DIRECTIVE 2009/105/EC OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL
of 16 September 2009
relating to simple pressure vessels
(codified version)
(Text with EEA relevance)
THE EUROPEAN PARLIAMENT AND THE COUNCIL OF THE EUROPEAN UNION,
Having regard to the Treaty establishing the European Community, and in particular Article 95 thereof,
Having regard to the proposal from the Commission,
Having regard to the opinion of the European Economic and Social Committee (1),
Acting in accordance with the procedure laid down in Article 251 of the Treaty (2),
Whereas:
(1)
Council Directive 87/404/EEC of 25 June 1987 on the harmonization of the laws of the Member States relating to simple pressure vessels (3) has been substantially amended several times (4). In the interests of clarity and rationality the said Directive should be codified.
(2)
Member States have the responsibility of ensuring the safety on their territory of persons, domestic animals and property with regard to the hazards resulting from the leakage or bursting of simple pressure vessels.
(3)
In each Member State, mandatory provisions define in particular the safety level required of simple pressure vessels by specifying design and operating characteristics, conditions of installation and use and inspection procedures before and after the placing on the market. These mandatory provisions do not necessarily lead to different safety levels from one Member State to another but do, by their disparity, hinder trade within the Community.
(4)
This Directive should therefore contain only mandatory and essential requirements. To facilitate proof of conformity with the essential requirements, it is necessary to have harmonised standards at Community level, in particular as to the design, operation and installation of simple pressure vessels, so that products complying with them may be assumed to conform to the safety requirements. These standards harmonised at Community level are drawn up by private bodies and should remain non-mandatory texts. For that purpose, the European Committee for Standardisation (CEN), the European Committee for Electrotechnical Standardisation (Cenelec) and the European Telecommunications Standards Institute (ETSI) are recognised as the competent bodies for the adoption of harmonised standards in accordance with the general guidelines (5) for cooperation between the Commission, the European Free Trade Association (EFTA) and those three bodies signed on 28 March 2003.
(5)
The Council has already adopted a series of Directives designed to remove technical barriers to trade in accordance with the principles established in its Resolution of 7 May 1985 on a new approach to technical harmonisation and standards (6); each of those Directives provides for the affixing of the ‘CE’ marking. The Commission, in its Communication of 15 June 1989 on a global approach to certification and testing (7), proposed that common rules be drawn up concerning a ‘CE’ marking with a single design. The Council, in its Resolution of 21 December 1989 on a global approach to conformity assessment (8), approved as a guiding principle the adoption of a consistent approach such as this with regard to the use of the ‘CE’ marking. The two basic elements of the new approach which should be applied are the essential requirements and the conformity assessment procedures.
(6)
A check on compliance with the relevant technical requirements is necessary in order to provide effective protection for users and third parties. The existing inspection procedures differ from one Member State to another. In order to avoid multiple inspections, which are in effect barriers to the free movement of vessels, arrangements should be made for the mutual recognition of inspection procedures by the Member States. In order to facilitate the mutual recognition of inspection procedures, Community procedures should be established as well as the criteria for appointing the bodies responsible for carrying out tests, surveillance and verification.
(7)
The presence on a simple pressure vessel of the ‘CE’ marking should raise a presumption that it satisfies the provisions of this Directive and should therefore make it unnecessary, upon the importation and putting into service of the vessel, to repeat the inspections already carried out. Nevertheless simple pressure vessels might represent a safety hazard. Provision should therefore be made for a procedure to reduce this hazard.
(8)
This Directive should be without prejudice to the obligations of the Member States relating to the time limits for transposition into national law and application of the Directives set out in Annex IV, Part B,
HAVE ADOPTED THIS DIRECTIVE:
CHAPTER I
SCOPE, DEFINITIONS, PLACING ON THE MARKET AND FREE MOVEMENT
Article 1
1. This Directive applies to simple pressure vessels manufactured in series.
2. The following vessels shall be excluded from the scope of this Directive:
(a)
vessels specifically designed for nuclear use, failure of which may cause an emission of radioactivity;
(b)
vessels specifically intended for installation in or the propulsion of ships and aircraft;
(c)
fire extinguishers.
3. For the purposes of this Directive the following definitions shall apply:
(a)
‘simple pressure vessel’ or ‘vessel’ means any welded vessel subjected to an internal gauge pressure greater than 0,5 bar which is intended to contain air or nitrogen and which is not intended to be fired.
The parts and assemblies contributing to the strength of the vessel under pressure shall be made either of non-alloy quality steel or of non-alloy aluminium or non-age hardening aluminium alloys.
The vessel shall be made of either:
(i)
a cylindrical part of circular cross-section closed by inwardly dished and/or flat ends which revolve around the same axis as the cylindrical part; or
(ii)
two dished ends revolving around the same axis.
The maximum working pressure of the vessel shall not exceed 30 bar and the product of that pressure and the capacity of the vessel (PS x V) shall not exceed 10 000 bar.l.
The minimum working temperature must be no lower than - 50 °C and the maximum working temperature must not be higher than 300 °C for steel and 100 °C for aluminium or aluminium alloy vessels;
(b)
a ‘harmonised standard’ means a technical specification (European standard or harmonisation document) adopted by the European Committee for Standardisation (CEN), the European Committee for Electrotechnical Standardisation (Cenelec) or the European Telecommunications Standards Institute (ETSI) or by two or three of those bodies upon a remit from the Commission in accordance with Directive 98/34/EC of the European Parliament and of the Council of 22 June 1998 laying down a procedure for the provision of information in the field of technical standards and regulations and of rules on Information Society services (9) and the general guidelines for cooperation between the Commission, the European Free Trade Association (EFTA) and those three bodies signed on 28 March 2003.
Article 2
1. Member States shall take all necessary steps to ensure that the vessels may be placed on the market and put into service only if they do not compromise the safety of persons, domestic animals or property when properly installed and maintained and used for the purposes for which they are intended.
2. The provisions of this Directive shall not affect the right of Member States to specify - with due observance of the Treaty - the requirements they deem necessary in order to ensure that workers are protected when using vessels, provided it does not mean that those vessels are modified in a way unspecified in this Directive.
Article 3
1. Vessels in respect of which the product of PS x V exceeds 50 bar.l must satisfy the essential safety requirements set out in Annex I.
2. Vessels in respect of which the product of PS x V is 50 bar.l or less must be manufactured in accordance with sound engineering practice in one of the Member States and bear markings as laid down in point 1 of Annex II, with the exception of the ‘CE’ marking referred to in Article 16.
Article 4
Member States shall not impede the placing on the market and the putting into service in their territory of vessels which satisfy the requirements of this Directive.
Article 5
1. Member States shall presume that vessels bearing the ‘CE’ marking comply with all the provisions of this Directive.
Conformity of vessels with the national standards which transpose the harmonised standards, the reference numbers of which have been published in the Official Journal of the European Union, shall result in a presumption of conformity to the essential safety requirements set out in Annex I.
Member States shall publish the reference numbers of such national standards.
2. Member States shall presume that vessels for which the standards referred to in the second subparagraph of paragraph 1 do not exist or in respect of which the manufacturer has not applied or has only partially applied such standards, comply with the essential safety requirements set out in Annex I, where, after receipt of an EC type-examination certificate, their conformity with the approved model has been certified by the affixation of the ‘CE’ marking.
3. Where vessels are subject to other Directives covering other aspects and which also provide for the affixing of the ‘CE’ marking, the latter shall indicate that the vessels in question are also presumed to conform to the provisions of those other Directives.
However, where 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 to the Directives applied by the manufacturer. In this case, particulars of the Directives applied, as published in the Official Journal of the European Union, shall be given in the documents, notices or instructions required by the Directives and accompanying such vessels.
Article 6
Where a Member State or the Commission considers that the harmonised standards referred to in Article 5(1) do not entirely meet the essential safety requirements set out in Annex I, the Commission or the Member State concerned shall bring the matter before the standing committee set up under Article 5 of Directive 98/34/EC, hereinafter referred to as ‘the committee’, giving the reasons therefor.
The committee shall deliver an opinion without delay.
In the light of the committee’s opinion, the Commission shall inform the Member States whether or not it is necessary to withdraw those standards from the publications referred to in Article 5(1).
Article 7
1. Where a Member State finds that vessels bearing the ‘CE’ marking and used in accordance with their intended purpose might compromise the safety of persons, domestic animals or property, it shall take all appropriate measures to withdraw those products from the market or to prohibit or restrict their being placed on the market.
The Member State concerned 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 meet the essential safety requirements set out in Annex I, where the vessel does not meet the harmonised standards referred to in Article 5(1);
(b)
incorrect application of the harmonised standards referred to in Article 5(1);
(c)
shortcomings in the harmonised standards referred to in Article 5(1).
2. The Commission shall enter into consultation with the parties concerned as soon as possible. Where, after such consultation, the Commission finds that any measure as referred to in paragraph 1 is justified, it shall immediately so inform the Member State that took the action and the other Member States.
Where the decision referred to in paragraph 1 is attributed to shortcomings in the standards, the Commission, after consulting the parties concerned, shall bring the matter before the committee within two months if the Member State which has taken the measures intends to maintain them and shall set in motion the procedure referred to in Article 6.
3. Where a vessel which does not comply bears the ‘CE’ marking, the competent Member State shall take appropriate action against whomsoever has affixed the marking and shall inform the Commission and the other Member States thereof.
4. The Commission shall ensure that the Member States are kept informed of the progress and outcome of the procedure referred to in paragraphs 1, 2 and 3.
CHAPTER II
CERTIFICATION
SECTION 1
Certification procedures
Article 8
1. Prior to production of pressure vessels of which the product of PS x V exceeds 50 bar.l, manufactured in accordance with the harmonised standards referred to in Article 5(1), the manufacturer, or his authorised representative established within the Community, shall at his own choice either:
(a)
inform an approved inspection body as referred to in Article 9, which, after examining the design and manufacturing schedule referred to in point 3 of Annex II, shall draw up a certificate of adequacy attesting that the schedule is satisfactory; or
(b)
submit a prototype vessel for the EC type-examination referred to in Article 10.
2. Prior to production of pressure vessels of which the product of PS x V exceeds 50 bar.l, not manufactured, or manufactured only partly, in accordance with the harmonised standards referred to in Article 5(1), the manufacturer, or his authorised representative established within the Community, shall submit a prototype vessel for the EC type-examination referred to in Article 10.
3. Vessels manufactured in accordance with the harmonised standards referred to in Article 5(1) or with the approved prototype shall, prior to their being placed on the market, be subject:
(a)
to the EC verification referred to in Article 11 where the product of PS x V exceeds 3 000 bar.l;
(b)
at the choice of the manufacturer, where the product of PS x V does not exceed 3 000 bar.l but exceeds 50 bar.l, either:
(i)
to the EC declaration of conformity referred to in Article 12; or
(ii)
to the EC verification referred to in Article 11.
4. The records and correspondence relating to the certification procedures referred to in paragraphs 1, 2 and 3 shall be drafted in an official language of the Member State in which the approved inspection body is established or in a language accepted by that body.
Article 9
1. Member States shall notify the Commission and the other Member States of the approved inspection bodies which they have appointed to carry out the procedures referred to in Article 8(1), (2) and (3) 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 Union 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. For the purposes of approval of the bodies referred to in paragraph 1, Member States shall meet the minimum criteria set out in Annex III.
3. A Member State which has approved an inspection body shall withdraw approval if it finds that the body no longer meets the minimum criteria set out in Annex III.
It shall immediately inform the Commission and the other Member States accordingly.
SECTION 2
EC type-examination
Article 10
1. EC type-examination is the procedure whereby an approved inspection body ascertains and certifies that a prototype vessel satisfies the provisions of this Directive which apply to it.
2. The application for EC type-examination shall be lodged by the manufacturer or by his authorised representative with a single approved inspection body in respect of a prototype vessel or of a prototype representing a family of vessels. That authorised representative must be established in the Community.
The application shall include:
(a)
the name and address of the manufacturer or of his authorised representative and the place of manufacture of the vessels;
(b)
the design and manufacturing schedule referred to in point 3 of Annex II.
It shall be accompanied by a vessel which is representative of the production envisaged.
3. The approved inspection body shall carry out the EC type-examination in the manner referred to in the second and third subparagraphs.
It shall examine not only the design and manufacturing schedule in order to check its conformity, but also the vessel submitted.
When examining the vessel, the body shall:
(a)
verify that the vessel has been manufactured in conformity with the design and manufacturing schedule and may safely be used under its intended working conditions;
(b)
perform appropriate examinations and tests to check that the vessel complies with the essential requirements applicable to it.
4. If the prototype complies with the provisions applicable to it the approved inspection body shall draw up an EC type-examination certificate which shall be forwarded to the applicant. That certificate shall state the conclusions of the examination, indicate any conditions to which its issue may be subject and be accompanied by the descriptions and drawings necessary for identification of the approved prototype.
The Commission, the other approved inspection bodies and the other Member States may obtain a copy of the certificate and, on a reasoned request, a copy of the design and manufacturing schedule and the reports on the examinations and tests carried out.
5. An approved inspection body which refuses to issue an EC type-examination certificate shall so inform the other approved inspection bodies.
An approved inspection body which withdraws an EC type-examination certificate shall so inform the Member State which approved it. The latter shall inform the other Member States and the Commission thereof, giving the reasons for the decision.
SECTION 3
EC verification
Article 11
1. EC verification is the procedure whereby a manufacturer or his authorised representative established within the Community ensures and declares that the vessels which have been checked in accordance with paragraph 3 are in conformity with the type described in the EC type-examination certificate or with the design and manufacturing schedule referred to in point 3 of Annex II having received a certificate of adequacy.
2. The manufacturer shall take all necessary measures for the manufacturing process to ensure that the vessels conform to the type described in the EC type-examination certificate or to the design and manufacturing schedule referred to in point 3 of Annex II. The manufacturer or his authorised representative established within the Community shall affix the ‘CE’ marking to each vessel and draw up a declaration of conformity.
3. The approved inspection body shall carry out the appropriate examinations and tests in order to check the conformity of the vessels with the requirements of this Directive by examination and testing of vessels in accordance with the second to tenth subparagraphs.
The manufacturer shall present his vessels in the form of uniform batches and shall take all necessary measures in order that the manufacturing process ensures the uniformity of each batch produced.
Those batches shall be accompanied by the EC type-examination certificate referred to in Article 10 or, where the vessels are not manufactured in accordance with an approved prototype, by the design and manufacturing schedule referred to in point 3 of Annex II. In the latter case the approved inspection body shall, prior to EC verification, examine the schedule in order to certify its conformity.
When a batch is examined, the approved inspection body shall ensure that the vessels have been manufactured and checked in accordance with the design and manufacturing schedule, and shall perform a hydrostatic test or a pneumatic test of equivalent effect on each vessel in the batch at a pressure Ph equal to 1,5 times the vessel’s design pressure in order to check its soundness. The pneumatic test shall be subject to acceptance of the test safety procedures by the Member State in which the test is performed.
Moreover, the approved inspection body shall carry out tests on test-pieces taken from a representative production test-piece or from a vessel, as the manufacturer chooses, in order to examine the weld quality. The tests shall be carried out on longitudinal welds. However, where differing weld techniques are used for longitudinal and circular welds, the tests shall be repeated on the circular welds.
For the vessels referred to in point 2.1.2 of Annex I, these tests on test-pieces shall be replaced by a hydrostatic test on five vessels taken at random from each batch in order to check that they conform to the essential safety requirements set out in point 2.1.2 of Annex I.
In the case of accepted batches, the approved inspection body shall affix its identification number, or cause that number to be affixed, to each vessel and shall draw up a written certificate of conformity relating to the tests carried out. All vessels in the batch may be placed on the market except for those which have not successfully undergone a hydrostatic test or a pneumatic test.
If a batch is rejected, the approved inspection body shall take appropriate measures to prevent the placing on the market of that batch. In the event of frequent rejection of batches, the approved inspection body may suspend the statistical verification.
The manufacturer may, under the responsibility of the approved inspection body, affix the latter’s identification number during the manufacturing process.
The manufacturer or his authorised representative must be able to supply on request the approved inspection body’s certificates of conformity referred to in the seventh subparagraph.
SECTION 4
EC declaration of conformity
Article 12
1. A manufacturer fulfilling the obligations arising under Article 13 shall affix the ‘CE’ marking provided for in Article 16 to vessels which he declares to be in conformity with:
(a)
the design and manufacturing schedule referred to in point 3 of Annex II in respect of which a certificate of adequacy has been drawn up; or
(b)
an approved prototype.
2. By the EC declaration of conformity procedure the manufacturer becomes subject to EC surveillance, in cases where the product of PS x V exceeds 200 bar.l.
The purpose of EC surveillance is to ensure, as required by the second paragraph of Article 14, that the manufacturer duly fulfils the obligations arising under Article 13(2). Surveillance shall be performed by the approved inspection body which issued the EC type-examination certificate referred to in the first subparagraph of Article 10(4) where the vessels have been manufactured in accordance with an approved prototype or, if this is not the case, by the approved body to which the design and manufacturing schedule was sent in accordance with Article 8(1)(a).
Article 13
1. Where a manufacturer makes use of the procedure referred to in Article 12, he shall, before commencing manufacture, send the approved inspection body which issued the EC type-examination certificate or the certificate of adequacy a document describing the manufacturing processes and all of the predetermined systematic measures taken to ensure conformity of the pressure vessels to the standards referred to in Article 5(1) or the approved prototype.
2. The document referred to in paragraph 1 shall include:
(a)
a description of the means of manufacture and checking appropriate to the construction of the vessels;
(b)
an inspection document describing the appropriate examinations and tests to be carried out during manufacture, together with the procedures in respect thereof and the frequency with which they are to be performed;
(c)
an undertaking to carry out the examinations and tests in accordance with the inspection document referred to in point (b) and to have a hydrostatic test or, subject to the agreement of the Member State, a pneumatic test carried out on each vessel manufactured at a test pressure equal to 1,5 times the design pressure;
those examinations and tests shall be carried out under the responsibility of qualified staff who are sufficiently independent from production personnel, and shall be the subject of a report;
(d)
the addresses of the places of manufacture and storage and the date on which manufacture is to commence.
3. When the product of PS x V exceeds 200 bar.l, manufacturers shall authorise access to the said places of manufacture and storage by the body responsible for EC surveillance, for inspection purposes, and shall allow that body to select sample vessels and shall provide it with all necessary information, and in particular:
(a)
the design and manufacturing schedule;
(b)
the inspection report;
(c)
the EC type-examination certificate or certificate of adequacy, where appropriate;
(d)
a report on the examinations and tests carried out.
Article 14
The approved inspection body which issued the EC type-examination certificate or certificate of adequacy shall, before the date on which any manufacture begins, examine both the document referred to in Article 13(1) and the design and manufacturing schedule referred to in point 3 of Annex II, in order to certify its conformity, where vessels are not manufactured in accordance with an approved prototype.
In addition, where the product of PS x V exceeds 200 bar.l, that body shall during manufacture:
(a)
ensure that the manufacturer actually checks series-produced vessels in accordance with Article 13(2)(c);
(b)
take random samples at the places of manufacture or at the place of storage of vessels for inspection purposes.
The approved inspection body shall supply the Member State which approved it and, on request, the other approved inspection bodies, the other Member States and the Commission, with a copy of the inspection report.
CHAPTER III
‘CE’ MARKING AND INSCRIPTIONS
Article 15
Without prejudice to Article 7:
(a)
where a Member State establishes that the ‘CE’ marking has been affixed unduly, the manufacturer or his authorised representative established within the Community shall be obliged to make the product conform with the provisions concerning the ‘CE’ marking and to end the infringement under the conditions imposed by that Member State;
(b)
where the non-conformity continues, 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 procedure laid down in Article 7.
Article 16
1. The ‘CE’ marking and the inscriptions provided for in point 1 of Annex II, shall be affixed in a visible, legible and indelible form to the vessel or to a data plate attached to the vessel in such a way that it cannot be removed.
The ‘CE’ marking shall consist of the initials ‘CE’ in the form shown in the specimen in point 1.1 of Annex II. The ‘CE’ marking shall be followed by the identification number referred to in Article 9(1) of the approved inspection body responsible for ‘CE’ verifications or ‘CE’ surveillance.
2. The affixing on the vessels of markings which are likely to deceive third parties as to the meaning and form of the ‘CE’ marking shall be prohibited. Any other marking may be affixed to the vessels or the data plate provided that the visibility and legibility of the ‘CE’ marking are not thereby reduced.
CHAPTER IV
FINAL PROVISIONS
Article 17
Any decision taken pursuant to this Directive which results in restrictions on the placing on the market or the putting into service of a vessel shall state the exact grounds on which it is based. Such a decision shall be notified without delay to the party concerned, who shall at the same time be informed of the judicial remedies available to him under the laws in force in the Member State in question and of the time limits to which such remedies are subject.
Article 18
Member States shall communicate to the Commission the text of the main provisions of national law which they adopt in the field covered by this Directive.
Article 19
Directive 87/404/EEC, as amended by the Directives listed in Annex IV, Part A, is repealed, without prejudice to the obligations of the Member States relating to the time limits for transposition into national law and application of the Directives set out in Annex IV, Part B.
References to the repealed Directive shall be construed as references to this Directive and shall be read in accordance with the correlation table in Annex V.
Article 20
This Directive shall enter into force on the 20th day following its publication in the Official Journal of the European Union.
Article 21
This Directive is addressed to the Member States.
Done at Strasbourg, 16 September 2009.