Identifying and Managing Substances of Concern in Electronics

Intertek Cleeve Road, Leatherhead, Surrey KT22 7SB UK

[email protected] 01372 370900 www.intertek.com

Identifying and Managing Substances of Concern in Electronics


www.intertek.com/rohs/eu-directive 1

Contents

Contents ............................................................................................................. 1 Introduction......................................................................................................... 2 Overview of Regulated Substance Obligations...................................................... 2 EU REACH Regulation ...................................................................................... 2 REACH Communication Obligations ................................................................. 3 SVHC Authorization ......................................................................................... 3 EU RoHS Recast................................................................................................ 3

Compliance Strategy and Tools ............................................................................ 4 Assessing Product for Substance Use Restrictions (IEC 62476) ........................... 4 Material Declaration (IEC62474) ....................................................................... 5 Declarable Substances List ................................................................................ 5 Data Exchange ................................................................................................. 6 Declaration Procedure ...................................................................................... 6 Analytical Testing (IEC 62321) .......................................................................... 6

A Systematic Approach to Compliance Assurance ................................................ 7 Product Planning and Design for Compliance ................................................... 7 Supplier Information ........................................................................................ 8 Manufacturing Operations ............................................................................... 9 The Role of Analytical Testing......................................................................... 10

Experience with SVHCs ...................................................................................... 11 Methodology - Analytical Testing for REACH SVHC ........................................ 11 Results of SVHC Analytical Test Studies .......................................................... 11 Testing Study - Original 15 SVHC ................................................................... 11 Testing Study 2012 ........................................................................................ 12

Summary ........................................................................................................... 13 About Intertek ................................................................................................... 13

Authored by: • Walter Jager, Intertek, Ottawa, Canada

• Joe Langton, Intertek, Allentown, PA, USA

• Torben Nørlem, Intertek, Copenhagen, Denmark



Introduction

As new environmental regulations continue to emerge from around the world, environmental compliance is a moving target and will remain a major challenge for the electrical and electronics equipment (EEE) industry in the foreseeable future. The EU REACH obligation to communicate information on Substances of Very High Concern (SVHC), the subsequent Authorization requirements for SVHCs, and the conformity assessment requirements of the RoHS recast are examples that are discussed in section 2 of this paper.

Section 3 summarizes the requirements for a compliance strategy and discusses tools in the form of standards that are available to the EEE industry for managing environmental compliance.

A systematic approach to compliance assurance which has been implemented with numerous manufacturers and suppliers in the industry is described in Section 4.

Engineering experience can be an important source of information in achieving regulated substance compliance of products. Experience with testing for REACH SVHCs is presented in Section 5.

Overview of Regulated Substance Obligations

EU REACH Regulation

REACH Regulation (EC No 1907/2006)1 is a European chemicals regulation that applies to nearly all products that are manufactured or imported into the European Union. It is a complex regulation consolidating over 40 previous legislations, while adding various new requirements.

REACH requires industry to be responsible for the safe manufacture and use of chemicals. In this paper, we will be discussing only one set of the REACH requirements - SVHC in articles. Organizations that manufacture or import products containing an SVHC have compliance obligations.

The first SVHC candidate list was officially published on October 28, 2008 with 15 substances. As of December 2013, the SVHC candidate list has grown to 138 entries with additional substances added twice a year. When new SVHC are added, there are immediate communication requirements for manufacturers and importers.

1 EU Regulation (EC) No 1907/2006 concerning the Registration, Evaluation, Authorization and Restriction of Chemicals (REACH), 18 December 2008.



REACH Communication Obligations

REACH Article 33 “Duty to communicate information on substances in articles” has been the key obligation driving manufacturers, importers, and distributers to determine whether SVHC exist in their products. If a candidate list SVHC is in the article at greater than 0.1% weight over weight, the manufacturer or importer has communication obligations to recipients.

Reporting obligations require, at a minimum, identification of the chemical and information on safe use. For organizations that are not in the EU, but whose products may end up in the EU, their customers will need the information for downstream reporting.

SVHC Authorization

SVHC listed on the Candidate List are eligible for inclusion in REACH Annex XIV (Authorization) subject to a decision of the EU Authorities and based on their hazardous properties and volume on the EU Market.

Authorization requires a complex and costly application from the subject companies at the latest by the date specified in Annex XIV (Sunset Date). The application will undergo a lengthy and detailed assessment by the EU Authorities and will be subject to time limited review if granted as the basic intention in practical terms is to substitute the SVHC with less problematic alternatives.

In conclusion Annex XIV in many cases marks the final stage of the phase out process for the SVHC on the EU market as Authorization is very costly and will only represent a workable solution until suitable alternatives are identified.

EU RoHS Recast

The recast of the EU RoHS Directive (2011/65/EU)2 has introduced new obligations for conformity assessment, declaration and marking of EEE. RoHS becomes a CE marking directive, meaning that the CE mark on the EEE product will be a declaration by the producer that the product is RoHS compliant. The recast Directive identifies specific obligations for manufacturers, importers, and distributors.

Manufacturers will need to carry out conformity assessments based on internal production control procedures that are in conformance with EU Decision 768/2008/EC and EU Regulation 765/2008/EC. Technical documentation that

2 EU Directive 2011/65/EU, on the restriction of the use of certain hazardous substances in electrical and electronic equipment (recast), 8 June 2011.



specifies the conformity of product will need to meet the minimum requirements as specified in the EN 50581 standard.

Various governments have implemented other Restricted Substances requirements, which will not be discussed in this paper. However, the subject paper will show how to handle such requirements in general.

Compliance Strategy and Tools

Compliance to the variety of global substance regulations is a significant challenge. Unlike other product conformity requirements (such as electrical safety) there is no single test that can be performed to confidently determine whether a product is compliant.

A multi-faceted compliance assurance system (CAS) that covers all stages of product realization is needed to create high confidence that a product is compliant. A CAS must have effective restricted substance controls and sufficient information from the supply chain to properly assess products for compliance.

Industry best practices and International Standards provide valuable tools to electronic equipment producers for environmental compliance. The use of International Standards is in particular crucial for a common framework and efficient flow of environmental information through a global supply chain. The developed practices and standards must be applied and adapted as appropriate to the subject legislative requirements in order to correctly reflect the specific subject matter.

Assessing Product for Substance Use Restrictions (IEC 62476)

IEC/TR 62476 “Guidance for evaluation of product with respect to substance use restrictions in electrical and electronic equipment” provides a framework and guidelines for restricted substance controls (RSC).

The guidance document suggests internationally accepted standards, tools and practices and is applicable to companies that produce finished EEE product and to their supply chain. It segments RSC requirements into three areas: product planning and design, sources of information and data, and product evaluation.

It recommends a risk based approach to evaluating products for potential non-compliance. This is particularly relevant when assessing compliance to the RoHS Directive, given the large number of homogeneous materials in most EEE products. A risk based approach helps ensure that effort is directed where it can provide the most benefit.



IEC/TR 62474 also discusses the possible sources of information and data, considerations for data selection and supplier information such as material declaration.

Material Declaration (IEC62474)

Materials declaration is a methodology for suppliers to provide downstream producers with information about the substance and material content of their products. Materials declarations may be provided against a specific list of declarable substances or they may be a full material declaration of all substances in the product.

The IEC 62474 International Standard for “Material declaration for products of and for the electrotechnical industry” was published in March 2012. The standard provides a declaration procedure, an XML-schema for data exchange of material declaration information, and a declarable substance list.

The standard leverages the work already done in other industry standards such as JIG-101, IPC 1752 and JGPSSI. It also incorporates forward looking requirements for material composition information that are needed to support Environmentally Conscious Design (ECD).

Declarable Substances List

The declarable substance list 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. The declarable substance list is available online at the IEC 62474 database3. Each substance or substance group entry that is included in the list is also accompanied with reportable applications and a threshold level that triggers the disclosure.

The declarable substance list needs to be regularly updated and is maintained by a validation team of international representatives from Europe, North America, and Asia.

The declarable substances are categorized in three criteria levels: criteria 1currently 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 and 2 substances that are present in their product above the threshold level. The declaration of criteria 3 substances is optional.

3 http://std.iec.ch/iec62474/



Data Exchange

Material declarations should be exchanged between supplier and customer using the data format provided in the XML schema.

Declaration Procedure

IEC 62474 overcomes several limitations of early materials declaration systems by providing the recipient with enough information to assess the product for compliance.

Suppliers are required to report all occurrences where a substance threshold is exceeded. For example, the IEC 62474 database entry for “Lead/Lead Compounds” that corresponds to the EU RoHS restriction specifies a reporting threshold of “0.1 mass% of total Pb in homogenous material”. Therefore, the material declaration must include all such instances of lead in homogeneous materials, allowing the recipient to assess the declaration for exemptions and compliance. In many previous material declaration formats, only the ‘highest’ concentration of lead in the product was declared, potentially masking a lower level of lead in another material and limiting the usefulness of the data.

The method 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.

In the case of REACH SVHCs, the threshold of the SVHC is based on the mass percentage of the article, thus only one declaration is required for the article.

Analytical Testing (IEC 62321)

Analytical testing evaluates a product sample for the presence of specific substances. If sufficiently accurate and appropriate test methods are used, analytical testing can provide confirmation that a restricted substance is present or not present.

IEC 62321 “Determination of levels of six regulated substances” is the International Standard that defines methods to test for the RoHS substances in EEE. It specifies the sample preparation methods and test methods for Lead, Cadmium, and Mercury in metals, polymers (plastic) and electronics; PBB/PBDE in polymers; Hexavalent Chromium in metal conversion coatings; and Hexavalent Chromium in polymers. It also provides guidance on XRF screening.



A Systematic Approach to Compliance Assurance

Manufacturers are responsible for providing specific information and documentation on demand to enforcement authorities to prove that they have complied with restricted substance regulations, such as EU RoHS and REACH. Without the proper measures and documentation a manufacturer is exposed to sanctions from these enforcement authorities including fines, blocked shipments, blocked sales and negative brand perceptions, due to a lack of due diligence as well as subsequent claims for damages and indemnification due to breach of contract.

A system that contains all necessary processes and procedures for compliance is known as a Compliance Assurance System (CAS). A restricted substance CAS should contain all applicable policies, manufacturing processes and records to demonstrate that all reasonable steps have been implemented to ensure that products conform to the RoHS requirements. This system should be a risk based approach to determine the amount of data collection, verification, testing or auditing required. A risk assessment should be performed to determine the possibility that a restricted substance may be present in a product.

The CAS elements described below allow manufacturers to compile technical documents that are compliant with EN 50581 for RoHS-2.

Product Planning and Design for Compliance

An organization’s top management should ensure that a documented strategy on the control of restricted substances is defined and appropriate for the purpose of the organization. The first step would be to develop a corporate restricted substance compliance policy statement detailing the company’s commitment to and goals for achieving compliance. The objective is to have a formal document to respond to customer inquiries about substance compliance.

When designing a product for compliance to substance regulations, design engineers should define, document, and maintain a requirements specification for products that covers all applicable substance regulations. These requirements should be documented in an Engineering Specification and should specify the following: substance restrictions including the maximum allowable concentration, allowable substance usage exemptions, objective evidence of compliance, part/product verification, and data storage and retention.

Design engineering is responsible for specifying compliant parts from approved manufactures. The manufacturer is responsible for the restricted substance compliance of the part and engineering is responsible to verify this compliance by obtaining and reviewing appropriate objective evidence of compliance.



The following list contains examples of acceptable objective evidence of RoHS conformance that may be available for commercial of the shelf (COTS) parts manufacturers:

• Restricted substance capability assessment

• Supplier Declaration of Conformity

• Manufacturer’s material declaration

• Independent Analysis of Chemical Composition

Design engineering should also define all custom/fabricated parts using compliant materials and parts from approved suppliers. Engineering must ensure that all selected parts and materials are properly defined as compliant per the Engineering Specification or the fabrication drawings.

The following list contains examples of acceptable objective evidence of restricted substance conformance for raw materials.

• Metal Alloys - Material certifications to recognized international standard from material supplier that specifies the elemental composition of the alloy

• Metal Finishes - Restricted substance certification from the finish manufacturer or plating supplier

• Plastics - Restricted substance compliance certificate from the Resin manufacturer. In addition a certificate is needed for any colorants or other substances added during the moulding process.

• Independent Analysis of Chemical Composition

All evidence must be reviewed to assess the details and credibility of the claim.

Supplier Information

As part of a CAS, suppliers are expected to take responsibility for the quality and material content of products supplied, and to ensure that adequate tests and inspections are performed such that products meet the specifications. Maintaining an overall effective process to satisfy requirements is the best way to fulfill supplier responsibilities. Supplier/manufacturer selection and approval procedures are needed to ensure that the supplier base is capable of providing compliant products and reliable material declaration information.



Procurement procedures and processes need to be implemented that restrict the purchase of compliant materials, parts, and subassemblies to approved manufacturers and suppliers.

Quality and supply chain management should implement processes and procedures to monitor compliance of supplier and manufacturer parts and materials. These procedures will include a combination of periodic collection and verification of supplier Declaration of Conformity (DoC), capability assessments and part testing. The frequency of data verification and testing will depend on several factors including but not limited to supplier restricted substance capability assessment, age of the part DoC on file, and the materials used.

The level of due diligence that should be performed varies with products, the materials that are used and the supply chain. IEC/TR 62476 suggests that reliance on supplier DoCs alone will not be sufficient. When assessing the risk of restricted substance presence in a product, the type of material, the supplier’s RSC, and the manufacturing processes should be considered.

The assessment of the technical documentation for RoHS-2 must meet the requirements of EN 50581.

Manufacturing Operations

To consistently manufacture restricted substance compliant product, manufacturing practices that maintain the integrity of inventories, work in progress, and finished goods during the product realization, manufacturing, and service life cycle are required as well as on-going audits and verifications that continually evaluate and improve the effectiveness of these processes. Elements that should be implemented include:

• Receiving inspection procedures and processes that ensure supplied items demonstrate evidence of compliance.

• Inventory management procedures and processes that ensure restricted substance compliant procured items, work in progress, and finished goods are properly identified, controlled and stored so as to segregate compliant and non-compliant items and to mitigate the risk of contamination with restricted substances.

• Training to all employees to ensure that they understand their roles and responsibilities for restricted substances compliance and how this contributes to continued product compliance.

• Audit and verification procedures and processes to assess the effectiveness of the CAS.



The Role of Analytical Testing

The use of laboratory testing (which could be either non-destructive or destructive) to verify compliance with the requirements of required laws or directives will be used in many cases as part of an overall systematic approach. In order to obtain conclusive results of a product’s compliance, producers may choose to carry out analytical testing of materials in their products based on the risk that a regulated substance may be present.

It’s not practical to test every material in a complex product; however, testing for substances may be appropriate to supplement supplier information when dealing with high risk parts, materials and suppliers.

The internationally recognized standard IEC 62321 (described in section 4.3) specifies methods for sample preparation and analytical testing. For the RoHS-2 technical documentation, EN 50581 specifies that IEC 62321 be used for analytical testing.

Screening tests can be a cost-effective tool to help investigate areas of concern (parts and materials). However, screening tests are generally limited in accuracy and the ability to identify specific substances.

Verification testing may be required when inconclusive results are obtained from screening. Verification testing is a destructive test of the sample using a quantitative measurement method such as inductively coupled plasma mass spectrometry (ICP-MS) and other equipment. For Hexavalent Chromium, the standard defines the spot test and boiling water extraction procedures.

Use of an International Standard for analytical testing is critical for successful global supply chains. It is difficult to test for the RoHS substances in electronics at low concentration and false readings occur if the substance of interest is not properly extracted.

EEE producers and suppliers should pay particular attention to the information provided by the test lab in the test report. A test report should list the test method standard(s) being followed and any deviations to the standard(s). It should also clearly and unambiguously identify the sample being tested. IEC/TR 62476 provides a list of information in a test report that should be reviewed.



Experience with SVHCs

Experience with analytical testing for SVHCs can be a valuable tool in assisting manufacturers with assessing products for high risk substances.

Methodology - Analytical Testing for REACH SVHC

Products and materials may be tested for SVHC using analytical test methods. Selecting the correct sample preparation and analytical test method is critical for achieving accurate test results. For example, the substance must be fully extracted from the base material; otherwise the test results will be inaccurate. But the test strategy must also be cost efficient. This requires the use of clever test strategies to maximize the relevant information with a minimum numbers of tests. Techniques can also be used to eliminate the presence of certain SVHC by using specific tests combined with deductive reasoning.

A variety of test methods are used based on the substance under test and the base material. Two of the most common are gas chromatography - mass spectrometry (GC/MS) and Inductively Coupled Plasma Optical Emission Spectrometry (ICP-OES). Other methods may be used for specific circumstances.

Test strategies such as “Scan and Store” can help manufacturer’s reduce their future test requirements when additional SVHC are added to the Candidate List.

Results of SVHC Analytical Test Studies

This section summarizes the results of testing for REACH SVHC substances in EEE products. The information from the studies provides valuable insight during SVHC risk assessment.

The testing was conducted at Intertek analytical test labs in Europe, North America, and Asia.

Testing Study - Original 15 SVHC

A 2009 study4 of analytical testing for the original 15 SVHC illustrated that several of these substances could be found in EEE in sufficiently high concentration to trigger obligations. Results from testing of over 2000 different product and material samples were reviewed and synthesized as part of the study.

The most prevalent SVHC found in the samples was the phthalate DEHP (Bis (2-ethyl(hexyl)phthalate)). A histogram of the test results from North American

4 W. Jager, “Where are REACH SVHC in Electronic Products and Parts?” IPC APEX, Las Vegas, April 2010.



producers is shown in Figure 1. The results show that 64 of 391 samples tested contained the phthalate DEHP at levels above the REACH threshold of 0.1% by weight. This corresponds to over 16% of the samples that were tested.

Figure 1: Concentration Levels of Phthalate DEHP

The phthalate DBP and Short Chain Chlorinated Paraffins (SCCP) also occurred frequently enough to be an important risk. Several of the other SVHC were also detected but in fewer samples.

Overall, plastics materials were found most likely to contain an SVHC, including the three phthalates (DEHP, BBP, DBP), Short-chain chlorinated paraffins (SCCP), organic tin, or 4,4'- Diaminodiphenylmethane (MDA).

Testing Study 2012

A follow-on study on analytical testing for the current 84 SVHCs is currently underway. Preliminary results suggest that the phthalate DEHP is still the most frequent SVHC found in materials common to electronics; however, the incidence of DEHP appears to be decreasing. A survey of 200 test reports from a broad representation of North American brand owners indicates that 5% of samples had levels of DEHP above 0.1% of the sample (article) weight. However, another 3% of the samples had concentrations below 0.1%, suggesting that some of the parts contained DEHP. If any of these parts were to be manufactured in the EU or imported separately or if the REACH SVHC reporting level were changed to the part level - as proposed by six EU countries - these products would need to be declared. An analysis of over 900 test tests reports from a broader range of consumer products using similar materials shows a 4% incidence of DEHP.

Other SVHCs that were detected include cobalt dichloride, Short Chain Chlorinated Paraffins (SCCP), the phthalates DBP and DiBP, Boric acid, diarsenic pentaoxide, diarsenic trioxide, and hexabromocyclododecane (HBCDD).



Summary

Substance regulations have become a significant challenge for manufacturers and their downstream partners. Manufacturers must employ a combination of supply chain information, engineering judgment, and analytical testing to strike an effective balance between compliance assurance and costs.

Several of the SVHC on the Candidate List may be found in EEE. The REACH regulation imposes a requirement on manufacturers, importers, and distributors to disclose the presence of these SVHC in their products. The Phthalate DEHP was the most frequently appearing SVHC in the study, although several other SVHC occurred frequently enough to be a risk.

Manufacturers and suppliers need an effective, but flexible, CAS to deal with the expanse of substance regulations. Adequate processes and procedures are required across all stages in product realization. Tools in the form of International Standards and best practices can be leveraged to help provide consistency across a global supply chain.

Screening and test methods exist to identify the presence/absence of REACH SVHCs, RoHS and other regulated substances, but a good test strategy is needed to optimize the value of the testing performed.

About Intertek

Intertek is the leading quality solutions provider to industries worldwide. From auditing and inspection, to testing, training, advisory, quality assurance and certification, Intertek adds value to customers’ products, processes and assets. With a network of more than 1,000 laboratories and offices and over 35,000 people in more than 100 countries, Intertek supports companies’ success in a global marketplace. Intertek helps its customers to meet end users’ expectations for safety, sustainability, performance, integrity and desirability in virtually any market worldwide. Visit www.intertek.com.

For more information on specific testing and certification information, please contact Intertek at 1-800-WORLDLAB, email [email protected], or visit our website at www.intertek.com.

This publication is copyright Intertek and may not be reproduced or transmitted in any form in whole or in part without the prior written permission of Intertek. While due care has been taken during the preparation of this document, Intertek cannot be held responsible for the accuracy of the information herein or for any consequence arising from it. Clients are encouraged to seek Intertek’s current advice on their specific needs before acting upon any of the content.

Documents

Identifying and Managing Substances of Concern in Electronics