S.I. No. 136/2018 - European Union (Personal Protective Equipment) Regulations 2018

ARRANGEMENT OF REGULATIONS

PART 1 Preliminary and General

1.

2.

3.

4.

5.

PART 2 Obligations of Economic Operators

6.

7.

8.

9.

10.

11.

PART 3 Conformity of PPE

12.

13.

14.

15.

16.

17.

PART 4 Notification of Conformity Assessment Bodies

18.

19.

20.

21.

22.

23.

24.

25.

PART 5 Market Surveillance and Safeguard Procedure

26.

27.

28.

29.

PART 6 Powers of Market Surveillance Authority

30.

31.

32.

33.

34.

35.

36.

37.

38.

39.

40.

41.

42.

43.

PART 7 Offences and Penalties

44.

45.

46.

47.

PART 8 Miscellaneous

48.

49.

50.

51.

52.

53.

SCHEDULE 1 Text of Annex I to the PPE Regulation: Risk Categories of PPE

SCHEDULE 2 Text of Annex II to the PPE Regulation: Essential Health and Safety Requirements

SCHEDULE 3 Text of Annex III to the PPE Regulation: Technical Documentation for PPE

SCHEDULE 4 Text of Annex IV to the PPE Regulation: Internal Production Control (Module A)

SCHEDULE 5 Text of Annex V to the PPE Regulation: EU Type-Examination (Module B)

SCHEDULE 6 Text of Annex VI to the PPE Regulation: Conformity to Type Based On Internal Production Control (Module C)

SCHEDULE 7 Text of Annex VII to the PPE Regulation: Conformity to Type Based On Internal Production Control Plus Supervised Product Checks At Random Intervals (Module C2)

SCHEDULE 8 Text of Annex VIII to the PPE Regulation: Conformity to Type Based on Quality Assurance of the Production Process (Module D)

SCHEDULE 9 Text of Annex IX to the PPE Regulation: EU Declaration of Conformity No….

SCHEDULE 10 Text of Annex X to the PPE Regulation: Correlation Table

S.I. No. 136 of 2018

EUROPEAN UNION (PERSONAL PROTECTIVE EQUIPMENT) REGULATIONS 2018

Notice of the making of this Statutory Instrument was published in

“Iris Oifigiúil” of 4th May, 2018.

I, HEATHER HUMPHREYS, Minister for Business, 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 Regulation (EU) 2016/425 of the European Parliament and of the Council of 9 March 2016 on personal protective equipment and repealing Council Directive 89/686/EEC¹ 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 Preliminary and General

Citation and commencement

• (2) These Regulations shall come into operation on the 21 April 2018.

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 ;

“Act of 2014” means the Competition and Consumer Protection Act 2014 ;

“Authorised Officer” has the meaning assigned to it in Regulation 31;

“authorised representative” means any natural or legal person established within the market of the Member States who has received a written mandate from a manufacturer to act on his or her behalf in relation to specified tasks;

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

“competent national authority” means an authority of a State that is a competent national authority for the purposes of the PPE Regulation;

“conformity assessment” means the process demonstrating whether the essential health and safety requirements of the PPE Regulation and these Regulations relating to PPE 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;

“Directive” means Council Directive 89/686/EEC of 21 December 1989 on the approximation of the laws of the Member States relating to personal protective equipment³ , as amended;

“dispose”, in relation to PPE, means getting rid of the PPE in a manner which complies with requirements under the Waste Management Acts 1996 to 2013 and results in preventing the PPE being used, placed on the market or made available on the market;

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

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

“EU declaration of conformity” means a declaration drawn up in accordance with Article 15 of the PPE Regulation and Regulation 15 of these Regulations;

“forfeiture order” means an order provided for in Regulation 40;

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

“importer” means any natural or legal person established within the market of the Member States who places PPE from a third country on the said market;

“information notice” means the notice provided for in Regulation 41;

“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 PPE for distribution or use on the market of the Member States 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 PPE or has PPE designed or manufactured, and markets it under his or her name or trademark;

“market surveillance” means the activities carried out and measures taken by public authorities to ensure that products comply with the requirements set out in the relevant Union harmonisation legislation and do not endanger health, safety or any other aspect of public interest protection;

“market surveillance authority” means an authority of a State responsible for carrying out market serveillance on its territory and a reference to market surveillance authority in these Regulations shall, unless the context otherwise discloses, be taken to be a reference to an authority designated under Regulation 3 as a market surveillance authority of the State;

“Member States” means the Member States of the European Union and, in so far as may be necessary to give effect to the obligations of the State pursuant to the Agreement on the European Economic Area signed in Oporto on 2 May 1992, shall be construed as including a reference to those States (not being Member States of the European Union) which are contracting parties to that Agreement;

“notified body” means a conformity assessment body that is a notified body pursuant to the PPE Regulation and in these Regulations a reference to notified body shall, unless the context otherwise discloses, be taken to be a reference to a conformity assessment body that satisfies Regulation 18(2);

“notifying authority” means an authority designated by a Member State pursuant to Article 21 of the PPE Regulation as a notifying authority of that State and a reference to notifying authority in these Regulations shall, unless the context otherwise discloses, be taken to be a reference to an authority so designated as the notifying authority of the State by virtue of Regulation 3 of these Regulations;

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

“personal protective equipment” means:

• (a) equipment designed and manufactured to be worn or held by a person for protection against one or more risks to that persons health or safety;

• (b) interchangeable components for equipment referred to in point (a) which are essential for its protective function;

• (c) connection systems for equipment referred to in point (a) that are not held or worn by a person, that are designed to connect that equipment to an external device or to a reliable anchorage point, that are not designed to be permanently fixed and that do not require fastening works before use;

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

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

• (b) the person whom the Authorised Officer has reasonable grounds for believing is the person referred to in subparagraph (a);

“placing on the market” means the first making available of PPE on the market of the Member States;

“PPE” means personal protective equipment to which these Regulations apply by virtue of Regulation 4;

“PPE Regulation” means Regulation (EU) 2016/425 of 9 March 2016;

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

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

“Regulation (EC) No. 765/2008” means Regulation (EC) No 765/2008 of 9 July 2008;

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

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

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

“withdrawal”, in relation to PPE, means any measure aimed at preventing PPE 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 PPE Regulation has, unless the context otherwise requires, the same meaning in these Regulations as it has in the PPE Regulation.

• (3) References to the repealed Directive shall be construed in existing laws, regulations and administrative provisions of the State as references to the PPE Regulation and shall be read in accordance with the correlation table in Annex X to the PPE Regulation, the text of which is set out in Schedule 10 to these Regulations.

Designation

• (a) the following are designated as market surveillance authorities:

• (i) the Health and Safety Authority; and

• (ii) the Competition and Consumer Protection Commission, and

• (b) the Minister for Business, Enterprise and Innovation is designated as the notifying authority of the State.

• (2) An authority designated under paragraph (1) as a market surveillance authority shall be a competent national authority of the State.

• (3) The assessment and monitoring referred to in Article 21(1) and (2) of the PPE Regulation shall be carried out by the Irish National Accreditation Board.

• (4) The notifying authority shall act in accordance with Articles 21, 22 and 23 of the PPE Regulation and where the notifying authority delegates or otherwise entrusts the notification referred to in Article 21(3) to a body referred to in that Article, the body shall comply with Article 21(3).

Application

• (2) These Regulations do not apply to personal protective equipment:

• (a) specifically designed for use by the armed forces or in the maintenance of law and order;

• (b) designed to be used for self-defence, with the exception of personal protective equipment intended for sporting activities;

• (c) designed for private use to protect against:

• (i) atmospheric conditions that are not of an extreme nature;

• (ii) damp and water during dishwashing;

• (d) for exclusive use on seagoing vessels or aircraft that are subject to the relevant international treaties applicable in Member States;

• (e) for head, face or eye protection of users, that is covered by Regulation No. 22 of the United Nations Economic Commission for Europe on uniform provisions concerning the approval of protective helmets and their visors for drivers and passengers of motorcycles and mopeds.

Making available on market

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

• (a) a visible sign clearly indicates that the PPE does not comply with the PPE Regulation or these Regulations and further indicates that it is not to be made available on the market until it has been brought into conformity with the PPE Regulation and these Regulations, and

• (b) adequate measures are taken during any demonstration of the PPE to ensure the protection of persons.

PART 2 Obligations of Economic Operators

Obligations of manufacturers

• (a) ensure that PPE placed on the market by the manufacturer has been designed and manufactured in accordance with the applicable essential health and safety requirements set out in Annex II to the PPE Regulation, the text of which is set out in Schedule 2 to these Regulations,

• (b) draw up the technical documentation referred to in Annex III to the PPE Regulation, the text of which is set out in Schedule 3 to these Regulations, and carry out, or have carried out, the applicable conformity assessment procedure referred to in Regulation 14,

• (c) in a case where compliance of PPE with paragraph (a) has been demonstrated by the conformity assessment procedure carried out under paragraph (b)—

• (i) draw up an EU declaration of conformity,

• (ii) ensure that the EU declaration of conformity referred to in subparagraph (c)(i) accompanies the PPE or include in the instructions and information set out in point 1.4 of Annex II to the PPE Regulation the internet address at which the EU declaration of conformity can be accessed,

• (d) in a case where compliance of PPE with paragraph (a) has been demonstrated by the conformity assessment procedure carried out under paragraph (b), affix a CE marking to the PPE in accordance with Regulation 17,

• (e) retain the technical documentation and the EU declaration of conformity for 10 years after the PPE has been placed on the market,

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

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

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

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

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

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

• (i) indicate on the PPE or, where that is not possible, on its packaging or in a document accompanying the PPE, in a language easily understood by end-users and the market surveillance authorities, the manufacturer’s name, registered trade name or registered trade mark and the postal address at which he or she can be contacted, which address shall indicate a single point of contact,

• (j) ensure that the PPE is accompanied by the instructions and information set out in point 1.4 of Annex II to the PPE Regulation in a language which can be easily understood by consumers and other end-users and that such instructions and information, as well as any labelling, is clear, understandable, intelligible and legible,

• (k) in a case where the manufacturer has placed on the market PPE and considers or has reason to believe the PPE is not in conformity with the PPE Regulation or these Regulations—

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

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

and

• (l) further to a reasoned request from a competent national authority—

• (i) provide it with all the information and documentation, in paper or electronic form, necessary to demonstrate the conformity of the PPE with the PPE Regulation and 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 PPE placed on the market by the manufacturer.

Authorised representatives

• (2) The obligations referred to in Regulation 6(a) and the obligation to draw up technical documentation referred to in Regulation 6(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 and the technical documentation at the disposal of the market surveillance authorities of all Member States for 10 years after the PPE has been placed on the market,

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

and

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

Obligations of importers

• (2) An importer shall—

• (a) before placing on the market PPE, 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 PPE bears the CE marking and is accompanied by the documents required under the PPE Regulation and these Regulations, and

• (iv) the manufacturer has complied with the requirements set out in Regulation 6(h) and (i),

• (b) in a case where the importer considers or has reason to believe that PPE is not in conformity with the applicable essential health and safety requirements set out in Annex II to the PPE Regulation—

• (i) refrain from placing on the market the PPE until it has been brought into conformity, and

• (ii) where the PPE presents a risk, inform the manufacturer and the market surveillance authorities of all Member States of such risk,

• (c) indicate on PPE, or where that is not possible, on its packaging or in a document accompanying it, in a language easily understood by end-users and market surveillance authorities referred to in Article 10(3) of the PPE Regulation, 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 PPE is accompanied by instructions and information set out in point 1.4 of Annex II to the PPE Regulation in a language which can be easily understood by consumers and other end-users,

• (e) ensure that, while PPE is under the importer’s responsibility, storage or transport conditions do not jeopardise its conformity with the applicable essential health and safety requirements set out in Annex II to the PPE Regulation,

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

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

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

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

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

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

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

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

• (i) keep a copy of the EU declaration of conformity at the disposal of the market surveillance authorities of all Member States, 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 national authority—

• (i) provide it with all the information and documentation, in paper or electronic form, necessary to demonstrate the conformity of PPE, 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 the PPE which the importer has placed on the market.

Obligations of distributors

• (a) when making available on the market PPE, act with due care in relation to the requirements of the PPE Regulation and these Regulations,

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

• (i) the PPE bears the CE marking,

• (ii) the PPE is accompanied by the required documents and by the instructions and information set out in point 1.4 of Annex II to the PPE Regulation in a language which can be easily understood by consumers and other end-users in the Member State in which the PPE is to be made available on the market,

• (iii) the manufacturer and the importer have complied with the requirements set out in Regulations 6(h), 6(i) and 8(2)(c) respectively,

• (c) in a case where the distributor considers or has reason to believe that PPE is not in conformity with the applicable essential health and safety requirements set out in Annex II to the PPE Regulation—

• (i) refrain from making available on the market the PPE until it has been brought into conformity, and

• (ii) where the PPE presents a risk, inform the manufacturer or the importer and the market surveillance authorities of all Member States of such risk,

• (d) ensure that, while PPE is under the distributor’s responsibility, storage or transport conditions do not jeopardise its conformity with the applicable essential health and safety requirements set out in Annex II to the PPE Regulation,

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

• (i) ensure that the corrective measures necessary to bring the PPE into conformity, to withdraw it or to recall it, as appropriate, are taken, and

• (ii) where that PPE presents a risk, immediately inform the competent national authorities of the Member States in which the distributor has made available on the market the PPE of such risk, giving details, in particular, of the non-conformity and of any corrective measures taken,

and

• (f) further to a reasoned request from a competent national authority—

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

• (ii) co-operate with that authority, at its request, on any action taken to eliminate the risks posed by the PPE which the distributor has made available on the market.

Cases in which obligations of manufacturers apply to importers and distributors

• (a) places on the market PPE under his or her name or trademark, or

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

Identification of economic operators

• (a) any economic operator who has supplied the first named economic operator with PPE;

• (b) any economic operator to whom the first named economic operator has supplied PPE.

• (2) The first named economic operator shall be able to present the information referred to in paragraph (1) for 10 years after the first named economic operator has been supplied with or has supplied the PPE referred to in that paragraph.

PART 3 Conformity of PPE

Presumption of conformity on basis of harmonised standards

Risk categories of PPE

Conformity assessment procedures

• (a) Category I: internal production control (module A) set out in Annex IV to the PPE Regulation, the text of which is set out in Schedule 4 to these Regulations;

• (b) Category II: EU type-examination (module B) set out in Annex V to the PPE Regulation, the text of which is set out in Schedule 5 to these Regulations, followed by conformity to type based on internal production control (module C) set out in Annex VI to the PPE Regulation, the text of which is set out in Schedule 6 to these Regulations;

• (c) Category III: Subject to paragraph (2), EU type-examination (module B) set out in Annex V to the PPE Regulation and either of the following:

• (i) conformity to type based on internal production control plus supervised product checks at random intervals (module C2) set out in Annex VII to the PPE Regulation, the text of which is set out in Schedule 7 to these Regulations;

• (ii) conformity to type based on quality assurance of the production process (module D) set out in Annex VIII to the PPE Regulation, the text of which is set out in Schedule 8 to these Regulations.

• (2) Where PPE is produced as a single unit to fit an individual user and classified according to Category III, the procedure referred to in paragraph (1)(b) may be followed.

EU declaration of conformity

• (a) state that the fulfilment of the applicable essential health and safety requirements set out in Annex II to the PPE Regulation has been demonstrated,

• (b) have the model structure set out in Annex IX to the PPE Regulation, the text of which is set out in Schedule 9 to these Regulations,

• (c) contain the elements specified in the relevant modules set out in Annexes IV, VI, VII and VIII to the PPE Regulation,

• (d) be continuously updated,

and

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

• (2) Where PPE 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 PPE with the requirements laid down in the PPE Regulation and these Regulations.

General principles of CE marking

Rules and conditions for affixing CE marking and other markings

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

• (a) the PPE packaging, and

• (b) the documents accompanying the PPE.

• (3) For PPE falling within Category III of Annex I to the PPE Regulation, the CE marking shall be followed by the identification number of the notified body involved in the procedure set out in Annex VII or VIII to the PPE Regulation which identification number shall be affixed—

• (a) by the notified body itself, or

• (b) in accordance with the instructions of the notified body, by the manufacturer or his or her authorised representative.

• (4) The CE marking and, where applicable, the identification number of the notified body may be followed by a pictogram or other marking indicating the risk against which the PPE is intended to protect.

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

• (a) the PPE to which it relates conforms with the PPE Regulation and these Regulations, and

• (b) the CE marking is affixed in accordance with the PPE Regulation and these Regulations.

PART 4 Notification of Conformity Assessment Bodies

Notified bodies

• (2) A conformity assessment body shall be a notified body when the following conditions are satisfied:

• (a) the body has been notified to the European Commission and all other Member States as being a conformity assessment body authorised in terms of paragraph (1); and

• (b) no objections have been raised by the European Commission or other Member States within the time periods set down under Article 28(5) of the PPE Regulation to the notification referred to in paragraph (1).

Applications for notification by conformity assessment bodies

• (a) submit to the notifying authority an application, which application shall be in accordance with Article 27 of the PPE Regulation and shall be accompanied by the appropriate fee as may be prescribed by the notifying authority, and

• (b) meet the requirements set down in paragraphs 2 to 11 of Article 24 of the PPE Regulation.

• (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 24 of the PPE Regulation insofar as the applicable harmonised standards cover those requirements.

Notification of conformity assessment bodies

• (2) The notifying authority shall not notify the European Commission and all Member States that a conformity assessment body is authorised in terms of Regulation 18(1) unless the body has satisfied Regulation 19(1).

Changes to notification

• (2) Where the notifying authority has ascertained or has been informed that a notified body no longer meets the requirements laid down in Article 24 of the PPE Regulation, or that it is failing to fulfil its obligations under Article 32 or 34 of the PPE Regulation or under these Regulations, the authority shall restrict, suspend or revoke the notification as appropriate, depending on the seriousness of the failure to meet those requirements or fulfil those obligations, and shall immediately inform the European Commission and all other Member States accordingly.

• (3) In the event of restriction, suspension or revocation 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 body considered to be a notified body for the purposes of the PPE Regulation or kept available for the notifying authority of the State and market surveillance authorities of all the Member States at their request.

• (4) The notifying authority shall inform the notified body concerned of its decision to take the measure referred to in paragraph (2) and allow that body an opportunity to make representations to it within 7 days of being so informed.

• (5) The notifying authority shall establish a panel (in this Regulation “appeal panel”) for the purpose of considering appeals under this Regulation and the following shall apply:

• (a) Subject to subparagraph (b), 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;

• (b) where an appeal is taken against a decision of the notifying authority under this Regulation, an appeal panel shall not consist of any person who made the decision or was involved in the decision;

• (c) an appeal panel shall establish its own procedure.

• (6) The notifying authority may establish more than one appeal panel to consider one or more appeals.

• (7) Where the notifying authority decides to restrict, suspend or revoke a notification pertaining to a notified body, the notified body may, within 14 days beginning on the day of being informed of the decision, appeal the decision to an appeal panel and in determining the appeal, the appeal panel may, if it considers it appropriate to do so, confirm the decision, vary it or allow the appeal and shall notify the appellant of its decision.

• (8) Where an appeal is brought under paragraph (7), the appellant may apply for implementation of the decision the subject of the appeal to be suspended pending the outcome of the appeal and the appeal panel may grant this application if it sees fit.

• (9) Where a decision is made under paragraph (7), any person aggrieved may, within 14 days beginning on the day on which the decision is made, appeal against the decision to a judge of the District Court in the District Court district in which the notified body ordinarily resides and in determining the appeal the judge may, if he or she considers it appropriate to do so, confirm the decision of the appeal panel, vary it or allow the appeal.

• (10) Where an appeal is brought under paragraph (9), the appellant may apply to the District Court for implementation of the decision the subject of the appeal to be suspended pending the outcome of the appeal and the District Court may grant this application if it sees fit.

• (11) A decision under paragraph (9) shall be final, save that, on successful application to the High Court, an appeal from the decision shall lie to the High Court on a specified question of law.

• (12) An application referred to in paragraph (11) does not affect the decision of the District Court.

• (13) All expenses reasonably incurred by the notifying authority in relation to an appeal, whether before an appeal panel, the District Court or the High Court, shall be borne by the appellant where the appeal panel or the court confirms or varies the decision of the notifying authority.

• (14) The notifying authority may recover any expenses referred to in paragraph (13) 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 V, VII and VIII to the PPE Regulation,

• (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 applicable PPE technology 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 PPE Regulation or corresponding harmonised standards or other technical specifications have not been met by a manufacturer, require the manufacturer to take appropriate corrective measures and refrain from issuing a certificate or approval decision,

• (e) in a case where, in the course of the monitoring of conformity following the issue of a certificate or an approval decision, the notified body finds that PPE no longer complies, require the manufacturer to take appropriate corrective measures and suspend or revoke the certificate or the approval decision 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 revoke any certificate or approval decision, as appropriate,

• (g) inform the manufacturer referred to in subparagraph (f) of the decision to take the measure referred to in subparagraph (f),

and

• (h) participate in the sectoral group of notified bodies established in accordance with Article 36 of the PPE Regulation.

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

Appeals against decisions of notified bodies

• (a) subject to subparagraph (b), 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;

• (b) where an appeal is taken against a decision of a notified body to take a measure referred to in subparagraph (f) of Regulation 23(1), an appeal panel shall not consist of any person who decided or was involved in the decision;

• (c) an appeal panel shall establish its own procedure.

• (2) The notifying authority may establish more than one appeal panel to consider one or more appeals.

• (3) Where a notified body decides to take a measure referred to in subparagraph (f) of Regulation 23(1), the manufacturer affected by the decision may, within 14 days beginning on the day of being informed of the decision, appeal the decision to an appeal panel and in determining the appeal, the appeal panel may, if it considers it appropriate to do so, confirm the decision, vary it or allow the appeal and shall notify the appellant of its decision.

• (4) Where an appeal is brought under paragraph (3), the appellant may apply for implementation of the decision the subject of the appeal to be suspended pending the outcome of the appeal and the appeal panel may grant this application if it sees fit.

• (5) Where a decision is made under paragraph (3), any person aggrieved may, within 14 days beginning on the day on which the decision is made, appeal against the decision to a judge of the District Court in the District Court district in which the manufacturer ordinarily resides and in determining the appeal the judge may, if he or she considers it appropriate to do so, confirm the decision of the appeal panel, vary it or allow the appeal.

• (6) Where an appeal is brought under paragraph (5), the appellant may apply to the District Court for implementation of the decision the subject of an appeal to be suspended pending the outcome of the appeal and the District Court may grant this application if it sees fit.

• (7) A decision under paragraph (5) shall be final, save that, on successful application to the High Court, an appeal from the decision shall lie to the High Court on a specified question of law.

• (8) An application referred to in paragraph (7) does not affect the decision of the District Court.

Information obligation on notified bodies

• (a) inform the notifying authority of the matters referred to in Article 34(1) of the PPE Regulation, and

• (b) provide the other bodies notified under the PPE Regulation carrying out similar conformity assessment activities covering the same kinds of PPE with relevant information on issues relating to negative and, on request, positive conformity assessment results.

PART 5 Market Surveillance and Safeguard Procedure

Market surveillance authority

Procedure for dealing with PPE presenting a risk at national level

• (2) The economic operator relating to the PPE referred to in paragraph (1) (in this Part “relevant economic operator”) shall co-operate as necessary with the market surveillance authority in carrying out an evaluation under paragraph (1).

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

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

• (b) where applicable, inform the notified body that carried out the conformity assessment procedure on the PPE of the non-conformity of the PPE with the PPE Regulation or these Regulations or both and measures taken under subparagraph (a).

• (4) Article 21 of Regulation (EC) No. 765/2008 shall apply to any measure referred to in paragraph 3(a) of this Regulation.

• (5) Where the market surveillance authority considers that non-compliance referred to in paragraph (3) is not restricted to the State, it shall inform the European Commission and all other Member States of the results of the evaluation and of the actions which it has required the relevant economic operator to take.

• (6) The relevant economic operator shall ensure that all appropriate corrective action is taken in respect of all the PPE that it has placed on the market or made available on the market.

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

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

• (a) include all available details, in particular the data necessary for the identification of the non-compliant PPE, the origin of the PPE, the nature of the non-compliance alleged and the risk involved, the nature and duration of the measures taken by 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 PPE to meet requirements relating to health or safety of persons, or

• (ii) shortcomings in the harmonised standards referred to in Article 14 of the PPE Regulation conferring a presumption of conformity.

• (9) Where another Member State has initiated the procedure under Article 38 of the PPE Regulation, a competent national authority of the State shall, without delay, inform the European Commission and all other Member States—

• (a) of any measures adopted and of any additional information at its disposal relating to the non-compliance of the PPE the subject matter of the procedure, and

• (b) in the event it disagrees with the adopted measure of the first-mentioned Member State, of its objections.

• (10) Where, within three months of receipt of the information referred to in paragraph (8) by the European Commission and all other Member States, no objection has been raised by either a Member State or the Commission in respect of a provisional measure taken by a competent national authority of the State under paragraph (7), the measure shall be deemed to be justified.

Safeguard procedure

• (2) Where the European Commission adopts an implementing act in accordance with Article 39 of the PPE Regulation determining that a measure taken by a competent national authority of the State under Article 38 of the PPE Regulation or Regulation 27 of these Regulations is unjustified, that competent national authority shall withdraw that measure.

Compliant PPE which presents a risk

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

• (b) immediately inform the European Commission and all other Member States that, although the PPE is in compliance with the PPE Regulation and these Regulations, it presents a risk to the health or safety of persons and include all available details, in particular—

• (i) the data necessary for the identification of the PPE,

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

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

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

• (2) The relevant economic operator shall ensure that the corrective action required under paragraph (1) is taken in respect of all the PPE that the relevant economic operator has made available on the market.

PART 6 Powers of Market Surveillance Authority

General

Authorised Officer

• (a) appointed as an Authorised Officer pursuant to section 35 of the Act of 2014, or

• (b) appointed under section 33 or 62 of the Act of 2005.

• (2) An Authorised Officer shall, when exercising any power conferred on him or her by the PPE Regulation or these Regulations, if requested to do so by any person affected, produce the warrant of appointment, or a copy of it, furnished to him or her under section 35 of the Act of 2014 or 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 Authorised Officer

• (a) subject to paragraphs (3) and (5), at any time enter without warrant—

• (i) any place of business of an economic operator, or

• (ii) any other place where entry of the place is necessary to ensure that the objectives of the PPE Regulation and these Regulations are achieved;

• (b) make inquiries in respect of, search, examine or inspect, as appropriate—

• (i) any place, or any part of any place, referred to in subparagraph (a),

• (ii) any activity, process, procedure, matter or thing at, or carried on at, a place referred to at subparagraph (a),

• (iii) any PPE or any record relating to such PPE to ascertain whether the PPE Regulation 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 considers necessary;

• (c) require that a place referred to in subparagraph (a) and its contents remain undisturbed for as long as is reasonably necessary for the purposes of any inquiry, search, examination, investigation or inspection under the PPE Regulation or these Regulations;

• (d) require any person in charge of, employed at or other relevant person at, a place referred to in subparagraph (a) to—

• (i) produce to the Authorised Officer any PPE or partly completed PPE in possession or under the control of the person,

• (ii) produce to the Authorised Officer any books, documents or records, and where such books, documents or records are kept in a non-legible form, reproduce them in a legible form, and

• (iii) give to the Authorised Officer such information as the Authorised Officer may reasonably require in relation to any entries in the books, documents and records referred to in subparagraph (d)(ii);

• (e) inspect and take copies of or extracts from any books, documents or records or any electronic information system at a place referred to in subparagraph (a), 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 or extracts be provided;

• (f) require a person in charge of, employed at or other relevant person at, a place referred to in subparagraph (a) by whom or on whose behalf a computer is or has been used to produce or store records or require any other person having control of, or otherwise concerned with, the operation of the computer, to afford the Authorised Officer access to the records on that computer and all reasonable assistance as the Authorised Officer may require in respect of accessing such records;

• (g) remove from a place referred to in subparagraph (a) and detain any books, documents or records (including any information stored in a non-legible form) and any copies taken of such books, documents or records for such period as the Authorised Officer reasonably considers necessary for further examination or until the conclusion of any legal proceedings to which they relate;

• (h) require that any books, documents or records at a place referred to in subparagraph (a) be maintained for such period as may be reasonable;

• (i) require the person in charge of, employed at or other relevant person at, a place referred to in subparagraph (a) to give the Authorised Officer such information as the Authorised Officer may reasonably require for the purposes of any inquiry, search, examination, investigation or inspection under the PPE Regulation or these Regulations;

• (j) require the person in charge of, employed at or other relevant person at, a place referred to in subparagraph (a) to give the Authorised Officer such assistance and facilities within the person’s power or control as are reasonably necessary to enable the Authorised Officer to exercise any of his or her powers under these Regulations;

• (k) require any person (whether such person is at a place referred to in subparagraph (a) or otherwise) to produce to the Authorised Officer any records that the Authorised Officer may reasonably require that are under power or control of that person;

• (l) examine any person (whether such person is at a place referred to in subparagraph (a) or otherwise) whom the Authorised Officer reasonably believes to be able to give to the Authorised Officer information relevant to any inquiry, search, examination, investigation or inspection under the PPE Regulation or these Regulations and require the person to answer such questions as the Authorised Officer may ask relevant to the inquiry, search, examination, investigation or inspection and to sign a declaration of the truth of the answers;

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

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

• (o) take samples of air, soil, water or waste at or near a place referred to in subparagraph (a);

• (p) where appropriate, install, use and maintain at a place referred to in subparagraph (a) monitoring instruments, systems and seals for the purposes of the PPE Regulation or these Regulations;

• (q) cause any PPE found at any place in respect of which there has been or there appears to the Authorised Officer to have been a contravention of the PPE Regulation or these Regulations to be subjected, at the place it is found or any other location, to any testing, examination or analysis (but not so as to damage or destroy it unless this is necessary for the purposes of the PPE Regulation or these Regulations) and where an Authorised Officer proposes to exercise the power conferred by this subparagraph and if so requested by the person in charge, cause anything that is to be done by virtue of this subparagraph to be done in the presence of the person in charge save that the person in charge is responsible for his or her own costs in attending at the exercise of any power under this subparagraph and cannot unreasonably delay the Authorised Officer in the exercise of those powers;

• (r) For the purposes of exercising a power under paragraph (q)—

• (i) require the person in charge to supply to the Authorised Officer without charge any PPE or samples thereof, and

• (ii) where necessary, remove, or have removed, to another location, any PPE or samples thereof;

• (s) remove and retain for such period as is necessary any PPE found at a place for one or more of the following purposes:

• (i) to examine or arrange for the examination, testing or analysis of the PPE in accordance with paragraph (q);

• (ii) to ensure that the PPE is not tampered with before the examination, testing or analysis of it under subparagraph (s)(i) is completed;

• (iii) to ensure that the PPE is available for use as evidence in any proceedings.

• (2) Where PPE is found at a place referred to in paragraph (1)(q), and an inquiry is made by an Authorised Officer in the course of a search, examination, investigation or inspection as to the identity of the person who supplied the PPE, the person in charge shall give the Authorised Officer the name and address of the supplier from whom the PPE was purchased or otherwise obtained.

• (3) An Authorised Officer shall not enter a private dwelling other than—

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

• (b) in accordance with a warrant of the District Court issued under paragraph (6) authorising such entry.

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

• (5) Where an Authorised Officer is prevented from entering a place referred to in paragraph (1)(a), or in any other case where the Authorised Officer reasonably believes that entry to such a place will be prevented, the Authorised Officer may apply to a judge of the District Court in whose District Court district the place is situated for a warrant authorising entry of such place.

• (6) Where an application is made under paragraph (5), if a judge of the District Court is satisfied by information on oath of an Authorised Officer that there are reasonable grounds for believing that—

• (a) there is at any place any PPE or any books, documents, records or information (including information stored in a non-legible form) relating to a place or to PPE that the Authorised Officer requires to inspect for the purposes of the PPE Regulation or these Regulations, or

• (b) there is, or is likely to be, at a place referred to in subparagraph (a) evidence of a contravention of the PPE Regulation or these Regulations,

the judge may issue a warrant authorising an Authorised Officer, accompanied by such other Authorised Officers 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 the place specified in the warrant, if necessary by the use of reasonable force, and perform the functions conferred on an Authorised Officer by these Regulations.

• (7) Where an Authorised Officer has reasonable grounds for apprehending any serious obstruction in the performance of any 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 a market surveillance authority, when performing any functions conferred on him or her by or under the PPE Regulation or these Regulations.

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

• (9) A statement or admission made by a person pursuant to a requirement under paragraph (1)(i) or (l) shall not be admissible in proceedings brought against that person for any offence other than an offence under Regulation 44(4) relating to a breach of, or failure to comply with, any obligation in the said paragraph (1)(i) or (l).

• (10) In this Regulation, reference to PPE shall be deemed to include PPE components and constituent materials.

Direction to end non-compliance

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

• (b) the CE marking has not been affixed;

• (c) the identification number of the notified body involved in the production control phase has been affixed in violation of Article 17 of the PPE Regulation or Regulation 17 of these Regulations or, where required by that Article or Regulation to be affixed, has not been affixed;

• (d) the EU declaration of conformity has not been drawn up;

• (e) the EU declaration of conformity has not been drawn up correctly;

• (f) the technical documentation is either not available or not complete;

• (g) the information referred to in Article 8(6) or 10(3) of the PPE Regulation or Regulation 6(i) or 8(2)(c) of these Regulations is absent, false or incomplete;

• (h) any other administrative requirement provided for in Article 8 or 10 of the PPE Regulation or Regulation 6 or 8 of these Regulations is not fulfilled;

• (i) there is non-compliance with any other requirement under the PPE Regulation or these Regulations.

Contravention notice

• (a) is contravening or has contravened any of the provisions of the PPE Regulation or these Regulations, or

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

may serve a contravention notice on the economic operator.

• (2) A contravention notice shall—

• (a) state that the Authorised Officer is of the opinion referred to in paragraph (1),

• (b) specify the grounds for the opinion,

• (c) specify every provision (including the particular paragraph and subparagraph of such provision as appropriate) upon which the opinion is based,

• (d) direct that the person, where required, do one or more of the following:

• (i) remedy the contravention or the matters occasioning the contravention notice;

• (ii) refrain from placing on the market the PPE to which the notice relates;

• (iii) refrain from making available on the market that PPE;

• (iv) withdraw that PPE from the market;

• (v) recall that PPE;

• (vi) dispose of that PPE;

• (vii) destroy that PPE;

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

• (e) inform the person on whom the contravention notice is served that he or she may appeal the notice to the District Court in accordance with Regulation 35,

• (f) state that if the person on whom the contravention notice is served fails to comply with the notice within the time period specified in the notice, that person commits an offence,

and

• (g) be signed and dated by the Authorised Officer.

• (3) A contravention notice may include—

• (a) directions as to the measures to be taken to remedy any contravention or matter to which the contravention notice relates, or to otherwise comply with the notice,

• (b) directions to bring the contravention notice to the attention of any person who may be affected by it or to the attention of the public generally,

and

• (c) any other requirement that the Authorised Officer considers appropriate.

• (4) Subject to Regulation 35(5), the contravention notice shall take effect on the later of—

• (a) the expiration of the period for making an appeal to the District Court, or

• (b) the day specified in the contravention notice.

• (5) A person on whom a contravention notice has been served under paragraph (1) shall comply with the notice.

• (6) A person on whom a contravention notice has been served who is of the opinion that the notice has been complied with, shall confirm such compliance in writing to the Authorised Officer.

• (7) Where a person on whom a contravention notice has been served confirms in accordance with paragraph (6), the Authorised Officer, on being satisfied that the person has complied with the notice, shall within one month of receipt of such confirmation, give notice to the person of compliance with the contravention notice.

• (8) An Authorised Officer may—

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

• (b) where no appeal is made or pending under Regulation 35, extend the period specified under paragraph (2)(d) of this Regulation.

Appeal against contravention 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 at the hearing of the appeal.

• (3) Where a decision is made under paragraph (1), any person aggrieved may, within 14 days beginning on the day on which the decision was made, appeal it to the Circuit Court in the circuit in which the contravention notice was served and in determining the appeal, the court may, if it considers it appropriate to do so, confirm the decision of the District Court, vary it or allow the appeal.

• (4) A decision under paragraph (3) shall be final, save that, by leave of the High Court, an appeal from the decision shall lie to the High Court on a specified question of law.

• (5) Where an appeal is taken and the contravention notice is not withdrawn by the Authorised Officer, the notice shall take effect on the later of—