Environmental compliance is a moving target — each region can impose unique environmental requirements on products sold in their market and new regulations continue to emerge. Different global substance regulations create significant challenges for all actors in the electrical and electronics industry. Substances added twice a year to the EU REACH1 SVHC Candidate List and the potential additional RoHS2 substances are prime examples of new or changing regulatory requirements.
The first step in regulatory compliance evaluation for substance restrictions is to determine the substances of concern contained within the parts that comprise a finished electronic product. This article describes an internationally recognized standard that is available to engineers to help identify the substances of concern that need to be taken into consideration when designing, procuring, and manufacturing electrical and electronic equipment (EEE) products for a global marketplace. It also presents a summary of the updates made to the industry Declarable Substance List (DSL) in 2013 and early 2014 to meet the changes in global requirements.
Organizations need to implement internal processes that are flexible to accommodate new regulations and to leverage information from a global supply chain. The new International Standard IEC 62474 Ed. 1.0 titled Material Declaration for Products of and for the Electrotechnical Industry (hereafter referred to as IEC 62474)3 described in this article is invaluable in assisting organizations to meet these global requirements.
The Market Need for Material Declarations
Restricted substance compliance is a challenge that is continuing to grow – Manufacturers need to be aware of the substances of concern in their products.
A key benefit of the IEC 62474 material declaration standard is that it includes an internationally recognized DSL specific to the electronic industry. The IEC 62474 DSL is based heavily on the Joint Industry Guide (JIG-101), which was the EEE industry’s de-facto substance list from 2005 through 2012. The JIG 101 substance list maintenance activity has now been officially sunset and transitioned to the IEC 62474 validation team (for more on this visit https://www.incompliancemag.com/press/1404_F2.)
The IEC 62474 DSL contains information on what substances to declare and the conditions under which they need to be reported. To help users, it also includes information about common uses of the chemicals in electronic products. The information in the IEC 62474 DSL helps companies to design and manufacture their products to meet global market requirements.
Manufacturers need to know the materials contained in their products. This is important input for environmentally conscious design (ECD) to understand opportunities to improve environmental performance.
Organizations with ECD processes need to understand environmental aspects associated with their products across the various product life cycle stages. A robust ECD process will collect data to understand which environmental aspects are significant during each life cycle stage and evaluate what may be done to improve these aspects. Examples of common environmental aspects include material use, energy use, water use, waste generation, and wastewater and air emissions.
IEC 62474 can assist organizations determine their global regulatory compliance status, as well as to declare data on the type of materials that are contained in their products. With this information product design teams may better understand the opportunities available to improve environmental life cycle performance. For example, the data may indicate that several different types of plastics are present in certain parts and indicate there are opportunities to reduce these materials to improve overall product recyclability.
The IEC 62474 standard supports ECD through the establishment of fifteen defined material classes. These classes are defined non-overlapping categories of materials that can be used to fully describe the contents of an electronic product. The material classes cover both inorganic and organic material categories.
EU RoHS 2 has new CE marking technical documentation requirements — material declaration can play a significant role
RoHS 2 – the recast of the EU RoHS Directive (2011/65/EU) – is a CE Marking Directive that introduced new obligations for manufacturers, importers, and distributors. In particular, manufacturers now have obligations for conformity assessment of products, marking, manufacturing, technical documentation and notification and tracking of any possible non-conformances.
RoHS 2 specifies that manufacturers must carry out conformity assessments based on internal production control procedures in conformance with EU Decision 768/2008/EC and EU Regulation (EC) No 765/2008. It also specifies that manufacturers must compile technical documentation that demonstrates conformity of their products before the products are put on the EU market. To assist manufacturers with understanding the expectations for technical documentation, the European Commission issued a Communication specifying the CENELEC standard EN 505814 as the RoHS 2 harmonized standard for technical documentation.
EN 50581 Technical Documentation for the Assessment of Electrical and Electronic Products with Respect to the Restriction of Hazardous Substances specifies minimum requirements for technical documentation. In determining the information that is needed, EN 50581 suggests that manufacturers use a risk assessment approach to consider the probability of restricted substances being present in the product and also the trustworthiness of the supplier.
To demonstrate the absence of restricted substance content in materials, parts, and sub-assemblies, EN 50581 identifies three types of information that may be appropriate for the technical documentation:
- Supplier declarations and/or contractual agreements;
- material declarations; and
- analytical test results.
For materials declaration, the standard references EN 62474, the European version of IEC 62474. An IEC 62474 material declaration will communicate information about all instances of RoHS substances in the product above the restriction threshold, allowing the downstream manufacturer to determine conformity and assess the applicability of any RoHS exemptions that have been identified by the supplier. This makes IEC 62474 material declarations suitable as RoHS 2 technical documentation.
Manufacturers may also test their products for RoHS restricted substances, but this can become expensive very quickly and is not always practical, making material declarations a cost effective way to meet the technical documentation requirements.
REACH SVHCs require a systematic and flexible approach
Organizations that manufacture or import products into the European Union must comply with the EU REACH regulation (EC) No 1907/
2006 – this includes manufacturers of EEE products. REACH is a comprehensive chemicals regulation with many requirements. For EEE manufacturers, the most common requirement is the obligation to communicate information about the presence of any Substances of Very High Concern (SVHC). SVHCs include substances that are carcinogenic, mutagenic, toxic to reproduction, persistent, bioaccumulative and/or endocrine disrupting. Only the SVHCs on the SVHC Candidate List that is published by the European Chemical Agency (ECHA) incur this obligation, but as of April 2014, the SVHC Candidate List had grown to 151 entries with additional substances added twice a year. When new SVHCs are added, the communication requirements are immediate.
Maintaining REACH compliance is a challenge given the large number of SVHCs on the Candidate List and the frequent additions. A systematic and flexible approach is needed 5, 6. Good communication of substance content information down the entire supply chain is invaluable. Also, awareness of which SVHCs can occur in EEE versus those that are not realistically present helps narrow the focus to specific substances of concern. For example, many of the current 151 SVHCs are manufacturing intermediate chemicals that are not expected to remain in a finished electronic product. One way that the IEC 62474 DSL provides value-added information for the electronics industry is by identifying most likely uses of REACH SVHCs.
Challenges with Material Declaration
There are many challenges to get the substance and material data needed by electronics manufacturers. These include:
- Suppliers do not know the countries that a downstream manufacturer will sell to, and even if they did, they usually do not have the resources to research and know all substance restriction regulations.
- Without a standardized list of minimum substances to report, each customer requests the substances it wants its suppliers to report. This means many different variations and details as to what a supplier has to report, making it difficult and costly to prepare.
- Without a standardized way to exchange material declaration data, suppliers receive customer-specific forms and formats to report in. Many suppliers provide hardcopy data that has to be entered again manually for the next declaration down the manufacturing chain. This leads to extra effort, costs and reporting errors.
- There have been no internationally accepted rules to report substances or materials, and this leads to variation and data errors.
- Suppliers provide information on a case-by-case basis according to individual contracts. In some cases, the data is provided at no cost, in some cases it is provided at additional cost and in some cases, not provided at all. This leads to market barriers that tend to give advantage to larger organizations and to those that purchase in large quantities.
How IEC 62474 Helps Organizations Obtain Material Declaration Data
The IEC 62474 Standard on material declaration includes an internationally recognized DSL, a material declaration procedure and a data exchange format.
The standardized rules and data exchange format provided by IEC 62474 enables manufacturers and suppliers to exchange material and substance information using a common language. A supplier that prepares their material declarations in conformance with IEC 62474 enables their customers to correctly interpret the information to assess conformance of the product against substance restrictions.
The requirements for creating a material declaration that conforms to IEC 62474 are listed in the various parts of the standard. The declaration rules specified in Clause 4 of the IEC 62474 standard ensures that specific minimum information about substance content in the product is provided and specific requirements are followed for declaring optional information. The DSL in the IEC 62474 database specifies the minimum set of substances that must be declared if they are present in the product above the reporting threshold; and the data exchange format (specified by the XML schema and developer’s table) allows supplier and customer to exchange the data using a common format. Several of the features and benefits of IEC 62474 material declaration are discussed below.
IEC 62474 is an International Standard recognized by the World Trade Organization (WTO) and is therefore intended to have a harmonizing effect across the global industry. It has been adopted by the EU and several other countries as a national standard, including China. Japan is adopting the International Standard for their JGPSSI and JAMP material declaration systems. And IPC 1752 is now referencing the IEC 62474 DSL. The IEC 62474 and IPC 1752 (class D) XML formats are already quite similar and efforts are underway to bring these further into alignment.
The IEC 62474 DSL has already gained significant adoption within the EEE industry – many organizations are now using the DSL for engineering and procurement specifications— and Environmental Product Declaration (EPD) standards are referencing the list in their environmental performance criteria. Nevertheless, it takes time and effort to implement new functionality in IT systems; therefore the adoption of IEC 62474 by manufacturers may take some time. However, once the standard is widely adopted, the efficiency of data exchange throughout the supply will enable companies to meet expanding regulatory requirements in a timely and cost-efficient manner.
A unique aspect of IEC 62474 compared to most other IEC and ISO standards is that it not only includes the International Standard document, but is designed to work with a companion publicly available online database for information that needs to be updated regularly. The IEC 62474 database is publicly available at http://std.iec.ch/iec62474. The business rules governing the reporting and how declarable substances are added/removed from the list are more stable and, consequently, are contained in the standard itself.
Declarable Substance List (DSL)
The DSL is a list of substances and substance groups (e.g. lead and lead compounds) that a manufacturer is required to declare if present in the product at a concentration level above the reporting threshold. Figure 1 provides a screen capture of the main web page of the IEC 62474 database. The DSL may be accessed from the IEC 62474 database via the menu bar on the left side of the web page – click on Declarable Substance Groups and Declarable Substances and then select the substance from the drop down list. There is also an option to export the entire DSL in Excel or XML format.
Figure 1: Introduction Page of IEC 62474 database
Each substance or substance group entry in the list is accompanied with a reportable application and a reporting threshold level. For example, selecting Lead/Lead Compounds presents five entries with different reportable application/reporting threshold combinations – the first entry corresponds to the RoHS restriction. Clicking on the Details button reveals information about reference substances, typical EEE applications, regulations, and other information (see Figure 2).
Figure 2: IEC 62474 DB entry for RoHS Lead Restriction
The reportable application and reporting threshold level fields provide criteria for a supplier to determine whether they must report the presence of a substance or substance group in their product.
The declarable substances are categorized in three criteria levels: criteria 1 currently regulated; criteria 2 for assessment; and criteria 3 for information only. For a supplier to declare that their material declaration conforms to IEC 62474, they must declare all criteria 1 or 2 substances that are present in their product above the threshold level for the specified reportable application. The declaration of criteria 3 substances is optional.
Key functionality, flexibility and power of IEC 62474
A strength of the IEC 62474 International Standard is the flexibility in material declaration reporting. A supplier may declare just the mandatory declarable substances/declarable substance groups or they may provide a full declaration of all materials and substances in the product using the same XML-based data exchange format.
The information in an IEC 62474 material declaration is captured in a tree data structure using an XML format. Figure 3 illustrates a simplified conceptual representation of the elements in the tree data structure. The product is at the top of the tree with product parts, materials, substance groups and substances underneath. In most circumstances, declaring product parts and materials is optional; however, there are occasional circumstances when a product part must be declared – these circumstances are described below. There may also be information on material classes in the declaration, although this information is not shown in Figure 3.
Figure 3: Example Material Declaration with Optional Declaration of Product Parts and Materials
The XML schema specifies the basic format of the XML file but must be used in conjunction with the developer’s table, which specifies additional rules that must be met in an XML material declaration file – for example, the multiplicity of data fields and the maximum number of characters allowed in text fields (i.e., maximum string length). The multiplicity of data fields refers to whether only one instance of a specific data field is allowed or if multiple instances may be provided. Multiplicity of greater than one is important for information such as RoHS exemptions for which multiple entries may need to be reported. The developer’s table is also available from the IEC 62474 database.
IEC 62474 states that material declarations should be exchanged between supplier and customer using the data format provided in the XML schema; but it also allows a paper format to be used. The paper format capability was provided because not all organizations around the world have the computer tools available for electronic data exchange. A paper-based material declaration must still provide all of the information specified in the standard.
For an electronic material declaration to conform to IEC 62474, it must meet all of the applicable requirements in the XML schema, the developer’s table and the IEC 62474 document.
The declaration procedure (rules), as defined in Clause 4 of the IEC 62464 document, is partitioned into base requirements for a minimum declaration and additional requirements that must be met when a supplier provides additional (optional) information. The requirements identify key information that must be provided in the material declaration and how the information must be organized. Following these requirements is necessary to ensure that the recipient is able to interpret the information and assess conformity of the product.
IEC 62474 material declarations allow conformity to be calculated
An important objective for the development of IEC 62474 was to ensure that the recipient of a material declaration has sufficient information to properly assess the conformity of a material or product – this overcomes a limitation of several earlier material declaration specifications. For example, a material declaration that reports only a single highest concentration of lead in the product can be deceiving when assessing RoHS compliance, which is based on homogeneous materials. The highest concentration may be covered by a RoHS exemption, potentially masking a lower concentration of lead in another material. The IEC 62474 DSL listing of lead and lead compounds for EU RoHS requires that all instances of lead in homogeneous materials above 0.1 mass percent must be declared. This requires the supplier to provide more information about declarable substances in their product, but it significantly improves what the recipient can do with the information.
There are also a few circumstances when a product part must be declared. For example, when the substance reporting threshold is mass percent of a battery, a battery included in a product is a product part and it must be explicitly declared so that the recipient of the material declaration can properly assess conformity.
In the case of REACH SVHCs, the threshold of the substance is based on the mass percent of the article1; thus, in general, only one declaration of the substance is required if the SVHC substance declaration is assigned directly to the product. However, if product parts, materials or substance groups are declared, then the SVHC must be allocated and assigned to each applicable product part, material and/or substance group that contains the SVHC. Note that even if the SVHC is allocated across several materials or parts, the reporting is still based on 0.1% of mass (w/w) of the entire article and not the mass percent of individual occurrences.
Keeping the Declarable Substance List Up-to-Date
The key challenge with publishing a list of substances is keeping the list up to date with environmental regulations. The IEC 62474 DSL is maintained by a Validation Team (VT 62474) that currently consists of 39 representatives from 14 countries (including the authors of this article) covering North and South America, Europe, Asia and Australia. VT 62474 includes experts from chemical manufacturers, component manufacturers, finished product manufacturers, and consultants.
The VT 62474 typically conducts maintenance cycles to update the database content two or three times per year. The update process is triggered when a National Committee or a VT 62474 member submits a formal change request. The VT 62474 will also pro actively screen new substances added to existing regulations (such as substances being considered for the EU REACH SVHC Candidate List).
The IEC 62474 standard specifies the rules that the VT 62474 follows to evaluate a change request and the decision criteria it uses to determine whether or not a substance should be included on the DSL. Two key evaluation criteria used by VT62474 are:
- Is the substance contained in electronic products; and
- Does the substance remain in the product above the regulatory threshold?
After the VT evaluates the change request and supporting evidence, a final validation phase requires each participating country to vote on the change.
Updates to the IEC 62474 database content were made in June 2013 and September 2013. Another maintenance cycle was launched in October 2013 with final validation voting just completed at the time that this article was being written. The update to the IEC 62474 database is expected in March 2014. The June and September 2013 updates included 35 additions and 10 modifications to the DSL. Most of the updates were the result of additional substances added to the REACH SVHC Candidate List, but there were also a few modifications and a couple of substance deletions. The maintenance cycle that was started in October 2013 focused on the REACH SVHCs that were added to the SVHC Candidate List on December 16, 2013. A comprehensive summary of the changes is available at: http://rohs.ca/IEC62474.html.
How to Get More Information
The IEC 62474 International Standard is available from the IEC webstore or your favorite reseller of standards documents. The IEC 62474 database containing the DSL, XML schema and developer’s table is publicly available at http://std.iec.ch/iec62474. A user guidance document is also in the works. The user guidance, which will be designated IEC 62474-1 has an expected publication date of late 2014.
The online database includes a news page that provides information on the status of the database and a summary of updates and a contact page. Additional information and a discussion forum are also available on a blog hosted by ECD Compliance at http://iec62474.rohs.ca.
Maintaining the compliance of products to environmental regulations has become a significant challenge and effort for product manufacturers. Internal processes are needed to identify requirements, obtain information from a global supply chain, assess conformity/risks, and to maintain documentation (particularly for the RoHS 2 technical documentation requirement). This needs to be accomplished efficiently and cost effectively and be flexible enough to accommodate new regulations. Leveraging industry best practices, including the use of risk assessment can be particularly valuable.
For substance restrictions and disclosure, identifying the substances of concern that need to be considered during the design, procurement, and manufacturing phases of a product is an important and practical first step to help focus the conformity efforts. The Declarable Substance List (DSL) included in IEC 62474 provides a convenient starting point for engineering and procurement specifications and helps organizations focus on key substances for market acceptance. The standardized rules and data exchange format provided by IEC 62474 enable manufacturers and suppliers to exchange material and substance information using a common language and rules. A supplier that prepares their material declarations in conformance with IEC 62474 enables their customers to interpret the information to assess conformance of the product against substance restrictions.
- EU Regulation (EC) No 1907/2006 concerning the Registration, Evaluation, Authorisation and Restriction of Chemicals (REACH), 18 December 2008.
- EU Directive 2011/65/EU, on the restriction of the use of certain hazardous substances in electrical and electronic equipment (recast), 8 June 2011.
- IEC 62474 Material declaration for products of and for the electrotechnical industry may be purchased from the IEC webstore at http://webstore.iec.ch or a reseller of IEC International Standards.
- EN 50581 Technical documentation for the assessment of electrical and electronic products with respect to the restriction of hazardous substances is available in English as BSI EN 50581:2012 from the British Standards Institute (BSI)
- W. Jager, J. Langton, and T. Norlem, “Identifying and Managing Substances of Concern in Electronics”, Electronics Goes Green, Berlin, September 2012.
- W. Jager, “Where are REACH SVHC in Electronic Products and Parts?” IPC APEX, Las Vegas, April 2010.
Walter Jager is principal consultant at ECD Compliance where he has worked extensively with product manufacturers and suppliers on regulatory requirements and implementation of environmental compliance such as RoHS, REACH, energy efficiency and ecodesign. He also has significant experience with product verification to environmental product declarations (EPDs) such as EPEATTM. Mr. Jager has contributed to the development of International Environmental Standards and guidance documents and he administers the IEC 62474 database. He holds Master’s Degrees in Electrical Engineering and in Business Administration and has held positions in product development, quality and reliability engineering, supply chain management, and environmental compliance.
Rob Friedman is currently Sr. Principal, EHS for Siemens Healthcare Diagnostics. He has more than 25 years’ experience in technical, systems and standards EHS support. Rob co-chairs the US Technical Advisory Group (TAG) to TC111 Environmental standardization for electrical and electronic products and systems, and is convenor for both the Working Group that developed the IEC 62474 standard and Validation Team 62474 that maintains the list of declarable substances and data exchange format requirements. Rob has a BS degree in Chemical Engineering from the University of Pennsylvania and a MS degree in Environmental Engineering from Illinois Institute of Technology.
Linda Young has over 25 years experience in the environmental field. She is currently Intel’s Global Product Ecology Manger; responsible for developing product ecology vision and direction for Intel and establishing strategies for addressing emerging regulatory and customer requirements. She represents Intel in external forums to set industry environmental standards for products. Linda has participated as US technical representative on various IEC TC111 Environmental Committee working groups/project teams. Linda has been a member of the IEC TC111 US TAG since 2006 and a co-chair since 2010. Linda has a BS degree in Chemical Engineering from Oregon State University.