S.I. No. 233/2017 - European Union (Pressure Equipment) Regulations 2017

ARRANGEMENT OF REGULATIONS

PART 1 CITATION, INTERPRETATION

1.

2.

3.

4.

5.

6.

PART 2 OBLIGATIONS OF ECONOMIC OPERATORS

7.

8.

9.

10.

11.

12.

PART 3 CONFORMITY OF PRODUCTS

13.

14.

15.

16.

17.

18.

19.

20.

21.

PART 4 NOTIFICATION OF CONFORMITY ASSESSMENT BODIES

22.

23.

24.

25.

26.

27.

28.

29.

PART 5 MARKET SURVEILLANCE, SAFEGUARD PROCEDURE

30.

31.

32.

33.

34.

PART 6 POWERS OF THE MARKET SURVEILLANCE AUTHORITY

35.

36.

37.

38.

39.

40.

41.

42.

43.

44.

45.

PART 7 OFFENCES AND PENALTIES

46.

47.

48.

49.

PART 8 MISCELLANEOUS

50.

51.

52.

53.

54.

55.

56.

SCHEDULE 1 Text of Annex I to the Directive

Essential safety requirements.

SCHEDULE 2 Text of Annex II to the Directive

Conformity assessment tables.

SCHEDULE 3 Text of Annex III to the Directive

Conformity assessment procedures.

SCHEDULE 4 Text of Annex IV to the Directive

EU declaration of conformity.

SCHEDULE 5 Text of Annex VI to the Directive

Correlation Table.

S.I. No. 233 of 2017

EUROPEAN UNION (PRESSURE EQUIPMENT) REGULATIONS 2017

Notice of the making of this Statutory Instrument was published in

“Iris Oifigiúil” of 2nd June, 2017.

I, MARY MITCHELL O’CONNOR, Minister for Jobs, Enterprise and Innovation, in exercise of the powers conferred on me by section 3 of the European Communities Act 1972 (No. 27 of 1972) (as amended by section 2 of the European Communities Act 2007 ) (No. 18 of 2007)) and for the purpose of giving effect to Directive 2014/68/EU of the European Parliament and of the Council of 15 May 2014¹ and of giving further effect to Regulation (EC) No. 765/2008 of the European Parliament and of the Council of 9 July 2008² , hereby make the following regulations:

PART 1 CITATION, INTERPRETATION

Citation

Interpretation

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

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

“assemblies” means several pieces of pressure equipment assembled by a manufacturer to constitute an integrated and functional whole;

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

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

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

“competent authority” means—

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

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

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

“conformity assessment body” means a body that performs conformity assessment activities including calibration, testing, certification and inspection and includes notified bodies, recognised third-party organisations or user inspectorates;

“contravention notice” means the notice provided for in Regulation 38;

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

“Directive” means Directive 2014/68/EU of the European Parliament and of the Council of 15 May 2014;

“Directive 97/23/EC” means Directive 97/23/EC of the European Parliament and of the council of 29 May 1997³ ;

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

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

“EU declaration of conformity” means a declaration of conformity drawn up in accordance with Regulation 19;

“European approval for materials” means a technical document defining the characteristics of materials intended for repeated use in the manufacture of pressure equipment which are not covered by any harmonised standard;

“fluids” means gases, liquids and vapours in pure phase as well as mixtures thereof and fluids may contain a suspension of solids;

“harmonised standard” means harmonised standard as defined in point (c) of Point 1 of Article 2 of Regulation (EU) No 1025/2012 of the European Parliament and of the Council of 25 October 2012⁴ ;

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

“information notice” means the notice provided for in Regulation 43;

“inspector” has the meaning assigned to it in Regulation 35(2);

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

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

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

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

“maximum allowable pressure PS” means the maximum pressure for which the equipment is designed, as specified by the manufacturer, and defined at a location specified by him, being either the connection of protective and/or limiting devices, or the top of equipment or, if not appropriate, any point specified;

“maximum/minimum allowable temperature TS” means the maximum/minimum temperatures for which the equipment is designed, as specified by the manufacturer;

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

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

“nominal size (DN)” means a numerical designation of size which is common to all components in a piping system other than components indicated by outside diameters or by thread size; it is a convenient round number for reference purposes and is only loosely related to manufacturing dimensions; the nominal size is designated by DN followed by a number;

“notified body” means—

• (a) in the State, a body authorised to carry out conformity assessment tasks in accordance with Articles 14 and 15 of the Directive and Regulations 15 and 16 of these Regulations and notified by the notifying authority pursuant to Regulation 22;

• (b) in another Member State, a body authorised to carry out conformity assessment tasks in accordance with Articles 14 and 15 of the Directive and notified by the relevant notifying authority pursuant to the Directive;

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

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

“permanent joints” means joints which cannot be disconnected except by destructive methods;

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

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

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

“piping” means piping components intended for the transport of fluids, when connected together for integration into a pressure system and includes in particular a pipe or system of pipes, tubing, fittings, expansion joints, hoses, or other pressure-bearing components as appropriate; heat exchangers consisting of pipes for the purpose of cooling or heating air shall be considered as piping;

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

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

“pressure” means pressure relative to atmospheric pressure, i.e. gauge pressure and, as a consequence, vacuum is designated by a negative value;

“pressure accessories” means devices with an operational function and having pressure-bearing housings;

“pressure equipment” means vessels, piping, safety accessories and pressure accessories, including, where applicable, elements attached to pressurised parts, such as flanges, nozzles, couplings, supports, lifting lugs;

“product” means the items specified in Regulation 4(1);

“prohibition notice” means the notice provided for in Regulation 40;

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

“recall” means any measure aimed at achieving the return of a product that have already been made available to consumers or other users;

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

“Regulations of 1999” means the European Communities (Pressure Equipment) Regulations ( S.I. No. 400 of 1999 );

“safety accessories” means devices designed to protect pressure equipment against the allowable limits being exceeded, including devices for direct pressure limitation, such as safety valves, bursting disc safety devices, buckling rods, controlled safety pressure relief systems (CSPRS), and limiting devices, which either activate the means for correction or provide for shutdown or shutdown and lockout, such as pressure switches or temperature switches or fluid level switches and safety related measurement control and regulation (SRMCR) devices;

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

“ recognised third-party organisation” means—

• (a) in the State, a body recognised by the notifying authority for the purposes of the tasks referred to in points 3.1.2 and 3.1.3 of Annex I to the Directive, the text of which is set out in Schedule 1 to these Regulations and notified by the notifying authority in accordance with Regulation 22;

• (b) in another Member State, a body recognised by the notifying authority for the purposes of the tasks referred to in points 3.1.2 and 3.1.3 of Annex I to the Directive and notified by that authority pursuant to the Directive;

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

“user inspectorate” means—

• (a) in the State, a body authorised to carry out conformity assessment tasks in accordance with Article 16 of the Directive and Regulation 17 of these Regulations and notified by the notifying authority pursuant to Regulation 22;

• (b) in another Member State, a body authorised to carry out conformity assessment tasks in accordance with Article 16 of the Directive and notified by the relevant notifying authority pursuant to the Directive;

“vessel” means a housing designed and built to contain fluids under pressure including its direct attachments up to the coupling point connecting it to other equipment and a vessel may be composed of more than one chamber;

“volume (V)” means the internal volume of a chamber, including the volume of nozzles to the first connection or weld and excluding the volume of permanent internal parts;

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

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

• (3) References to the repealed Directive 97/23/EC shall be construed in existing laws, regulations and administrative provisions of the State as references to the Directive and shall be read in accordance with the correlation table in Annex VI to the Directive, the text of which is set out in Schedule 5 to these Regulations.

Designation

1. For the purposes of the Directive and these Regulations—

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

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

   Application

   1. (1) Subject to paragraph (2), these Regulations apply to the design, manufacture and conformity assessment of pressure equipment and assemblies with a maximum allowable pressure PS greater than 0.5 bar.

2. (2) These Regulations do not apply to the equipment and items referred to in Article 1(2) of the Directive.

Making available on the market and putting into service

1. (1) Subject to paragraph (2), a person shall not make available on the market or put into service a product unless it satisfies the requirements of the Directive or these Regulations when properly installed and maintained and used for the purpose for which it is intended.

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

   • (a) a visible sign clearly indicates that the product does not comply with the Directive or these Regulations and that it will not be made available on the market or put into service until it has been brought into conformity, and

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

   Essential safety requirements

   1. (1) Subject to paragraph (4), pressure equipment listed in Article 4(1)(a) to 4(1)(d) of the Directive shall satisfy the essential safety requirements set out in Annex I to the Directive, the text of which is set out in Schedule 1 to these Regulations.

3. (2) Subject to paragraphs (3) and (4), assemblies which include at least one item of pressure equipment covered by paragraph (1) and listed in Article 4(2)(a) and 4(2)(b) of the Directive shall satisfy the essential safety requirements set out in Annex I to the Directive, the text of which is set out in Schedule 1 to these Regulations.

4. (3) Assemblies intended for generating warm water at temperatures not greater than 110 °C which are manually fed with solid fuels and have a PS·V greater than 50 bar·L shall comply with the essential safety requirements referred to in points 2.10, 2.11, 3.4, 5 (a) and 5 (d) of Annex I to the Directive, the text of which is set out in Schedule 1 to these Regulations.

5. (4) Pressure equipment and assemblies, below or equal to the limits set out in Article 4(1) (a), (b) and (c) and Article 4(2) to the Directive respectively, shall be designed and manufactured in accordance with sound engineering practice in a Member State in order to ensure safe use and accompanied by adequate instructions for use but, subject to other applicable Union harmonisation legislation providing for its affixing, such equipment or assemblies shall not bear the CE marking referred to in Article 18 of the Directive.

PART 2 OBLIGATIONS OF ECONOMIC OPERATORS

Obligations of manufacturers

• (a) subject to Regulation 6(3), ensure that when placing the pressure equipment or assemblies referred to in Regulation 6(1), (2) or (3) on the market or when using same for the manufacturer’s own purposes, that that equipment or those assemblies have been designed and manufactured in accordance with the essential safety requirements set out in Annex I to the Directive, the text of which is set out in Schedule 1 to these Regulations,

• (b) ensure that when placing the pressure equipment or assemblies referred to in Regulation 6(4) on the market or when using same for the manufacturer’s own purposes, that that equipment or those assemblies have been designed and manufactured in accordance with sound engineering practice in a Member State,

• (c) in the case of pressure equipment or assemblies referred to in Regulation 6(1), (2) or (3), draw up the technical documentation referred to in Annex III, the text of which is set out at Schedule III to these Regulations, and carry out the relevant conformity assessment procedure referred to in Regulation 15 or have it carried out,

• (d) in a case where compliance of pressure equipment or assemblies referred to in Regulation 6(1), (2) or (3) with the applicable requirements has been demonstrated by the conformity assessment procedure carried out under paragraph (c)—

• (i) draw up an EU declaration of conformity in accordance with Regulation 19, and

• (ii) affix the CE marking in accordance with Regulation 21,

• (e) retain the technical documentation and the EU declaration of conformity for 10 years after the pressure equipment or assemblies have been placed on the market,

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

• (g) in a case where it is deemed appropriate by the market surveillance authority, with regard to the risks presented by pressure equipment or assemblies and in order to protect the health and safety of consumers and other users—

• (i) carry out sample testing of pressure equipment or assemblies made available on the market,

• (ii) investigate and keep a register of complaints of non-conforming pressure equipment and assemblies and recalls of such equipment, and

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

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

• (i) indicate on the pressure equipment or assembly in a language easily understood by consumers, other users and the competent authorities, the manufacturer’s name, registered trade name or registered trade mark and the postal address at which they can be contacted, which address shall indicate a single point of contact or, where that is not possible, on the packaging or in a document accompanying the equipment or assembly,

• (j) ensure that the pressure equipment or assembly referred to in Regulation 6(1), (2) and (3) is accompanied by instructions and safety information in accordance with point 3.4 of Annex I to the Directive, the text of which is set out in Schedule 1 to these Regulations and in the case of the equipment or assemblies referred to in Regulation 6(1) or (2), also accompanied by instructions and safety information in accordance with point 3.3 of Annex I to the Directive, in a language easily understood by consumers and other users and that such instructions and safety information are clear, understandable and intelligible,

• (k) ensure that the pressure equipment or assembly referred to in Regulation 6(4) which it has placed on the market are accompanied by instructions and safety information in accordance with Regulation 6(4) in a language easily understood by consumers and other users and that such instructions and safety information are clear, understandable and intelligible,

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

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

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

and

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

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

• (ii) cooperate with that authority, at its request, on any action taken to eliminate the risks posed by any pressure equipment or assembly placed on the market by the manufacturer.

Authorised representatives

• (2) The obligations laid down in Regulation 7(a), (b) and the obligation to draw up technical documentation under Regulation 7(c) 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 competent authorities for 10 years after the pressure equipment or assembly has been placed on the market,

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

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

Obligations of importers

• (2) An importer shall—

• (a) before placing any pressure equipment or assembly referred to in Regulations 6(1), (2) or (3) on the market, ensure that—

• (i) the appropriate conformity assessment procedure referred to in Regulation 15, has been carried out by the manufacturer,

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

• (iii) the pressure equipment or assembly bears the CE marking,

• (iv) the pressure equipment or assembly is accompanied by instructions and safety information in accordance with point 3.4 of Annex I, the text of which is set out in Schedule 1 to these Regulations and in the case of equipment or assemblies referred to in Regulation 6(1) or (2), also accompanied by instructions and safety information in accordance with point 3.3 of Annex I.

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

• (b) before placing any pressure equipment or assembly referred to in Regulation 6(4) on the market ensure that—

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

• (ii) they are accompanied by adequate instructions for use, and

• (iii) the manufacturer has complied with the requirements set out in Regulation 7(h) and (i),

• (c) in a case where the importer considers or has reason to believe that the pressure equipment or assembly is not in conformity with the essential safety requirements set out in Annex I to the Directive, the text of which is set out in Schedule 1 to these Regulations—

• (i) not place the pressure equipment or assembly on the market until they have been brought into conformity, and

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

• (d) indicate on the pressure equipment or assembly, in a language which can be easily understood by consumers, other users and market surveillance authorities, or where it is not possible to do so on the equipment or assembly, on its packaging or in a document accompanying the equipment or assembly, the importer’s name, registered trade name or registered trade mark, and the postal address at which the importer can be contacted,

• (e) ensure that pressure equipment or assemblies referred to in Regulation 6(1), (2) or (3) are accompanied by instructions and safety information in accordance with point 3.4 of Annex I to the Directive, the text of which is set out in Schedule I to these Regulations and in the case of equipment or assemblies referred to in Regulation 6(1) and (2), also accompanied by instructions and safety information in accordance with point 3.3 of Annex I, in a language which can be easily understood by consumers and other users as determined by the Member State concerned,

• (f) ensure that pressure equipment or assemblies referred to in Regulation 6(4) are accompanied by instructions and safety information in a language which can be easily understood by consumers and other users as determined by the Member State concerned,

• (g) ensure that while pressure equipment or assemblies referred to in Regulation 6(1),(2) or (3) are under the importer’s responsibility, their storage or transport conditions do not jeopardise their compliance with the essential safety requirements set out in Annex I to the Directive, the text of which is set out in Schedule I to these Regulations,

• (h) in a case where it is deemed appropriate by the market surveillance authority, with regard to the risks presented by pressure equipment or assemblies and in order to protect the health and safety of consumers and other users the importer shall—

• (i) carry out sample testing of pressure equipment or assemblies made available on the market,

• (ii) investigate and keep a register of complaints, of non-conforming pressure equipment or assemblies and recalls of such equipment, and

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

• (i) in a case where an importer considers or has reason to believe that pressure equipment or assemblies which the importer has placed on the market are not in conformity with the Directive or these Regulations—

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

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

• (j) for 10 years after the pressure equipment or assembly has been placed on the market by the importer—

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

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

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

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

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

Obligations of distributors

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

• (b) before making the pressure equipment or assemblies referred to in Regulations 6(1),(2) or (3) available on the market, verify that—

• (i) the pressure equipment or assembly bears the CE marking,

• (ii) the pressure equipment or assembly is accompanied by the required documents and by instructions and safety information in accordance with point 3.4 of Annex I to the Directive, the text of which is set out in Schedule I to these Regulations, and in the case of the equipment or assemblies referred to in Regulation 6(1) and (2), also accompanied by instructions and safety information in accordance with point 3.3 of Annex I, in a language which can be easily understood by consumers and other users in the Member State in which the equipment or assembly is to be made available on the market,

• (iii) the manufacturer and the importer have complied with the requirements set out in Regulations 7(h) and (i) and Regulation 9(2)(d) respectively,

• (c) in a case where a distributor considers or has reason to believe that any pressure equipment or assembly referred to in Regulation 6(1), (2) or 6(3) are not in conformity with the relevant essential safety requirements set out in Annex I to the Directive, the text of which is set out in Schedule 1 to these Regulations—

• (i) not make the equipment or assembly available on the market until they have been brought into conformity,

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

• (d) before making the pressure equipment or assemblies referred to in Regulation 6(4) available on the market, verify that—

• (i) the equipment or assembly is accompanied by adequate instructions for use, in a language which can be easily understood by consumers and other users in the Member State in which the equipment or assembly is to be made available on the market, and

• (ii) the manufacturer and the importer have complied with the requirements set out in Regulations 7(h) and (i) and Regulation 9(2)(d) respectively,

• (e) ensure that while the pressure equipment or assemblies referred to in Regulation 6(1), (2) or (3) are the distributor’s responsibility, their storage or transport conditions do not jeopardise their compliance with the essential safety requirements set out in Annex I to the Directive, the text of which is set out in Schedule 1 to these Regulations,

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

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

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

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

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

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

Cases in which obligations of manufacturers apply to importers and distributors

• (i) places pressure equipment or an assembly on the market under the importer’s or distributor’s name or trademark, or

• (ii) modifies pressure equipment or an assembly already placed on the market in such a way that compliance with the Directive or these Regulations may be affected.

Identification of economic operators

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

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

• (ii) to whom the first named 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

• (a) the pressure equipment or assemblies referred to in Regulation 6(1), (2) and (3) which are in conformity with harmonised standards, or parts thereof, the references to which have been published in the Official Journal, shall be presumed to be in conformity with the essential safety requirements covered by those standards or parts thereof, referred to in Annex I to the Directive, the text of which is set out in Schedule 1 to these Regulations, and

• (b) the materials used for the manufacture of pressure equipment or assemblies which are in conformity with European approvals for materials, the references of which have been published in the Official Journal in accordance with Article 15(4) of the Directive, shall be presumed to be in conformity with the applicable essential safety requirements set out in Annex I to the Directive, the text of which is set out in Schedule 1 to these Regulations.

Classification of pressure equipment

• (2) Where a vessel is composed of a number of chambers, it shall be classified in the highest category applicable to the individual chambers.

• (3) Where a chamber contains several fluids, classification shall be on the basis of the fluid which requires the highest category.

Conformity assessment procedures

• (2) The market surveillance authority may, where justified, allow individual pressure equipment items and assemblies which have not been subjected to the conformity assessment procedures under paragraph (1) to be made available on the market or put into service if the use to which they will be put is in the interests of experimentation.

European approval for materials

• (2) Where a European approval for materials is issued under paragraph (1), a copy shall be sent to the Member States, the notified bodies and the European Commission.

• (3) In a case where a notified body issues a European approval for materials under paragraph (1) but finds that—

• (a) the approval should not have been issued, or

• (b) the type of materials is covered by a harmonised standard,

that body shall withdraw that approval and immediately inform the other Member States, the notified bodies and the European Commission of such withdrawal.

User inspectorates

• (2) For the purposes of paragraph (1), the notifying authority may appoint a user inspectorate to carry out conformity assessment procedures provided that—

• (a) the inspectorate meets the requirements of Article 25 of the Directive, and

• (b) the group of which the inspectorate is part applies a common safety policy as regards the technical specifications for the design, manufacture, inspection, maintenance and use of pressure equipment and assemblies,

• (3) An appointment of a user inspectorate under paragraph (2)—

• (a) shall be of fixed duration,

• (b) may be subject to such conditions as the notifying authority thinks fit, for the efficient and proper functioning of a user inspectorate,

• (4) Pressure equipment and assemblies the conformity of which has been assessed by a user inspectorate shall—

• (a) not bear the CE marking,

• (b) only be used in establishments operated by the group of which the inspectorate is part, which group shall apply a common safety policy as regards the technical specifications for the design, manufacture, inspection, maintenance and use of pressure equipment and assemblies.

• (5) User inspectorates appointed under paragraph (2) shall—

• (a) act exclusively for the group of which they are part,

• (b) apply the conformity assessment procedures at modules A2, C2, F and G of Annex III to the Directive, the text of which is set out in Schedule 3 to these Regulations.

Recognised third-party organisations

• (2) An appointment of a recognised third party organisation under paragraph (1)—

• (a) shall be of fixed duration,

• (b) may subject to such conditions as the notifying authority thinks fit, for the efficient and proper functioning of a recognised third party organisation,

EU declaration of conformity

• (a) state that the fulfilment of the essential safety requirements set out in Annex I to the Directive, the text of which is set out in Schedule 1 to these Regulations, has been demonstrated,

• (b) have the model structure set out in Annex IV to the Directive, the text of which is set out in Schedule 4 to these Regulations,

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

• (d) be continuously updated,

• (e) be translated into the language or languages required by the Member State in whose market the pressure equipment or assembly is placed or made available on the market.

• (2) Where pressure equipment or an assembly 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, which declaration shall contain the identification of the European Union acts including their publication references.

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

General principles of the CE marking

Rules and conditions for affixing the CE Marking

• (a) each item of pressure equipment referred to in Regulation 6(1) or its dataplate, or

• (b) each assembly referred to in Regulation 6(2) or its dataplate.

• (2) Where it is not possible to affix the CE marking to the pressure equipment or assembly or where it is not warranted on account of the nature of the equipment or assembly, the CE marking shall be affixed to the packaging and to the accompanying documents.

• (3) The item of pressure equipment or assembly referred to in paragraphs 1(a) and (b) shall be complete or shall be in a state permitting final assessment as described in point 3.2 of Annex I to the Directive, the text of which is set out in Schedule 1 to these Regulations.

• (4) It shall not be necessary to affix the CE marking to each individual item of pressure equipment making up an assembly and individual items of pressure equipment already bearing the CE marking when incorporated into the assembly shall continue to bear that marking.

• (5) The CE marking on products shall be followed by the identification number of the notified body, where that body is involved in the production control phase and shall be affixed by the body itself or, under its instructions, by the manufacturer or its authorised representative.

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

PART 4 NOTIFICATION OF CONFORMITY ASSESSMENT BODIES

Notified bodies, recognised third-party organisations, user inspectorates

• (a) the notified bodies authorised under these Regulations to carry out conformity assessment tasks in accordance with Article 14 and 15 of the Directive and Regulation 15 and 16 of these Regulations,

• (b) the third-party organisations the authority has recognised, for the purposes of the tasks referred to in points 3.1.2 and 3.1.3 of Annex I to the Directive, the text of which is set out in Schedule 1 to these Regulations, and

• (c) the user inspectorates authorised under these Regulations to carry out conformity assessment tasks in accordance with Article 16 of the Directive and Regulation 17 of these Regulations.

• (2) Only bodies which have been notified to the European Commission and other Member States in accordance with these Regulations and against whom no objections are raised by the European Commission or other Member States within the time periods set down under Article 29(5) of the Directive, shall be a notified body, third-party organisation or user inspectorate, as appropriate, for the purposes of the Directive and these Regulations.

Application for notification by conformity assessment bodies

• (2) A conformity assessment body seeking to become a recognised third-party organisation shall meet the requirements set down in paragraphs 2 to 11 of Article 24 of the Directive.

• (3) A conformity assessment body seeking to become a user inspectorate shall meet the requirements set down in paragraphs 2 to 11 of Article 25 of the Directive.

• (4) Without prejudice to paragraphs (1) and (2) where a conformity assessment body seeking to become a notified body or a recognised third-party organisation 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 of Article 24 in so far as the applicable harmonised standards cover those requirements.

• (5) Without prejudice to paragraph (3) where a conformity assessment body seeking to become a user inspectorate demonstrates its conformity with the criteria laid down in the relevant harmonised standards or parts thereof, the references to which have been published in the Official Journal, it shall be presumed to comply with the requirements of Article 25 in so far as the applicable harmonised standards cover those requirements.

• (6) A conformity assessment body seeking to become a notified body, a recognised third-party organisation or a user inspectorate shall submit to the notifying authority an application, which application shall be in accordance with Article 28 of the Directive and shall be accompanied by the appropriate fee as may be prescribed by the notifying authority.

Notification of conformity assessment bodies

• (a) has made an application in accordance with Article 28 of the Directive, and

• (b) meets the requirements of Article 24 of the Directive in the case of a body seeking to become a notified body or a recognised third-party organisation or of Article 25 of the Directive in the case of a body seeking to become a user inspectorate.

• (2) Notifications by the notifying authority under paragraph (1) shall be made in accordance with the notification procedure set down in Article 29(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 21(2) of the Directive shall be carried out by the Irish National Accreditation Board.

Changes to notifications

• (2) Where the notifying authority has ascertained or has been informed that a user inspectorate no longer meets the requirements in Article 25 of the Directive, or that it is failing to fulfil its obligations under the Directive or these Regulations, that authority shall restrict, suspend, or withdraw the notification, as appropriate, depending on the seriousness of the failure to meet those requirements or fulfil those obligations.

• (3) In the event of restriction, suspension or withdrawal of notification under paragraphs (1) or (2) the notifying authority shall immediately inform the European Commission and the other Member States of the restriction, suspension or withdrawal of same.

• (4) In the event of restriction, suspension or withdrawal of notification under paragraphs (1) or (2) or where the notified body, recognised third-party organisation or user inspectorate has ceased its activity, the notifying authority shall take appropriate steps to ensure that the files of the relevant body are either processed by another notified body, recognised third party organisation or user inspectorate or kept available for the responsible notifying and competent authorities at their request.

• (5) The notifying authority shall inform the notified body, recognised third-party organisation or user inspectorate of any decision under paragraphs (1) and (2) and allow that body an opportunity to make representations to it.

• (6) 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, recognised third party organisation or user inspectorate. An appeal panel shall establish its own procedure.

• (7) Where the notifying authority decides to restrict, suspend or withdraw notification pertaining to a notified body, recognised third party organisation or user inspectorate, that body may, within 14 days of the notification under paragraph (5), appeal to an appeal panel against the restriction, suspension or withdrawal, as the case may be. The notification pertaining to a notified body, recognised third party organisation or user inspectorate stands restricted, suspended or withdrawn, as the case may be, from the date of the notification of the decision under paragraph (5), 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.

• (8) 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 conformity assessment bodies

Operational obligations of notified bodies, user inspectorates and recognised third party organisations

• (a) carry out conformity assessments in accordance with the conformity assessment tasks provided for in Article 14, Article 15, Article 16 of the Directive or in points 3.1.2 and 3.1.3 of Annex I to the Directive, the text of which is set out in Schedule 1 to these Regulations, as appropriate,

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

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

• (d) in a case where they find that the essential safety requirements set out in Annex I to the Directive, the text of which is set out in Schedule 1 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, recognised third-party organisation or user inspectorate finds that pressure equipment 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, third party organisations or user inspectorates in accordance with Article 38 of the Directive.

• (2) In carrying out their functions under paragraph 1(b) and 1(c) of this Regulation, the notified body, recognised third-party organisation or user inspectorate shall nevertheless respect the degree of rigour and the level of protection required for the compliance of pressure equipment with the Directive or these Regulations.

Appeal against decisions of notified bodies, recognised third-party organisations and user inspectorates

• (2) Where a notified body, recognised third-party organisation or user inspectorates decides to restrict, suspend or withdraw a certificate held by a manufacturer, the latter may, within 14 days of the notification under Regulation 27(1)(g), appeal to an appeal panel against the restriction, suspension or withdrawal, as the case may be. The certificate or approval decision stands restricted, suspended or withdrawn, as the case may be, from the date of notification of the decision under Regulation 27(1)(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, recognised third-party organisations and user inspectorates

• (a) inform the notifying authority of the matters referred to in Article 36(1)(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 pressure equipment with relevant information on issues relating to negative conformity assessment results, and

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

PART 5 MARKET SURVEILLANCE, SAFEGUARD PROCEDURE

Market surveillance

Procedure for dealing with pressure equipment or assemblies presenting a risk at national level

• (2) The relevant economic operator shall cooperate 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 pressure equipment or assembly 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 pressure equipment or assembly 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 pressure equipment or assembly of the non-compliance of that equipment or assembly, 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 pressure equipment or assembly from being made available on the market in the State, to withdraw the pressure equipment or assembly 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 pressure equipment or assembly, the origin of the pressure equipment or assembly, 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 40 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 their disposal relating to the non-compliance of the product concerned, or

• (b) of its objections, in the event of disagreement with the adopted measure adopted 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 the withdrawal of the product from the market, are taken in respect of the product concerned without delay.

Safeguard procedure

• (2) Where a national measure taken by a Member State under Article 40 of the Directive is considered unjustified by the European Commission in accordance with the procedure in Article 41(1) of the Directive, the market surveillance authority shall withdraw that measure.

Compliant pressure equipment or assemblies which present a risk

• (a) require the 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 supply chain of the product,

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

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

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

Formal non-compliance

• (a) the CE marking has been affixed in violation of Article 30 of Regulation (EC) No. 765/2008, Article 19 of the Directive, or Regulation 21 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 19 of the Directive or Regulation 21(5) or has not been affixed,

• (d) the marking and labelling referred to in point 3.3. of Annex I to the Directive, the text of which is set out in Schedule 1 to these Regulations, have not been affixed or have been affixed in violation of Regulation 21 or point 3.3 of Annex I to the Directive,

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

• (f) the EU declaration 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 Regulation 7(i) or Regulation 9(2)(d) is absent, false or incomplete;

• (i) any other administrative requirement provided for in Article 6 or 8 of the Directive or Regulation 7 or Regulation 9 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 making available on the market of the product or ensure that it is recalled or withdrawn from the market.

PART 6 POWERS OF THE MARKET SURVEILLANCE AUTHORITY

General

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

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

Powers of inspectors

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

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

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

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

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

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

• (iii) any pressure equipment or assembly or any record relating to such pressure equipment or assembly, 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—