these Regulations—

(

a

) forges or counterfeits any such document,

(

b

) gives or signs a document or makes a marking knowing it to be false in any material particular,

(

c

) knowingly uses a marking or document so forged or counterfeited, or which is false as aforesaid,

(

d

) knowingly uses as applying to any person or product a marking or document which does not so apply,

(

e

) knowingly connives at any such forging, counterfeiting, giving, signing, or using,

(

f

) knowingly makes a false entry in any such document which is so required to be kept, served or sent,

(

g

) knowingly uses any such false entry, or

(

h

) knowingly has, without lawful authority, a forged marking or document or an altered marking or document in his or her possession,

commits an offence.

(4) Any person who obstructs or interferes with an inspector or a member of the Garda Síochána in the course of exercising a power conferred on him or her by these Regulations or a warrant under Regulation 32(7) or impedes the exercise by the inspector or member, as the case may be, of such power, or fails or refuses to comply with a request or requirement of, or to answer a question asked by, an inspector or such a member pursuant to a power conferred by these Regulations, or in purported compliance with such request or requirement, or who in answer to such question gives information to the inspector or member that he or she knows to be false or misleading in any material respect, commits an offence.

(5) A person who falsely represents himself or herself to be an inspector commits an offence.

(6) A person who, at any time during the period of 3 months immediately following the affixing of a notice in accordance with Regulation 40(1)(

e

), removes, alters, damages or defaces the notice without lawful authority commits an offence.

(7) A person who, prevents or attempts to prevent any person from answering any question to which an inspector may require an answer under Regulation 32, commits an offence.

(8) A person who, fails to comply with a bona fide request, instruction or directions from an inspector in the exercise of his or her functions under these Regulations, commits an offence.

(9) Where an offence under any of these Regulations is committed by reason of a failure to do something at or within a time fixed by or under any of those provisions, the offence shall be deemed to continue until that thing is done.

(10) A person who states to the market surveillance authority that another person has committed an offence under this Regulation or has failed to comply with a provision of these Regulations, knowing the statement to be false, commits an offence.

(11) A person who, in purported compliance with a requirement in an information notice, furnishes information to the market surveillance authority that he or she knows to be false or misleading in a material respect commits an offence.

Penalties

43. (1) A person guilty of an offence under Regulation 42 shall be liable—

(

a

) on summary conviction, to a class A fine or imprisonment for a term not exceeding 6 months or both, or

(

b

) on conviction on indictment, to a fine not exceeding €500,000 or imprisonment for a term not exceeding 2 years or both.

(2) Where a person is convicted of an offence under these Regulations in proceedings brought by the market surveillance authority, or instituted following an investigation by the authority, the court shall, unless it is satisfied that there are special and substantial reasons for not so doing, order the person to pay to the authority the costs and expenses, measured by the court, incurred by the authority in relation to the investigation, detection and prosecution of the offence, including the costs and expenses incurred in the taking of samples, the carrying out of tests, examinations and analyses and in respect of the remuneration and other expenses of employees, consultants and advisers engaged by the authority.

Offences by bodies corporate

44. Where an offence under these Regulations has been committed by a body corporate and is proved to have been committed with the consent or connivance of, or to be attributable to any neglect on the part of, a person being a director, manager, secretary or other officer of the body corporate, or a person who was purporting to act in any such capacity, that person as well as the body corporate commits an offence and shall be liable to be proceeded against and punished as if he or she had committed the first-mentioned offence.

Prosecution of offences

45. (1) Subject to paragraph (2), summary proceedings in relation to an offence under these Regulations may be brought and prosecuted by the market surveillance authority.

(2) Notwithstanding section 10(4) of the

Petty Sessions (Ireland) Act 1851

, summary proceedings for an offence under Regulation 42 may be instituted at any time within 12 months from the date on which the offence was committed or alleged to have been committed.

PART 8

MISCELLANEOUS

Appeal to Circuit Court from certain orders of District Court

46. For the avoidance of doubt, an order of the District Court confirming, varying or cancelling a notice under Regulation 34, 36 or 39 is a decision of a judge of the District Court for the purposes of section 84 of the Courts of Justice Acts 1924.

Notice or direction to be in writing

47. Any notice or direction under these Regulations shall be in writing.

Immunity

48. None of the following persons, that is to say, the market surveillance authority, an inspector, or a member or a member of staff of the market surveillance authority shall be liable in damages in respect of any act done or omitted to be done by it or him or her in the performance, or purported performance, of that person’s functions under these Regulations, unless the act or omission concerned was done in bad faith.

Indemnification

49. The market surveillance authority shall, subject to the provisions of any enactment or rule of law, indemnify an inspector appointed by it, or a member or a member of staff of the market surveillance authority, in respect of any act done or omitted to be done by him or her in the performance, or purported performance, of his or her functions under these Regulations as such inspector, member or member of staff, unless the act or omission concerned was done in bad faith.

Restrictions on the disclosure of information

50. A person in receipt of information as a result of the application of these Regulations shall treat same as confidential. In particular, business, professional and trade secrets shall be treated as confidential unless the divulging of such information is—

(

a

) for the purpose of the discharge of functions under these Regulations,

(

b

) made with the consent of the person to whom the information applies, or

(

c

) for the purposes of—

(i) any legal proceedings (including by means of a report to a coroner holding an inquest under the Coroners Acts 1962 and 2005 on the body of a person whose death may have been caused through personal injury), or

(ii) any investigation or special report under section 70 of the Act of 2005,

(

d

) necessary in order to protect the health and safety of persons,

(

e

) required by the provisions of these Regulations or the Directive, or

(

f

) ordered by a court of law.

Transitional

51. (1) The making available on the market of products or the putting into service of a product, in conformity with Directive 94/9/EC or the Regulations of 1999, and which was placed on the market or put into service before 20 April 2016 continues to be lawful.

(2) Certificates issued under Directive 94/9/EC or the Regulations of 1999 continue to be valid under these Regulations.

Revocation

52. The European Communities (Equipment and Protective Systems Intended for Use in Potentially Explosive Atmospheres) Regulations, (

S.I. No. 83 of 1999

) are revoked.

Regulation 2

SCHEDULE 1

TEXT OF ANNEX I TO THE DIRECTIVE

CRITERIA DETERMINING THE CLASSIFICATION OF EQUIPMENT-GROUPS INTO CATEGORIES