7.—(1) Subject to regulation 11, no person who is a responsible person shall place on the market or put into service any pressure equipment described in paragraph 2 unless the requirements of paragraph (3) have been complied with in relation to it.
(2) For the purposes of paragraph (1), the following are pressure equipment—
(a)vessels, except those referred to in sub-paragraph (b), for—
(i)gases, liquefied gases, gases dissolved under pressure, vapours and also those liquids whose vapour pressure at the maximum allowable temperature is greater than 0.5 bar above normal atmospheric pressure, (1 013 mbar) within the following limits—
(aa)for fluids in Group 1, with a volume greater than 1L and a product of PS and V greater than 25 bar-L, or with a pressure PS greater than 200 bar;
(bb)for fluids in Group 2, with a volume greater than 1L and a product of PS and V greater than 50 bar-L, or with a pressure PS greater than 1 000 bar, and all portable extinguishers and bottles for breathing apparatus;
(ii)liquids having a vapour pressure at the maximum allowable temperature of not more than 0.5 bar above normal atmospheric pressure (1 013 mbar) within the following limits—
(aa)for fluids in Group 1, with a volume greater than 1L and a product of PS and V greater than 200 bar-L, or with a pressure PS greater than 500 bar;
(bb)for fluids in Group 2, with a pressure PS greater than 10 bar and a product of PS and V greater than 10 000 bar-L, or with a pressure PS greater than 1 000 bar;
(b)fired or otherwise heated pressure equipment with the risk of overheating intended for generation of steam or super-heated water at temperatures higher than 110°C(1) having a volume greater than 2L, and all pressure cookers;
(c)piping intended for—
(i)gases, liquefied gases, gases dissolved under pressure, vapours and those liquids whose vapour pressure at the maximum allowable temperature is greater than 0.5 bar above normal atmospheric pressure (1 013 mbar) within the following limits—
(aa)for fluids in Group 1, with a DN greater than 25;
(bb)for fluids in Group 2, with a DN greater than 32 and a product of PS and DN greater than 1 000 bar;
(ii)liquids having a vapour pressure at the maximum allowable temperature of not more than 0.5 bar above normal atmospheric pressure (1 013 mbar), within the following limits—
(aa)for fluids in Group 1, with a DN greater than 25 and a product of PS and DN greater than 2 000 bar;
(bb)for fluids in Group 2, with a PS greater than 10 bar, a DN greater than 200 and a product of PS and DN greater than 5 000 bar;
(d)subject to regulation 9, safety and pressure accessories intended for equipment covered by sub-paragraphs (a), (b) and (c), including where such equipment is incorporated into an assembly.
(3) The requirements in respect of pressure equipment described in paragraph 2 are that—
(a)it satisfies the relevant essential requirements and for the purpose of satisfying those requirements where a transposed harmonised standard covers one or more of the relevant essential requirements, any pressure equipment constructed in accordance with that transposed harmonised standard shall be presumed to comply with that or, as the case may be, those essential requirements;
(b)the appropriate conformity assessment procedure in respect of the pressure equipment has been carried out in accordance with regulation 13(1);
(c)the CE marking has been affixed to it by the manufacturer of the pressure equipment or his authorised representative established within the Community in accordance with regulation 16 and Schedule 5;
(d)a declaration of conformity has been drawn up in respect of it by the manufacturer of the pressure equipment or his authorised representative established within the Community containing the information listed in Schedule 6; and
(e)it is in fact safe.
(4) Any technical documentation or other information in relation to an item of pressure equipment required to be retained under the conformity assessment procedure used shall be retained by the person specified in that respect in that conformity assessment procedure for any period specified in that procedure.
(5) In respect of pressure equipment to be placed on the market and put into service in the United Kingdom, where the requirements of paragraphs 3.3 and 3.4 of Schedule 2 are to be met, the marking, labelling, information and instructions shall be in English.
8.—(1) Subject to regulation 11, no person who is a responsible person shall place on the market or put into service an assembly described in paragraph 2 unless the requirements of paragraph (3) have been complied with in relation to it.
(2) For the purposes of paragraph (1), an assembly is—
(a)an assembly which includes at least one item of pressure equipment described in paragraph (2) of regulation 7 and—
(i)is intended for generating steam or superheated water at a temperature higher than 110°C(2) comprising at least one item of fired or other heated pressure equipment presenting a risk of overheating; or,
(ii)not being a product included in sub-paragraph (i) above, is intended by the manufacturer to be placed on the market and put into service as an assembly; or
(b)an assembly which is intended for generating warm water at temperatures not greater than 110°C, which is manually fed with the solid fuels and has a PS.V greater than 50 bar-L.
(3) (a) The requirements in respect of an assembly described in paragraph (2)(a) are that—
(i)it satisfies the relevant essential requirements and for the purpose of satisfying those requirements where a transposed harmonised standard covers one or more of the relevant essential requirements, any assembly constructed in accordance with that transposed harmonised standard shall be presumed to comply with that or, as the case may be, those essential safety requirements;
(ii)the appropriate conformity assessment procedure in respect of the assembly has been carried out in accordance with regulation 14;
(iii)the CE marking has been affixed to it by the manufacturer of that assembly or his authorised representative established within the Community in accordance with regulation 16 and Schedule 5;
(iv)a declaration of conformity has been drawn up in respect of it by the manufacturer of the assembly or his authorised representative established within the Community containing the information listed in Schedule 6; and
(v)it is in fact safe.
(b)The requirements in respect of any assembly described in paragraph (2)(b) are that—
(i)it satisfies the essential requirements referred to in paragraphs 2.10, 2.11, 3.4, 5(a) and 5(d) of Schedule 2, and
(ii)it complies with the requirements listed in sub-paragraphs (a)(ii) to (v) inclusive above.
(4) Any technical documentation or other information in relation to an assembly required to be retained under the conformity assessment procedure used shall be retained by the person specified in that respect in that conformity assessment procedure for any period specified in that procedure.
(5) In respect of an assembly to be placed on the market in the United Kingdom, where the requirements of paragraphs 3.3 and 3.4 of Schedule 2 are to be met, the marking, labelling, information and instructions shall be in English.
9.—(1) Subject to regulation 11, no person who is a responsible person shall place on the market or put into service any pressure equipment or assembly to which these Regulations apply below or equal to the limits in regulations 7(2)(a), (b) or (c) or regulation 8(2) unless the requirements of paragraph (2) below have been complied with in relation to it.
(2) The requirements referred to in paragraph (1) are that the pressure equipment or assembly—
(a)is designed and manufactured in accordance with sound engineering practice in order to ensure safe use;
(b)must be accompanied by adequate instructions for use;
(c)must bear markings to permit identification of the manufacturer or of his authorised representative established within the Community; and
(d)be safe.
(3) For the avoidance of doubt, pressure equipment or assemblies to which this regulation applies shall not bear the CE marking.
10. Subject to regulation 11, no person, who is not a responsible person, shall supply any pressure equipment or assembly unless that pressure equipment or assembly is safe.
11. For the purposes of regulation 7, 8, 9, or 10, pressure equipment or an assembly shall not be regarded as being placed on the market or supplied, as the case may be—
(a)where that pressure equipment or assembly—
(i)will be put into service in a country outside the Community; or
(ii)is imported into the Community for re-export to a country outside the Community,
save that this paragraph shall not apply if the CE marking, or any inscription liable to be confused therewith, is affixed thereto; or
(b)by the exhibition at trade fairs and exhibitions of that pressure equipment or an assembly, in respect of which the provisions of these Regulations are not satisfied, if—
(i)a notice is displayed in relation to the pressure equipment or assembly in question to the effect—
(aa)that it does not satisfy those provisions; and
(bb)that it may not be placed on the market or supplied until those provisions are satisfied by the manufacturer of pressure equipment or assembly or his authorised representative established within the Community; and
(ii)appropriate safety measures are taken when demonstrating such pressure equipment or assembly to ensure the safety of persons.
12.—(1) For the purposes of regulation 13, pressure equipment referred to in regulation 7(2) shall be classified by category in accordance with Schedule 3 according to ascending level of hazard.
(2) The appropriate table for pressure equipment coming within regulation 7(2)(a) to (c) inclusive shall be as follows:
for pressure equipment coming within,
regulation 7(2)(a)(i)(aa), table 1;
regulation 7(2)(a)(i)(bb), table 2;
regulation 7(2)(a)(ii)(aa), table 3;
regulation 7(2)(a)(ii)(bb), table 4;
regulation 7(2)(b), table 5;
regulation 7(2)(c)(i)(aa), table 6;
regulation 7(2)(c)(i)(bb), table 7;
regulation 7(2)(c)(ii)(aa), table 8; or
regulation 7(2)(c)(ii)(bb), table 9.
(3) For pressure equipment coming within regulation 7(2)(d), the category shall be determined in accordance with paragraphs 2 and 3 of Schedule 3.
(4) Where a vessel is composed of a number of chambers, it shall be classified in the highest category applicable to the individual chambers and where a chamber contains several fluids, classification shall be on the basis of the fluid which requires the highest category.
13.—(1) For the purposes of regulation 7(3)(b), the appropriate conformity assessment procedure for pressure equipment shall be one of the procedures set out in Schedule 4 as determined in accordance with paragraph (3).
(2) The manufacturer shall apply either,
(i)one of the conformity assessment procedures which may be chosen from among those laid down in paragraph (3) for the category in which the pressure equipment is classified, or
(ii)one of the procedures which apply to a higher category of pressure equipment, if available.
(3) The relevant conformity assessment procedures set out in Schedule 4 to be applied for the various categories of pressure equipment determined in accordance with regulation 12 above are as follows:
(i)for category I, module A;
(ii)for category II, any of the following modules:
A1,
D1, or
E1;
(iii)for category III, any of the following modules:
B1 plus D,
B1 plus F,
B plus E,
B plus C1, or
H;
(iv)for category IV, any of the following modules:
B plus D,
B plus F,
G, or
H1.
14. For the purposes of regulation 8(3)(a)(ii), the relevant conformity assessment procedure to be applied by the manufacturer in respect of the assembly shall be a global conformity assessment procedure comprising:
(a)assessment of each item of pressure equipment making up the assembly and referred to in regulation 7(2)(a) to (d) which has not been previously subjected to a conformity assessment procedure and to a separate CE marking; the assessment procedure shall be determined by the category of each item of equipment;
(b)the assessment of the integration of the various components of the assembly as referred to in paragraphs 2.3, 2.8 and 2.9 of Schedule 2 which shall be determined by the highest category applicable to the equipment concerned other than that applicable to any safety accessories;
(c)the assessment of the protection of an assembly against exceeding the permissible operating limits as referred to in paragraphs 2.10 and 3.2.3 of Schedule 2 shall be conducted in the light of the highest category applicable to the items of equipment to be protected.
15.—(1) Regulations 13 and 14 shall not apply to an item of pressure equipment or an assembly the use of which is in the interests of experimentation.
(2) For the purpose of this regulation “experimentation” means pressure equipment or an assembly designed or adapted for the purpose only of conducting any test or measurement in relation to that pressure equipment or assembly.
16.—(1) The CE marking shall be accompanied by the identification number of the notified body involved at the production control phase.
(2) Subject to paragraph (3), the CE marking shall be affixed in a visible, easily legible and indelible fashion to each item of pressure equipment referred to in regulation 7, or assembly referred to in regulation 8 which is complete or is in a state permitting final assessment as described in paragraph 3.2 of Schedule 2.
(3) It is not necessary for the CE marking to be affixed to each individual item of pressure equipment making up an assembly as referred to in regulation 8 but individual items of pressure equipment already bearing the CE marking when incorporated into the assembly shall continue to bear that marking.
(4) Subject to paragraph (5), where the pressure equipment or assembly is subject to other Directives covering other aspects which provide for the affixing of the CE marking, the latter shall indicate that the pressure equipment or assembly in question is also presumed to conform to the provisions of those other Directives.
(5) Where one or more of the other Directives referred to in paragraph (4) allow the manufacturer, during a transitional period, to choose which arrangements to apply, the CE marking shall indicate conformity only with the Directives applied by the manufacturer, and in this case, particulars of the Directives applied, as published in the Official Journal of the European Communities, must be given in the documents, notices or instructions required by the Directives and accompanying the pressure equipment or assembly.
(6) The affixing of markings on pressure equipment or an assembly which are likely to mislead third parties as to the meaning or form of the CE marking is prohibited.
(7) Any other marking may be affixed to pressure equipment or an assembly provided that the visibility and legibility of the CE marking is not thereby reduced.
17. European approval for materials shall be issued, at the request of one or more manufacturers of materials or equipment, by one of the notified bodies referred to in regulation 18 specifically designated for that task and in accordance with the procedures set out in Schedule 7.
18. For the purposes of these Regulations, a notified body is a body which has been appointed to carry out one or more of the conformity assessment procedures mentioned or referred to in regulation 13 or 14 or to issue a European approval for materials as referred to in regulation 17 and which has been—
(a)appointed as a notified body in the United Kingdom pursuant to regulation 20; or
(b)appointed by a member State other than the United Kingdom, and has been notified by the member State concerned to the Commission and the other member States pursuant to Article 12 of the Pressure Equipment Directive.
19. For the purposes of these Regulations, a recognised third-party organisation, is an organisation which has been appointed for the purposes of carrying out the tasks referred to in paragraphs 3.1.2(3) and 3.1.3 of Schedule 2, and which has been—
(a)appointed as a recognised third-party organisation in the United Kingdom pursuant to regulation 20; or
(b)appointed by a member State other than the United Kingdom, and has been notified by the member State concerned to the Commission and the other member States pursuant to Article 12 of the Pressure Equipment Directive.
20.—(1) The Secretary of State may from time to time appoint such persons as he thinks fit to be notified bodies or recognised third-party organisations for the purposes of these Regulations.
(2) An appointment—
(a)may relate to all descriptions of pressure equipment or assemblies or such descriptions (which may be framed by reference to any circumstances whatsoever) of pressure equipment or assemblies as the Secretary of State may from time to time determine;
(b)may be made subject to such conditions as the Secretary of State may from time to time determine, and such conditions may include conditions which are to apply upon or following termination of the appointment;
(c)shall, without prejudice to the generality of sub-paragraph (b) and subject to paragraph (4), require that body to carry out the procedures and specific tasks for which it has been appointed including (where so provided as part of those procedures) surveillance to ensure that the manufacturer of the pressure equipment or assemblies or his authorised representative established within the Community or the importer, as the case may be, duly fulfils the obligations arising out of the relevant conformity assessment procedure;
(d)shall be terminated upon 90 days' notice in writing to the Secretary of State at the request of the notified body or recognised third-party organisation; and
(e)may be terminated if it appears to the Secretary of State that any of the conditions of the appointment are not complied with.
(3) Subject to paragraphs (2)(d) and (e), an appointment under this regulation may be for the time being or for such period as may be specified in the appointment.
(4) A notified body or recognised third-party organisation appointed by the Secretary of State shall not be required to carry out the functions referred to in paragraph (2)(c) if—
(a)the documents submitted to it in relation to carrying out such functions are not in English or another language acceptable to that body;
(b)the person making the application has not submitted with his application the amount of the fee which the body requires to be submitted with the application pursuant to regulation 21; or
(c)the body reasonably believes that, having regard to the number of applications made to it in relation to its appointment under these Regulations which are outstanding, it will be unable to commence the required work within three months of receiving the application.
(5) If for any reason the appointment of a notified body or recognised third-party organisation is terminated under this regulation, the Secretary of State may—
(a)give such directions (either to the body the subject of the termination or to another notified body or recognised third-party organisation) for the purpose of making such arrangements for the determination of outstanding applications as he considers appropriate; and
(b)without prejudice to the generality of the foregoing, authorise another notified body or recognised third-party organisation to take over its functions in respect of such cases as he may specify.
(6) Where a notified body is minded to refuse to issue an EC type-examination certificate or EC design-examination certificate(4) it shall—
(a)give notice in writing to the applicant of the reasons why it is minded to do so; and
(b)give the applicant the opportunity to make representations within a period of 28 days of the said notice being given and consider any representations made within that period by the applicant.
(7) In the framework of quality assurance procedures for pressure equipment in categories III and IV referred to in regulations (2)(a)(i) and (ii)(aa) and (b) the notified body shall,
(a)when performing unexpected visits, take a sample of equipment from the manufacturing or storage premises in order to perform, or have performed, the final assessment as referred to in paragraph 3.2.2 of Schedule 2 and to this end, the manufacturer shall inform the notified body of the intended schedule of production, and
(b)shall carry out at least two visits during the first year of manufacturing, the frequency of subsequent visits being determined by the notified body on the basis of the criteria set out in section 4.4 of the relevant modules.
(8) In the case of one-off production of vessels and pressure equipment in category III referred to in regulation 7(2)(b) under the module H procedure, the notified body shall perform or have performed the final assessment, as referred to in paragraph 3.2.2 of Schedule 2, for each unit and to this end, the manufacturer shall communicate the intended schedule of production to the notified body.
21.—(1) Without prejudice to the power of the Secretary of State, where he is appointed as a notified body in the United Kingdom, to charge fees pursuant to regulations made under section 56 of the Finance Act 1973(5) and subject to paragraph (2), a notified body or recognised third-party organisation appointed by the Secretary of State may charge such fees in connection with, or incidental to, carrying out its duties in relation to the functions referred to in regulation 20(2)(c) as it may determine; provided that such fees shall not exceed the sum of the following—
(a)the costs incurred or to be incurred by the notified body or recognised third-party organisation in performing the relevant function; and
(b)an amount on account of profit which is reasonable in the circumstances having regard to—
(i)the character and extent of the work done or to be done by the body on behalf of the applicant; and
(ii)the commercial rate normally charged on account of profit for that work or similar work.
(2) The power in paragraph (1) includes the power to require the payment of fees or a reasonable estimate thereof in advance of carrying out the work requested by the applicant.
22.—(1) For the purposes of these Regulations, a user inspectorate is a body which has been appointed to carry out one or more of the conformity assessment procedures referred to in regulations 13 and 14 and as more specifically defined in paragraph (7) and, which has been—
(a)appointed in the United Kingdom pursuant to paragraph (2); or,
(b)appointed by a member State other than the United Kingdom, and has been notified by the member State concerned to the Commission and other member States pursuant to Article 12 of the Pressure Equipment Directive.
(2) The Secretary of State may from time to time appoint such persons and on such conditions as he thinks fit to be a user inspectorate.
(3) No body shall be appointed under this regulation unless the Secretary of State is satisfied that the group of which the user 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.
(4) An appointment—
(a)may relate to all descriptions of pressure equipment or assemblies or such descriptions (which may be framed by reference to any circumstances whatsoever) of pressure equipment or assemblies as the Secretary of State may from time to time determine;
(b)may be made subject to such conditions as the Secretary of State may from time to time determine, and such conditions may include conditions which are to apply upon or following termination of the appointment;
(c)shall, without prejudice to the generality of sub-paragraph (b) above, require that body, subject to paragraph (10), to carry out the procedures and specific tasks for which it has been appointed including (where so provided as part of those procedures) surveillance to ensure that the manufacturer of the pressure equipment or assemblies or his authorised representative established within the Community or the importer, as the case may be, duly fulfils the obligations arising out of the relevant conformity assessment procedure;
(d)shall be terminated upon 90 days' notice in writing to the Secretary of State at the request of the user inspectorate; and
(e)may be terminated if it appears to the Secretary of State that any of the conditions of the appointment are not complied with.
(5) Subject to paragraphs (4)(d) and (e), an appointment under this regulation may be for the time being or for such period as may be specified in the appointment.
(6) The user inspectorates shall act exclusively for the group of which they are part.
(7) The conformity assessment procedures applicable by user inspectorates shall be modules A1, C1, F and G, as described in Schedule 4 and for this purpose references in those modules to “notified body” shall be read as if they are references to “user inspectorate”.
(8) The pressure equipment and assemblies to which the application relates may be used only in establishments operated by the group of which the user inspectorate is part.
(9) The pressure equipment and assembly, the conformity of which has been assessed by a user inspectorate, shall not bear the CE marking.
(10) A user inspectorate appointed by the Secretary of State shall not be required to carry out the functions referred to in paragraph (4)(c) if the documents submitted to it in relation to carrying out such functions are not in English or another language acceptable to that body.
23.—(1) Subject to paragraph (2), any pressure equipment or assembly which—
(a)bears the CE marking in accordance with regulation 7(3)(c) or 8(3)(a)(iii); and
(b)is accompanied by an EC declaration of conformity in accordance with regulation 7(3)(d) or 8(3)(a)(iv),
shall be taken to conform with all the provisions of these Regulations which apply to it, including the appropriate conformity assessment procedure specified in regulation 13, unless there are reasonable grounds for suspecting that it does not so conform.
(2) Paragraph (1) does not apply in relation to an enforcement authority where a person fails or refuses to make available to the enforcement authority the documentation which he is required, by the conformity assessment procedure which applies to that pressure equipment or assembly, to retain a copy thereof.
Corrigendum to Directive 97/23/EC published at OJ No. L265, 27.9.97, p. 110.
Corrigendum to Directive 97/23/EC published at OJ No. L265, 27.9.97, p. 110.
There is an error in the English text of the Pressure Equipment Directive. The text uses “3.2.2” instead of “3.1.2”.
Module B and Module B1 in Schedule 4, respectively, concern the application for and issue of an EC type examination certificate and an EC design-examination certificate.