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Royal Decree 187/2016, Of 6 May, Laying Down Safety Requirements For Electrical Equipment Intended For Use In Certain Voltage Limits Are Regulated.

Original Language Title: Real Decreto 187/2016, de 6 de mayo, por el que se regulan las exigencias de seguridad del material eléctrico destinado a ser utilizado en determinados límites de tensión.

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TEXT

Royal Decree No 7/1988 of 8 January relating to the safety requirements of electrical equipment intended for use in certain voltage limits, came to be transposed by Council Directive 73 /23/EEC of 19 February 1988. 1973 on the approximation of the laws of the Member States relating to electrical equipment intended for use with certain voltage limits (the "low voltage" Directive) and subsequently, Royal Decree 154/1995 of 3 February 1995, regulating the safety requirements of the electrical equipment intended to be used in certain voltage limits, modified the previous one to adapt it to the fundamental elements of the new approach which were the essential requirements and the conformity assessment procedures and the placement and use of the CE marking, as provided for in Council Directive 93 /68/EEC of 22 July 1993 amending Directives 87 /404/EEC (simple pressure vessels), 88 /378/EEC (safety of toys), 89 /106/EEC (construction products), 89 /336/EEC (electromagnetic compatibility), 89 /392/EEC (machines), 89 /686/EEC (equipment) Individual protection), 90 /384/EEC (non-automatic weighing instruments), 90 /385/EEC (active implantable medical devices), 90 /396/EEC (gas appliances), 91 /263/EEC (telecommunications terminal equipment), 92 /42/EEC (boilers) new hot water supplied with liquid or gaseous fuels), and 73 /23/EEC (electrical equipment intended for use with certain voltage limits).

In July 2008, the Council and the European Parliament adopted the so-called New Legislative Framework (NML), establishing a battery of measures aimed at removing barriers that could still exist for free marketing of products in the European Union while maintaining the levels of safety and health for users.

The NML consists of two complementary instruments: Regulation (EC) No 765/2008 of the European Parliament and of the Council of 9 July 2008 laying down the requirements for accreditation and market surveillance concerning the placing on the market of the products and repealing Regulation (EEC) No 339/93 and Decision 768 /2008/EC of the European Parliament and of the Council of 9 July 2008 on a common framework for the marketing of products and repealing Council Decision 93 /465/EEC.

Regulation (EC) No 765/2008 of the European Parliament and of the Council of 9 July 2008, which entered into force on 1 January 2010 and is directly applicable in all Member States, regulates the accreditation of the conformity assessment bodies, adopts a framework for market surveillance of products and for checks on products from third countries and sets out the general principles of the CE marking.

For their part, Decision 768 /2008/EC of the European Parliament and of the Council of 9 July 2008 was intended to function as a framework for the future review of Community technical harmonisation legislation, so that its provisions should be integrated into any new or revised legislation.

According to this NML, the European Parliament and the Council of the European Union have adopted Directive 2014 /35/EU of 26 February 2014 on the harmonisation of the laws of the Member States relating to the marketing of of electrical equipment intended for use with certain voltage limits, for which 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 is recast Member States on electrical equipment intended for use with certain voltage limits (codified version), with the provisions introduced in the NML, modifying various aspects of the NML. Thus, the inclusion of definitions on basic concepts, such as economic agents (manufacturer, authorised representative, importer, distributor), marketing, commissioning, accreditation, etc., is appropriate to include definitions. determination of the obligations of the economic operators and the adaptation of the conformity assessment procedures, the CE marking and the EU declaration of conformity.

Consequently, the present royal decree aims to transpose the aforementioned Directive 2014 /35/EU into national law, thereby harmonising, with the other EU Member States, the national provisions on the placing on the market of electrical equipment intended for use with certain voltage limits, in order to ensure the free movement of electrical equipment in this field and in the operation of the internal market.

On the other hand, it should be noted that Royal Decree 330/2008 of 29 February adopting measures for the control of imports of certain products in respect of the applicable safety standards for the products, establishes a reinforced control procedure for a number of products from third countries, considered as sensitive, including the small electrical equipment, which is part of this provision.

According to the provisions of Article 24.1.c) of Law 50/1997 of 27 November 1997, the present provision has been submitted to the hearing, referring to the industrial sectors concerned. The competent bodies of the autonomous communities have also been consulted. This royal decree is dictated by the provisions of Rule 13 (13) of the Constitution, which attributes to the State the competence on the basis and coordination of the overall planning of the economy.

In its virtue, on the proposal of the Minister of Economy and Competitiveness, by the Minister of Industry, Energy and Tourism, in agreement with the Council of State and after deliberation of the Council of Ministers at its meeting of the 6th of May 2016,

DISPONGO:

CHAPTER I

General provisions

Article 1. Object and scope of application.

1. It is the purpose of this royal decree to ensure that the electrical equipment marketed complies with the requirements which provide a high level of protection of the health and safety of persons, and of domestic animals and animals. goods, while ensuring the functioning of the internal market.

2. The provisions of this royal decree shall apply to electrical equipment intended for use with a nominal voltage of between 50 and 1 000 V in alternating current and between 75 and 1 500 V in continuous current, with the exception of materials and phenomena referred to in Annex II.

3. The telecommunications equipment shall not be subject to the provisions of Chapters IV and V of this royal decree, governing the market surveillance and sanctioning regime as set out in Royal Decree 188/2016, 6 of May the Council adopt a proposal for a Regulation laying down the requirements for the placing on the market, putting into service and use of radio equipment, and regulating the procedure for the assessment of conformity, market surveillance and the sanctioning regime for telecommunications equipment.

Article 2. Definitions.

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

1) "placing on the market" means any supply, paid or free, of electrical equipment for distribution, consumption or use on the European Union market in the course of a commercial activity;

2) "placing on the market": the first marketing of electrical equipment on the European Union market;

3) "manufacturer" means any natural or legal person who manufactures electrical equipment or who is responsible for the design or manufacture of electrical equipment and places such material on the market under his registered name or trademark;

4) "authorised representative" means any natural or legal person established in the European Union who has received a written mandate from a manufacturer to act on his behalf on specific tasks;

5) 'importer' means any natural or legal person established in the European Union who places electrical equipment from a third country on the European Union market;

6) "distributor" means any natural or legal person integrated in the distribution chain, other than the manufacturer or the importer, who places electrical equipment on the market;

7) "economic operators" means the manufacturer, the authorised representative, the importer and the distributor;

8) "technical specification" means a document defining the technical requirements of an electrical equipment;

9) "harmonised standard" means a harmonised standard as defined in Article 2.1 (c) of Regulation (EU) No 1025/2012 of the European Parliament and of the Council of 25 October 2012 on European standardisation, amend Council Directives 89 /686/EEC and 93 /15/EEC and 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 of the Council and repealing the Decision 87 /95/EEC of the Council and Decision No 1673 /2006/EC of the European Parliament and of the Council;

10) "conformity assessment" means the process by which it is assessed whether the safety objectives referred to in Article 3 and set out in Annex I in relation to electrical equipment are satisfied;

11) "recovery" means any measure intended to obtain the return of electrical equipment already made available to the end user;

12) "withdrawal" means any measure intended to prevent the placing on the market of electrical equipment in the supply chain;

13) "European Union harmonisation legislation" means any EU legislation that harmonises the conditions for the marketing of products;

14) 'CE marking' means a marking by which the manufacturer indicates that the electrical equipment is in conformity with all applicable requirements laid down in the harmonisation legislation of the European Union providing for its affixing.

15) "Telecommunication equipment" means any fixed apparatus or installation used for the transmission, emission or reception at a distance of signs, signals, writings, images, sounds or information of any nature by wire, radio, optical or other electromagnetic systems.

Article 3. Marketing and security objectives.

Only electrical equipment which, having been manufactured in accordance with the technical safety criteria in force in the European Union, shall not be placed on the market, shall not be placed in danger when its installation and maintenance are the correct and its use is in line with the intended purpose, health and safety of persons and domestic animals, as well as of the goods.

Annex I lists the main elements of the security objectives.

Article 4. Free movement.

No one will hinder, as far as the extremes referred to by this royal decree are concerned, the marketing of electrical equipment that complies with the provisions in it.

Article 5. Distribution of electricity.

The competent authorities shall ensure that the electricity distribution companies do not condition the connection to the grid and the supply of electricity to the users of electrical equipment to safety requirements more The security objectives referred to in Article 3 and set out in Annex I shall be strict.

CHAPTER II

Obligations of economic operators

Article 6. Obligations of manufacturers.

1. When placing electrical equipment on the market, manufacturers shall ensure that they have been designed and manufactured in accordance with the safety objectives referred to in Article 3 and set out in Annex I.

2. Manufacturers shall draw up the technical documentation referred to in Annex III and shall carry out the conformity assessment procedure referred to in Annex III or shall ensure that it is carried out.

Where, by means of the conformity assessment procedure referred to in the first subparagraph, the electrical equipment has been shown to meet the safety objectives referred to in Article 3 and set out in the Annex I, manufacturers shall draw up an EU declaration of conformity and affix the CE marking.

3. Manufacturers shall keep the technical documentation referred to in Annex III and the EU declaration of conformity for 10 years after the electrical equipment has been placed on the market.

4. Manufacturers shall ensure that there are procedures in place for serial production to maintain their conformity with this royal decree. Changes in the design or characteristics of electrical equipment and changes in the harmonised standards referred to in Article 12 shall be duly taken into account in international or national standards referred to in Article 12. Articles 13 and 14, or in other technical specifications according to which their conformity is declared.

Whenever it is considered appropriate with regard to the risks presented by electrical equipment, for the protection of health and safety of consumers, manufacturers shall test samples of the electrical equipment. on the market, they shall investigate and, where appropriate, keep a register of complaints, non-compliant electrical equipment and electrical equipment recoveries, and shall keep distributors informed of any such monitoring.

5. Manufacturers shall ensure that the electrical equipment which they have placed on the market bears a type, batch or serial number or any other element which permits their identification or, if the size or nature of the electrical equipment does not allows, that the required information is contained in its packaging or in a document accompanying the electrical equipment.

6. Manufacturers shall indicate in the electrical equipment their name, registered trade name or registered trade mark and their postal address of contact or, where that is not possible, on the packaging or in a document accompanying the electrical equipment. The address shall indicate a single place where the manufacturer can be contacted. The contact details shall be at least in Spanish.

7. Manufacturers shall ensure that electrical equipment is accompanied by instructions and safety information at least in Spanish. Such instructions and information relating to safety, as well as any labelling, shall be clear, comprehensible and intelligible.

8. Manufacturers who consider or have reason to believe that an electrical equipment which they have placed on the market is not in conformity with this royal decree shall immediately take the necessary corrective measures to ensure that they are in conformity, remove it from the market or recall it, if necessary. In addition, where the electrical equipment presents a risk, manufacturers shall immediately inform the competent authorities of the autonomous communities in which they placed the electrical equipment on the market and provide details, in particular, of the non- compliance and the corrective measures taken.

9. In response to a reasoned request from the competent authority of an autonomous community, manufacturers shall provide all necessary information and documentation, in paper or electronic form, to demonstrate the conformity of electrical equipment. with this royal decree, at least in Spanish, unless the competent authorities, in each case and at the request of the person concerned, consider their presentation in English admissible. At the request of the Autonomous Communities, they shall cooperate in any action aimed at avoiding the risks posed by the electrical equipment which they have placed on the market.

Article 7. Authorised representatives.

1. A manufacturer may, by any means valid in law, designate an authorised representative to be entitled to the right of representation.

The obligations laid down in Article 6.1 and the obligation to draw up technical documentation referred to in Article 6.2 shall not form part of the mandate of the authorised representative.

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

(a) maintain the EU declaration of conformity and the technical documentation at the disposal of the national market surveillance authorities for a period of 10 years after the introduction of the electrical equipment into the market;

(b) in response to a reasoned request from the competent authorities of the Autonomous Communities, to provide that authority with all the information and documentation necessary to demonstrate the conformity of the electrical equipment;

(c) cooperate with the competent authorities of the autonomous communities, at their request, in any action to avoid the risks posed by the electrical equipment covered by the authorised representative's mandate.

Article 8. Obligations of importers.

1. Importers shall only place on the market electrical equipment in accordance with the safety requirements referred to in Article 3 and set out in Annex I.

2. Before placing electrical equipment on the market, importers shall ensure that the manufacturer has carried out the due process of conformity assessment. They shall ensure that the manufacturer has drawn up the technical documentation, that the electrical equipment bears the CE marking and is accompanied by the necessary documents, and that the manufacturer has complied with the requirements laid down in Article 6.5 and 6.

Where an importer considers or has reason to believe that a particular electrical material is not in conformity with the safety requirements referred to in Article 3 and set out in Annex I, it shall not introduce such material. power in the market until it is compliant. In addition, where the electrical equipment presents a risk, the importer shall inform the manufacturer and the competent authorities of the autonomous communities.

3. Importers shall indicate in the electrical equipment their name, registered trade name or registered trade mark and their postal address of contact or, where that is not possible, on their packaging or in a document accompanying the electrical equipment. The contact details shall be at least in Spanish.

4. Importers shall ensure that the electrical equipment is accompanied by the instructions and safety information at least in Spanish.

5. Importers shall ensure that, while they are responsible for electrical equipment, the conditions of their storage or transport do not jeopardise the fulfilment of the safety objectives referred to in Article 3 and laid down in the Directive. Annex I.

6. Whenever it is considered appropriate with regard to the risks presented by electrical equipment, in order to protect the health and safety of consumers, importers shall test samples of the electrical equipment placed on the market. and, where appropriate, keep a register of complaints, non-compliant electrical equipment and electrical equipment recoveries, and shall keep distributors informed of any such monitoring.

7. Importers who consider or have reason to believe that the electrical equipment they have placed on the market is not in conformity with this royal decree shall immediately take the necessary corrective measures to ensure that they are in conformity, remove it from the market or recall it, if necessary. In addition, where the electrical equipment presents a risk, importers shall immediately inform the competent authorities of the autonomous communities in which they placed the electrical equipment on the market and provide details, in particular, of the non- compliance and the corrective measures taken.

8. For 10 years after the electrical equipment has been placed on the market, importers shall keep a copy of the EU declaration of conformity at the disposal of the competent authorities of the autonomous communities and shall ensure that, upon request, such authorities receive a copy of the technical documentation.

9. In response to a reasoned request from the competent authority of an autonomous community, importers shall provide, on paper or electronic form, all the information and documentation necessary to demonstrate the conformity of electrical equipment. at least in Spanish, unless the competent authorities, in each case and at the request of the person concerned, consider their English presentation admissible. They shall cooperate with that authority, at their request, in any action to avoid the risks posed by the electrical equipment which they have placed on the market.

Article 9. Obligations of distributors.

1. When marketing electrical equipment, distributors shall act with due diligence in relation to the requirements of this royal decree.

2. Before placing the electrical equipment on the market, distributors shall ensure that the electrical equipment bears the CE marking, accompanied by the required documents and the instructions and information relating to safety at least in the case of electrical equipment. The manufacturer and the importer have complied with the requirements laid down in Articles 6.5 and 6 and in Article 8.3 respectively.

When a distributor considers or has reason to believe that electrical equipment is not in conformity with the safety objectives referred to in Article 3 and set out in Annex I, it shall not introduce such electrical equipment. on the market until it is compliant. In addition, where the electrical equipment presents a risk, the distributor shall inform the manufacturer or the importer thereof, as well as the competent market surveillance authorities.

3. Where they are responsible for electrical equipment, distributors shall ensure that the conditions of their storage or transport do not jeopardise the fulfilment of the safety objectives referred to in Article 3 and laid down in the Annex I.

4. Distributors who consider or have reason to believe that the electrical equipment they have placed on the market is not in conformity with this royal decree shall ensure that the necessary corrective measures are taken immediately to ensure that is compliant, withdrawn from the market or recovered if necessary. In addition, where the electrical equipment presents a risk, distributors shall immediately inform the competent authorities of the autonomous communities in which they placed the electrical equipment on the market and provide details, in particular, of the non- compliance and the corrective measures taken.

5. Distributors shall, on the basis of a reasoned request from a competent authority, provide, on paper or electronic form, all the information and documentation necessary to demonstrate the conformity of electrical equipment. They shall cooperate with that authority, at their request, in any action to avoid the risks posed by the electrical equipment they have placed on the market.

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

For the purposes of this Royal Decree, it shall be considered a manufacturer and shall therefore be subject to the obligations of the manufacturer in accordance with Article 6, an importer or distributor which introduces electrical equipment into the market with its trade name or mark or modify electrical equipment which has already been placed on the market in such a way that its conformity with this royal decree may be affected.

Article 11. Identification of economic operators.

1. Economic operators shall, upon request, identify with the competent market surveillance authorities:

(a) any economic operator who has supplied them with electrical equipment;

(b) any economic operator to whom they have supplied electrical equipment.

2. Economic operators may submit the information referred to in paragraph 1 for 10 years after they have been supplied with the electrical equipment and for 10 years after they have supplied the electrical equipment.

CHAPTER III

Electrical material compliance

Article 12. Presumption of conformity of electrical equipment under harmonised standards.

The electrical equipment which is in conformity with harmonised standards or parts thereof, the references of which have been published in the Official Journal of the European Union, shall be presumed in accordance with the safety objectives referred to in the Article 3 and set out in Annex I, to which such standards or parts of these rules apply.

Article 13. Presumption of conformity under international standards.

1. Where the harmonised standards referred to in Article 12 have not been drawn up and published, the marketing effects referred to in Article 3 or the free movement provided for in Article 4 shall be deemed to be the same as those laid down in Article 4. complies with the safety objectives referred to in Article 3 and set out in Annex I, the electrical equipment which complies with the safety provisions of the international standards set out by the Electrotechnical Commission International (IEC) in respect of which the procedure of publication established in the paragraphs 2 and 3 of this Article.

2. The Ministry of Industry, Energy and Tourism shall communicate to the European Commission, within three months, any objection to the safety provisions referred to in paragraph 1 notified by the European Commission to the Member States, for consultation, pointing out the security reasons for their recognition.

The references of the security provisions to which no objection has been objected are published in the "Official Journal of the European Union" for information purposes.

Article 14. Presumption of conformity under national rules.

Where the harmonised standards referred to in Article 12 have not been drawn up and published and the international standards referred to in Article 13 have not been published, they shall be considered for the purposes of marketing or of the free movement, which also complies with the safety objectives, the electrical equipment manufactured in accordance with the safety provisions of the rules in force in the Member State of manufacture, provided that it ensures a level of safety security equivalent to that required on its own territory.

Article 15. EU declaration of conformity.

1. The EU declaration of conformity shall indicate that compliance with the safety objectives referred to in Article 3 and set out in Annex I has been demonstrated.

2. The EU declaration of conformity shall conform to the structure of the model set out in Annex IV, contain the elements specified in Module A of Annex III and shall be continuously updated. This declaration shall be drawn up at least in Spanish if it differs substantially from the model set out in Annex IV for that electrical equipment which is introduced and marketed in Spain.

3. Where electrical equipment is subject to more than one European Union act requiring an EU declaration of conformity, a single EU declaration of conformity shall be drawn up in respect of all such acts of the European Union. This declaration shall contain the identification of the relevant European Union acts and their publication references.

4. When drawing up an EU declaration of conformity, the manufacturer shall assume responsibility for the conformity of the electrical equipment with the requirements set out in this royal decree.

Article 16. General principles of the CE marking.

The CE marking shall be subject to the general principles referred to in Article 30 of Regulation (EC) No 765/2008 of the European Parliament and of the Council of 9 July 2008 laying down the accreditation requirements and market surveillance relating to the placing on the market of products and repealing Regulation (EEC) No 339/93.

Article 17. Rules and conditions for affixing the CE marking.

1. The CE marking shall be affixed visibly, legibly and indelibly on the electrical equipment or on its nameplate. Where this is not possible or cannot be ensured due to the nature of the electrical equipment, it shall be placed on the packaging and in the attached documents.

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

3. The competent authorities of the autonomous communities shall ensure the correct application of the arrangements governing the CE marking and shall take appropriate measures in the event of improper use, and shall inform the Ministry of Industry, and Tourism thereof to initiate, where appropriate, the safeguard procedure described in Article 20 of this royal decree.

CHAPTER IV

Market surveillance, control of electrical equipment entering such market and safeguard procedure of the European Union

Article 18. Market surveillance and control of electrical equipment that enters the market.

1. They shall apply to electrical equipment covered by this royal decree, as laid down in Article 15.3 and Articles 16 to 29 of Regulation (EC) No 765/2008 of the European Parliament and of the Council of 9 July 2008.

2. The market surveillance of the electrical equipment included in the scope of this royal decree, will be carried out by the competent bodies of the autonomous communities, in accordance with the provisions of Law 21/1992, of July 16, of Industry, without prejudice to the powers of other authorities in the field of their powers by application of other supplementary rules to that included in the scope of this royal decree.

In accordance with the provisions of Article 14.2 of Law 21/1992 of 16 July 1992, without prejudice to the actions of inspection and control that the autonomous communities competent in the field develop in their field The Ministry of Industry, Energy and Tourism will be able to promote, in collaboration with the respective autonomous communities, plans and campaigns of a national nature of verification by means of sampling, of the conditions of safety of the material electricity referred to in Article 1 of this royal decree.

Article 19. Procedure in the case of electrical equipment that presents a national risk.

1. Where the competent market surveillance authorities have sufficient reason to believe that electrical equipment subject to this royal decree poses a risk to the health or safety of persons or domestic animals or to animals for the purposes of the property, shall carry out an assessment related to the electrical equipment in question on the basis of all the relevant requirements set out in this royal decree. To this end, the relevant economic operators shall cooperate in accordance with the requirements with the market surveillance authorities.

When, in the course of the assessment referred to in the first subparagraph, the competent market surveillance authorities find that electrical equipment does not comply with the requirements set out in this Royal Decree, it shall without delay request the relevant economic operator to take all appropriate corrective measures to adapt the electrical equipment to those requirements, to withdraw it from the market or to recall it within a reasonable time, proportional to the nature of the risk, which they prescribe.

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

2. Where the competent market surveillance authorities consider that the non-compliance is not limited to the national territory, they shall inform the European Commission and the other Member States, through the Ministry of Industry, Energy and Tourism, of the following: the results of the assessment and of the measures that they have requested from the economic operator to take.

3. The economic operator shall ensure that all relevant corrective measures are taken in relation to all electrical equipment which has been placed on the market throughout the European Union.

4. If the relevant economic operator does not take the appropriate corrective measures within the period referred to in the second subparagraph of paragraph 1, the market surveillance authorities shall take all appropriate provisional measures to prohibit or restrict the marketing of electrical equipment on the domestic market, withdraw it from that market or recall it.

The affected autonomous communities shall communicate to the Ministry of Industry, Energy and Tourism the provisional measures taken and shall inform the European Commission and the other Member States of such measures.

Where the measures taken or planned to be adopted are in accordance with the provisions of Article 20 of Regulation (EC) No 765/2008 of the European Parliament and of the Council of 9 July 2008 laying down the requirements for accreditation and market surveillance relating to the placing on the market of the products and repealing Regulation (EEC) No 339/93 shall be notified without delay to the European Commission in accordance with the procedure laid down in the Article 22 of that Regulation.

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

(a) the electrical equipment does not meet the safety objectives referred to in Article 3 and set out in Annex I relating to the health or safety of persons or pets or to the goods, or

b) there are deficiencies in the harmonised standards referred to in Article 12 or in international or national standards referred to in Articles 13 and 14 which confer a presumption of conformity.

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

7. The autonomous communities shall ensure that appropriate restrictive measures are taken without delay in respect of the electrical equipment concerned, such as the withdrawal of the electrical equipment.

8. When a restrictive measure adopted on non-compliant electrical equipment is received from a Member State or the European Commission, the Ministry of Industry, Energy and Tourism in the field of Law 21/1992 of 16 July of Industry will inform the autonomous communities on the measure in question and, in the event of disagreement with the measure taken, may object to it. Those objections shall be analysed and, where appropriate, referred to the European Commission.

Article 20. The safeguard procedure of the European Union.

1. If, upon completion of the procedure laid down in Article 19.3 and 4, objections are raised against measures taken by a Member State, or if the European Commission considers that such measures are contrary to the legislation of the European Union, the safeguard procedure of the European Union shall apply.

2. If the measure is considered justified, the Ministry of Industry, Energy and Tourism and the Autonomous Communities shall ensure that such measures are complied with and that the non-compliant electrical equipment is withdrawn from the market, informing the Commission European Union. If the measure is not considered justified, that measure shall be withdrawn.

3. Where the national measure is considered to be justified and the non-conformity of electrical equipment is attributed to a deficiency of the harmonised standards referred to in Article 19.5.b) of this royal decree, the procedure shall apply. provided for in Article 11 of Regulation (EU) No 1025/2012 of the European Parliament and of the Council of 25 October 2012.

Article 21. Compliant products which, however, present a risk.

1. If, after an assessment pursuant to Article 19 (1), the competent authorities of the autonomous communities verify that a certain electrical equipment, although in accordance with this royal decree, presents a risk to the health or safety of persons or other aspects of protection of the public interest, shall require the relevant economic operator to take all appropriate measures to ensure that the electrical equipment in question does not present that risk when enter the market, either to withdraw it from the market or to recall it within the time limit reasonable, proportionate to the nature of the risk, to be determined by the authority, immediately informing the Ministry of Industry, Energy and Tourism.

2. The economic operator shall ensure that the necessary corrective measures are taken in relation to all the electrical equipment concerned which it has placed on the market throughout the European Union.

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

4. The national measures taken shall be subject to the examination procedures provided for in Articles 5 and 8 of Regulation (EU) No 182/2011 of the European Parliament and of the Council of 16 February 2011 laying down rules and procedures for the general principles concerning the arrangements for monitoring by the Member States of the exercise of implementing powers by the European Commission.

Decisions which, by means of the implementing acts adopted by the European Commission, will be carried out by the Ministry of Industry, Energy and Tourism to the competent authorities of the Autonomous Communities and to the the relevant economic operators.

Article 22. Formal non-compliance.

1. Without prejudice to Article 19, if the competent authorities of the autonomous communities have one of the following situations, they shall ask the relevant economic operator to remedy the lack of conformity in the question:

(a) the CE marking has been affixed in violation of Article 30 of Regulation (EC) No 765/2008 of the European Parliament and of the Council of 9 July 2008 or Article 17 of this Royal Decree;

b) CE marking has not been placed;

c) the EU declaration of compliance is not set;

d) the EU declaration of compliance was not set correctly;

e) the technical documentation is not available or incomplete;

(f) the information referred to in Article 6.6 or in Article 8.3 of this royal decree is either false or incomplete;

g) any other administrative requirements set out in Article 6 or Article 8 of this royal decree are not met.

2. If the lack of conformity referred to in paragraph 1 persists, the competent authorities of the autonomous communities shall take all appropriate measures to restrict or prohibit the placing on the market of electrical equipment or to ensure that it is recovered or withdrawn from the market.

CHAPTER V

Sanctioning Regime

Article 23. Penalties.

The violations of this royal decree will be sanctioned in accordance with the provisions of Title V of Law 21/1992, of July 16, of Industry.

Single additional disposition. Updating regulatory references.

The references made in the laws, regulations and administrative provisions in force to Royal Decree 7/1988 of 8 January concerning the safety requirements of electrical equipment intended for use in the certain voltage limits shall be construed as references to this royal decree.

Single transient arrangement. Placing on the market and putting into service of electrical equipment complying with Royal Decree 7/1988 of 8 January.

By way of derogation from the single derogation provision, electrical equipment complying with the provisions of Royal Decree 7/1988 of 8 January 1988 on the safety requirements of electrical equipment intended to be used for certain voltage limits, it may continue to be placed on the market and put into service as long as it has been placed on the market before 20 April 2016.

Single repeal provision. Regulatory repeal.

The Royal Decree No 7/1988 of 8 January 1988 relating to the safety requirements of electrical equipment intended for use in certain voltage limits is hereby repealed and the provisions of the same or lower range object to the provisions of this royal decree.

Final disposition first. Competence title.

This royal decree is dictated by the provisions of Rule 13 (13) of the Constitution, which attributes to the State the competence on the basis and coordination of the overall planning of the economy.

Final disposition second. Incorporation of European Union law.

This royal decree incorporates into Spanish law 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 the placing on the market of electrical equipment intended for use with certain voltage limits and repealing Directive 2006 /95/EC.

Final disposition third. Development and implementation of the royal decree.

The Minister of Industry, Energy and Tourism will, in the field of his competences, dictate the necessary provisions for the development and implementation of the provisions of this royal decree.

Final disposition fourth. Authorisation for the amendment of the Annexes.

The Minister of Industry, Energy and Tourism is also authorized to update the contents of the annexes of this royal decree by order, in order to keep it permanently adapted to the progress of the technique, as well as to the rules of law of the European Union or other international bodies.

Final disposition fifth. Entry into force.

This royal decree will enter into force on the day following its publication in the "Official State Gazette".

Given in Madrid, on May 6, 2016.

FELIPE R.

The Minister of Industry, Energy and Tourism,

P. S. (Royal Decree 160/2016, of April 15),

The Minister of Economy and Competitiveness,

LUIS DE GUINDOS JURADO

ANNEX I

Main elements of safety objectives for electrical equipment intended for use with certain voltage limits

1. General Conditions

(a) The essential characteristics, the recognition and observance of which must ensure that the electrical equipment is used safely and in accordance with its destination, shall be included in the electrical equipment or, where this is not possible, in the accompanying document.

(b) The electrical equipment and its components shall be manufactured in such a way as to enable safe and adequate assembly and connection.

(c) The electrical equipment must be designed and constructed in such a way as to ensure protection against the hazards referred to in paragraphs 2 and 3, provided that it is used in a manner consistent with its destination and is subject to of appropriate maintenance.

2. Protection against hazards arising from the electrical equipment itself

Measures of a technical nature shall be established in accordance with paragraph 1 to ensure that:

(a) persons and domestic animals are adequately protected from the danger of physical injury or other damage that may cause direct or indirect contact;

(b) do not produce dangerous temperatures, arcs or radiations;

(c) persons, domestic animals and property against hazards of a non-electric nature caused by electrical equipment which are detached from experience shall be adequately protected;

d) the isolation system is appropriate for the foreseeable conditions of use.

3. Protection against hazards caused by external influences on electrical equipment

Technical measures shall be established in accordance with paragraph 1 in order to ensure that electrical equipment:

a) respond to the expected mechanical requirements so that people, pets and goods are not endangered;

(b) resists non-mechanical influences in the expected environmental conditions in such a way that people, domestic animals and goods are not endangered;

c) do not endanger people, pets and property in the foreseeable overload conditions.

ANNEX II

Material and phenomena excluded from the scope of this Royal Decree

Electrical equipment intended for use in an explosive atmosphere.

Electrical equipment for radiology and for medical purposes.

Electric parts of lifts and hoists.

Electrical counters.

Current Tomas (plugs and plugs) for home use.

Electrical Fence Controllers.

Radio interference.

Specialised electrical equipment, intended for use in ships, aircraft and railways, which complies with the safety provisions laid down by international bodies to which the Member States are part.

Evaluation kits, manufactured by order, intended to be used by professionals exclusively in research and development facilities for such purposes.

ANNEX III

Module A

Internal production control

1. The internal control of production is the conformity assessment procedure whereby the manufacturer fulfils the obligations set out in paragraphs 2, 3 and 4, and ensures and declares, under his sole responsibility, that the Electrical material in question satisfies the requirements of this royal decree, which are applicable to it.

2. Technical documentation.

The manufacturer will produce the technical documentation. The documentation shall allow the assessment of whether the electrical equipment meets the relevant requirements and shall include an appropriate risk assessment and assessment. It shall specify the applicable requirements and shall, in so far as it is relevant for the assessment, design, manufacture and operation of electrical equipment. The technical documentation shall include, where appropriate, at least the following elements:

a) a general description of the electrical equipment;

b) the design and manufacturing plans and the schemas of the components, subassemblies, circuits, etc.;

(c) the descriptions and explanations necessary for the understanding of such plans and schemes and the operation of the electrical equipment;

(d) a list of harmonised standards, applied in whole or in part, the references of which have been published in the Official Journal of the European Union or the international or national standards referred to in Articles 13 and 14; and where such harmonised standards or international or national standards have not been applied, the description of the solutions adopted to meet the safety objectives of this Royal Decree together with a list of other technical specifications applied; in the case of harmonised standards which are applied in part or in part international or national standards referred to in Articles 13 and 14, the parts that have been applied shall be specified in the technical documentation;

e) the results of the design calculations performed, the examinations performed, etc., and

f) the reports on the trials.

3. Manufacturing.

The manufacturer shall take all necessary steps to ensure that the manufacturing process and its monitoring ensure the conformity of the electrical equipment manufactured with the technical documentation referred to in paragraph 2 and with the requirements of the present royal decree that apply to you.

4. CE marking and EU declaration of conformity.

4.1 The manufacturer shall affix the CE marking to any electrical equipment that satisfies the applicable requirements of this royal decree.

4.2 The manufacturer shall draw up an EU declaration of conformity for each product model and keep it, together with the technical documentation, at the disposal of the competent market surveillance authorities for 10 years. after the introduction of the electrical equipment into the market. The EU declaration of conformity shall identify the electrical equipment for which it has been drawn up.

A copy of the EU declaration shall be provided in accordance with the relevant market surveillance authorities requesting it.

5. Authorized representative.

The manufacturer's obligations referred to in paragraph 4 of this Annex may be fulfilled by his authorised representative, on his behalf and under his responsibility, provided that they are specified in his mandate.

ANNEX IV

EU Declaration of Conformity (n. XXXX) 1

1 The manufacturer may give an optional number to the declaration of conformity.

1. Product/Product Model (product, type, batch, or serial number):

2. Name and address of the manufacturer or his authorised representative:

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

4. The purpose of the declaration (identification of the electrical equipment allowing traceability; may include an image in colour of sufficient sharpness if necessary for the identification of the electrical equipment).

5. The purpose of the statement described above is in accordance with the relevant harmonisation legislation of the European Union:

6. References to the relevant harmonised standards used, including the dates of the standards, or references to the other technical specifications, including the dates of the specifications, for which conformity is declared:

7. Additional information:

Signed on behalf of:

(place and date of issue):

(name, charge) (signature):