Renewed RoHS Directive requires CE Marking
The RoHS Directive (Restriction of Certain Hazardous Substances), which limits the use of hazardous substances in electrical equipment and their components, has been renewed. The new directive (2011/65/EU) was implemented on June 28, 2001 and its transition time is up to January 2, 2013.
The RoHS Directive limits the use of six hazardous substances (cadmium, lead, mercury, hexavalent chromium and brominated flame retardants PBB and PBDE) in products. The RoHS Directive applies to the majority of electrical equipment. The key changes of the RoHS directive are the following:
- Compliance with the RoHS Directive requires CE marking and Declaration of Conformity as well as technical file
- Medical devices and monitoring and control instrument will be included in the scope the Directive in addition to present products after their corresponding transition periods
- All other electrical products will be included in the scope the Directive after transition period
- The responsibility of the whole supplier chain (manufacturer, importer, distributor and authorised representative) verification of compliance with requirements are defined
- A new methodology to add hazardous substances to the directive will be implemented
- Exemption mechanism renewed and more exact definitions are implemented
New product groups
The renewed RoHS directive is implemented:
- from July 22, 2014 for medical devices and monitoring and control instruments entering the market
- from July 22, 2016 for medical devices used for in vitro diagnostics entering the market
- from July 22, 2017 for industrial control and monitoring equipment and
- from July 22, 2019 all other electrical products
Additional substances on the prioritization list
Although the renewal of the RoHS directive does not add limited substances, four substances will be included in the prioritization list - HBCDD, DEHG, BBP and DBP. These substances might be added to the list of limited substances in the future.
Actions to be taken by manufacturers and importers as a result of the new RoHS directive
The major change of the RoHS directive is that compliance with the RoHS directive is verified with CE marking. As CE marking requires that requirements of other valid directives must be fulfilled, the manufacturer and importer must ensure the conformity of these directives (e.g. Low Voltage and EMC Directives).
In order to CE mark their products in accordance with the RoHS directive, the manufacturer or the authorised representative must complete the technical file and update the Declaration of Conformity. The technical file must include at the least material and component suppliers’ verifications regarding the quantity of the substances the use of which are limited by the RoHS directive. On request also analysis results must be provided in order to verify the product’s conformity with the RoHS directive.
With the help of SGS Fimko’s services companies can make sure that their products are in conformance with all the above mentioned directives. SGS RoHS services are among others analysis of hazardous substances and XRF screening, CB RoHS services and assessment service for conformity with the RoHS directive.
CB RoHS certificate for the concentration of hazardous substances in components and substances
The IECEE HS (Hazardous Substances) STR (Statement of Test Results) report service, which has been created under the management of SGS Fimko, provides an effective way to identify and verify the concentrations of hazardous substances with the help of globally approved measuring procedures (IEC 62321). IECEE HS STR (so-called CB RoHS) and their rest reports issued by SGS Fimko are a reliable basis for the technical file of the final product.
SGS Fimko has seven laboratories testing in accordance with the IECEE HS STR scheme. These laboratories are located in Finland, China, Taiwan, Hong Kong, Korea, Japan and Thailand.
For more information please contact:
Mr. Tom Törn
t: +358 9 6963 475/+358 40 5235 944
Mr. Olli-Pekka Jaakola
t: +358 40 705 9117
SGS Fimko Ltd
P.O. Box 30 (Särkiniementie 3)
t: +358 9 696 361
f: +358 9 6925 474
SGS is the world’s leading inspection, verification, testing and certification company. SGS is recognized as the global benchmark for quality and integrity. With more than 67,000 employees, SGS operates a network of over 1,250 offices and laboratories around the world.