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Hazardous substances control in electrical and electronic equipment

Original Language Title: Regeling gevaarlijke stoffen in elektrische en elektronische apparatuur

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Regulation of the Secretary of State for the Environment of 11 December 2012, No IENM/BSK-2012/218548 laying down rules relating to the restriction of the use of certain hazardous substances in electrical and electronic equipment (System of Dangerous Substances in Electrical and Electronic Equipment)

The State Secretary for Infrastructure and the Environment,

Having regard to Directive No 2011/65 European Parliament and of the Council of 8 June 2011 on the restriction of the use of certain hazardous substances in electrical and electronic equipment (PbEU 2011, L 174/88) and the Articles 9.2.2.1, 1st and 2nd Member and Point 21.6, sixth paragraph, of the Environmental Protection Act ;

Decision:


§ 1. Conceptual provisions and scope

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Article 1

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  • The following definitions shall apply:

    • a. Active implantable medical device: active implantable medical device within the meaning of Article 1 (c), second paragraph, of Directive 90 /385/EEC of the Council of 20 June 1990 on the approximation of the laws of the Member States relating to active implantable medical devices (PbEU 1990, L 189);

    • b. CE marking: the marking by which the manufacturer indicates that the product is in conformity with all the requirements of the European Union harmonisation legislation applicable to its affixing;

    • c. conformity assessment: process demonstrating compliance with the requirements of Directive No 2011/65 /EU in relation to electrical and electronic equipment;

    • ed. availability of a substitute substance: possibility of producing and delivering a replacement substance within a time frame that is reasonable compared to the time required to complete the Annex II of Directive No 2011/65 -manufacture and supply of such substances;

    • e. reliability of a replacement substance: Probability that electrical and electronic equipment using that replacement material fills in a required function for a given period of error in calibrated conditions;

    • f. distributor: any natural or legal person in the supply chain, other than the manufacturer or the importer, who offers electrical and electronic equipment on the market;

    • g. Electrical and electronic equipment: devices which, in order to perform at least one intended function, require electrical currents or electromagnetic fields to function properly and devices for the generation, transmission and measurement of those flows and fields, and those intended for the purpose of are for use with a voltage of not more than 1000 volts at alternating current and 1500 volts at DC power;

    • h. Manufacturer: natural or legal person who manufactures, manufactures or manufactures electrical and electronic equipment and markets under his or her name or trade mark;

    • i. Harmonised standard: standard which, on the basis of a request submitted by the Commission, in accordance with Article 6 of Directive 98 /34/EC of the European Parliament and of the Council of 22 June 1998 laying down a procedure for the provision of information in the field of technical standards and regulations and of rules on information society services (OJ 1998 L 204/37), adopted by the Commission by the Commission (COM (1998) 427 final). from the European standardisation bodies listed in Annex I to that Directive;

    • j. Delegate: natural or legal person established in the European Union who is authorised in writing by a manufacturer to perform specific tasks on his behalf;

    • k. large, non-mobile industrial installations: large set of machines, equipment or components that work together for a particular application, being installed or degraded by professionals in a permanent place and used and maintained by professionals in an industrial production environment or a centre for research and development;

    • l. large, fixed installation: large scale assembly of various types of apparatus and possibly other devices fitted and installed by professionals and intended for permanent use at a specified and specially designated place, and which are vakpeople are broken down;

    • m. the recall: measure intended to return a product already made available to the end-user,

    • n. take off from the market: measure aimed at preventing a product from being offered in the supply chain on the market;

    • o. Homogeneous material: either one material of uniform composition, or a material consisting of a combination of materials and not capable of being detached from each other in separate materials or separated by mechanical acts such as looting, cutting, crushing, grinding or grinding;

    • P. Importer: any natural or legal person established in the European Union who places electrical and electronic equipment from a third country on the market in the European Union;

    • q. placing on the market: for the first time on the market of electrical and electronic equipment on the market in the European Union;

    • r. Industrial measuring and control equipment: Measurement and control equipment designed solely for use for industrial or professional purposes;

    • s. cables: Cables for a voltage of less than 250 volts that serve as connection and extension cords to connect electrical and electronic equipment with an electrical outlet or two or more electrical and electronic devices;

    • t. operators: manufacturer, authorised, importer or distributor;

    • u. market surveillance: activities and measures of competent authority to ensure that electrical and electronic equipment complies with the requirements set out in Directive No 2011/65 /EU and that such equipment does not endanger health and safety or other aspects of protection of the public interest;

    • v. medical device: medical device within the meaning of Article 1 (a), second paragraph, of Directive 93 /42/EEC the Council of 14 June 1993 concerning medical devices (PbEG 1993, L 169), which is also electrical and electronic equipment;

    • w. medical device for in vitro diagnostic medical devices: In vitro diagnostic medical device within the meaning of Article 1 (b), second paragraph, of Directive 98 /79/EC from the European Parliament and the Council of 27 October 1998 on in vitro diagnostic medical devices (PbEU 1998, L 331/ 1);

    • x. Mobile machinery not available for the road and solely for the professional use: machinery with an internal power source, the operation of which requires mobility, either permanent or semi-permanent movement between a set of fixed work locations in the course of work, and which is made available only for professional purposes Use;

    • y. Offering on the market: provide electrical and electronic equipment with a view to distribution, consumption or use on the market within the European Union, in the context of a commercial activity, whether in return for payment or non-payment;

    • z. spare part: Component of electrical and electronic equipment capable of replacing any part of an electrical and electronic equipment, where:

      • 1 ° without that component, electrical and electronic equipment cannot be used as intended; and

      • 2 ° the effectiveness of electrical and electronic equipment shall be repaired or corrected if the part is replaced;

    • aa. Directive No 2011 /65/EU: Directive No 2011/65 /EU of the European Parliament and of the Council of 8 June 2011 on the restriction of the use of certain hazardous substances in electrical and electronic equipment (PbEU 2011, L 174/88);

    • Bb. Technical specification: document that determines the technical requirements to be met by a product, a process, or a service.


Article 2

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  • 1 This arrangement shall apply to all electrical and electronic equipment falling within the scope of Annex I to this Regulation. Directive No 2011/65 /EU listed categories.

  • 2 This arrangement shall not apply by way of derogation from the first paragraph:

    • a. Equipment necessary for the protection of the essential security interests of the State, including weapons, ammunition and war material intended for specifically military purposes;

    • b. Equipment designed to leave the atmosphere;

    • c. Equipment specially designed, and to be installed, as part of any other type of equipment excluded from the application of this scheme or not falling within the scope of this arrangement, which only serves as a function of may be part of that equipment and which can only be replaced by the same specially designed equipment;

    • d. large, non-mobile industrial plants,

    • e. large fixed installations,

    • (f) means of transport for persons or goods, except for two-wheel electric two-wheel type-approval,

    • g. Non-road mobile machinery for use exclusively for professional use,

    • h. Active, implantable medical devices,

    • i. Photovoltaic panels intended for use in a system designed, mounted and installed by craftsmen for permanent use in a particular place to produce energy from sunlight for public, commercial, industrial and residential applications; and

    • j. Equipment designed (special) solely for the purposes of research and development, and which is made available only by a company to another holding.


§ 2. Prohibitions

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Article 3

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  • 1 The placing on the market of electrical and electronic equipment, including cables and spare parts for repairing, reusing, adapting functional aspects or improving its capacity, is prohibited. where it is listed in Annex II of Directive No 2011/65 /EU contains substances containing, in a homogenous material, the maximum concentration values specified in the said Annex II.

  • 2 The first paragraph shall not apply to:

    • a. Medical devices and measuring and control equipment placed on the market before 22 July 2014;

    • b. Medical devices for in vitro diagnostic medical devices placed on the market before 22 July 2016; and

    • c. Industrial measurement and control equipment placed on the market before 22 July 2017.

  • 3 The first paragraph shall not apply to cables or spare parts for repair, re-use, adaptation of functional aspects, or to improving the capacity of:

    • a. Electrical and electronic equipment placed on the market before 1 July 2006,

    • b. Medical devices placed on the market before 22 July 2014,

    • c. Medical devices for in vitro diagnostic medical devices placed on the market before 22 July 2016,

    • d. Control and control equipment placed on the market before 22 July 2014; and

    • e. Industrial measurement and control equipment placed on the market before 22 July 2017.

    • f. electrical and electronic equipment for which the European Commission has granted relief and which has been placed on the market for the purpose of the date of the exemption, in so far as it concerns that specific exemption.

  • 4 The first paragraph shall not apply to reused spare parts recovered from electrical and electronic equipment placed on the market before 1 July 2006, and used in equipment that is on the market before 1 July 2016. provided that the re-use takes place in verifiable closed business-to-business return systems and that the consumer is informed of the reuse of spare parts.

  • 5 The first paragraph shall not apply to the provisions of Annexes III and IV to this Regulation. Directive No 2011/65 /EU listed applications.


§ 3. Obligations of market participants

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Article 4. Obligations of manufacturers

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  • 1 Manufacturers placing electrical and electronic equipment on the market:

    • a. draw up the required technical documentation;

    • (b) conduct the established internal production controls in accordance with Module A of Annex II to Decision No Council Regulation (EC) No 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 (PbEU 2008, L 218/101),

    • c. to prepare an EU declaration of conformity in accordance with Article 10 , where the procedures referred to in point (b) demonstrate that the electrical and electronic equipment complies with the applicable requirements, and indicate the CE marking on the finished product.

  • 2 If other applicable European Union law requires the application of a conformity assessment procedure that is at least as stringent as the procedures referred to in paragraph 1 (b), proof that compliance with the requirements is met may be Of Article 3, first paragraph , it is provided in that procedure and is sufficient to draw up a single technical documentation.

  • 3 A manufacturer shall keep the technical documentation and the EU declaration of conformity of electrical and electronic equipment until at least 10 years after it has been placed on the market;

  • 4 A manufacturer shall have procedures to continue to ensure the conformity of his series production, taking careful account of changes in the design or characteristics of the electrical and electronic equipment, and changes in the harmonised standards or technical specifications referred to in the attestation of conformity of the equipment;

  • 5 A manufacturer shall keep a register of non-compliant products and recalls of electrical and electronic equipment and shall keep distributors informed.

  • 6 A manufacturer shall affers to its electrical and electronic equipment a type, batch or serial number or another means of identification, or where it is not possible by the size or nature of the electrical and electronic equipment, put this information on the packaging, or enter it in a document accompanying the electrical and electronic equipment.

  • 7 A manufacturer shall indicate his name, registered trade name or registered trade mark and contact address on the electrical and electronic equipment, or where this is not possible, on the packaging or in any of the electrical and electronic equipment. equipment attached, where in all cases a single place is indicated where the manufacturer can be reached.

  • 8 Where other relevant legislation of the European Union contains provisions for the name and address of the manufacturer which are at least as stringent as this arrangement, by way of derogation from the seventh paragraph, these rules shall apply.

  • 9 If a manufacturer considers or has reason to believe that electrical and electronic equipment placed on the market by the manufacturer does not comply with this scheme:

    • a. Takes immediate corrective action to ensure that the electrical and electronic equipment is fulfilled;

    • b. If necessary, ensure the placing on the market or recall of the electrical and electronic equipment; and

    • c. If the electrical and electronic equipment presents a risk, it shall immediately inform the competent authority, in particular on non-compliance and with a detailed description of the corrective actions taken. measures.

  • 10 A manufacturer shall, on a reasoned request from the competent authority, provide all the necessary information and documentation to demonstrate compliance with this scheme, in a language which the competent authority can easily understand, and grant Request of the competent authority to cooperate with all measures taken to ensure that electrical and electronic equipment placed on the market complies with the provisions of this Regulation.


Article 5. Obligations of authorised representatives

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  • 1 A manufacturer may, by written mandate, establish an authorised representative which carries out at least the following tasks:

    • a. the retention of the EU declaration of conformity and the technical documentation until at least 10 years after the placing on the market of electrical and electronic equipment specified in: Article 4, third paragraph ,

    • (b) provide all necessary information and documentation in order to demonstrate compliance with the provisions of this Arrangement, at the reasoned request of the competent authority, to demonstrate compliance with this scheme Article 4, 10th paragraph , and

    • (c) cooperate, at the request of the competent authority, of measures taken to ensure that electrical and electronic equipment is covered by the mandate in accordance with the provisions of this Regulation. Article 4, 10th paragraph .

  • 2 The obligations under Article 3 and the preparation of technical documentation is not part of the mandate of the authorised representative.


Article 6. Obligations of importers

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  • 1 Importers shall ensure that prior to placing on the market electrical and electronic equipment:

    • a. The manufacturer has carried out the appropriate conformity assessment,

    • (b) the manufacturer has prepared the technical documentation;

    • c. The electrical and electronic equipment is provided with the CE marking required and is accompanied by the required documents; and

    • d. the manufacturer Article 4, fifth and sixth paragraphs That's true.

  • 2 If an importer considers that or has reason to believe that certain electrical and electronic equipment does not comply with Article 3 ensure that the placing on the market of these electrical and electronic equipment does not take place than after it has been brought into conformity with that Article and the manufacturer and the competent authority have been informed thereof.

  • 3 An importer shall indicate his name, registered trade name or registered trade mark and contact address on the electrical and electronic equipment, or where this is not possible, on the packaging or any of the electrical and electronic equipment equipment attached.

  • 4 If other relevant legislation of the European Union contains provisions for the name and address of the importer which are at least as stringent as this arrangement, these rules shall apply.

  • 5 An importer shall keep a register of non-compliant products and recalled electrical and electronic equipment and shall keep distributors informed thereof.

  • 6 If an importer considers or has reason to believe that any electrical and electronic equipment which it has placed on the market does not comply with the provisions of this Regulation:

    • a. shall immediately take the necessary corrective measures to ensure that the electrical and electronic equipment is complied with;

    • b. If necessary, ensure that electrical and electronic equipment are taken out of the market or recall; and

    • c. If the electrical and electronic equipment is present at risk, it shall immediately inform the competent authority, in particular on non-compliance and with a detailed description of the corrective actions taken. measures.

  • 7 An importer shall keep for 10 years after the placing on the market of electrical and electronic equipment a copy of the EU declaration of conformity which may be made available to the competent authority and shall, upon request, provide the technical documentation to the competent authority.

  • 8 An importer shall, upon a reasoned request from the competent authority, provide all the necessary information and documentation to demonstrate compliance with this scheme, in a language which the competent authority can easily understand, and grant Request of the competent authority to cooperate with all measures taken to ensure that electrical and electronic equipment placed on the market complies with the provisions of this Regulation.


Article 7. Obligations of distributors

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  • 1 Distributors shall ensure that before making any electrical and electronic equipment available on the market:

    • a. due diligence in relation to the applicable requirements has been exercised, in particular by checking that the electrical and electronic equipment is marked with the CE marking and is accompanied by the required documents in a language which to understand consumers and other end-users, and

    • b. The manufacturer or the importer to the Articles 4, 6th and 7th , and 6, third member That's true.

  • 2 If a distributor is of opinion or has reason to assume that certain electrical and electronic equipment does not comply with Article 3 ensure that the placing on the market of these electrical and electronic equipment does not take place than after it has been brought into conformity with that Article and the manufacturer and the competent authority have been informed thereof.

  • 3 If a distributor considers or has reason to believe that certain electrical and electronic equipment which it has placed on the market does not comply with this scheme:

    • a. Takes the necessary corrective measures to ensure that the electrical and electronic equipment is complied with;

    • b. If necessary, ensure the placing on the market or recall of the electrical and electronic equipment; and

    • c. If the electrical and electronic equipment is present at risk, it shall immediately inform the competent authority, in particular on non-compliance and with a detailed description of the corrective actions taken. measures.

  • 4 A distributor shall, at the reasoned request of the competent authority, provide all the necessary information and documentation to demonstrate compliance with this scheme and, at the request of the competent authority, shall cooperate with all the Member States concerned. measures to ensure that electrical and electronic equipment placed on the market complies with the provisions of this Regulation.


§ 4. Identification and marking

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Article 8. Cases in which the obligations of manufacturers apply to importers and distributors

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Importers or distributors shall be considered as manufacturer and shall comply with the requirements of this Regulation. Articles 3 and 4 if they place electrical and electronic equipment on their own name or brand name on the market, or are already placing on the market electrical and electronic equipment so as to ensure that compliance with this scheme is no longer established.


Article 9. Identification of economic operators

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Operators shall, at the request of the competent authority, provide data for a period of 10 years after the placing on the market of electrical and electronic equipment, relating to:

  • a. which economic operator has supplied certain electrical and electronic equipment; or

  • (b) any operator supplied with certain electrical and electronic equipment.


Article 10. Eu declaration of conformity

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  • 1 The EU declaration of conformity for electrical and electronic equipment shall state that it has been demonstrated that it is not in conflict with Article 3 was acted.

  • 2 The structure of the EU declaration of conformity corresponds to the model in Annex VI to this Regulation. Directive No 2011/65 /EU, contains the elements listed therein and is constantly updated.

  • 3 An EU declaration of conformity for the placing on the market or the supply of electrical and electronic equipment on the market in the Netherlands is set out in English or English.

  • 4 If other applicable European Union legislation requires the application of a conformity assessment procedure that is at least as stringent as this scheme, proof that compliance with the requirements of the applicable legislation may be applied may be Article 3, first paragraph These procedures and the preparation of a single technical documentation shall be sufficient.

  • 5 By drawing up an EU declaration of conformity, the manufacturer shall assume responsibility for the conformity of the electrical and electronic equipment with this arrangement.


Article 11. General principles of the CE marking

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The CE marking of electrical and electronic equipment shall comply with the general principles set out in Article 30 of this Directive. Regulation (EC) 765/2008 of the European Parliament and of the Council of 9 July 2008 setting out the requirements for accreditation and market surveillance relating to the marketing of products and repealing Regulation (EEC) No 1418/EEC 339/93 (PbEU 2008, L 218/30).


Article 12. Requirements for affixing the CE marking

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  • 1 The CE marking shall be affixed to the finished electrical and electronic equipment or to the data plate for the placing on the market in a visible, legible and indelible manner.

  • 2 If, due to the nature of electrical and electronic equipment, this is not possible or justified, the CE marking shall be affixed to the packaging and in the accompanying documents.


Article 13. Presumption of conformity

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  • 1 Where the proof of the contrary is lacking, the competent authority shall assume that electrical and electronic equipment bearing the CE marking complies with the provisions of this Regulation.

  • 2 Materials, components and electrical and electronic equipment which have undergone tests and measurements which have been shown to comply with Article 3 , or assessed in accordance with harmonised standards in the EU, the references of which are published in the Official Journal of the European Union, shall be considered in accordance with the provisions of this Arrangement.


§ 4 *. Transitional duty

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Article 14

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Without prejudice Article 3, second and third paragraphs , until 22 July 2019, this arrangement does not apply to electrical and electronic equipment on which Article 2 of the Management Decision for electrical and electronic equipment As it was before 2 January 2013, it was not applicable.


§ 5. Final provisions

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Article 15

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An amendment to the Annexes to Directive No 2011/65 For the purpose of applying this system, it shall apply from the date on which it is to be implemented, except where a ministerial order published in the Official Journal of the European Union provides for a change in time.


Article 16

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This arrangement shall enter into force on 2 January 2013.


Article 17

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This arrangement is cited as: Regulations of hazardous substances in electrical and electronic equipment.

This arrangement will be set out in the Official Journal.

The

State Secretary

of Infrastructure and the Environment,

W.J. Mansveld.