Modifications to the EU RoHS directive and its response strategies
The EU RoHS Directive (2002/95/EC) is currently being revised. The restrictions under Annex 17 of the EU REACH Act will come into effect on June 1, 2009. This article aims to briefly analyze the potential impact and countermeasures of the revised RoHS Directive, starting with its background and main contents. It argues that incorporating the approach of Hazardous Substance Process Management (HSPM) from IECQ HSPM QC 080000 is the best choice, and that IECQ HSPM QC 080000 can also be applied to address the restrictions on hazardous substances and elements under the EU REACH Regulation.
Background of the EU RoHS Directive Revision
The EU RoHS Directive (2002/95/EC), published on January 23, 2003, and effective on July 1, 2006, has had a positive effect on the control of hazardous substances in electrical and electronic equipment entering the EU market, and has had a significant impact on the global electrical and electronic industry, including China's electrical and electronic exports. Meanwhile, the implementation of this directive has also encountered some problems, such as uncertainty in its scope, unclear clauses and definitions, differences in member states' methods for determining product conformity, less-than-ideal market surveillance activities, inconsistencies with other regulations or technological advancements (e.g., REACH/EuP), exclusion of medical devices and control and monitoring instruments, and overlap with other EU regulations, all of which lead to unnecessary administrative costs.
Objectives of the EU RoHS Directive Amendment
To improve the implementation and supervision of the directive, enhance consistency with relevant EU product regulations, improve cost-effectiveness, and improve environmental benefits, the EU initiated an amendment process. The aim was to make the scope and definitions of the directive clearer, to introduce medical devices and monitoring and measuring instruments into the RoHS product scope in a phased manner, to incorporate all relevant clauses in the EU's "product sale" regulatory system concerning member states' market surveillance activities and mechanisms for assessing product conformity, to establish a clear mechanism for identifying and, where necessary, restricting other hazardous substances, to explore all possible synergistic mechanisms with other EU chemical regulations, and to establish a list of substances that require immediate review under this mechanism. The draft amendment was published at the end of 2008.
Main Amendments to the EU RoHS Directive
The main amendments to the RoHS directive include clarifying the scope of application, defining relevant terms, adjusting restrictions, changing exemption mechanisms, clarifying obligations for different economic operators, and introducing market monitoring mechanisms.
Regarding the scope of application, the annex to the WEEE directive is no longer used; instead, two new annexes have been added, specifying the product range. The first defines broad product categories, and the second specifies specific products within each major category. Medical devices and monitoring and control instruments, not included in the original directive, will be included in the scope of application in a phased manner. The amended directive provides clearer definitions for several situations where the directive is not applicable.
The amended directive clarifies relevant terms, removes the definition of "producer," and aligns the definition of "economic operators" with the market for the product. New definitions have been added for medical devices and homogeneous materials. Harmonized definitions are aligned with relevant EU regulations to increase legal clarity and reduce administrative costs.
Regarding the adjustment of the directive's restriction requirements, the existing list of restricted substances and their maximum concentrations remain unchanged. Four substances have been recommended for priority inclusion in the restricted substance list: hexabromocyclododecane (HBCDD), di(2-ethylhexyl) phthalate (DEHP), benzyl butyl phthalate (BBP), and dibutyl phthalate (DBP). For the introduction of new restricted substances, the REACH approach has been adopted to ensure consistency and enhance synergy. With the amendments, the directive's chapter arrangement also differs significantly from the current RoHS directive.
The exemption mechanism has been changed, modifying the exemption procedures, scope, criteria, and duration. For example, the previous 4-year annual review for exemptions has been changed to a maximum exemption period of 4 years. It is stipulated that exemptions can be renewed, and applications for renewal must be submitted 18 months before the expiry date. These changes require the industry to pay closer attention to the progress of exemptions and take corresponding measures. The revised directive will clarify the obligations of different economic actors, such as manufacturers, authorized representatives, importers, and distributors. Regarding the introduction of market surveillance mechanisms, the revised directive will require Member States to conduct market surveillance in accordance with Articles 15-29 of Regulation 765/2008. Market surveillance authorities should conduct appropriate inspections of product characteristics on a sufficient scale, through document review, and, where appropriate, through physical or laboratory sampling. In carrying out this work, established risk assessments, complaints, and other information should be considered. Market surveillance authorities should require economic actors to prepare the necessary information and documentation, and, if necessary, enter their premises and take product samples. When economic actors submit test reports or certificates of conformity issued by accredited conformity assessment bodies, market surveillance authorities should give full consideration to such reports and certificates. Market surveillance methods mainly include the identity of economic actors, the EC Declaration of Conformity, and the conformity assumption. The new directive requires that economic actors be able to determine, for 10 years, who supplied them with products and to whom they sold their products. The European Community Declaration of Conformity (DCC) should declare that the requirements for limiting hazardous substances have been proven and bear the CE marking. The new directive, building upon the basic rule set forth in Article 30 of Regulation (EC) No 765/2008, further specifies the rules and conditions for affixing the CE marking. Product compliance with the directive is based on the following assumptions: that Member States consider products bearing the CE marking to comply with the directive; or that products tested and measured according to harmonized standards (whose reference numbers have been published in the Official Journal of the European Union) are considered to comply with all relevant requirements of this directive relating to those standards.
Impact and Countermeasures
The revised RoHS directive will primarily impact businesses with higher implementation requirements, stricter market monitoring, and heavier penalties. After the revised directive comes into effect, EU importers (i.e., direct customers of Chinese manufacturers) will be required to comply with the requirements for importers. As EU importers (i.e., customers of Chinese manufacturers) actively comply with the regulations, it's easy to understand that the requirements for importers in the revised RoHS Directive will translate into requirements for suppliers (i.e., Chinese manufacturers). For Chinese manufacturers, in terms of practical control, they can refer to the requirements for manufacturers in the revised RoHS Directive, especially point two regarding manufacturer responsibilities, which mentions the need to develop technical documentation and implement internal production control procedures according to Annex II, Mode A, of Resolution 768/2008/EC. However, how can these obligations and requirements be systematically managed and related measures organically combined? The author believes that the approach of Hazardous Substance Process Management (HSPM) in IECQ HSPM QC 080000 is the best choice.
QC 080000 (IECQ HSPM) was published by the International Electrotechnical Commission (IEC) in October 2005. IECQ HSPM is based on ISO 9001; however, its fundamental difference lies in its emphasis on technical aspects. It forms the foundation of management processes, incorporating sufficient technical rigor, robust technical evidence of compliance with WEEE, RoHS, and green processes, and the company's requirement for appropriate controls and testing. IECQ HSPM is a technical approach that provides a flexible framework for implementing and maintaining processes that control HS (Hazardous Substances) and ensure HSF production. The development of IECQ HSPM aims to enable suppliers to demonstrate to third parties their compliance with a wide range of customer requirements for HSF electronic components, thereby meeting local, national, and international requirements. IECQ HSPM is designed to be more cost-effective than post-production product-based testing. The IECQ HSPM audit phase should obtain relevant evidence, such as appropriate testing, thorough and comprehensive evaluation of technical data, adequate supply chain control, sufficient training for personnel involved in controlling hazardous substances, and control measures demonstrating that HS does not contaminate HSF products or processes. The emphasis on technical factors is precisely what enables IECQ HSPM to truly function effectively in the management of hazardous substances, and this is where its core value lies. Since its release in October 2005, the IECQ HSPM QC080000 standard has received widespread attention from the industry, leading to a booming certification business. Two certificates were issued in 2005, 137 in 2006, 682 in 2007, 663 in 2008, and 125 in 2009. As of March 5, 2009, 1579 IECQ HSPM QC 080000 certification certificates had been issued globally. The number of companies applying for IECQ HSPM QC080000 certification is steadily increasing. Currently, IECQ HSPM QC 080000 certification covers multiple directives related to hazardous substances, including the EU RoHS Directive (2002/95/EC), Packaging Directive (96/42/EC), Battery Directive (2006/66/EC), and ELV Directive (2005/32/EC). The trend is that more and more requirements related to hazardous substances can apply the hazardous substance process management principles outlined in these directives; the restrictions on hazardous substances and elements in the EU REACH Regulation are a prime example. SGS Related Services
Leveraging its dual strengths in hazardous substance testing and certification, SGS has achieved remarkable results in IECQ HSPM QC 080000 certification audits, consistently maintaining a leading position globally. On March 15, 2007, SGS issued its 100th certificate globally; on May 14, 2008, it issued its 300th certificate; and on February 9, 2009, it issued its 500th certificate. Most SGS-certified companies believe that the introduction of QC 080000 for hazardous substance process management and the pursuit of certification were driven by market pressure. They believe that the implementation and certification process has positive effects on reducing the risks of hazardous substance control and gaining customer recognition, thereby driving order or business growth.
SGS provides comprehensive training, certification and testing in the management of hazardous substances.
