New RoHS Directive

The new RoHS Directive, 2011/65/EU, was published on 8 June 2011. The EU Member States must implement this new directive no later than 2 January 2013. DEKRA, as one of the leading test organisations, would like to inform you about the new RoHS Directive and especially those aspects in which it differs from the old directive (2002/95/EC).

Scope

The first aspect is the scope. The new RoHS Directive will apply to categories of products that were not covered by the old RoHS Directive. The categories of products and dates of applicability are as follows:

  • Medical devices (excl. active implantable medical devices) - as of 22 July 2014
  • Monitoring and control instruments - as of 22 July 2014
  • In-vitro diagnostic medical devices - as of 22 July 2016
  • Industrial monitoring and control instruments - as of 22 July 2017


Another category which is now included in the scope (Annex I) of the new RoHS Directive is “other Electrical and Electronic Equipment (EEE) not covered by the categories above” (where “categories above” refers to the categories defined in the old RoHS Directive). With the introduction of this “category” it was necessary to explicitly list the products to which the Directive does not apply. This list is provided in Article 2.4 of the Directive, and as it is quite long we refer you to Article 2.4 in the PDF copy of the Directive, which can be found here:

http://eur-lex.europa.eu/LexUriServ/LexUriServ.do?uri=OJ:L:2011:174:0088:0110:EN:PDF

EEE that did not fall under the old RoHS Directive but to which the new RoHS Directive does apply and which do not belong in the four categories listed above do not have to comply with the requirements of the new Directive until 22 July 2019.

EEEAnother change to the scope with regard to EEE is that the new Directive also applies to “cables and spare parts for its repair, its reuse, updating of its functionalities or upgrading of its capacity”, where cables are to be understood to be “cables with a rated voltage of less than 250 volts that serve as a connection or an extension to connect EEE to the electrical outlet or to connect two or more EEE to each other”.

These cables and spare parts do not have to comply with the directive if they are being used for EEE that does not have to comply with the or did not have to comply with the Directive at the time they were placed on the market.

Obligations

What is also new in the new RoHS Directive is that it lists the obligations of manufacturers, authorised representatives, importers and distributors. Simply put, these obligations see to it that EEE placed on the market has been designed and manufactured in accordance with the requirements of the Directive. Manufacturers must draw up technical documentation, carry out internal production control procedures, draw up an EU declaration of conformity and affix the CE marking to the product if it complies.

Importers and distributors must ensure that the above have been done by the manufacturer. If you have more specific questions about these obligations please contact your DEKRA representative within the DEKRA organisation.

Annexes

What has also changed in the new RoHS Directive is that the use of lead, mercury, cadmium, hexavalent chromium, PBBs and PBDEs is no longer completely forbidden. Annex II now lists the maximum concentration values tolerated by weight in homogeneous materials, which are as follows:

  • Lead  0.1%
  • Mercury  0.1%
  • Cadmium  0.01%
  • Hexavalent chromium  0.1%
  • Polybrominated biphenyls (PBB)  0.1%
  • Polybrominated diphenyl ethers (PBDE)  0.1%


Annex III of the Directive lists all the applications which do not have to comply with the requirements of the Directive; this list is unchanged since the latest version of the old RoHS Directive (dated 8 September 2011). Annex IV is completely new and lists the applications which do not have to comply with the restrictions of the directive specific to medical devices and monitoring and control equipment. Finally, Annex VI lists the requirements for the contents of the EU declaration of conformity.

Summary

The new RoHS Directive, which will replace the old Directive as of 2 January 2013, will be applicable to medical devices and monitoring and control instruments. The new Directive requires manufacturers to draw up technical documentation and a declaration of conformity and to affix the CE marking to a product if it complies with the Directive.

If you have any further questions please do not hesitate to contact us at export-support@dekra.com  

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