DIRECTIVE 2014/68/EU OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL
of 15 May 2014
on the harmonisation of the laws of the Member States relating to the making available on the
market of pressure equipment
(recast)
(Text with EEA relevance)
THE EUROPEAN PARLIAMENT AND THE COUNCIL OF THE EUROPEAN UNION,
Having regard to the Treaty on the Functioning of the European Union, and in particular Article 114 thereof, Having regard to the proposal from the European Commission,
After transmission of the draft legislative act to the national parliaments,
sky angleHaving regard to the opinion of the European Economic and Social Committee (1),
Acting in accordance with the ordinary legislative procedure (2),
Whereas:
(1)Directive 97/23/EC of the European Parliament and of the Council (3) has been substantially amended (4). Since
further amendments are to be made, that Directive should be recast in the interests of clarity.
(2)Regulation (EC) No 765/2008 of the European Parliament and of the Council (5) lays down rules on the accredi
tation of conformity asssment bodies, provides a framework for the market surveillance of products and for controls on products from third countries, and lays down the general principles of the CE marking.
(3)Decision No 768/2008/EC of the European Parliament and of the Council (6) lays down common principles and
reference provisions intended to apply across ctoral legislation in order to provide a coherent basis for revision or recasts of that legislation. Directive 97/23/EC should therefore be adapted to that Decision.
(4)This Directive covers pressure equipment and asmblies which are new to the Union market when they are placed
on the market; that is to say they are either new pressure equipment or asmblies made by a manufacturer established in the Union or pressure equipment or asmblies, whether new or cond-hand, imported from a third country.
(5)This Directive should apply to all forms of supply, including distance lling.
(1) OJ C 67, 6.3.2014, p. 101.
(2) Position of the European Parliament of 15 April 2014 (not yet published in the Official Journal) and decision of the Council of
13 May 2014.
(3) 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 (OJ L 181, 9.7.1997, p. 1).
(4) See Annex V, Part A.
(5) Regulation (EC) No 765/2008 of the European Parliament and of the Council of 9 July 2008 tting out the requirements for
accreditation and market surveillance relating to the marketing of products and repealing Regulation (EEC) No 339/93 (OJ L 218,
13.8.2008, p. 30).
(6) Decision No 768/2008/EC of the European Parliament and of the Council of 9 July 2008 on a common framework for the
marketing of products and repealing Council Decision 93/465/EEC (OJ L 218, 13.8.2008, p. 82).
(6)This Directive should apply to pressure equipment subject to a maximum allowable pressure PS greater than 0,5
bar. Pressure equipment subject to a pressure of not more than 0,5 bar does not po a significant risk due to pressure. Therefore, there should not be any obstacle to its free movement within the Union.
(7)This Directive should also apply to asmblies compod of veral pieces of pressure equipment asmbled to
constitute an integrated and functional whole. Tho asmblies may range from simple asmblies such as pressure cookers to complex asmblies such as water tube boilers. If the manufacturer of an asmbly intends to place it on the market and put it into rvice as an asmbly —and not in the form of its constituent non- asmbled elements —that asmbly should comply with this Directive. However, this Directive should not apply to the asmbly of pressure equipment on the site and under the responsibility of a ur who is not the manu facturer, as in the ca of industrial installations.
(8)This Directive should harmoni national provisions on risks due to pressure. The other risks which this equipment
may prent may fall within the scope of other Directives dealing with tho risks.
(9)However, some pressure equipment is covered by other Directives bad on Article 114 of the Treaty on the
Functioning of the European Union (TFEU). The provisions laid down in some of tho Directives deal also with the risk due to pressure. Tho Directives are considered adequate to provide appropriate protection where the risk due to pressure associated with such equipment remains small. Therefore, such equipment should be excluded from the scope of this Directive.
(10)For some pressure equipment covered by international agreements for its international transport, national transport
and pressure hazards and risks are dealt with by Union Directives bad on such agreements. Tho Directives extend the application of tho agreements to national transport, in order to ensure the free movement of dangerous goods whilst enhancing transport safety. Such equipment which is covered by Directive 2008/68/EC of the European Parliament and of the Council (1) and by Directive 2010/35/EU of the European Parliament and of the Council (2) should be excluded from the scope of this Directive.
(11)Certain types of pressure equipment, although subject to a maximum allowable pressure PS greater than 0,5 bar,
do not prent any significant risk due to pressure, and therefore the free movement of such equipm
ent in the Union should not be hindered if it has been legally manufactured or placed on the market in a Member State. It is not necessary in order to ensure free movement of such equipment to include it within the scope of this Directive.
Conquently it should be expressly excluded from its scope.
(12)Other pressure equipment subject to a maximum allowable pressure greater than 0,5 bar and prenting a
significant risk due to pressure, but in respect of which free movement and an appropriate level of safety are guaranteed, should be excluded from the scope of this Directive. Such exclusions should, however, be regularly reviewed in order to ascertain whether it is necessary to take action at Union level.
(13)The scope of this Directive should be bad on a general definition of the term ‘pressure equipment’so as to allow
for the technical development of products.
(14)Compliance with the esntial safety requirements is necessary in order to ensure the safety of
pressure equipment.
Tho requirements should be subdivided into general and specific requirements that need to be met by pressure equipment. In particular the specific requirements should take account of particular types of pressure equipment.
Certain types of pressure equipment in categories III and IV should be subject to a final asssment comprising final inspection and proof tests.
(1) Directive 2008/68/EC of the European Parliament and of the Council of 24 September 2008 on the inland transport of dangerous
goods (OJ L 260, 30.9.2008, p. 13).
(2) Directive 2010/35/EU of the European Parliament and of the Council of 16 June 2010 on transportable pressure equipment and
repealing Council Directives 76/767/EEC, 84/525/EEC, 84/526/EEC, 84/527/EEC and 1999/36/EC (OJ L 165, 30.6.2010, p. 1).
(15)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. During demonstrations, appropriate safety measures should be taken in accordance with the general safety rules of the Member State concerned to ensure the safety of persons.
(16)Directive 97/23/EC provides for a classification of pressure equipment in categories, according to the ascending
level of hazard. This includes the classification of the fluid contained in the pressure equipment as dangerous or not, according to Council Directive 67/548/EEC (1). On 1 June 2015 Directive 67/548/EEC is to be repealed and replaced by Regulation (EC) No 1272/2008 of the European Parliament and of the Council (2), which implements in the Union the Globally Harmonid System of Classification and Labelling of Chemicals that has been adopted at international level, within the United Nations structure. Regulation (EC) No 1272/2008 introduces new hazard class and categories only partially corresponding to tho provided for by Directive 67/548/EEC. Directive 97/23/EC should therefore be aligned to Regulation (EC) No 1272/2008 while maintaining the existing levels of protection provided for in that Directive.
(17)Economic operators should be responsible for the compliance of pressure equipment and asmblies with the
requirements of this Directive, in relation to their respective roles in the supply chain, so as to ensure a high level of protection of public interests, such as health and safety of persons, and the protection of domestic animals and of property, and to guarantee fair competition on the Union market.tray是什么意思
(18)All economic operators intervening in the supply and distribution chain should take appropriate measures to
ensure that they only make available on the market pressure equipment and asmblies which are in conformity with this Directive. It is necessary to provide for a clear and proportionate distribution of obligations which correspond to the role of each economic operator in the supply and distribution chain.
(19)The manufacturer, having detailed knowledge of the design and production process, is best placed to carry out the
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conformity asssment procedure. Conformity asssment should therefore remain solely the obligation of the manufacturer.
(20)In order to facilitate the communication between economic operators, market surveillance authorities and
consumers, Member States should encourage economic operators to include a website address in addition to the postal address.
(21)It is necessary to ensure that pressure equipment and asmblies from third countries entering the Union market
comply with the requirements of this Directive, and in particular that appropriate conformity asssment procedures have been carried out by manufacturers with regard to that pressure equipment or tho asmblies.
Provision should therefore be made for importers to make sure that the pressure equipment or asmbly they place on the market complies with the requirements of this Directive and that they do not place on the market pressure equipment or asmblies which do not comply with such requirements or prents a risk. Provision should also be made for importers to make sure that the conformity asssment procedures have been carried out and that marking of pressure equipment or asmblies and documentation drawn up by manufacturers are available for inspection by the co
高铁英语mpetent national authorities.
天才枪手(22)When placing pressure equipment or asmblies on the market, every importer should indicate on the pressure
equipment or asmbly his name, registered trade name or registered trade mark and the postal address at which he can be contacted. Exceptions should be provided for in cas where the size or nature of the pressure equipment or asmbly does not allow it. This includes cas where the importer would have to open the packaging to put his name and address on the pressure equipment or asmbly.
(1) 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 (OJ 196, 16.8.1967, p. 1).
(2) Regulation (EC) No 1272/2008 of the European Parliament and of the Council of 16 December 2008 on classification, labelling and
packaging of substances and mixtures, amending and repealing Directives 67/548/EEC and 1999/45/
EC, and amending Regulation (EC) No 1907/2006 (OJ L 353, 31.12.2008, p. 1).
(23)The distributor makes pressure equipment or asmblies available on the market after they have been placed on the
market by the manufacturer or the importer and should act with due care to ensure that its handling of the pressure equipment or asmbly does not adverly affect the compliance of the pressure equipment or asmbly with the requirements of this Directive.
(24)Any economic operator that either places pressure equipment or asmblies on the market under his own name or
trademark or modifies pressure equipment or asmblies in such a way that compliance with the requirements of this Directive may be affected should be considered to be the manufacturer and should assume the obligations of the manufacturer.
(25)Distributors and importers, being clo to the market place, should be involved in market surveillance tasks carried
out by the competent national authorities, and should be prepared to participate actively, providing th
灶神之妻o authorities with all necessary information relating to the pressure equipment or asmbly concerned.
(26)Ensuring traceability of pressure equipment and asmblies throughout the whole supply chain helps to make
market surveillance simpler and more efficient. An efficient traceability system facilitates market surveillance authorities’task of tracing economic operators who made non-compliant pressure equipment or asmblies available on the market.
(27)When keeping the information required under this Directive for the identification of other economic operators,
economic operators should not be required to update such information in respect of other economic operators who have either supplied them with pressure equipment or an asmbly or to whom they have supplied pressure equipment or an asmbly.
accomplishment
(28)This Directive should be limited to the expression of the esntial safety requirements. In order to facilitate
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conformity asssment with tho requirements it is necessary to provide for a presumption of conformity for pressure equipment or asmblies which are in conformity with harmonid standards that are adopted in accordance with Regulation (EU) No 1025/2012 of the European Parliament and of the Council (1) for the purpo of expressing detailed technical specifications of tho requirements, especially with regard to the design, manufacture and testing of pressure equipment or asmblies.
(29)Regulation (EU) No 1025/2012 provides for a procedure for objections to harmonid standards where tho
standards do not entirely satisfy the requirements of this Directive.
(30)Manufacturing of pressure equipment calls for the utilisation of safe materials. In the abnce of harmonid
standards the characteristics of the materials intended for repeated u should be established. Tho characteristics should be established by European approvals for materials, such approvals being issued by one of the notified bodies specifically designated for that task. The materials conforming to the European approvals should benefit from a presumption of conformity with the es
ntial safety requirements of this Directive.
(31)In view of the nature of the risks involved in the u of pressure equipment and asmblies and in order to enable
economic operators to demonstrate and the competent authorities to ensure that pressure equipment or asmblies made available on the market comply with the esntial safety requirements, it is necessary to provide for conformity asssment procedures. Tho procedures should be devid in the light of the level of hazard which is inherent in the pressure equipment or asmbly. Therefore, for each category of pressure equipment
(1) Regulation (EU) No 1025/2012 of the European Parliament and of the Council of 25 October 2012 on European standardisation,
amending Council Directives 89/686/EEC and 93/15/EEC and Directives 94/9/EC, 94/25/EC, 95/16/EC, 97/23/EC, 98/34/EC, 2004/22/EC, 2007/23/EC, 2009/23/EC and 2009/105/EC of the European Parliament and of the Council and repealing Council Decision 87/95/EEC and Decision No 1673/2006/EC of the European Parliament and of the Council (OJ L 316, 14.11.2012, p. 12).
there should be an adequate procedure or a choice between different procedures of equivalent stringency. Decision No 768/2008/EC establishes modules for conformity asssment procedures, which include procedures from the least to the most stringent, in proportion to the level of risk involved and the level of safety required. In order to ensure inter-ctoral coherence and to avoid ad-hoc variants, conformity asssment procedures should be chon from among tho modules. The details added to tho procedures are justified by the nature of the verification required for pressure equipment.
(32)Member States should be in a position to authori ur inspectorates to carry out certain tasks for conformity
asssment in the framework of this Directive. For that purpo this Directive should t out criteria for the authorisation of ur inspectorates by Member States.
广州会计培训(33)Under certain procedures for conformity asssment it should be possible for each item to be inspected and tested
by a notified body or a ur inspectorate as part of the final asssment of the pressure equipment or asmbly. In other cas provision should be made to ensure that the final asssment may be m
onitored by a notified body by means of unexpected visits.
(34)Manufacturers should draw up an EU declaration of conformity to provide information required under this
Directive on the conformity of the pressure equipment or asmbly with the requirements of this Directive and of other relevant Union harmonisation legislation.
(35)To ensure effective access to information for market surveillance purpos, in cas where pressure equipment or
an asmbly is covered by veral pieces of Union harmonisation legislation, the information required to identify all applicable Union acts should be available in a single EU declaration of conformity. In order to reduce the administrative burden on economic operators, that single EU declaration of conformity may be a dossier made up of relevant individual declarations of conformity.badminton的音标
(36) A check on compliance with the esntial safety requirements is necessary in order to provide effective protection
for consumers, other urs and third parties.
(37)Pressure equipment and asmblies should, as a general rule, bear the CE marking. The CE marking, indicating the
conformity of pressure equipment or asmblies, is the visible conquence of a whole process comprising conformity asssment in a broad n. General principles governing the CE marking and its relationship to other markings are t out in Regulation (EC) No 765/2008. Rules governing the affixing of the CE marking should be laid down in this Directive.
(38)For pressure equipment defined in this Directive which prents only a minor pressure risk and for which
certification procedures are therefore not justified, the CE marking should not be affixed.
(39)Certain conformity asssment procedures t out in this Directive require the intervention of conformity
asssment bodies, which are notified by the Member States to the Commission.
(40)Experience has shown that the criteria t out in Directive 97/23/EC that conformity asssment bodies have to
fulfil to be notified to the Commission are not sufficient to ensure a uniformly high level of performance of tho bodies throughout the Union. It is, however, esntial that all conformity asssment bodies perform their functions to the same level and under conditions of fair competition. That requires the tting of obligatory requirements for conformity asssment bodies wishing to be notified in order to provide conformity asssment rvices.
(41)If a conformity asssment body demonstrates conformity with the criteria laid down in harmonid standards, it
should be presumed to comply with the corresponding requirements t out in this Directive.
