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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 ]

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

ASSENTCOMPLIANCE

Krystal CameronDireCtor – regulatory affairs613.882.1429 [email protected]

How do tHey affect you?



ASSENTCOMPLIANCE

AgendA• assent Compliance Corporate overview

• How are sVHCs added?

• reaCH responsibilities overview

• neW sVHCs

• upcoming sVHCs

• authorization list update

• upcoming authorisation list substances

• sVHC roadmap

• industry benchmarks for reaCH

• reaCH Compliance – the practical side

• reaCH enforcement

• Q&a



ASSENTCOMPLIANCE

About Assentassent Compliance delivers saas environmental Compliance services to companies who must comply with local, national and global environmental regulations. assent also supports its software division with a team of highly experienced industry consultants to provide our clients with turnkey compliance solutions. industry experts at tier 1 compa-nies rank assent Compliance amongst the top environmental compliance solutions in the world and one of the only global solution providers to offer a full service solution from end to end.

our MissionIs tohelpourclientscomplywithenvironmental regulations in themostefficientandcost effective manner possible. this is achieved through saas automation of processes andworkingwithclientstobuildefficientinternalcomplianceprogramsthatmeetglobalcompliance requirements.



ASSENTCOMPLIANCE

How tHe Assent CoMpliAnCe MAnAgeMent systeM works

integrAtes witH MAjor erp/plM

systeMs

built-in CrM for CoMpliAnCe tAsks, due diligenCe reporting

And Audit trAils

Modules to CoMply witH All MAjor environMentAl

regulAtions

pulls bill of MAteriAl (boM) into A CentrAlized CoMpliAnCe dAtA bAse

or operAtes As A stAnd-Alone systeM.

build ipC 1752-A forMs. iMport/export viA xMl

Allows internAl stAff to MAke engineering override

AssessMents

CoMMuniCAtes witH supply CHAin in bi-direCtionAl fAsHion

to proCure environMentAl inforMAtion froM suppliers

HoMogenize proprietAry supplier doC forMAts in xMl

ACts As A repository for Any CoMpliAnCe relAted MAteriAl




ASSENTCOMPLIANCE

Compliance assessment services for environmental regulations

internal standard operating procedure Consulting

Compliance plan Development

Compliance strategy Consulting

Conflict mineral Compliance

it system integration

Consulting serviCes



ASSENTCOMPLIANCE

our Clientsassent serves clients ranging from small Business to fortune 500. in global supply chains companies of all sizes must comply with environmental regulations. regardless of size assent has products and services to help any sized company meet their environmental compliance obligations.



ASSENTCOMPLIANCE

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• 6 Currently registered: 5 since 2008, 1 since 2011

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)• 10 substances on Current Consultations

• Consultation Closes october 16th

4. after commenting periods – candidate list (article 33 Requirements kick in)• 4 added June 16th

• next addition, as per eCHa mo, Between December 16th and 18th

5. prioritisation list – order in which substances will be reviewed for authorisation• 22 substances

• Consultation Closes november 30th

6. authorisation list – Restrictions and authorisations handed out• 31 substances noW on list



ASSENTCOMPLIANCE

requireMents reviewwHAt 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.

ThelegalobligationsrelatedtoSVHCsincludeCommunicationandNotification.

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;



ASSENTCOMPLIANCE


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 pro-vide the consumer with sufficient information, available to the supplier, to allow safe use of the article including, as a minimum, the name of that substance.

The relevant information shall be provided, free of charge, within 45 days of receipt of the request.



ASSENTCOMPLIANCE


• 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.



ASSENTCOMPLIANCE


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)

• AnotificationiscreatedusingthesamesoftwareasaREACHregistration–IUCLID.

• it is a much less intense dossier than a registration dossier.



ASSENTCOMPLIANCE

AutHorisAtionany 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.

*



ASSENTCOMPLIANCElAtest svHC AdditionwHere Are tHey used?

substAnCe nAMe

eC nuMber

CAs nuMber uses/industries

1,2-Benzenedicarboxylic acid, dihexyl ester, branched and linear

271-093-5 68515-50-4

note: also known as DiHp (Diisohexyl phthalate).

DiHp is used as lubricant in steering fluid and as plas-ticizers. in australia, DiHp is imported for use in auto transmission lubricants. Non-confident commercialand consumer uses include rubber and plastics prod-ucts and others.

sodium perborate; perboric acid, sodium salt

239-172-9; 234-390-0

—Bleaching component in detergent products and bleach-ing agents. mostly used in laundry detergents and wash-ing powders. (Has included hair dyes in the past!)

sodium peroxometaborate 231-556-4 7632-04-4Bleaching agent in washing detergents and machine dishwashing products.

cadmium chloride 233-296-7 10108-64-2

Cadmium chloride is used in the preparation of cad-miumsulfide,usedas“CadmiumYellow”,abrilliant-yellow stable inorganic pigment. Cadmium chloride is also used for photocopying, dyeing and electroplating.

also used in the past in photovoltaic cells (solar pan-els, solar charging cells) however based on the fact thattherearegenerallyintendedfora“greener”mind-set, alternatives have been developed.



ASSENTCOMPLIANCE

lAtest svHCs proposedAll publisHed sept 1 2014, deAdline for CoMMenting is oCt 16 2014

substAnCe nAMe

eC nuMber

CAs nuMber

proposing AutHority

reAson for proposing

2-(2H-benzotriazol-2-yl)-4,6-ditertpentylphenol (UV-328)

247-384-8 25973-55-1 Germany pBt (article 57 d); vpvB (article 57 e)

2-benzotriazol-2-yl-4,6-di-tert-butylphenol (UV-320)

223-346-6 3846-71-7 Germany pBt (article 57 d); vpvB (article 57 e)

2-ethylhexyl 10-ethyl-4,4-dioctyl-7-oxo-8-oxa-3,5-di-thia-4-stannatetradecanoate (DoTe)

239-622-4 15571-58-1 austria toxic for reproduction (article 57 c)

Benzyl butyl phthalate (BBp) 201-622-7 85-68-7 Denmark

equivalent level of concern having probable serious effects to human health and the environment (article 57 f)



ASSENTCOMPLIANCE

substAnCe nAMe

eC nuMber

CAs nuMber

proposing AutHority


Bis(2-ethylhexyl) phthalate (DeHp)

204-211-0 117-81-7 Denmark

equivalent level of concern having probable serious effects to human health and the environment(article 57 f)

cadmium fluoride 232-222-0 7790-79-6 sweden

Carcinogenic (article 57 a);mutagenic (article 57 b);toxic for reproduction (article 57 c);equivalent level of concern hav-ing probable serious effects to hu-man health (article 57 f)

cadmium sulphate 233-331-610124-36-4; 31119-53-6

sweden

Carcinogenic (article 57 a); muta-genic (article 57 b);toxic for re-production (article 57 c);equivalent level of concern having probable serious effects to human health (article 57 f)

Dibutyl phthalate (DBp) 201-557-4 84-74-2 Denmark




ASSENTCOMPLIANCE

substAnCe nAMe

eC nuMber

CAs nuMber

proposing AutHority


Diisobutyl phthalate (DiBp) 201-553-2 84-69-5 Denmark


Reaction mass of 2-ethyl-hexyl 10-ethyl-4,4-dioctyl-7-oxo-8-oxa-3,5-dithia-4-stannatetradecanoate and 2-ethylhexyl 10-eth-yl-4-[[2-[(2-ethylhexyl)oxy]-2-oxoethyl]thio]-4-oc-tyl-7-oxo-8-oxa-3,5-dithia-4-stannatetradecanoate (reaction mass of DoTe and moTe)

— — austria toxic for reproduction (article 57 c)



ASSENTCOMPLIANCE

AutHorisAtion list h 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



ASSENTCOMPLIANCE

AutHorisAtion listlAtest Additions• 31 in total• 9 new additions

substAnCe nAMe

eC nuMber

CAs nuMber

dAte Added to svHC list

sunset dAte

lAtest AppliCAtion

dAte

pentazinc chromate octahy-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'-methylene-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



ASSENTCOMPLIANCE

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



ASSENTCOMPLIANCE

AutHorisAtion listreCoMMended for inClusion – prioritisAtion list

• 22 recommended

• eCHa accepting comments until nov 30th, 2014

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 215-540-41330-43-4, 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



ASSENTCOMPLIANCE


CAs nuMber

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



ASSENTCOMPLIANCE


CAs nuMber

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, dipentylester, branched and linear

284-032-2 84777-06-0

pitch, coal tar, high temp. 266-028-2 65996-93-2



ASSENTCOMPLIANCE

svHC roAdMApwHere is tHe CAndidAte list going?

• released february 6th, 2013

• PertainstotheidentificationofSVHCsandimplementationofRiskManagementMeasuresfromnowuntil2020

• 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

• no RoaDmap lisT Has YeT Been ReleaseD



ASSENTCOMPLIANCE

reACH CoMpliAnCeTo 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



ASSENTCOMPLIANCE

reACHbenCHMArks

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 » TechnicalSpecifications » other design and manufacturer/supplier agreements



ASSENTCOMPLIANCE

reACH CoMpliAnCe – tHe prACtiCAl siderisk AssessMent

• likelihood

• High risk materials

• Weight

• How is the article shipped?

• What is the materials makeup of the article?



ASSENTCOMPLIANCE

reACH CoMpliAnCe – tHe prACtiCAl sideHigH-risk MAteriAls

♦ the high risk materials have not changed drastically with each sVHC Candidate list expansion some of thematerials 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



ASSENTCOMPLIANCE

reACH CoMpliAnCe – tHe prACtiCAl sidesvHCs 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



ASSENTCOMPLIANCE

reACH CoMpliAnCe – tHe prACtiCAl sidethe practical approach to reaCH should include:

• supplier Declaration Gathering

• TestingtofillindeclarationgapsaswellasQA

• Assessmenttocomplete“declarations”onlowriskorknownmaterialcontent

• Documentation continuity

» adds control mechanisms and comprehensiveness

list updates – every 6 months!

• assessment plays an important role again



ASSENTCOMPLIANCE

reACH CoMpliAnCe – tHe prACtiCAl sidedeClArAtions

• DoesnothavethesamespecificrequirementsasaDoC(inaccordancewiththeCEMark)asRoHS

• should include:

• products/parts it applies to

• legal reference

• SpecificSVHCList

• 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



ASSENTCOMPLIANCE

reACH CoMpliAnCe – tHe prACtiCAl sideprovision of deClArAtions

• 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



ASSENTCOMPLIANCE

reACHenforCeMent• After2013’sregistrationdeadlinethereisa5year“break”

• roadmap places increased emphasis on sVHCs

• nGos are getting testy

• EEB(EuropeanEnvironmentalBureau)positionisthatRoadmapisinsufficientandcontrarytoREACH’smain 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 (market pressure is not diminishing) to a combination of market pressure and legal enforcement

» Customs stoppages

» entry refusal

» repeat offenses

• fines

• Jail time



ASSENTCOMPLIANCE

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 [email protected]@assentCompliance.com

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assentComplianCe › wp-content › ... · How tHe Assent CoMpliAnCe MAnAgeMent systeM works integrAtes witH MAjor erp/plM systeM s built-in CrM for CoMpliAnCe tAsks, due diligenCe