RoHS (pronounced “ROSS”) is an acronym that stands for the Restriction of Hazardous Substances. The European Union (EU) began in approximately 1999 to generate an EU Directive (2002/95/EC) that would restrict the use of certain hazardous substances. This Directive was based upon the Article 95 of the EU Treaty where changes to the Directive must be agreed to in advance by all EU Member States. The EU RoHS Directive ban the putting on the EU market of new Electrical and Electronic Equipment (EEE) containing more than permitted levels of the following:
RoHS: Restriction of the use of Certain Hazardous Substances
RoHS is the EU Directive that restricts the use of certain hazardous substances in electrical and electronic products (EEE products). The current list of restricted substances is found in Annex II of the Directive and includes four heavy metals (lead, mercury, cadmium, and hexavalent chromium) and two brominated flame retardants (polybrominated biphenyls (PBB) and polybrominated diphenyl ethers (PBDE)).
The European Commission will likely add additional substances to Annex II in before the end of 2015. If new substances are added, it is not clear when the restrictions will enter into force. Companies with questions can follow developments on this website (http://ec.europa.eu/environment/waste/rohs_eee/events_rohs1_en.htm). You may also contact the Commercial Service at the e-mail address provided at the bottom of this page.
RoHS mandates that EEE products must not contain more than 0.1% (except for cadmium which is limited to 0.01%) by weight of homogenous material of any of listed substances. Homogenous material means a material that cannot be mechanically disjointed into different materials.
The original RoHS Directive was adopted on January 27, 2003. However, the European Parliament and Council revised this legislation June 8, 2011. Today, this revised directive is often referred to as “RoHS II”. RoHS II is an “open scope” Directive. This means that the Directive will apply to all EEE products that are “dependent on electric current or electromagnetic fields for at least one intended function. The transition will be completed in 2019.
Some products may benefit from a temporary or permanent exclusion from the application of the Directive. In other cases, the European Commission may have issued a limited exemption allowing a restricted substance to be used for a certain purposes. In either case, the European Commission adopts a very narrow interpretation of these provisions. U.S. exporters should consult the text of the Directive, contact our office, or seek specialized guidance if they have questions on whether their products benefit from an exclusion or exemption.
Exemptions and Exclusions
RoHS II exempts certain applications from the substance restrictions. The exemptions are temporary and reviewed at least every four years. The current list of exemptions is contained in Annex III. The European Commission has amended Annex III several times. This website contains a complete list of those amendments: http://ec.europa.eu/environment/waste/rohs_eee/legis_en.htm.
Specific exemptions for medical devices and monitoring and control instruments are listed in Annex IV of ROHS II.
U.S. exporters that wish to seek an exemption from the application of the Directive to their products can find the application requirements listed in Annex V of the Directive. Applications should be submitted to the European Commission Directorate General for Environment located at:
Environment DG, Unit C2
B - 1049 Brussels
The European Commission has published the two guidance documents to assist companies seeking an exemption. These materials are available at: http://ec.europa.eu/environment/waste/rohs_eee/exemptions_en.htm
Permanent exclusions from RoHS include the following: military equipment, space equipment, equipment designed to be part of another piece of equipment falling outside the scope of RoHS, large scale industry tools, large scale fixed installations, means of transport for persons or goods, non-road mobile machinery, active implantable medical devices, photovoltaic panels, equipment for research and development only available business to business. As noted above, the European Commission adopts a very narrow interpretation of the categories of products to which these exclusions apply.
Labeling and CE Marking
RoHS II is a CE Mark Directive. This means that each product covered by ROHS must have technical testing and accompanying documents, a declaration of conformity, and the CE marking affixed to the product. The format of the declaration of conformity is outlined in Annex VI of the Directive. The CE mark for ROHS products entered into force on 2 January 2013.
Legal Documents and Guidance
U.S. businesses exporting products covered by RoHS II may find the following documents useful:
- RoHS I Directive: Directive 2002/95/EC
- RoHS II Directive: Directive 2011/65/EU
- Annex III Amendments: http://ec.europa.eu/environment/waste/rohs_eee/legis_en.htm
- European Commission RoHS II FAQ Document: RoHS FAQ (December 2012) This document provides interpretive guidance to industry on the RoHS II Directive.
- U.S. Commercial Service RoHS FAQ Document: RoHS FAQ (December 2011) This document answers the questions most frequently received by the Commercial Service office at the U.S. Mission to the European Union about RoHS compliance.