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Restricted Substances, April 2007
1
www.intertek.com
Ensuring Compliance to the Restricted Substances Directives
The Global Chemical Compliance Challenge Dr. Ruud A. Overbeek [email protected]
Global Director
Restricted Hazardous Substances
Intertek Groupwww.intertek-rohs.com
April 2007
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Profile
• An extensive global network– Laboratories /Offices 930
– People 18,000
– Countries 110
• Floated May 2002
• Company heritage dating back to Thomas Edison (1891)
• FTSE 250, London, Support Services sector
• Market capitalisation at 15 March 2007 £1.38bn ($2.7bn)
• 2006 revenues £665mn ($1.3bn)
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ConsumerConsumer
GoodsGoods
Oil, Chemical Oil, Chemical & Agri& Agri
Commercial & Commercial & ElectricalElectrical
Government Government ServicesServices
• Import duty assessment• Standards testing• Industrial inspection• Container scanning
• Textiles, Toys, Hardlines• Food• Consumer goods• Supply Chain Management• Social & Environmental Compliance
• Oil, Petroleum & Gas• Automotive• Chemical• Agricultural products• Laboratory Outsourcing
• Electrical and Electronic, Telecom, HVAC• Medical Equipment• Building products • Systems Certification Services• Automotive
• Environmental Product Compliance: needs and requirements growing and services provided in every sector!
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• All global E&E compliance and certification solutions (chemical, electrical, safety, systems) under a single expert umbrella
• Linkage of global electrical capabilities and network with chemicals and consumer goods capabilities, expertise and network
• Strong presence in Far East and other manufacturing nations
ETL Listed Mark (U.S. and Canada)
S Mark (Europe)
Geprüfte Sicherheit (GS) Mark (Europe)
CE Mark(Europe)
Intertek RoHS Mark(EU and more)
Why Intertek?
Intertek Systems Certification
Restricted Substances, April 2007
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Environmental Product Compliance
A Multi-Dimensional Global Challenge
• By Country
• By Application (= product category)
• Managing Customer Expectations
• Handling NGO pressure
• Meeting Legislation and Regulation
• RoHS, REACH, VOC emissions, and others
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StateLaws
WEEE/RoHS
REACH
EUP
ChinaRoHS
JGPSSIELV
KoreanRoHS
JapanRoHS
Austr.RoHS
The Global Challenge
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And A Real Life Problem
• Chromium VI
• Cadmium
• Lead
• Mercury
• PBB
• PBDE
=
Erin Brockovic: Cr VI in
water supply
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EU RoHS – A Summary
• Restriction of the use of certain Hazardous Substances– Covers 6 known hazardous substances in EEE (Pb, Cd, Hg, Cr VI, PBB,
PBDE) in homogeneous materials– Specific application exemptions (29 published) and covered product
categories
• “Putting a Product on the Market” implies Compliance (presumption of compliance)
• Strict liability– Exceeding the Maximum Concentration Values without an exemption
is a violation and likely a prohibition on sale
• Enforcement authorities may take whatever actions appropriate to the circumstances and to the powers assigned to them – Largest impact of non-conformance is loss of sales!
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Level of Compliance Support Required
Solders, finishes, plastics, metals, etc.
Example: capacitor
Six different materials requiring
compliance documentation
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EU RoHS Directive – Direct Impact
• Millions of products affected and any organization involved in the production, sale or distribution of E&E equipment in the EU market
• Covers E&E equipment categories:– Large and small household appliances– IT & telecommunications equipment– Consumer equipment, such as TV’s, DVD/CD players– Lighting equipment, including filament light bulbs & household
luminaires– Electrical & electronic tools, such as DIY and gardening tools
– Except large stationary industrial tools– Toys, leisure & sports equipment– Automatic dispensers, such as ATM’s, drink dispensers
• Exemption (temporary) for medical devices and monitoring and control equipment
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EU RoHS Directive – Indirect Impact
• Industry conversion to RoHS compliant leads to component obsolescence
• Limited availability of non-RoHS compliant parts
• Cost of End of Life events or non-compliant parts
• Manufacturing processes conversion related to component changes
• Issues with equipment not sufficiently tested for reliability and sustained performance
• Recertification needs for converted equipment (e.g., Electrical Safety)
• Differentiator for companies that have converted to RoHS compliant
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EU RoHS Enforcement
• Enforcement guidance provides self-declaration “requirements”:1. Initial provision of compliance documentation for
homogeneous materials in products/parts2. Documentary evidence of more structured internal
systems demonstrating a producer’s ability to manage RoHS compliance
• And approach to RoHS compliance investigations:1. Initial self-declaration; 2. More detailed assessment in those cases where
evidence from producers does not support compliance;3. In cases of concern, detailed sampling and testing
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How Prepared is the Industry?
• Received notice that UK’s National Weights and Measures has started enforcement process focusing on high volume products– None of the items NWS tested so far was compliant
• According to Forbes, Palm and Apple have voluntarily withdrawn various products due to non-compliance with the RoHS directive– Forbes.com News August 14, 2006
• According to a newspaper in Taiwan up to five of Taiwan's electronics companies have been fined for failure to meet RoHS:– One company had NT$100mm (US$3.1mm) merchandise returned
• Intertek review of manufacturer and supplier documentation has so far exposed major compliance gaps (>50% failed to support compliance)
Restricted Substances, April 2007
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EU RoHS Copycats
The Multi-Dimensional Global Compliance Challenge
Restricted Substances, April 2007
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California RoHS
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California RoHS Background
The Electronic Waste Recycling Act (EWRA), which was signed into law in September of 2003, requires the Department of Toxic Substances Control (DTSC) to adopt regulations to prohibit covered electronic devices, as defined, ” from being “sold or offered for sale” in California if they are prohibited from sale in the European Union (EU) because they contain certain heavy metals
Effective January 1, 2007
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Current Scope of California RoHS
• Covered Electronic Devices– Cathode ray tube containing devices (CRT devices) – Cathode ray tubes (CRTs) – Computer monitors containing cathode ray tubes – Laptop computers with liquid crystal display (LCD) – LCD containing desktop – Televisions containing cathode ray tubes – Televisions containing liquid crystal display (LCD) screens – Plasma televisions
• MCV’s currently only applicable to the heavy metals
• Plan to fully adapt to EU RoHS
Applicable only to devices with a video display screen 4” or larger, measured diagonally.
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Manufacturers Registration & Reporting
• No registration required by the EWRA
• Regulations require manufacturers to submit an annual report to CIWMB that includes information on the use of restricted substances in covered electronic devices
• Reports are due by July 1 and cover products sold during previous calendar year
• Manufacturers are required to provide the “estimated average amount in milligrams for mercury, cadmium, lead, hexavalent chromium, including their alloys and compounds, and PBBs used in covered electronic devices, and all their component parts by product category.”
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California vs. EU RoHS
• Metals only – Pb, Hg, Cr6+ <1000 PPM– Cd <100 PPM
• MCV’s also apply to a “homogeneous material”
• Reporting requirements
• Other RS Bans in California– pentaBDE and octoBDE ban: AB302 / 2587 / 263– Hg relays/switches ban: AB1415 / SB423
• Health and safety Code precludes DTSC from prohibiting sales of devices not covered under EU RoHS Directive
– California recognizes same exemptions as EU– Thus far narrower scope of devices covered
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China RoHS
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China RoHS Background
• Administrative Measure on the Control of Pollution Caused by Electronic Information Products (EIP)– EIP selling in the China market, excluding export and
military products
• Regulation - March 1, 2007
• Regulates same Restricted Substances: Pb, Cd, Hg, Cr VI, PBB and PBDE– Standards Establishment
– Catalogue Management
– Hazardous Substances Substitution
Website http://www.mii.gov.cn/art/2006/03/16/art_1221_8441.html
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“China RoHS”
• The Administrative Measure adopts a “two-step” approach:
• Step 1: Labeling to inform downstream users (consumers) on:• Names and contents of toxic and hazardous substances, • Environment-friendly use period, and• Product Recyclability
• Step 2: When listed in the Administrative Catalogue, • Products should meet the limit(s) set by the standard(s) for
toxic and hazardous substances• Products must meet 3C certification before entering the
market!• Step 2 MCV’s same as EU but applied to 3 groups
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For all EIPsSelf-declaration
Entry market
Products inCatalogue
Self-declaration +3C certification
Entry market
Entry Catalogue
EIPsentering market –
by Marking & Labeling
EIPs in Catalogueentering market –admittance control
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Other RoHS-like requirements – Japan, Korea
• Japan “RoHS” (J-MOSS) – July 1st, 2006– Promoting the use of recyclable resources by providing
information on chemical substances contained in EEE– Same 6 substances, MCV’s, for seven types of EEE– Compulsory content Marking requirement in Japanese
language
• Korea’s “Act for Resource Recycling of Electrical/Electronic Products and Automobiles” – proposed into force Jan 1st, 2008– Incorporates aspects of RoHS, WEEE, ELV and EuP– Also a self-declaration process, requiring a mark– Manufacturers must maintain compliance records in a
centralized database– Only for new products “put on the market”
Restricted Substances, April 2007
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www.intertek.com
Need to Know?Managing Environmental Product Compliance
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What Chemicals are Used in Your Products?
• Need to know at least concentrations of 6 RoHS Substances
• Labeling
• Disclosure
• Bans / Self declaration
• Disclosure of other Substances• Extended material declarations (JIG, OEM/Brand specific)
• Proposition 65
• REACH!
• It comes down to managing information and risk
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Intertek’s Steps to Managing Risk…
• Manage the Supply Chain!!
• Collect available information
• Verify collected information and fill in compliance gaps
• Execute risk-based assessments– Chemical risk, Exposure risk, Supplier risk, etc.
• Store information and frequently audit and update the information from the supply chain
• Where possible, minimize failure!– Certification (Products and System)– Assessments (Suppliers, Risk, Product, Legislation, Automatic)
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Documentation Review
By client or Intertek
ISCAN
TCF Builder
BOM Review
Intertek specialists accessing information and databases
Uploaded Supplier CoC’s/SDoC’s + supporting documentation
Compliant P/N definition
Risk-based Monitoring: e.g., Supplier Performance, Audits,
Product Testing, Inspection
Statistics, Status Reporting, TCF Monitor
Optional Product
Certification
… Is Building a Technical Compliance File
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Documentation Review
By client or Intertek
ISCAN
TCF Builder
BOM Review
Intertek specialists accessing information and databases
Uploaded Supplier CoC’s/SDoC’s + supporting documentation
Compliant P/N definition
Optional Product
Certification
Risk-based Monitoring: e.g., Supplier Performance, Audits,
Product Testing, Inspection
Statistics, Status Reporting, TCF Monitor
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• Tool specifically developed to facilitate the chemical compliance process
• Web-based with 4 major functions:
1. Compliance Data:• Complete product manifestation• Appropriate compliance
documentation• A conformity report will be issued
when required documentation is in place and meets compliance criteria established
2. Compliance Data Control
3. Interactive Platform for Stakeholders
4. Data analysis
ISCAN – Intertek Supply Chain Assurance Network
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Documentation Review
By client or Intertek
ISCAN
TCF Builder
BOM Review
Intertek specialists accessing information and databases
Uploaded Supplier CoC’s/SDoC’s + supporting documentation
Compliant P/N definition
Risk-based Monitoring: e.g., Supplier Performance, Audits,
Product Testing, Inspection
Statistics, Status Reporting, TCF Monitor
Optional Product
Certification
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STEP 1. - STEP 1. - RoHS AUDIT AND/OR MANUAL DOCUMENTATION REVIEWRoHS AUDIT AND/OR MANUAL DOCUMENTATION REVIEW IDENTIFYING THE RISK GRADING OF SUPPLIERS BASED ON THEIR DOCUMENTATION AND/OR SYSTEMIDENTIFYING THE RISK GRADING OF SUPPLIERS BASED ON THEIR DOCUMENTATION AND/OR SYSTEM
COMPANY or INTERTEKCOMPANY or INTERTEK
STEP 2. -STEP 2. - RE-AUDIT (IF APPLICABLE)RE-AUDIT (IF APPLICABLE)FOR NEW DOCUMENTATION PROVIDED, OR NEW PARTS, OR WHEN FAILEDFOR NEW DOCUMENTATION PROVIDED, OR NEW PARTS, OR WHEN FAILED
COMPANY or INTERTEKCOMPANY or INTERTEK
STEP 3. -STEP 3. - SCANTEST FINISHED PRODUCT TESTINGSCANTEST FINISHED PRODUCT TESTINGX% OF WET CHEMICAL TEST: Y% OF XRF SCREENINGX% OF WET CHEMICAL TEST: Y% OF XRF SCREENING
INTERTEK INTERTEK
STEP 4. -STEP 4. - MASS PRODUCTION SAMPLINGMASS PRODUCTION SAMPLINGXRF (ON-SITE) INSPECTION, AND FOLLOW-UP XRF (ON-SITE) INSPECTION, AND FOLLOW-UP TESTING IF NECESSARYTESTING IF NECESSARY
INTERTEKINTERTEK
Intertek Verification Program
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Documentation Review
By client or Intertek
ISCAN
TCF Builder
BOM Review
Intertek specialists accessing information and databases
Uploaded Supplier CoC’s/SDoC’s + supporting documentation
Compliant P/N definition
Risk-based Monitoring: e.g., Supplier Performance, Audits,
Product Testing, Inspection
Statistics, Status Reporting, TCF Monitor
Optional Product
Certification
34www.intertek.com Restricted Substances, April 2007
Product Certification
• Upon receiving documents from laboratories and inspection body, certification process starts
• If satisfactory, the Intertek RoHS certificate is issued to clients.
• Based on the certificate, clients can label the Intertek RoHS Certification Mark on certified products, components or materials
Type Testing and Documentation
Review
• A compliance file is built as the client submits documentation
• Document review done by Intertek and a test plan is drafted
• Due Diligence Testing by Intertek test labs to verify test reports/data or fill in missing documentation gaps
Factory Surveillance
• Initial Factory Audit
• Annual follow up factory surveillance and follow up testing where required
• Factory surveillance done by nearest competent Intertek Office to save time and cost for clients
RoHS Certification Steps
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Documentation Review
By client or Intertek
ISCAN
TCF Builder
BOM Review
Intertek specialists accessing information and databases
Uploaded Supplier CoC’s/SDoC’s + supporting documentation
Compliant P/N definition
Risk-based Monitoring: e.g., Supplier Performance, Audits,
Product Testing, Inspection
Statistics, Status Reporting, TCF Monitor
Plan
Do
Check
ActOptional Product
Certification
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China RoHS Services
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Additional Capabilities: China RoHS Services
• EIP Categorization: Intertek “Letter of Information”
• Hazardous Substance Table Development (Step 1)
– Determination of hazardous substances:• Testing • Documentation review • Design of the hazardous substance table - translation of components/parts
into Chinese
• Logo recommendation and Packaging Marking
• Intertek RoHS laboratories w/w are recognized by CIQ to support China RoHS CCC Certification Program
• Mandatory CCC Certification officially supported only by 18 China designated governmental bodies
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In Summary:
Two Simple, Applicable Models
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“Design & Manufacture” Model (own control)
• Building a technical compliance file, TCF by:– collecting material declarations
– reviewing and verifying material declarations
– assessing risk based on the collected material declarations
– verification of compliance
• Implementation of a restricted substances control, RS, management system via:– RS control management system assessment
– RS management system implementation
– RS Compliance Inspection during manufacturing (integrated service)
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“Outsourced Manufacture” Model (supplier control)
• Assuring that the Contract Manufacturer’s product technical compliance file (TCF) is in place and is sufficient to support compliance by:– reviewing of part, component and material declarations by means of
sampling
– assessing risk based on the integrity of the manufacturer declarations
– verification of compliance when necessary
• Assuring that Contract Manufacturer has an adequate restricted substances control management system and policy in place via:– Management system assessment
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Contact Us
Websites:
• www.intertek.com
• www.intertek-rohs.com
• www.intertek-etlsemko.com
E-mail:
• [email protected] www.intertek-rohs.com