First Regulation on the Product Safety Act

Original Language Title: Erste Verordnung zum Produktsicherheitsgesetz

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First Regulation on the Product Safety Act (Regulation on electrical equipment-1. ProdSV)

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1. ProdSV

Date of completion: 17.03.2016

Full quote:

" Regulation on electrical equipment of 17 March 2016 (BGBl. I p. 502) "

Replaces V 8053-4-1 v. 11.6.1979 I 629 (TechArbmGV 1)

For more details, please refer to the menu under Notes

1: This Regulation shall be used for the implementation of Directive 2014 /35/EU of the European Parliament and of the Council of 26 February 2014 on the harmonisation of the laws of the Member States relating to the provision of electrical equipment for use within certain voltage limits on the market (OJ L 327, 22.4. OJ L 96, 29.3.2014, p. 357).

Footnote

(+ + + Text credits: 20.4.2016 + + +) 
(+ + + For application cf.  § 2 p. 2 + + +) 
  
(+ + + Official note from the norm-provider on EC law: 
 Implementation of the 
 EURL 35/2104 (CELEX Nr: 32014L0035) + + +)

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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
§ 4	Presumption of conformity on the basis of harmonized standards
§ 5	Presumption of conformity on the basis of international standards
§ 6	Presumption of conformity on the basis of national standards

Section 2Duties of economic operators

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

Section 3Market monitoring

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

Section 4Administrative 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

This Regulation shall apply to new electrical equipment which is made available on the market, provided that such electrical equipment is used for use at a rated voltage of between 50 and 1 000 volts for alternating current and between 75 and 1 500 volts for direct current. (2) This Regulation is not applicable to

1.: electrical equipment for use in an explosive atmosphere,
2.: electro-radiological and electro-medical equipment,
3.: electrical parts of passenger and load elevators,
4.: electricity meter,
5.: Budgetary plug-in devices,
6.: Electrical power supply devices for electric fences,
7.: electrical equipment under the aspect of radio interference suppression,
8.: special electrical equipment intended for use on ships, in aeroplanes or in railways, and in accordance with the safety provisions of international bodies to which the Member States belong,
9.: Customer-specific and application-specific test modules, which are used by experts exclusively in research and development facilities for research and development purposes.

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§ 2 Definitions

For the purposes of this Regulation:

1.: EU declaration of conformity: a declaration in accordance with Article 15 of Directive 2014 /35/EU of the European Parliament and of the Council of 26 February 2014 on the harmonisation of the laws of the Member States relating to the provision of electrical energy Means of operation for use within certain voltage limits on the market (OJ L 327, 30.4.2004 OJ L 96, 29.3.2014, p.357),
2.: 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),
3.: Manufacturer: any natural or legal person who makes or manufactures an electrical equipment and which markets this electrical equipment under his or her own name or trademark,
4.: technical specification: a document in which the technical requirements to be met by an electrical equipment 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

Electrical equipment may be made available on the market only if it is

1.: agree with the safety objectives set out in Annex I to Directive 2014 /35/EU,
2.: have been manufactured in accordance with the state of security technology in force in the European Union, and
3.: in the case of proper installation and maintenance and in the case of intended use, do not endanger the health and safety of humans, domestic animals and livestock and goods.

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§ 4 Conformity of conformity on the basis of harmonized standards

In the case of electrical equipment which complies with harmonized standards or parts of these standards, the references of which have been published in the Official Journal of the European Union, it shall be presumed that they meet the requirements laid down in § 3, to the extent that such standards are covered by the relevant standards or by parts of those standards. Unofficial table of contents

§ 5 Conformity presumption on the basis of international standards

In the case of electrical equipment which complies with the safety provisions of the international standards laid down by the International Electrotechnical Commission, the references of which have been published in the Official Journal of the European Union, shall be presumed to comply with the requirements laid down in § 3. Unofficial table of contents

§ 6 Conformity of conformity on the basis of national standards

Unless harmonised standards have been published in accordance with § 4 and no international standards pursuant to § 5, electrical equipment shall be used which shall comply with the safety provisions of the standards applicable in the issuing Member State. , it shall be presumed that they comply with the requirements of § 3 if the standards in force in the issuing Member State comply with the German safety level.

Section 2
Duties of economic operators

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§ 7 General obligations of the manufacturer

(1) The manufacturer shall ensure that the electrical equipment is placed on the market, that it has been designed and manufactured in accordance with the requirements of § 3. (2) The manufacturer may place electrical equipment only on the market if the the technical documentation referred to in point 2 of Annex III to Directive 2014 /35/EU and the conformity assessment procedure referred to in point 1 of Annex III to Directive 2014 /35/EU has been carried out. If the conformity assessment procedure has demonstrated that the electrical equipment meets the requirements of § 3, the manufacturer shall draw up an EU declaration of conformity for the electrical equipment and shall bring the CE marking according to § 7 of the Product Safety Act. (3) The manufacturer must make the technical documentation and the EU declaration of conformity from the placing on the market of the electrical operating medium for the duration of ten years for the Market surveillance authorities. (4) The manufacturer has to do so by means of appropriate procedures for ensure conformity with the requirements of this Regulation in the case of series production. Changes to the design or characteristics of an electrical operating medium, as well as changes in the standards referred to in § § 4 to 6 or other technical specifications referred to in the EU declaration of conformity, shall be appropriate to: (5) In view of the risks associated with an electrical equipment supplied by it on the market, the manufacturer considers it appropriate to protect the health and safety of end-users. Samples, tests them, and investigates complaints concerning non-conformers electrical equipment. Where necessary, it shall list the complaints and the recalls of electrical equipment. The manufacturer shall keep the traders informed of the surveillance activities. (6) If the manufacturer has reason to believe that an electrical equipment placed on the market is not in conformity with the requirements of this Regulation, he shall immediately take the necessary corrective measures to establish conformity, or he shall withdraw the electrical equipment or call it back. Where risks are associated with the electrical equipment, the manufacturer shall immediately inform the market surveillance authorities of the Member States of the European Union in which he has made available the electrical equipment on the market, in particular on the risks, the nature of non-compliance and the corrective measures taken. Unofficial table of contents

§ 8 Special marking and information requirements of the manufacturer

(1) The manufacturer must ensure that his electrical equipment, when placed on the market, carries a type, batch or serial number, or any other information, for its identification. If this is not possible due to the size or nature of the electrical operating means, the manufacturer shall ensure that the information required for identification on the packaging or in the electrical equipment is (2) The manufacturer must attach his name, registered trade name or registered trade mark to the placing on the market and his postal address on the electrical equipment. If this is not possible due to the size or nature of the electrical operating means, these contact data must be indicated on the packaging or in the documents accompanying the electrical equipment. The postal address is the address of a central location under which the manufacturer can be contacted. The contact details must be written in a language which can be easily understood by the end-users and the market surveillance authorities. (3) The manufacturer must ensure that the electrical equipment is used for the management of the plant and the (4) All markings, operating instructions and safety information must be clear, comprehensible and clear. (5) The manufacturer shall be obliged to provide the market surveillance authority with the following information: the request of which all information and documents on paper or shall be made available electronically in order to demonstrate the conformity of the electrical operating means 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 electrical equipment which it has placed on the market. Unofficial table of contents

§ 9 authorized 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 and the EU declaration of conformity in accordance with § 7 (3) ready,
2.: the obligation to provide the market surveillance authority with the information and documents referred to in Article 8 (5); and
3.: the obligation to cooperate with the market surveillance authority, at the request of the competent authority, in all measures relating to the use of the risks associated with the electrical equipment which are part of the mandate of the authorised representative.

(4) The obligation pursuant to Section 7 (1) and the obligation to draw up the technical documentation pursuant to Section 7 (2) shall not be allowed to transfer the manufacturer to an authorized representative. Unofficial table of contents

§ 10 General obligations of the importer

(1) The importer shall only place on the market electrical equipment which satisfies the requirements of this Regulation. (2) The importer shall not place an electrical equipment on the market until it has ensured that:

1.: the manufacturer has carried out the conformity assessment procedure in accordance with point 1 of Annex III to Directive 2014 /35/EU,
2.: the manufacturer has produced the technical documentation,
3.: the electrical equipment is marked with the CE marking,
4.: the electrical equipment is accompanied by the operating instructions and the safety information in the German language, and
5.: the manufacturer has fulfilled the obligations laid down in Article 8 (1) and (2).

(3) If the importer has reason to believe that an electrical equipment does not meet the requirements of § 3, it shall not place such electrical equipment on the market until the conformity is established. Where there is a risk associated with the electrical equipment, the importer shall inform the manufacturer and the market surveillance authorities thereof. (4) As long as an electrical equipment is in the responsible area of the importer, the operator shall be informed of the risk of such a risk. (4) responsible for the fact that the storage and transport conditions do not affect the conformity of the electrical equipment with the requirements of § 3. (5) If the importer is responsible for the risks associated with one of his the electrical equipment supplied to the market shall be deemed to be it considers, in order to protect the health and safety of end-users, samples, examines them and investigates complaints concerning non-conformant electrical equipment. Where necessary, it shall list the complaints and the recalls of electrical equipment. The importer shall keep the traders informed of these surveillance activities. (6) If the importer has reason to believe that an electrical equipment placed on the market is not in accordance with the requirements of this Regulation, he shall immediately take the necessary corrective measures to establish conformity, or he shall withdraw the electrical equipment or call it back. Where risks are associated with the electrical equipment, the importer shall immediately inform the market surveillance authorities of the Member States of the European Union in which it has provided the electrical equipment on the market, in particular on the risks, the nature of non-compliance and the corrective measures taken. Unofficial table of contents

§ 11 Special marking 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 and his postal address on the electrical equipment. If this is not possible due to the size or nature of the electrical operating means, these contact data must be indicated on the packaging or in the documents accompanying the electrical equipment. 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 period of ten years from the placing on the market of the electrical equipment. to keep a copy of the EU declaration of conformity available to the market surveillance authority and to ensure that it can submit the technical documentation at the request of the market surveillance authority. (3) The importer is obliged to provide the market surveillance authority on the basis of the Request all information and documents on paper or electronically , which are necessary for the verification of the conformity of the electrical operating means 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 electrical equipment which he has placed on the market. Unofficial table of contents

§ 12 Duties of the trader

(1) The trader shall take due care of the requirements of this Regulation with due diligence when providing an electrical equipment on the market. (2) Before the trader provides an electrical equipment on the market, the trader shall be responsible for the he has to check whether

1.: the electrical equipment is marked with the CE marking,
2.: the electrical equipment is accompanied by the operating instructions and the safety information in the German language, and
3.: the manufacturer has fulfilled his obligations pursuant to Article 8 (1) and (2) and the importer has fulfilled his obligations pursuant to Article 11 (1).

(3) If the trader has reason to believe that an electrical equipment does not comply with the requirements of § 3, it may not provide this electrical equipment on the market until the conformity is established. Where there is a risk associated with the electrical equipment, the trader shall also inform the manufacturer or importer and the market surveillance authorities thereof. (4) As long as an electrical equipment is responsible for the The dealer is responsible for the fact that the storage and transport conditions do not affect the conformity of the electrical operating means with the requirements of § 3. (5) If the trader has reason to believe that a electrical equipment supplied by it on the market does not include the It shall ensure that the necessary measures are taken in order to ensure conformity or that the electrical equipment is withdrawn or recalled. Where risks are associated with the electrical equipment, the trader shall immediately inform the market surveillance authorities of the Member States in which he has made available the electrical equipment on the market, in particular through the risks, the nature of non-compliance and the corrective measures taken. (6) The trader is obliged to make available to the market surveillance authority all information and documents on paper or electronically at the request of the market surveillance authority, which shall: for the verification of the conformity of the electrical equipment with the the requirements of this Regulation are required. 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 electrical equipment which it has made available on the market. Unofficial table of contents

§ 13 Importer or distributor as manufacturer

§ § 7 and 8 shall apply mutatily to a importer or a trader if he/she is

1.: place an electrical operating medium on the market under its own name or trademark, or
2.: an electrical operating medium on the market so changes that conformity with the requirements of this Regulation can be compromised.

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Section 14 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 referred to an electrical equipment, and
2.: to which he has given an electrical equipment.

(2) The economic operator shall be able to provide the information referred to in paragraph 1 for a period of ten years after the receipt of the electrical operating means and after the supply of the electrical operating means.

Section 3
Market surveillance

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Section 15 Corrective measures of economic operators

(1) Where the market surveillance authority has reason to believe that an electrical equipment poses a risk to the health or safety of humans or to domestic and commercial animals or goods, it shall assess whether the electrical equipment is: Operating equipment 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 electrical equipment meets the requirements of the , it shall immediately invite the economic operator concerned to take all appropriate corrective measures, within a time limit fixed by it, of the nature of the risk, with a view to the conformity of the to manufacture electrical equipment with these requirements, or (3) If the market surveillance authority has reason to believe that the electrical equipment in question is also available on the market in other Member States of the European Union, , the Federal Institute for Occupational Safety and Health shall inform the Federal Institute for Occupational Safety and Health of the outcome 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 is taking extend to all the electrical equipment 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

(1) where the economic operator does not take appropriate corrective measures within the time limit laid down in the first sentence of Article 15 (2), the market surveillance authority shall take all appropriate provisional measures to ensure the provision of the electrical (2) If the market surveillance authority has reason to believe that the market surveillance authority has reason to believe that the use of such equipment on the market is prohibited, or that it will not be available on the market. (2) the electrical equipment complained of also in other Member States the European Union on the market, it shall immediately inform the Bundesanstalt für Arbeitsschutz und Arbeitsmedizin (Federal Institute for Occupational Safety and Health) 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 relating to the identification of the electrical equipment concerned, its origin, the nature of the alleged non-conformity and the risk as well as the nature and duration of the provisional measures taken, as well as the arguments of the the economic operator concerned. In particular, the market surveillance authority shall indicate whether the non-compliance is due to the fact that:

1.: the electrical equipment does not meet the requirements of § 3, or
2.: the standards referred to in § § 4 to 6, which are subject to a presumption of conformity, are deficient.

(4) If the Market Surveillance Authority is informed by the Bundesanstalt für Arbeitsschutz und Arbeitsmedizin that a provisional measure pursuant to Article 19 (4) of Directive 2014 /35/EU in another Member State of the European Union is to be notified to the European Union 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 electrical operating medium. 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 electrical operating means. Unofficial table of contents

§ 17 Conformant electrical equipment posing a risk

(1) In the context of an assessment in accordance with Article 15 (1), the Market Surveillance Authority shall establish that an electrical equipment poses a risk to the health or safety of humans or to domestic and livestock animals or goods, although the Where electrical equipment meets the requirements of this Regulation, it shall invite the economic operator concerned to take all appropriate corrective measures to ensure that, within a reasonable time limit to the nature of the risk, appropriate corrective measures are taken to ensure: that the electrical equipment does not pose any risk when placed on the market or that the electrical equipment is withdrawn or recalled. (2) The Market Surveillance Authority shall inform the Federal Institute for Occupational Safety and Health on the determination and the measures to be taken by the Federal Agency for Occupational Safety and Health (Bundesanstalt für Arbeitsschutz und Arbeitsmedizin) Economic actor has asked. The information shall include all available information, in particular the data for the identification of the electrical equipment concerned, its origin, its supply chain, the nature of the risk, and the nature and duration of the measures taken. (3) The economic operator shall ensure that the corrective measures which it takes extend to all the electrical equipment concerned which it has made available on the market in the European Union. (4) The Federal Agency for Occupational health and safety management guides the information referred to in paragraph 2 immediately 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 EU declaration of conformity has not been issued or has not been properly issued,
3.: the technical documentation is not available or is not complete;
4.: the information provided by the manufacturer in accordance with Section 8 (2) or the importer in accordance with Article 11 (1) is missing, incorrect or incomplete, or
5.: a different formal requirement in accordance with § § 7, 8, 10 or § 11 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 provision of the electrical equipment on the market or prohibit the provision on the market. or ensures that the electrical equipment is recalled or withdrawn.

Section 4
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 7 (2), first sentence, an electrical equipment is placed on the market,
2.: Contrary to the first sentence of Article 8 (1), it does not ensure that an electrical equipment carries a number or other information mentioned therein,
3.: Contrary to Article 8 (1), second sentence, the information referred to in paragraph 1 shall not be declared as providing information,
4.: the data referred to in the first sentence of Article 8 (2) or the first sentence of Article 11 (1) shall not be applied, not correct, in full or in a timely manner,
5.: Contrary to Article 8 (3), it is not ensured that an operating instructions and the safety information are attached to an electrical equipment, or
6.: In accordance with Article 10 (2) (1), (3) or (4), an electrical equipment shall be placed 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 § 7 (3), also in conjunction with Section 9 (3) (1), or in breach of § 11 (2), a technical document, an EU declaration of conformity or a copy referred to therein shall not be held for at least ten years,
2.: contrary to § 8 (5) sentence 1, even in conjunction with Section 9 (3) (2), contrary to § 11 (3) sentence 1 or § 12 (6) sentence 1, an information or a document does not, not correct, not complete, not in the prescribed manner or does not make available in time, or
3.: Contrary to Article 14 (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

Electrical equipment which meets the requirements of Directive 2006 /95/EC of the European Parliament and of the Council of 12 December 2006 on the approximation of the laws of the Member States relating to electrical equipment for use in the field of electrical equipment within certain voltage limits (OJ L 327, 10), which has been repealed by Directive 2014 /35/EU, and which has been placed on the market before 20 April 2016, may be made available on the market. 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 regulation on the provision of electrical equipment for use within certain voltage limits occurs on the market of 11 June 1979 (BGBl. 629), as last amended by Article 15 of the Law of 8 November 2011 (BGBl). 2178), except for force. Unofficial table of contents

Final formula

The Federal Council has agreed.