U.S. companies exporting “electrical and electronic equipment” (“EEE products”) to the European Union need to be mindful of the requirements imposed by the Restriction of the Use of Certain Hazardous Substances Directive (“RoHS II” Directive - Directive 2011/65/EU). This Directive limits the use of a number of heavy metals in EEE products subject to a limited number of exemptions. EEE products that fail to comply with the Directive’s requirements may not be sold in the European Union. The Commercial Service at the U.S. Mission to the European Union (EU) prepared this report to give such exporters an overview of the Directive’s requirements. It also contains web links so that businesses may obtain more detailed information.
Last Published: 2/22/2016
1. Introduction
 
U.S. companies exporting “electrical and electronic equipment” (“EEE products”) to the European Union need to be mindful of the requirements imposed by the Restriction of the Use of Certain Hazardous Substances Directive (“RoHS II” Directive - Directive 2011/65/EU). This Directive limits the use of a number of heavy metals in EEE products subject to a limited number of exemptions.  EEE products that fail to comply with the Directive’s requirements may not be sold in the European Union.  The Commercial Service at the U.S. Mission to the European Union (EU) prepared this report to give such exporters an overview of the Directive’s requirements.  It also contains web links so that businesses may obtain more detailed information.  
 

2. Overview  
The basic requirements of the RoHS legislation have been in place since 2002, when the European Parliament and the Council adopted the first RoHS Directive, also known as RoHS I (Directive 2002/95/EC).  RoHS II, which is the recast version of RoHS I, will apply to a wider range of products than the original Directive as it is an “open scope” legislation.  This means that all products requiring electric current to operate will become subject to RoHS II, unless a specific exemption applies. 
 
The table below shows the transition to the open scope framework.  U.S. exporters will note that starting next year, RoHS II will apply to medical devices and monitoring and control instruments.  More products will be covered in 2016 and 2017.  The transition will be complete on July 23, 2019. 
 
RoHS II – Transition to Open Scope
DateFrom July 22, 2014From July 22, 2016From July 22, 2017Open Scope (from July 23, 2019)
New EEE covered
 
- Medical devices
- Monitoring and control instruments
- In vitro diagnostic medical devices- Industrial monitoring and control instrumentsExtension to all EEE except for the ones explicitly excluded
 
RoHS II restricts the use of the same six substances in EEE products as were listed by RoHS I.  These substances are identified in sub-section (b) below.     
 
Each EU Member State implements RoHS II through national or local legislation. Therefore it is essential for U.S. companies to ensure that they, or their EU based business partners, comply with the applicable legislation in the Member States where they operate.  However, U.S. exporters should bear in mind that such implementing legislation varies among the EU Member States.  Therefore, U.S. exporters should understand that each EU Member State will have a slightly different approach to ensuring products comply with RoHS II.
 
The deadline for EU Member States to adopt legislation implementing RoHS II expired on January 2, 2013.
 
3. Scope
 
a. Products covered
 
As mentioned above, RoHS II is transitioning to become an open scope Directive.  However, at present, the Directive applies to EEE falling within one of 11 product categories.  The Directive defines EEE as “equipment which is dependent on electric current or electromagnetic fields in order to work properly, and equipment for the generation, transfer and measurement of such currents and fields, and designed for use with a voltage rating not exceeding 1000V for AC and 1500V DC.”  The European Commission interprets this to mean that RoHS II applies to any product that requires an electric spark to begin operating.
 
The 11 product categories are:
 
  • Large household appliances.
  • Small household appliances.
  • IT and telecommunications equipment.
  • Consumer equipment and photovoltaic panels.
  • Lighting equipment.
  • Electrical and electronic tools.
  • Toys, leisure and sports equipment. 
  • Medical devices
  • Monitoring and control instruments including industrial monitoring and control instruments
  • Automatic dispensers
  • Other EEE not covered by any of the categories above
 
b. Restricted substances
 
RoHS II restricts the use of the following six substances (“restriction list”):
 
  • Bis(2-ethylhexyl) phthalate (DEHP)
  • Butyl benzyl phthalate (BBP)
  • Dibutyl phthalate (DBP)
  • Diisobutyl phthalate (DIBP)
 
The Commission is currently developing a framework on the process by which it will add more substances to the restriction list.  The first four substances likely to be added are:  Hexabromocyclododecane (HBCDD); Bis (2- ethylhexyl) phthalate (DEHP); Butyl benzyl phthalate (BBP); and, Dibutyl phthalate (DBP).  The European Commission expects to complete this work in 2014.

c. Medical devices 
As of July 22, 2014, RoHS II restrictions apply to medical devices that contain any of the substances on the Annex III “restriction list.” RoHS II adopts the definition outlined in Article 1.2.a of Directive 93/42/EEC, and adds that the products must be EEE. Directive 93/42/EEC defines a ‘medical device’ as such:
 
'Medical device' means any instrument, apparatus, appliance, material or other article, whether used alone or in combination, including the software necessary for its proper application intended by the manufacturer to be used for human beings for the purpose of:
  • diagnosis, prevention, monitoring, treatment or alleviation of disease, 
  • diagnosis, monitoring, treatment, alleviation of or compensation for an injury or handicap;
  • investigation, replacement or modification of the anatomy or of a physiological process;
  • control of conception; and, which does not achieve its principal intended action in or on the human body by pharmacological, immunological or metabolic means, but which may be assisted in its function by such means;
RoHS II does not include “in vitro diagnostic medical devices,” which will be restricted starting July 22, 2016. In vitro diagnostic medical devices are described in Directive 98/79/EC. Examples of medical devices that are subjected to RoHS II Directive include: radiotherapy equipment, cardiology, dialysis, pulmonary ventilators, nuclear medicine, laboratory equipment; other appliances for detecting, preventing, monitoring, treating or alleviating illness, injury or disability.

4. Exemptions & Exclusions  
Similar to the original RoHS Directive, RoHS II contains a limited number of exemptions that benefit specific uses of the restricted substances.  Exclusions benefit specific product categories.  U.S. exporters should note that most exclusions and all exemptions have expiration dates.  Therefore, U.S. exporters need to ensure that they make the necessary adjustments to their manufacturing processes in anticipation of those dates.
 
As for the product category exclusions, these benefit items such as photovoltaic panels, products used in the means of transport for persons and goods, large scale fixed installations, large-scale stationary industrial tools or equipment intended specifically for military purposes. 
 
U.S. exporters may want to review the RoHS II Frequently Asked Questions (FAQ) document published by the European Commission in December 2012.  The document provides non-legally binding guidance to businesses and national authorities responsible for implementing the Directive.  It is particularly helpful in identifying whether a product is covered by a categorical exemption.
 
Annex III contains the list of exemptions identified by substance and application.  Annex III is regularly amended and U.S. exporters should check the European Commission ROHS II website to verify they have the latest update.
 
U.S. exporters that are unable to benefit from an exemption, yet believe they require one, may check the following website containing information on how to apply for an exemption: RoHS II Exemption Application Information

5. Requirements for U.S. Exporters

a. Definition of “manufacturer”
 
The RoHS II Directive defines manufacturer as “any natural or legal person who manufactures an EEE or who has an EEE designed or manufactured and markets it under his name or trademark”.

b. Manufacturer obligations
 
Manufacturers of EEE must, among other things:
 
  • Ensure that all EEE products placed on the EU market has been designed and manufactured in accordance with the requirements of RoHS II;
  • Draw up the required technical documentation and carry out the internal production control procedure or have it carried out;
  • Draw up an EU declaration of conformity and affix the CE marking; and,
  • Keep the technical documentation and the EU declaration of conformity for 10 years after the EEE has been placed on the market.
  
c. EU declaration of conformity
 
By drawing up the declaration of conformity, the manufacturer assumes responsibility for the compliance of his product with the Directive. The declaration of conformity must contain the following elements:
 
  • EEE’s identification number;
  • Name and address of the manufacturer or his authorized representative;
  • A description and picture of the object; and,
  • Where applicable, references to the relevant harmonized standards used or references to the technical specifications in relation to which conformity is declared.
6. Labeling requirements  
The RoHS II Directive requires that manufacturers mark EEE sold in Europe with the CE symbol (depicted below). Furthermore, all EEE within the scope must include a reference to RoHS II on the declaration of conformity from the date when the substance restrictions apply. 
 
CE symbol which is for electrical and electronic equipment

7. Additional Information  
The following links provide additional WEEE information and resources for U.S. companies. For More Information
 
The U.S. Commercial Service at the U.S. Mission to the European Union can be contacted via email at: matthew.kopetski@trade.gov; Phone:  +32 2-811-5684; Fax: +32 2-811-5151; or visit our website: http://www.export.gov/europeanunion.
 
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With its network of offices across the United States and in more than 80 countries, the U.S. Commercial Service of the U.S. Department of Commerce utilizes its global presence and international marketing expertise to help U.S. companies sell their products and services worldwide.  Locate the U.S. Commercial Service trade specialist in the U.S. nearest you by visiting http://www.export.gov/eac.
 
We welcome your comments and suggestions regarding this market research.  You can e-mail us your comments/suggestions to:  Market_Research_Feedback@trade.gov.  Please include the name of the applicable market research in your message.  We greatly appreciate your feedback.
 
Disclaimer:  The information provided in this report is intended to be of assistance to U.S. exporters.  While we make every effort to ensure its accuracy, neither the United States government nor any of its employees make any representation as to the accuracy or completeness of the information in this or any other United States government document.  Readers are advised to independently verify any information prior to reliance thereon.  The information provided in this report does not constitute legal advice.  The U.S. Commercial Service reference to or inclusion of material by a non-U.S. Government entity in this document is for informational purposes only and does not constitute an endorsement by the U.S. Commercial Service of the entity, its materials, or its products or services.
 
International copyright, U.S. Department of Commerce, 2013.  All rights reserved outside of the United States.
 
*Last updated on December 22, 2015

Prepared by our U.S. Embassies abroad. With its network of 108 offices across the United States and in more than 75 countries, the U.S. Commercial Service of the U.S. Department of Commerce utilizes its global presence and international marketing expertise to help U.S. companies sell their products and services worldwide. Locate the U.S. Commercial Service trade specialist in the U.S. nearest you by visiting http://export.gov/usoffices.



European Union 28 Medical Devices Electronics Export Regulations