Are You Prepared for RoHS 2?
RoHS 2, the set of revisions to the original Restriction of Hazardous Substances (RoHS) Directive (2002/95/EC), will be adopted in the near future. Do you know how RoHS 2 will affect your business?
A recent European Commission (EC) impact assessment study showed that almost half of the Electrical and Electronic Equipment (EEE) currently placed on the EU market is not fully RoHS compliant. As a consequence, more stringent market surveillance may be expected.
A new draft of RoHS 2 was published at the beginning of September 2009, and revisions to the Directive will not only cover EEEs, unless specifically excluded, but will also introduce the regulation of more substances, modify exemption procedures and implement a more effective market surveillance system.
The Major Changes
One of the most important changes of the new recast is that ROHS 2 will cover all EEEs unless specifically excluded from the scope. The exclusion procedures, however, will need further definition.
Article 4 (3) will introduce product categories: Eight (Medical Devices) Nine (Monitoring and Control Instruments) They will be included in Annex I, with implementation dates set between 2014 and 2017. Several exemptions are taken into consideration in Annex VI. The EC is also considering the inclusion into Annex I of implantable medical devices, by 2020.
Another significant change is the clarification of definitions; the vague term “producers” will be replaced by “manufacturers”, “importers”, “distributors” and “authorized representatives” thus sharing responsibility for RoHS compliance between all industry partners. All elements of the supply chain will have to assess and report any nonconformity, risking substantial fines if they fail to do so.
More Potential Restricted Substances
Adding to the existing six substances, RoHS 2 addresses new priority substances. Four substances that are already on the REACH Candidate List of Substances of Very High Concern (SVHC) have been proposed for priority assessment for RoHS 2:
- Hexabromocycloddecane (HBCDD)
- Diethylhxyl phthalate (DEHP)
- Butyl benzyl phthalate (BBP)
- Dibutyl phthalate (DBP)
HBCDD is a flame retardant, the other three substances are plasticizers and all could be added to RoHS 2 in the future, after scientific review of their danger to health and environment, leaving industries a bit of time to find suitable replacements.
With RoHS 2 exemptions will expire after four years, with an option for renewal, provided that manufacturers & suppliers apply for an extension 18 months before the exemption expires.
Preparing Your Business for RoHS 2
At present, the recast of RoHS is in the draft stage, but formal approval from the EU Parliament and Council is expected by the first half of 2010. RoHS 2 will become a CE Marking Directive, which means manufacturers will have to perform conformity tests based on EC Directive 768/2008/EC and Regulation 765/2008/EC. They will share RoHS compliance responsibility with retailers and importers. Therefore, manufacturers should rethink and redesign products to comply with the new requirements, while importers and retailers should find the support to assess technical documentation presented by manufacturers.
Since some RoHS exemptions will undergo a review at the same time new ones for category eight and nine are being created, EU retailers and importers will have to make sure that they are placing compliant products on the market.
SGS is one of the leading RoHS testing and certification companies, with more than 24 RoHS laboratories worldwide. SGS RoHS experts have a deep understanding of the RoHS legislation and can assist you in preparing for RoHS 2 and other related requirements, such as safety and battery requirements, Packaging Directive, Electromagnetic Compatibility (EMC) Directive, and Registration, Evaluation, Authorization and Restriction of Chemicals (REACH).
Find more info on RoHS. Contact:
Dr. Udo Krischke
Global Technical Manager RSTS
SGS Germany GmbH
t: +49 6128 246 816
The SGS Group is the global leader and innovator in inspection, verification, testing and certification services. Founded in 1878, SGS is recognized as the global benchmark in quality and integrity. With more than 56,000 employees, SGS operates a network of over 1,000 offices and laboratories around the world.