Reach SVHC List Update Webinar Jan 2015

I N F O @ A S S E N T C O M P L I A N C E . C O M W W W. A S S E N T C O M P L I A N C E . C O M T E L : 1 ( 8 6 6 ) 9 6 4 - 6 9 3 1
ASSENTCOMPLIANCEASSENTCOMPLIANCE
C U S T O M S O L U T I O N S F O R C O M P L I A N C E [ R E A C H | R o H S | C P S I A | R S L | P R O P 6 5 ]
REACH SVHC List Updated
Implications For Your Products,
Company and Compliance Program
Krystal Cameron
Director, Regulatory Affairs
613.882.1429
krystal.cameron@assentcompliance.com

• Assent Compliance Corporate Overview
• How are SVHCs Added?
• REACH Responsibilities Overview
• NEW SVHCs
• Registry of Intentions
• Authorisation List Update
• Upcoming Authorisation List Substances
• SVHC Roadmap
• Industry benchmarks for REACH
• REACH Compliance – the Practical Side
• REACH Enforcement
• Q&A
Agenda

About Assent
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comply with local, national and global environmental regulations. Assent also supports its
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build efficient internal compliance programs that meet global compliance requirements.

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How do SVHCs get added to the Candidate List?
Review of the Authorisation Process - Annex 15 Dossiers
1. Registry of intentions – intention to submit dossier
• 8 Currently Registered: 5 since 2008, 1 since 2011, 2 in 2014
2. Submission of annex XV dossier (SVHC Dossier) to ECHA for Compliance Check
3. Publication of Annex XV dossier (once it has passed compliance check)
• No Current Consultations
4. After commenting periods – candidate list (article 33 Requirements kick in)
• 6 Added December 17th
• Next Addition, as per eCHa mo, between June 15th and 20th
5. Prioritisation List – order in which substances will be reviewed for authorisation
• 22 Substances
• Consultation Extended to January 12th, NOW CLOSED
6. Authorisation list – Restrictions and authorisations handed out
• Currently 31 substances

requireMents review
wHAt do svHCs MeAn for your CoMpAny?
Companies will need to assess whether they have legal obligations resulting from the inclusion of the new
substances in the Candidate list.
The legal obligations related to SVHCs include Communication and Notification.
CoMMuniCAtion
Any producers or importers of articles placed on the market1
in the eu must declare the presence of any of
these substances in an article in a concentration exceeding 0.1% w/w.
1
Article 3.12 of the REACH Regulation specifies:
• Placing on the market: means supplying or making available, whether in return for payment or free of charge, to a third party.
Import shall be deemed to be placing on the market;

requireMents review
ArtiCle 33 – sourCe of CoMpliAnCe requireMent:
Duty to communicate information on substances in articles:
1. Any supplier of an article containing a substance meeting the criteria in Article 57 and identified in accor dance with
Article 59(1) in a concentration above 0,1 % weight by weight (w/w) shall provide the recipient of the article with
sufficient information, available to the supplier, to allow safe use of the article including, as a minimum, the name of
that substance.
2. On request by a consumer any supplier of an article containing a substance meeting the criteria in Article 57 and
identified in accordance with Article 59(1) in a concentration above 0,1 % weight by weight (w/w) shall provide the
consumer with sufficient information, available to the supplier, to allow safe use of the article including, as a mini-
mum, the name of that substance.
The relevant information shall be provided, free of charge, within 45 days of receipt of the request.

requireMents review
ArtiCle 33 – sourCe of CoMpliAnCe requireMent:
What does this mean?
• Once a substance has been added to the SVHC list, you must declare its presence to your down
stream users if the concentration is above 0.1% of your products weight.
• This is to be done upon immediately for professional customers and within 45 days from request for
consumers.
What is an article?
There are disputes between member states as to the exact definition however, based on ECHA
guidance, the 0.1% weight threshold is applicable to an article as produced or imported;
» if one of your products is shipped in multiple pieces, the concentration threshold will apply
to each separate piece.
» this weight threshold also impacts the separate components of kits and also applies to
each level of packaging.

requireMents review
notifiCAtion
Furthermore, these same producers and importers have six months from the date the new sVHCs were included
(16 June 2014) to notify the ECHA if:
a. The (SVHC) is present in those articles in quantities totalling over 1 tonne per producer or importer per year
(and)
b. The (SVHC) is present in those articles above a concentration of 0,1 % weight by weight (w/w)
• A notification is created using the same software as a REACH registration – IUCLID.
• It is a much less intense dossier than a registration dossier.

AutHorisAtion
Any chemicals placed on the Candidate list can also eventually be approved for an authorization list where
they will then be banned from use unless an authorization is submitted and approved before the applicable
sunset date.
• Most, if not all, substances on the current SVHC list will eventually move onto the authorisation list
and therefore require an authorisation for their use.
• Authorisations are required on a per substance, per use, per supply chain (you or an actor up your
supply chain must have been granted an authorisation) basis.
NOTE: (ECHA Guidance on requirements for substances in articles – rip 3.8 – section 1.3)
substances being (an integral) part of imported articles cannot be subject to authorisation.
This means that in order to import articles into the eea an authorisation cannot be required.
*

Substance Name EC Number CAS Number Uses
Cadmium fluoride 232-222-0 7790-79-6
Use in research applications, e.g. in solid ionic transport studies. Cadmium
fluoride is fluorescent and can therefore be used in certain phosphorus for
luminescent screens. Other uses are for manufacturing of glass, in nuclear
reactor control, for electric brushes, high temperature dry-film lubricant, optical
applications, and as starting material for crystals for lacer. Was used as an
active component in fluxes for soldering of aluminum and its alloys.
Cadmium sulphate 233-331-6
10124-36-4;
31119-53-6
Possible: used as intermediate for industrial production of inorganic cadmium
compounds, and as laboratory reagent. Impurities in pigments (plastic, ceram-
ic, glass, rubber, paper, ink). As an additive it might increases the performance
of lead acid batteries
2-benzotriazol-2-yl-4,6-di-
tert-butylphenol (UV-320)
223-346-6 3846-71-7
Light Stabilizer (UV-absorbers, especially for transparent plastic materials).
Used in a variety of plastics and organic substrates including unsaturated
polyesters, PVC and PVC plastisol.
Can also be used in polycarbinates, polyurethanes, polyamides, synthetic
fibers, particularly those with a polyester, epoxy resin base. UV-protection
agents in coatings especially for cars and special industrial wood coatings.
UV-protection agents for plastics, rubber and polyurethanes. The rest is used
in cosmetics (e.g. as sun protection agents).
Latest SVHC Addition
Classification Added to DEHP

Substance Name EC Number CAS Number Uses
2-ethylhexyl 10-ethyl-4,4-dioc-
tyl-7-oxo-8-oxa-3,5-dithia-4-
stannatetradecanoate (DOTE)
239-622-4 15571-58-1
Possible: used as heat stabilizer in plastic
(mainly PVC processing)
2-(2H-benzotriazol-2-yl)-4,6-
ditertpentylphenol (UV-328)
247-384-8 25973-55-1
Light Stabilizer (UV-absorbers, especially for
transparent plastic materials) for plastics
and other organic polymers. UV-protection
agents in coatings especially for cars and
special industrial wood coatings. UV-protec-
tion agents for plastics, rubber and polyure-
thanes. The rest is used in cosmetics
(e.g. as sun protection agents).
Reaction mass of 2-ethylhexyl
10-ethyl-4,4-dioctyl-7-oxo-
8-oxa-3,5-dithia-4-stannatet-
radecanoate and 2-ethylhexyl
10-ethyl-4-[[2-[(2-ethylhexyl)
oxy]-2-oxoethyl]thio]-4-octyl-7-
oxo-8-oxa-3,5-dithia-4-stanna-
tetradecanoate (reaction mass
of DOTE and MOTE)
239-622-4
248-227-6
15571-58-1
27107-89-7
Possible: used as heat stabilizer in plastic
(mainly PVC processing)

Latest SVHC Addition
Classification Added to DEHP
• 4 phthalates that are already on the SVHC Candidate List and the Authorisation List were proposed for an “update”
to have them assessed against the criteria for identification as an SVHC under Article 57(f) due to its endocrine
disrupting properties causing probable serious effects to the environment.
• BBP, DEHP, DBP and DIBP were all assessed
• ONLY bis(2-ethylhexyl) phthalate (DEHP) was found to meet the criteria
• The other 3 phthalates were withdrawn as proposals so further elaborate on
the justifications.
• DEHP is already included in the Candidate List based on its toxic for reproduction properties,
this entry will be updated to address the additional reason for inclusion.
• DEHP is also already listed in the Authorisation List (Annex XIV), What does this mean?
• Companies that were initially exempt from the Authorisation requirement may, in the future, be subject
to Authorisation.
• Before this could happen, the European Commission would need to amend the corresponding entry for DEHP
in the Authorisation List.

Substance Name EC Number CAS Number
Proposing
authority
Notes
(including uses)
Karanal 413-720-9 117933-89-8 Netherlands
Used in fine fragrances and in soaps and
detergents.
1,2-benzenedicarboxylic
acid, di-C6-10-alkyl esters
271-094-0 68515-51-5 Sweden
Materials:Plastics and Rubbers,
Synonym: Di(C6-C10)alkyl phthalate
Category: phthalate esters
Used to make polymer foils, PVC products,
plastic products, and rubber products, in
coatings, cable compounding, cable ap-
plications, artists supplies, and adhesives;
[ExPub: ECHA REACH Registrations] Used
as a plasticizer for polyurethane adhesives;
[3M MSDS]
2 other 1,2-benzenedicarboxylic acid…alkyl
esters are already on Candidate List
Current Registry of Intentions List
No SVHCs proposed at the moment!

Authorization List
• Once a substance is on the SVHC Candidate List, the ECHA then must regularly submit recommendations of
substances that should be subject to authorization
• Once a substance is on the authorization list, it can now be considered, in layman’s terms, a restricted or
prohibited substance rather than simply a declarable substance
» Authorized substances cannot be used in the EC beyond the hazard thresholds established
by the DSD/DPD/CLP
» Substances already an integral part of articles are not subject to authorization
• Therefore the ECHA prioritizes which substances should be on the Authorisation List
• Further information on these steps can be found at:
http://echa.europa.eu/web/guest/addressing-chemicals-of-concern/authorisation/
recommendation-for-inclusion-in-the-authorisation-list
The Authorization List itself can be found at:
http://echa.europa.eu/addressing-chemicals-of-concern/authorisation/recommendation-for-inclusion-in-
the-authorisation-list/authorisation-list

substAnCe nAMe
EC
Number
CAS
Number
dAte Added
to svHC list
sunset
dAte
lAtest
AppliCAtion
dAte
pentazinc chromate oc-
tahy- droxide
256-418-0 49663-84-5 19/12/2011 22/01/2019 22/07/2017
potassium hydroxyoctaox-
odizincatedichromate
234-329-8 11103-86-9 19/12/2011 22/01/2019 22/07/2017
Dichromium tris(chromate) 246-356-2 24613-89-6 19/12/2011 22/01/2019 22/07/2017
strontium chromate 232-142-6 7789-06-2 19/12/2011 22/01/2019 22/07/2017
2,2’-dichloro-4,4’-methy-
lene- dianiline (moca)
202-918-9 101-14-4 19/12/2011 22/11/2017 22/05/2016
1,2-Dichloroethane (eDc) 203-458-1 107-06-2 19/12/2011 22/11/2017 22/05/2016
AutHorisAtion list
lAtest Additions
• 31 in Total
• 9 new additions

substAnCe nAMe
EC
Number
CAS
Number
dAte Added
to svHC list
sunset
dAte
lAtest
AppliCAtion
dAte
Arsenic acid 231-901-9 7778-39-4 19/12/2011 22/08/2017 22/02/2016
formaldehyde, oligomeric
reaction products with
aniline (technical mDa)
500-036-1 25214-70-4 19/12/2011 22/08/2017 22/02/2016
Bis(2-methoxyethyl) ether
(Diglyme)
203-924-4 111-96-6 19/12/2011 22/08/2017 22/02/2016

substAnCe nAMe EC Number CAS Number
1,2-Benzenedicarboxylic acid, di-c6-8-
branched alkyl esters, c7-rich
276-158-1 71888-89-6
Disodium tetraborate, anhydrous 215-540-4 1330-43-4, 12179-04-3, 1303-96-4
Acetic acid, lead salt, basic 257-175-3 51404-69-4
1-bromopropane (n-propyl bromide) 203-445-0 106-94-5
AutHorisAtion list
Recommended for Inclusion – Prioritisation List
• 22 Recommended
• ECHA extended comment period from November 30th to January 12th 2015.

4-nonylphenol, branched and linear, ethoxylated
[substances with a linear and/or branched alkyl
chain with a carbon number of 9 covalently bound
in position 4 to phenol, ethoxylated covering UVCB
– and well-defined substances, polymers and
homologues, which include any of the indi- vidual
isomers and/or combinations thereof]
— —
Bis(2-methoxyethyl) phthalate 204-212-6 117-82-8
Lead monoxide (lead oxide) 215-267-0 1317-36-8
1,2-Benzenedicarboxylic acid, di-c7-11-branched
and linear alkyl esters
271-084-6 68515-42-4
Dipentyl phthalate (Dpp) 205-017-9 131-18-0
Pentalead tetraoxide sulphate 235-067-7 12065-90-6
Tetraboron disodium heptaoxide, hydrate 235-541-3 12267-73-1
Anthracene oil 292-602-7 90640-80-5

Orange lead (lead tetroxide) 215-235-6 1314-41-6
pyrochlore, antimony lead yellow 232-382-1 8012-00-8
Diboron trioxide 215-125-8 1303-86-2
N-pentyl-isopentylphthalate — 776297-69-9
Boric acid 233-139-2, 234-343-4 10043-35-3, 11113-50-1
Diisopentylphthalate 210-088-4 605-50-5
Silicic acid, lead salt 234-363-3 11120-22-2
Tetralead trioxide sulphate 235-380-9 12202-17-4
1,2-Benzenedicarboxylic acid, dipentyles-
ter, branched and linear
284-032-2 84777-06-0
Pitch, coal tar, high temp. 266-028-2 65996-93-2

SVHC Roadmap
Where is the Candidate List Going?
• Released February 6th, 2013
• Pertains to the identification of SVHCs and implementation of Risk Management Measures from now until 2020
• Goal of ECHA Vice-President and Commissioner to ID and include ALL relevant SVHCs in the EU on the Candidate List
by 2020
• Substances exempted from authorisation or controlled by other EU legislation, such as RoHS, should not be included,
in most instances
• Exceptions are suggested for:
» PBTs and vPvBs
» Substances of equivalent concern without harmonised criteria in Annex 1 of CLP, such as endocrine
disrupting chemicals (EDCs).
• No target number was set for the SVHC List
• An estimate was given to help with resource planning:
• 440 substances will require RMO assessment between 2013 and 2020
» Around 55/year
• There is no “ROADMAP Substance List” but there is a Public Activities Coordination Tool (PACT) that lists the
substances for which a Risk Management Option Analysis (RMOA), known as the PACT-RMOA substance list
• CoRAP (Community Rolling Action Plan) List – where does this fit in?

PACT-RMOA List
http://echa.europa.eu/addressing-chemicals-of-concern/substances-of-potential-concern/svhc-roadmap-
implementation-plan/pact
This Public Activities Coordination Tool (PACT) lists the substances for which a Risk Management Option Analysis
(RMOA) is either under development or has been completed since the implementation of the SVHC Roadmap commenced
in February 2013.
The criteria to define if a SVHC is relevant are based on the screening of the registration dossiers as a first step and on the
RMO assessment as a second step.
NOTE: Potential SVHCs excluded by the application of these criteria could still be considered after 2020 on a case-by-
case basis.
If a substance makes it through the screening and RMO and is still “in the running” then it is considered for either:
• official SVHC identification (starts going through the Authorisation process) or
• Restriction

CoRap List
http://echa.europa.eu/information-on-chemicals/evaluation/community-rolling-action-plan/corap-table
If a substance is on this list, it means that a member state has evaluated or will evaluate it over the coming years.
For each substance, the table shows the evaluating Member State, the (planned) year of evaluation and a short
description of the concern which led to it being placed on the list.
Key Points:
• Neither a black list nor a sunset list, i.e. it will not cause a substance to be taken off the market.
• It is a mechanism to evaluate and get more information on the substances listed therein, when there are concerns that
the substances may pose a risk to human health or the environment.
• The evaluation can result in the conclusion that the concern is resolved and thus no further action is needed.
• If the initial concern is confirmed in substance evaluation, the Member State may consider further risk management
options such as:
• Harmonised classification and labelling (CLP),
• Restriction
• Authorisation
» That would be subject to a separate process.

REACH Compliance
To Remember:
• REACH is NOT a ban from a legal perspective
• Be aware if client/customer agreements elevate these requirements
• REACH does not explicitly call out the requirements for a declaration
• Testing
• Supplier Declarations
• Risk Assessment

REACH
Benchmarks
REACH compliance is becoming an element of:
• RFP processes
• Extended Producer Requirements (EPRs)
• DELL
• HP
• Sony Green
• Intel
Similar to RoHS over time:
• the exposure to REACH has increased
• companies are decreasing response times
• it is becoming an expectation
Steps that are being taken:
• Declaration collection and assessment
• Engineering Assessments
• REACH compliance requirement included in:
» POs
» Ts&Cs
» Technical Specifications
» Other design and manufacturer/supplier agreements

REACH Compliance – The Practical Side
Risk Assessment
• Likelihood
• High Risk Materials
• Weight
• How is the article shipped?
• What is the materials makeup of the article?

High-Risk Materials
The high risk materials have not changed drastically with each SVHC Candidate List expansion.
Some of the materials and products that are most likely to include SVHCs are listed below:
• Cables
• Plastics, Rubbers, Silicones, Polyolefins, Polymers
• Polyvinyl Chloride (PVC)
• High Impact Polystyrene (HIPS)
• Resins
• Adhesives
• Inks, Coatings and Paints
• Capacitors and Semiconductors
• Printed circuit boards (PCBs)
• Batteries

SVHCs in Articles
• Phthalates = Plasticizers
• Cables
• PVC (VINYL)
• Foam…Handles!
» Common Sense:
» Low Cost = High Phthalate Content
» High Risk Materials declared as No Phthalate – Assume the worst!
• Cadmium = Red Dye, Brass and Brass Alloys
• Many other cadmium substances have been added recently
• Boric Acid = Silicone Rubber

The practical approach to REACH should include:
• Supplier Declaration Gathering
• Testing to fill in declaration gaps as well as QA
• Assessment to complete “declarations” on low risk or known material content
• Documentation continuity
» Adds control mechanisms and comprehensiveness
List updates – every 6 months!
• Assessment plays an important role again

Declarations
• Does not have the same specific requirements as a DoC (in accordance with the CE Mark) as RoHS
• Should include:
• Products/Parts it applies to
• Legal Reference
• Specific SVHC List
• Appropriate Signee
• Dated
• Some sources state it is easier to declare than measure when there is essentially a guarantee of SVHC appearing
• i.e. EGDME in button cell batteries
• Be aware of risks from a business perspective
» Agreements/Contracts/POs/Ts and Cs containing restrictions beyond the legal requirements

SVHCs in Articles
• Technically the requirement for REACH is that the article should be compliant to the REACH Candidate List
the moment a new substance is added to that list
• Therefore the declaration should be provided at time of sale
• In reality:
• Provided upon request, or
• Posted on site

REACH
Enforcement
• After 2013’s registration deadline there is a 5 year “break”
• Roadmap places increased emphasis on SVHCs
• NGOs are getting testy
• EEB (European Environmental Bureau) position is that Roadmap is insufficient and contrary to
REACH’s main objectives and legal principles
• Authorisation List substances are becoming part of EPR (Extended Producer Responsibility) Lists
• Whether Authorisation applies or not from a legal perspective, there is BUSINESS RISK
• RESULT:
• There will be a shift from REACH SVHC compliance from primarily market pressure to a combination
of market pressure (market pressure is NOT diminishing) and legal enforcement
» Customs stoppages
» Entry refusal
» Repeat offenses
• Fines
• Jail time

questions?
Please submit your questions in writing using the Q&A tool along the top menu tool bar.
Any questions not addressed during the Q&A portion of this webinar will be addressed in private correspondence
after the webinar and in an FAQ document posted to the Assent Compliance Webinars page.
Thanks for attending!
wAnt A deMo?
matt.whitteker@assentcompliance.com
info@assentcompliance.com

Reach SVHC List Update Webinar Jan 2015

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