Transcript Slide 1

Ensuring Compliance to the
Restricted Substances Directives
The Global Chemical Compliance Challenge
Dr. Ruud A. Overbeek
[email protected]
Global Director
Restricted Hazardous Substances
Intertek Group
www.intertek-rohs.com
April 2007
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Profile
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An extensive global network
– Laboratories/Offices 930
– People
– Countries
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18,000
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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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Textiles, Toys, Hardlines
Food
Consumer goods
Supply Chain Management
Social & Environmental Compliance
Oil, Chemical
& Agri
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Oil, Petroleum & Gas
Automotive
Chemical
Agricultural products
Laboratory Outsourcing
Commercial &
Electrical
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Electrical and Electronic, Telecom, HVAC
Medical Equipment
Building products
Systems Certification Services
Automotive
Government
Services
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Import duty assessment
Standards testing
Industrial inspection
Container scanning
Consumer
Goods
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Environmental Product Compliance: needs and requirements growing
and services provided in every sector!
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Why Intertek?
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All global E&E compliance and certification solutions (chemical,
electrical, safety, systems) under a single expert umbrella
ETL Listed Mark
(U.S. and Canada)
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Geprüfte Sicherheit (GS)
Mark (Europe)
S Mark (Europe)
CE Mark
(Europe)
Intertek RoHS Mark
(EU and more)
Intertek Systems
Certification
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
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Environmental Product Compliance
A Multi-Dimensional Global Challenge
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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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The Global Challenge
WEEE/
RoHS
State
Laws
ELV
EUP
REACH
Korean
RoHS
China
RoHS
JGPSSI
Japan
RoHS
Austr.
RoHS
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And A Real Life Problem
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Chromium VI
Cadmium
Lead
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Mercury
PBB
PBDE
Erin Brockovic:
Cr VI in
water supply
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EU RoHS – A Summary
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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
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“Putting a Product on the Market” implies Compliance (presumption
of compliance)
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Strict liability
– Exceeding the Maximum Concentration Values without an exemption
is a violation and likely a prohibition on sale
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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
Example: capacitor
Six different
materials requiring
compliance documentation
Solders, finishes, plastics, metals, etc.
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EU RoHS Directive – Direct Impact
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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:
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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
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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
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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
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Enforcement guidance provides self-declaration “requirements”:
1. Initial provision of compliance documentation for
homogeneous materials in products/parts
2. Documentary evidence of more structured internal
systems demonstrating a producer’s ability to manage
RoHS compliance
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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?
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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
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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
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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
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Intertek review of manufacturer and supplier documentation has so
far exposed major compliance gaps (>50% failed to support
compliance)
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EU RoHS Copycats
The Multi-Dimensional Global
Compliance Challenge
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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
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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
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Metals only
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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
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Health and safety Code precludes DTSC from prohibiting
sales of devices not covered under EU RoHS Directive
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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
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Administrative Measure on the Control of Pollution
Caused by Electronic Information Products (EIP)
– EIP selling in the China market, excluding export and
military products
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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”
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The Administrative Measure adopts a “two-step” approach:
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Step 1: Labeling to inform downstream users (consumers) on:
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Step 2: When listed in the Administrative Catalogue,
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Names and contents of toxic and hazardous substances,
Environment-friendly use period, and
Product Recyclability
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 EIPs
Self-declaration
Entry market
EIPs
entering market –
by Marking &
Labeling
Entry market
EIPs in Catalogue
entering market –
admittance control
Entry
Catalogue
Products in
Catalogue
Self-declaration +
3C certification
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Other RoHS-like requirements – Japan, Korea
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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
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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”
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Need to Know?
Managing Environmental Product Compliance
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Restricted Substances, April 2007
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What Chemicals are Used in Your Products?
• Need to know at least concentrations of 6 RoHS
Substances
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Labeling
Disclosure
Bans / Self declaration
• Disclosure of other Substances
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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…
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Manage the Supply Chain!!
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Collect available information
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Verify collected information and fill in compliance gaps
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Execute risk-based assessments
– Chemical risk, Exposure risk, Supplier risk, etc.
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Store information and frequently audit and update the information
from the supply chain
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Where possible, minimize failure!
– Certification (Products and System)
– Assessments (Suppliers, Risk, Product, Legislation, Automatic)
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… Is Building a Technical Compliance File
Optional
Product
Certification
Statistics, Status Reporting,
TCF Monitor
Compliant P/N
definition
ISCAN
TCF Builder
Risk-based Monitoring: e.g.,
Supplier Performance, Audits,
Product Testing, Inspection
Documentation Review
BOM Review
By client or Intertek
Intertek specialists accessing
information and databases
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Uploaded Supplier CoC’s/SDoC’s
+ supporting documentation
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Optional
Product
Certification
Statistics, Status Reporting,
TCF Monitor
Compliant P/N
definition
ISCAN
TCF Builder
Risk-based Monitoring: e.g.,
Supplier Performance, Audits,
Product Testing, Inspection
Documentation Review
BOM Review
By client or Intertek
Intertek specialists accessing
information and databases
Restricted Substances, April 2007
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Uploaded Supplier CoC’s/SDoC’s
+ supporting documentation
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ISCAN – Intertek Supply Chain Assurance Network
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Tool specifically developed to facilitate
the chemical compliance process
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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
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Optional
Product
Certification
Statistics, Status Reporting,
TCF Monitor
Compliant P/N
definition
ISCAN
TCF Builder
Risk-based Monitoring: e.g.,
Supplier Performance, Audits,
Product Testing, Inspection
Documentation Review
BOM Review
By client or Intertek
Intertek specialists accessing
information and databases
Restricted Substances, April 2007
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Uploaded Supplier CoC’s/SDoC’s
+ supporting documentation
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Intertek Verification Program
INTERTEK
STEP 4. - MASS PRODUCTION SAMPLING
XRF (ON-SITE) INSPECTION, AND FOLLOW-UP
TESTING IF NECESSARY
INTERTEK
STEP 3. - SCANTEST FINISHED PRODUCT TESTING
X% OF WET CHEMICAL TEST: Y% OF XRF SCREENING
COMPANY or INTERTEK
STEP 2. - RE-AUDIT (IF APPLICABLE)
FOR NEW DOCUMENTATION PROVIDED, OR NEW PARTS, OR WHEN FAILED
COMPANY or INTERTEK
STEP 1. - RoHS AUDIT AND/OR MANUAL DOCUMENTATION REVIEW
IDENTIFYING THE RISK GRADING OF SUPPLIERS BASED ON THEIR DOCUMENTATION AND/OR SYSTEM
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Optional
Product
Certification
Statistics, Status Reporting,
TCF Monitor
Compliant P/N
definition
ISCAN
TCF Builder
Risk-based Monitoring: e.g.,
Supplier Performance, Audits,
Product Testing, Inspection
Documentation Review
BOM Review
By client or Intertek
Intertek specialists accessing
information and databases
Restricted Substances, April 2007
www.intertek.com
Uploaded Supplier CoC’s/SDoC’s
+ supporting documentation
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RoHS Certification Steps
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
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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
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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
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Plan
Optional
Product
Certification
Do
Act
Check
Statistics, Status Reporting,
TCF Monitor
Compliant P/N
definition
ISCAN
TCF Builder
Risk-based Monitoring: e.g.,
Supplier Performance, Audits,
Product Testing, Inspection
Documentation Review
BOM Review
By client or Intertek
Intertek specialists accessing
information and databases
Restricted Substances, April 2007
www.intertek.com
Uploaded Supplier CoC’s/SDoC’s
+ supporting documentation
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China RoHS Services
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Additional Capabilities: China RoHS Services
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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
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Logo recommendation and Packaging Marking
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Mandatory CCC Certification officially supported only by 18
China designated governmental bodies
Intertek RoHS laboratories w/w are recognized by CIQ to
support China RoHS CCC Certification Program
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In Summary:
Two Simple, Applicable Models
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“Design & Manufacture” Model (own control)
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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
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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)
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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
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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]
• [email protected]
• [email protected]
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www.intertek-rohs.com
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