Control Hazardous Substances In Electrical And Electronic Equipment

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

Subscribe to a Global-Regulation Premium Membership Today!

Key Benefits:

Subscribe Now for only USD$20 per month, or Get a Day Pass for only USD$4.99.
Arrangement of the State Secretary of environment of 11 december 2012, nr. I and E/BSK-2012/218548 containing rules relating to restriction of the use of certain hazardous substances in electrical and electronic equipment (Control hazardous substances in electrical and electronic equipment) the State Secretary for infrastructure and the environment, having regard to Council Directive 74/60/EEC. 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 (Ojeu 2011, L 174/88) and the first and second paragraph 9.2.2.1 above articles and 21.6, sixth paragraph, of the law on the environment;
Decision: § 1.
Definitions and scope Article 1 1 In this regulation, the following definitions shall apply: a. active implantable medical device: active implantable medical device within the meaning of article 1, second paragraph, (c) of Council Directive 90/385/EEC of 20 June 1990 on the approximation of the laws of the Member States relating to active implantable medical devices (Oj L 189, 1990);
b. CE marking: marking by which the manufacturer indicates that the product conforms to the applicable requirements of the European Union harmonisation legislation providing for its affixing;
c. conformity assessment: process demonstrating whether compliance with the requirements of Directive 74/60/EEC. 2011/65/EU relating to electrical and electronic equipment;
d. availability of a substitute: possibility to manufacture and deliver a substitute within a time frame that is reasonable compared to the time required in annex II to Directive 74/60/EEC. 2011/65/EU to manufacture and deliver the substances listed;
e. reliability of a substitute: probability that electrical and electronic equipment that uses that substitute, in appropriate circumstances a required feature for a certain period error free;
f. Distributor: natural or legal person in the supply chain, other than the manufacturer or the importer, who makes electrical and electronic equipment on the market;
g. electrical and electronic equipment means equipment which, in order to fulfill at least one intended function, is dependent on electric currents or electromagnetic fields in order to work properly and equipment for the generation, transfer and measurement of such currents and fields and that are intended for use with a voltage rating not exceeding 1000 volt for alternating current and 1500 volt for direct current;
h. manufacturer: natural or legal person who manufactures or electrical and electronic equipment designed or manufactured and markets under his name or trademark;
i. harmonized standard: standard which, on the basis of a request 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 EC 1998, L 204/37) has been established by a in annex I to that directive European standards bodies;
j. delegate: natural or legal person established in the European Union in writing by also act on behalf of a manufacturer is to carry out a particular task;
k. large stationary industrial tools: large set of machines, equipment or parts that work together for a specific application, be installed by professionals at a fixed place or broken off and are used by professionals and maintained in an industrial production environment or a Centre for research and development;
l.
large, fixed installation: large-scale Assembly of various types of devices and possibly other tools that is assembled and installed by professionals and is intended to be used permanently at a predefined and dedicated place, and that is broken off by professionals;
m. the recall means any measure aimed at achieving the return a product that has already been made available to the end user;
n. the "withdrawal" means any measure aimed at preventing a product in the supply chain, being made available on the market;
o. homogeneous material: either one material of uniform composition, either a material consisting of a combination of materials and not in separate materials from each other can be detached or can be separated by mechanical actions such as unscrewing, cutting, crushing, grinding and grinding;
p. importer: natural or legal person established in the European Union that electrical and electronic equipment from a third country on the market in the European Union;
q. the placing on the market: for the first time in the European Union on the market of electrical and electronic equipment;
r. industrial monitoring and control instruments: measurement and control equipment intended exclusively for use for industrial or professional purposes is designed;
s. cables: cables for a voltage of less than 250 volts that serve as liaison and extension cord electrical and electronic equipment with an outlet or two or more electrical and electronic devices;
t. operators: manufacturer, agent, importer or distributor;
you. market surveillance: activities carried out and measures taken by the competent authority to ensure that electrical and electronic equipment meets the requirements contained in Directive 74/60/EEC. 2011/65/EU and that that equipment does not endanger the health and safety or any other aspect of public interest protection;
v. medical device: medical device within the meaning of article 1, second paragraph, of Directive 93/42/EEC of 14 June 1993 concerning medical devices (OJ 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, second paragraph, (b) of Directive 98/79/EC of the European Parliament and of the Council of 27 October 1998 on in vitro diagnostic medical devices (Oj 1998, L 331/1);
x. non-road and made available exclusively for the professional use mobile machine: machine with an internal power source, whose operation requires either mobility, either permanent or semi-permanent displacement between a succession of fixed working locations during work, and is made available exclusively for professional use;
y. on the market: in the course of a commercial activity, whether in return for payment, providing electrical and electronic equipment with a view to distribution, consumption or use on the market in the European Union;
z. spare part: part of electrical and electronic equipment that part of a can replace the electrical and electronic equipment, where: 1 ° without that part the electrical and electronic equipment may not work as intended, and 2 ° the efficacy of the electrical and electronic equipment shall be rectified or corrected if the part is replaced;
AA.
Directive 74/60/EEC. 2011/65/EU: Directive 74/60/EEC. 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 (Ojeu 2011, L 174/88);
BB.
technical specification: document that determines the technical requirements to which a product, process or service must meet.

Article 2 1 the arrangement shall apply to all electrical and electronic equipment that falls within the in annex I to Directive 74/60/EEC. 2011/65/EU categories listed.
2 this arrangement is by way of derogation from the first paragraph do not apply to: a. equipment which is necessary for the protection of the essential interests of the security of the State, including arms, munitions and war material that is intended for specifically military purposes, b. equipment designed to leave the atmosphere, c. equipment designed specifically , and is to be installed, as part of another type of equipment that is excluded from the application of this scheme or not within the scope of this scheme, that its function only if it is part of that equipment can fulfill and that only can be replaced by the same specially designed equipment, d. large-scale stationary industrial tools, e. large fixed installations , f. means of transport for persons or property, with the exception of electric two-wheelers without type-approval, g. and non-road mobile machinery made available exclusively for professional use, h., active implantable medical devices, i. photovoltaic panels intended for use in a system that is designed, assembled and installed by professionals for permanent use at a certain place in order to produce energy from sunlight for public , commercial, industrial and residential applications, and j. equipment (Special) is designed solely for purposes of research and development and used exclusively by a company to another company.

§ 2.
Prohibitions Article 3


1 the placing on the market of electrical and electronic equipment, including cables and spare parts for the repair, reuse, adjusting the functional aspects or improving the capacity of it, is forbidden if they are in annex II to Directive 74/60/EEC. 2011/65/EU substances, taking in a homogeneous material referred to in annex II the maximum concentration values are exceeded.
2 the first paragraph shall not apply to: a. before 22 July 2014 marketed medical devices and monitoring and control instruments, b. before 22 July 2016 marketed medical devices for in-vitro diagnostics, and c. before 22 July 2017 in industrial monitoring and control instruments placed on the market.
3 the first paragraph shall not apply to cables or spare parts for repair, reuse, adjusting the functional aspects or improving the capacity of: a. put on the market before 1 July 2006 electrical and electronic equipment, b. before 22 July 2014 medical devices placed on the market, c. before 22 July 2016 medical devices placed on the market for in vitro diagnostics , d. before 22 July 2014 in monitoring and control instruments placed on the market, and e. before 22 July 2017 in industrial monitoring and control instruments placed on the market.
f. electrical and electronic equipment for which the European Commission has granted exemption and that for the time the exemption ends has been placed on the market, as far as that particular exemption.
4 the first paragraph shall not apply to recycled spare parts that are reclaimed from electrical and electronic equipment placed on the market before 1 July 2006, and used in equipment which was placed on the market before 1 July 2016, provided that it takes place in verifiable reuse, closed business-to-business return systems and the consumer in the event of the reuse of spare parts.
5 the first paragraph shall not apply to in annexes III and IV to Directive 74/60/EEC. 2011/65/EU applications listed.

§ 3.
Market parties article 4 obligations. Obligations of manufacturers 1 manufacturers that electrical and electronic equipment: a. notify the required technical documentation on, b. carry out the established internal production checks in accordance with module A of annex II to decision 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 Decision 93/465/EEC (Ojeu 2008, L 218/101) from or let this run, c. couples an EU Declaration of conformity referred to in article 10, when with the procedures referred to in subparagraph (b) it is demonstrated that the electrical and electronic equipment complies with the applicable requirements and the CE marking to bring on the end product.
2 where other applicable European Union legislation requires the application of a procedure for conformity assessment which are at least as strict as the procedures referred to in paragraph (b), proof that compliance with the requirements of article 3, paragraph 1, are delivered in a single procedure and that sufficient preparation of technical documentation.
3 a manufacturer shall keep the technical documentation and the EU Declaration of conformity of electrical and electronic equipment to at least 10 years after it has been placed on the market;
4 a manufacturer has procedures to ensure the conformity of production to continue his series, which he carefully takes into account changes in product design or characteristics of the electrical and electronic equipment and with changes in the harmonised standards or technical specifications referred to in the Declaration of conformity of the equipment is referred;
5 a manufacturer keeps a register of non-conforming products and electrical and electronic equipment and keeps the distributors recalled.
6 A manufacturer must affix its electrical and electronic equipment a type, batch or serial number or other identification means to, or, where the size or nature of the electrical and electronic equipment is not possible, he brings this information to the packaging or mentions this in a document attached to the electrical and electronic equipment.
7 A manufacturer shall mark his name, registered trade name or registered trade mark and contact address on the electrical and electronic equipment or, where that is not possible, on its packaging or in a document attached to the electrical and electronic equipment, which in all cases a single location shows where the manufacturer can be achieved.
8 where other applicable European Union legislation requirements for putting name and address of the manufacturer that is at least as stringent as this scheme, by way of derogation from paragraph 7 shall apply in these rules.
9 If a manufacturer considers or has reason to believe that by him in electrical and electronic equipment placed on the market do not meet these rules: a. He immediately takes the necessary corrective measures to meet the electrical and electronic equipment, b. He wears if necessary care for its withdrawal or recall of the electrical and electronic equipment He brings, and c. If the electrical and electronic equipment presents a risk, the competent authority shall immediately inform, in particular relating to the non-compliance and with a detailed description of all corrective actions taken.
10 A manufacturer shall provide to a reasoned request from the competent authority, all the information and documentation necessary to demonstrate compliance with this regulation, the competent authority in a language that can easily understand, and at the request of the competent authority, on any action taken to ensure that the electrical and electronic equipment placed on the market complies with this control.

Article 5. Obligations of agents 1 a manufacturer may with a written mandate, appoint an authorised representative setting out at least the following tasks: a. preserving the EU Declaration of conformity and the technical documentation to at least 10 years following the placing on the market of electrical and electronic equipment referred to in article 4, third paragraph, (b) further to a reasoned request from the competent authority providing all the information and documentation necessary to demonstrate compliance with this arrangement to show as referred to in article 4, paragraph 10, and (c) at the request of the competent authority contribute action taken to ensure that electrical and electronic equipment under the mandate meets the scheme referred to in article 4, paragraph 10.
2 the obligations laid down in article 3 and the drawing up of technical documentation are not part of the authorised representative's mandate.

Article 6. Obligations of importers 1 Importers shall ensure that before they electrical and electronic equipment: a. the appropriate conformity assessment, the manufacturer b. the manufacturer has drawn up the technical documentation, c. the electrical and electronic equipment is equipped with the required CE marking and accompanied by the required documents, and d. the manufacturer to article 4 , fifth and sixth member, has met.
(2) If an importer considers or has reason to believe that certain electrical and electronic equipment does not comply with article 3 shall ensure that the placing on the market of the electrical and electronic equipment does not take place until after this is in accordance with that article and the manufacturer and the competent authority thereof.
3 an importer mentions his name, registered trade name or registered trade mark and contact address on the electrical and electronic equipment or, where that is not possible, on its packaging or in a document attached to the electrical and electronic equipment.
4 where other applicable European Union legislation requirements for putting name and address of the importer that is at least as stringent as this arrangement shall be subject to these requirements.
5 an importer shall keep records of non-conforming products and electrical and electronic equipment and keeps the distributors recalled that at the height.
6 If an importer considers or has reason to believe that certain marketed by him in the electrical and electronic equipment does not comply with this arrangement: a. He immediately takes the necessary corrective measures to the electrical and electronic equipment to do, b. He wears if necessary care for its withdrawal or recall of the electrical and electronic equipment and , c. If the electrical and electronic equipment presents a risk, he shall immediately inform the competent authority, in particular relating to the non-compliance and with a detailed description of all corrective actions taken.
7 an importer shall keep for 10 years following the placing on the market of electrical and electronic equipment a copy of the EU Declaration of conformity that can be made available to the competent authority and provided on request the technical documentation to the competent authority.

8 an importer shall, further to a reasoned request from the competent authority, all the information and documentation necessary to demonstrate compliance with this regulation, the competent authority in a language that can easily understand, and at the request of the competent authority, on any action taken to ensure that the electrical and electronic equipment placed on the market complies with this control.

Article 7. Obligations distributors 1 Distributors shall ensure that before they electrical and electronic equipment on the market: a. the due care has been taken in relation to the applicable requirements, in particular by verifying that the electrical and electronic equipment bearing the CE marking and accompanied by the required documents in a language that consumers and other end users , can understand, and (b) the manufacturer or the importer to articles 4, sixth and seventh member, and 6, third paragraph, have been fulfilled.
(2) If a distributor considers or has reason to believe that certain electrical and electronic equipment does not comply with article 3 shall ensure that the placing on the market of the electrical and electronic equipment does not take place until after this is in accordance with that article and the manufacturer and the competent authority thereof.
3 where a distributor considers or has reason to believe that certain marketed by him in the electrical and electronic equipment does not comply with this arrangement: a. shall take the necessary corrective measures to the electrical and electronic equipment to do, b. He wears if necessary care for its withdrawal or recall of the electrical and electronic equipment and c. If the electrical and electronic equipment presents a risk, he shall immediately inform the competent authority, in particular relating to the non-compliance and with a detailed description of all corrective actions taken.
4 a distributor provided, further to a reasoned request from the competent authority, all the information and documentation necessary to demonstrate compliance with this arrangement, and requested to do so by the competent authority, on any action taken to ensure that the electrical and electronic equipment placed on the market complies with this control.

§ 4.
Identification and marking article 8. Cases in which obligations of manufacturers apply to importers and distributors Importers or distributors are regarded as manufacturer and shall comply with articles 3 and 4 if they electrical and electronic equipment under his own name or trademark or the placing on the market or already in electrical and electronic equipment placed on the market that line with this arrangement no longer it is established.

Article 9. Identification of economic operators economic operators shall, upon the request of the competent authority, for a period of 10 years following the placing on the market of the electrical and electronic equipment data concerning: (a) any economic operator who has supplied certain electrical and electronic equipment, or (b) any economic operator to whom certain electrical and electronic equipment is delivered.

Article 10. EU-Declaration of conformity EU Declaration of conformity 1 in electrical and electronic equipment shall state that the fulfilment not contrary to article 3 is acted.
2 the structure of the EU Declaration of conformity shall have the model in annex VI to Directive 74/60/EEC. 2011/65/EU, contains the elements listed in it and it is constantly being updated.
3 an EU Declaration of conformity for placing on the market or in Netherlands on the market of electrical and electronic equipment is in the Dutch or English.
4 where other applicable European Union legislation requires the application of a procedure for conformity assessment that is at least as stringent as this arrangement, for proof that compliance with the requirements of article 3, paragraph 1, be sufficient to that procedure and the preparation of a single technical documentation.
5 through the establishment of a EU-Declaration of conformity the manufacturer shall assume the responsibility for the compliance of the electrical and electronic equipment with this arrangement.

Article 11. General principles of the CE marking the CE marking of electrical and electronic equipment complies with the General principles laid down in article 30 of Regulation (EC) No. 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 2454/93. 339/93 (2008, Ojeu L 218/30).

Article 12. Requirements for the affixing of the CE marking the CE marking is 1 for the marketing be affixed visibly, legibly and indelibly on the finished electrical and electronic equipment or to its data plate.
2 If this is due to the nature of the electrical and electronic equipment is not possible or is justified, is affixed to the packaging and in the accompanying documents.

Article 13. Presumption of conformity 1 if evidence to the contrary is missing, the competent authority believed that electrical and electronic equipment CE marking comply with this arrangement.
2 materials, components and electrical and electronic equipment on which tests and measurements have been subjected has shown that compliance with article 3, or that have been assessed in accordance with the EU harmonised standards, the references of which have been published in the official journal of the European Union, shall be construed as consistent with this scheme.

§ 4*.
Transitional law article 14 without prejudice to article 3, paragraphs 2 and 3, is this arrangement to 22 July 2019 does not apply to electrical and electronic equipment to which article 2 of the decision management electrical and electronic equipment such as that was for 2 January 2013, did not apply.

§ 5.
Final provisions article 15, an amendment to the annexes to Directive 74/60/EEC. 2011/65/EU goes for the application of this scheme are current as of the day on which that change must be given to implementation, unless by ministerial decision, which shall be published in the Government Gazette, a different time is fixed.

Article 16 this arrangement shall enter into force on 2 January 2013.

Article 17 this arrangement is cited as: Control hazardous substances in electrical and electronic equipment.
This scheme will be placed with the notes in the Government Gazette.
The State Secretary for infrastructure and environment, W.J. M.

Related Laws