Transcript Understanding the Consumer Product Safety Modernization Act

EU RoHS AMENDMENTS:
Meet the New RoHS. Same as
the Old RoHS?
Information Technology Industry Council
Spring Meeting
March 19, 2009
Jean-Cyril Walker
Partner
Keller and Heckman LLP
1001 G St., NW
Washington, D.C. 20001
202-434-4181
[email protected]
www.khlaw.com
Washington, D.C. ● Brussels ● San Francisco ● Shanghai
Why revise RoHS?
 Review required under Article 6 of current directive
 Clearer directive – simpler in operation
 Improve enforcement at the national level
 Adapt to technical and scientific progress
 Complement and increase coherence with other EU
legislation
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Summary of Key Changes
• Change to RoHS scope
• Use of REACH methodology for new substances
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No new substances proposed
• RoHS exemptions - limited to 4 years – new review
mechanism
• Incorporate Market Surveillance to reduce non-compliant
products
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Changes to RoHS Scope
• Basic objectives remain the same
• RoHS de-linked from WEEE
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WEEE Categories 8 & 9 added
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Medical devices, monitoring and control instruments – 1/2014
In vitro diagnostic and medical devices – 1/2016
Industrial monitoring and control instruments – 1/2017
Active implantable medical devices – TBD by 2020
• Excludes spare parts for repair or re-use
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“Placed on the market” before 7/1/2006
Category 8 & 9 products placed on the market before dates above
Equipment subject to an exemption and placed on market before
exemption expires
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New Substances
• Based on unacceptable risk to human health or environment
• Substances to be chosen “based on” Articles 69-72 of
REACH (lengthy process)
• Particular attention to substances in Articles III
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Hexabromocyclododecane (HBCDD)
Diethylhexyl phthalate (DEHP)
Butyl benzyl phthalate (BBP)
Dibutyl phthalate (DBP)
!!!! TBBPA – not listed for consideration!!!
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Changes to Exemption Process
• 4 year limitation – subject to renewal
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Submit renewal requests 18 months before expiration
• Additional exemption criteria
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Availability and reliability of substitutes
Consideration of “socio-economic” factors
• Exemption review – should be less political
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Dealt with by TAC not Parliament & Council
• Commission to develop rules for exemption process
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Application data
Substitution plan (in line with REACH)
• Decision process – need for certainty pending decision
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Market Surveillances
• RoHS II to incorporate new legislative framework
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Specifies obligations – manufacturers, imports, distributors
- Sample testing
- Identification labeling
- Defect/recall information/notification
• CE marking required
• Conformity assessment – standard TBD
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Presumption of conformity
• Member states to conduct market surveillance
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Timing and Opportunities
• Timing Estimates (Rough)
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First reading – late 2009/early 2010
Adoption – Spring/Summer 2010
Entry into Force – mid/late 2012
• Opportunities for Impact
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Members of Environmental Committee
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Rapporteurs
Department of Commerce
WTO consultation process?
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Any questions?
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Thank you!
Jean-Cyril Walker
Partner
Keller and Heckman LLP
1001 G St., NW
Washington, D.C. 20001
202-434-4181
[email protected]
www.khlaw.com
Washington, D.C. ● Brussels ● San Francisco ● Shanghai