Eleventh Ordinance on the Product Safety Act (explosion protection product regulation-11. ProdSV)

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11. ProdSV

Date of completion: 06.01.2016

Full quote:

" Explosion protection product regulation of 6 January 2016 (BGBl. 39) "

Replaced V 8053-4-14 v. 12.12.1996 I 1914 (GSGV 11)

For more details, please refer to the menu under Notes

1

This Regulation provides for the implementation of Directive 2014 /34/EU of the European Parliament and of the Council of 26 February 2014 on the harmonisation of the laws of the Member States relating to equipment and protective systems intended for use in Potentially explosive atmospheres (OJ OJ L 96, 29.3.2014, p. 309).

Footnote

(+ + + Text credits: 20.4.2016 + + +) 
(+ + + For application cf.  § 1 + + +) 
(+ + + For application cf.  § 2 sentence 2 + + +) 
(+ + + Official note from the norm-provider on EC law: 
 Implementation of the 
 EURL 34/2014 (CELEX Nr: 32014L0034) + + +) 

  

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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), which is defined by Article 435 (1) of the Regulation of 31 August 2015 (BGBl. 1474), 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, is ordering the Federal Ministry for the Environment, Nature conservation, construction 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	General obligations of the importer
§ 9	Special identification and information requirements of the importer
§ 10	Obligations of the trader
§ 11	Importer or distributor as manufacturer
§ 12	Indication of economic operators

Section 3Conformity assessment procedures;
Special explosion protection markings

§ 13	Conformity assessment procedures
§ 14	Special explosion protection markings

Section 4Market monitoring

§ 15	Corrective measures taken by economic operators
§ 16	Provisional measures of the market surveillance authority
§ 17	Conformable products posing a risk
§ 18	Formal non-compliance

Section 5Administrative Offences,
Offences and final provisions

§ 19	Irregularities
§ 20	Offences
Section 21	Transitional provisions
Section 22	Entry into force, external force

Section 1
General provisions

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§ 1 Scope

(1) This Regulation shall apply to the following new products, which are made available on the market, issued or used for the first time:

1.

equipment and protective systems intended for use in potentially explosive atmospheres;

2.

Safety, control and control devices intended for use outside potentially explosive atmospheres, but which are necessary for the safe operation of equipment and protective systems in view of the explosion risks, or safe operation, and

3.

Components intended for installation in the equipment and protective systems referred to in paragraph 1.

(2) This Regulation shall not apply to:

1.

medical equipment intended for use in medical areas,

2.

equipment and protective systems in which the risk of explosion is caused solely by the presence of explosives or chemically unstable substances;

3.

equipment intended for use in domestic and non-commercial environments in which an explosive atmosphere can be formed only rarely and only as a result of accidental fuel leakage,

4.

personal protective equipment within the meaning of the Regulation on the provision of personal protective equipment on the market, as amended by the Notice of 20 February 1997 (BGBl. 316), as last amended by Article 16 of the Law of 8 November 2011 (BGBl). 2178),

5.

Seagoing ships and movable off-shore installations, as well as the equipment on board these vessels and on these installations,

6.

Means of transport, that is to say, vehicles and associated trailers intended exclusively for the transport of persons in the air, on the road, on the rail or on the water, and means of transport, insofar as they are intended for the transport of: air, public roads and rails or on water are designed; vehicles to be used in potentially explosive atmospheres shall not be excluded from the scope of this Regulation,

7.

Products within the meaning of Article 346 (1) (b) of the Treaty on the Functioning of the European Union.

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§ 2 Definitions

For the purposes of this Regulation:

1.

intended use: the use

a)

equipment in accordance with the equipment group and equipment category specified by the manufacturer, or

b)

a protection system, a device or a component, having regard to all the manufacturer's information necessary for the safe operation;

2.

EU declaration of conformity: a declaration in accordance with Article 14 of Directive 2014 /34/EU of the European Parliament and of the Council of 26 February 2014 on the harmonisation of the laws of the Member States relating to equipment and protective systems intended use in potentially explosive atmospheres (OJ L 327, 30.4.2004 OJ L 96, 29.3.2014, p. 309),

3.

explosive atmospheres: a mixture of air and combustible gases, vapours, mists or dusts under atmospheric conditions, in which the combustion process, after ignition has occurred, transfers to the whole unburned mixture,

4.

potentially explosive atmospheres: an area in which the atmosphere can be explosive due to local and operational conditions,

5.

Equipment: machinery, equipment, stationary or mobile devices, control and equipment components, and warning and prevention systems which:

a)

individually or in combination for the production, transmission, storage, measurement, regulation or conversion of energies or for the processing of materials, and

b)

have their own potential sources of ignition and can thus cause an explosion,

6.

Equipment group I: equipment intended for use in underground operations of mines or intended for use in its installations which may be endangered by mine gas or combustible dusts; the equipment group I comprises the equipment group I, in which: Annex I of Directive 2014 /34/EU, categories M1 and M2,

7.

Equipment group II: equipment intended for use in all areas likely to be endangered by explosive atmospheres, with the exception of the areas referred to in point 6; equipment group II shall include those set out in Annex I to the Directive 2014 /34/EU categories 1, 2 and 3,

8.

equipment category: a category in which equipment within each set of equipment shall be classified according to the level of safety required to be guaranteed;

9.

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),

10.

Manufacturer: any natural or legal person who produces or manufactures a product and which markets or markets this product under its own name or trademark or uses it for its own purposes,

11.

components: those components which are necessary for the safe operation of equipment and protective systems without, however, having to perform an autonomous function,

12.

Certificate of conformity: a certificate referred to in Article 13 (3), second sentence, of Directive 2014 /34/EU,

13.

Protective systems: all devices other than the components of equipment intended to immediately stop the explosions or to limit the area affected by an explosion and, separately, on the market as a system with an autonomous function ,

14.

technical specification: a document in which the technical requirements which a product must meet are required.

In addition, the definitions of § 2 of the Product Safety Act of 8 November 2011 (BGBl. I p. 2178, 2179; 2012 I p. 131), which is based on Article 435 of the Regulation of 31 August 2015 (BGBl. I p. 1474). Unofficial table of contents

§ 3 Provision on the market and commissioning

Products 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 used in accordance with their intended use. Unofficial table of contents

§ 4 Conformity of conformity

Products 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 meet the essential health and safety requirements of: Annex II to Directive 2014 /34/EU, to the extent that these are covered by the relevant standards or parts of those standards.

Section 2
Duties of economic operators

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§ 5 General obligations of the manufacturer

(1) The manufacturer shall ensure that products are placed on the market or used for their own purposes for the first time that they are designed according to the essential health and safety requirements set out in Annex II to Directive 2014 /34/EU, and (2) The manufacturer may only place products on the market or use them for their own purposes for the first time if the technical documentation referred to in point 3 (c) of Annex III, in accordance with point 3.1 (e) of Annex IV, in accordance with Annex VII, point (e) 3.1 (e), in accordance with point 2 of Annex VIII, or in point 2 of Annex IX to Directive 2014 /34/EU , and the conformity assessment procedure has been carried out in accordance with the first sentence of Article 13 (1). Where the conformity assessment procedure has shown that the product complies with the relevant essential health and safety requirements set out in Annex II to Directive 2014 /34/EU, the manufacturer shall provide the product with the following:

1.

in the case of a device, a protection system or a safety, control or regulating device, an EU declaration of conformity and affixing the CE marking in accordance with Section 7 of the Product Safety Act,

2.

if the component is a component, a written certificate of conformity.

(3) The manufacturer must ensure that a copy of the EU declaration of conformity or of the certificate of conformity is attached to each product. If a large number of identical products are delivered to the same user, the relevant batch or delivery may be accompanied by a single copy. (4) The manufacturer must have the technical documentation and the EU declaration of conformity or the Certificate of conformity as from the placing on the market of the product for the period of ten years for the market surveillance authorities. (5) The manufacturer must ensure, by means of appropriate procedures, that conformity is always carried out in the case of series production. the requirements of this Regulation. Any changes to the design or characteristics of a product, as well as changes in the harmonised standards or other technical specifications referred to in the EU declaration of conformity or the certificate of conformity, shall be appropriate. (6) If the manufacturer considers it appropriate, in view of the risks associated with a product which it provides on the market, it shall take samples to protect the health and safety of end-users, and it investigates complaints. Where necessary, it shall keep a list of complaints, non-compliant products and recalls. The manufacturer shall keep the traders informed of the surveillance activities. (7) If the manufacturer has reason to believe that a product he has placed on the market is not in conformity with the requirements of this Regulation, he shall take the necessary steps to ensure that the manufacturer has Immediately take the necessary corrective measures to ensure conformity or withdraw the product or call it back. Where risks are associated with the product, the manufacturer shall immediately inform the market surveillance authorities of the Member States of the European Union in which he has provided the product on the market, in particular the risks involved, the nature of the products and the risks involved. the non-compliance and the corrective measures taken. Unofficial table of contents

§ 6 Special marking and information requirements of the manufacturer

(1) The manufacturer must ensure that his products bear a type, batch or serial number or other information for their identification when placing on the market or when used for the first time for their own purposes. If this is not possible due to the size or nature of the product, the manufacturer must ensure that the information required for identification is indicated on the packaging or in the documents attached to the product. (2) The The manufacturer must ensure that his products are provided with the special explosion protection markings according to § 14 when they are placed on the market or used for the first time for their own purposes. Sentence 1 shall not apply to components. (3) The manufacturer shall have his name, registered trade name or registered trade mark as well as his postal address when placing on the market or for the first time for his own use. on the product. If this is not possible due to the size or nature of the product, these contact data must be indicated on the packaging or in the documents attached to the product. 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 the end-users and the market surveillance authorities. (4) The manufacturer must ensure that the product is the operating instructions and the safety information in (5) All markings, operating instructions and safety information must be clear, comprehensible and clear. (6) The manufacturer is obliged to provide the market surveillance authority at the request of the market surveillance authority. Information and documents available on paper or electronically available , which are necessary to demonstrate the conformity of the product with the requirements of this Regulation. The information and documents must be written in German or in a language which can be easily 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 products which it has placed on the market. 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) A manufacturer who uses an authorized representative shall at least have the following: Transfer duties:

1.

the obligation to keep the technical documentation, the EU declaration of conformity or the certificate of conformity in accordance with § 5 (4) ready,

2.

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

3.

the obligation to cooperate with the market surveillance authority, at the request of the market surveillance authority, in all measures relating to the use of the risks associated with the products belonging to the authorised representative.

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

§ 8 General obligations of the importer

(1) The importer may only place products on the market which meet the requirements of this Regulation. (2) The importer shall not place a product on the market until it has ensured that:

1.

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

2.

the manufacturer has produced the technical documentation,

3.

the product, if it is a device, a protection system or a safety, control or regulating device, is marked with the CE marking and the EU declaration of conformity is attached to it,

4.

the product, if it is a component, is accompanied by the certificate of conformity,

5.

the product is accompanied by the operating instructions and the safety information in the German language, and

6.

the manufacturer has fulfilled the obligations laid down in Article 6 (1) to (3).

(3) If the importer has reason to believe that a product does not meet the essential health and safety requirements set out in Annex II to Directive 2014 /34/EU, it may not place this product on the market until the conformity of the product is in conformity with the requirements of Annex II to Directive 2014 /34/EU. is manufactured. Where a risk is associated with the product, the importer shall inform the manufacturer and the market surveillance authorities thereof. (4) As long as a product is in the area of responsibility of the importer, the importer shall be responsible for ensuring that the product is in the responsibility of the importer. Storage and transport conditions do not affect the conformity of the product with the essential health and safety requirements set out in Annex II to Directive 2014 /34/EU. (5) If the importer is responsible for the risks associated with is connected to a product made available on the market, as appropriate , it takes samples to protect the health and safety of end-users, inspects them and investigates complaints. Where necessary, it shall keep a list of complaints, non-compliant products and recalls. The importer shall keep the traders informed of these surveillance activities. (6) If the importer has reason to believe that a product he has placed on the market is not in accordance with the requirements of this Regulation, he shall take the necessary steps to ensure that the operator is informed of the need to Immediately take the necessary corrective measures to ensure conformity or withdraw the product or call it back. Where risks are associated with the product, the importer shall immediately inform the market surveillance authorities of the Member States of the European Union in which he has provided the product on the market, in particular the risks involved, the nature of the product and the nature of the product. the non-compliance and the corrective measures taken. Unofficial table of contents

§ 9 Special identification and information requirements of the importer

(1) The importer shall attach his name, registered trade name or registered trade mark to the placing on the market, as well as his postal address on the product. If this is not possible due to the size or nature of the product, these contact data must be indicated on the packaging or in the documents attached to the product. The postal address is the address of a central location under which the importer can be contacted. The contact details shall be written in a language which may be easily understood by the end-users and the market surveillance authorities. (2) The importer shall have a copy of the product for a period of ten years from the date on which the product is placed on the market. to ensure that the EU declaration of conformity or the certificate of conformity is available to the market surveillance authorities and to ensure that it can submit the technical documentation at the request of the market surveillance authorities. (3) The importer shall be obliged to: the market surveillance authority, at the request of the market surveillance authority, all information and documents on paper or shall be made available electronically in order to demonstrate the conformity of the product with the requirements of this Regulation. The information and documents must be written in German or in a language which can be easily understood by the market surveillance authority. The importer shall cooperate with the market surveillance authority, at the request of the importer, in all measures relating to the use of risks associated with the products which he has placed on the market. Unofficial table of contents

§ 10 Duties of the trader

(1) The trader shall take due care of the requirements of this Regulation with due care if it provides a product on the market. (2) Before the trader provides a product on the market, he shall verify whether

1.

the product, if it is a device, a protection system or a safety, control or regulating device, is marked with the CE marking and the EU declaration of conformity is attached to it,

2.

the product, if it is a component, is accompanied by the certificate of conformity,

3.

the product is accompanied by the operating instructions and the safety information in the German language, and

4.

the manufacturer has fulfilled his obligations pursuant to Article 6 (1) to (3) and the importer has fulfilled his obligations pursuant to Article 9 (1).

(3) If the trader has reason to believe that a product does not meet the essential health and safety requirements set out in Annex II to Directive 2014 /34/EU, it may not provide that product on the market until the conformity of the product is in conformity with the requirements of is manufactured. Where a risk is associated with the product, the trader shall also inform the manufacturer or importer and the market surveillance authorities thereof. (4) As long as a product is in the area of responsibility of the trader, the trader shall be responsible for the risk. responsible that the storage and transport conditions do not affect the conformity of the product with the essential health and safety requirements set out in Annex II to Directive 2014 /34/EU. (5) The trader has reason to It is assumed that a product made available on the market does not include the the requirements of this Regulation, it shall ensure that the necessary measures are taken to establish conformity or that the product is withdrawn or recalled. When risks are associated with the product, the trader shall immediately inform the market surveillance authorities of the Member States in which he has provided the product on the market, in particular the risks, the nature of non-compliance and the nature of the product on the market. (6) The trader shall be obliged to make available to the market surveillance authority, at the request of the market surveillance authority, all information and documents on paper or electronically, which shall be used to demonstrate the conformity of the product with the requirements of this Regulation. The trader 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 products which it has made available on the market. Unofficial table of contents

§ 11 Importer or distributor as manufacturer

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

1.

is placing a product on the market under its own name or trademark, or

2.

a product present on the market so as to be capable of being affected by compliance with the requirements of this Regulation.

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Section 12 Information of economic operators

(1) The economic operator shall indicate to the market surveillance authorities, at the request of the market surveillance authorities, the economic operators,

1.

of which he has obtained a product, and

2.

to which he has delivered a product.

(2) The economic operator shall be able to provide the information referred to in paragraph 1 for a period of ten years after the product has been referred to and after the product has been delivered.

Section 3
Conformity assessment procedures; special explosion protection markings

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Section 13 Conformity assessment procedures

(1) In accordance with the requirements of Article 13 (1) to (4) of Directive 2014 /34/EU, the conformity assessment procedures referred to in Annexes III to IX of Directive 2014 /34/EU shall be carried out in respect of products. The documents and the correspondence relating to the conformity assessment procedures shall be drawn up in the German language or in a language recognised by the notified body. (2) By way of derogation from paragraph 1, the The market surveillance authority shall, on a duly substantiated request, authorise products to be placed on the market or put into service for which no conformity assessment procedure has been carried out, provided that the use of these products is carried out in the Interest in the protection of people, of domestic animals and of livestock or of goods is offered. Record 1 is not applicable to components. Unofficial table of contents

Section 14 Special explosion protection markings

(1) Behind the CE marking in accordance with § 7 of the Product Safety Act and, if applicable, the identification number of the notified body

1.	the special explosion protection mark , the identifiers that refer to the device group and device category to which the product belongs, and
2.	the other markings and information referred to in Annex II, point 1.0.5 of Directive 2014 /34/EU, to the extent that they are necessary.

(2) Products intended for use in a certain explosive atmosphere shall be labelled accordingly.

Section 4
Market surveillance

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Section 15 Corrective measures of economic operators

Where the market surveillance authority has reason to believe that a product poses a risk to the health or safety of humans or to domestic and commercial animals or goods, it shall assess whether the product meets the requirements of this Regulation. is fulfilled. Economic operators are obliged to cooperate with the market surveillance authorities to the extent necessary. (2) The market surveillance authority shall reach the conclusion that the product does not 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, in order to ensure that the product is in conformity with the product requirements, or to take back the product, or to recall. The market surveillance authority shall inform the relevant notified body of the non-compliance. (3) If the market surveillance authority has reason to believe that the products in question are also available in other Member States of the European Union, the market surveillance authority shall inform the market surveillance authority of the fact that it has not been notified. The Federal Institute for Occupational Safety and Health shall inform the Bundesanstalt für Arbeitsschutz und Arbeitsmedizin about the result of the assessment referred to in paragraph 1 and the measures to be taken by the economic operator to take. The Bundesanstalt für Arbeitsschutz und Arbeitsmedizin (Federal Institute for Occupational Safety and Health) shall immediately forward the information of the market surveillance authority to the European Commission and the other Member States of the European Union. (4) The economic operator shall ensure that: the corrective measures it takes extend to all the products concerned, which it has made available on the market in the European Union. Unofficial table of contents

Section 16 Preliminary measures of the market surveillance authority

Where the economic operator does not take appropriate corrective measures within the period laid down in the first sentence of Article 15 (2), the market surveillance authority shall take all appropriate provisional measures to ensure that the product is made available on the market. (2) If the Market Surveillance Authority has reason to believe that the products in question are also in other cases, the market surveillance authority shall have reason to believe that the products in question shall not be withdrawn or withdrawn. Member States of the European Union shall be provided on the market, shall inform the Federal Institute for Occupational Safety and Health immediately of the provisional measures referred to in paragraph 1. 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 available information, in particular the data for the identification of the product concerned, its origin, the nature of the alleged non-conformity and the risk, and the nature and Duration of the provisional measures taken and the arguments of the Economic actor. In particular, the market surveillance authority shall indicate whether the non-compliance is due to the fact that:

1.

the product does not meet the requirements relating to the health or safety of humans or the protection of domestic and domestic animals or goods, or

2.

the harmonized standards where compliance with Article 4 is subject to a presumption of conformity are deficient.

(4) Where the Market Surveillance Authority is informed by the Bundesanstalt für Arbeitsschutz und Arbeitsmedizin that a provisional measure pursuant to Article 35 (4) of Directive 2014 /34/EU in another Member State of the European Union is to be taken into account in the the market surveillance authority shall, if it deems this measure to be justified, shall take all appropriate provisional measures as referred to in paragraph 1. 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 product. Provided that the market surveillance authority does not consider the provisional measure taken by the other Member State to be justified, it shall inform the Federal Institute for Occupational Safety and Health within two months of this and shall give its Objections. The Federal Institute for Occupational Safety and Health 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 of three months after the information referred to in the first sentence of paragraph 2 or the receipt of information referred to in the first sentence of paragraph 4, no information on an objection against a provisional decision taken by it or any other Member State of the European Union In the event of a measure, this provisional measure shall be deemed to be justified. The market surveillance authority shall, in this case, immediately take appropriate restrictive measures, such as the withdrawal of the product. Unofficial table of contents

§ 17 Conformous products posing a risk

(1) In the context of an assessment in accordance with Article 15 (1), the Market Surveillance Authority shall establish that a product presents a risk to the health or safety of humans or to domestic and commercial animals or goods, even though the product is the product of It shall require the economic operator concerned to take all appropriate corrective measures to ensure that the product does not pose any risk to the placing on the market or that the product is not Product taken back or recalled within a reasonable period of risk (2) The Market Surveillance Authority shall inform the Federal Institute for Occupational Safety and Health on the determination and the measures which it has requested the economic operator to take. The information shall include all available information, in particular the data for the identification of the product concerned, its origin, its supply chain, the nature of the risk, and the nature and duration of the measures taken. (3) The The Bundesanstalt für Arbeitsschutz und Arbeitsmedizin (Federal Institute for Occupational Safety and Health) guarantees that the corrective measures which it takes extend to all the products concerned which it has made available on the market in the European Union. shall forward the information referred to in paragraph 2 without delay to the European Commission and to the other Member States of the European Union. Unofficial table of contents

§ 18 Formal non-compliance

(1) Regardless of the corrective measures referred to in § 15, 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 has been affixed in violation of Section 7 of the Product Safety Act;

2.

the special explosion protection markings have not been affixed or have been affixed in violation of § 14;

3.

the identification number of the notified body has not been affixed, or in breach of Section 7 (4) of the Product Safety Act,

4.

the EU declaration of conformity or the certificate of conformity has not been issued or has not been duly issued,

5.

the EU declaration of conformity or the certificate of conformity is not annexed to the product,

6.

the technical documentation is not available or is not complete;

7.

the information provided by the manufacturer in accordance with Article 6 (3) or the importer in accordance with Article 9 (1) is missing, are incorrect or incomplete, or

8.

a different formal requirement in accordance with § § 5, 6, 8 or § 9 is not fulfilled.

(2) If the non-compliance referred to in paragraph 1 continues, the market surveillance authority shall take all appropriate measures to restrict the supply of the product to the market, or shall prohibit the provision on the market or shall ensure that: that the product is recalled or withdrawn.

Section 5
Irregularities, offences and final provisions

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§ 19 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 (2), first sentence, placing a product on the market or for the first time using

2.

does not ensure that a copy thereof is attached to the product in accordance with the first sentence of Article 5 (3),

3.

Contrary to Article 6 (1), first sentence, it does not ensure that a product bears a number or other information,

4.

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

5.

Contrary to the first sentence of Article 6 (2), it does not ensure that a product is marked with a marking in accordance with Article 14 (1) (1),

6.

the data referred to in the first sentence of Article 6 (3) or the first sentence of Article 9 (1) shall not be applied, not correct, in full or in a timely manner,

7.

Contrary to § 6 (4), it does not ensure that a product is accompanied by an operating instructions and the safety information, or

8.

in accordance with Article 8 (2) (1), (3), (4) or (5), placing a product on the market.

(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 in breach of § 9 (2), a technical document, an EU declaration of conformity, a certificate of conformity or a copy referred to therein, or not at least ten years holds in place,

2.

contrary to § 6 (6) sentence 1, also in conjunction with Section 7 (3) (2), contrary to § 9 (3) sentence 1 or § 10 (6) sentence 1, an information or a document not, not correct, not complete, not in the prescribed manner or not be made available in good time, or

3.

Contrary to Article 12 (1), an economic operator shall not be called or not in good time.

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§ 20 Crime

Anyone who persistently repeats an intentional act referred to in § 19 (1) or endangers the life or health of another or a foreign property of significant value by such intentional act is in accordance with § 40 of the German Act. Product safety law punishable. Unofficial table of contents

Section 21 Transitional provisions

(1) Products which comply with the requirements of Directive 94 /9/EC of the European Parliament and of the Council of 23 March 1994 on the approximation of the laws of the Member States relating to equipment and protective systems intended for use in Potentially explosive atmospheres (OJ 1), which has been repealed by Directive 2014 /34/EU, and which has been placed on the market until 20 April 2016, may be made available on the market and put into service. (2) Certificates issued by Notified bodies have been issued in accordance with Directive 94 /9/EC, and shall remain valid under this Regulation. Unofficial table of contents

Section 22 Entry into force, external force

This Regulation shall enter into force on 20 April 2016. At the same time, the explosion protection ordinance of 12 December 1996 (BGBl. I p. 1914), most recently by Article 21 of the Law of 8 November 2011 (BGBl. 2178), except for force. Unofficial table of contents

Final formula

The Federal Council has agreed.