European standards specify the technical document requirements of the "Restriction of Hazardous Substances Directive 2"
On November 23, 2012, the Official Journal of the European Union published reference information and the name of the harmonized EU standard EN 50581. Manufacturers must comply with this new standard to prove that their products comply with Directive 2011/65/EU (RoHS 2), an amendment to the Restriction of Hazardous Substances in Electrical and Electronic Equipment. The new standard has been adopted by the European Committee for Electrotechnical Standardization (CENELEC), stipulating that EU member states must implement a harmonized standard by July 16, 2013, and that EU national standards conflicting with EN 50581 must be withdrawn by July 16, 2015.
RoHS 2 imposes restrictions on the same material standards for six hazardous substances contained in electrical and electronic equipment placed on the EU market, with only a few exceptions.
Homogeneous materials refer to materials that cannot be mechanically separated into different substances. Mechanical decomposition includes processes such as turning, shearing, crushing, grinding, and milling.
Therefore, all components of electrical and electronic equipment must comply with the maximum limits for hazardous substances in RoHS 2. These maximum limits are the same as those set forth in the original Restriction of Hazardous Substances Directive. Annex II of RoHS 2 specifies the restricted substances and their maximum limits.
The new standard stipulates that manufacturers of the final product must demonstrate that the product complies with applicable substance restrictions. However, the new standard acknowledges that requiring manufacturers to test all homogeneous materials within the final assembled product is indeed impractical.
Manufacturers can request technical documentation from suppliers proving that the supplied materials comply with relevant substance restrictions. This European standard aims to specify the requirements for technical documentation so that manufacturers can prepare relevant documents to demonstrate that their products meet the regulations.
The new European standard's technical documentation should include at least the following points:
- General description of the product
- Documents concerning materials, parts, and/or subassemblies
- Explain the technical documents and information relating to the relevant materials, parts and/or sub-components within the product.
- List of harmonized standards and other technical specifications used in the compilation of documents
Manufacturers are responsible for determining the necessary information and then collecting it. Furthermore, they must verify the accuracy of the information and decide whether it is suitable for inclusion in technical documentation. Additionally, manufacturers must regularly review and update the information to ensure its accuracy.
The new standard requires manufacturers to assess the likelihood of their products containing restricted substances (e.g., through technical assessment) and the credibility of their suppliers. The assessment must also consider other materials added during the production of electrical and electronic products, such as soldering agents, paints, and adhesives.
The new standard also specifies the types of information that manufacturers must provide:
A statement from the supplier – confirming that the supplied materials and parts conform to specifications;
The signed contract – proves that the manufacturer complies with the maximum permitted levels of restricted substances;
Material Declaration – Provides information on the content of specific materials and indicates any applicable exemptions. Manufacturers intending to use this approach can purchase a copy of the current EN 62474 standard, which contains the procedures, types, and contents related to material declarations.
Manufacturers must establish procedures to evaluate the aforementioned documents to determine their authenticity and adequacy. Therefore, manufacturers must trace back to the source and evaluate the content of each received document. If the content is deemed correct and sufficient, it must be included in the technical documentation; otherwise, manufacturers can request additional information from suppliers or conduct their own material analysis.
Sources: Hong Kong Trade Development Council Economic and Trade Research (2012-12-14)
