Annexes to COM(2011)768 - Harmonisation of the laws of the Member States relating to making available on the market of simple pressure vessels - Main contents
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dossier | COM(2011)768 - Harmonisation of the laws of the Member States relating to making available on the market of simple pressure vessels. |
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document | COM(2011)768 |
date | February 26, 2014 |
(5) OJ L 218, 13.8.2008, p. 30.
(6) OJ L 218, 13.8.2008, p. 82.
(7) OJ L 316, 14.11.2012, p. 12.
(8) OJ L 55, 28.2.2011, p. 13.
ANNEX I
ESSENTIAL SAFETY REQUIREMENTS
1. Materials
Materials shall be selected according to the intended use of the vessels and in accordance with points 1.1 to 1.4.
1.1. Pressurised parts
The materials used for manufacturing the pressurised parts of the vessels shall be:
(a) | capable of being welded; |
(b) | ductile and tough, so that a rupture at minimum working temperature does not give rise to either fragmentation or brittle-type fracture; |
(c) | not adversely affected by ageing. |
For steel vessels, the materials shall in addition meet the requirements set out in point 1.1.1 and, for aluminium or aluminium alloy vessels, those set out in point 1.1.2.
They shall be accompanied by an inspection slip as defined in point (i) of point 3.1 of Annex III, drawn up by the producer of the materials.
1.1.1. Steel vessels
Non-alloy quality steels shall meet the following requirements:
(a) | they shall be non-effervescent and supplied after normalisation treatment, or in an equivalent state; |
(b) | the content per product of carbon shall be less than 0,25 % and that of sulphur and phosphorus shall each be less than 0,05 %; |
(c) | they shall have the following mechanical properties per product:
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1.1.2. Aluminium vessels
Non-alloy aluminium shall have an aluminium content of at least 99,5 % and the alloys referred to in point (b) of Article 1(1) shall display adequate resistance to intercrystalline corrosion at maximum working temperature.
Moreover, these materials shall satisfy the following requirements:
(a) | they shall be supplied in an annealed state; |
(b) | they shall have the following mechanical characteristics per product:
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1.2. Welding materials
The welding materials used to manufacture the welds on or of the vessel shall be appropriate to and compatible with the materials to be welded.
1.3. Accessories contributing to the strength of the vessel
These accessories (for example bolts and nuts) shall be made of a material specified in point 1.1 or of other kinds of steel, aluminium or an appropriate aluminium alloy compatible with materials used for the manufacture of pressurised parts.
The latter materials shall at minimum working temperature have an appropriate elongation after fracture and bending rupture energy.
1.4. Non-pressurised parts
All unpressurised parts of welded vessels shall be of materials which are compatible with that of the components to which they are welded.
2. Vessel design
(a) | The manufacturer shall, when designing the vessel, define the use to which it will be put, and select:
However, should a minimum working temperature exceeding – 10 °C be selected, the qualities required of the materials shall be satisfied at – 10 °C. |
(b) | The manufacturer shall also take account of the following provisions:
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(c) | The manufacturer shall take account of the fact that under the conditions of use envisaged:
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(d) | Circumferential and longitudinal seams shall be made using full penetration welds or welds of equivalent effectiveness. Convex ends other than hemispherical ones shall have a cylindrical edge. |
2.1. Wall thickness
If the product of PS × V is not more than 3 000 bar.L, the manufacturer shall select one of the methods described in points 2.1.1 and 2.1.2 for determining vessel wall thickness; if the product of PS × V is more than 3 000 bar.L, or if the maximum working temperature exceeds 100 °C, such thickness shall be determined by the method described in point 2.1.1.
The actual wall thickness of the cylindrical section and ends shall, however, be not less than 2 mm in the case of steel vessels and not less than 3 mm in the case of aluminium or aluminium alloy vessels.
2.1.1. Calculation method
The minimum thickness of pressurised parts shall be calculated having regard to the intensity of the stresses and to the following provisions:
(a) | the calculation pressure to be taken into account shall not be less than the maximum working pressure PS selected; |
(b) | the permissible general membrane stress shall not exceed the lower of the values 0,6 ReT or 0,3 Rm. The manufacturer shall use the ReT and Rm minimum values guaranteed by the producer of the material in order to determine the permissible stress. |
However, where the cylindrical portion of the vessel has one or more longitudinal welds made using a non-automatic welding process, the thickness calculated as referred to in the first paragraph shall be multiplied by the coefficient 1,15.
2.1.2. Experimental method
Wall thickness shall be so determined as to enable the vessels to resist at ambient temperature a pressure equal to at least five times the maximum working pressure, with a permanent circumferential deformation factor of no more than 1 %.
3. Manufacturing processes
Vessels shall be constructed and subjected to production checks in accordance with points 2, 3 or 4 of Annex II.
3.1. Preparation of the component parts
Preparation of the component parts (for example forming and chamfering) shall not give rise to surface defects or cracks or changes in the mechanical characteristics likely to be detrimental to the safety of the vessels.
3.2. Welds on pressurised parts
The characteristics of welds and adjacent zones shall be similar to those of the welded materials and shall be free of any surface or internal defects detrimental to the safety of the vessels.
Welds shall be performed by qualified welders or operators possessing the appropriate level of competence, in accordance with approved welding processes. Such approval and qualification tests shall be carried out by notified bodies.
The manufacturer shall also, during manufacture, ensure consistent weld quality by conducting appropriate tests using adequate procedures. These tests shall be the subject of a report.
4. Putting into service of the vessels
Vessels shall be accompanied by the instructions drawn up by the manufacturer, as referred to in point 2 of Annex III.
ANNEX II
CONFORMITY ASSESSMENT PROCEDURES
1. EU-Type examination (Module B)
1.1. | EU-type examination is the part of a conformity assessment procedure in which a notified body examines the technical design of a vessel and verifies and attests that the technical design of the vessel meets the requirements of this Directive that apply to it. |
1.2. | EU-type examination shall be carried out in either of the following manners in accordance with Article 13:
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1.3. | The manufacturer shall lodge an application for EU-type examination with a single notified body of his choice. The application shall include:
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1.4. | The notified body shall: For the vessel:
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1.5. | The notified body shall draw up an evaluation report that records the activities undertaken in accordance with point 1.4 and their outcomes. Without prejudice to its obligations vis-à-vis the notifying authorities, the notified body shall release the content of that report, in full or in part, only with the agreement of the manufacturer. |
1.6. | Where the type meets the requirements of this Directive, the notified body shall issue an EU-type examination certificate to the manufacturer. That certificate shall contain the name and address of the manufacturer, the conclusions of the examination, the conditions (if any) for its validity and the necessary data for identification of the approved type. The EU-type examination certificate may have one or more annexes attached. The EU-type examination certificate and its annexes shall contain all relevant information to allow the conformity of manufactured vessels with the examined type to be evaluated and to allow for in-service control. It shall also indicate any conditions to which its issue may be subject and be accompanied by the descriptions and drawings necessary for identification of the approved type. Where the type does not satisfy the applicable requirements of this Directive, the notified body shall refuse to issue an EU-type examination certificate and shall inform the applicant accordingly, giving detailed reasons for its refusal. |
1.7. | The notified body shall keep itself apprised of any changes in the generally acknowledged state of the art which indicate that the approved type may no longer comply with the applicable requirements of this Directive, and shall determine whether such changes require further investigation. If so, the notified body shall inform the manufacturer accordingly. The manufacturer shall inform the notified body that holds the technical documentation relating to the EU-type examination certificate of all modifications to the approved type that may affect the conformity of the vessel with the essential safety requirements of this Directive or the conditions for validity of that certificate. Such modifications shall require additional approval in the form of an addition to the original EU-type examination certificate. |
1.8. | Each notified body shall inform its notifying authority concerning the EU-type examination certificates and/or any additions thereto which it has issued or withdrawn, and shall, periodically or upon request, make available to its notifying authority the list of such certificates and/or any additions thereto refused, suspended or otherwise restricted. Each notified body shall inform the other notified bodies concerning the EU-type examination certificates and/or any additions thereto which it has refused, withdrawn, suspended or otherwise restricted, and, upon request, concerning such certificates and/or additions thereto which it has issued. The Commission, the Member States and the other notified bodies may, on request, obtain a copy of the EU-type examination certificates and/or additions thereto. On request, the Commission and the Member States may obtain a copy of the technical documentation and the results of the examinations carried out by the notified body. The notified body shall keep a copy of the EU-type examination certificate, its annexes and additions, as well as the technical file including the documentation submitted by the manufacturer, until the expiry of the validity of that certificate. |
1.9. | The manufacturer shall keep a copy of the EU-type examination certificate, its annexes and additions together with the technical documentation at the disposal of the national authorities for 10 years after the vessel has been placed on the market. |
1.10. | The manufacturer’s authorised representative may lodge the application referred to in point 1.3 and fulfil the obligations set out in points 1.7 and 1.9, provided that they are specified in the mandate. |
2. Conformity to type based on internal production control plus supervised vessel testing (Module C1)
2.1. Conformity to type based on internal production control plus supervised vessel testing is the part of a conformity assessment procedure whereby the manufacturer fulfils the obligations laid down in points 2.2, 2.3 and 2.4, and ensures and declares on his sole responsibility that the vessels concerned are in conformity with the type described in the EU-type examination certificate and satisfy the requirements of this Directive that apply to them.
2.2. Manufacturing
The manufacturer shall take all measures necessary so that the manufacturing process and its monitoring ensure conformity of the manufactured vessels with the type described in the EU-type examination certificate and with the requirements of this Directive that apply to them.
Before commencing manufacture, the manufacturer shall provide a notified body of his choice with all necessary information, and in particular:
(a) | the technical documentation, which shall also include:
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(b) | the 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) | the EU-type examination certificate. |
2.3. Vessel checks
2.3.1. | For each individual vessel manufactured, the notified body shall carry out the appropriate examinations and tests in order to verify the conformity of the vessel with the type described in the EU-type examination certificate and with the corresponding requirements of this Directive in accordance with the following points:
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2.3.2. | The notified body shall supply the Member State which notified it and, on request, the other notified bodies, the other Member States and the Commission, with a copy of the inspection report issued by it. |
2.3.3. | The manufacturer shall, under the responsibility of the notified body, affix the notified body’s identification number during the manufacturing process. |
2.4. CE marking and EU declaration of conformity
2.4.1. | The manufacturer shall affix the CE marking to each individual vessel that is in conformity with the type described in the EU-type examination certificate and satisfies the applicable requirements of this Directive. |
2.4.2. | The manufacturer shall draw up a written EU declaration of conformity for each vessel model and keep it at the disposal of the national authorities for 10 years after the vessel has been placed on the market. The EU declaration of conformity shall identify the vessel model for which it has been drawn up. |
2.4.3. | A copy of the EU declaration of conformity shall be made available to the relevant authorities upon request. |
2.5. Authorised representative
The manufacturer’s obligations set out in point 2.4 may be fulfilled by his authorised representative, on his behalf and under his responsibility, provided that they are specified in the mandate.
3. Conformity to type based on internal production control plus supervised vessel checks at random intervals (Module C2)
3.1. Conformity to type based on internal production control plus supervised vessel checks at random intervals is the part of a conformity assessment procedure whereby the manufacturer fulfils the obligations laid down in points 3.2, 3.3 and 3.4, and ensures and declares on his sole responsibility that the vessels concerned are in conformity with the type described in the EU-type examination certificate and satisfy the requirements of this Directive that apply to them.
3.2. Manufacturing
3.2.1. | The manufacturer shall take all measures necessary so that the manufacturing process and its monitoring ensure conformity of the manufactured vessels with the type described in the EU-type examination certificate and with the requirements of this Directive that apply to them. |
3.2.2. | Before commencing manufacture, the manufacturer shall provide a notified body of his choice with all necessary information, and in particular:
The notified body shall, before the date on which any manufacture begins, examine those documents in order to certify their conformity with the EU-type examination certificate. |
3.2.3. | The document referred to in point (c) of point 3.2.2 shall include:
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3.3. Vessel checks
The notified body shall carry out vessel checks or have them carried out on random samples at random intervals determined by the body, in order to verify the quality of the internal checks on the vessel, taking into account, inter alia, the technological complexity of the vessels and the quantity of production. An adequate sample of the final vessels, taken on site by the notified body before the placing on the market, shall be examined and appropriate tests as identified by the relevant parts of the harmonised standards and/or equivalent tests set out in other relevant technical specifications, shall be carried out to check the conformity of the vessel with the type described in the EU-type examination certificate and with the relevant requirements of this Directive.
The notified body shall also ensure that the manufacturer actually checks series-produced vessels in accordance with point (c) of point 3.2.3.
Where a sample does not conform to the acceptable quality level, the notified body shall take appropriate measures.
The acceptance sampling procedure to be applied is intended to determine whether the manufacturing process of the vessel performs within acceptable limits, with a view to ensuring conformity of the vessel.
The notified body shall supply the Member State which notified it and, on request, the other notified bodies, the other Member States and the Commission, with a copy of the inspection report issued by it.
The manufacturer shall, under the responsibility of the notified body, affix the notified body’s identification number during the manufacturing process.
3.4. CE marking and EU declaration of conformity
3.4.1. | The manufacturer shall affix the CE marking to each individual vessel that is in conformity with the type described in the EU-type examination certificate and satisfies the applicable requirements of this Directive. |
3.4.2. | The manufacturer shall draw up a written EU declaration of conformity for each vessel model and keep it at the disposal of the national authorities for 10 years after the vessel has been placed on the market. The EU declaration of conformity shall identify the vessel model for which it has been drawn up. |
3.4.3. | A copy of the EU declaration of conformity shall be made available to the relevant authorities upon request. |
3.5. Authorised representative
The manufacturer’s obligations set out in point 3.4 may be fulfilled by his authorised representative, on his behalf and under his responsibility, provided that they are specified in the mandate.
4. Conformity to type based on internal production control (Module C)
4.1. Conformity to type based on internal production control is the part of a conformity assessment procedure whereby the manufacturer fulfils the obligations laid down in points 4.2 and 4.3, and ensures and declares that the vessels concerned are in conformity with the type described in the EU-type examination certificate and satisfy the requirements of this Directive that apply to them.
4.2. Manufacturing
The manufacturer shall take all measures necessary so that the manufacturing process and its monitoring ensure conformity of the manufactured vessels with the approved type described in the EU-type examination certificate and with the requirements of this Directive that apply to them.
Before commencing manufacture, the manufacturer shall provide the notified body which issued the EU-type examination certificate with all necessary information, and in particular:
(a) | the certificates relating to the suitable qualification of the welding operations and of the welders or welding operators; |
(b) | the inspection slip for the materials used in the manufacture of parts and components contributing to the strength of the vessel; |
(c) | a report on the examinations and tests performed; |
(d) | a document describing the manufacturing processes and all of the predetermined systematic measures taken to ensure conformity of the vessels with the type described in the EU-type examination certificate. That document shall include:
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The notified body shall, before the date on which any manufacture begins, examine those documents in order to certify their conformity with the EU-type examination certificate.
4.3. CE marking and EU declaration of conformity
4.3.1. | The manufacturer shall affix the CE marking to each individual vessel that is in conformity with the type described in the EU-type examination certificate and satisfies the applicable requirements of this Directive. |
4.3.2. | The manufacturer shall draw up a written EU declaration of conformity for each vessel model and keep it at the disposal of the national authorities for 10 years after the vessel has been placed on the market. The EU declaration of conformity shall identify the vessel model for which it has been drawn up. |
4.3.3. | A copy of the EU declaration of conformity shall be made available to the relevant authorities upon request. |
4.4. Authorised representative
The manufacturer’s obligations set out in point 4.3 may be fulfilled by his authorised representative, on his behalf and under his responsibility, provided that they are specified in the mandate.
ANNEX III
INSCRIPTIONS, INSTRUCTIONS, DEFINITIONS AND SYMBOLS
1. CE marking and inscriptions
1.1. | Vessels of which the product of PS × V exceeds 50 bar.L must bear the CE marking provided for in Annex II of Regulation (EC) No 765/2008 and the last two digits of the year in which the CE marking was affixed. |
1.2. | Vessels or their data plates shall bear at least the following information:
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1.3. | Where the data plate is used, it shall be so designed that it cannot be reused and shall include a vacant space to enable other information to be provided. |
2. Instructions and safety information
The instructions shall contain the following information:
(a) | the particulars given in point 1.2 except for the vessel’s serial or batch identification; |
(b) | the intended use of the vessel; |
(c) | the maintenance and installation requirements for vessel safety. |
3. Definitions and symbols
3.1. Definitions
(a) | The design pressure ‘P’ is the gauge pressure chosen by the manufacturer and used to determine the thickness of the vessel’s pressurised parts. |
(b) | The maximum working pressure ‘PS’ is the maximum gauge pressure which may be exerted under normal conditions of use of the vessel. |
(c) | The minimum working temperature Tmin is the lowest stabilised temperature which the wall of the vessel may attain under normal conditions of use. |
(d) | The maximum working temperature Tmax is the highest stabilised temperature which the wall of the vessel may attain under normal conditions of use. |
(e) | The yield strength ‘ReT’ is the value at the maximum working temperature Tmax of any of the following:
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(f) | Families of vessels: Vessels form part of the same family if they differ from the prototype only in diameter, provided that the permissible requirements referred to in points 2.1.1 and 2.1.2 of Annex I are complied with, and/or in the length of their cylindrical portion within the following limits:
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(g) | A batch of vessels consists at the most of 3 000 vessels of the model of the same type. |
(h) | There is series manufacture within the meaning of this Directive if more than one vessel of the same type is manufactured during a given period by a continuous manufacturing process, in accordance with a common design and using the same manufacturing processes. |
(i) | Inspection slip: document by which the producer of the materials certifies that the products delivered meet the requirements of the order and in which he sets out the results of the routine in-plant inspection test, in particular chemical composition and mechanical characteristics, performed on products made by the same production process as the supply, but not necessarily on the products delivered. |
3.2. Symbols
A | elongation after fracture (Lo = 5,65√So) | % |
A80 mm | elongation after fracture (Lo = 80 mm) | % |
KCV | bending rupture energy | J/cm2 |
P | design pressure | Bar |
PS | maximum working pressure | Bar |
Ph | hydrostatic or pneumatic test pressure | Bar |
Rp0,2 | 0,2 % proof strength | N/mm2 |
ReT | yield strength at maximum working temperature | N/mm2 |
ReH | upper yield point | N/mm2 |
Rm | tensile strength | N/mm2 |
Rm, max | maximum tensile strength | N/mm2 |
Rp1,0 | 1,0 % proof strength | N/mm2 |
Tmax | maximum working temperature | °C |
Tmin | minimum working temperature | °C |
V | capacity of the vessel | L |
ANNEX IV
EU DECLARATION OF CONFORMITY (No XXXX) (1)
1. | Vessel/vessel model (product, type, batch or serial number): |
2. | Name and address of the manufacturer and, where applicable, his authorised representative: |
3. | This declaration of conformity is issued under the sole responsibility of the manufacturer. |
4. | Object of the declaration (identification of the vessel allowing traceability; it may, where necessary for the identification of the vessel, include an image): |
5. | The object of the declaration described above is in conformity with the relevant Union harmonisation legislation: |
6. | References to the relevant harmonised standards used or references to the other technical specifications in relation to which conformity is declared: |
7. | The notified body … (name, number) performed … (description of intervention) and issued the certificate: |
8. | Additional information: Signed for and on behalf of: (place and date of issue): (name, function) (signature): |
(1) It is optional for the manufacturer to assign a number to the declaration of conformity.
ANNEX V
PART A
Repealed Directive with the amendment thereto
(referred to in Article 43)
Directive 2009/105/EC of the European Parliament and of the Council (OJ L 264, 8.10.2009, p. 12). | |
Regulation (EU) No 1025/2012 of the European Parliament and of the Council (OJ L 316, 14.11.2012, p. 12). | Only point (j) of Article 26(1) |
PART B
Time-limits for transposition into national law and dates of application of the Directives set out in Part B of Annex IV to Directive 2009/105/EC
(referred to in Article 43)
Directive | Time-limits for transposition | Date of application |
87/404/EEC | 31 December 1989 | 1 July 1990 (1) |
90/488/EEC | 1 July 1991 | — |
93/68/EEC | 30 June 1994 | 1 January 1995 (2) |
(1) In accordance with the third subparagraph of Article 18(2) of Directive 87/404/EEC, Member States shall, for the period up to 1 July 1992, permit the placing on the market and/or in service of vessels conforming to the rules in force in their territories before 1 July 1990.
(2) In accordance with Article 14(2) of Directive 93/68/EEC, until 1 January 1997 Member States shall allow the placing on the market and the bringing into service of products which comply with the marking arrangements in force before 1 January 1995.
ANNEX VI
CORRELATION TABLE
Directive 2009/105/EC | This Directive |
Article 1(1) | Article 1(1), introductory wording |
Article 1(2) | Article 1(2) |
Article 1(3)(a) | Article 1(1), points (a) to (e) |
Article 1(3)(b) | — |
Article 2 | Article 3 |
— | Article 2 |
Article 3 | Article 4 |
Article 4 | Article 5 |
— | Article 6 |
— | Article 7 |
— | Article 8 |
— | Article 9 |
— | Article 10 |
— | Article 11 |
— | Article 12 |
Article 5 | — |
Article 6 | — |
Article 7 | — |
Article 8 | — |
— | Article 13 |
Article 9 | — |
Article 10 | — |
Article 11(1) and (2) | — |
Article 11(3) | Annex II, point 2.3 |
Article 12 | — |
Article 13(1) | Annex II, point 3.2.1 |
Article 13(2) | Annex II, point 3.2.2 |
Article 13(3) | — |
Article 14 | — |
— | Article 14 |
— | Article 15 |
— | Article 16 |
— | Article 17 |
— | Article 18 |
— | Article 19 |
— | Article 20 |
— | Article 21 |
— | Article 22 |
— | Article 23 |
— | Article 24 |
— | Article 25 |
— | Article 26 |
— | Article 27 |
— | Article 28 |
— | Article 29 |
— | Article 30 |
— | Article 31 |
— | Article 32 |
— | Article 33 |
Article 15 | — |
Article 16 | — |
Article 17 | — |
— | Article 34 |
— | Article 35 |
— | Article 36 |
— | Article 37 |
— | Article 38 |
— | Article 39 |
— | Article 40 |
— | Article 41 |
Article 18 | Article 42(2) |
— | Article 42(1) |
Article 19 | Article 43 |
Article 20 | Article 44 |
Article 21 | Article 45 |
Annex I | Annex I |
— | Annex II |
Annex II, points 1, 2 and 4 | Annex III |
Annex II, point 3 | Annex II, points 1.3(c), 2.2, 3.2.2 and 4.2(a)(b)(c) |
Annex III | — |
— | Annex IV |
Annex IV | Annex V |
Annex V | Annex VI |
STATEMENT OF THE EUROPEAN PARLIAMENT
The European Parliament considers that only when and insofar as implementing acts in the sense of Regulation (EU) No 182/2011 are discussed in meetings of committees, can the latter be considered as ‘comitology committees’ within the meaning of Annex I to the Framework Agreement on the relations between the European Parliament and the European Commission. Meetings of committees thus fall within the scope of point 15 of the Framework Agreement when and insofar as other issues are discussed.