Fourteenth Ordinance on the Product Safety Act (Pressure Equipment Regulation-14. ProdSV)

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14. ProdSV

Date of completion: 13.05.2015

Full quote:

" Pressure Equipment Ordinance of 13 May 2015 (BGBl. 692), as defined by Article 2 of the Regulation of 6 April 2016 (BGBl. I p. 597).

Status:	Amended by Art. 2 V v. 6.4.2016 I 597
§ 12 is gem. Section 24 (1) of this V entered into force on 1.6.2015
Replacing V 8053-4-17 v. 27.9.2002 I 3777, 3806 (GSGV 14)

For more details, please refer to the menu under Notes

1

This Regulation is designed to implement Directive 2014 /68/EU of the European Parliament and of the Council of 15 May 2014 on the harmonisation of the laws of the Member States relating to the provision of pressure equipment on the market (OJ L 327, 30.4.2014, p. OJ L 189 of 27.6.2014, p. 164).

Footnote

(+ + + Text evidence from: 19.7.2016 + + +) 
(+ + + For application cf.  § 1, 8, 9, 10 + + +) 
(+ + + Official note from the norm-provider on EC law: 
 Implementation of the 
 EURL 68/2014 (CELEX Nr: 32014L0068) + + +) 

  

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Input formula

Due to § 8 paragraph 1 of the Product Safety Act of 8 November 2011 (BGBl. I p. 2178, 2179; 2012 I p. 131) in conjunction with Section 1 (2) of the Jurisdiction Adjustment Act of 16 August 2002 (BGBl). I p. 3165) and with the organisation's Decree of 17 December 2013 (BGBl. 4310), the Federal Ministry of Labour and Social Affairs, in agreement with the Federal Ministry for Economic Affairs and Energy, the Federal Ministry of Food and Agriculture, the Federal Ministry for the Environment, Nature Conservation, Building and Reactor safety, the Federal Ministry of Transport and Digital Infrastructure and the Federal Ministry of Defence after hearing the Committee on Product Safety: Unofficial table of contents

Content Summary

Section 1General provisions

§ 1	Scope
§ 2	Definitions
§ 3	Provision on the market and commissioning
§ 4	Presumption of conformity

Section 2Duties of economic operators

§ 5	General obligations of the manufacturer
§ 6	Special characteristics and information requirements of the manufacturer
§ 7	Authorised representative of the manufacturer
§ 8	Obligations of the importer
§ 9	Obligations of the trader
§ 10	Importer or distributor as manufacturer
§ 11	Indication of economic operators

Section 3Conformity assessment

§ 12	Classification of pressure equipment
§ 13	Conformity assessment procedures
§ 14	European material authorisation
§ 15	CE marking

Section 4Notification of
recognised independent audit bodies
and operator inspection bodies as conformity assessment bodies

§ 16	Recognised independent verifiers
§ 17	Operator inspection bodies

Section 5Market monitoring

§ 18	Corrective measures taken by economic operators
§ 19	Provisional measures of the market surveillance authority
§ 20	Conformable pressure equipment or assemblies posing a risk
Section 21	Formal non-compliance

Section 6Administrative Offences, Crime and Final Provisions

Section 22	Offences and regularties
Section 23	Transitional provisions
§ 24	Entry into force, external force

Section 1
General provisions

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§ 1 Scope

(1) This Regulation shall apply to new pressure equipment and assemblies with a maximum allowable pressure of more than 0,5 bar made available, exhibited or used for the first time on the market. (2) This Regulation shall not apply to products. , as referred to in Article 1 (2) of Directive 2014 /68/EU of the European Parliament and of the Council of 15 May 2014 on the harmonisation of the laws of the Member States relating to the provision of pressure equipment on the market (OJ L 327, 30.4.2014, p. OJ L 189 of 27.6.2014, p. 164). Unofficial table of contents

§ 2 Definitions

For the purposes of this Regulation:

1.

Assemblies: several pressure equipment, which are connected by a manufacturer to a coherent functional unit;

2.

Pressure: the pressure applied to atmospheric pressure, that is, an overpressure; accordingly, a pressure in the vacuum area is expressed by a negative value;

3.

Pressure equipment: tanks, piping, safety-function equipment and pressure-holding equipment, including, where appropriate, pressure-bearing parts, such as flanges, connectors, couplings, carrying elements, hoisting eyes;

4.

European material authorisation: a technical document setting out the characteristics of the materials intended for repeated use in the manufacture of pressure equipment and which are not regulated in a harmonised standard;

5.

Harmonised standard: a harmonized standard within the meaning of Article 2 (1) (c) of Regulation (EU) No 1025/2012 of the European Parliament and of the Council of 25 November 2012 European standardisation, amending Council Directives 89 /686/EEC and 93 /15/EEC as well as Directives 94 /9/EC, 94 /25/EC, 95 /16/EC, 97 /23/EC, 98 /34/EC, 2004 /22/EC, 2007 /23/EC, 2009 /23/EC and 2009 /105/EC of the European Parliament and the Council and repealing Council Decision 87 /95/EEC and Decision No 1673 /2006/EC of the European Parliament and of the Council (OJ L 136, 31.5.2002, p. OJ L 316, 14.11.2012, p.12);

6.

Manufacturer: any natural or legal person who produces or manufactures a pressure equipment or an assembly and which markets this pressure equipment or assembly under its own name or trade mark or used for their own purposes;

7.

Putting into service: the first use of a pressure equipment or assembly by its user or its users;

8.

maximum permissible pressure (PS): the maximum pressure specified by the manufacturer, for which the pressure equipment is designed and which is fixed for a position selected by the manufacturer, either with the connection point of the equipment, the safety function or the highest point of the pressure equipment, or, if these points are not suitable, another specified location;

9.

technical specification: a document which requires the technical requirements to be met by a pressure equipment or an assembly;

10.

EU declaration of conformity: a declaration pursuant to Article 17 of Directive 2014 /68/EU.

Where reference is made to Articles 4 or 13 of Directive 2014 /68/EU, the definitions in Article 2 of Directive 2014 /68/EU shall apply. In addition, the definitions of the Product Safety Act shall apply. Unofficial table of contents

§ 3 Provision on the market and commissioning

Pressure equipment and assemblies may only be made available on the market and put into service if they comply with the requirements of this Regulation if they are properly installed and maintained and in accordance with their intended operation. Unofficial table of contents

§ 4 Conformity of conformity

(1) In the case of the pressure equipment and assemblies referred to in Article 4 (1) and (2) of Directive 2014 /68/EU, which comply with harmonised standards or parts of these standards, the references of which have been published in the Official Journal of the European Union, shall be presumed to comply with the essential safety requirements set out in Annex I to Directive 2014 /68/EU, to the extent that they are covered by the relevant standards or parts of those standards. (2) In the case of the manufacture of pressure equipment, or Assemblies used for which a European The material authorisation has been issued, the reference point of which has been published in the Official Journal of the European Union in accordance with Article 15 (4) of Directive 2014 /68/EU, it shall be presumed that it shall meet the relevant essential safety requirements in accordance with Annex I of Directive 2014 /68/EU.

Section 2
Duties of economic operators

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§ 5 General obligations of the manufacturer

(1) The manufacturer shall ensure that the pressure equipment or assemblies referred to in Article 4 (1) and (2) of Directive 2014 /68/EU are placed on the market or used for their own purposes that they are subject to the essential safety requirements designed and manufactured in accordance with Annex I to Directive 2014 /68/EU. (2) The manufacturer shall ensure that the pressure equipment or assemblies referred to in Article 4 (3) of Directive 2014 /68/EU are placed on the market or used for their own purposes shall be used in accordance with the good conditions laid down in a Member State of the European Union (3) The manufacturer may place the pressure equipment or assemblies referred to in Article 4 (1) and (2) of Directive 2014 /68/EU only on the market or use them for their own purposes, if the Conformity assessment procedures in accordance with Article 13 (1) or (2) have been carried out. Where the conformity assessment procedure has demonstrated that the pressure equipment or assemblies comply with the essential safety requirements set out in Annex I to Directive 2014 /68/EU, the manufacturer shall draw up an EU declaration of conformity and (4) The manufacturer must keep the technical documentation and the EU declaration of conformity ready for market surveillance authorities for ten years after the placing on the market of pressure equipment or assemblies. (5) The Manufacturer shall ensure by appropriate procedures that: Compliance with the requirements of this Regulation shall be ensured. Modifications to the design or characteristics of a pressure equipment or assembly, as well as modifications to the harmonized standards or other technical specifications, to which the declaration of conformity of a pressure equipment or an assembly (6) If, in the light of the risks associated with the pressure equipment or assemblies which it provides on the market, the manufacturer considers that it is appropriate to protect the health and safety of the equipment, it should be considered appropriate. Safety of consumers and other users samples and carries out audits. Where necessary, it shall keep a list of complaints about non-compliant pressure equipment or assemblies and the recalls of such pressure equipment or assemblies. The manufacturer shall keep the traders informed of such monitoring. (7) If the manufacturer has reason to believe that a pressure equipment or an assembly placed on the market by him does not comply with the requirements of this Regulation , it shall immediately take the necessary corrective measures to establish conformity, or withdraw or return the pressure equipment or assembly. Where risks are associated with the pressure equipment or assembly, the manufacturer shall, in addition, immediately inform the market surveillance authorities of the Member States in which he or she has provided this pressure equipment or assembly on the market and provide the necessary information, in particular on the nature of the non-compliance and of the corrective measures taken.

Footnote

(+ + + § 5: For application, see § 10 Input rate + + +)
(+ + + § 5 (6) and (7): For the purpose of application, see Section 8 (7) + + +)
(+ + + § 5 (7) sentence 2: For application, see Section 9 (5) sentence 2 + + +) Unofficial table of contents

§ 6 Special marking and information requirements of the manufacturer

(1) The manufacturer must ensure that his or her pressure equipment or assemblies bear a type, batch or serial number or other information for their identification when placing on the market or in use for their own purposes. If this is not possible due to the size or type of the pressure equipment or the assembly, the manufacturer must ensure that the information required for identification on the packaging or in the pressure equipment or assembly (2) The manufacturer shall have his name, registered trade name or registered trade mark, as well as his postal address on the printer, when placing on the market or in use for his own purposes. or the assembly. If this is not possible due to the size or type of the pressure equipment or assembly, the contact details must be indicated on the packaging or in the documents attached to the pressure equipment or assembly. The postal address is the address of a central location under which the manufacturer can be contacted. The contact details are to be written in a language which can be easily understood by consumers, other users and market surveillance authorities. (3) The manufacturer must ensure that:

1.

the pressure equipment or assemblies referred to in Article 4 (1) and (2) of Directive 2014 /68/EU shall be accompanied by the operating instructions and the safety information referred to in points 3.3 and 3.4 of Annex I to Directive 2014 /68/EU in the German language, and

2.

the pressure equipment or assemblies referred to in Article 4 (3) of Directive 2014 /68/EU are accompanied by the instruction manual in German.

The operating instructions and the safety information shall be clear, comprehensible and clear. (4) The manufacturer shall be obliged to provide the market surveillance authority with all information and documents on paper or electronically, at the request of the competent authority. shall be made available for the purpose of demonstrating the conformity of the pressure equipment or the assembly with the requirements of this Regulation. The information and documents must be written in German or in a language which can easily be understood by the market surveillance authority. The manufacturer shall cooperate with the market surveillance authority, at the request of the market surveillance authority, in all measures relating to the use of risks associated with the pressure equipment or assemblies which it has placed on the market.

Footnote

(+ + + § 6: For application, see § 10 Input rate + + +)
(+ + + § 6 (2) sentence 2 to 4: For application see § 8 (2) sentence 3 and Section 8 (3) sentence 3 + + +)
(+ + + § 6 (4): For application, see Section 8 (7) + + +)
(+ + + § 6 (4) sentence 3: For application see Section 9 (7) + + +) Unofficial table of contents

§ 7 Representative of the manufacturer

(1) The manufacturer may nominate an authorized representative in writing. (2) The authorized representative shall carry out the duties assigned to him by the manufacturer. (3) The manufacturer who uses an authorized representative shall at least have the following: Transfer tasks:

1.

the preparation of the EU declaration of conformity and the technical documentation referred to in Article 5 (4),

2.

provide the market surveillance authority with the information and documents referred to in Article 6 (4); and

3.

, at the request of the market surveillance authority, cooperation with the market surveillance authority in all measures to avoid the risks associated with the pressure equipment or assemblies which are part of the mandate of the authorised representative.

(4) The obligations laid down in § 5 (1) and (2) and the obligation to draw up the technical documentation pursuant to Article 5 (3) may not be transferred to an authorised representative by the manufacturer. Unofficial table of contents

§ 8 Duties of the importer

(1) The importer shall only place on the market pressure equipment or assemblies which meet the requirements of this Regulation. (2) The importer shall be entitled to a pressure equipment listed in Article 4 (1) and (2) of Directive 2014 /68/EU, or to a pressure equipment listed in that Directive. shall not be placed on the market unless it has ensured that:

1.

the manufacturer has carried out the conformity assessment procedure in accordance with Article 13 (1) or (2), or

2.

the manufacturer has complied with the obligations laid down in Article 6 (1), (2) and (3), first sentence, point 1.

The importer shall affix his name, registered trade name or registered trade mark, as well as his postal address, on the pressure equipment or assembly when placed on the market. (3) The importer may not place a pressure device or an assembly listed in Article 4 (3) of Directive 2014 /68/EU until such time as it has ensured that the pressure equipment has been placed on the market.

1.

the manufacturer has produced the technical documentation, or

2.

the manufacturer has fulfilled the obligations laid down in Article 6 (1), (2) and (3), first sentence, point 2.

The importer shall affix his name, registered trade name or registered trade mark, as well as his postal address, on the pressure equipment or assembly when placed on the market. (4) If the importer has reason to believe that a pressure device or an assembly does not comply with the requirements of this Regulation, it shall not be allowed to use this pressure equipment or assembly in the Transport traffic when conformity is established. Where a risk is associated with the pressure equipment or assembly, the importer shall inform the manufacturer and the market surveillance authorities thereof. (5) As long as a pressure equipment listed in Article 4 (1) and (2) of Directive 2014 /68/EU is concerned, the importer shall inform the manufacturer and the market surveillance authorities thereof. (5) where an assembly is located in the importer's area of responsibility, the importer is responsible for ensuring that the storage or transport conditions are in accordance with the conformity of the pressure equipment or the assembly with the essential Do not affect the safety requirements set out in Annex I to Directive 2014 /68/EU. (6) After placing the pressure equipment or assembly on the market, importer shall keep a copy of the EU declaration of conformity to the market surveillance authorities for a period of ten years and shall ensure that he/she has the technical documentation on the market (7) In addition, the provisions of Section 5 (6) and (7) and Article 6 (4) shall be applied accordingly for the importer.

Footnote

(+ + + § 8 (5): For application, see Section 9 (7) + + +) Unofficial table of contents

§ 9 Duties of the trader

(1) The trader shall take due care of the requirements of this Regulation with due diligence when providing a pressure equipment or assembly on the market. (2) Before the trader is a member of the Article 4 (1) and (2) of Directive 2014 /68/EU on the market, it shall verify whether the pressure equipment or the assembly listed therein is available on the market,

1.

the pressure equipment or assembly is marked with the CE marking,

2.

the required documents, as well as the operating instructions and safety information in the German language, are attached to the pressure equipment or assembly; and

3.

the manufacturer has fulfilled his obligations pursuant to Article 6 (1) and (2) and the importer has fulfilled his obligations pursuant to Article 8 (2) sentence 2.

(3) If the trader has reason to believe that the pressure equipment or assembly does not meet the essential safety requirements set out in Annex I to Directive 2014 /68/EU, the trader shall not be allowed to enter the pressure equipment or assembly on the market until the end of the when the compliance is made. Where there is a risk associated with the pressure equipment or assembly, the trader shall also inform the manufacturer or importer and the market surveillance authorities thereof. (4) Before the trader is a member of Article 4 (3) of Directive 2014 /68/EU, the trader shall inform the in the case of a printed equipment or an assembly listed there on the market, it shall verify that the pressure equipment or assembly is accompanied by a suitable instruction manual in the German language and whether the manufacturer is responsible for the duties in accordance with Article 6 (1) and (2) and the importer has fulfilled the obligations laid down in the second sentence of Article 8 (3). (5) the trader's reason to believe that a pressure equipment supplied by it on the market or an assembly provided on the market does not comply with the requirements of this Regulation, it must ensure that the necessary Corrective measures are taken to make the conformity of this pressure equipment or assembly with the requirements, or that the pressure device or assembly is withdrawn or recalled. § 5 (7) sentence 2 shall apply accordingly. (6) The trader shall, at the request of the market surveillance authority, hand out all the information and documents referred to in the second sentence, which shall be used to demonstrate the conformity of a pressure equipment or assembly are required. This information can be supplied on paper or electronically. (7) In addition, the provisions of § 6 (4) sentence 3 and § 8 (5) are to be applied accordingly for the trader. Unofficial table of contents

§ 10 Importer or distributor as manufacturer

§ § 5 and 6 shall apply mutatily to a importer or a trader if he/she is

1.

a printer or an assembly under its own name or a registered trademark is placed on the market or

2.

a pressure equipment on the market or an assembly located on the market so as to be capable of affecting conformity with the requirements of this Regulation.

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Section 11 Information of economic operators

(1) The economic operators shall call the market surveillance authorities, at their request, the economic operators,

1.

of which they have obtained a pressure device or an assembly, and

2.

to which they have delivered a pressure device or an assembly.

(2) Economic operators shall be able to provide the information referred to in paragraph 1 after the reference of the pressure equipment or assembly and after the delivery of the pressure equipment or assembly for ten years.

Section 3
Conformity assessment

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§ 12 Classification of pressure equipment

The pressure equipment referred to in Article 4 (1) of Directive 2014 /68/EU shall be classified in categories by the manufacturer in the light of the increasing danger potential. Classification shall be made in accordance with Article 13 of Directive 2014 /68/EU. Unofficial table of contents

Section 13 Conformity assessment procedures

For the pressure equipment referred to in Article 4 (1) of Directive 2014 /68/EU, the conformity assessment procedures referred to in Article 14 (1) to (5), in conjunction with Annex III to Directive 2014 /68/EU, shall be in accordance with the category in which they are placed (2) For the assemblies listed in Article 4 (2) of Directive 2014 /68/EU, the conformity assessment procedure referred to in Article 14 (6), in conjunction with Annex III to Directive 2014 /68/EU, shall be (3) The market surveillance authorities may, in individual cases, allow: for experimental purposes, individual pressure equipment and assemblies on the market shall be made available or put into service for which no conformity assessment procedures have been carried out. (4) The records and correspondence relating to the Conformity assessment procedures shall be drawn up in the German language or in a language recognised by the conformity assessment body. Unofficial table of contents

Section 14 European Material authorisation

The procedure laid down in Article 15 of Directive 2014 /68/EU shall apply to materials for which a European material authorisation is requested in accordance with Article 2, sentence 1, point 4. Unofficial table of contents

§ 15 CE marking

(1) The CE marking is in accordance with Article 7 (1) and (3) to (5) of the Product Safety Act (Product Safety Act) on the pressure device or assembly listed in Article 4 (1) and (2) of Directive 2014 /68/EU or on the respective type plate . If the type of pressure equipment or assembly does not permit or does not justify it, the CE marking shall be affixed to the packaging and the accompanying documents. (2) The pressure equipment or assembly shall be ready-made or in the form of a document. a condition which allows the acceptance in accordance with point 3.2 of Annex I to Directive 2014 /68/EU. (3) It is not necessary to affix the CE marking to each of the pressure equipment made up of an assembly. The individual pressure equipment, which already carries the CE marking when it is installed in the assembly, shall retain this marking. (4) The pressure equipment and assemblies referred to in Article 4 (3) of Directive 2014 /68/EU, as well as pressure equipment and Assemblies the conformity of which has been established by an operator inspection body in accordance with § 17 shall not be accompanied by the CE marking referred to in paragraph 1. This is without prejudice to the obligation to affix the CE marking in accordance with other legislation.

Section 4
Notification of recognised independent testing bodies and operator inspection bodies as conformity assessment bodies

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§ 16 Recognizing independent verifiers

The notification of recognised independent inspection bodies shall be carried out in accordance with the provisions of § § 12 to 19 of the Product Safety Act of 8 November 2011 (BGBl. I p. 2178, 2179; 2012 I p. 131) on the notification of conformity assessment bodies. Unofficial table of contents

Section 17 Operator inspection bodies

(1) The notification of operator inspection bodies shall be carried out in accordance with the provisions of Articles 12 and 14 to 19 of the Product Safety Act as well as in accordance with Article 25 of Directive 2014 /68/EU. (2) The pressure equipment evaluated by an operator's inspection body or Assemblies may be used exclusively in companies belonging to the group of companies to which the inspection body belongs. This group of companies applies a common security policy with regard to the technical design, production, control, maintenance and use conditions for pressure equipment and assemblies. (3) The operating inspection bodies are working exclusively for the group of companies to which they belong. (4) Only the procedures set out in Annex III, Module A2, C2, F and G of Directive 2014 /68/EU, may be applied for conformity assessment by operator inspection bodies.

Section 5
Market surveillance

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Section 18 Corrective measures of economic operators

(1) Where the market surveillance authority has reason to believe that a pressure equipment or an assembly falling within the scope of this Regulation poses a risk to the health or safety of humans or to domestic and commercial animals or goods; it shall assess whether the pressure equipment or assembly meets the requirements of this Regulation. Economic operators shall be obliged to cooperate with the market surveillance authorities to the extent necessary to this end. (2) The Market Surveillance Authority shall reach the conclusion that the pressure equipment or assembly shall meet the requirements of this Regulation, it shall, without delay, request the economic operator concerned to take all appropriate corrective measures, within a time-limit fixed by it, of the nature of the risk, to take account of the conformity of the to manufacture pressure equipment or assembly with these requirements, or Retract or recall the printer or assembly. The market surveillance authority shall inform the relevant notified body of the non-compliance. (3) If the market surveillance authority considers that non-compliance is not limited to the scope of this Regulation, the Federal Institute for Occupational Safety and Health (Bundesanstalt für Arbeitsschutz und Arbeitsmedizin) informs you about the result of the evaluation and the measures that she has asked the economic operator to take. (4) The economic operator guarantees that all Corrective measures it shall take to all the pressure equipment or assemblies concerned , which it has made available in the European Union on the market. Unofficial table of contents

Section 19 Preliminary measures of the market surveillance authority

Where the economic operator does not take appropriate corrective measures within the period referred to in the first sentence of Article 18 (2), the market surveillance authority shall take all appropriate provisional measures to ensure that the pressure equipment or the equipment is available to the market. (2) The Market Surveillance Authority shall immediately inform the Federal Institute for Occupational Safety and Health (Bundesanstalt für Arbeitsschutz und Arbeitsmedizin) about this provisional measures if the non-compliance is not based on the The scope of this Regulation is limited. The Bundesanstalt für Arbeitsschutz und Arbeitsmedizin (Federal Institute for Occupational Safety and Health) immediately forwards the information of the market surveillance authority to the European Commission and the other Member States of the European Union. (3) The information provided by the The market surveillance authority referred to in the first sentence of paragraph 2 shall contain all the information available, in particular the data for the identification of the pressure equipment or assembly concerned, the origin of the pressure equipment or the assembly, the type the alleged non-compliance and risk, as well as the nature and duration of the action taken provisional measures and the arguments of the economic operator concerned. In particular, the market surveillance authority shall indicate whether the non-compliance is due to the fact that:

1.

the pressure equipment or assembly does not comply with the requirements of this Regulation with regard to the health or safety of humans or the protection of domestic animals or goods, or goods, or

2.

the harmonized standards where compliance with Article 4 (1) is subject to a presumption of conformity, are defective.

(4) If the market surveillance authority is informed by the Bundesanstalt für Arbeitsschutz und Arbeitsmedizin that a provisional measure pursuant to Article 40 (4) of Directive 2014 /68/EU in another Member State of the European Union , the market surveillance authority shall take all appropriate provisional measures, provided that it agrees to this measure. It informs the Federal Institute for Occupational Safety and Health (Bundesanstalt für Arbeitsschutz und Arbeitsmedizin) as well as about all other information available to it regarding the non-compliance of the pressure equipment or the assembly. If the market surveillance authority does not agree to the provisional measure taken by the other Member State, it shall inform the Federal Institute for Occupational Safety and Health within two months of this and shall state its objections. The Federal Institute for Occupational Safety and Health (Bundesanstalt für Arbeitsschutz und Arbeitsmedizin) shall immediately forward the information referred to in sentences 2 and 3 to the European Commission and to the other Member States of the European Union. (5) The market surveillance authority shall be within the following conditions: Three months after the information referred to in the first sentence of paragraph 2 or the information referred to in the first sentence of paragraph 4, no information on an objection against a provisional measure taken by the European Union or any other Member State of the European Union , this provisional measure shall be deemed to be justified. In such a case, the market surveillance authority shall immediately take appropriate restrictive measures, such as the withdrawal of the pressure equipment or the assembly. Unofficial table of contents

§ 20 Conformers of pressure equipment or assemblies posing a risk

(1) In the context of an assessment in accordance with Article 18 (1), the Market Surveillance Authority shall establish that a pressure device or an assembly poses a risk to the health or safety of humans or to domestic and livestock animals or goods, although the the pressure equipment or the assembly satisfies the requirements of this Regulation, it shall invite the economic operator concerned to take all appropriate corrective measures to ensure that the pressure equipment or the assembly shall, in the case of the Placing on the market no longer poses any risk or that the pressure equipment or assembly (2) The Market Surveillance Authority shall inform the Federal Institute for Occupational Safety and Health of the determination and the measures to be taken by the Federal Agency for the Protection of Health and Safety has asked the economic operator. The information shall include all available information, in particular the data for the identification of the pressure equipment or assemblies concerned, their origin, their supply chain, the nature of the risk, and the nature and duration of the measures taken. (3) The economic operator shall ensure that all the corrective measures which it takes extend to all the pressure equipment or assemblies concerned which it has made available on the market in the European Union. (4) The Federal Agency for The information referred to in paragraph 2 shall be transmitted without delay to the information referred to in paragraph 2 European Commission and the other Member States of the European Union. Unofficial table of contents

§ 21 Formal non-compliance

(1) Regardless of the corrective measures referred to in § 18, the market surveillance authority shall require the economic operator concerned to correct the following non-compliance cases:

1.

the CE marking has not been affixed, or in breach of Section 7 of the Product Safety Act, in conjunction with Article 15 of this Regulation,

2.

the identification number of the notified body has not been affixed, or in breach of Section 7 (4) of the Product Safety Act, in conjunction with Article 15 of this Regulation;

3.

the marking and labelling referred to in point 3.3 of Annex I to Directive 2014 /68/EU has not been affixed, or in breach of section 15 or point 3.3 of Annex I to Directive 2014 /68/EU,

4.

the EU declaration of conformity has not been issued or has not been properly issued,

5.

the technical documentation is either not available or incomplete;

6.

the information provided by the manufacturer in accordance with Article 6 (2) or the importer in accordance with the second sentence of Article 8 (2) or the second sentence of paragraph 3 is missing, incorrect or incomplete, or

7.

a different formal requirement in accordance with § § 5 and 6 or § 8 is not fulfilled.

Where the non-compliance referred to in paragraph 1 continues, the market surveillance authority shall take all appropriate measures to restrict or prohibit the provision of the pressure equipment or assemblies on the market, or to ensure that: they are called back or withdrawn.

Section 6
Irregularities, offences and final provisions

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Section 22 Crime offences and administrative offences

(1) In the sense of Section 39 (1) (7) (a) of the Product Safety Act, who intentionally or negligently acts in accordance with the provisions of Section 39 (1) (7)

1.

, contrary to Article 5 (3), first sentence, a pressure device or an assembly is placed on the market or used for its own purposes,

2.

Contrary to the first sentence of Article 6 (1), it is not ensured that a pressure device or an assembly bears a number or other information,

3.

Contrary to Article 6 (1) sentence 2, the information referred to therein shall not be declared;

4.

the data referred to in the second sentence of Article 6 (2) or the second sentence of Article 8 (2) or the second sentence of Article 8 (3), second sentence, shall not be applied, not correct, in full or in a timely manner, or

5.

, contrary to the provisions of the first sentence of Article 8 (2) or the first sentence of paragraph 3, a pressure device or an assembly is placed on the

(2) In the sense of Section 39 (1) (7) (b) of the Product Safety Act, who intentionally or negligently acts in the sense of the order of law

1.

contrary to § 5 (4), also in conjunction with Section 7 (3) (1), or contrary to § 8 (6), a technical document or an EU declaration of conformity or a copy referred to in that paragraph shall not be held for at least ten years,

2.

contrary to § 6 (4) sentence 1, even in conjunction with Section 7 (3) (2) or (8) (7), or in breach of § 9 (6) sentence 1, an information or a document not, not correct, not complete, not in the prescribed manner or not shall be made available in time or not, not properly, not in full, in the prescribed manner or not in good time, or

3.

Contrary to Article 11 (1), an economic operator shall not be called or not in good time.

(3) Anyone who persistently repeats an intentional act referred to in paragraph 1 or endangers the life or health of another or other property of significant value by such intentional act is in accordance with § 40 of the Product safety law punishable. Unofficial table of contents

Section 23 Transitional provisions

(1) Pressure equipment and assemblies which comply with the requirements of Directive 97 /23/EC of the European Parliament and of the Council of 29 May 1997 on the approximation of the laws of the Member States relating to pressure equipment (OJ L 378, 27.11.1997, p. 1) and which have been placed on the market until 29 May 2002. (2) Pressure equipment and assemblies meeting the requirements of Directive 97 /23/EC and to be placed on the market before 19 July 2016 (3) certificates and decisions issued or taken by conformity assessment bodies in accordance with Directive 97 /23/EC shall remain within the framework of the of this Regulation. Unofficial table of contents

Section 24 Entry into force, external force

(1) § 12 shall enter into force on 1 June 2015. (2) In addition, this Regulation shall enter into force on 19 July 2016. At the same time, the Pressure Equipment Ordinance of 27 September 2002 (BGBl. 3777, 3806), as last amended by Article 24 of the Law of 8 November 2011 (BGBl). 2178), except for force. Unofficial table of contents

Final formula

The Federal Council has agreed.