EdLaw
Economic-operator obligations, EU declaration, CE marking, penalties
Manufacturer obligations (internal design control per Module A of Decision 768/2008/EC, EU declaration of conformity, CE marking), the presumption of conformity, and national penalties.
Article 7 — Obligations of manufacturers
Verbatim from EUR-Lex (Directive 2011/65/EU (RoHS 2) 02011L0065-20260701), via the Publications Office Cellar API.
Member States shall ensure that:
- (a) 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;
- (b) 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;
- (c) where compliance of EEE with the applicable requirements has been demonstrated by the procedure referred to in point (b), manufacturers draw up an EU declaration of conformity and affix the CE marking on the finished product. Where other applicable Union legislation requires the application of a conformity assessment procedure which is at least as stringent, compliance with the requirements of Article 4(1) of this Directive may be demonstrated within the context of that procedure. A single technical documentation may be drawn up;
- (d) manufacturers keep the technical documentation and the EU declaration of conformity for 10 years after the EEE has been placed on the market;
- (e) manufacturers ensure that procedures are in place for series production to remain in conformity. Changes in product design or characteristics and changes in the harmonised standards or in technical specifications by reference to which conformity of EEE is declared shall be adequately taken into account;
- (f) manufacturers keep a register of non-conforming EEE and product recalls, and keep distributors informed thereof;
- (g) manufacturers ensure that their EEE bears a type, batch or serial number or other element allowing its identification, or, where the size or nature of the EEE does not allow it, that the required information is provided on the packaging or in a document accompanying the EEE;
- (h) manufacturers 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. The address must indicate a single point at which the manufacturer can be contacted. Where other applicable Union legislation contains provisions for the affixing of the manufacturer’s name and address which are at least as stringent, those provisions shall apply;
- (i) manufacturers who consider or have reason to believe that EEE which they have placed on the market is not in conformity with this Directive immediately take the necessary corrective measures to bring that EEE into conformity, to withdraw it or recall it, if appropriate, and immediately inform the competent national authorities of the Member States in which they made the EEE available to that effect, giving details, in particular, of the non-compliance and of any corrective measures taken;
- (j) manufacturers, further to a reasoned request from a competent national authority, provide it with all the information and documentation necessary to demonstrate the conformity of the EEE with this Directive, in a language which can be easily understood by that authority, and that they cooperate with that authority, at its request, on any action taken to ensure compliance with this Directive of EEE which they have placed on the market.
Article 13 — EU declaration of conformity
Verbatim from EUR-Lex (Directive 2011/65/EU (RoHS 2) 02011L0065-20260701), via the Publications Office Cellar API.
1. The EU declaration of conformity shall state that it has been demonstrated that the requirements specified in Article 4 have been met.
2. The EU declaration of conformity shall have the model structure and shall contain the elements specified in Annex VI and shall be updated. It shall be translated into the language or languages required by the Member State on the market of which the product is placed or made available.
Where other applicable Union legislation requires the application of a conformity assessment procedure which is at least as stringent, compliance with the requirements of Article 4(1) of this Directive may be demonstrated within the context of that procedure. A single technical documentation may be drawn up.
3. By drawing up the EU declaration of conformity, the manufacturer shall assume responsibility for the compliance of the EEE with this Directive.
Article 14 — General principles of the CE marking
Verbatim from EUR-Lex (Directive 2011/65/EU (RoHS 2) 02011L0065-20260701), via the Publications Office Cellar API.
The CE marking shall be subject to the general principles set out in Article 30 of Regulation (EC) No 765/2008.
Article 15 — Rules and conditions for affixing the CE marking
Verbatim from EUR-Lex (Directive 2011/65/EU (RoHS 2) 02011L0065-20260701), via the Publications Office Cellar API.
1. The CE marking shall be affixed visibly, legibly and indelibly to the finished EEE or to its data plate. Where that is not possible or not warranted on account of the nature of the EEE, it shall be affixed to the packaging and to the accompanying documents.
3. Member States shall build upon existing mechanisms to ensure the correct application of the regime governing the CE marking and take appropriate action in the event of improper use of the CE marking. Member States shall also provide for penalties for infringements, which may include criminal sanctions for serious infringements. Those penalties shall be proportionate to the seriousness of the offence and constitute an effective deterrent against improper use.
Article 16 — Presumption of conformity
Verbatim from EUR-Lex (Directive 2011/65/EU (RoHS 2) 02011L0065-20260701), via the Publications Office Cellar API.
1. In the absence of evidence to the contrary, Member States shall presume EEE bearing the CE marking to comply with this Directive.
2. Materials, components and EEE on which tests and measurements demonstrating compliance with the requirements of Article 4 have been performed, or which have been assessed, in accordance with harmonised standards, the references of which have been published in the Official Journal of the European Union, shall be presumed to comply with the requirements of this Directive.
Article 23 — Penalties
Verbatim from EUR-Lex (Directive 2011/65/EU (RoHS 2) 02011L0065-20260701), via the Publications Office Cellar API.
The Member States shall lay down the rules on penalties applicable to infringements of the national provisions adopted pursuant to this Directive and shall take all measures necessary to ensure that they are implemented. The penalties provided for must be effective, proportionate and dissuasive. The Member States shall notify those provisions to the Commission by 2 January 2013 and shall notify it without delay of any subsequent amendment affecting them.
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