DIRECTIVE 97/23/EC OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL of 29 May 1997 on the approximation of the laws of the Member States concerning pressure equipment
THE EUROPEAN PARLIAMENT AND THE COUNCIL OF THE EUROPEAN UNION,
Having regard to the Treaty establishing the European Community, and in particular Article 100a thereof,
Having regard to the proposals from the Commission (1),
Having regard to the Opinion of the Economic and Social Committee (2),
Acting in accordance with the procedure laid down in Article 189b of the Treaty (3), in the light of the joint text approved by the Conciliation Committee on 4 February 1997,
1. Whereas the internal market is an area without internal frontiers in which the free movement of goods, persons, services and capital is ensured;
2. Whereas there are differences in the content and scope of the laws, regulations and administrative provisions in force in the Member States with regard to the safety and protection of health of persons and, where appropriate, domestic animals or property, where pressure equipment not covered by present Community legislation is concerned; whereas the certification and inspection procedures for such equipment differ from one Member State to another; whereas such disparities may well constitute barriers to trade within the Community;
3. Whereas the harmonization of national legislation is the only means of removing these barriers to free trade; whereas this objective cannot be achieved satisfactorily by the individual Member States; whereas this Directive only lays down indispensable requirements for the free circulation of the equipment to which it is applicable;
4. Whereas equipment subject to a pressure of not more than 0,5 bar does not pose a significant hazard due to pressure; whereas there should not therefore be any obstacle to its free movement within the Community; whereas this Directive applies to equipment subject to a maximum allowable pressure PS exceeding 0,5 bar;
5. Whereas this Directive relates also to assemblies composed of several pieces of pressure equipment assembled to constitute an integrated and functional whole; whereas these assemblies may range from simple assemblies such as pressure cookers to complex assemblies such as watertube boilers; whereas, if the manufacturer of an assembly intends it to be placed on the market and put into service as an assembly - and not in the form of its constituent non-assembled elements - that assembly must conform to this Directive; whereas, on the other hand, this Directive does not cover the assembly of pressure equipment on the site and under the responsibility of the user, as in the case of industrial installations;
6. Whereas this Directive harmonizes national provisions on hazards due to pressure; whereas the other hazards which this equipment may present accordingly may fall within the scope of other Directives dealing with such hazards; whereas, however, pressure equipment may be included among products covered by other Directives based on Article 100a of the Treaty; whereas the provisions laid down in some of those Directives deal with the hazard due to pressure; whereas those provisions are considered adequate to provide appropriate protection where the hazard due to pressure associated with such equipment remains small; whereas, therefore, there are grounds for excluding such equipment from the scope of this Directive;
7. Whereas, for pressure equipment covered by international Conventions, transport and pressure hazards are due to be dealt with as soon as possible by forthcoming Community Directives based on such Conventions or by supplements to existing Directives; whereas such equipment is accordingly excluded from the scope of this Directive;
8. Whereas certain types of pressure equipment, although subject to a maximum allowable pressure PS higher than 0,5 bar, do not present any significant hazard due to pressure, and therefore the freedom of movement of such equipment in the Community should not be hindered if it has been legally manufactured or placed on the market in a Member State; whereas it is not necessary in order to ensure free movement of such equipment to include it in the scope of this Directive; whereas consequently it is expressly excluded from its scope;
9. Whereas other pressure equipment subject to a maximum allowable pressure higher than 0,5 bar and presenting a significant hazard due to pressure, but in respect of which free movement and an appropriate level of safety are guaranteed, is excluded from the scope of this Directive; whereas such exclusions should, however, be regularly reviewed in order to ascertain whether it is necessary to take action at Union level;
10. Whereas regulations to remove technical barriers to trade must follow the new approach provided for in the Council Resolution of 7 May 1985 on a new approach to technical harmonization and standards (4), which requires a definition of the essential requirements regarding safety and other requirements of society without reducing existing, justified levels of protection within the Member States; whereas that Resolution provides that a very large number of products be covered by a single Directive in order to avoid frequent amendments and the proliferation of Directives;
11. Whereas the existing Community Directives on the approximation of the laws of the Member States relating to pressure equipment have made positive steps towards removing barriers to trade in this area; whereas those Directives cover that sector only to a minor extent; whereas Council Directive 87/404/EEC of 25 June 1987 on the harmonization of the laws of the Member States relating to simple pressure vessels (5) is the first case of application of the new approach to the sector of pressure equipment; whereas the present Directive will not apply to the area covered by Directive 87/404/EEC; whereas, no later than three years after the present Directive enters into force, a review will be carried out of the application of Directive 87/404/EEC in order to ascertain the need for the integration thereof into the present Directive;
12. Whereas the framework Directive, Council Directive 76/767/EEC of 27 July 1976 on the approximation of the laws of the Member States relating to common provisions for pressure vessels and methods for inspecting them (6) is optional; whereas it provides for a procedure for the bilateral recognition of testing and certification of pressure equipment which did not operate satisfactorily and which therefore must be replaced by effective Community measures;
13. Whereas the scope of this Directive must be based on a general definition of the term 'pressure equipment` so as to allow for the technical development of products;
14. Whereas compliance with the essential safety requirements is necessary in order to ensure the safety of pressure equipment; whereas those requirements have been subdivided into general and specific requirements which must be met by pressure equipment; whereas in particular the specific requirements are intended to take account of particular types of pressure equipment; whereas certain types of pressure equipment in categories III and IV must be subject to a final assessment comprising final inspection and proof tests;
15. Whereas Member States should be in a position to allow the showing at trade fairs of pressure equipment which is not yet in conformity with the requirements of this Directive; whereas, during demonstrations, appropriate safety measures must be taken in accordance with the general safety rules of the Member State concerned to ensure the safety of persons;
16. Whereas in order to ease the task of demonstrating compliance with the essential requirements, standards harmonized at European level are useful, especially with regard to the design, manufacture and testing of pressure equipment, compliance with which enables a product to be presumed to meet the said essential requirements; whereas standards harmonized at European level are drawn up by private bodies and must retain their non-mandatory status; whereas, for this purpose, the European Committee for Standardization (CEN) and the European Committee for Electrotechnical Standardization (Cenelec) are recognized as being the bodies that are competent to adopt harmonized standards that follow the general guidelines for cooperation between the Commission and those two bodies signed on 13 November 1984;
17. Whereas, for the purposes of this Directive, a harmonized standard is a technical specification (European standard or harmonization document) adopted by one or other of those bodies, or by both, at the request of the Commission pursuant to Council Directive 83/189/EEC of 28 March 1983 laying down a procedure for the provision of information in the field of technical standards and regulations (7) and in accordance with the general guidelines referred to above; whereas, in relation to standardization, it would be advisable for the Commission to be assisted by the Committee set up pursuant to Directive 83/189/EEC; whereas the Committee will, if necessary, consult technical experts;
18. Whereas manufacturing of pressure equipment calls for the utilization of safe materials; whereas in the absence of harmonized standards it is useful to define the characteristics of the materials intended for repeated use; whereas this definition is established by European approvals for materials, such approvals being issued by one of the notified bodies specifically designated for that task; whereas the materials conforming to the European approvals shall be presumed to satisfy the essential requirements of this Directive;
19. Whereas, in view of the nature of the hazards involved in the use of pressure equipment it is necessary to establish procedures for assessing compliance with the basic requirements of the Directives; whereas these procedures must be devised in the light of the level of danger which is inherent in the pressure equipment; whereas, therefore, for each category of pressure equipment there must be an adequate procedure or a choice between different procedures of equivalent stringency; whereas the procedures adopted are as required by Council Decision 93/465/EEC of 22 July 1993 concerning the modules for the various phases of the conformity assessment procedures and the rules for the affixing and use of the CE conformity marking, which are intended to be used in the technical harmonization Directives (8); whereas the details added to these procedures are justified by the nature of the verification required for pressure equipment;
20. Whereas Member States should be in a position to authorize user inspectorates to carry out certain tasks for conformity assessment in the framework of this Directive; whereas for that purpose this Directive sets out criteria for the authorization of user inspectorates by Member States;
21. Whereas, under the conditions laid down by this Directive, certain procedures for conformity assessment may require each item to be inspected and tested by a notified body or a user inspectorate as part of the final assessment of the pressure equipment; whereas in other cases provision should be made to ensure that the final assessment may be monitored by a notified body by means of unexpected visits;
22. Whereas pressure equipment will, as a general rule, bear the CE marking affixed either by the manufacturer or by his authorized representative established within the Community; whereas the CE marking means that the pressure equipment complies with the provisions of this Directive and those of other applicable Community directives on CE marking; whereas for pressure equipment defined in this Directive which presents only a minor pressure hazard and for which certification procedures are therefore not justified, the CE marking will not be affixed;
23. Whereas it is appropriate that the Member States, as provided for by Article 100a of the Treaty, may take provisional measures to limit or prohibit the placing on the market, putting into service and use of pressure equipment in cases where it presents a particular risk to the safety of persons and, where appropriate, domestic animals or property, provided that the measures are subject to a Community control procedure;
24. Whereas the addressees of any decision taken under this Directive must be aware of the reasons behind that decision and the means of appeal open to them;
25. Whereas it is necessary to lay down a transitional arrangement enabling pressure equipment manufactured in compliance with the national regulations in force on the date of entry into force of this Directive to be marketed and put into service;
26. Whereas the requirements laid down in the Annexes should be made as clear as possible so as to allow all users, including small and medium-sized enterprises (SMEs), to comply with them easily;
27. Whereas an agreement on a modus vivendi between the European Parliament, the Council and the Commission concerning the implementing measures for acts adopted in accordance with the procedure laid down in Article 189b of the Treaty was reached on 20 December 1994 (9),
HAVE ADOPTED THIS DIRECTIVE:
Article 1 Scope and definitions
1. This Directive applies to the design, manufacture and conformity assessment of pressure equipment and assemblies with a maximum allowable pressure PS greater than 0,5 bar.
2. For the purposes of this Directive:
2.1. 'Pressure equipment` means vessels, piping, safety accessories and pressure accessories.
Where applicable, pressure equipment includes elements attached to pressurized parts, such as flanges, nozzles, couplings, supports, lifting lugs, etc.
2.1.1. '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. A vessel may be composed of more than one chamber.
2.1.2. 'Piping` means piping components intended for the transport of fluids, when connected together for integration into a pressure system. Piping 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.
2.1.3. 'Safety accessories` means devices designed to protect pressure equipment against the allowable limits being exceeded. Such devices include:
- 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.
2.1.4. 'Pressure accessories` means devices with an operational function and having pressure-bearing housings.
2.1.5. 'Assemblies` means several pieces of pressure equipment assembled by a manufacturer to constitute an integrated and functional whole.
2.2. 'Pressure` means pressure relative to atmospheric pressure, i.e. gauge pressure. As a consequence, vacuum is designated by a negative value.
2.3. 'Maximum allowable pressure PS` means the maximum pressure for which the equipment is designed, as specified by the manufacturer.
It is defined at a location specified by the manufacturer. This must be the location of connection of protective and/or limiting devices or the top of equipment or if not appropriate any point specified.
2.4. 'Maximum/minimum allowable temperature TS` means the maximum/minimum temperatures for which the equipment is designed, as specified by the manufacturer.
2.5. '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.
2.6. '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.
2.7. 'Fluids` means gases, liquids and vapours in pure phase as well as mixtures thereof. A fluid may contain a suspension of solids.
2.8. 'Permanent joints` means joints which cannot be disconnected except by destructive methods.
2.9. '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 harmonized standard.
3. The following are excluded from the scope of this Directive:
3.1. pipelines comprising piping or a system of piping designed for the conveyance of any fluid or substance to or from an installation (onshore or offshore) starting from and including the last isolation device located within the confines of the installation, including all the annexed equipment designed specifically for pipelines. This exclusion does not apply to standard pressure equipment such as may be found in pressure reduction stations or compression stations;
3.2. networks for the supply, distribution and discharge of water and associated equipment and headraces such as penstocks, pressure tunnels, pressure shafts for hydroelectric installations and their related specific accessories;
3.3. equipment covered by Directive 87/404/EEC on simple pressure vessels;
3.4. equipment covered by Council Directive 75/324/EEC of 20 May 1975 on the approximation of the laws of the Member States relating to aerosol dispensers (10);
3.5. equipment intended for the functioning of vehicles defined by the following Directives and their Annexes:
- Council Directive 70/156/EEC of 6 February 1970 on the approximation of the laws of the Member States relating to the type-approval of motor vehicles and their trailers (11),
- Council Directive 74/150/EEC of 4 March 1974 on the approximation of the laws of the Member States relating to the type-approval of wheeled agricultural or forestry tractors (12),
- Council Directive 92/61/EEC of 30 June 1992 relating to the type-approval of two or three-wheel motor vehicles (13);
3.6. equipment classified as no higher than category I under Article 9 of this Directive and covered by one of the following Directives:
- Council Directive 89/392/EEC of 14 June 1989 on the approximation of the laws of the Member States relating to machinery (14),
- European Parliament and Council Directive 95/16/EC of 29 June 1995 on the approximation of the laws of the Member States relating to lifts (15),
- Council Directive 73/23/EEC of 19 February 1973 on the harmonization of the laws of the Member States relating to electrical equipment designed for use within certain voltage limits (16),
- Council Directive 93/42/EEC of 14 June 1993 concerning medical devices (17),
- Council Directive 90/396/EEC of 29 June 1990 on the approximation of the laws of the Member States relating to appliances burning gaseous fuels (18),
- Directive 94/9/EC of the European Parliament and the Council of 23 March 1994 on the approximation of the laws of the Member States concerning equipment and protective systems intended for use in potentially explosive atmospheres (19);
3.7. equipment covered by Article 223 (1) (b) of the Treaty;
3.8. items specifically designed for nuclear use, failure of which may cause an emission of radioactivity;
3.9. well-control equipment used in the petroleum, gas or geothermal exploration and extraction industry and in underground storage which is intended to contain and/or control well pressure. This comprises the wellhead (Christmas tree), the blow out preventers (BOP), the piping manifolds and all their equipment upstream;
3.10. equipment comprising casings or machinery where the dimensioning, choice of material and manufacturing rules are based primarily on requirements for sufficient strength, rigidity and stability to meet the static and dynamic operational effects or other operational characteristics and for which pressure is not a significant design factor. Such equipment may include:
- engines including turbines and internal combustion engines,
- steam engines, gas/steam turbines, turbo-generators, compressors, pumps and actuating devices;
3.11. blast furnaces including the furnace cooling system, hot-blast recuperators, dust extractors and blast-furnace exhaust-gas scrubbers and direct reducing cupolas, including the furnace cooling, gas converters and pans for melting, re-melting, de-gassing and casting of steel and non-ferrous metals;
3.12. enclosures for high-voltage electrical equipment such as switchgear, control gear, transformers, and rotating machines;
3.13. pressurized pipes for the containment of transmission systems, e.g. for electrical power and telephone cables;
3.14. ships, rockets, aircraft and mobile off-shore units, as well as equipment specifically intended for installation on board or the propulsion thereof;
3.15. pressure equipment consisting of a flexible casing, e.g. tyres, air cushions, balls used for play, inflatable craft, and other similar pressure equipment;
3.16. exhaust and inlet silencers;
3.17. bottles or cans for carbonated drinks for final consumption;
3.18. vessels designed for the transport and distribution of drinks having a PS 7V of not more than 500 bar 7L and a maximum allowable pressure not exceeding 7 bar;
3.19. equipment covered by the ADR (20), the RID (21), the IMDG (22) and the ICAO Convention (23);
3.20. radiators and pipes in warm water heating systems;
3.21. vessels designed to contain liquids with a gas pressure above the liquid of not more than 0,5 bar.
Article 2 Market surveillance
1. Member States shall take all appropriate measures to ensure that the pressure equipment and the assemblies referred to in Article 1 may be placed on the market and put into serive only if, when properly installed and maintained and used for their intended purpose, they do not endanger the health and safety of persons and, where appropriate, domestic animals or property.
2. The provisions of this Directive shall not affect Member States' entitlement to lay down, with due regard to the provisions of the Treaty, such requirements as they may deem necessary to ensure that persons and, in particular, workers are protected during use of the pressure equipment or assemblies in question provided that this does not mean modifications to such equipment or assemblies in a way not specified in this Directive.
3. At trade fairs, exhibitions, demonstrations, etc., Member States shall not prevent the showing of pressure equipment or assemblies as defined in Article 1 not in conformity with the provisions of this Directive, provided that a visible sign clearly indicates their non-conformity and their non-availability for sale until brought into conformity by the manufacturer or by his authorized representative established within the Community. During demonstrations, appropriate safety measures shall be taken in accordance with any requirements laid down by the competent authority of the Member State concerned in order to ensure the safety of persons.
Article 3 Technical requirements
1. The pressure equipment referred to in 1.1, 1.2, 1.3 and 1.4 must satisfy the essential requirements set out in Annex I:
1.1. Vessels, except those referred to in 1.2 for:
(a) 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:
- for fluids in Group 1 with a volume greater than 1 L and a product of PS and V greater than 25 bar 7L, or with a pressure PS greater than 200 bar (Annex II, table 1),
- for fluids in Group 2, with a volume greater than 1 L and a product of PS and V is greater than 50 bar 7L, or with a pressure PS greater than 1 000 bar, and all portable extinguishers and bottles for breathing apparatus (Annex II, table 2);
(b) 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:
- for fluids in Group 1 with a volume greater than 1 L and a product of PS and V greater than 200 bar 7L, or with a pressure PS greater than 500 bar (Annex II, table 3),
- 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 7L, or with a pressure PS greater than 1 000 bar (Annex II, table 4).
1.2. Fired or otherwise heated pressure equipment with the risk of overheating intended for generation of steam or super-heated water at temperatures higher than 100 °C having a volume greater than 2L, and all pressure cookers (Annex II, table 5).
1.3. Piping intended for:
(a) gases, liquified 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:
- for fluids in Group 1 with a DN greater than 25 (Annex II, table 6),
- for fluids in Group 2 with a DN greater than 32 and a product of PS and DN greater than 1 000 bar (Annex II, table 7);
(b) 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:
- for fluids in Group 1 with a DN greater than 25 and a product of PS and DN greater than 2 000 bar (Annex II, table 8),
- 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 (Annex II, table 9).
1.4. Safety and pressure accessories intended for equipment covered by 1.1, 1.2 and 1.3 including where such equipment is incorporated into an assembly.
2. The assemblies defined in Article 1, section 2.1.5, which include at least one item of pressure equipment covered by section 1 of this Article and which are listed in 2.1, 2.2 and 2.3 of this Article must satisfy the essential requirements set out in Annex I.
2.1. Assemblies intended for generating steam or superheated water at a temperature higher than 100 °C comprising at least one item of fired or otherwise heated pressure equipment presenting a risk of overheating.
2.2. Assemblies other than those referred to in 2.1, if the manufacturer intends them to be placed on the market and put into service as assemblies.
2.3. By way of derogation from the introductory paragraph to this section, assemblies intended for generating warm water at temperatures not greater than 110 °C which are manually fed with solid fuels and have a PS 7V greater than 50 bar 7L must comply with the essential requirements referred to in 2.10, 2.11, 3.4, 5 (a) and 5 (d) of Annex I.
3. Pressure equipment and/or assemblies below or equal to the limits in sections 1.1, 1.2 and 1.3 and section 2 respectively must be designed and manufactured in accordance with the sound engineering practice of a Member State in order to ensure safe use. Pressure equipment and/or assemblies must be accompanied by adequate instructions for use and must bear markings to permit identification of the manufacturer or of his authorized representative established within the Community. Such equipment and/or assemblies must not bear the CE marking referred to in Article 15.
Article 4 Free movement
1.1. Member States shall not, on grounds of the hazards due to pressure, prohibit, restrict or impede the placing on the market or putting into service under the conditions specified by the manufacturer of pressure equipment or assemblies referred to in Article 1 which comply with this Directive and bear the CE marking indicating that they have undergone conformity assessment in accordance with Article 10.
1.2. Member States shall not, on grounds of the hazards due to pressure, prohibit, restrict or impede the placing on the market or putting into service of pressure equipment or assemblies which comply with Article 3 (3).
2. Member States may require, to the extent that it is needed for safe and correct use of pressure equipment and assemblies, the information referred to in Annex I sections 3.3 and 3.4 to be provided in the official language(s) of the Community which may be determined in accordance with the Treaty by the Member State in which the equipment or assembly reaches the final user.
Article 5 Presumption of conformity
1. Member States shall regard pressure equipment and assemblies bearing the CE marking provided for in Article 15 and the EC declaration of conformity provided for in Annex VII as conforming to all the provisions of this Directive, including the conformity assessment provided for in Article 10.
2. Pressure equipment and assemblies which conform to the national standards transposing the harmonized standards the reference numbers of which have been published in the Official Journal of the European Communities shall be presumed to conform to the essential requirements referred to in Article 3. Member States shall publish the reference numbers of the national standards referred to above.
3. Member States shall ensure that appropriate measures are taken to enable both sides of industry to have an input at national level in the process of preparing and monitoring the harmonized standards.
Article 6 Committee on technical standards and regulations
Where a Member State or the Commission considers that the standards referred to in Article 5 (2) do not entirely meet the essential requirements referred to in Article 3, the Member State concerned or the Commission shall inform the Standing Committee set up by Article 5 of Directive 83/189/EEC giving the reasons therefor. The Committee shall issue an opinion as a matter of urgency.
Taking into account the Committee's opinion, the Commission shall notify the Member States as to whether or not those standards should be withdrawn from the publications referred to in Article 5 (2).
Article 7 Committee on Pressure Equipment
1. The Commission may take any appropriate measure to implement the following provisions:
Where a Member State considers that, for very serious safety reasons,
- an item or family of pressure equipment referred to in Article 3 (3) should be subject to the requirements of Article 3 (1), or
- an assembly or family of assemblies referred to in Article 3 (3) should be subject to the requirements of Article 3 (2), or
- an item or family of pressure equipment should be classified, by way of derogation from the requirements of Annex II, in another category,
it shall submit a duly substantiated request to the Commission and ask it to take the necessary measures. Those measures shall be adopted in accordance with the procedure laid down in paragraph 3.
2. The Commission shall be assisted by a Standing Committee, hereafter referred to as 'the Committee`, composed of representatives appointed by the Member States and chaired by a representative of the Commission.
The Committee shall draw up its own rules of procedure.
3. The representative of the Commission shall submit to the Committee a draft of the measures to be taken pursuant to paragraph 1. The Committee shall deliver its opinion on the draft, within a time limit which the chairman may lay down according to the urgency of the matter, if necessary by taking a vote.
The opinion shall be record in the minutes; in addition, each Member State shall have the right to ask to have its position recorded in the minutes.
The Commission shall take the utmost account of the opinion delivered by the Committee. It shall inform the Committee of the manner in which its opinion has been taken into account.
4. The Committee may furthermore examine any other matter relating to the implementation and practical application of this Directive and raised by its chairman either on his own initiative or at the request of a Member State.
Article 8 Safeguard clause
1. Where a Member State ascertains that pressure equipment or assemblies referred to in Article 1, bearing the CE marking and used in accordance with their intended use are liable to endanger the safety of persons and, where appropriate, domestic animals or property, it shall take all appropriate measures to withdraw such equipment or assemblies from the market, prohibit the placing on the market, putting into service or use thereof, or restrict free movement thereof.
The Member State shall immediately inform the Commission of any such measure, indicating the reasons for its decision and, in particular, whether non-conformity is due to:
(a) failure to satisfy the essential requirements referred to in Article 3;
(b) incorrect application of the standards referred to in Article 5 (2);
(c) shortcomings in the standards referred to in Article 5 (2);
(d) shortcomings in the European approval of pressure equipment materials as referred to in Article 11.
2. The Commission shall enter into consultation with the parties concerned without delay. Where the Commission considers, after this consultation, that the measure is justified, it shall immediately so inform the Member State which took the initiative and the other Member States.
Where the Commission considers, after this consultation, that the measure is unjustified, it shall immediately so inform the Member State which took the initiative and the manufacturer, or his authorized representative established within the Community. Where the decision referred to in paragraph 1 is based on a shortcoming in the standards or in European approvals for materials and where the Member State at the origin of the decision maintains its position the Commission shall immediately inform the Committee referred to in Article 6 in order to initiate the procedure referred to in the first paragraph of Article 6.
3. Where pressure equipment or an assembly which does not comply bears the CE marking, the competent Member State shall take appropriate action against the person(s) having affixed the CE marking and shall so inform the Commission and the other Member States.
4. The Commission shall ensure that the Member Sates are kept informed of the progress and outcome of this procedure.
Article 9 Classification of pressure equipment
1. Pressure equipment referred to in Article 3 (1) shall be classified by category in accordance with Annex II, according to ascending level of hazard.
For the purposes of such classification fluids shall be divided into two groups in accordance with 2.1 and 2.2.
2.1. Group 1 comprises dangerous fluids. A dangerous fluid is a substance or preparation covered by the definitions in Article 2 (2) of Council Directive 67/548/EEC of 27 June 1967 on the approximation of the laws, regulations and administrative provisions relating to the classification, packaging and labelling of dangerous substances (24).
Group 1 comprises fluids defined as:
- explosive,
- extremely flammable,
- highly flammable,
- flammable (where the maximum allowable temperature is above flashpoint),
- very toxic,
- toxic,
- oxidizing.
2.2. Group 2 comprises all other fluids not referred to in 2.1.
3. Where a vessel is composed of a number of chambers, it shall be classified in the highest category applicable to the individual chambers. Where a chamber contains several fluids, classification shall be on the basis of the fluid which requires the highest category.
Article 10 Conformity assessment
1.1. Before placing pressure equipment on the market, the manufacturer shall subject each item of equipment to one of the conformity assessment procedures described in Annex III, according to the conditions given in this Article.
1.2. The conformity assessment procedures to be applied to an item of pressure equipment with a view to affixing the CE marking shall be determined by the category, as defined in Article 9, in which the equipment is classified.
1.3. The conformity assessment procedures to be applied for the various categories are as follows:
- category I
Module A
- category II
Module A1
Module D1
Module E1
- category III
Module B1 + D
Module B1 + F
Module B + E
Module B + C1
Module H
- category IV
Module B + D
Module B + F
Module G
Module H1
1.4. Pressure equipment shall be subjected to one of the conformity assessment procedures which may be chosen by the manufacturer among those laid down for the category in which it is classified. The manufacturer may also choose to apply one of the procedures which apply to a higher category, if available.
1.5. In the framework of quality assurance procedures for equipment in categories III and IV referred to in Article 3, section 1.1 (a), section 1.1 (b) first indent and section 1.2, the notified body shall, 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 Annex I, section 3.2.2. To this end, the manufacturer shall inform the notified body of the intended schedule of production. The notified body shall carry out at least two visits during the first year of manufacturing. The frequency of subsequent visits shall be determined by the notified body on the basis of the criteria set out in section 4.4 of the relevant modules.
1.6. In the case of one-off production of vessels and equipment in Category III referred to in Article 3, section 1.2 under the module H procedure, the notified body shall perform or have performed the final assessment, as referred to in Annex I, section 3.2.2, for each unit. To this end, the manufacturer shall communicate the intended schedule of production to the notified body.
2. Assemblies referred to in Article 3 (2) shall be subjected to a global conformity assessment procedure comprising:
(a) assessment of each item of pressure equipment making up the assembly and referred to in Article 3 (1) 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 sections 2.3, 2.8 and 2.9 of Annex I 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 sections 2.10 and 3.2.3 of Annex I shall be conducted in the light of the highest category applicable to the items of equipment to be protected.
3. By way of derogation from paragraphs 1 and 2, the competent authorities may, where justified, allow the placing on the market and putting into service in the territory of the Member State concerned of individual pressure equipment items and assemblies referred to in Article 1 (2), in respect of which the procedures referred to in paragraphs 1 and 2 of this Article have not been applied and the use of which is in the interests of experimentation.
4. Records and correspondence relating to conformity assessment shall be drawn up in the official language(s) of the Community which may be determined in accordance with the Treaty by the Member State where the body responsible for carrying out these procedures is established, or in a language accepted by that body.
Article 11 European approval for materials
1. European approval for materials, as defined in Article 1, section 2.9, shall be issued at the request of one or more manufacturers of materials or equipment, by one of the notified bodies referred to in Article 12 specifically designated for that task. The notified body shall determine and perform, or arrange for the performance of, the appropriate inspections and tests to certify the conformity of the types of material with the corresponding requirements of this Directive; in the case of materials recognized as being safe to use before 29 November 1999, the notified body shall take account of the existing data when certifying such conformity.
2. Before issuing European approval for materials, the notified body shall inform the Member States and the Commission by sending them the appropriate information. Within three months, a Member State or the Commission may refer the matter to the Standing Committee set up by Article 5 of Directive 83/189/EEC, giving its reasons. In that case, the Committee shall issue an opinion as a matter of urgency.
The notified body shall issue the European approval for materials taking into account, where appropriate, the opinion of the Committee and the comments submitted.
3. A copy of the European approval for pressure equipment materials shall be sent to the Member States, the notified bodies and the Commission. The Commission shall publish and keep up to date a list of European approvals for materials in the Official Journal of the European Communities.
4. The materials used for the manufacture of pressure equipment conforming with European approvals for materials, the references of which have been published in the Official Journal of the European Communities, shall be presumed to conform to the applicable essential requirements of Annex I.
5. The notified body which issued the European approval for pressure equipment materials shall withdraw that approval if it finds that it should not have been issued for if the type of materials is covered by a harmonized standard. It shall immediately inform the other Member States, the notified bodies and the Commission of any withdrawal of an approval.
Article 12 Notified bodies
1. Member States shall notify the Commission and the other Member States of the bodies which they have appointed to carry out the procedures referred to in Article 10 and Article 11, together with the specific tasks which those bodies have been appointed to carry out and the identification numbers assigned to them beforehand by the Commission.
The Commission shall publish in the Official Journal of the European Communities a list of the notified bodies, with their identification numbers and the tasks for which they have been notified. The Commission shall ensure that this list is kept up to date.
2. Member States shall apply the criteria set out in Annex IV for the designation of bodies. Bodies meeting the criteria laid down in the relevant harmonized standards shall be presumed to fulfil the corresponding criteria in Annex IV.
3. A Member State which has notified a body must withdraw such notification if it finds that the body no longer meets the criteria referred to in paragraph 2.
It shall forthwith inform the other Member States and the Commission of any such withdrawal of a notification.
Article 13 Recognized third-party organizations
1. Member States shall notify the Commission and the other Member States of the third-party organizations which they have recognized for the purposes of the tasks referred to in Annex I, sections 3.2.2 and 3.1.3.
The Commission shall publish in the Official Journal of the European Communities a list of the recognized organizations with the tasks for which they have been recognized. The Commission shall ensure that this list is kept up to date.
2. Member States shall apply the criteria set out in Annex IV for the recognition of organizations. Organizations meeting the criteria laid down in the relevant harmonized standards shall be presumed to fulfil the corresponding criteria in Annex IV.
3. A Member State which has recognized an organization must withdraw such recognition if it finds that the organization no longer meets the criteria referred to in paragraph 2.
It shall forthwith inform the other Member States and the Commission of any such withdrawal of a recognition.
Article 14 User inspectorates
1. By way of derogation from the provisions relating to the tasks carried out by the notified bodies, Member States may authorize in their territory the placing on the market, and the putting into service by users, of pressure equipment or assemblies referred to in Article 1 of which conformity with the essential requirements has been assessed by a user inspectorate designated in accordance with the criteria referred to in paragraph 8.
2. When a Member State has designated a user inspectorate in accordance with the criteria set out in this Article, it may not, on grounds of the hazards due to pressure, prohibit, restrict or impede the placing on the market or putting into service under the conditions provided for in this Article of pressure equipment or assemblies the conformity of which has been assessed by a user inspectorate designated by another Member State in accordance with the criteria set out in this Article.
3. Pressure equipment and assemblies the conformity of which has been assessed by a user inspectorate shall not bear the CE marking.
4. The pressure equipment and assemblies referred to may be used only in establishments operated by the group of which the inspectorate is part. The 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. The user inspectorates shall act exclusively for the group of which they are part.
6. The conformity assessment procedures applicable by user inspectorates shall be modules A1, C1, F and G, as described in Annex III.
7. Member States shall inform the other Member States and the Commission which user inspectorates they have authorized, the tasks for which they have been designated and, for each inspectorate, a list of the establishments satisfying the provisions of paragraph 4.
8. In designating the user inspectorates, the Member States shall apply the criteria listed in Annex V and ensure that the group of which the inspectorate is part applies the criteria referred to in the second sentence of paragraph 4.
9. A Member State that has authorized a user inspectorate shall withdraw that authorization if it finds that the user inspectorate no longer meets the criteria referred to in paragraph 8. It shall inform the other Member States and the Commission thereof.
10. The effects of this Article shall be monitored by the Commission and evaluated three years after the date specified in Article 20 (3). To this end, Member States shall forward to the Commission any useful information on the implementation of this Article. If necessary the evaluation shall be accompanied by a proposal for amendment of the Directive.
Article 15 CE marking
1. The CE marking consists of the initials 'CE` in accordance with the model in Annex VI.
The CE marking shall be accompanied by the identification number, as referred to in Article 12 (1), of the notified body involved at the production control phase.
2. The CE marking shall be affixed in a visible, easily legible and indelible fashion to each
- item of pressure equipment referred to in Article 3 (1), or
- assembly referred to in Article 3 (2)
which is complete or is in a state permitting final assessment as described in section 3.2 of Annex I.
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 Article 3 (2). Individual items of pressure equipment already bearing the CE marking when incorporated into the assembly shall continue to bear that marking.
4. 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.
However, should one or more of those Directives 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. In this case, the particulars of the said Directives, 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.
5. The affixing of markings on pressure equipment or assemblies which are likely to mislead third parties as to the meaning or form of the CE marking shall be prohibited. Any other marking may be affixed to pressure equipment or assemblies provided that the visibility and legibility of the CE marking is not thereby reduced.
Article 16 Unduly affixed CE marking
Without prejudice to Article 8:
(a) where a Member State establishes that the CE marking has been affixed unduly, the manufacturer, or his authorized representative established within the Community, shall be obliged to make the product conform as regards the provisions concerning the CE marking and to end the infringement under the conditions imposed by the Member State;
(b) should non-conformity persist, the Member State must take all appropriate measures to restrict or prohibit the placing on the market of the product in question or to ensure that it is withdrawn from the market in accordance with the procedures laid down in Article 8.
Article 17
Member States shall take appropriate measures in order to encourage the authorities responsible for implementing this Directive to cooperate with each other and provide each other and the Commission with information in order to assist the functioning of this Directive.
Article 18 Decisions entailing refusal or restriction
Any decision taken pursuant to this Directive which restricts the placing on the market and the putting into service or requires the withdrawal from the market of pressure equipment or assemblies shall state the exact grounds on which it is based. Such decision shall be notified forthwith to the party concerned, who shall at the same time be informed of the legal remedies available to him under the laws in force in the Member State concerned and of the time limits to which such remedies are subject.
Article 19 Repeal
Article 22 of Directive 76/767/EEC shall cease to apply as from 29 November 1999 in respect of pressure equipment and assemblies covered by this Directive.
Article 20 Transposition and transitional provisions
1. Before 29 May 1999 Member States shall adopt and publish the laws, regulations and administrative provisions necessary to comply with this Directive. They shall forthwith inform the Commission thereof.
When Member States adopt the measures referred to in the first subparagraph, they shall contain a reference to this Directive or shall be accompanied by such reference on the occasion of their official publication. The methods of making such reference shall be laid down by Member States.
Member States shall apply such provisions as from 29 November 1999.
2. Member States shall communicate to the Commission the texts of the provisions of national law which they adopt in the field governed by this Directive.
3. Member States must permit the placing on the market of pressure equipment and assemblies which comply with the regulations in force in their territory at the date of application of this Directive until 29 May 2002, and permit such equipment and assemblies to be put into service beyond that date.
Article 21 Addressees of the Directive
This Directive is addressed to the Member States.
Done at Brussels, 29 May 1997.