Emtract Ingest

Overview

Jurisdiction: European Union
Topic: Environment
Instrument type: Directive
Reference number: 2011/65/EU
Valid from: 2011-07-21
Valid to: 3112-12-31
Modified date: 2011-06-08
Listed at: 2026-08-06
Withdrawn at: -
Description: The directive restricts the use of certain hazardous substances in electrical and electronic equipment and sets requirements for manufacturers, authorised representatives, importers and distributors, including conformity assessment, technical documentation, the EU declaration of conformity, CE marking, traceability, and corrective, withdrawal and recall measures.

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Sources

Source URL	Crawler	Publish date
https://publications.europa.eu/resource/celex/32011L0065	Schokolade

Logs

	Type	Status	Started at	Finished at
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Rule sets

	Label	Effective
	Manufacturers of electrical and electronic equipment	2013-01-02 — 9999-12-31
	Applies from milestone: Transposition Deadline (2013-01-02) Expires at milestone: - Conditions: Products contains No Linked Attribute Value “electrical and electronic equipment (EEE)” …
	Authorised representatives of manufacturers	2013-01-02 — 9999-12-31
	Applies from milestone: Transposition Deadline (2013-01-02) Expires at milestone: - Conditions: Products contains No Linked Attribute Value “electrical and electronic equipment (EEE)” …
	Importers of electrical and electronic equipment	2013-01-02 — 9999-12-31
	Applies from milestone: Transposition Deadline (2013-01-02) Expires at milestone: - Conditions: Products contains No Linked Attribute Value “electrical and electronic equipment (EEE)” …
	Distributors of electrical and electronic equipment	2013-01-02 — 9999-12-31
	Applies from milestone: Transposition Deadline (2013-01-02) Expires at milestone: - Conditions: Products contains No Linked Attribute Value “electrical and electronic equipment (EEE)” …
	Importers or distributors treated as manufacturers	2013-01-02 — 9999-12-31
	Applies from milestone: Transposition Deadline (2013-01-02) Expires at milestone: - Conditions: Products contains No Linked Attribute Value “electrical and electronic equipment (EEE)” …

Questions this regulation asks

Attributes only this regulation asks about — criteria no general attribute expresses. A company answers each once.

This regulation asks no questions of its own — every condition uses a general attribute.

Obligations

Title	Kind	Rule set
Comply with restricted-substance limits	Other	-
Description: Design and manufacture EEE so that substances listed in Annex II do not exceed the maximum concentration values in homogeneous materials. Frequency: Continuous Check frequency: Event-triggered Products/Services: Electrical and electronic equipment, including cables and spare parts Checking responsibility: Manufacturer; national market surveillance authorities Check method: Review of material data and homogeneous materials through market surveillance Rule set: - Source reference: Article 7(a) and Article 4(1)-(2) Source excerpt: when placing EEE on the market, manufacturers ensure that it has been designed and manufactured in accordance with the requirements set out in Article 4
Technical documentation and internal production control	Record Keeping	-
Description: Draw up technical documentation and carry out, or have carried out, internal production control under Module A. Frequency: Event-triggered Check frequency: Event-triggered Products/Services: EEE placed on the market Checking responsibility: Manufacturer; market surveillance authorities Check method: Review of technical documentation and internal production control Rule set: - Source reference: Article 7(b) Source excerpt: manufacturers draw up the required technical documentation and carry out the internal production control procedure in line with module A of Annex II to Decision No 768/2008/EC or have it carried out
Draw up the EU declaration of conformity	Approval	-
Description: Document demonstrated conformity by drawing up and updating an EU declaration of conformity and translating it into the required languages. Frequency: Event-triggered Check frequency: Event-triggered Products/Services: EEE placed on the market Checking responsibility: Manufacturer; market surveillance authorities Check method: Review of the EU declaration of conformity against Annex VI Rule set: - Source reference: Article 7(c), Article 13 and Annex VI Source excerpt: manufacturers draw up an EU declaration of conformity and affix the CE marking on the finished product
Keep documentation for ten years	Record Keeping	-
Description: Keep the technical documentation and EU declaration of conformity for ten years after placing the EEE on the market. Frequency: Continuous Check frequency: Event-triggered Products/Services: EEE placed on the market Checking responsibility: Manufacturer; market surveillance authorities Check method: Document request and review by the competent authority Rule set: - Source reference: Article 7(d) Source excerpt: manufacturers keep the technical documentation and the EU declaration of conformity for 10 years after the EEE has been placed on the market
Verify conformity of imported EEE	Due Diligence	-
Description: Before placing EEE on the market, ensure that conformity assessment was carried out, technical documentation was prepared, CE marking is present, required documents accompany the product and manufacturer details are provided. Frequency: Event-triggered Check frequency: Event-triggered Products/Services: Imported EEE Checking responsibility: Importer; market surveillance authorities Check method: Review of conformity assessment, documentation, CE marking and operator details Rule set: - Source reference: Article 9(b) Source excerpt: importers, before placing an EEE on the market, ensure that the appropriate conformity assessment procedure has been carried out by the manufacturer, and that they further ensure that the manufacturer has drawn up the technical documentation, that the EEE bears the CE marking and is accompanied by the required documents
Distributor due diligence	Due Diligence	-
Description: Act with due care when making EEE available and verify the CE marking, accompanying documents and manufacturer and importer details. Frequency: Continuous Check frequency: Event-triggered Products/Services: EEE made available by distributors Checking responsibility: Distributor; market surveillance authorities Check method: Incoming-goods checks of CE marking and accompanying documents Rule set: - Source reference: Article 10(a) Source excerpt: when making an EEE available on the market, distributors act with due care in relation to the requirements applicable in particular by verifying that the EEE bears the CE marking
Trace supply-chain operators	Record Keeping	-
Description: For ten years following placing on the market, be able on request to identify the economic operators that supplied or received EEE. Frequency: Continuous Check frequency: Event-triggered Products/Services: EEE in the supply chain Checking responsibility: Economic operator; market surveillance authorities Check method: Traceability records supplied on request Rule set: - Source reference: Article 12 Source excerpt: Member States shall ensure that economic operators, on request, identify the following to the market surveillance authorities, for 10 years following the placing on the market of the EEE
Apply to renew an exemption	Approval	-
Description: Submit an application to renew an exemption no later than 18 months before the exemption expires. Frequency: Event-triggered Check frequency: Event-triggered Products/Services: Materials or components subject to an exemption application Checking responsibility: Applicant company; European Commission Check method: Review of receipt date and application deadline Rule set: - Source reference: Article 5(5) Source excerpt: An application for renewal of an exemption shall be made no later than 18 months before the exemption expires.
Control reuse of spare parts	Other	-
Description: Use auditable closed-loop business-to-business return systems and notify consumers of the reuse. Frequency: Event-triggered Check frequency: Event-triggered Products/Services: Reused spare parts recovered from older EEE Checking responsibility: Company reusing the spare parts; market surveillance authorities Check method: Audit of the closed-loop return system and consumer notification Rule set: - Source reference: Article 4(5) Source excerpt: provided that reuse takes place in auditable closed-loop business-to-business return systems, and that the reuse of parts is notified to the consumer
Keep documentation available as authorised representative	Record Keeping	-
Description: Keep the EU declaration of conformity and technical documentation at the disposal of national surveillance authorities for ten years following placing on the market. Frequency: Continuous Check frequency: Event-triggered Products/Services: Electrical and electronic equipment Checking responsibility: Authorised representative; competent national authorities Check method: Retention and review of the declaration and technical documentation Rule set: - Source reference: Article 8(b) Source excerpt: keep the EU declaration of conformity and the technical documentation at the disposal of national surveillance authorities for 10 years following the placing on the market of the EEE
Cooperate with authorities	Reporting	-
Description: Upon a reasoned request, provide information and documentation demonstrating conformity and cooperate with the authority on compliance actions. Frequency: Event-triggered Check frequency: Event-triggered Products/Services: Electrical and electronic equipment Checking responsibility: Authorised representative; competent national authorities Check method: Review of supplied information and documentation Rule set: - Source reference: Article 8(b) Source excerpt: further to a reasoned request from a competent national authority, provide that authority with all the information and documentation necessary to demonstrate the conformity of an EEE with this Directive
Indicate importer details	Other	-
Description: Indicate the name or trade name, registered trademark and contact address on the EEE, its packaging or an accompanying document. Frequency: Event-triggered Check frequency: Event-triggered Products/Services: Imported EEE Checking responsibility: Importer; market surveillance authorities Check method: Visual inspection of the marking Rule set: - Source reference: Article 9(d) Source excerpt: importers indicate their name, registered trade name or registered trade mark and the address at which they can be contacted on the EEE or, where that is not possible, on its packaging or in a document accompanying the EEE
Keep a register of non-compliant imports	Record Keeping	-
Description: Keep a register of non-compliant EEE and recalls and keep distributors informed. Frequency: Continuous Check frequency: Event-triggered Products/Services: Non-compliant imported EEE and product recalls Checking responsibility: Importer; market surveillance authorities Check method: Review of the register and distributor communications Rule set: - Source reference: Article 9(e) Source excerpt: importers, in order to ensure compliance with this Directive, keep a register of non-compliant EEE and EEE recalls, and keep distributors informed thereof
Submit an exemption application	Approval	-
Description: Submit applications for granting, renewing or revoking an exemption with the required information and justification. Frequency: Event-triggered Check frequency: Event-triggered Products/Services: Materials or components subject to an exemption application Checking responsibility: Applicant company; European Commission Check method: Commission review and evaluation of the application Rule set: - Source reference: Annex V Source excerpt: Applications for exemptions, renewal of exemptions or, mutatis mutandis, for revoking an exemption may be submitted by a manufacturer, the authorised representative of a manufacturer, or any economic operator in the supply chain and shall include at least the following:
Withhold and report non-compliant EEE	Reporting	-
Description: Do not make non-compliant EEE available, ensure corrective, withdrawal or recall measures and immediately inform the competent authorities. Frequency: Event-triggered Check frequency: Event-triggered Products/Services: EEE found to be non-compliant Checking responsibility: Distributor; competent national authorities Check method: Review of notifications and corrective-action evidence Rule set: - Source reference: Article 10(b)-(c) Source excerpt: where a distributor considers or has reason to believe that an EEE is not in conformity with Article 4, that distributor does not make the EEE available on the market until it has been brought into conformity

Measures

No measures.

Penalties

Description	Kind	Rule set
Effective, proportionate and dissuasive penalties for infringements of national implementing provisions.	Other	-
Responsible authority: Member States / competent national authorities Source reference: Article 23 Source excerpt: The penalties provided for must be effective, proportionate and dissuasive.
Penalties, including potentially criminal sanctions for serious infringements, for improper use of the CE marking.	Criminal Liability	-
Responsible authority: Member States / competent national authorities Source reference: Article 15(3) Source excerpt: Member States shall also provide for penalties for infringements, which may include criminal sanctions for serious infringements.
Non-compliant EEE may not be placed or made available on the market and may be withdrawn or recalled.	Prohibition of Sales	-
Responsible authority: National market surveillance authorities Source reference: Articles 7(i), 9(c), 10(b)-(c) Source excerpt: immediately take the necessary corrective measures to bring that EEE into conformity, to withdraw it or recall it, if appropriate

Milestones

Date	Type	Description
2011-06-08	Adopted	Directive 2011/65/EU adopted in Strasbourg.
Source reference: Article 28 Source excerpt: Done at Strasbourg, 8 June 2011.
2011-07-21	Entry into Force	The Directive enters into force on the 20th day following its publication.
Source reference: Article 27 Source excerpt: This Directive shall enter into force on the 20th day following its publication in the Official Journal of the European Union.
2013-01-02	Transposition Deadline	Deadline for Member States to transpose the Directive.
Source reference: Article 25(1) Source excerpt: Member States shall adopt and publish, by 2 January 2013, the laws, regulations and administrative provisions necessary to comply with this Directive.
2013-01-03	Repeal	Directive 2002/95/EC is repealed.
Source reference: Article 26 Source excerpt: Directive 2002/95/EC as amended by the acts listed in Annex VII, Part A is repealed with effect from 3 January 2013
2014-07-22	Application Start	Substance restrictions start applying to medical devices and monitoring and control instruments.
Source reference: Article 4(3) Source excerpt: Paragraph 1 shall apply to medical devices and monitoring and control instruments which are placed on the market from 22 July 2014
2016-07-22	Application Start	Substance restrictions start applying to in vitro diagnostic medical devices.
Source reference: Article 4(3) Source excerpt: to in vitro diagnostic medical devices which are placed on the market from 22 July 2016
2017-07-22	Application Start	Substance restrictions start applying to industrial monitoring and control instruments.
Source reference: Article 4(3) Source excerpt: and to industrial monitoring and control instruments which are placed on the market from 22 July 2017
2019-07-22	Other	End of the transitional period for certain previously out-of-scope EEE.
Source reference: Article 2(2) Source excerpt: Member States shall provide that EEE that was outside the scope of Directive 2002/95/EC, but which would not comply with this Directive, may nevertheless continue to be made available on the market until 22 July 2019.
2021-07-22	Other	Deadline for the general review of the Directive.
Source reference: Article 24(2) Source excerpt: No later than 22 July 2021 the Commission shall carry out a general review of this Directive, and shall present a report to the European Parliament and the Council

Linked regulations

	Type	Regulation
	Cites	REACH Regulation
	Source reference: Article 2(3) Source excerpt: This Directive shall apply without prejudice to the requirements of Union legislation on safety and health, and on chemicals, in particular Regulation (EC) No 1907/2006, as well as the requirements of specific Union waste management legislation.
	Cites	Council Directive 93/42/EEC concerning medical devices
	Source reference: Article 3(21) Source excerpt: ‘medical device’ means a medical device within the meaning of point (a) of Article 1(2) of Directive 93/42/EEC and which is also EEE;
	Cites	Directive 98/79/EC of the European Parliament and of the Council on in vitro diagnostic medical devices
	Source reference: Article 3(22) Source excerpt: ‘in vitro diagnostic medical device’ means an in vitro diagnostic medical device within the meaning of point (b) of Article 1(2) of Directive 98/79/EC;
	Cites	Decision No 768/2008/EC of the European Parliament and of the Council on a common framework for the marketing of products
	Source reference: Article 7(b) Source excerpt: manufacturers draw up the required technical documentation and carry out the internal production control procedure in line with module A of Annex II to Decision No 768/2008/EC or have it carried out;
	Cites	Regulation (EC) No 765/2008 of the European Parliament and of the Council setting out the requirements for accreditation and market surveillance relating to the marketing of products
	Source reference: Article 14 Source excerpt: The CE marking shall be subject to the general principles set out in Article 30 of Regulation (EC) No 765/2008.
	Cites	Regulation (EU) No 182/2011 of the European Parliament and of the Council laying down the rules and general principles concerning mechanisms for control by Member States of the Commission’s exercise of implementing powers
	Source reference: Article 19(2) Source excerpt: Where reference is made to this paragraph, Article 5 of Regulation (EU) No 182/2011 shall apply.
	Cites	Council Directive 69/493/EEC
	Source reference: Annex III, point 29 Source excerpt: Lead bound in crystal glass as defined in Annex I (Categories 1, 2, 3 and 4) of Council Directive 69/493/EEC
	Repeals	Directive 2002/95/EC
	Source reference: Article 26 Source excerpt: Directive 2002/95/EC as amended by the acts listed in Annex VII, Part A is repealed with effect from 3 January 2013 without prejudice to the obligations of the Member States relating to the time-limits for transposition into national law and application of the Directive set out in Annex VII, Part B.
	Supersedes	Directive 2002/95/EC of the European Parliament and of the Council on the restriction of the use of certain hazardous substances in electrical and electronic equipment
	Source reference: Recital (1) Source excerpt: A number of substantial changes are to be made to Directive 2002/95/EC of the European Parliament and of the Council of 27 January 2003 on the restriction of the use of certain hazardous substances in electrical and electronic equipment. In the interest of clarity, that Directive should be recast.
	Repeals	Directive 2008/35/EC of the European Parliament and of the Council
	Source reference: Annex VII, Part A Source excerpt: Directive 2008/35/EC of the European Parliament and of the Council
	Repeals	Commission Decision 2005/618/EC
	Source reference: Annex VII, Part A Source excerpt: Commission Decision 2005/618/EC
	Repeals	Commission Decision 2010/571/EU
	Source reference: Annex VII, Part A Source excerpt: Commission Decision 2010/571/EU
	Repeals	Commission Decision 2005/717/EC
	Source reference: Annex VII, Part A Source excerpt: Commission Decision 2005/717/EC
	Repeals	Commission Decision 2005/747/EC
	Source reference: Annex VII, Part A Source excerpt: Commission Decision 2005/747/EC
	Repeals	Commission Decision 2006/310/EC
	Source reference: Annex VII, Part A Source excerpt: Commission Decision 2006/310/EC
	Repeals	Commission Decision 2006/690/EC
	Source reference: Annex VII, Part A Source excerpt: Commission Decision 2006/690/EC
	Repeals	Commission Decision 2006/691/EC
	Source reference: Annex VII, Part A Source excerpt: Commission Decision 2006/691/EC
	Repeals	Commission Decision 2006/692/EC
	Source reference: Annex VII, Part A Source excerpt: Commission Decision 2006/692/EC
	Repeals	Commission Decision 2008/385/EC
	Source reference: Annex VII, Part A Source excerpt: Commission Decision 2008/385/EC
	Repeals	Commission Decision 2009/428/EC
	Source reference: Annex VII, Part A Source excerpt: Commission Decision 2009/428/EC
	Repeals	Commission Decision 2009/443/EC
	Source reference: Annex VII, Part A Source excerpt: Commission Decision 2009/443/EC
	Repeals	Commission Decision 2010/122/EU
	Source reference: Annex VII, Part A Source excerpt: Commission Decision 2010/122/EU
	Cites	Directive 2008/98/EC of the European Parliament and of the Council on waste
	Source reference: Recital (4) Source excerpt: Directive 2008/98/EC of the European Parliament and of the Council of 19 November 2008 on waste gives first priority to prevention in waste legislation.
	Cites	Council Resolution of 25 January 1988 on a Community action programme to combat environmental pollution by cadmium
	Source reference: Recital (5) Source excerpt: Council Resolution of 25 January 1988 on a Community action programme to combat environmental pollution by cadmium invited the Commission to pursue without delay the development of specific measures for such a programme.
	Cites	Regulation (EC) No 850/2004 of the European Parliament and of the Council on persistent organic pollutants
	Source reference: Recital (6) Source excerpt: Regulation (EC) No 850/2004 of the European Parliament and of the Council of 29 April 2004 on persistent organic pollutants recalls that the objective of protecting the environment and human health from persistent organic pollutants cannot be sufficiently achieved by the Member States
	Cites	Directive 2002/96/EC of the European Parliament and of the Council on waste electrical and electronic equipment (WEEE)
	Source reference: Annex V(e) Source excerpt: information on the possible preparation for reuse or recycling of materials from waste EEE, and on the provisions relating to the appropriate treatment of waste according to Annex II to Directive 2002/96/EC;
	Cites	Directive 2009/125/EC of the European Parliament and of the Council establishing a framework for the setting of ecodesign requirements for energy-related products
	Source reference: Recital (13) Source excerpt: Directive 2009/125/EC of the European Parliament and of the Council of 21 October 2009 establishing a framework for the setting of ecodesign requirements for energy-related products enables specific ecodesign requirements to be set for energy-related products which may also be covered by this Directive.
	Cites	Directive 2006/66/EC of the European Parliament and of the Council on batteries and accumulators and waste batteries and accumulators
	Source reference: Recital (14) Source excerpt: This Directive should apply without prejudice to Union legislation on safety and health requirements and specific Union waste management legislation, in particular Directive 2006/66/EC of the European Parliament and of the Council of 6 September 2006 on batteries and accumulators and waste batteries and accumulators and Regulation (EC) No 850/2004.
	Cites	Directive 2009/28/EC of the European Parliament and of the Council on the promotion of the use of energy from renewable sources
	Source reference: Recital (17) Source excerpt: Directive 2009/28/EC of the European Parliament and of the Council of 23 April 2009 on the promotion of the use of energy from renewable sources recalls that there should be coherence between those objectives and other Union environmental legislation.
	Cites	Council Directive 90/385/EEC on the approximation of the laws of the Member States relating to active implantable medical devices
	Source reference: Article 3(23) Source excerpt: ‘active implantable medical device’ means any active implantable medical device within the meaning of point (c) of Article 1(2) 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;
	Cites	Interinstitutional Agreement on better law-making
	Source reference: Recital (29) Source excerpt: In accordance with paragraph 34 of the Interinstitutional Agreement on better law-making, Member States are encouraged to draw up, for themselves and in the interests of the Union, their own tables, which will, as far as possible, illustrate the correlation between this Directive and their transposition measures, and to make those tables public.
	Cites	Directive 98/34/EC of the European Parliament and of the Council laying down a procedure for the provision of information in the field of technical standards and regulations and of rules on Information Society services
	Source reference: Article 3(13) Source excerpt: ‘harmonised standard’ means a standard adopted by one of the European standardisation bodies listed in Annex I to 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 of rules on Information Society services on the basis of a request made by the Commission in accordance with Article 6 of Directive 98/34/EC;

RoHS Directive (restriction of hazardous substances in EEE) In force