# Directive 2014/29/EU of the European Parliament and of the CouncilShow full title

Directive 2014/29/EU of the European Parliament and of the Council of 26 February 2014 on the harmonisation of the laws of            the Member States relating to the making available on the market of simple pressure vessels (recast) (Text with EEA relevance)         

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# Directive 2014/29/EU of the European Parliament and of the Council

# of 26 February 2014

# on the harmonisation of the laws of the Member States relating to the making available on the market of simple pressure vessels

# (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,

Having regard to the opinion of the European Economic and Social Committee(1),                        

Acting in accordance with the ordinary legislative procedure(2),                        

Whereas:

(1)Directive 2009/105/EC of the European Parliament and of the Council of 16 September 2009 relating to simple pressure vessels(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 of 9 July 2008 setting out the requirements for                              accreditation and market surveillance relating to the marketing of products(5) lays down rules on the accreditation of conformity assessment 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 of 9 July 2008 on a common framework for the marketing                              of products(6) lays down common principles and reference provisions intended to apply across sectoral legislation in order to provide a                              coherent basis for revision or recasts of that legislation. Directive 2009/105/EC should be adapted to that Decision.

(4)This Directive covers simple pressure vessels which are new to the Union market when they are placed on the market; that is                              to say they are either new simple pressure vessels made by a manufacturer established in the Union or simple pressure vessels,                              whether new or second-hand, imported from a third country.

(5)This Directive should apply to all forms of supply, including distance selling.

(6)Member States should ensure on their territory the protection of the health and safety of persons, and the protection of domestic                              animals and property with regard to the hazards resulting from the leakage or bursting of simple pressure vessels.

(7)Economic operators should be responsible for the compliance of simple pressure vessels with 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 the health                              and safety of persons, and protection of domestic animals and property, and to guarantee fair competition on the Union market.

(8)All economic operators intervening in the supply and distribution chain should take appropriate measures to ensure that they                              only make available on the market simple pressure vessels 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.

(9)In order to facilitate communication between economic operators, market surveillance authorities and end-users, Member States                              should encourage economic operators to include a website address in addition to the postal address.

(10)The manufacturer, having detailed knowledge of the design and production process, is best placed to carry out the conformity                              assessment procedure for simple pressure vessels. Conformity assessment should therefore remain solely the obligation of the                              manufacturer.

(11)It is necessary to ensure that simple pressure vessels from third countries entering the Union market comply with this Directive,                              and in particular that the appropriate conformity assessment procedures have been carried out by manufacturers with regard                              to those simple pressure vessels. Provision should therefore be made for importers to make sure that the simple pressure vessels                              they place on the market comply with the requirements of this Directive and that they do not place on the market simple pressure                              vessels which do not comply with such requirements or present a risk. Provision should also be made for importers to make                              sure that conformity assessment procedures have been carried out and that product marking and documentation drawn up by manufacturers                              are available for inspection by the competent national authorities.

(12)When placing a simple pressure vessel on the market, every importer should indicate on the simple pressure vessel 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 cases where the nature of the simple pressure vessel does not allow it.

(13)The distributor makes a simple pressure vessel available on the market after it has been placed on the market by the manufacturer                              or the importer and should act with due care to ensure that its handling of the simple pressure vessel does not adversely                              affect the compliance of the simple pressure vessel.

(14)Any economic operator that either places a simple pressure vessel on the market under its own name or trade mark or modifies                              a simple pressure vessel in such a way that compliance with this Directive may be affected should be considered to be the                              manufacturer and should assume the obligations of the manufacturer.

(15)Distributors and importers, being close 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 those authorities with all necessary                              information relating to the simple pressure vessel concerned.

(16)Ensuring traceability of a simple pressure vessel throughout the whole supply chain helps to make market surveillance simpler                              and more efficient. An efficient traceability system facilitates the market surveillance authorities’ task of tracing economic                              operators who made non-compliant simple pressure vessels available on the market. 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 a simple pressure vessel or to whom                              they have supplied a simple pressure vessel.

(17)This Directive should be limited to the expression of the essential safety requirements. In order to facilitate conformity                              assessment with those requirements it is necessary to provide for a presumption of conformity for simple pressure vessels                              which are in conformity with harmonised standards that are adopted in accordance with Regulation (EU) No 1025/2012 of the                              European Parliament and of the Council of 25 October 2012 on European Standardisation(7) for the purpose of expressing detailed technical specifications of those requirements.

(18)Regulation (EU) No 1025/2012 provides for a procedure for objections to harmonised standards where those standards do not                              entirely satisfy the requirements of this Directive.

(19)In order to enable economic operators to demonstrate and the competent authorities to ensure that simple pressure vessels                              made available on the market comply with the essential safety requirements, it is necessary to provide for conformity assessment                              procedures. Decision No 768/2008/EC establishes modules for conformity assessment 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-sectoral coherence and to avoid ad-hoc variants, conformity assessment procedures should be chosen from among                              those modules.

(20)Manufacturers should draw up an EU declaration of conformity to provide information required under this Directive on the conformity                              of a simple pressure vessel with this Directive and other relevant Union harmonisation legislation.

(21)To ensure effective access to information for market surveillance purposes, 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.

(22)The CE marking, indicating the conformity of a simple pressure vessel, is the visible consequence of a whole process comprising                              conformity assessment in a broad sense. General principles governing the CE marking and its relationship to other markings                              are set out in Regulation (EC) No 765/2008. Rules governing the affixing of the CE marking should be laid down in this Directive.

(23)A check on compliance with the relevant essential safety requirements is necessary in order to provide effective protection                              for end-users and third parties.

(24)The conformity assessment procedures set out in this Directive require the intervention of conformity assessment bodies, which                              are notified by the Member States to the Commission.

(25)Experience has shown that the criteria set out in Directive 2009/105/EC that conformity assessment bodies have to fulfil to                              be notified to the Commission are not sufficient to ensure a uniformly high level of performance of notified bodies throughout                              the Union. It is, however, essential that all notified bodies perform their functions to the same level and under conditions                              of fair competition. That requires the setting of obligatory requirements for conformity assessment bodies wishing to be notified                              in order to provide conformity assessment services.

(26)If a conformity assessment body demonstrates conformity with the criteria laid down in harmonised standards, it should be                              presumed to comply with the corresponding requirements set out in this Directive.

(27)In order to ensure a consistent level of conformity assessment quality it is also necessary to set requirements for the notifying                              authorities and other bodies involved in the assessment, notification and monitoring of notified bodies.

(28)The system set out in this Directive should be complemented by the accreditation system provided for in Regulation (EC) No 765/2008.                              Since accreditation is an essential means of verifying the competence of conformity assessment bodies, it should also be used                              for the purposes of notification.

(29)Transparent accreditation as provided for in Regulation (EC) No 765/2008, ensuring the necessary level of confidence in certificates                              of conformity, should be considered by the national public authorities throughout the Union as the preferred means of demonstrating                              the technical competence of conformity assessment bodies. However, national authorities may consider that they possess the                              appropriate means of carrying out that evaluation themselves. In such cases, in order to ensure the appropriate level of credibility                              of evaluations carried out by other national authorities, they should provide the Commission and the other Member States with                              the necessary documentary evidence demonstrating the compliance of the conformity assessment bodies evaluated with the relevant                              regulatory requirements.

(30)Conformity assessment bodies frequently subcontract parts of their activities linked to the assessment of conformity or have                              recourse to a subsidiary. In order to safeguard the level of protection required for the simple pressure vessels to be placed                              on the Union market, it is essential that conformity assessment subcontractors and subsidiaries fulfil the same requirements                              as notified bodies in relation to the performance of conformity assessment tasks. Therefore, it is important that the assessment                              of the competence and the performance of bodies to be notified and the monitoring of bodies already notified cover also activities                              carried out by subcontractors and subsidiaries.

(31)It is necessary to increase the efficiency and transparency of the notification procedure and, in particular, to adapt it                              to new technologies so as to enable online notification.

(32)Since notified bodies may offer their services throughout the Union, it is appropriate to give the other Member States and                              the Commission the opportunity to raise objections concerning a notified body. It is therefore important to provide for a                              period during which any doubts or concerns as to the competence of conformity assessment bodies can be clarified before they                              start operating as notified bodies.

(33)In the interests of competitiveness, it is crucial that notified bodies apply the conformity assessment procedures without                              creating unnecessary burdens for economic operators. For the same reason, and to ensure equal treatment of economic operators,                              consistency in the technical application of the conformity assessment procedures needs to be ensured. That can best be achieved                              through appropriate coordination and cooperation between notified bodies.

(34)In order to ensure legal certainty, it is necessary to clarify that rules on Union market surveillance and control of products                              entering the Union market provided for in Regulation (EC) No 765/2008 apply to simple pressure vessels. This Directive should                              not prevent Member States from choosing the competent authorities to carry out those tasks.

(35)Member States should take all appropriate measures to ensure that simple pressure vessels may be placed on the market only                              if, when properly stored and used for their intended purpose, or under conditions of use which can be reasonably foreseen,                              they do not endanger the health and safety of persons. Simple pressure vessels should be considered as non-compliant with                              the essential safety requirements laid down in this Directive only under conditions of use which can be reasonably foreseen,                              that is when such use could result from lawful and readily predictable human behaviour.

(36)Directive 2009/105/EC already provides for a safeguard procedure allowing the Commission to examine the justification for                              a measure taken by a Member State against simple pressure vessels it considers to be non-compliant. In order to increase transparency                              and to reduce processing time, it is necessary to improve the existing safeguard procedure, with the aim of making it more                              efficient and of drawing on the expertise available in the Member States.

(37)The existing system should be supplemented by a procedure under which interested parties are informed of measures intended                              to be taken with regard to simple pressure vessels presenting a risk to the health or safety of persons, or to domestic animals                              or property. It should also allow market surveillance authorities, in cooperation with the relevant economic operators, to                              act at an earlier stage in respect of such simple pressure vessels.

(38)Where the Member States and the Commission agree as to the justification of a measure taken by a Member State, no further                              involvement of the Commission should be required, except where non-compliance can be attributed to shortcomings of a harmonised                              standard.

(39)In order to ensure uniform conditions for the implementation of this Directive, implementing powers should be conferred on                              the Commission. Those powers should be exercised in accordance with Regulation (EU) No 182/2011 of the European Parliament                              and of the Council of 16 February 2011 laying down the rules and general principles concerning mechanisms for control by Member                              States of the Commission’s exercise of implementing powers(8).

(40)The advisory procedure should be used for the adoption of implementing acts requesting the notifying Member State to take                              the necessary corrective measures in respect of notified bodies that do not meet or no longer meet the requirements for their                              notification.

(41)The examination procedure should be used for the adoption of implementing acts with respect to compliant simple pressure vessels                              which present a risk to the health or safety of persons or to other aspects of public interest protection.

(42)The Commission should adopt immediately applicable implementing acts where, in duly justified cases relating to compliant                              simple pressure vessels which present a risk to the health or safety of persons, to domestic animals or to property, imperative                              grounds of urgency so require.

(43)In line with established practice, the committee set up by this Directive can play a useful role in examining matters concerning                              the application of this Directive raised either by its chair or by a representative of a Member State in accordance with its                              rules of procedure.

(44)When matters relating to this Directive, other than its implementation or infringements, are being examined, i.e. in a Commission                              expert group, the European Parliament should in line with existing practice receive full information and documentation and,                              where appropriate, an invitation to attend such meetings.

(45)The Commission should, by means of implementing acts and, given their special nature, acting without the application of Regulation                              (EU) No 182/2011, determine whether measures taken by Member States in respect of non-compliant simple pressure vessels are                              justified or not.

(46)Member States should lay down rules on penalties applicable to infringements of the provisions of national law adopted pursuant                              to this Directive and ensure that those rules are enforced. The penalties provided for should be effective, proportionate                              and dissuasive.

(47)It is necessary to provide for reasonable transitional arrangements that allow the making available on the market and putting                              into service, without the need to comply with further product requirements, of simple pressure vessels that have already been                              placed on the market in accordance with Directive 2009/105/EC before the date of application of national measures transposing                              this Directive. Distributors should therefore be able to supply simple pressure vessels that have been placed on the market,                              namely stock that is already in the distribution chain, before the date of application of national measures transposing this                              Directive.

(48)Since the objective of this Directive, namely to ensure that simple pressure vessels on the market fulfil the requirements                              providing for a high level of protection of health and safety of persons, as well as protection of domestic animals and property                              while guaranteeing the functioning of the internal market, cannot be sufficiently achieved by the Member States, but can rather,                              by reason of its scale and effects, be better achieved at Union level, the Union may adopt measures, in accordance with the                              principle of subsidiarity as set out in Article 5 of the Treaty on European Union. In accordance with the principle of proportionality,                              as set out in that Article, this Directive does not go beyond what is necessary in order to achieve that objective.

(49)The obligation to transpose this Directive into national law should be confined to those provisions which represent a substantive                              amendment as compared to the earlier Directive. The obligation to transpose the provisions which are unchanged arises under                              the earlier Directive.

(50)This Directive should be without prejudice to the obligations of the Member States relating to the time-limits for transposition                              into national law and the dates of application of the Directives set out in Annex V, Part B,

HAVE ADOPTED THIS DIRECTIVE:

## CHAPTER 1U.K.**GENERAL PROVISIONS**

### Article 1U.K.Scope

1.This Directive shall apply to simple pressure vessels (‘vessels’) manufactured in series with the following characteristics:                  

(a)the vessels are welded, intended to be subjected to an internal gauge pressure greater than 0,5 bar and to contain air or                        nitrogen, and are not intended to be fired;                  

(b)the parts and assemblies contributing to the strength of the vessel under pressure are made either of non-alloy quality steel                        or of non-alloy aluminium or non-age hardening aluminium alloys;                  

(c)the vessel is made of either of the following elements:                  

a cylindrical part of circular cross-section closed by outwardly dished and/or flat ends which revolve around the same axis                              as the cylindrical part;                           

two dished ends revolving around the same axis;

(d)the maximum working pressure of the vessel does not exceed 30 bar and the product of that pressure and the capacity of the                        vessel (PS × V) does not exceed 10 000 bar.L;                  

(e)the minimum working temperature is no lower than – 50 °C and the maximum working temperature is not higher than 300 °C for                        steel and 100 °C for aluminium or aluminium alloy vessels.                  

2.This Directive shall not apply to:                  

(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.                  

### Article 2U.K.Definitions

For the purposes of this Directive, the following definitions shall apply:

‘making available on the market’ means any supply of a vessel for distribution or use on the Union market in the course of                              a commercial activity, whether in return for payment or free of charge;                           

‘placing on the market’ means the first making available of a vessel on the Union market;

‘manufacturer’ means any natural or legal person who manufactures a vessel or has a vessel designed or manufactured, and markets                              that vessel under his name or trade mark;                           

‘authorised representative’ means any natural or legal person established within the Union who has received a written mandate                              from a manufacturer to act on his behalf in relation to specified tasks;                           

‘importer’ means any natural or legal person established within the Union who places a vessel from a third country on the                              Union market;                           

‘distributor’ means any natural or legal person in the supply chain, other than the manufacturer or the importer, who makes                              a vessel available on the market;                           

‘economic operators’ means the manufacturer, the authorised representative, the importer and the distributor;

‘technical specification’ means a document that prescribes technical requirements to be fulfilled by a vessel;

‘harmonised standard’ means harmonised standard as defined in point (c) of point 1 of Article 2 of Regulation (EU) No 1025/2012;

‘accreditation’ means accreditation as defined in point 10 of Article 2 of Regulation (EC) No 765/2008;

‘national accreditation body’ means national accreditation body as defined in point 11 of Article 2 of Regulation (EC) No 765/2008;

‘conformity assessment’ means the process demonstrating whether the essential safety requirements of this Directive relating                              to a vessel have been fulfilled;                           

‘conformity assessment body’ means a body that performs conformity assessment activities including calibration, testing, certification                              and inspection;                           

‘recall’ means any measure aimed at achieving the return of a vessel that has already been made available to the end-user;

‘withdrawal’ means any measure aimed at preventing a vessel in the supply chain from being made available on the market;

‘Union harmonisation legislation’ means any Union legislation harmonising the conditions for the marketing of products;

‘CE marking’ means a marking by which the manufacturer indicates that the vessel is in conformity with the applicable requirements                              set out in Union harmonisation legislation providing for its affixing.                           

### Article 3U.K.Making available on the market and putting into service

1.Member States shall take all necessary steps to ensure that the vessels may be made available on the market and put into service                        only if they satisfy the requirements of this Directive 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 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 4U.K.Essential requirements

1.Vessels of which the product of PS × V exceeds 50 bar.L shall satisfy the essential safety requirements set out in Annex I.                  

2.Vessels of which the product of PS × V is 50 bar.L or less shall be designed and manufactured in accordance with the sound                        engineering practice in one of the Member States.                  

### Article 5U.K.Free movement

Member States shall not impede the making available on the market and the putting into service on their territory of vessels                     which satisfy the requirements of this Directive.                  

## CHAPTER 2U.K.**OBLIGATIONS OF ECONOMIC OPERATORS**

### Article 6U.K.Obligations of manufacturers

1.When placing on the market their vessels of which the product of PS × V exceeds 50 bar.L, manufacturers shall ensure that                        they have been designed and manufactured in accordance with the essential safety requirements set out in Annex I.                  

When placing on the market their vessels of which the product of PS × V is 50 bar.L or less, manufacturers shall ensure that                     they have been designed and manufactured in accordance with the sound engineering practice in one of the Member States.                  

2.For vessels of which the product of PS × V exceeds 50 bar.L, manufacturers shall draw up the technical documentation referred                        to in Annex II and carry out the relevant conformity assessment procedure referred to in Article 13 or have it carried out.                  

Where compliance of a vessel of which the product of PS × V exceeds 50 bar.L with the applicable requirements has been demonstrated                     by that procedure, manufacturers shall draw up an EU declaration of conformity and affix the CE marking and the inscriptions                     provided for in point 1 of Annex III.                  

Manufacturers shall ensure that vessels of which the product of PS × V is 50 bar.L or less, bear the inscriptions laid down                     in point 1 of Annex III.                  

3.Manufacturers shall keep the technical documentation and the EU declaration of conformity for 10 years after the vessel has                        been placed on the market.                  

4.Manufacturers shall ensure that procedures are in place for series production to remain in conformity with this Directive.                        Changes in vessels design or characteristics and changes in the harmonised standards or in other technical specifications                        by reference to which conformity of a vessel is declared shall be adequately taken into account.                  

When deemed appropriate with regard to the risks presented by a vessel, manufacturers shall, to protect the health and safety                     of end-users, carry out sample testing of vessels made available on the market, investigate, and, if necessary, keep a register                     of complaints, of non-conforming vessels and vessel recalls, and shall keep distributors informed of any such monitoring.                  

5.Manufacturers shall ensure that vessels which they have placed on the market bear a type and serial or batch identification                        allowing their identification.                  

6.Manufacturers shall indicate on the vessel their name, registered trade name or registered trade mark and the postal address                        at which they can be contacted. The address shall indicate a single point at which the manufacturer can be contacted. The                        contact details shall be in a language easily understood by end-users and market surveillance authorities.                  

7.Manufacturers shall ensure that the vessel is accompanied by the instructions and safety information referred to in point                        2 of Annex III, in a language which can be easily understood by end-users, as determined by the Member State concerned. Such                        instructions and safety information, as well as any labelling, shall be clear, understandable and intelligible.                  

8.Manufacturers who consider or have reason to believe that a vessel which they have placed on the market is not in conformity                        with this Directive shall immediately take the corrective measures necessary to bring that vessel into conformity, to withdraw                        it or recall it, if appropriate. Furthermore, where the vessel presents a risk, manufacturers shall immediately inform the                        competent national authorities of the Member States in which they made the vessel available on the market to that effect,                        giving details, in particular, of the non-compliance and of any corrective measures taken.                  

9.Manufacturers shall, further to a reasoned request from a competent national authority, provide it with all the information                        and documentation in paper or electronic form necessary to demonstrate the conformity of the vessel with this Directive, in                        a language which can be easily understood by that authority. They shall cooperate with that authority, at its request, on                        any action taken to eliminate the risks posed by vessels which they have placed on the market.                  

### Article 7U.K.Authorised representatives

1.A manufacturer may, by a written mandate, appoint an authorised representative.                  

The obligations laid down in Article 6(1) and the obligation to draw up technical documentation referred to in Article 6(2)                     shall not form part of the authorised representative’s mandate.                  

2.An authorised representative shall perform the tasks specified in the mandate received from the manufacturer. The mandate                        shall allow the authorised representative to do at least the following:                  

(a)keep the EU declaration of conformity and the technical documentation at the disposal of national market surveillance authorities                        for 10 years after the vessel has been placed on the market;                  

(b)further to a reasoned request from a competent national authority, provide that authority with all the information and documentation                        necessary to demonstrate the conformity of a vessel;                  

(c)cooperate with the competent national authorities, at their request, on any action taken to eliminate the risks posed by vessels                        covered by the authorised representative’s mandate.                  

### Article 8U.K.Obligations of importers

1.Importers shall place only compliant vessels on the market.                  

2.Before placing on the market a vessel of which the product of PS × V exceeds 50 bar.L, importers shall ensure that the appropriate                        conformity assessment procedure referred to in Article 13 has been carried out by the manufacturer. They shall ensure that                        the manufacturer has drawn up the technical documentation, that the vessel bears the CE marking and the inscriptions provided                        for in point 1 of Annex III and is accompanied by the required documents, and that the manufacturer has complied with the                        requirements set out in Article 6(5) and (6).                  

Where an importer considers or has reason to believe that a vessel of which the product of PS × V exceeds 50 bar.L is not                     in conformity with the essential safety requirements set out in Annex I, he shall not place the vessel on the market until                     it has been brought into conformity. Furthermore, where the vessel presents a risk, the importer shall inform the manufacturer                     and the market surveillance authorities to that effect.                  

Before placing on the market a vessel of which the product of PS × V is 50 bar.L or less, importers shall ensure that it has                     been designed and manufactured in accordance with the sound engineering practice in one of the Member States, bears the inscriptions                     provided for in point 1.2 of Annex III and that the manufacturer has complied with the requirements set out in Article 6(5)                     and (6).                  

3.Importers shall indicate on the vessel their name, registered trade name or registered trade mark and the postal address at                        which they can be contacted or, where that is not possible, in a document accompanying the vessel. The contact details shall                        be in a language easily understood by end-users and market surveillance authorities.                  

4.Importers shall ensure that the vessel is accompanied by the instructions and safety information referred to in point 2 of                        Annex III, in a language which can be easily understood by end-users, as determined by the Member State concerned.                  

5.Importers shall ensure that, while a vessel in respect of which the product of PS × V exceeds 50 bar.L is under their responsibility,                        its storage or transport conditions do not jeopardise its compliance with the essential safety requirements set out in Annex                        I.                  

6.When deemed appropriate with regard to the risks presented by a vessel, importers shall, to protect the health and safety                        of end-users, carry out sample testing of vessels made available on the market, investigate, and, if necessary, keep a register                        of complaints, of non-conforming vessels and vessel recalls, and shall keep distributors informed of any such monitoring.                  

7.Importers who consider or have reason to believe that a vessel which they have placed on the market is not in conformity with                        this Directive shall immediately take the corrective measures necessary to bring that vessel into conformity, to withdraw                        it or recall it, if appropriate. Furthermore, where the vessel presents a risk, importers shall immediately inform the competent                        national authorities of the Member States in which they made the vessel available on the market to that effect, giving details,                        in particular, of the non-compliance and of any corrective measures taken.                  

8.For vessels of which the product of PS × V exceeds 50 bar.L, importers shall, for 10 years after the vessel has been placed                        on the market, keep a copy of the EU declaration of conformity at the disposal of the market surveillance authorities and                        ensure that the technical documentation can be made available to those authorities, upon request.                  

9.Importers shall, further to a reasoned request from a competent national authority, provide it with all the information and                        documentation in paper or electronic form necessary to demonstrate the conformity of a vessel in a language which can be easily                        understood by that authority. They shall cooperate with that authority, at its request, on any action taken to eliminate the                        risks posed by vessels which they have placed on the market.                  

### Article 9U.K.Obligations of distributors

1.When making a vessel available on the market distributors shall act with due care in relation to the requirements of this                        Directive.                  

2.Before making available on the market a vessel of which the product of PS × V exceeds 50 bar.L, distributors shall verify                        that the vessel bears the CE marking and the inscriptions provided for in point 1 of Annex III, that it is accompanied by                        the required documents and by instructions and safety information referred to in point 2 of Annex III in a language which                        can be easily understood by end-users in the Member State in which the vessel is to be made available on the market, and that                        the manufacturer and the importer have complied with the requirements set out in Article 6(5) and (6) and Article 8(3) respectively.                  

Where a distributor considers or has reason to believe that a vessel of which the product of PS × V exceeds 50 bar.L is not                     in conformity with the essential safety requirements set out in Annex I, he shall not make the vessel available on the market                     until it has been brought into conformity. Furthermore, where the vessel presents a risk, the distributor shall inform the                     manufacturer or the importer to that effect as well as the market surveillance authorities.                  

Before making available on the market a vessel of which the product of PS × V is 50 bar.L or less, distributors shall verify                     that the vessel bears the inscriptions provided for in point 1.2 of Annex III and is accompanied by the instructions and safety                     information referred to in point 2 of Annex III in a language which can be easily understood by end-users in the Member State                     in which the vessel is to be made available on the market, and that the manufacturer and the importer have complied with the                     requirements set out in Article 6(5) and (6) and Article 8(3) respectively.                  

3.Distributors shall ensure that, while a vessel of which the product of PS × V exceeds 50 bar.L is under their responsibility,                        its storage or transport conditions do not jeopardise its compliance with the essential safety requirements set out in Annex                        I.                  

4.Distributors who consider or have reason to believe that a vessel which they have made available on the market is not in conformity                        with this Directive shall make sure that the corrective measures necessary to bring that vessel into conformity, to withdraw                        it or recall it, if appropriate, are taken. Furthermore, where the vessel presents a risk, distributors shall immediately                        inform the competent national authorities of the Member States in which they made the vessel available on the market to that                        effect, giving details, in particular, of the non-compliance and of any corrective measures taken.                  

5.Distributors shall, further to a reasoned request from a competent national authority, provide it with all the information                        and documentation in paper or electronic form necessary to demonstrate the conformity of a vessel. They shall cooperate with                        that authority, at its request, on any action taken to eliminate the risks posed by vessels which they have made available                        on the market.                  

### Article 10U.K.Cases in which obligations of manufacturers apply to importers and distributors

An importer or distributor shall be considered a manufacturer for the purposes of this Directive and he shall be subject to                     the obligations of the manufacturer under Article 6, where he places a vessel on the market under his name or trade mark or                     modifies a vessel already placed on the market in such a way that compliance with this Directive may be affected.                  

### Article 11U.K.Identification of economic operators

Economic operators shall, on request, identify the following to the market surveillance authorities:

any economic operator who has supplied them with a vessel;

any economic operator to whom they have supplied a vessel.

Economic operators shall be able to present the information referred to in the first paragraph for 10 years after they have                     been supplied with the vessel and for 10 years after they have supplied the vessel.                  

## CHAPTER 3U.K.**CONFORMITY OF VESSELS OF WHICH THE PRODUCT OF PS × V EXCEEDS 50 bar.L**

### Article 12U.K.Presumption of conformity of vessels of which the product of PS × V exceeds 50 bar.L

Vessels of which the product of PS × V exceeds 50 bar.L and which are in conformity with harmonised standards or parts thereof                     the references of which have been published in the *Official Journal of the European Union* shall be presumed to be in conformity with the essential safety requirements set out in Annex I covered by those standards                     or parts thereof.                  

### Article 13U.K.Conformity assessment procedures

1.Prior to their manufacture, vessels of which the product of PS × V exceeds 50 bar.L shall be subject to the EU-type examination                        (Module B) set out to in point 1 of Annex II, as follows:                  

(a)for vessels manufactured in accordance with the harmonised standards referred to in Article 12, at the choice of the manufacturer,                        in either of the following two manners:                  

assessment of the adequacy of the technical design of the vessel through examination of the technical documentation and supporting                              evidence without examination of a specimen (Module B – design type);                           

assessment of the adequacy of the technical design of the vessel through examination of the technical documentation and supporting                              evidence, plus examination of a prototype, representative of the production envisaged, of the complete vessel (Module B –                              production type).                           

(b)for vessels not manufactured, or manufactured only partly, in accordance with the harmonised standards referred to in Article                        12, the manufacturer shall submit for examination a prototype, representative of the production envisaged, of the complete                        vessel and the technical documentation and supporting evidence for examination and assessment of the adequacy of the technical                        design of the vessel (Module B – production type).                  

2.Prior to their placing on the market, vessels shall be subject to the following procedures:                  

(a)where the product of PS × V exceeds 3 000 bar.L, to conformity to type based on internal production control plus supervised                        vessel testing (Module C1) set out in point 2 of Annex II;                  

(b)where the product of PS × V does not exceed 3 000 bar.L but exceeds 200 bar.L, at the choice of the manufacturer, to either                        of the following:                  

conformity to type based on internal production control plus supervised vessel testing (Module C1) set out in point 2 of Annex                              II;                           

conformity to type based on internal production control plus supervised vessel checks at random intervals (Module C2) set                              out in point 3 Annex II;                           

(c)where the product of PS × V does not exceed 200 bar.L but exceeds 50 bar.L, at the choice of the manufacturer, to either of                        the following:                  

conformity to type based on internal production control plus supervised vessel testing (Module C1) set out in point 2 of Annex                              II;                           

conformity to type based on internal production control (Module C) set out in point 4 of Annex II.

3.The records and correspondence relating to the conformity assessment procedures referred to in paragraphs 1 and 2 shall be                        drawn up in an official language of the Member State in which the notified body is established or in a language accepted by                        that body.                  

### Article 14U.K.EU declaration of conformity

1.The EU declaration of conformity shall state that the fulfilment of the essential safety requirements set out in Annex I has                        been demonstrated.                  

2.The EU declaration of conformity shall have the model structure set out in Annex IV, shall contain the elements specified                        in the relevant modules set out in Annex II and shall be continuously updated. It shall be translated into the language or                        languages required by the Member State in which the vessel is placed or made available on the market.                  

3.Where a vessel is subject to more than one Union act requiring an EU declaration of conformity, a single EU declaration of                        conformity shall be drawn up in respect of all such Union acts. That declaration shall contain the identification of the Union                        acts concerned including their publication references.                  

4.By drawing up the EU declaration of conformity, the manufacturer shall assume responsibility for the compliance of the vessel                        with the requirements laid down in this Directive.                  

### Article 15U.K.General principles of the CE marking

The CE marking shall be subject to the general principles set out in Article 30 of Regulation (EC) No 765/2008.

### Article 16U.K.Rules and conditions for affixing the CE marking and inscriptions

1.The CE marking and the inscriptions referred to in point 1 of Annex III shall be affixed visibly, legibly and indelibly to                        the vessel or to its data plate.                  

2.The CE marking shall be affixed before the vessel is placed on the market.                  

3.The CE marking shall be followed by the identification number of the notified body involved in the production control phase.                  

The identification number of the notified body shall be affixed by the body itself or, under its instructions, by the manufacturer                     or his authorised representative.                  

4.The CE marking and the identification number of the notified body may be followed by any other mark indicating a special risk                        or use.                  

5.Member States shall build upon existing mechanisms to ensure correct application of the regime governing the CE marking and                        shall take appropriate action in the event of improper use of that marking.                  

## CHAPTER 4U.K.**NOTIFICATION OF CONFORMITY ASSESSMENT BODIES**

### Article 17U.K.Notification

Member States shall notify the Commission and the other Member States of bodies authorised to carry out third-party conformity                     assessment tasks under this Directive.                  

### Article 18U.K.Notifying authorities

1.Member States shall designate a notifying authority that shall be responsible for setting up and carrying out the necessary                        procedures for the assessment and notification of conformity assessment bodies and the monitoring of notified bodies, including                        compliance with the provisions of Article 23.                  

2.Member States may decide that the assessment and monitoring referred to in paragraph 1 shall be carried out by a national                        accreditation body within the meaning of and in accordance with Regulation (EC) No 765/2008.                  

3.Where the notifying authority delegates or otherwise entrusts the assessment, notification or monitoring referred to in paragraph                        1 to a body which is not a governmental entity, that body shall be a legal entity and shall comply mutatis mutandis with the                        requirements laid down in Article 19. In addition it shall have arrangements to cover liabilities arising out of its activities.                  

4.The notifying authority shall take full responsibility for the tasks performed by the body referred to in paragraph 3.                  

### Article 19U.K.Requirements relating to notifying authorities

1.A notifying authority shall be established in such a way that no conflict of interest with conformity assessment bodies occurs.                  

2.A notifying authority shall be organised and operated so as to safeguard the objectivity and impartiality of its activities.                  

3.A notifying authority shall be organised in such a way that each decision relating to notification of a conformity assessment                        body is taken by competent persons different from those who carried out the assessment.                  

4.A notifying authority shall not offer or provide any activities that conformity assessment bodies perform or consultancy services                        on a commercial or competitive basis.                  

5.A notifying authority shall safeguard the confidentiality of the information it obtains.                  

6.A notifying authority shall have a sufficient number of competent personnel at its disposal for the proper performance of                        its tasks.                  

### Article 20U.K.Information obligation on notifying authorities

Member States shall inform the Commission of their procedures for the assessment and notification of conformity assessment                     bodies and the monitoring of notified bodies, and of any changes thereto.                  

The Commission shall make that information publicly available.

### Article 21U.K.Requirements relating to notified bodies

1.For the purposes of notification, a conformity assessment body shall meet the requirements laid down in paragraphs 2 to 11.                  

2.A conformity assessment body shall be established under the national law of a Member State and have legal personality.                  

3.A conformity assessment body shall be a third-party body independent of the organisation or the vessel it assesses.                  

A body belonging to a business association or professional federation representing undertakings involved in the design, manufacturing,                     provision, assembly, use or maintenance of vessels which it assesses, may, on condition that its independence and the absence                     of any conflict of interest are demonstrated, be considered such a body.                  

4.A conformity assessment body, its top level management and the personnel responsible for carrying out the conformity assessment                        tasks shall not be the designer, manufacturer, supplier, installer, purchaser, owner, user or maintainer of the vessels which                        they assess, nor the representative of any of those parties. This shall not preclude the use of assessed vessels that are                        necessary for the operations of the conformity assessment body or the use of such vessels for personal purposes.                  

A conformity assessment body, its top level management and the personnel responsible for carrying out the conformity assessment                     tasks shall not be directly involved in the design, manufacture or construction, the marketing, installation, use or maintenance                     of those vessels, or represent the parties engaged in those activities. They shall not engage in any activity that may conflict                     with their independence of judgement or integrity in relation to conformity assessment activities for which they are notified.                     This shall in particular apply to consultancy services.                  

Conformity assessment bodies shall ensure that the activities of their subsidiaries or subcontractors do not affect the confidentiality,                     objectivity or impartiality of their conformity assessment activities.                  

5.Conformity assessment bodies and their personnel shall carry out the conformity assessment activities with the highest degree                        of professional integrity and the requisite technical competence in the specific field and shall be free from all pressures                        and inducements, particularly financial, which might influence their judgement or the results of their conformity assessment                        activities, especially as regards persons or groups of persons with an interest in the results of those activities.                  

6.A conformity assessment body shall be capable of carrying out all the conformity assessment tasks assigned to it by point                        3.2 of Annex I and by Annex II and in relation to which it has been notified, whether those tasks are carried out by the conformity                        assessment body itself or on its behalf and under its responsibility.                  

At all times and for each conformity assessment procedure and each kind of vessel in relation to which it has been notified,                     a conformity assessment body shall have at its disposal the necessary:                  

(a)personnel with technical knowledge and sufficient and appropriate experience to perform the conformity assessment tasks;                  

(b)descriptions of procedures in accordance with which conformity assessment is carried out, ensuring the transparency and the                        ability of reproduction of those procedures. It shall have appropriate policies and procedures in place that distinguish between                        tasks it carries out as a notified body and other activities;                  

(c)procedures for the performance of activities which take due account of the size of an undertaking, the sector in which it                        operates, its structure, the degree of complexity of the product technology in question and the mass or serial nature of the                        production process.                  

A conformity assessment body shall have the means necessary to perform the technical and administrative tasks connected with                     the conformity assessment activities in an appropriate manner and shall have access to all necessary equipment or facilities.                  

7.The personnel responsible for carrying out conformity assessment tasks shall have the following:                  

(a)sound technical and vocational training covering all the conformity assessment activities in relation to which the conformity                        assessment body has been notified;                  

(b)satisfactory knowledge of the requirements of the assessments they carry out and adequate authority to carry out those assessments;                  

(c)appropriate knowledge and understanding of the essential safety requirements set out in Annex I, of the applicable harmonised                        standards and of the relevant provisions of Union harmonisation legislation and of national legislation;                  

(d)the ability to draw up certificates, records and reports demonstrating that assessments have been carried out.                  

8.The impartiality of the conformity assessment bodies, their top level management and of the personnel responsible for carrying                        out the conformity assessment tasks shall be guaranteed.                  

The remuneration of the top level management and personnel responsible for carrying out the conformity assessment tasks of                     a conformity assessment body shall not depend on the number of assessments carried out or on the results of those assessments.                  

9.Conformity assessment bodies shall take out liability insurance unless liability is assumed by the State in accordance with                        national law, or the Member State itself is directly responsible for the conformity assessment.                  

10.The personnel of a conformity assessment body shall observe professional secrecy with regard to all information obtained in                        carrying out their tasks under point 3.2 of Annex I and under Annex II or any provision of national law giving effect to it,                        except in relation to the competent authorities of the Member State in which its activities are carried out. Proprietary rights                        shall be protected.                  

11.Conformity assessment bodies shall participate in, or ensure that their personnel responsible for carrying out the conformity                        assessment tasks are informed of, the relevant standardisation activities and the activities of the notified body coordination                        group established under the relevant Union harmonisation legislation and shall apply as general guidance the administrative                        decisions and documents produced as a result of the work of that group.                  

### Article 22U.K.Presumption of conformity of notified bodies

Where a conformity assessment body demonstrates its conformity with the criteria laid down in the relevant harmonised standards                     or parts thereof the references of which have been published in the *Official Journal of the European Union* it shall be presumed to comply with the requirements set out in Article 21 insofar as the applicable harmonised standards                     cover those requirements.                  

### Article 23U.K.Subsidiaries of and subcontracting by notified bodies

1.Where a notified body subcontracts specific tasks connected with conformity assessment or has recourse to a subsidiary, it                        shall ensure that the subcontractor or the subsidiary meets the requirements set out in Article 21 and shall inform the notifying                        authority accordingly.                  

2.Notified bodies shall take full responsibility for the tasks performed by subcontractors or subsidiaries wherever these are                        established.                  

3.Activities may be subcontracted or carried out by a subsidiary only with the agreement of the client.                  

4.Notified bodies shall keep at the disposal of the notifying authority the relevant documents concerning the assessment of                        the qualifications of the subcontractor or the subsidiary and the work carried out by them under point 3.2 of Annex I and                        under Annex II.                  

### Article 24U.K.Application for notification

1.A conformity assessment body shall submit an application for notification to the notifying authority of the Member State in                        which it is established.                  

2.The application for notification shall be accompanied by a description of the conformity assessment activities, the conformity                        assessment module or modules and the vessel or vessels for which that body claims to be competent, as well as by an accreditation                        certificate, where one exists, issued by a national accreditation body attesting that the conformity assessment body fulfils                        the requirements laid down in Article 21.                  

3.Where the conformity assessment body concerned cannot provide an accreditation certificate, it shall provide the notifying                        authority with all the documentary evidence necessary for the verification, recognition and regular monitoring of its compliance                        with the requirements laid down in Article 21.                  

### Article 25U.K.Notification procedure

1.Notifying authorities may notify only conformity assessment bodies which have satisfied the requirements laid down in Article                        21.                  

2.They shall notify the Commission and the other Member States using the electronic notification tool developed and managed                        by the Commission.                  

3.The notification shall include full details of the conformity assessment activities, the conformity assessment module or modules                        and vessel or vessels concerned and the relevant attestation of competence.                  

4.Where a notification is not based on an accreditation certificate as referred to in Article 24(2), the notifying authority                        shall provide the Commission and the other Member States with documentary evidence which attests to the conformity assessment                        body’s competence and the arrangements in place to ensure that that body will be monitored regularly and will continue to                        satisfy the requirements laid down in Article 21.                  

5.The body concerned may perform the activities of a notified body only where no objections are raised by the Commission or                        the other Member States within two weeks of a notification where an accreditation certificate is used or within two months                        of a notification where accreditation is not used.                  

Only such a body shall be considered a notified body for the purposes of this Directive.

6.The notifying authority shall notify the Commission and the other Member States of any subsequent relevant changes to the                        notification.                  

### Article 26U.K.Identification numbers and lists of notified bodies

1.The Commission shall assign an identification number to a notified body.                  

It shall assign a single such number even where the body is notified under several Union acts.

2.The Commission shall make publicly available the list of the bodies notified under this Directive, including the identification                        numbers that have been assigned to them and the activities for which they have been notified.                  

The Commission shall ensure that the list is kept up to date.

### Article 27U.K.Changes to notifications

1.Where a notifying authority has ascertained or has been informed that a notified body no longer meets the requirements laid                        down in Article 21, or that it is failing to fulfil its obligations, the notifying authority shall restrict, suspend or withdraw                        notification as appropriate, depending on the seriousness of the failure to meet those requirements or fulfil those obligations.                        It shall immediately inform the Commission and the other Member States accordingly.                  

2.In the event of restriction, suspension or withdrawal of notification, or where the notified body has ceased its activity,                        the notifying Member State shall take appropriate steps to ensure that the files of that body are either processed by another                        notified body or kept available for the responsible notifying and market surveillance authorities at their request.                  

### Article 28U.K.Challenge of the competence of notified bodies

1.The Commission shall investigate all cases where it doubts, or doubt is brought to its attention regarding the competence                        of a notified body or the continued fulfilment by a notified body of the requirements and responsibilities to which it is                        subject.                  

2.The notifying Member State shall provide the Commission, on request, with all information relating to the basis for the notification                        or the maintenance of the competence of the notified body concerned.                  

3.The Commission shall ensure that all sensitive information obtained in the course of its investigations is treated confidentially.                  

4.Where the Commission ascertains that a notified body does not meet or no longer meets the requirements for its notification,                        it shall adopt an implementing act requesting the notifying Member State to take the necessary corrective measures, including                        withdrawal of notification if necessary.                  

That implementing act shall be adopted in accordance with the advisory procedure referred to in Article 39(2).

### Article 29U.K.Operational obligations of notified bodies

1.Notified bodies shall carry out conformity assessments in accordance with the conformity assessment procedures provided for                        in Annex II.                  

2.Conformity assessments shall be carried out in a proportionate manner, avoiding unnecessary burdens for economic operators.                  

Conformity assessment bodies shall perform their activities taking due account of the size of an undertaking, the sector in                     which it operates, its structure, the degree of complexity of the vessel technology in question and the mass or serial nature                     of the production process.                  

In so doing they shall nevertheless respect the degree of rigour and the level of protection required for the compliance of                     the vessel with this Directive.                  

3.Where a notified body finds that the essential safety requirements set out in Annex I or corresponding harmonised standards                        or other technical specifications have not been met by a manufacturer, it shall require that manufacturer to take appropriate                        corrective measures and shall not issue a certificate of conformity.                  

4.Where, in the course of the monitoring of conformity following the issue of a certificate, a notified body finds that a vessel                        no longer complies, it shall require the manufacturer to take appropriate corrective measures and shall suspend or withdraw                        the certificate if necessary.                  

5.Where corrective measures are not taken or do not have the required effect, the notified body shall restrict, suspend or withdraw                        any certificates, as appropriate.                  

### Article 30U.K.Appeal against decisions of notified bodies

Member States shall ensure that an appeal procedure against decisions of the notified bodies is available.

### Article 31U.K.Information obligation on notified bodies

1.Notified bodies shall inform the notifying authority of the following:                  

(a)any refusal, restriction, suspension or withdrawal of a certificate;                  

(b)any circumstances affecting the scope of or conditions for notification;                  

(c)any request for information which they have received from market surveillance authorities regarding conformity assessment                        activities;                  

(d)on request, conformity assessment activities performed within the scope of their notification and any other activity performed,                        including cross-border activities and subcontracting.                  

2.Notified bodies shall provide the other bodies notified under this Directive carrying out similar conformity assessment activities                        covering the same vessels with relevant information on issues relating to negative and, on request, positive conformity assessment                        results.                  

### Article 32U.K.Exchange of experience

The Commission shall provide for the organisation of exchange of experience between the Member States’ national authorities                     responsible for notification policy.                  

### Article 33U.K.Coordination of notified bodies

The Commission shall ensure that appropriate coordination and cooperation between bodies notified under this Directive are                     put in place and properly operated in the form of a sectoral group or groups of notified bodies.                  

Member States shall ensure that the bodies notified by them participate in the work of that or those group or groups, directly                     or by means of designated representatives.                  

## CHAPTER 5U.K.**UNION MARKET SURVEILLANCE, CONTROL OF VESSELS ENTERING THE UNION MARKET AND UNION SAFEGUARD PROCEDURE**

### Article 34U.K.Union market surveillance and control of vessels entering the Union market

Article 15(3) and Articles 16 to 29 of Regulation (EC) No 765/2008 shall apply to vessels covered by Article 1 of this Directive.

### Article 35U.K.Procedure for dealing with vessels presenting a risk at national level

1.Where the market surveillance authorities of one Member State have sufficient reason to believe that a vessel covered by this                        Directive presents a risk to the health or safety of persons, or to domestic animals or property, they shall carry out an                        evaluation in relation to the vessel concerned covering all relevant requirements laid down in this Directive. The relevant                        economic operators shall cooperate as necessary with the market surveillance authorities for that purpose.                  

Where, in the course of the evaluation referred to in the first subparagraph, the market surveillance authorities find that                     the vessel does not comply with the requirements laid down in this Directive, they shall without delay require the relevant                     economic operator to take all appropriate corrective actions to bring the vessel into compliance with those requirements,                     to withdraw the vessel from the market, or to recall it within a reasonable period, commensurate with the nature of the risk,                     as they may prescribe.                  

The market surveillance authorities shall inform the relevant notified body accordingly.

Article 21 of Regulation (EC) No 765/2008 shall apply to the measures referred to in the second subparagraph of this paragraph.

2.Where the market surveillance authorities consider that non-compliance is not restricted to their national territory, they                        shall inform the Commission and the other Member States of the results of the evaluation and of the actions which they have                        required the economic operator to take.                  

3.The economic operator shall ensure that all appropriate corrective action is taken in respect of all the vessels concerned                        that it has made available on the market throughout the Union.                  

4.Where the relevant economic operator does not take adequate corrective action within the period referred to in the second                        subparagraph of paragraph 1, the market surveillance authorities shall take all appropriate provisional measures to prohibit                        or restrict the vessel’s being made available on their national market, to withdraw the vessel from that market or to recall                        it.                  

The market surveillance authorities shall inform the Commission and the other Member States, without delay, of those measures.

5.The information referred to in the second subparagraph of paragraph 4 shall include all available details, in particular the                        data necessary for the identification of the non-compliant vessel, the origin of the vessel, the nature of the non-compliance                        alleged and the risk involved, the nature and duration of the national measures taken and the arguments put forward by the                        relevant economic operator. In particular, the market surveillance authorities shall indicate whether the non-compliance is                        due to either of the following:                  

(a)failure of the vessel to meet requirements relating to the health or safety of persons, to the protection of domestic animals                        or property; or                  

(b)shortcomings in the harmonised standards referred to in Article 12 conferring a presumption of conformity.                  

6.Member States other than the Member State initiating the procedure under this Article shall without delay inform the Commission                        and the other Member States of any measures adopted and of any additional information at their disposal relating to the non-compliance                        of the vessel concerned, and, in the event of disagreement with the adopted national measure, of their objections.                  

7.Where, within three months of receipt of the information referred to in the second subparagraph of paragraph 4, no objection                        has been raised by either a Member State or the Commission in respect of a provisional measure taken by a Member State, that                        measure shall be deemed justified.                  

8.Member States shall ensure that appropriate restrictive measures, such as withdrawal of the vessel from the market, are taken                        in respect of the vessel concerned without delay.                  

### Article 36U.K.Union safeguard procedure

1.Where, on completion of the procedure set out in Article 35(3) and (4), objections are raised against a measure taken by a                        Member State, or where the Commission considers a national measure to be contrary to Union legislation, the Commission shall                        without delay enter into consultation with the Member States and the relevant economic operator or operators and shall evaluate                        the national measure. On the basis of the results of that evaluation, the Commission shall adopt an implementing act determining                        whether the national measure is justified or not.                  

The Commission shall address its decision to all Member States and shall immediately communicate it to them and the relevant                     economic operator or operators.                  

2.If the national measure is considered justified, all Member States shall take the necessary measures to ensure that the non-compliant                        vessel is withdrawn from their market, and shall inform the Commission accordingly. If the national measure is considered                        unjustified, the Member State concerned shall withdraw that measure.                  

3.Where the national measure is considered justified and the non-compliance of the vessel is attributed to shortcomings in the                        harmonised standards referred to in point (b) of Article 35(5) of this Directive, the Commission shall apply the procedure                        provided for in Article 11 of Regulation (EU) No 1025/2012.                  

### Article 37U.K.Compliant vessels which present a risk

1.Where, having carried out an evaluation under Article 35(1), a Member State finds that although a vessel is in compliance                        with this Directive, it presents a risk to the health or safety of persons, to domestic animals or property, it shall require                        the relevant economic operator to take all appropriate measures to ensure that the vessel concerned, when placed on the market,                        no longer presents that risk, to withdraw the vessel from the market or to recall it within a reasonable period, commensurate                        with the nature of the risk, as it may prescribe.                  

2.The economic operator shall ensure that corrective action is taken in respect of all the vessels concerned that he has made                        available on the market throughout the Union.                  

3.The Member State shall immediately inform the Commission and the other Member States. That information shall include all available                        details, in particular the data necessary for the identification of the vessel concerned, the origin and the supply chain                        of the vessel, the nature of the risk involved and the nature and duration of the national measures taken.                  

4.The Commission shall without delay enter into consultation with the Member States and the relevant economic operator or operators                        and shall evaluate the national measures taken. On the basis of the results of that evaluation, the Commission shall decide                        by means of implementing acts whether the national measure is justified or not and, where necessary, propose appropriate measures.                  

The implementing acts referred to in the first subparagraph of this paragraph shall be adopted in accordance with the examination                     procedure referred to in Article 39(3).                  

On duly justified imperative grounds of urgency relating to the protection of health and safety of persons, or of domestic                     animals or of property, the Commission shall adopt immediately applicable implementing acts in accordance with the procedure                     referred to in Article 39(4).                  

5.The Commission shall address its decision to all Member States and shall immediately communicate it to them and the relevant                        economic operator or operators.                  

### Article 38U.K.Formal non-compliance

1.Without prejudice to Article 35, where a Member State makes one of the following findings, it shall require the relevant economic                        operator to put an end to the non-compliance concerned:                  

(a)the CE marking has been affixed in violation of Article 30 of Regulation (EC) No 765/2008 or of Article 16 of this Directive;                  

(b)the CE marking has not been affixed;                  

(c)the identification number of the notified body involved in the production control phase has been affixed in violation of Article                        16 or has not been affixed;                  

(d)the inscriptions referred to in point 1 of Annex III have not been affixed or have been affixed in violation of Article 16                        or point 1 of Annex III;                  

(e)the EU declaration of conformity has not been drawn up;                  

(f)the EU declaration of conformity has not been drawn up correctly;                  

(g)the technical documentation is either not available or not complete.                  

(h)the information referred to in Article 6(6) or Article 8(3) is absent, false or incomplete;                  

(i)any other administrative requirement provided for in Article 6 or Article 8 is not fulfilled.                  

2.Where the non-compliance referred to in paragraph 1 persists, the Member State concerned shall take all appropriate measures                        to restrict or prohibit the vessel being made available on the market or ensure that it is recalled or withdrawn from the                        market.                  

## CHAPTER 6U.K.**COMMITTEE, TRANSITIONAL AND FINAL PROVISIONS**

### Article 39U.K.Committee procedure

1.The Commission shall be assisted by the Committee on Simple Pressure Vessels. That committee shall be a committee within the                        meaning of Regulation (EU) No 182/2011.                  

2.Where reference is made to this paragraph, Article 4 of Regulation (EU) No 182/2011 shall apply.                  

3.Where reference is made to this paragraph, Article 5 of Regulation (EU) No 182/2011 shall apply.                  

4.Where reference is made to this paragraph, Article 8 of Regulation (EU) No 182/2011, in conjunction with Article 5 thereof,                        shall apply.                  

5.The committee shall be consulted by the Commission on any matter for which consultation of sectoral experts is required by                        Regulation (EU) No 1025/2012 or by any other Union legislation.                  

The committee may furthermore examine any other matter concerning the application of this Directive raised either by its chair                     or by a representative of a Member State in accordance with its rules of procedure.                  

### Article 40U.K.Penalties

Member States shall lay down rules on penalties applicable to infringements by economic operators of the provisions of national                     law adopted pursuant to this Directive and shall take all measures necessary to ensure that they are enforced. Such rules                     may include criminal penalties for serious infringements.                  

The penalties provided for shall be effective, proportionate and dissuasive.

### Article 41U.K.Transitional provisions

Member States shall not impede the making available on the market and/or the putting into service of vessels covered by Directive                     2009/105/EC which are in conformity with that Directive and which were placed on the market before 20 April 2016.                  

Certificates issued by approved inspection bodies under Directive 2009/105/EC shall be valid under this Directive.

### Article 42U.K.Transposition

1.Member States shall adopt and publish by 19 April 2016, the laws, regulations and administrative provisions necessary to comply                        with Article 2, Articles 6 to 41, Annex II and Annex IV. They shall forthwith communicate the text of those measures to the                        Commission.                  

They shall apply those measures from 20 April 2016.

When Member States adopt those measures, they shall contain a reference to this Directive or be accompanied by such a reference                     on the occasion of their official publication. They shall also include a statement that references in existing laws, regulations                     and administrative provisions to the Directive repealed by this Directive shall be construed as references to this Directive.                     Member States shall determine how such reference is to be made and how that statement is to be formulated.                  

2.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 43U.K.Repeal

Directive 2009/105/EC, as amended by the Regulation listed in Annex V, Part A, is repealed with effect from 20 April 2016,                     without prejudice to the obligations of the Member States relating to the time limits for transposition into national law                     and the dates of application of the Directives set out in Annex V, 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 VI.                  

### Article 44U.K.Entry into force and application

This Directive shall enter into force on the twentieth day following that of its publication in the *Official Journal of the European Union*.                  

Articles 1, 3, 4 and 5 and Annexes I and III shall apply from 20 April 2016.

### Article 45U.K.Addressees

This Directive is addressed to the Member States.

Done at Strasbourg, 26 February 2014.

*For the European Parliament*                            

*The President*                            

M. Schulz                            

*For the Council*                            

*The President*                            

D. Kourkoulas                            

## ANNEX IU.K.ESSENTIAL SAFETY REQUIREMENTS

### 1.**Materials**U.K.

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*U.K.

The materials used for manufacturing the pressurised parts of the vessels shall be:

capable of being welded;

ductile and tough, so that a rupture at minimum working temperature does not give rise to either fragmentation or brittle-type                              fracture;                           

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*U.K.

Non-alloy quality steels shall meet the following requirements:

they shall be non-effervescent and supplied after normalisation treatment, or in an equivalent state;

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 %;

they shall have the following mechanical properties per product:

the maximum tensile strength Rm,max shall be less than 580 N/mm2;                                    

the elongation after fracture shall be:

if test pieces are taken parallel to the direction of rolling:

if test pieces are taken perpendicular to the direction of rolling:

the average bending rupture energy KCV for three longitudinal test pieces at minimum working temperature shall not be less                                       than 35 J/cm2. Not more than one of the three figures may be less than 35 J/cm2, with a minimum of 25 J/cm2. In the case of steels intended to be used in the manufacture of vessels the minimum working temperature of which is lower                                       than – 10 °C and the wall thickness of which exceeds 5 mm, this property shall be checked.                                    

##### 1.1.2.*Aluminium vessels*U.K.

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:

they shall be supplied in an annealed state;

they shall have the following mechanical characteristics per product:
                -  the maximum tensile strength Rm,max shall be no more than 350 N/mm2,                                  
                -  the elongation after fracture shall be:                    -  A ≥ 16 % if the test piece is taken parallel to the direction of rolling, 
                  -  A ≥ 14 % if the test piece is taken perpendicular to the direction of rolling. 

#### 1.2.*Welding materials*U.K.

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*U.K.

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*U.K.

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**U.K.

The manufacturer shall, when designing the vessel, define the use to which it will be put, and select:

the minimum working temperature Tmin;                                    

the maximum working temperature Tmax;                                    

the maximum working pressure PS.

However, should a minimum working temperature exceeding – 10 °C be selected, the qualities required of the materials shall                              be satisfied at – 10 °C.                           

The manufacturer shall also take account of the following provisions:

it shall be possible to inspect the inside of vessels;

it shall be possible to drain the vessels;

the mechanical qualities shall be maintained throughout the period of use of the vessel for the intended purpose;

the vessels shall, bearing in mind their prescribed use, be adequately protected against corrosion.

The manufacturer shall take account of the fact that under the conditions of use envisaged:

the vessels shall not be subjected to stresses likely to impair their safety in use;

internal pressure shall not permanently exceed the maximum working pressure PS. However, it may momentarily do so by up to                                       10 %.                                    

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*U.K.

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*U.K.

The minimum thickness of pressurised parts shall be calculated having regard to the intensity of the stresses and to the following                     provisions:                  

the calculation pressure to be taken into account shall not be less than the maximum working pressure PS selected;

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*U.K.

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**U.K.

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*U.K.

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*U.K.

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**U.K.

Vessels shall be accompanied by the instructions drawn up by the manufacturer, as referred to in point 2 of Annex III.

## ANNEX IIU.K.CONFORMITY ASSESSMENT PROCEDURES

### 1.**EU-Type examination (Module B)**U.K.

#### 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.U.K.

#### 1.2.EU-type examination shall be carried out in either of the following manners in accordance with Article 13:U.K.

          -  assessment of the adequacy of the technical design of the vessel through examination of the technical documentation and supporting                           evidence referred to in point 1.3, plus examination of a prototype, representative of the production envisaged, of the complete                           vessel (production type),                         
          -  assessment of the adequacy of the technical design of the vessel through examination of the technical documentation and supporting                           evidence referred to in point 1.3, without examination of a prototype vessel (design type).                         

#### 1.3.The manufacturer shall lodge an application for EU-type examination with a single notified body of his choice.U.K.

The application shall include:

the name and address of the manufacturer and, if the application is lodged by the authorised representative, his name and                              address as well;                           

a written declaration that the same application has not been lodged with any other notified body;

the technical documentation. The technical documentation shall make it possible to assess the vessel’s conformity with the                              applicable requirements of this Directive and shall include an adequate analysis and assessment of the risk(s).                           

The technical documentation shall specify the applicable requirements and cover, as far as relevant for the assessment, the                              design, manufacture and operation of the vessel. The technical documentation shall contain, wherever applicable, at least                              the following elements:                           

a general description of the vessel;

conceptual design and manufacturing drawings and schemes of components, etc.;

descriptions and explanations necessary for the understanding of those drawings and schemes and the operation of the vessel;

a list of the harmonised standards applied in full or in part, the references of which have been published in the *Official Journal of the European Union*, and, where those harmonised standards have not been applied, descriptions of the solutions adopted to meet the essential                                       safety requirements of this Directive, including a list of other relevant technical specifications applied. In the event of                                       partly applied harmonised standards, the technical documentation shall specify the parts which have been applied;                                    

results of design calculations made, examinations carried out, etc.;

test reports;

the instructions and safety information referred to in point 2 of Annex III;

a document describing:
                      -  the materials selected, 
                      -  the welding processes selected, 
                      -  the checks selected, 
                      -  any pertinent details as to the vessel design; 

where applicable, the prototype vessels representative of the production envisaged. The notified body may request further                              prototype vessels if needed for carrying out the test programme;                           

the supporting evidence for the adequacy of the technical design solution. This supporting evidence shall mention any documents                              that have been used, in particular where the relevant harmonised standards have not been applied in full. The supporting evidence                              shall include, where necessary, the results of tests carried out in accordance with other relevant technical specifications                              by the appropriate laboratory of the manufacturer, or by another testing laboratory on his behalf and under his responsibility.                           

When a prototype vessel is examined, the technical documentation shall also include:
                -  the certificates relating to the suitable qualification of the welding operations and of the welders or welding operators, 
                -  the inspection slip for the materials used in the manufacture of parts and components contributing to the strength of the                                    vessel,                                  
                -  a report on the examinations and tests performed or a description of the proposed checks. 

#### 1.4.The notified body shall:U.K.

For the vessel:

examine the technical documentation and supporting evidence to assess the adequacy of the technical design of the vessel.

For the prototype vessel(s):

verify that the prototype vessel(s) has/have been manufactured in conformity with the technical documentation, that it may                              safely be used under its intended working conditions and identify the elements which have been designed in accordance with                              the applicable provisions of the relevant harmonised standards, as well as the elements which have been designed in accordance                              with other relevant technical specifications;                           

carry out appropriate examinations and tests, or have them carried out, to check whether, where the manufacturer has chosen                              to apply the solutions in the relevant harmonised standards, these have been applied correctly;                           

carry out appropriate examinations and tests, or have them carried out, to check whether, where the solutions in the relevant                              harmonised standards have not been applied, the solutions adopted by the manufacturer applying other relevant technical specifications                              meet the corresponding essential safety requirements of this Directive;                           

agree with the manufacturer on a location where the examinations and tests will be carried out.

#### 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.U.K.

#### 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.U.K.

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.U.K.

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.U.K.

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.U.K.

#### 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.U.K.

### 2.**Conformity to type based on internal production control plus supervised vessel testing (Module C1)**U.K.

#### 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.U.K.

#### 2.2.*Manufacturing*U.K.

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:                  

the technical documentation, which shall also include:
                -  the certificates relating to the suitable qualification of the welding operations and of the welders or welding operators, 
                -  the inspection slip for the materials used in the manufacture of parts and components contributing to the strength of the                                    vessel,                                  
                -  a report on the examinations and tests performed; 

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;                           

the EU-type examination certificate.

#### 2.3.*Vessel checks*U.K.

##### 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:U.K.

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.                           

When a batch is examined, the notified body shall ensure that the vessels have been manufactured and checked in accordance                              with the technical documentation, 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 strength. 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 notified 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 circumferential welds, the tests shall be repeated                              on the circumferential welds.                           

For the vessels subject to the experimental method 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 notified 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 notified body shall take appropriate measures to prevent the placing on the market of that batch.                              In the event of frequent rejection of batches, the notified body may suspend the statistical verification.                           

The manufacturer shall be able to supply on request by the relevant authorities the notified body’s certificates of conformity                              referred to in point (e).                           

##### 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.U.K.

##### 2.3.3.The manufacturer shall, under the responsibility of the notified body, affix the notified body’s identification number during                        the manufacturing process.U.K.

#### 2.4.*CE marking and EU declaration of conformity*U.K.

##### 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.U.K.

##### 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.U.K.

##### 2.4.3.A copy of the EU declaration of conformity shall be made available to the relevant authorities upon request.U.K.

#### 2.5.*Authorised representative*U.K.

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)**U.K.

#### 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.U.K.

#### 3.2.*Manufacturing*U.K.

##### 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.U.K.

##### 3.2.2.Before commencing manufacture, the manufacturer shall provide a notified body of his choice with all necessary information,                        and in particular:U.K.

the technical documentation, which shall also include:
                -  the certificates relating to the suitable qualification of the welding operations and of the welders or welding operators, 
                -  the inspection slip for the materials used in the manufacture of parts and components contributing to the strength of the                                    vessel,                                  
                -  a report on the examinations and tests performed; 

the EU-type examination certificate;

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.                           

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:U.K.

a description of the means of manufacture and checking appropriate to the construction of the vessels;

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;                           

an undertaking to carry out the examinations and tests in accordance with the inspection document 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 independent from production personnel, and shall be the subject of a report;                           

the addresses of the places of manufacture and storage and the date on which manufacture is to commence.

#### 3.3.*Vessel checks*U.K.

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*U.K.

##### 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.U.K.

##### 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.U.K.

##### 3.4.3.A copy of the EU declaration of conformity shall be made available to the relevant authorities upon request.U.K.

#### 3.5.*Authorised representative*U.K.

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)**U.K.

#### 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.U.K.

#### 4.2.*Manufacturing*U.K.

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:                  

the certificates relating to the suitable qualification of the welding operations and of the welders or welding operators;

the inspection slip for the materials used in the manufacture of parts and components contributing to the strength of the                              vessel;                           

a report on the examinations and tests performed;

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:

a description of the means of manufacture and checking appropriate to the construction of the vessels;

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;                                    

an undertaking to carry out the examinations and tests in accordance with the inspection document 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 independent from production personnel, and shall be the subject of a report;                                    

the addresses of the places of manufacture and storage and the date on which manufacture is to commence.

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*U.K.

##### 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.U.K.

##### 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.U.K.

##### 4.3.3.A copy of the EU declaration of conformity shall be made available to the relevant authorities upon request.U.K.

#### 4.4.*Authorised representative*U.K.

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 IIIU.K.INSCRIPTIONS, INSTRUCTIONS, DEFINITIONS AND SYMBOLS

### 1.**CE marking and inscriptions**U.K.

#### 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.U.K.

#### 1.2.Vessels or their data plates shall bear at least the following information:U.K.

the maximum working pressure (PS in bar);

the maximum working temperature (Tmax in °C);                           

the minimum working temperature (Tmin in °C);                           

the capacity of the vessel (V in L);

the name, registered trade name or registered trade mark and the address of the manufacturer;

the type and serial or batch identification of the vessel.

#### 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.U.K.

### 2.**Instructions and safety information**U.K.

The instructions shall contain the following information:

the particulars given in point 1.2 except for the vessel’s serial or batch identification;

the intended use of the vessel;

the maintenance and installation requirements for vessel safety.

### 3.**Definitions and symbols**U.K.

#### 3.1.*Definitions*U.K.

The design pressure ‘P’ is the gauge pressure chosen by the manufacturer and used to determine the thickness of the vessel’s                              pressurised parts.                           

The maximum working pressure ‘PS’ is the maximum gauge pressure which may be exerted under normal conditions of use of the                              vessel.                           

The minimum working temperature Tmin is the lowest stabilised temperature which the wall of the vessel may attain under normal conditions of use.                           

The maximum working temperature Tmax is the highest stabilised temperature which the wall of the vessel may attain under normal conditions of use.                           

The yield strength ‘ReT’ is the value at the maximum working temperature Tmax of any of the following:                           

the upper yield point ReH, for a material with both a lower and an upper yield point;                                    

the 0,2 % proof strength Rp0,2;                                    

the 1,0 % proof strength Rp1,0 in the case of non-alloy aluminium.                                    

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:                           

where a prototype has one or more shell rings in addition to the ends, variants shall have at least one shell ring;

where a prototype has just two dished ends, variants shall have no shell rings.

Variations in length causing the apertures and/or penetrations to be modified shall be shown in the drawing for each variant.

A batch of vessels consists at the most of 3 000 vessels of the model of the same type.

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.                           

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*U.K.

## ANNEX IVU.K.EU DECLARATION OF CONFORMITY (No XXXX)(9) 

### 1.Vessel/vessel model (product, type, batch or serial number):U.K.

### 2.Name and address of the manufacturer and, where applicable, his authorised representative:U.K.

### 3.This declaration of conformity is issued under the sole responsibility of the manufacturer.U.K.

### 4.Object of the declaration (identification of the vessel allowing traceability; it may, where necessary for the identification                        of the vessel, include an image):U.K.

### 5.The object of the declaration described above is in conformity with the relevant Union harmonisation legislation:U.K.

### 6.References to the relevant harmonised standards used or references to the other technical specifications in relation to which                        conformity is declared:U.K.

### 7.The notified body ... (name, number) performed ... (description of intervention) and issued the certificate:U.K.

### 8.Additional information:U.K.

Signed for and on behalf of:

(place and date of issue):

(name, function) (signature):

## ANNEX VU.K.

## PART AU.K.

### **Repealed Directive with the amendment thereto**

**(referred to in Article 43)**

## PART BU.K.

### **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)**

## ANNEX VIU.K.

### CORRELATION TABLE

U.K.

# 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.                        

1

OJ C 27, 3.2.2009, p. 41.                           

2

Position of the European Parliament of 5 February 2014 (not yet published in the Official Journal) and decision of the Council                              of 20 February 2014.                           

3

OJ L 264, 8.10.2009, p. 12. Directive 2009/105/EC is the codification of Council Directive 87/404/EEC of 25 June 1987 on the harmonization of the laws                              of the Member States relating to simple pressure vessels (OJ L 220, 8.8.1987, p. 48).                           

4

See Annex V, Part A.

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.                           

9

It is optional for the manufacturer to assign a number to the declaration of conformity.