RoHS Substance Addition
Answering the Key Questions
Krystal Cameron
Regulatory Affairs
[email protected]
AGENDA
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Introduction
Substance Addition - DBP, BBP, DEHP, DIBP:
➢ Where will you find these substances in your products?
➢ 5th prioritized substance that WASN’T added
➢ What is the scope?
➢ When do you have to comply to these new restrictions?
➢ What impact does this have on you and your products (CE MARKING)?
➢ How do you best comply?
Exemption expiry and applications
Scope Review Publication
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Slide 3
Introduction - Assent
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Assent Compliance Manager
Consulting
Every Vertical - from Retail to Aerospace to Medical
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Testing Partners
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Slide 4
Introduction
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2011/65/EU - Published in the Official Journal of the European Union: July 2011
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Major Differences
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Categories
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Timelines
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Scope
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Slide 5
Official Journal has NOT been published yet!
What does that mean?
The proposed act is what we are
working from. The notification
has been made to the WTO, we
know it WILL be published and
we know a scope clarification
that will be added in the
published act.
Where will you find these substances?
Acronym
EC Number
CAS Number
USE/Industry
DEHP
204-211-0
117-81-7
EC proposed act for amendment states it is the most common plasticiser used in PVC.
According to the European Council for Plasticisers and Intermediates (ECPI),
Low orthophthalates are commonly used in medical devices (DEHP), general purpose
PVC applications, adhesives and inks. Use of DEHP in medical applications is regulated
by the Medical Devices Directive and not by REACH i.e. there is no need for REACH
Authorisation for DEHP in medical applications – it can continue to be used subject to
the Medical Devices Directive.
DBP
201-557-4
84-74-2
Flooring, Automotive , Inks and waxes are main applications according to the European
Council for Plasticisers and Intermediates (ECPI) .
EC proposed act for amendment states similar to DEHP.
BBP
201-622-7
85-68-7
Flooring is main application according to the European Council for Plasticisers and
Intermediates (ECPI) .
EC proposed act for amendment states similar to DEHP.
DIBP
201-553-2
84-69-5
Automotive , Adhesives & Sealants, Inks and waxes are main applications according to
the European Council for Plasticisers and Intermediates (ECPI) .
EC proposed act for amendment states available data collected by the Commission’s
consultants suggests that DIBP is currently not used in traditional EEE. It is however
used as a plasticiser in glues and inks for paper and food packaging, and in toys,
childcare articles and a wide range of consumer products, some of which indeed might
be in the scope of RoHS 2.
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Slide 7
Why wasn’t HBCDD Added?
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Known to be an issue and regulated in a multitude of ways and jurisdictions
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The EC considered a ban disproportionate and refrained from it - EEE is not
used in the EU.
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A complete phase-out of HBCDD in electronics, whether imported or
produced in Europe, will only be a matter of years.
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Slide 8
Scope and Timelines
22 July 2019 - ALL Categories of EEE except 8 and 9
22 July 2021 - Categories 8 and 9 - medical devices including in vitro medical
devices and monitoring and control instruments including industrial monitoring
and control instruments.
Cables or spare parts for products placed on the market before the relevant
compliance deadline are excluded from the new substance restriction
Crossover with REACH, Timelines impact?
❖ DEHP, BBP and DBP - Toys
❖ All 4 are on the Candidate AND Authorisation List - February 2015 Banned!
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Slide 9
CE Marking
RoHS falls under the CE Marking Directive
❖ Declaration of Conformity (DoC)
❖ Technical file
❖ CE Mark
➢ Finished products in scope of RoHS
The CE Mark, when present on a product, indicates compliance to the
regulations/directives for which the product is in scope at the time it is placed
on the market.
What does that mean?
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Slide 10
Compliance Implications
❖ Measure Impact
➢ Substances
➢ Exemptions
❖ Supplier Education
❖ Yearly Audits
❖ Supplier Data Gathering, Testing and Risk Assessment
❖ FMDs?
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Slide 11
Exemption Expirations
Consultations
Project “Pack 7” has started: 4 requests for renewal/amendment - 7b, 9b, 13a, 13b
September 2015
NOTE: April 9th - Application to renew 7b was withdrawn
Requests
Requests to renew exemptions - several!
http://ec.europa.eu/environment/waste/rohs_eee/pdf/renewal_exemptions_oct14-jan15.pdf
IPC Submitted extension requests for 14 Exemptions
Timelines
Commission must decide no later than 6 months before the expiry date of the existing
exemption.
Consequences
If you are using an exemption and it expires =
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Slide 12
Exemption Additions
3 New Exemptions:
❖ Mercury in intravascular ultrasound imaging systems - 30 June 2019
❖ Lead in polyvinyl chloride (PVB) sensors in in vitro diagnostic medical
devices – 31 December 2018
❖ Cadmium in downshifting cadmium-based semiconductor nanocrystal
quantum dots for use in display lighting applications - 30 June 2018
1 Exemption Extension:
❖ Cadmium in colour-converting LEDs for illumination and display (suggested)
until 30 June 2017
Sent to the European Parliament and the EU Council of Ministers - two months to
oppose the measures - April 25th, 2015.
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Slide 13
Scope Review Publication
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Published 12/03/2015
Covers:
➢ non-road mobile machinery without an on-board power source
➢ on windows and doors with electric functions
➢ on the refurbishment of medical devices
Makes specific recommendations to the European Commission in regards to
areas to be further clarified.
Makes a recommendation for a change to the legal text to allow free
circulation for refurbished medical devices
Can be downloaded via: http://rohs.exemptions.oeko.
info/fileadmin/user_upload/reports/20150312_RoHS_scope_review_final_a.pdf
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Slide 14
SUMMARY
The RoHS Directive is undergoing serious changes.
To be reactive will be too late:
❏ Assess your areas of risk
❏ Assess the impact to your products
❏ Educate suppliers
❏ Test when needed
❏ Prepare for the update to the needed documentation.
You must be tracking all of these changes and the impact to your products to stay in compliance, meet
the needs of your customers and stay...
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Slide 15
CANADA
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Ottawa | ON | K1J 1A4
Krystal Cameron
1-866-964-6931
[email protected]
613-882-1429
USA
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UNITED KINGDOM
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