How Standards Assist Environmental Compliance in the Electronics Industry

Assent ComplianceDirector, Compliance Programs

Introductions

Regulatory overview

IEC/TC111 Standardization

Substance management • Requirements from IEC TR 62476 and EN 50581• Types of documentation• Standards to support compliance assessment and

documentation• Importance of risk assessment • Technical documentation

ECD CompliancePrincipal

© ECD Compliance, 201677

• Consulting and technical support on global environmental regulations

– Global regulatory requirements/changes

– Impact on products and markets

– Education and training seminars

– Development of compliance programs

• Eco-labels and sustainability programs

– EPEAT™ (verification)

– Voluntary programs

• Standards Development

– Representation, consulting, and implementation

– IEC/TC111 – Environmental Standardization

• IEC 62474 material declaration

– IEEE 1680.X and IPC-175X

– ISO/IEC JTC1/SC39 – Sustainability by and for IT

• Environmentally Conscious Design (ECD)

– Ecodesign , energy efficiency, LCA

About ECD Compliance


Impact of Environmental Regulations

• Environmental Legislation is regulating an increasing number of environmental aspects and environmental impacts

– Hazardous Substances

– Energy Efficiency

– End of Life Management

– Carbon Footprint

– eco-design (ECD)

• Organizations must adopt flexible processes to comply

• Communication through the supply chain is a key challenge

Environmental compliance has become a significant factor

in the design, manufacturing, and marketing of products.


Environmental Standardization

The International Electrotechnical Commission (IEC) established Technical Committee TC111 in 2004

– Mandate to create international environmental standards and guidelines for electrical and electronic products and systems.

– Membership and voting is by National Committees

– 24 participating countries; 13 observer countries

IEC/TC111: Environmental standardization for electrical and

electronic products and systems


• Chemical Substances (focus for this webinar)

• Environmental Conscious Design (ECD)

• Recover/Recycling/Reuse

• Greenhouse Gases (GHG)

• Resource Efficiency

• Environmental Product Declarations

• Update to standardization roadmap is currently underway

IEC/TC111 Standardization Areas


• Identifying compliant parts and materials

• Reliability of Supply Chain data

• On-going problems with non-compliance

• Difficult (impossible) to obtain 100% compliance assurance of complex

products

• Where to draw the line for due diligence

• Where to store the environmental data

• New substance restrictions

Restricted Substances Challenges


• Framework:

– IEC TR 62476: Guidance for evaluation of product with respect to substance use restrictions

• Analytical Testing:

– IEC 62321-X: Analytical test methods of regulated substances in EEE

• Materials Declaration

– IEC 62474: 2012 – Materials Declaration for EEE

– IEC TR 62474-1:2015 - Guidance for implementation

• Documentation

– EN 50581/IEC 63000: Technical documentation for assessment of EEE

• Specifications

– IEC 63031: Definition of Low Halogen Materials

Management of Substances in EEE Products


Evaluating Products for Restricted Substances

• IEC TR 62476:2010

– Title: Guidance for evaluation of product with respect to substance use restrictions in electrical and electronic equipment

– Framework and guidelines for Restricted Substance Controls (RSC).

• Uses internationally accepted standards, tools and practices.

• Applicable to finished product producer and supply chain

– Recommends a risk based approach to evaluation


IEC 62476 Family Tree

IEC TR 62476

Guidance for evaluation of product with respect to substance use restrictions in electrical and electronic

equipment

EN 50581

EU RoHS technical documentation

IEC 63000

Technical documentation for restricted substances


IEC 62476: Framework

• Identification of Requirements

– Regulatory and Stakeholder requirements

• Restricted Substance Controls (RSC)

– Product Planning and Design

– Sources of Information and Data

– Product Evaluation

• Documentation of Evaluation Results

“Each producer in the supply chain is responsible for defining his own evaluation methods for each product or

product category”


Product Planning and Design

• Strategy for control of restricted substances

• List of restricted substances

• Evaluation methods for different types of materials

“Framework for evaluation of a

product may leverage an

Environmentally Conscious Design

(ECD) Process”


Source of Information and Data

Product evaluation may be based on information from a combination of sources

• Supplier Information

– Supplier declaration of conformity (ISO 17050-1)

– Material Declaration (IEC 62474)

– Analytical test results (IEC 62321-X)

– Contracts

• Analytical Testing

– Analytical test methods (IEC 62321-X)

• Manufacturing and Assembling Procedures


Considerations for Data Selection

• Risk of restricted substance being present in the product

– Used to help select the type and level of assessment that is required

• Not practical to test every material in a complex product

– It may not be possible or necessary to test every material, part, and sub-assembly

• Test results are only valid for the specific product unit that was tested.


Supplier Information

• Acquisition and assessment of supplier information has been a key methodology in assessment for RoHS and REACH compliance.

• Types of documentation

– Supplier Declaration of Conformity

– Material Declaration

– Test results

– Other technical documentation

• Evaluation of Supplier Information

– Evaluate supplier information -> meets requirements?

– Supplier has implemented acceptable RSC?

• Incomplete or suspect information may need to be supplemented with additional information or evaluation


• International standard for material declaration

– Recognized by World Trade Organization to reduce trade barriers

• Developed by IEC/TC111: Environmental standardization for electrical and electronic products and systems

– 27 participating countries; 7 observer countries

• Leverages previous work in materials declaration

• Key Objectives

– Flexible material declaration (base declaration to FMD)

– Enough data to calculate conformity

– Features for Future requirements

IEC 62474 - Material Declaration for Electrical and Electronic Products


• Declaration Procedure and Rules

– Specified in IEC 62474 standard (pdf file)

– Base declaration requirements

– Requirements for declaring additional information

• List of Declarable Substances and Materials

– Maintained in an online database

– Declarable Substances and Declarable Substance Groups

– Material Classes (Types of materials)

• Supports Environmentally Conscious Design

• Data exchange format

– XML schema and Developer’s table

IEC 62474 - Three Sets of Requirements


• Declared information is based on reporting threshold

• For homogeneous material restrictions, declaration of each occurrence of a restricted substance in the product is required.

– Prevents masking occurrences at lower concentration levels.

• If declarable substance threshold is at the part level (e.g. lead in battery), product parts must be declared

Calculating Conformity


IEC 62474 Database

http://std.iec.ch/iec62474 -- select “ENTER” button on top right hand corner

http://std.iec.ch/iec62474


Declarable Substances


• Database available at: http://std.iec.ch/iec62474

• The IEC 62474 Validation Team (VT) maintains the information on the IEC 62474 Database

– Update one to three times per year (as required)

– Proactive screening of SVHCs (REACH Candidate List) for use in EEE

• Current Database Version:

– Declarable Substance List and Material Classes: D11.00

– Data Exchange (XML schema): X6.01

• Last updates: Dec 17, 2015 and March 28, 2016

– Added SVHCs, impact of ECJ ruling, and new reporting level

Updates to IEC 62474 Database

http://std.iec.ch/iec62474


• IEC TC111 WG1 has developed a guidance document

– Section 1 – Purpose

– Section 2 – Industry Needs & Benefits

– Section 3 – Approach & Flexibility of Standard

– Section 4 – User Examples

• Electronic Component

• Product Family of Capacitors

• Circuit Board Assembly with a battery

• Product which contains a substance under both REACH Annex XVII and SVHC Candidate list

• Power Adapter – example of declaring additional information and use of query list

• Thresholds referring to metals

User Guidance Document – IEC 62474-1


• Guidance on declaring optional information

• Complex declaration scenarios

– Constituents versus reaction chemicals

– Proprietary information (trade secrets)

– Substances that are really mixtures

– Complex substances such as UVCBs

• Interpretation of reporting thresholds and reportable applications

• Declaring exemptions

• Use of mass, mass percent (%) or material mass percent

• Interpretation of XML data fields that have a “conditional” obligation

• Absence Declaration

• Use of the query list feature

Some Topics in the User Guidance


• Adoption

– Several regions/countries have adopted as national standard

• EU (EN 62474), China (GB/Z 26668-2011), Brazil, ….

– Japan METI national material declaration program

• National program to utilize IEC 62474

• Maintenance is a required part of IEC standards

– Leverage best practices from industry standards

– Simplify implementation but maintain compatibility

• Forward compatibility of data

– New features

– Maintain key premise of calculating conformity to substance regulations

IEC 62474 Adoption and Maintenance


• Analytical test procedures measure the concentrations of substances in samples.

• Important for High Risk parts and materials

• Supplements Supplier Information

– Close gaps in incomplete supplier information

– Establish or confirm supplier capability

– Confirm compliance of Materials / Parts with a high risk of containing a regulated substance

• Random Testing as part of a quality assurance system

– Incoming, In-process, and/or outgoing inspection

The Role of Analytical Testing

Important Factors need to be considered for accuracy


Analytical Testing Considerations

• Specific testing techniques and sample preparation methods are generally required for different types of materials.

• Critical Factors Affecting Accuracy

– Sampling and sample preparation are critical to the accuracy of analytical tests.

– Measurement accuracy and calibration of lab equipment

• Test Method Limitations

– International Interlaboratory Studies showed variations for certain tests.

• Key Information provided in Test Reports


Importance of IEC 62321

• Reliable analytical testing for RoHS substances was an early priority for IEC/TC111

– Key concern for international trade and enforcement

• Accurate substance concentration levels near the legal thresholds are difficult to obtain

• When different test methods are being used, it is difficult to reconcile differences in test results.

• Consistent Use of IEC 62321 reduces business risk of non-compliance

– Recognized by enforcement authorities

• CB Scheme (conformity) established for certifying test labs to IEC 62321.


Project Title Status

IEC 62321-1 Part 1: Introduction and overview Published

IEC 62321-2 Part 2: Disassembly, disjunction and mechanical sample preparation Published

IEC 62321-3-1Part 3-1: Screening - Lead, mercury, cadmium, total chromium and total bromine using X-ray fluorescence spectrometry

Published

IEC 62321-3-2Part 3-2: Screening - Total bromine in polymers and electronics by Combustion - Ion Chromatography(in revision to include fluorine and chlorine)

Published

IEC 62321-4Part 4: Mercury in polymers, metals and electronics by CV-AAS, CV-AFS, ICP-OES and ICP-MS

Published

IEC 62321-5Part 5: Cadmium, lead and chromium in polymers and electronics and cadmium and lead in metals by AAS, AFS, ICP-OES and ICP-MS

Published

IEC 62321-6Part 6: Polybrominated biphenyls and polybrominated diphenyl ethers in polymers by gas chromatograhy -mass spectometry (GC-MS)

Published

IEC 62321-7-1Part 7-1: Hexavalent chromium - Presence of hexavalent chromium (Cr(VI)) in colourless and coloured corrosion-protected coatings on metals by the colorimetric method

Published

IEC 62321-7-2 Part 7-2: hexavalent chromium (Cr(VI)) in polymers and electronics by the colorimetric method.

In Ballot

IEC 62321-8 Part 8: Phthalates in polymers In Ballot

IEC 623321-9 Part 9: Hexabromocyclododecane (HBCDD) in polymers In Development

IEC 62321-10 Part 10: Polycyclic aromatic hydrocarbons (PAHs) in polymers and electronics In Development

IEC 62321-3-3Part 3-3: Screening of polybrominated biphenyls, polybrominated diphenyl ethers and phthalates in polymers by pyrolysis (Py-GC-MS) or thermal desorption (TD-GC-MS) gas chromatography-mass spectrometry

In Development

Testing for Substances in EEE


IEC 62476: Product Evaluation

• Evaluation of product based on information acquired.

– Sufficient valid information is available for all the materials, parts, and subassemblies composing the product; and

– All the materials, parts, and subassemblies meet restricted substance requirements.

• Decide if additional information/data is needed.

– Re-evaluate if result was not satisfactory

• Re-evaluate the product whenever aspects that could impact the use of restricted substances occur


• Content of the technical documentation

• Information on materials, parts, and/or sub-assemblies

– Tasks to be undertaken by the manufacturer

– Determine the information needed

• Risk assessment for material risk and supplier risk -> what information is necessary

– Information on materials, parts, and/or sub-assemblies

– Collecting information

– Evaluation of information

• Assessment of the documentation received is critical to effective restricted substance controls

– Review of the technical documentation

Technical Documentation (EN 50581/IEC 63000)


• Title: Technical documentation for the assessment of electrical and electronic products with

respect to the restriction of hazardous substances

• Scope:

– opportunity to use for any substance restriction

• Clarification of requirements:

– supplier documentation such as declaration of conformity and material declaration

– Figure 1 representation of process to create the technical documentation

• Status:

– Has been on a fast track within committee

– draft completed; voting closes on July 1, 2016

IEC 63000

International Standard enables harmonization across countries


IEC 62476 Summary

• Define, document and execute Restricted Substance Controls for all operations related to the product

• Identify potential sources of non-compliance

• Leverage risk-based assessment approaches and methods.

• Ensure the execution of adequate RSC by suppliers

• Provides flexibility in implementation

– Restricted Substance Controls are specific to a producer

– Application of evaluation strategies and methods

• Maintain technical documentation that demonstrates effective RSC.


Walter JagerECD Compliance

[email protected]

www.ECDcompliance.comwww.rohs.ca

.

Thank you

Questions?

Environmental

Energy Efficiency

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October 20, 2016 | Chicago

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December 1, 2016

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