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Real Decree 1388 / 2011, From 14 Of October, By Which Is Dictate Them Provisions Of Application Of The Directive 2010 / 35 / Eu Of The Parliament European And Of The Council Of 16 Of June Of 2010 On Teams To Pressure Transportable And By Which Is Repea...

Original Language Title: Real Decreto 1388/2011, de 14 de octubre, por el que se dictan las disposiciones de aplicación de la Directiva 2010/35/UE del Parlamento Europeo y del Consejo de 16 de junio de 2010 sobre equipos a presión transportables y por la que se derogan las ...

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TEXT

Royal Decree 222/2001 of 2 March 2001 laying down detailed rules for the application of Council Directive 1999 /36/EC of 29 April on transportable pressure equipment transposed into national law This Directive introduces a greater requirement for safety in order to facilitate the use of such equipment in the territories of other Member States within a transport operation.

Later, the Council of the European Union adopted Directive 2010 /35/EU of 16 June 2010 on transportable pressure equipment and repealing Directives 76 /767/EEC, 84 /525/EEC, 84 /526/EEC, 84 /527/EEC and 1999 /36/EC of the Council.

This Directive takes account of developments in transport safety, as well as the content of Directive 2008 /68/EC of the European Parliament and of the Council of 24 September 2008 on land transport of dangerous goods, which is to extend the scope of the provisions of certain international agreements in such a way as to apply to domestic traffic, in order to harmonize the conditions in the whole of the European Union the transport of dangerous goods by road, rail and inland waterways interiors. Directive 2008 /68/EC has not yet been transposed into national law. However, their annexes do form part of the rules applicable in the national territory, since they reproduce the provisions of the European Agreement on the International Carriage of Dangerous Goods by Road (ADR), concluded in Geneva on 30 September 1957, as amended, and the Regulations on International Transport by Rail of Dangerous Goods (RID), set out in Appendix C to the Convention on International Transport by Railway (COTIF), signed in Berne on 9 May 1980 and amended by the Protocol made in Vilnius on 3 June 1999 ,which are part of the Spanish legal order irrespective of the Directive because Spain is part of the ADR and is bound by the RID.

Directive 2010 /35/EU is intended to avoid conflict of rules, in particular with regard to the requirements of conformity, conformity assessment and conformity assessment procedures, applicable to transportable pressure equipment.

In compliance with the obligations arising from the provisions of Article 42 of Directive 2010 /35/EU of 16 June, it is necessary to lay down the national provisions which provide for and adopt the forecasts contained in the This Directive shall be adopted by 30 June 2011 at the latest. This rule also constitutes a development of the provisions of Chapter I of Title III of Law 21/1992 of 16 July 1992 on Industry relating to industrial safety.

According to the provisions of Article 24.1.e) of Law 50/1997 of 27 November 1997, the Government has submitted this provision to the hearing that it establishes, referring to the sectors concerned. The competent bodies of the Autonomous Communities have also been consulted.

The text of the provision has the favourable reports of the Committee on the Coordination of Dangerous Goods Transport and the Council for the Coordination of Industrial Security. He has also been subject to a report from the Ministry of Public Works and Defense.

In its virtue, on the proposal of the Minister of Industry, Tourism and Trade, in agreement with the Council of State and after deliberation of the Council of Ministers at its meeting on October 14, 2011,

DISPONGO:

CHAPTER I

Scope and definitions

Article 1. Object and scope of application.

1. It constitutes the object of the present royal decree the establishment of norms for the development of the international regulations in relation to the obligations of the operators and the requirements that must be met by the transportable pressure equipment, in order to to strengthen security and to ensure the free movement of such equipment in the European Union.

2. This royal decree will apply to:

(a) New transportable pressure equipment, as defined in Article 2 (1), which does not bear the conformity marking provided for in Royal Decree 222/2001 of 2 March 2001 laying down detailed rules for the the application of Council Directive 1999 /36/EC of 29 April on transportable pressure equipment for the purposes of placing on the market;

(b) the transportable pressure equipment as defined in Article 2 (1) bearing the conformity marking provided for in this Royal Decree or in Royal Decree 222/2001 of 2 March 2001 as regards the regular checks, intermediate checks, extraordinary checks and their use;

(c) the transportable pressure equipment as defined in Article 2 (1) which does not bear the conformity marking provided for in Royal Decree 222/2001 of 2 March 2001 as regards the revaluation of the compliance.

3. This royal decree will not apply to:

(a) Transportable pressure equipment placed on the market before the date of application of Royal Decree 222/2001 of 2 March 2001 and which have not been subject to a reassessment of conformity.

(b) transportable pressure equipment exclusively used for the transport of dangerous goods between Member States and third countries, carried out in accordance with the provisions of the Agreement European on the International Transport of Dangerous Goods by Road (hereinafter referred to as ADR), held in Geneva on 30 September 1957, as amended, and with the Regulations on International Carriage by Rail Dangerous Goods (hereinafter referred to as RID) in Appendix C to the Convention on International Transport by Rail (hereinafter COTIF), signed in Bern on 9 May 1980 and amended by the Protocol made in Vilnius on 3 June 1999, unless otherwise stipulated.

Article 2. Definitions.

For the purposes of this royal decree, the following definitions shall apply:

1. Transportable pressure equipment:

(a) All pressure vessels, as well as their valves and other accessories, as included in Chapter 6.2 of the RID and ADR;

(b) tanks, vehicles/wagons in battery, multi-element gas containers (CGEM), as well as, where applicable, their valves and other accessories, as included in section 6.8 of the RID and ADR, when equipment referred to in paragraphs (a) or (b) are used in accordance with the RID or ADR for the transport of gases of Class 2, excluding gases or articles with figures 6 and 7 in the classification code, and for the transport of substances dangerous of other classes, as set out in Annex I to this royal decree.

Transportable pressure equipment shall be understood to include gas cartridges (UN number 2037) and excluding aerosols (UN 1950), open cryogenic containers, gas cylinders for appliances respiratory, fire extinguishers (UN 1044), transportable pressure equipment exempted in accordance with point 1.1.3.2 of the RID and ADR and transportable pressure equipment exempted from the construction and testing requirements of the packaging in accordance with the special provisions of point 3.3 of the RID and ADR;

2. Placing on the market: first placing on the market of transportable pressure equipment on the national or European Union market;

3. placing on the market: any supply, paid or free, of a transportable pressure equipment for distribution or use on the domestic or European Union market in the course of a commercial activity or public service;

4. use: filling, temporary storage related to the transport, emptying and filling of transportable pressure equipment;

5. withdrawal: any measure intended to prevent the placing on the market or use of a transportable pressure equipment;

6. recovery: any measure aimed at obtaining the return of a transportable pressure equipment already made available to the end user;

7. manufacturer: any natural or legal person who manufactures a transportable pressure equipment, or parts thereof, or who has the design or manufacture of such equipment and markets it under his name or trademark;

8. authorised representative: any natural or legal person established in the national territory or in the European Union who has received a written mandate from a manufacturer to act on his behalf on specific tasks;

9. 'importer' means any natural or legal person established on the national territory or in the European Union who places a transportable pressure equipment, or parts thereof, on the domestic or European Union market from a third country;

10. distributor: any natural or legal person established on the national territory or in the European Union, other than the manufacturer or the importer, who markets a transportable pressure equipment or parts thereof;

11. owner: any natural or legal person established in the national territory or in the European Union who is the holder of the ownership of a transportable pressure equipment;

12. user: any natural or legal person established in the national territory or in the European Union using a transportable pressure equipment;

13. economic operators: the manufacturer, the authorised representative, the importer, the distributor, the owner or the user involved in the course of a commercial or public service activity, whether for consideration or free of charge;

16. conformity assessment: assessment and conformity assessment procedure laid down in the RID and ADR;

14. II marking: marking indicating that the transportable pressure equipment complies with the applicable conformity assessment requirements laid down in the RID and ADR and in this royal decree;

15. revaluation of conformity: a procedure for the subsequent assessment, at the request of the owner or the user, of the conformity of transportable pressure equipment manufactured and placed on the market before the date of application of the Royal Decree 222/2001 of 2 March 2001;

16. periodic checks: regular checks and procedures governing such controls, in accordance with the provisions of the RID and ADR;

17. intermediate controls: intermediate controls and procedures governing this type of controls, in accordance with the requirements of the RID and ADR;

18. extraordinary controls: extraordinary controls and procedures governing such controls, in accordance with the requirements of the RID and ADR;

19. accreditation: declaration by a national accreditation body that a control body complies with the requirements set out in the second paragraph of point 1.8.6.8 of the RID and ADR;

20. notifying authority: authority designated by a Member State responsible for establishing and implementing the procedures necessary for the assessment, notification and subsequent supervision of notified bodies;

21. notified body: control body which meets the requirements laid down in the RID and ADR and the conditions set out in Articles 18 and 23 of this royal decree and notified in accordance with Article 20 of this royal decree;

22. notification: a process by which the condition of the notified body is granted to a control body and which includes the communication of this information to the European Commission, hereinafter referred to as the Commission, and to the Member States;

23. market surveillance: activities carried out and measures taken by the public authorities to ensure that transportable pressure equipment complies with the requirements of the RID and ADR and in the actual present during its life cycle decree and do not entail a risk to health and safety or to other aspects related to the protection of the public interest.

Article 3. Additional requirements.

The competent authorities in the field of industrial safety of the Autonomous Communities may lay down additional requirements for storage in the medium or long term or for use on the spot of transportable pressure equipment. These requirements must be published in the Official Journal of the Autonomous Community. However, the Autonomous Communities may not lay down additional requirements for transportable pressure equipment as such.

CHAPTER II

Obligations of economic operators

Article 4. Obligations of manufacturers.

1. When placing their transportable pressure equipment on the market, manufacturers shall ensure that such equipment has been designed, manufactured and documented in accordance with the requirements set out in the RID and ADR and in the actual present decree.

2. Where it has been established by the process of conformity assessment provided for in the RID and ADR and in this royal decree that the transportable pressure equipment complies with the applicable requirements, manufacturers shall affix the compliance with Article 14 of this royal decree.

3. Manufacturers shall keep the technical documentation specified in the RID and ADR. This documentation shall be kept for the period specified therein.

4. Manufacturers who consider or have reason to believe that a transportable pressure equipment which they have placed on the market is not in conformity with the RID and ADR or with this royal decree shall immediately take the necessary corrective measures. to do so according to, withdraw or recall it, if applicable. In addition, where the transportable pressure equipment presents a risk, manufacturers shall immediately inform the competent authority in the field of industrial safety in the Autonomous Community where the manufacturer has his registered office. It shall forward the information received to the Ministry of Industry, Tourism and Trade within a period of not more than three months, which shall forward it to the competent national authorities of the Member States in which it has marketed the transportable pressure equipment. The Autonomous Communities will also provide details, in particular, of the non-compliance and the corrective measures taken to the Ministry of Industry, Tourism and Trade.

5. Manufacturers shall document all such cases of non-compliance and corrective measures.

6. On the basis of a reasoned request from the competent authority in the field of industrial safety in an Autonomous Community, manufacturers shall provide it with all the information and documentation necessary to demonstrate the conformity of the equipment under pressure. transportable, in a language that can easily be understood by that organ. They shall cooperate with that body, at its request, in any action to eliminate the risks involved in the transportable pressure equipment which they have placed on the market.

7. Manufacturers shall only provide users with information that complies with the requirements set out in the RID and ADR and in this Royal Decree.

Article 5. Authorised representatives.

1. Manufacturers may designate, by a written mandate, an authorised representative.

The obligations laid down in Article 4 (1) and (2) and the preparation of the technical documentation shall not form part of the mandate of the authorised representative.

2. The authorised representative shall carry out the tasks specified in the mandate received from the manufacturer. The command must allow the authorized representative to perform at least the following tasks:

(a) Keep the technical documentation at the disposal of the supervisory authorities of the Autonomous Communities for at least the period established in the RID and ADR for the manufacturers;

(b) on the basis of a reasoned request from a competent authority in the field of industrial safety in an Autonomous Community, to provide that body with all the information and documentation necessary to demonstrate the conformity of the transportable pressure equipment, in a language which can be easily understood by that organ;

(c) cooperate with the competent authorities in the field of industrial safety of the Autonomous Communities, at their request, in any action aimed at eliminating the risks involved in the transportable pressure equipment. of your command.

3. The identity and address of the authorised representative shall be indicated in the certificate of conformity specified in the RID and ADR.

4. Authorised representatives shall only provide users with information that complies with the requirements set out in the RID and ADR and in this Royal Decree.

Article 6. Obligations of importers.

1. Importers shall only introduce transportable pressure equipment which is in conformity with the RID and ADR and with the present Royal Decree on the market of the national territory.

2. Before placing a transportable pressure equipment on the market, importers shall ensure that the manufacturer has carried out the proper conformity assessment. They shall ensure that the manufacturer has drawn up the technical documentation and that the transportable pressure equipment bears the Π marking and is accompanied by the certificate of conformity specified in the RID and ADR.

If the importer considers or has reason to believe that a transportable pressure equipment is not in conformity with the RID and ADR or with the present royal decree, he/she will not be able to enter the market until it is compliant. In addition, where the transportable pressure equipment presents a risk, the importer shall inform the manufacturer and the competent bodies of its Autonomous Community in the field of industry.

3. Importers shall indicate their name and address of contact in the certificate of conformity specified in the RID and ADR, or attach this information to it.

4. As long as they are responsible for a transportable pressure equipment, importers shall ensure that storage or transport conditions do not jeopardise compliance with the requirements laid down in the RID and ADR.

5. Importers who consider or have reason to believe that a transportable pressure equipment which they have placed on the domestic market is not in conformity with the RID and ADR or with this royal decree shall immediately take the corrective measures necessary to do so, to withdraw or recall it, if appropriate. In addition, where the transportable pressure equipment presents a risk, importers shall immediately inform the manufacturer and the competent authority in the field of industrial safety in the Autonomous Community where the importer has his/her In particular, it shall provide details of the non-compliance and the corrective measures taken. The Authority shall forward the information received to the Ministry of Industry, Tourism and Trade within a period of not more than three months.

Importers will document all of these non-compliance cases and corrective measures.

6. For at least the period laid down in the RID and ADR for manufacturers, importers shall keep a copy of the technical documentation at the disposal of the competent bodies of their Autonomous Community in the field of industry and shall ensure which, upon request, a copy of the same is received by those authorities.

7. On the basis of a reasoned request from the competent authority in the field of industrial safety in an Autonomous Community, importers shall provide it with all the information and documentation necessary to demonstrate the conformity of the equipment under pressure. transportable, in a language that can easily be understood by that organ. They shall cooperate with that body, at its request, in any action to eliminate the risks involved in the transportable pressure equipment which they have placed on the market.

8. Importers shall only provide users with information that complies with the requirements set out in the RID and ADR and in this Royal Decree.

Article 7. Obligations of distributors.

1. The distributors will only commercialize in the market of the national territory transportable pressure equipments that are in conformity with the RID and ADR and with the present royal decree. Before placing on the market a transportable pressure equipment, distributors shall verify that they bear the Π marking and that it is accompanied by the certificate of conformity and the contact address referred to in Article 6 (3) of this Royal decree.

If a distributor considers or has reason to believe that a transportable pressure equipment is not in conformity with the RID and ADR or with the present royal decree, it may only proceed to market after it has done so. In addition, where the transportable pressure equipment presents a risk, the distributor shall inform the manufacturer or the importer as well as the competent bodies of its Autonomous Community in the field of industry.

2. As long as they are responsible for a transportable pressure equipment, distributors shall ensure that storage or transport conditions do not jeopardise compliance with the requirements set out in the RID and ADR.

3. Distributors who consider or have reason to believe that a transportable pressure equipment which they have placed on the market is not in conformity with the RID and ADR or with this royal decree shall ensure that the necessary corrective measures are taken. to do so as appropriate, to withdraw or recall it, as appropriate. In addition, where the transportable pressure equipment presents a risk, distributors shall immediately inform the manufacturer, the importer, where appropriate, and the competent industrial safety bodies of the Communities. Autonomous regions in which they have placed the equipment on the market for transportable pressure and shall provide details, in particular, of the non-compliance and of the corrective measures taken. The said bodies shall send the information received to the Ministry of Industry, Tourism and Trade within a period of not more than three months.

Distributors will document all of these non-compliance cases and corrective measures.

4. On the basis of a reasoned request from the competent authority in the field of industrial safety in an Autonomous Community, distributors shall provide it with all the information and documentation necessary to demonstrate the conformity of the equipment under pressure. transportable, in a language that can easily be understood by that organ. They shall cooperate with that body, at its request, in any action to eliminate the risks involved in the transportable pressure equipment which they have placed on the market.

5. Distributors shall only provide users with information that complies with the requirements set out in the RID and ADR and in this Royal Decree.

Article 8. Obligations of the owners.

1. If an owner considers or has reason to believe that a transportable pressure equipment is not in conformity with the RID and ADR, including the requirements relating to periodic checks, or with this royal decree, he shall not market or use it. until it is compliant. In addition, where the transportable pressure equipment presents a risk, the owner shall inform the manufacturer or the importer or the distributor thereof, as well as the competent authority of its Autonomous Community in the field of industry.

The owners will document all of these non-compliance cases and the corrective measures.

2. As long as they are responsible for transportable pressure equipment, owners shall ensure that storage or transport conditions do not jeopardise compliance with the requirements laid down in the RID and ADR or in the APQ-5 JTI. Royal Decree 379/2001 of 6 April approving the Regulation on the storage of chemical products and their complementary technical instructions MIE-APQ-1, MIE-APQ-2, MIE-APQ-3, MIE-APQ-4, MIE-APQ-5, MIE-APQ-6 and MIE-APQ-7.

3. Owners shall only provide information to users in accordance with the requirements set out in the RID and ADR and in this royal decree.

4. This Article shall not apply to individuals who intend to use transportable pressure equipment for their personal or domestic use or for their sporting or leisure activities.

Article 9. User obligations.

1. Users shall only use transportable pressure equipment that complies with the requirements set out in the RID and ADR and in this royal decree.

2. Where the transportable pressure equipment presents a risk, the user shall inform the owner and the competent authority of his/her Autonomous Community of industry.

Article 10. Cases where the obligations of the manufacturers apply to importers and distributors.

For the purposes of this Royal Decree, it shall be considered a manufacturer and shall therefore be subject to the obligations of the manufacturer in accordance with Article 4, to the importer or distributor which he places in the market a transportable pressure equipment with its name or trade mark, or which modifies a transportable pressure equipment already placed on the market in such a way that compliance with the applicable requirements may be affected.

Article 11. Identification of economic operators.

Economic operators shall identify, upon request of the competent authority of their Autonomous Community in the field of industry and for a period of at least 10 years:

(a) Any economic operator who has supplied them with transportable pressure equipment;

(b) any economic operator to whom they have supplied a transportable pressure equipment.

CHAPTER III

Conformity of transportable pressure equipment

Article 12. Conformity of the transportable pressure equipment and assessment thereof.

1. The transportable pressure equipment referred to in Article 1 (2) (a) shall comply with the relevant requirements concerning the conformity assessment and the regular, intermediate and extraordinary checks, as laid down in Article 1 (2) (a). in the RID and ADR and in Chapters III and IV of this royal decree.

2. The transportable pressure equipment referred to in Article 1 (2) (b) shall comply with the specifications of the documentation according to which it has been manufactured. The equipment shall be subject to periodic, intermediate and extraordinary checks in accordance with the RID and ADR and the requirements of Chapters III and IV of this Royal Decree.

3. Certificates of conformity assessment, certificates of conformity assessment and reports of periodic, intermediate and extraordinary checks issued by a notified body shall be valid throughout the territory of the Member State concerned. national and all Member States.

For the removable parts of rechargeable transportable pressure equipment, an independent conformity assessment may be carried out.

Article 13. General principles of the Π marking.

1. The II marking shall be affixed only by the manufacturer or, in the case of reassessment of conformity, in accordance with the provisions of Annex II to this Royal Decree. In relation to the gas cylinders previously in conformity with the Order of the Ministry of Industry and Energy of 3 July 1987 amending the supplementary technical instruction MIE-AP7 of the Regulation of pressure equipment, concerning bottles and bottles for compressed gases, liquefied and dissolved under pressure, the Π marking shall be affixed by the notified body or under the supervision of the notified body.

2. The Π marking shall be placed exclusively on transportable pressure equipment which:

a) Cumplan the requirements relating to conformity assessment established in the RID and ADR and in this royal decree, or

(b) comply with the requirements concerning the revaluation of the conformity referred to in the single transitional provision.

Not to be placed on any other transportable pressure equipment.

3. With the placement of the II marking, the manufacturer indicates that he assumes responsibility for the conformity of the transportable pressure equipment with all applicable requirements set out in the RID and ADR and in this royal decree.

4. For the purposes of this royal decree, the II marking shall be the only marking to demonstrate the conformity of the transportable pressure equipment with the applicable requirements laid down in the RID and ADR and in this royal decree.

5. The affixing of marked transportable pressure equipment, signs and inscriptions which may mislead third parties into the meaning or form of the II marking shall be prohibited.

Any other marking shall be placed on the transportable pressure equipment in such a way that it does not affect the visibility, readability and meaning of the II marking.

6. The removable parts of the rechargeable transportable pressure equipment with a direct safety function shall bear the II marking.

7. The Autonomous Communities shall ensure the correct application of the arrangements governing the marking and shall take appropriate action in the event of incorrect use of the marking. The Autonomous Communities shall also lay down the appropriate penalties. Such penalties shall be proportionate to the seriousness of the infringement and shall constitute an effective deterrent against the incorrect use of the marking.

Article 14. Rules and conditions for placement of the Π marking.

1. The Π marking shall consist of the symbol reproduced in the following model:

Imagen: img/disp/2011/249/16174_001.png

2. The minimum height of the II marking shall be 5 mm. For transportable pressure equipment with a diameter of 140 mm or less the minimum height shall be 2,5 mm.

3. The proportions of the graduated drawing in paragraph 1 of this Article shall be respected. The grid is not part of the marking.

4. The II marking shall be affixed to the transportable pressure equipment or to its data plate in a visible, legible and indelible manner, as well as in the removable parts of the rechargeable transportable pressure equipment which fulfil a direct function of security.

5. The II marking shall be affixed before a new transportable pressure equipment or removable parts of the rechargeable transportable pressure equipment which fulfil a direct safety function are placed on the market.

6. The II marking shall be followed by the identification number of the notified body involved in the initial checks and tests.

The identification number of the notified body shall be affixed by the body itself, or following its instructions, by the manufacturer.

7. The marking of the date of the periodic check or, where appropriate, the intermediate control shall be accompanied by the identification number of the notified body responsible for periodic monitoring.

8. In relation to the gas cylinders previously in conformity with the Order of the Ministry of Industry and Energy of 3 July 1987 amending the supplementary technical instruction MIE-AP7 of the Regulation of pressure equipment, concerning bottles and bottles for compressed gases, liquefied and dissolved under pressure not bearing the II marking, on the occasion of the first periodic inspection carried out in accordance with this royal decree the identification number of the notified body must be preceded by the Π marking.

Article 15. Free movement of transportable pressure equipment.

Without prejudice to the safeguard procedures provided for in Articles 27 and 28 of this Royal Decree and of the market surveillance framework laid down in Regulation (EC) No 765/2008 of the European Parliament and of the European Parliament Council of 9 July 2008 laying down the requirements for accreditation and market surveillance relating to the placing on the market of products and repealing Regulation (EEC) No 339/93, no Autonomous Community may prohibit, restrict or impede on its territory the free movement, marketing and use of the transportable pressure equipment complying with the provisions of this royal decree.

CHAPTER IV

Notifying authority and notified bodies

Article 16. Notifying authority.

The notifying authority, responsible for establishing and implementing the procedures necessary for the assessment, notification and subsequent supervision of notified bodies, is the Ministry of Industry, Tourism and Trade.

Article 17. Reporting obligation of the notifying authorities.

The Ministry of Industry, Tourism and Trade shall inform the Commission of the procedures for the assessment, notification and monitoring of notified bodies, as well as any changes to the information transmitted.

Article 18. Requirements for notified bodies.

1. The Spanish notified bodies responsible for carrying out the certification procedures referred to in this royal decree shall have the status of a control body referred to in Chapter I, Title III of Law 21/1992, July 16, Industry, developed in Chapter IV of the Infrastructure Regulation for Quality and Industrial Safety, approved by Royal Decree 2200/1995 of 28 December.

2. Any competent authority within the meaning of the RID and ADR may be a notified body provided that it complies with the requirements laid down in the RID and ADR and in this Royal Decree and that it does not act as a notifying authority.

3. Notified bodies shall be established in accordance with the rules in force.

4. Notified bodies shall participate in the relevant standardisation activities and in the activities of the coordination group of notified bodies established in accordance with Article 26, or shall ensure that their assessment staff be informed in this respect, and shall apply in the manner of general guidelines the decisions and administrative documents resulting from the activities of that group.

Article 19. Request for notification.

1. The control bodies shall submit a request for notification to the competent industrial safety authority of the Autonomous Community in which each control body has its registered office.

2. The application shall be accompanied by a description of:

(a) Activities related to conformity assessment, periodic, intermediate and extraordinary controls, and the revaluation of conformity;

(b) the procedures relating to the activities referred to in subparagraph (a)

(c) transportable pressure equipment for which the body is considered competent;

(d) an accreditation certificate issued by the National Accreditation Entity, ENAC, stating that the control body complies with the requirements set out in Article 18 of this royal decree.

3. The competent bodies of the Autonomous Communities shall send to the Ministry of Industry, Tourism and Trade copies of the request of the inspection bodies which have requested to be notified, indicating the tasks for which they have been requested. been accredited, for the purpose of dissemination and eventual communication to the other competent authorities, as well as to the European Commission and the other Member States, subject to the allocation of the corresponding identification numbers by of the European Commission.

Article 20. Notification procedure.

1. The Ministry of Industry, Tourism and Trade may only notify those bodies which satisfy the requirements laid down in Article 18.

2. The department shall notify them to the Commission and to the other Member States by means of the electronic system developed and managed by the Commission.

3. The notification shall include the information required by Article 19 (2

.

4. The body concerned may carry out the activities of a notified body only if no objection has been raised by the Commission or the other Member States within two weeks of the notification.

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

5. The Ministry of Industry, Tourism and Trade shall inform the Commission and the other Member States of any relevant changes after the notification.

6. The internal control services of the applicant, defined in the RID and ADR, shall not be notified.

Article 21. Changes to the notification.

1. If the National Accreditation Entity, ENAC, checks or is informed that a notified body no longer meets the requirements laid down in Article 18 or is not fulfilling its obligations, it shall restrict, suspend or withdraw the certificate of accreditation referred to in Article 19.2.d), as the case may be, depending on the seriousness of the non-compliance with those requirements or obligations. It shall immediately inform the competent authority in the field of industrial safety of the Autonomous Community in which the body has its registered office and the Ministry of Industry, Tourism and Trade, which shall provide the information to the Commission and the other Member States.

2. In the event of withdrawal, restriction or suspension of the notification or if the notified body has ceased its activity, the authority responsible for industrial safety in the Autonomous Community in which the body has its registered office take appropriate measures to ensure that the files of that body are processed by another notified body or made available to the responsible market surveillance authorities when they so request.

3. The Ministry of Industry, Tourism and Trade shall be informed of the measures taken within a period not exceeding six months after the withdrawal, restriction or suspension of the notification or cessation of the body.

Article 22. Questioning the competence of notified bodies.

1. The Commission shall investigate all cases where it doubts or doubts whether a notified body is competent or continues to comply with the requirements and responsibilities required of it.

2. The Autonomous Community in which the body in question requested its notification shall provide the Ministry of Industry, Tourism and Trade, at the latter's request, with all the information on which the notification or maintenance of the competition is based. of the body concerned. The Ministry of Industry, Tourism and Trade shall forward the information received to the Commission.

3. The Autonomous Communities, the Ministry of Industry, Tourism and Trade, the National Accreditation Entity and the Commission shall ensure the confidential treatment of all sensitive information collected in the course of their investigations.

4. Where the Commission finds that a notified body does not meet or no longer meets the requirements of its notification, it shall inform the Ministry of Industry, Tourism and Trade in this respect and shall request it to take the necessary corrective measures, which may consist, if necessary, in the cancellation of the notification.

Article 23. Operational obligations of notified bodies.

1. Notified bodies shall carry out conformity assessments and regular, intermediate and extraordinary checks in accordance with the terms of their notification and the procedures laid down in the RID and ADR.

2. The notified bodies shall carry out revaluations of the conformity in accordance with the provisions of Annex II to this Royal Decree.

3. Bodies notified by a Member State shall be authorised to work in all Member States. The notifying authority which has carried out the initial assessment and notification shall remain responsible for monitoring the ongoing activities of the notified body.

Article 24. Reporting obligation for notified bodies.

1. Notified bodies shall inform the competent authority in the industrial safety of the Autonomous Community:

a) Any denial, restriction, suspension, or withdrawal of a certificate;

b) of any circumstance affecting the scope and conditions of notification;

(c) of any request for information which they have received from market surveillance authorities in relation to the activities carried out, unless the request comes from the competent authority itself in industrial safety of the stand-alone community;

(d) upon request, of the activities carried out within the scope of its notification and of any other activities carried out, including cross-border activities and subcontracting.

2. The competent bodies of the Autonomous Communities shall forward to the Ministry of Industry, Tourism and Trade copies of the information in the preceding paragraph.

3. Each notified body shall provide relevant information on issues related to negative results and, upon request, with positive results of the conformity assessment, to the other notified bodies under the (a) a decree that carries out conformity assessment activities and similar periodic, intermediate and extraordinary controls in relation to the same transportable pressure equipment.

Article 25. Exchange of experiences.

The Ministry of Industry, Tourism and Trade is the department responsible for coordinating the representation of the Kingdom of Spain with the Commission, for the exchange of experiences between the national authorities of the States responsible members, in accordance with this royal decree, of:

a) The notification policy;

b) market surveillance.

Article 26. Coordination of notified bodies.

1. The Ministry of Industry, Tourism and Trade shall designate every two years, in accordance with the procedure laid down in this royal decree, a notified body to represent the collective of national notified bodies to the working group. the Commission may constitute, in order to establish and manage appropriate coordination and cooperation between the notified bodies.

2. The Autonomous Communities, together with the collective of notified bodies, shall present a terna, of which the Ministry of Industry, Tourism and Trade shall select the notified body referred to in the preceding paragraph.

3. The notified body thus selected must transmit to the other notified bodies the agenda for future meetings and the minutes of the meetings held, as well as any other relevant agreement or information that may occur. during meetings.

4. Notwithstanding the foregoing, any notified body may, on an individual basis, be a party to the said working group.

CHAPTER V

Safeguarding procedures

Article 27. Procedure in the case of transportable pressure equipment posing a national risk.

1. Where the Autonomous Communities adopt measures in accordance with Article 20 of Regulation (EC) No 765/2008 of the European Parliament and of the Council of 9 July 2008, or have sufficient grounds to consider that a transportable pressure equipment is subject to the This royal decree carries some risk to the health or safety of the persons or in other aspects of protection of the public interest contemplated in the present royal decree, will carry out an evaluation related to the equipment in question taking into account all the requirements set out in this royal decree. The relevant economic operators shall cooperate with the competent bodies of the Autonomous Community in industry, inter alia by allowing access to their premises and by providing samples, as appropriate.

If in the course of the assessment, the competent bodies of the Autonomous Community in the field of industry note that the transportable pressure equipment does not meet the requirements laid down in the RID and ADR or in the actual present Decree, shall without delay request the relevant economic operator to take the appropriate corrective measures to bring it into conformity with those requirements, to withdraw it from the market or to recall it within a reasonable period of time. signal, proportional to the nature of the risk.

The competent bodies of the Autonomous Community in the field of industry shall inform the notified body concerned thereof.

Article 21 of Regulation (EC) No 765/2008 of the European Parliament and of the Council of 9 July 2008 shall apply to the corrective measures referred to in the second subparagraph of this paragraph.

2. Where the competent bodies of the Autonomous Community in the field of industry consider that the non-compliance is not limited to the national territory, they shall inform the Ministry of Industry, Tourism and Trade, which shall transmit to the Commission and to the other Member States the results of the assessment and the measures they have requested to be taken by the economic operator.

3. The economic operator shall ensure that all relevant corrective measures are taken in relation to the transportable pressure equipment which has been placed on the market in the national and market territory of the European Union.

4. If the economic operator concerned does not take the appropriate corrective measures within the time limit referred to in the second subparagraph of paragraph 1, the competent authorities of the Autonomous Community in the field of industry shall take all measures necessary to ensure that the appropriate provisional measures to prohibit or restrict the marketing of transportable pressure equipment on the domestic market, to withdraw it from the market or to recall it.

The competent bodies of the Autonomous Community in the field of industry shall report to the Ministry of Industry, Tourism and Trade, which shall without delay transmit to the Commission and the other Member States such measures.

5. The information referred to in paragraph 4 shall include all available details, in particular the data necessary for the identification of the non-compliant transportable pressure equipment, the origin of the equipment, the nature of the alleged non-compliant conformity and the risk posed, and the nature and duration of the measures taken, as well as the reasons expressed by the economic operator concerned. In particular, the competent bodies of the Autonomous Community in the field of industry shall indicate whether the non-conformity is due to one of the following reasons:

(a) The transportable pressure equipment does not meet the requirements related to the health or safety of persons or raises other aspects of public interest protection established in the RID and ADR and in the actual present decree, or

(b) shortcomings in the standards or technical codes referred to in the RID and ADR or other provisions of such agreements.

6. Where a procedure has been initiated in another Member State, the Autonomous Communities shall inform the Ministry of Industry, Tourism and Trade without delay of any measure they adopt and of any additional information they have at their disposal on the non-compliance of the transportable pressure equipment in question. That Ministry shall immediately inform the Commission and the other Member States of these measures.

7. If, within two months of receipt of the information referred to in paragraph 4, no objection has been raised by any Member State or the Commission on a provisional measure taken, the measure shall be deemed to be justified.

8. The Ministry of Industry, Tourism and Trade shall ensure that appropriate restrictive measures are taken without delay in respect of the transportable pressure equipment concerned, such as the removal of the equipment from the market.

9. The Ministry of Industry, Tourism and Trade is the body responsible for receiving and transmitting to the Autonomous Communities all the information referred to in this Chapter from other Autonomous Communities, the Commission or other Member States.

Article 28. The safeguard procedure of the European Union.

In the event that the Ministry of Industry, Tourism and Trade receives from the Commission, or from some other Member State, a communication requiring the removal of the market from a transportable pressure equipment, fruit of a Justified measure, the ministerial department referred to shall give the Autonomous Communities a transfer to the Autonomous Communities for withdrawal from the market, thereby giving the Commission an account.

Article 29. Transportable pressure equipment as it poses a risk to health and safety.

1. If, after carrying out an assessment pursuant to Article 27 (1), an Autonomous Community finds that a transportable pressure equipment, although in accordance with the requirements of the RID and ADR and of this Royal Decree, carries some risk for the health or safety of persons or other aspects of protection of the public interest, it shall ask the economic operator concerned to take all appropriate measures to ensure that the equipment concerned is no longer at risk when it is placed on the market or to be withdrawn from the market or to be recovered within a period of time reasonable to the same point, proportional to the nature of the risk.

2. The economic operator shall ensure that the necessary corrective measures are taken in respect of all the transportable pressure equipment concerned which it has placed on the market or which it uses throughout the national territory, and throughout the Union European.

3. The Autonomous Community shall immediately inform the Ministry of Industry, Tourism and Trade, which shall forward the information to the Commission and the other Member States. The information provided shall include all available details, in particular the data necessary to identify the transportable pressure equipment in question and determine its origin and supply chain, the nature of the risk posed and the nature and duration of the national measures taken.

Article 30. Formal non-compliance.

1. Without prejudice to Article 27, if an Autonomous Community finds one of the following situations, it shall ask the relevant economic operator to remedy the non-compliance in question:

(a) That the placement of the II marking is in breach of Articles 12, 13, 14 or the single transitional arrangement;

b) that the Π marking has not been placed;

c) that the technical documentation is not available or incomplete;

d) that the requirements of the RID and ADR and of the present royal decree have not been met.

2. If the lack of conformity referred to in paragraph 1 persists, the Autonomous Community in question shall take all appropriate measures to restrict or prohibit the placing on the market of transportable pressure equipment or shall ensure that it is retrieves or withdraws from the market.

Additional disposition first. Recognition of equivalence.

1. Certificates of EEC model approval applicable to transportable pressure equipment issued in accordance with the Order of the Ministry of Industry and Energy of 3 July 1987 amending the technical instruction complementary MIE-AP7 of the Regulation of pressure equipment, concerning bottles and bottles for compressed, liquefied and dissolved gas, and EC design examination certificates issued in accordance with Royal Decree 222/2001 of 2 Council Directive 1999 /36/EC of 29 March 1999 on the application of Council Directive 1999 /36/EC of 29 March 1990 on the April, concerning transportable pressure equipment, is recognised as equivalent to the approval certificates referred to in the RID and ADR and shall be governed by the provisions relating to the time limits for the validity of the recognition of certificates of approval provided for in those international agreements.

2. The valves and fittings referred to in Article 3 (3) of Royal Decree 222/2001 of 2 March 2001 and bearing the marking laid down in Royal Decree 769/1999 of 7 May 1999 may continue to be used, implementing provisions of the Directive of the European Parliament and of the Council, 97 /23/EC on pressure equipment and amending Royal Decree 1244/1979 of 4 April 1979 which approved the Regulation of pressure equipment, in accordance with Article 3, Paragraph 4 of the Royal Decree 222/2001 of 2 March 2001.

Additional provision second. Periodic inspections.

1. The periodic, intermediate and extraordinary controls of transportable pressure equipment collected in the field of application of this royal decree shall be carried out within the time limits and conditions laid down in the RID and ADR.

2. The owner, his authorised representative established in the European Union or the user, shall keep the relevant certificate and documentation generated up to at least the following periodic check. Both the certificate and the documentation generated shall be made available to the market surveillance authorities.

Additional provision third. Communication of actions.

The notified bodies, as control bodies, are obliged to communicate their actions on an annual basis, pursuant to Article 48.2 (a) of Royal Decree 2200/1995 of 28 December 1995, to the body responsible for industry in the autonomous community where they were performed.

Additional provision fourth. Powers of the Ministry of Defence.

The administrative powers in relation to transportable pressure equipment affected by the National Defense services correspond to the authorities of the Ministry of Defense, without prejudice to the assistance provided by the Ministry of Defense. They can apply from different Public Administrations.

Single transient arrangement. Reassessment of compliance.

The conformity of the transportable pressure equipment referred to in Article 1 (2) (c) manufactured and put into operation before the date of application of Royal Decree 769/1999 of 7 May 1999 shall be accredited in accordance with the conformity assessment procedure set out in Annex II to this Royal Decree.

Single repeal provision. Repeal.

Royal Decree 222/2001 of 2 March 2001 laying down detailed rules for the application of Council Directive 1999 /36/EC of 29 April on transportable pressure equipment is hereby repealed without prejudice to the provisions of Directive 1999 /36/EC of the European Parliament and of the Council laid down in the additional first provision in respect of the EEC model approval certificates applicable to transportable pressure equipment, issued in accordance with the Order of the Ministry of Industry and Energy of 3 July 1987, the EC design examination certificates, issued in accordance with Royal Decree 222/2001 of 2 December 2001, In March, and in respect of the use of the valves and fittings referred to in Article 3 (3) of Royal Decree 222/2001 of 2 March 2001 and which bear the marking in accordance with the provisions of Article 3 (4) of the Royal Decree No 222/2001, decree.

Final disposition first. Amendment of Royal Decree 2060/2008 of 12 December approving the Regulation of Equipment to Pressure and its accompanying technical instructions.

A new additional provision is added to Royal Decree 2060/2008, dated December 12, with the following wording:

" Additional disposal sixth. Powers of the Ministry of Defence.

The administrative powers in relation to the pressure equipment affected by the National Defense services correspond to the authorities of the Ministry of Defense, without prejudice to the assistance they may provide. request from the different Public Administrations. "

Final disposition second. Competence title.

This royal decree is dictated by the state competence on the basis and coordination of the general planning of economic activity, as provided for in Article 149.1.13. of the Constitution.

Final disposition third. Regulatory enablement.

The Minister of Industry, Tourism and Trade, within the scope of his competences, is authorized to dictate the rules for the development of this royal decree, as well as the adaptation of the content of the annexes to the progress of the scientific and technological.

Final disposition fourth. Entry into force.

1. This royal decree will enter into force on the day following its publication in the ‹ ‹Official Gazette of the State › ›.

2. However, the entry into force of the provisions for pressure vessels, their valves and other accessories used for the transport of UN No 1745, UN No 1746 and UN No 2495 shall take place on 1 July 2013.

3. The provisions of Article 19 (2) (d) shall also enter into force on 1 January 2012.

Given in Madrid, on October 14, 2011.

JOHN CARLOS R.

The Minister of Industry, Tourism and Trade,

MIGUEL SEBASTIAN GASCON

ANNEX I

List of dangerous goods other than those in class 2

Number

Class

Dangerous Substance

1051

6.1

6.1

1052

8

1745

5.1

Pentafluoride bromine, excluding transport in cisterns.

1746

5.1

Bromo trifluoride, excluding transport in cisterns.

1790

8

Hydrofluoric acid, with more than 85% hydrogen fluoride

2495

5.1

Iodine Pentafluoride, excluding transport in cisterns.

ANNEX II

Procedure applicable to compliance reassessment

1. In order to ensure that the transportable pressure equipment referred to in Article 1 (2) (c) manufactured and put into service before the date of application of Royal Decree 222/2001 of 2 March 2001 complies with those provisions relevant to the RID and ADR and to this Royal Decree which are applicable at the time of the revaluation, the method set out in this Annex shall apply.

2. The owner or the user shall make available to a notified body which complies with the standard UNE-EN ISO/IEC 17020:2004 type A, notified for the reassessment of conformity, the data relating to transportable pressure equipment which allow the body to identify them accurately (origin, rules applied in the design field and, as far as the acetylene cylinders are concerned, also the indications referring to the porous material). The information shall include, where appropriate, the limitations of the use prescribed and the notes concerning any damage or repairs that have been carried out.

3. The notified body of type A, notified for the reassessment of conformity, shall assess whether the transportable pressure equipment has at least the same safety as the transportable pressure equipment referred to in the RID and ADR. The assessment shall be carried out on the basis of the data submitted within the meaning of paragraph 2 and, where appropriate, of the additional checks.

4. If the results of the evaluations referred to in paragraph 3 are satisfactory, the transportable pressure equipment shall be subjected to the periodic checks provided for in the RID and ADR. Where the requirements of such periodic checks are met, the notified body responsible for the periodic checks shall affix the II marking, in accordance with Article 13 (1) to (5), or supervise its placement. The II marking shall be followed by the identification number of the notified body responsible for the periodic checks. The notified body responsible for periodic checks shall issue a revaluation certificate in accordance with paragraph 6.

5. Where the pressure vessels have been manufactured in series, the conformity assessment relating to each of the containers, including their valves and other accessories used for transport, is authorised to be carried out by a body. notified for the periodic checks of the relevant transportable pressure vessels, provided that the type-conformity has been assessed, in accordance with paragraph 3, by a notified body of type A, responsible for the revaluation of the conformity, and a type revaluation certificate is issued. The II marking shall be followed by the identification number of the notified body responsible for the periodic checks.

6. In all cases, the notified body responsible for the periodic checks shall issue the revaluation certificate, which shall contain at least:

(a) The identification number of the notified body issuing the certificate and, where different, the identification number of the notified body of type A responsible for the reassessment of conformity according to the paragraph 3;

(b) the name and address of the owner or user referred to in paragraph 2;

(c) in case of application of the procedure provided for in paragraph 5, the data identifying the type revaluation certificate;

(d) the data for the identification of the transportable pressure equipment in which the Π marking has been affixed, including at least the serial number or numbers, and

e) the date of issue.

7. A type revaluation certificate shall be issued.

When the procedure provided for in paragraph 5 applies, the type A body, responsible for the revaluation of the conformity, shall issue the type revaluation certificate, which shall contain at least:

(a) The identification number of the notified body issuing the certificate;

(b) the name and address of the manufacturer and the holder of the original type-approval of the transportable pressure equipment when the holder is not the manufacturer;

(c) the data identifying the transportable pressure equipment belonging to the series;

d) the date of issue, and

e) the following indication: This certificate does not authorize the manufacture of transportable pressure equipment or parts thereof.

8. With the placement of the II marking, the owner or user indicates that he assumes responsibility for the conformity of the transportable pressure equipment with all applicable requirements established in the RID and ADR and in this royal decree as it is apply at the time of the revaluation.