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Alberi EcoTech, LLC © 2011 All Rights ReservedAlberi EcoTech, LLC © 2011 All Rights Reserved
Product Environmental Compliance UpdateREACH, RoHS, CM
Krista CrottyAlberi EcoTech LLC
Las Vegas, NV
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Agenda
REACH RoHS Recast Dodd-Frank Act (Conflict Minerals) Audits Benchmarking & Lessons Learned Question & Answer time
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REACH:For Articles Manufacturers
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Entered into force 1 June 2007 Why is it needed?
– Insufficient information on hazardous chemicals– Risk/Management / data transfer in sufficient
Aim– Improve protection on human health / environment– Better and earlier identification of intrinsic properties of
chemicals– Enhance innovation and competitiveness of EU chemicals
industry Administration
– ECHA – European Chemicals Agency (Helsinki)
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At a glance...
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http://echa.europa.eu/chem_data/authorisation_process/candidate_list_table_en.asp
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REACH SVHCs listing
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Alkanes, C10-13, chloro (Short Chain Chlorinated Paraffins)
Diisobutyl phthalate
Benzyl butyl phthalate (BBP) Disodium tetraborate, anhydrousBis (2-ethylhexyl)phthalate (DEHP) Hexabromocyclododecane (HBCDD) and all
major diastereoisomers identified:Alpha-hexabromocyclododecaneBeta-hexabromocyclododecaneGamma-hexabromocyclododecane
Bis(tributyltin)oxide (TBTO) Lead chromateBoric acid Lead chromate molybdate sulphate red (C.I.
Pigment Red 104)Cobalt dichloride Lead sulfochromate yellow (C.I. Pigment Yellow
34)Diarsenic pentaoxide Tetraboron disodium heptaoxide, hydrateDiarsenic trioxide Tris(2-chloroethyl)phosphateDibutyl phthalate (DBP)
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The potential EEE SVHC List
http://echa.europa.eu/chem_data/authorisation_process/candidate_list_table_en.asp
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Timeline for Registration2010 registration closed
21k substances submitted3,400 phase-in substances
Pre-registration is closed2M pre-registrations143K substances by
65k companies
Source: ECHA
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Registration of substances greater than 1 ton/year Communication along supply chain
– REACH status– Registration number– Application– Risk Management Measures– e-MSDS
Measure related to EHS (environment, health, safety) Continuous updates on chemical safety reports (CSR) Classification and labeling of inventory
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Duties – Substance/Mixture Manufacturers
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Information exchange – regardless of application– Upstream, downstream
Risk evaluation for applications (e-MSDS) Notification of applications which are not supported by
the supplier Implementation of risk management measures
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Duties – Downstream users
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10
Authorization vs. RestrictionAuthorization Restriction
Applicable to all kinds of usage (as long as not exempted)
Possibility to forbid all / specific uses of substance
Limited to SVHC substances No limitation
Applies to use of articles produced within EU
Applies to all imported products
Industry has to submit request for authorization
Restriction dossier created by EC
Authorized use possible No use possible
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MSDS for SVHCs MSDS for mixtures including SVHCs > 0.1%
required MSDS for non-hazardous mixtures on demand
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Information Duties – manufacturers of substances/mixtures
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Substances(SVHC) present above 0.1% w/w in article
Information transfer to industrial and consumers alike
From 1 Dec 2011: ECHA must be notified of SVHC in article
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Information Duties – manufacturers of articles
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Other Legislation:RoHS Recast, Conflict Minerals
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RoHS Recast Current:
◦ With member states for transposition into National Law Dates of compliance:
◦ All products (except as listed below)• 1 January 2013
◦ Medical Devices:• General: 22 July 2014• Invitro: 22 July 2016• Implantable: review in 2020
◦ Monitoring and Control Instrumentation• General: 22 July 2014• Industrial: 22 July 2017
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RoHS Recast – Spare Parts RoHS limits* shall not apply to cables or spare parts for the
repair, reuse, the updating of functionalitites or upgrading of capacity of the following:◦ (a) EEE placed on the market before 1 July 2006; ◦ (b) medical devices placed on the market before 22 July 2014; ◦ (c) in vitro diagnostic medical devices placed on the market
before 22 July 2016; ◦ (d) monitoring and control instruments placed on the market
before 22 July 2014; ◦ (e) industrial monitoring and control instruments placed on the
market before 22 July 2017; ◦ (f) EEE which benefited from an exemption and which was
placed on the market before that exemption expired as far as that specific exemption is concerned.
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RoHS Recast – spares, exemptions, etc.
Spare Parts:◦ RoHS Limits* shall not apply to reused spare parts, recovered
from EEE placed on the market before 1 July 2006 and used in equipment placed on the market before 1 July 2016, provided that reuse takes place in auditable closed-loop business-to-business return systems, and that the reuse of parts is notified to the consumer.
◦ *** shall not apply to the applications listed in Annexes III and IV (exemptions listings).
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RoHS & CE Mark Affixed to final product
Visibly, legibly, and indelibly If not on the final product, on the
packaging or accompanying documents Test houses unfamiliar with RoHS General principles – Article 14
EU Regulation 765/2008 – Article 30
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Other Changes Updated and expanded Definitions Expanded information on manufacturers, distributors, importers, authorized representatives Addition of Category 11 – any electronic product not specifically mentioned in the previous 10 categories.
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Conflict minerals:Waiting for the SEC...
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Terminology
“Conflict minerals” (§1502(e)(4) )Coltan, cassiterite, gold, wolframite, or their derivatives (common names: tantalum, tin, gold, tungsten)
“DRC conflict free minerals” (§1502(b))Product that do not contain minerals that directly or indirectly finance or benefit armed groups in the DRC or adjoining countries
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Dodd-Frank Act – Section 1502 Background:
◦ Passed in 2010 Dates of compliance:
◦ 1st Fiscal year after rulemaking (potentially in flux)
Current:◦ Waiting on SEC Rulemaking / guidelines to be released◦ Comments were taken until 01 Nov 2011◦ Several industry groups compiled comments around timing
for implementation, auditing, Dates of compliance: (in flux)
◦ 1st Fiscal year after rulemaking
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Audits:Preparing, Implementing, Surviving
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Government/Enforcement◦ Government checking on compliance◦ Enforcement agency check on compliance
Corporate◦ Business to business, customer to supplier,
supplier to customer
Regardless of audit type, mistakes are common across industries and companies.
Types of Audits
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Responsiveness – timely and complete◦ Timely
REACH: SVHC disclosure at time of shipment◦ Complete technical compliance file available to
auditor: eMSDS3rd party Audits of suppliersLegal classification of item Application of useRisk assessmentsInternal Policies and proceduresTest strategy & results
Aspects of a “Successful” Audit
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Assume nothing◦ Auditor will not familiar with your company or
products Be responsive
◦ Provide information in a timely manner◦ Provide complete technical compliance file; not
just materials information Prepare for/Anticipate questions
Audit Survival Tips
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Benchmarking Lessons Learned:Process, Data, Education, Audit
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Lessons Learned & Best Practices Lesson: Process approach
◦ With the constant possibility of changes to any product eco-compliance legislation, a process needs to be implemented; not simply a project for each type of legislation.
Best Practices: ◦ Ability to track products by compliance to multiple
requirements and legislative requirements◦ Methodology for auditing, tracking, and developing
suppliers.EU vs China, RoHS vs. REACH, USA by state
◦ Implementation of the next three lessons learned and best practices.
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Lessons Learned & Best Practices Lesson: More than materials documents
◦ More and more countries are creating requirements for materials reporting requirements or materials restrictions.
◦ During enforcement, auditors look at the total package, not just materials information.
◦ Countries with existing requirements are look at adding additional substances.
Best Practices:◦ Risk Matrix for materials, parts, suppliers.◦ Information by CAS number◦ Risk assessment / usage tables◦ Ability to search database for specific substance◦ Test matrix & strategy
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Lessons Learned & Best Practices Lesson: Keep informed
◦ With changes happening for existing legislation and new legislation being created, one needs a good service for keeping informed.
Best Practices: ◦ Industry involvement◦ News Services, newsletters, annual audit reviews◦ Targeted reports – not general knowledge databases or
“tech rags”Several services provide news; few provide only the info you need or assist with interpretation and action on changesBe wary of tech rags and make sure the information you’re using comes from a reputable source.
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Lessons Learned & Best Practices Lesson: Be ready for an audit
◦ No longer just government audits◦ Customers or suppliers audits are more and more common
Best Practices: ◦ Turn around time to deliver information varies
− Immediate, 24 Hours, 1 week, 1 month, on-going
◦ Remote access to data & informationTechnical compliance files should include: materials data, usage cases, corporate policies and procedures, classification/ justification documents, roadmap(s) of activities
◦ Information by substance, component, productInformation should be searchable by component, CAS number, supplier status, substance, exemption/variation
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EcoTech legislation world-wide:Looking back to prepare for the future
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Partial Listing of EcoTech Legislation Europe - EU
◦ REACH – 2007, ‘08, ’09, ‘10, '11◦ RoHS – 2003, ‘11◦ WEEE – 2003, ‘11◦ EuP – 2006, ‘08
Asia◦ China RoHS – 2006, ‘07, ’09◦ S. Korea RoHS/ELV/WEEE 2007◦ Japan JGPSSI◦ Japan – JAMP◦ Taiwan RoHS – 2006
USA◦ Conflict Minerals◦ CPSIA
State level:◦ Several
states/municipalities with e-waste legislation
◦ Several states with hazardous substance restrictions/bans
◦ CA-Prop65
South America◦ Argentina, Brazil, Chile,
Columbia, Venezuela w/e-waste legislation
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It’s a Process, not a project◦ Changing critical thinking
− Go beyond data and information on restricted substances
◦ Risk Minimization, Elimination− Process-based approach− Risk analysis, matrix
◦ Crisp presentation of corporate environmental stewardship
EcoTech compliance
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Websites of interest REACH
◦ http://echa.europa.eu/home_en.asp◦ http://echa.europa.eu/chem_data/authorisation_process/candidate_li
st_table_en.asp
RoHS◦ http://www.bis.gov.uk/nmo/enforcement/rohs-home
Conflict minerals◦ http://www.ipc.org/ContentPage.aspx?pageid=Conflict-Minerals
General Info, news, events, training◦ http://www.alberiecotech.com
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Krista CrottyFounder, Chief EcoGeek
702.677.6923www.AlberiEcoTech.com
[email protected] / [email protected]/in/KristaCrotty
Thank you!