Modifications to the EU RoHS directive and its response strategies
The EU RoHS Directive (2002/95/EC) is being revised. The restriction requirements of EU REACH Annex 17 will come into effect on June 1, 2009. This article intends to start with the background and main content of the revision of the EU RoHS Directive, briefly analyze the possible impacts and countermeasures of the revised RoHS Directive, and believe that the idea of introducing the Hazardous Substances Process Management (HSPM) in IECQ HSPM QC 080000 is the most effective It is the best choice, and it is believed that IECQ HSPM QC 080000 can also be used to deal with the EU REACH regulations on the restriction of hazardous substances and elements.
Background on the revision of the EU RoHS Directive
The EU RoHS Directive (2002/95/EC) was issued on January 23, 2003 and came into effect on July 1, 2006. It has had a positive effect on the control of hazardous substances in electronic and electrical equipment entering the EU market. The electronic and electrical industry includes China's electronic and electrical industry, which has a significant impact on exports. At the same time, there are also some problems in the implementation of the directive, such as uncertainty in the scope of the directive, unclear terms and definitions of the directive, differences in the methods of determining product conformity among member states, unsatisfactory market supervision activities, and other issues. Inconsistencies in regulations or technological advances, such as REACH/EuP, failure to include medical devices and control and monitoring instruments, and overlap with other EU regulations lead to unnecessary administrative costs.
EU RoHS Directive Modification Targets
In order 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 has initiated a revision process. In order to make the scope and definition of the directive clearer, medical equipment and monitoring and measurement tools will be introduced into the scope of RoHS-applicable products in a phased manner, and the EU "product sales" regulatory system will be introduced into the market supervision activities and mechanisms of relevant member states for evaluating products. All relevant provisions of compliance; establish a clear mechanism for identifying and, if necessary, restricting other hazardous substances, explore all possible synergy mechanisms with other EU chemicals regulations, and establish a list of substances that require immediate investigation under this mechanism. The revised draft will be published at the end of 2008.
Main modifications to the EU RoHS Directive
This RoHS revision mainly includes clarifying the scope of application of the directive, clarifying the relevant definitions of the directive, adjusting the restriction requirements of the directive, changing the exemption mechanism of the directive, clarifying the obligations of different economic operators and introducing a market monitoring mechanism.
For the definition of the scope of application of the directive, the annex of the WEEE directive is no longer used, but two annexes are added to specify the product scope. The first stipulates the broad categories of products, and the second stipulates the specific categories within each major category. product. Medical equipment and monitoring and control tools have not been included in the original directive, and will be included in the scope of products applicable to the directive in a phased manner in the new directive. The revised directive is more clear about several situations in which it does not apply.
The revised directive will clarify the relevant definitions of the directive, cancel the definition of producer, keep the definition of economic operators consistent with the market of the product, and add new definitions of medical equipment, uniform materials, etc. Harmonized definitions are aligned with relevant EU regulations to increase legal clarity and reduce administrative costs.
In terms of adjusting the restriction requirements of the directive, the existing list of restricted substances and their maximum concentrations remain unchanged, and four substances are recommended for priority inclusion in the list of restricted substances, namely: Hexabromocyclododecane (HBCDD), phthalic acid Bis (2-ethylhexyl) phthalate (DEHP), Butyl benzyl phthalate (BBP) and Dibutyl phthalate (DBP) . At the same time, for the introduction of new restricted substances, the method of REACH regulations is adopted to ensure the consistency between the two and improve the synergy effect. With the modification of the directive, its chapter arrangement is also quite different from the current RoHS directive.
The exemption mechanism of the change order has changed the exemption procedure, exemption scope, exemption standard and exemption period. For example, the four-year review of exemption has been changed to the maximum exemption validity period of four years. It stipulates that you can apply for renewal of exemption, and the application for renewal of exemption must be submitted 18 months before the exemption expires, etc. These changes require the industry to pay more attention to the progress of exemptions and take corresponding measures.
The revised directive will clarify the obligations of different economic operators such as manufacturers, authorized representatives, importers and distributors.
In terms of introducing a market surveillance mechanism, the revised directive will require member states to conduct market surveillance in accordance with Articles 15-29 of Regulation No. 765/2008. Market surveillance authorities should conduct appropriate inspections of product characteristics on a sufficient scale, through documentation inspections and, where appropriate, adequate sampling for physical or laboratory inspections. Established risk assessments, complaints and other information should be taken into account when carrying out this work. Market surveillance authorities should require economic operators to prepare the necessary information and documentation and, if necessary, to gain access to their premises and carry out product sampling. When economic operators submit test reports or certificates proving compliance issued by a recognized conformity assessment body, market surveillance authorities should give full consideration to such reports and certificates.
Market monitoring means mainly include the identity of economic operators, EC declaration of conformity and compliance assumptions. The new directive requires the identity of the economic operator. The economic operator should be able to determine for 10 years who supplied him with the product and to whom he sold the product. European Community Declaration of Conformity The Declaration of Conformity shall declare that compliance with the requirements for the restriction of hazardous substances has been proven and shall be affixed with the CE mark. The new directive further stipulates the rules and conditions for affixing the CE mark on the basis that the CE mark should comply with the basic rules set in Article 30 of Regulation (EC) No765/2008. Whether a product complies with the requirements of the directive is based on the following compliance assumptions: that is, member states believe that products with a CE mark comply with the requirements of the directive; or products that have been tested and measured in accordance with unified standards (whose reference numbers have been published in the EU official journal) should Be deemed to comply with all relevant requirements of this Directive relating to these standards.
Impact and Countermeasures
The impact of the revised RoHS Directive on enterprises is mainly reflected in the higher implementation requirements they face, the more stringent market surveillance they face, and the heavier penalties they face. After the revised directive comes into effect, EU importers (that is, direct customers of Chinese manufacturers) should fulfill the requirements for importers. While EU importers (i.e., customers of Chinese manufacturers) are implementing their own practices, it is not difficult to understand that the requirements for importers in the revised RoHS Directive will be transformed into requirements for suppliers (i.e., Chinese manufacturers). For Chinese manufacturers, in terms of actual control, they can refer to the requirements for manufacturers in the revised RoHS Directive for management, especially the second point on the manufacturer’s responsibilities, which requires the preparation of technical documents in accordance with 768/2008/ Mode A of Annex II of EC Resolution implements internal production control procedures. However, how to manage these obligations and requirements in a systematic manner and combine relevant measures organically? The author believes that the idea of Hazardous Substances Process Management (HSPM) in IECQ HSPM QC 080000 is the best choice.
QC 080000 (IECQ HSPM) was released by the International Electrotechnical Commission (IEC) in October 2005. IECQ HSPM is based on ISO 9001. However, IECQ HSPM is fundamentally different from ISO9001 in that it emphasizes technical aspects, which are the basis of the management process, coupled with sufficient technical rigor to comply with WEEE, RoHS and green processes. Sufficient technical evidence of compliance and the company must implement appropriate controls and testing, etc. IECQ HSPM is a set of technical methods that provide a flexible framework for implementing and maintaining the process of controlling HS (hazardous substances) and ensuring HSF production. The IECQ HSPM was developed 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 adequate evaluation of technical data, adequate supply chain controls, adequate training for employees related to the control of hazardous substances, and proof that HS does not contaminate HSF products or process controls. measures, etc. The formal emphasis on technical factors makes IECQ HSPM truly play a role in the management of hazardous substances, and its core value is also reflected in this.
Since the IECQ HSPM QC080000 standard was released in October 2005, it has received widespread attention from the industry, and the corresponding certification business has flourished. Two certificates were issued in 2005, 137 in 2006, 682 in 2007, 663 in 2008, and 125 have been issued in 2009. As of March 5, 2009, 1,579 IECQ HSPM QC 080000 certification certificates have been issued worldwide. The number of companies applying for IECQ HSPM QC080000 certification is growing steadily.
Currently, IECQ HSPM QC 080000 certification involves the EU RoHS Directive (2002/95/EC), Packaging Directive (96/42/EC), Battery Directive (2006/66/EC) and ELV (2005/32/EC) Directive, etc. Directives related to hazardous substances. The development trend is that more and more requirements related to hazardous substances can be applied to the hazardous substances process management ideas described in it. The restrictions on hazardous substances and elements involved in the EU REACH regulations are an important example.
SGS related services
Relying on its dual advantages in the hazardous substances testing and certification industry, SGS has achieved gratifying results in IECQHSPM QC 080000 certification audits and has been in a leading position globally. On March 15, 2007, SGS issued the 100th certificate worldwide, on May 14, 2008, the 300th certificate was issued, and on February 9, 2009, the 500th certificate was issued. Most SGS certified companies believe that the introduction of QC 080000 to implement hazardous substance process management and seek certification is due to market pressure. After the promotion, implementation and certification, it will have positive significance in reducing the risk of hazardous substance control and winning customer recognition. , thus driving order or business growth.
In terms of hazardous materials management, SGS provides a full range of training, certification and testing.
