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). It is an “open scope” directive which means that by July 22, 2019 it will apply to all EEE products that are “dependent on electric current or electromagnetic fields for at least one intended function. The current list of restricted substances is found in Annex II of the directive and currently includes: lead, mercury, cadmium, hexavalent chromium, polybrominated biphenyls (PBB), polybrominated diphenyl ethers (PBDE), bis(2-ethylhexyl) phthalate (DEHP), butyl benzyl phthalate (BBP), dibutyl phthalate (DBP), and diisobutyl (DIBP).
RoHS mandates that EEE products must not contain more than 0.1% weight by weight of homogenous material of any listed substance. Cadmium is an exception to this rule where the EU prohibits products from containing more than 0.01% of this substance. Homogenous material means a material that cannot be mechanically disjointed into different materials.
Some product categories may fall outside the scope of ROHS (are excluded). In other cases, the European Commission may have issued a limited exemption allowing a restricted substance to be used for a certain purpose. In either situation, 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:
Questions and further information
Please contact us at: Office.BrusselsEC@trade.gov
*Page last updated on December 14, 2015.