REACH Registration 2013 - Assent Compliance Webinar

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 : 6 1 3 . 2 9 0 . 8 0 4 4

ASSENTCOMPLIANCE

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 ]

REACHRegistRation 2013

assenT compliance

Krystal Noseworthy-BaKer pHone: 613.882.1429

[email protected]


ASSENTCOMPLIANCE

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 y [ r e a c H | r o H s | c p s i a | r s l | p r o p 6 5 ]

INTROduCTION TO ASSENT COMPLIANCEassenT compliance

•Consulting

•GlobalRequirements

•ComplianceStrategies

•RegulatoryInterpretationsandImpacts

• IT

•CloudComputing

•ApplicationDesign

•Operations

• ProgramImplementation

•DataManagement


ASSENTCOMPLIANCE

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 y [ r e a c H | r o H s | c p s i a | r s l | p r o p 6 5 ]

AgENdA•RecentECHAReleases

•RegistrationOverview

•Requirements

•Timelines

• Process

•FAQs

• Impacts

•OtherConcerns

•CLP

•CommonIndustryPractices

•Q&A



ASSENTCOMPLIANCE

RECENT ECHA RELEASESlaTe pre-regisTraTion of subsTances To beregisTered in 2013 closing soon (may 25TH, 2012)• Tobenefitfromtheextendeddeadlinesforregisteringphase-insubstancesundertheREACHRegulation:

•Registrantshaveto/hadtopre-registertheirphase-insubstances.

•Theopportunitytolatepre-registerphase-insubstancesduetoberegisteredbythe2013registrationdeadlinewas31May2012.

•All substanceswith phase-in status that are produced or imported into theEU in quantitiesabove100tonnesperyearmustberegisteredon31May2013atthelatest.

•Tobenefitfromthestaggeredregistrationdeadlines,phase-insubstancesthataremanufac-turedorimportedabovetheone-tonnethresholdneedeithertohavebeenpre-registeredbytheoriginalpre-registrationdeadlinein2008or“late”pre-registeredwithinsixmonthsofthefirstmanufactureorimportofthesubstance.

» Thepossibilityto“late”pre-registersubstancestoberegisteredby31May2013endsoneyearbeforethedeadline,i.e.on31May2012.

» Thepossibilityto“late”pre-registersubstancestoberegisteredby31May2018endsoneyearbeforethedeadline,i.e.on31May2017.



ASSENTCOMPLIANCE

•After31May2012(NOW):

» ForsubstancesduetoberegisteredbyMay312013thatarenotpre-registered:

» CompaniesneedtosubmitaninquirytoECHAandregisterthesubstancebeforemanufacturing/importingcantakeplace.

• Substancesthatneedtoberegisteredbythe2018REACHregistrationdeadlinecanstillbe“late”pre-registeredwithin6monthsofthefirstmanufacturingorimporting.

» 2018DeadlineSubstances=Substancesthatareforthefirsttimemanufacturedorimportedinquantitiesbetween1-100tonnesperyear(andnotclassifiedasCMRs)



ASSENTCOMPLIANCE

RECENT ECHA RELEASESregisTraTion, evaluaTion and auTHorisaTion discussed aT ecHa’s sTakeHolders’ day (may 23rd, 2012)•DuringtheStakeholders’Day,ECHAwilldrawtheattentionofregistrantstothetimelyprepara-

tionandqualityoftheirREACHregistrationdossiers.

• Asofthedateofpreparingthispresentation,areportonthedayhadnotbeenreleased

•ThenextregistrationdeadlineforsubstancesproducedorimportedintheEUinquantitiesatorabove100tonnesperyearis31May2013.Basedontheexperienceofevaluatingtheregistra-tionsfromthe2010deadline,ECHAurgesallregistrantstostepuptheirdossierpreparationeffortsnowandtopayspecialattentiontothequalityoftheirdossiers.

•Duringtheevent,ECHAwillinformindustryaboutitsnewcompliancecheckstrategywhichcomplementsitscurrentevaluationactivities.

•Thenewstrategyaimstosystematicallytargetdossierelementsthatareimmediatelyrel-evantforthesafeuseofthesubstance.

•Ratherthanevaluatingthefulldossiercontentatonce,apartofthecompliancecheckswill be addressing for example targeted endpoints which are related to the Persistent,BioaccumulativeandToxic(PBT)orCarcinogenic,MutagenicorToxictoreproduction(CMR)statusofasubstance.



ASSENTCOMPLIANCE

•TheECHAwillstartcheckingthosepartsofregistrationdossierswhichhavebeenidenti-fiedbasedonthisconcern-drivenapproach.

» As a consequence, registrantswho have submitted non-compliant dossiersmayreceivemultipledecisionsfromECHAforasingledossier.

» Inadditiontothesetargetedcompliancechecks,asignificantpartoftheoverallcompliance checks will still be addressing the full dossier content in order toassesstheoverallcomplianceofthedossieranditssafetyassessments.

• ECHAwill also introduce the substanceevaluationprocess that started inMarch2012anddescribehowitisfunctionallyinterlinkedwithotherevaluationandregulatoryriskmanagementprocesses.

• ECHAwillalsohighlightanexamplechemicalsafetyreport(CSR)thatithasdevelopedtosupportcompaniesincomplyingwiththeirobligationsunderREACH.TheexamplegivestipsfordevelopingagoodqualityCSRandadviceonhowtoavoidcommondeficienciesthathavebeenidentifiedbyECHA.



ASSENTCOMPLIANCE

REACH REgISTRATION 2013overview• AppliestosubstancesproducedorimportedintotheEUat≥100tonnesperyearpermanufacturer

orimporter.

•Greaternumberofsubstancesisexpectedtoberegisteredin2013thanin2010.

•Thetotaldatarequirementsfor≥100tonnesubstancesarelessthanthoseforthe≥1000tonnesubstances.

•Unfortunatelybecausethesesubstanceshavesmallertonnages,theyarelesswidelyusedwhichmeans it is more than possible that less data will be available to fulfill the REACH dossierinformationrequirements.

•Thismaymeanthereisincreaseduseofalternativemethodsforfillingdatagaps,(read-across,QuantitativeStructureActivityRelationships (QSARs),new testingor thecreationof testingplans.)

•ThebiggesthelptodossiercompletionareSIEFs(SubstanceInformationExchangeForums)andConsortiums–Lettersofaccesstothedossiersandinformationtheyhavealreadygatheredareessentialforpropercompletionofdatarequirements.Thecostoflettersofaccessisdeterminedbythenumberofregistrantssoitisimportanttoinvestigatethisassoonaspossible.



ASSENTCOMPLIANCE

REACH REgISTRATION 2013requiremenTs• InformationRequirementsareestablishedinAnnexVII,VIIIandIXoftheREACHRegulation:

StandardInformationRequirementsforSubstancesManufacturedorImportedinQuantitiesof1TonneorMore,10TonnesorMoreand100TonnesorMore

• Sections4-7oftheIUCLIDDossierarewheretheinformationalincreaseisconcentrated

•Asyoumove fromone tonnage level toanother, the registrationdossier information require-mentsincreasehoweverthesesannexesalsoestablishtherulesforanyadaptationfromtheinfor-mationrequirement



ASSENTCOMPLIANCE

REACH REgISTRATION 2013Timeline

Collection,verificationandentry

ofallnecessaryexisting

dossierdata.

LocateandappointOnlyRepresentativeifrequired.

CompletionofSection1.4

TestingUVIR

NMRMS

HPLCGC

Entryofremainingdataintodossier.

TCCDossierSubmission

Registration>1000tonnes,CMRs,R50-53

Dec1,2010

Registration>100tonnes

JuNE1,2013

SubMitMAy31,2013

Registration>1tonne<100

tonnes

JuNE1,2018

SubMitMAy31,2018

LatePre-Registration

Deadline

May31,2017

LOAAccessLetterand

ReceptionofLeadDossier

LatePre-Registration

Deadline

May31,2012

tODAyJuNE7,2012



ASSENTCOMPLIANCE

REACH REgISTRATION 2013 process

Gathermembershipdata

andcosts

ActiveSIEFandConsortiumInvestigation

DataGathering Gatherdataasnecessary

CompleteDossier

CompleteDossier

TCC

TCC

SubmitDossier

SubmitDossier

IdentifyDataGaps

Sections1–13

Gathermembership

process.GatherLoA.

GatherDossierInstructions

andSubstanceDataset

IdentifyDataGaps

Sections1&3

GatherDataasnecessary

YES

NO

IsthereanactiveSIEForCorsortium?

SubstanceReview



ASSENTCOMPLIANCE

REACH REgISTRATION faqs

What if there is no lead registrant?•CommunicatewithinSIEF

•DiscussDataRealities

•AppointanOR

ORcouldacceptLeadRegistrationonyourbehalf

What if I already have an Only Representative?•OnlyRepresentativetransferisnotacomplicatedprocessifrequired

What happens if we do not meet the 2013 Deadline?•Non-compliance.

•Cannotcontinueimportuntilregistrationiscomplete.

Once we have registered is there anything else we will need to worry about?•CLP,communicationsfromSIEF,communicationofregistrationnumber(SDS,etc.)



ASSENTCOMPLIANCE

IMPACTS regisTraTion 2013, reacH compliance•CustomsStoppages

•DeliveryDelaysorRejections

•NewProductLaunchdelays

• Fines

• Imprisonment

• Lossofbusiness

•REACHcompliance isquicklybecomingacontractualobligationand if theobligationcannotbemetthenpotentialcustomersmoveon



ASSENTCOMPLIANCE

OTHER CONCERNS fOR SubSTANCE ANd MIxTuRE PROduCERS/IMPORTERS classificaTion, labeling and packaging (clp)•Regulation(EC)No1272/2008

•GHS(GlobalHarmonisedSystem)Based

• Impactstheclassificationofsubstances,mixtures,including:

• SafetyDataSheets

• Packaging

• Labelling

•CLPClassificationDeadlines:

• Substances:1December2010

» Ifalreadyonthemarketbefore1December2010 1December2012

•Mixtures:1June2015

» Ifalreadyonthemarketbefore1June2015 1June2017

•CLPSDSs

•DeadlinesforSDSs(ANDLABELS),sameasclassificationdeadlines



ASSENTCOMPLIANCE

OTHER CONCERNS fOR SubSTANCE ANd MIxTuRE PROduCERS/IMPORTERS classificaTion, labeling and packaging (clp) -noTificaTion•CLPNotificationScope:

• SubstancessubjecttoregistrationunderREACH

» Unlessalreadyregistered(during2010registration)withtheCLPclassificationincluded

• SubstancesclassifiedashazardousunderCLPandplacedonmarket

» IRRESPECTIVEOFTONNAGE

• SubstancesclassifiedashazardousunderCLPandinamixtureaboveconcentrationlimits(AnnexICLP,orinDPD)whichresultsinmixturebeingclassifiedashazardousandthemixtureisplacedonthemarket

•CLPNotificationDeadlines:

• Substancesonmarket1December2010:January3rd,2011

• Substancesonmarketafter1December2010:1monthfromdateofplacementonmarket



ASSENTCOMPLIANCE

•ORshavenoroleunderCLP

•UPDATE:ECHAacceptsgroupnotificationtotheClassificationandLabellinginventoryforcompanieswhoarenotthemselvesmanufacturersorimporters(May3rd,2012)

ORs will be able to submit notifications on behalf of a group of manufacturers or importers

» ECHAhasannounceditwillacceptnotificationstotheclassificationandlabelling(C&L)inventoryfromgroupsotherthanmanufacturersandimporters.

» OnlyRepresentativeswillnowbeabletosubmitnotificationsonbehalfofnon-EUcompanies.

• Previously,companieshadtoimportsmallquantitiesofsubstancetoqualifyasimportersinordertomakethenotification.

» Conditions:

•The submitting companywillneed tobe able todocument that ithasbeenmandatedtoactinthiscapacity

•Themanufacturersor importers in thegroupacknowledge that they remainfullyresponsibleforfulfillingtheirobligationsassociatedwiththenotification.

•NotificationtomatchRegistration

•Harmonisedclassificationpublished-Notificationtobeupdated



ASSENTCOMPLIANCE

OTHER CONCERNS fOR SubSTANCE ANd MIxTuRE PROduCERS/IMPORTERS classificaTion, labeling and packaging (clp) -classificaTion •Atthistime,theprimaryimpactofCLPiscustomsstoppages.

•Registrationnumberand/orCLPNotificationnumbernotpresentontheSDS

Page 8 / 8

Safety Data Sheet - Europe

Therminol® RD

Date:.08.07.2011, Version: A 1. Date of revision: 08.07.2011 Date of previous issue: 00.00.0000

Revision comments:New software implementation Classification according to Regulation (EC) No. 1272/2008 [CLP/GHS] Abbreviations and acronyms : ATE = Acute Toxicity Estimate

CLP = Classification, Labelling and Packaging Regulation [Regulation (EC) No. 1272/2008] DNEL = Derived No Effect Level EUH statement = CLP-specific Hazard statement PNEC = Predicted No Effect Concentration RRN = REACH Registration Number LOAEL = Lowest observed adverse effect level NOEL = No Observed Effect Level LC50 = Median lethal concentration EC50 = Half maximal effective concentration LD50 = Median lethal dose dwt = dry weight OECD = Organisation for Economic Co-operation and Development PEL = Permissible Exposure Limit NOEC = No observable effect concentration LOEC = Lowest observable effect concentration EC10 = 10% effect concentration PBT = Persistent, bioaccumulative, toxic chemical vPvB = Very Persistent and Very Bioaccumulative

Number format: "," used as decimal separator.

TM, ® is a registered trademark of Solutia Inc. SOLUTIA is a trademark of Solutia Inc.

Notice to reader To the best of our knowledge, the information contained herein is accurate. However, neither the above-named supplier, nor any of its subsidiaries, assumes any liability whatsoever for the accuracy or completeness of the information contained herein. Final determination of suitability of any material is the sole responsibility of the user. All materials may present unknown hazards and should be used with caution. Although certain hazards are described herein, we cannot guarantee that these are the only hazards that exist.

Annex

Exposure Scenarios Not available.

Page 7 / 8


Therminol® RD


of surplus and non-recyclable products via a licensed waste disposal contractor. Disposal of this product, solutions and any by-products should at all times comply with the requirements of environmental protection and waste disposal legislation and any regional local authority requirements. Avoid dispersal of spilled material and runoff and contact with soil, waterways, drains and sewers.

b. Disposal precautions : Avoid dispersal of spilled material and runoff and contact with soil, waterways, drains and sewers.

14. TRANSPORT INFORMATION

ADR/RID ADN/ADNR IMDG IATA

14.1 UN number - - - -

14.2 UN proper shipping name

Not regulated. Not regulated. Not regulated. Not regulated.

14.3 Transport hazard class(es)

-

-

-

-

14.4 Packing group

14.5. Environmental hazards

14.6 Special precautions for user

Not available. Not available. Not available. Not available.

Additional information

14.7 Transport in bulk according to Annex II of MARPOL 73/78 and the IBC Code Not available.

15. REGULATORY INFORMATION 15.1 Safety, health and environmental regulations/legislation specific for the substance or mixture Other EU regulations

Integrated pollution prevention and control list (IPPC) - Air

: Not listed

Integrated pollution prevention and control list (IPPC) - Water

: Not listed

Directive 96/82/CE - SEVESO : Qualifying quantity (Art. 9) is: Qualifying quantity (Art. 6 & 7) is:

National regulations 15.2 Chemical Safety Assessment : Completed.

16. OTHER INFORMATION History Date of issue/ Date of revision : 08.07.2011 Date of previous issue : 00.00.0000 Version : 1. Reference number : 200000100553 Other information

Page 6 / 8


Therminol® RD


Chronic toxicity Conclusion/Summary : Not available. Mutagenicity Conclusion/Summary : Not available. Carcinogenicity Conclusion/Summary : No data available. Teratogenicity Conclusion/Summary : Not available. Reproductive toxicity Conclusion/Summary : Not available. Specific target organ toxicity (single exposure)

Product/ingredient name Category Route of exposure Target organs

Conclusion/Summary : Not sufficient for classification.

Aspiration hazard

Product/ingredient name Result

tetrapropylenebenzene ASPIRATION HAZARD - Category 1

Therminol® RD ASPIRATION HAZARDCategory 1 11.1.1.2 Other information : Not fulfilling criteria - EU - Substances of very high concern - CMR

12. ECOLOGICAL INFORMATION 12.1 Toxicity Conclusion/Summary : May cause long lasting harmful effects to aquatic life. 12.2 Persistence and degradability

Product/ingredient name Aquatic half-life Photolysis (Half-life) Biodegradability

tetrapropylenebenzene Not available.

Not available.

Not available.

12.3 Bioaccumulative potential

Product/ingredient name LogPow BCF Bioaccumulative potential

tetrapropylenebenzene 8.11 - not available

12.4 Mobility in soil

Soil/water partition coefficient (KOC)

: Not available.

Mobility : Not available. 12.5 Results of PBT and vPvB assessmentPBT : P: No data available.

B: No data available. T: No data available.

vPvB : vP: No data available. vB: No data available.

12.6 Other adverse effects : None known.

13. DISPOSAL CONSIDERATIONS 13.1 Waste treatment methods a. Disposal methods : The generation of waste should be avoided or minimized wherever

possible. Empty containers or liners may retain some product residues. This material and its container must be disposed of in a safe way. Dispose

Page 5 / 8


Therminol® RD


a. Appearance

Color : Clear. Physical state : Liquid b. Odor : odorless.

c. Odor threshold : Not determined

d. pH : Not applicable. e. Melting/freezing point : Pour point -55 °C

f. Initial boiling point and boiling range

: 275 - 300 °C @ 1,013 hPa

g. Flash point : 120 °C Pensky-Martens.

h. Evaporation rate : Not determined

i. Flammability (solid, gas) : Not applicable j. Upper/lower flammability or

explosive limits : Lower: Not available

Upper: Not available k. Vapor pressure : 0.0213 hPa [25 °C]

l. Vapor density : 8.1(Air = 1) m. Relative density : 0.872 g/cm3 @ 15 °C

n. Solubility(ies) : Water solubility : 0.00293 mg/l @ 25 °C(Estimated)

o. Partition coefficient: n-octanol/water

: > 1,000,000.000 @ 25 °C(Estimated)

p. Auto-ignition temperature : 395 °C

q. Decomposition temperature : Not determined

r. Viscosity : Dynamic: Not determined.

: Kinematic: 5.91 mm2/s @ 40 °C s. Explosive properties : non explosive

t. Oxidizing properties : Not oxidizing.

9.2 Other information

Not available.

10. STABILITY AND REACTIVITY 10.1 Reactivity : No specific test data related to reactivity available for this product or its

ingredients.

10.2 Chemical stability : The product is stable. 10.3 Possibility of hazardous reactions

: Under normal conditions of storage and use, hazardous reactions will not occur.

10.4 Conditions to avoid : Avoid all possible sources of ignition (spark or flame). 10.5 Incompatible materials : Strong oxidising agents.

strong acids 10.6 Hazardous decomposition products

: carbon oxides, Hydrocarbon.

11. TOXICOLOGICAL INFORMATION 11.1 Information on toxicological effects Acute toxicity

Product/ingredient name Result Species Dose Method

tetrapropylenebenzene

LD50 Oral Rat > 5,000 mg/kg -

LD50 Dermal Rabbit > 2,000 mg/kg - Conclusion/Summary : Not sufficient for classification. Irritation/Corrosion Conclusion/Summary skin : Not sufficient for classification. eyes : Slightly irritating to eyes but not sufficient for classification (rabbit). Respiratory : Not sufficient for classification. Sensitizer Conclusion/Summary skin : Not sufficient for classification. Respiratory : Not sufficient for classification.

Page 4 / 8


Therminol® RD


7.2 Conditions for safe storage, including any incompatibilities Storage

Store in accordance with local regulations. Store in original container protected from direct sunlight in a dry, cool and well-ventilated area, away from incompatible materials (see section 10) and food and drink. Keep container tightly closed and sealed until ready for use. Containers that have been opened must be carefully resealed and kept upright to prevent leakage. Do not store in unlabeled containers. Use appropriate containment to avoid environmental contamination. 7.3 Specific end use(s) Recommendations : Heat transfer fluids

Exposure Scenario information : Not available.

8. EXPOSURE CONTROLS/PERSONAL PROTECTION 8.1 Control parameters Ingredient name Occupational exposure limits

No exposure limit value known.

DNEL Summary : Not available. PNEC Summary : Not available. 8.2 Exposure controls : Do not discharge waste and/or cleaning water into the public sewer system.

8.2.1 Appropriate engineering controls : If this product contains ingredients with exposure limits, personal,

workplace atmosphere or biological monitoring may be required to determine the effectiveness of the ventilation or other control measures and/or the necessity to use respiratory protective equipment. Reference should be made to European Standard EN 689 for methods for the assessment of exposure by inhalation to chemical agents and national guidance documents for methods for the determination of hazardous substances.

: Good general ventilation should be sufficient to control worker exposure to

airborne contaminants. If this product contains ingredients with exposure limits, use process enclosures, local exhaust ventilation or other engineering controls to keep worker exposure below any recommended or statutory limits.

8.2.2 Individual protection measures Respiratory protection : Respirator selection must be based on known or anticipated exposure

levels, the hazards of the product and the safe working limits of the selected respirator.

Hand protection : Chemical-resistant, impervious gloves complying with an approved standard should be worn at all times when handling chemical products if a risk assessment indicates this is necessary. Suitable materials : Viton

Eye protection : Safety eyewear complying with an approved standard should be used when a risk assessment indicates this is necessary to avoid exposure to liquid splashes, mists or dusts.

Skin protection : Personal protective equipment for the body should be selected based on the task being performed and the risks involved and should be approved by a specialist before handling this product.

8.2.3 Environmental exposure controls Emissions from ventilation or work process equipment should be checked to ensure they comply with the requirements of environmental protection legislation., In some cases, fume scrubbers, filters or engineering modifications to the process equipment will be necessary to reduce emissions to acceptable levels.

9. PHYSICAL AND CHEMICAL PROPERTIES 9.1 Information on basic physical and chemical properties

Page 3 / 8


Therminol® RD


Notes to physician : No specific treatment. Treat symptomatically. Contact poison treatment specialist immediately if large quantities have been ingested or inhaled.

Specific treatments : Not available.

5. FIRE-FIGHTING MEASURES 5.1 Extinguishing media Suitable : Use an extinguishing agent suitable for the surrounding fire., Use dry

chemical, CO2, water spray (fog) or foam. Not suitable : Do not use water jet. 5.2 Special hazards arising from the substance or mixture

In a fire or if heated, a pressure increase will occur and the container may burst. Promptly isolate the scene by removing all persons from the vicinity of the incident if there is a fire. No action shall be taken involving any personal risk or without suitable training.

5.3 Advice for firefighters : Fire-fighters should wear appropriate protective equipment and self-contained breathing apparatus (SCBA) with a full face-piece operated in positive pressure mode.

6. ACCIDENTAL RELEASE MEASURES 6.1 Personal precautions, protective equipment and emergency procedures 6.1.1 For non-emergency personnel : Wear suitable respiratory protection (conforming to EN140 with Type A filter

or better) and gloves (type EN374) if regular skin contact likely.

6.1.2 For emergency responders : See also Section 8 for additional information on hygiene measures.

6.2 Environmental precautions : Avoid dispersal of spilled material and runoff and contact with soil,

waterways, drains and sewers. Inform the relevant authorities if the product has caused environmental pollution (sewers, waterways, soil or air).

6.3 Methods and materials for containment and cleaning up 6.3.1 Containment techniques : Small spill :

Stop leak if without risk. Move containers from spill area. Absorb with an inert material and place in an appropriate waste disposal container. Dispose of via a licensed waste disposal contractor. Large spill : Stop leak if without risk. Move containers from spill area. Prevent entry into sewers, water courses, basements or confined areas. Contain and collect spillage with non-combustible, absorbent material e.g. sand, earth, vermiculite or diatomaceous earth and place in container for disposal according to local regulations (see section 13). Dispose of via a licensed waste disposal contractor. Note: see section 1 for emergency contact information and section 13 for waste disposal.

6.3.2 Methods for cleaning up : Clear up spills immediately and dispose of waste safely. Note: see section 1 for emergency contact information and section 13 for waste disposal.

6.3.3 Other information : None.

6.4 Reference to other sections Note: see section 8 for personal protective equipment and section 13 for waste disposal.

7. HANDLING AND STORAGE 7.1 Precautions for safe handling 7.1.1 Recommendations If during normal use the material presents a respiratory hazard, use only with adequate ventilation or wear appropriate respirator. Wear suitable respiratory protection (conforming to EN140 with Type A filter or better) and gloves (type EN374) if regular skin contact likely. 7.1.2 Advice on general occupational hygiene Eating, drinking and smoking should be prohibited in areas where this material is handled, stored and processed. See also Section 8 for additional information on hygiene measures.

Page 2 / 8


Therminol® RD


Precautionary statements

Prevention : P273 Avoid release to the environment.

Response : P301 + P310 IF SWALLOWED: Immediately call a POISON CENTER or doctor/physician. P331 Do NOT induce vomiting.

Disposal : P501 Dispose of contents and container in accordance with all local, regional, national and international regulations.

2.3 Other hazards Other hazards which do not result in classification

: None known.

3. COMPOSITION/INFORMATION ON INGREDIENTS Substance : UVCB

Classification.

Product/ingredient/constituent Identifiers % 67/548/EEC Regulation (EC) No.

1272/2008 [CLP]

Type

tetrapropylenebenzene EC:246-772-4 CAS : 25265-78-5

85 - 100 Xn; R65 R53

Asp. Tox., 1, Aquatic toxicity (chronic), 4,

[1]

Type [1] Substance classified with a health or environmental hazard [2] Substance with a workplace exposure limit [3] PBT-substance [4] vPvB-substance

4. FIRST AID MEASURES 4.1 Description of first aid measures inhalation : Move exposed person to fresh air. Keep person warm and at rest. If not

breathing, if breathing is irregular or if respiratory arrest occurs, provide artificial respiration or oxygen by trained personnel. Get medical attention if symptoms occur.

Ingestion : Wash out mouth with water. Move exposed person to fresh air. Keep person warm and at rest. Do not induce vomiting unless directed to do so by medical personnel. If vomiting occurs, the head should be kept low so that vomit does not enter the lungs. Call medical doctor or poison control center immediately.

Skin contact : Flush contaminated skin with plenty of water. Remove contaminated clothing and shoes. Get medical attention if symptoms occur.

Eye contact : Immediately flush eyes with plenty of water, occasionally lifting the upper and lower eyelids. Check for and remove any contact lenses. Continue to rinse for at least 10 minutes. Get medical attention if irritation occurs.

4.2. Most important symptoms/effects, acute and delayed Potential acute health effects Eye contact : Not sufficient for classification.

inhalation : Not sufficient for classification.

Skin contact : Not sufficient for classification.

Ingestion : May be fatal if swallowed and enters airways.

4.3 Indication of immediate medical attention and special treatment needed, if necessary


Page 1 / 8


Conforms to Regulation (EC) No. 1907/2006 (REACH), Annex II and Regulation (EC) No. 1272/2008 (CLP)

1. IDENTIFICATION OF THE SUBSTANCE/MIXTURE AND OF THE COMPANY/UNDERTAKING 1.1 Product Identifier Product name : Therminol® RD REACH Registration number : 01-2119485396-25 EC number : 246-772-4 CAS number : 25265-78-5 Chemical name : Tetrapropylenebenzene 1.2 Relevant identified uses of the substance or mixture and uses advised againstIdentified uses : Heat transferring agents

Uses advised against : None identified. 1.3 Details of the supplier of the safety data sheet Solutia Europe SPRL/BVBA Corporate Village - Aramis Building Leonardo Da Vincilaan 1, B-1935 Zaventem - Belgium Telephone: +32(0)2.746.50.00 - Fax: +32(0)2.746.57.00 e-mail address of person responsible for this SDS

: [email protected]@Solutia.com

National contact : Not available.

1.4 Emergency telephone number

Emergency telephone number : +44 (0)1633 754280 (Europe)+44 (0)1633 754280 (Europe)

2. HAZARDS IDENTIFICATION 2.1 Classification of the substance or mixture Classification according to Regulation (EC) No. 1272/2008 [CLP/GHS] Classification.

: ASPIRATION HAZARD - ORAL Category 1 AQUATIC TOXICITY (CHRONIC) - Category 4

Hazard statements (code) : H304 May be fatal if swallowed and enters airways. H413 May cause long lasting harmful effects to aquatic life.

Classification according to Directive 67/548/EEC [DSD]/ EU Dangerous Preparations Directive 1999/45/EC. Classification.

: Xn Harmful R65 Harmful: may cause lung damage if swallowed. R53 May cause long-term adverse effects in the aquatic environment.

2.2 Label elements

Signal word : Danger

Hazard statements : H304 May be fatal if swallowed and enters airways. H413 May cause long lasting harmful effects to aquatic life.



ASSENTCOMPLIANCE

OTHER CONCERNS fOR SubSTANCE ANd MIxTuRE PROduCERS/IMPORTERS classificaTion, labeling and packaging (clp) -classificaTion •Atthistime,theprimaryimpactofCLPiscustomsstoppages.

•Registrationnumberand/orCLPNotificationnumbernotpresentontheSDS

EU SAFETY DATA SHEETaccording to Regulation (EC) No. 1907/2006 (REACH)

RTV Silicone sealantMaterial number RTV01

Date of print: 16/02/2010Revision date: 11/02/2010Date of first version: 11/02/2010

Version 1 / Page 6 of 6

This data sheet cannot cover all possible situations which the user may experience during processing. Each aspect of your operation should be examined to determine if, and which additional precautions may be necessary. All health and safety information contained in this data sheet should be provided to your employees and customers. It is your responsibility to develop appropriate workplace instructions and training programmes for employees.As the conditions and methods of use are beyond our control, we do not assume any responsibility and expressly disclaim any liability for any use of this product. The information supplied on this safety data sheet complies with our current level of knowledge as well as with national and EU regulations. All statements or suggestions are made without warranty, expressed or implied, regarding accuracy of information, the hazards connected with the use of the product or the results to be obtained from the use thereof.

printed by AIRTECH EUROPE ... with QualiSys SUMDAT





Air transport (IATA)Proper shipping name: Not restricted

Additional informationNot a hazardous material with respect to transportation regulations.

15. Regulatory informationLabelling (67/548/EEC or 1999/45/EC)Code letter and hazard symbol:

not applicableR phrase(s): not applicableS phrase(s): S 24 Avoid contact with skin.

S 51 Use only in well-ventilated areas.

National regulationsNational regulations - Great BritainHazchem-Code: -

National regulations - GermanyStorage class: 11= Combustible solidsWater Hazard Class: 1 = mild water pollutant

National regulations - EC member statesM Factor 0

National regulations - USAHazard rating systems

11 1

NFPA Hazard Rating: Health: 1 (Slight) Fire: 1 (Slight) Reactivity: 1 (Slight)

HEALTH 1

FLAMMABILITY 1

PHYSICAL HAZARD 1

X

HMIS Version III Rating: Health: 1 (Slight) Flammability: 1 (Slight) Physical Hazard: 1 (Slight) Personal Protection: X = Consult your supervisor

16. Other informationFurther remarksR phrase(s): R 10 = Flammable.

R 14 = Reacts violently with water.R 22 = Harmful if swallowed.R 34 = Causes burns.R 35 = Causes severe burns.

Group that issues data sheetContact person: see chapter 1, department responsible for information.






Hazardous decomposition products:Contact with moisture liberates acetic acid.Thermal breakdown of this product during fire or very high heat condition may evolve the following hazardous decomposition products: Silicon dioxide, traces of incompletely burned carbon compounds, formaldehyde, carbon monoxide and carbon dioxide.

Thermal decomposition: > 150 °CAdditional information: Product is stable under normal storage conditions.

11. Toxicological informationToxicological Tests:Following inhalation: In case of high vapour concentraitons:

Inhaling can lead to irritations of the respiratory tract and mucous membrane.After swallowing: May be harmful if swallowed.After skin contact: Product may cause light irritation to skin.After eye contact: Product can cause slight irritation.

General remarksWith exposure to moisture, product will release acetic acid .Information about acetic acid: Causes severe burns.> 150 °C discharge of small quantities of formaldehyde.Information about Formaldehyde:Toxic by inhalation, in contact with skin and if swallowed.Limited evidence of a carcinogenic effect.May cause chronic bronchitis and permanent allergic reactions.

12. Ecological informationEcotoxicityWater Hazard Class: 1 = mild water pollutantFurther details: No indication of bio-accumulation potential.

Additional ecological informationGeneral information: Do not allow to enter ground water, sewage or drains.

13. Disposal considerationsProductWaste key number 070217 = Waste containing siliconesRecommendation: Incinerate according to applicable local, state and federal regulations.

Contaminated packagingWaste key number 150102 = Plastic packagingRecommendation: Waste disposal according to official state regulations. Cleaned containers may be

recycled.

14. Transport informationOverland transport (ADR/RID)Product designation: Not restricted

Transport by sea (IMDG)Proper shipping name: Not restricted






8. Exposure controls / Personal protection equipmentExposure limit values

CAS-No. Chemical name Type Value64-19-7 Acetic acid Great Britain: WEL-TWA (EH40/2005) 10 ppm

Great Britain: WEL-TWA (EH40/2005) 25 mg/m³Great Britain: WEL-STEL (EH40/2005) 15 ppmGreat Britain: WEL-STEL (EH40/2005) 37 mg/m³Europe, IOELV: TWA 10 ppmEurope, IOELV: TWA 25 mg/m³

Exposure controlsProvide adequate ventilation, and local exhaust as needed.See also information in chapter 7, section storage.

Occupational exposure controlsRespiratory protection: Respiratory protection must be worn whenever the WEL levels have been exceeded.

Use filter type E according to EN 141.Respiratory protection is required when product is heated to 150°C or above.Combination filter B-P2 or B-P3 according to EN 141.

Hand protection: Protective gloves according to EN 374.Glove material: Fluororubber (Viton), butyl rubber, nitrile rubber, neoprene.Observe glove manufacturer's instructions concerning penetrability and breakthrough time.

Eye protection: Tightly sealed safety glasses according to EN 166.Skin protection: Wear suitable protective clothing.General protection and hygiene measures:

Avoid contact with skin, eyes, and clothing. Do not inhale vapours.Use only in well-ventilated areas. Change contaminated clothing.When using do not eat, drink or smoke.Wash hands before breaks and after work.Eye wash facility must be provided.

9. Physical and chemical propertiesAppearancePhysical state: pastyColour: redOdour: like acetic acid

Important health, safety and environmental informationDensity: 1,04 g/cm³Solubility in water: insolubleThermal decomposition: > 150 °C

10. Stability and reactivityConditions to avoid: Protect from moisture contamination.Materials to avoid: Strong oxidizing agents, water, moisture






After skin contact: Thoroughly wash skin with soap and water.Contaminated/fouled clothing and shoes must be removed immediately.Consult a doctor if skin irritation persists.

After eye contact: Immediately flush eyes with plenty of flowing water for 10 to 15 minutes holding eyelids apart. In case of troubles or persistent symptoms, consult an ophthalmologist.

After swallowing: Consult physician.

5. Fire fighting measuresSuitable extinguishing media:

Alcohol resistant foam, extinguishing powder, water fog, carbon dioxide.Special exposure hazards arising from the preparation itself, combustion products, resulting gases:

Thermal breakdown of this product during fire or very high heat condition may evolve the following hazardous decomposition products: Silicon dioxide, traces of incompletely burned carbon compounds, formaldehyde, carbon monoxide and carbon dioxide.

Special protective equipment for fire-fighters:Wear a self-contained breathing apparatus and chemical resistant suit.

Additional information: Hazchem-Code: -Cool endangered containers with water jetspray.Do not allow fire water to penetrate into surface or ground water. You have to dispose of contaminated extinguishing water according to the regulations of the authorities.

6. Accidental release measuresPersonal precautions: Provide adequate ventilation. Wear protective equipment.

Do not breathe vapour or spray. Avoid contact with skin and eyes.Environmental precautions:

Do not allow to enter ground water, sewage or drains.Methods for cleaning up: Remove mechanically, placing in appropriate containers for disposal.

Thoroughly clean surrounding area.Additional information: High slip hazard because of leaking or spilled product.

7. Handling and storageHandlingInformation for safe handling:

Provide adequate ventilation, and local exhaust as needed.Use only in well-ventilated areas. Wear protective equipment.Do not breathe vapour or spray. Avoid contact with skin and eyes.

Precautions against fire and explosion:Keep away from sources of ignition - No smoking.

StorageRequirements for storerooms and containers:

Keep container tightly closed and dry. Protect from frost.Keep away from heat sources, sparks and open flames.Protect from moisture contamination. Keep in a cool, well-ventilated place.

Information about storage in one common storage facility:Do not store together with: Oxidizing agents.

Storage class: 11= Combustible solids






1. Identification of the substance/preparationand of the company/undertaking

Identification of the substance or preparationName of product: RTV Silicone sealant

Use of the substance/preparationRTV Silicone sealant, one-component adhesive and sealing agent

Company/undertaking identificationCompany name: AIRTECH EUROPE SARLStreet/POB-No.: Z.I. HaneboeschState/city/postal code: L-4562 DifferdangeWorld Wide Web: www.airtech.luEmail: [email protected]: +352-582282-1Telefax: +352-584935Dept. responsible for information:

Telephone: +352-582282-1, E-mail [email protected]

Emergency telephone+352 58 2282-1This number is serviced during office hours.

2. Hazards identificationClassification according to directive 67/548/EEC or 1999/45/EC:

This preparation is classified as not hazardous.

Critical hazard to man and environment:Product can cause slight irritation.High slip hazard because of leaking or spilled product.Contact with moisture liberates acetic acid.Information about acetic acid: Causes severe burns.> 150 °C discharge of small quantities of formaldehyde.Information about formaldehyde:Toxic by inhalation, in contact with skin and if swallowed. Causes burns. Limited evidence of a carcinogenic effect. May cause sensitization by skin contact.

3. Composition/information on ingredientsChemical characterization (preparation)

Silicone elastomerDangerous ingredients:

CAS-No. EINECS / ELINCS Chemical name Content Classification17689-77-9 241-677-4 Triacetoxyethylsilane < 3 % C; R34. Xn; R224253-34-3 224-221-9 Methylsilanetriyl triacetate < 2 % C; R34. R14. Xn; R22

Additional information: Contact with moisture liberates acetic acid.

4. First aid measuresFollowing inhalation: Move victim to fresh air. Consult physician.




ASSENTCOMPLIANCE

COMMON INduSTRy PRACTICES –REACH ANd CLP•Registration:OnlyRepresentativeNomination

•Registration–JointDossier:REACHCentrumisacommonlyusedSIEFandConsortiumad-ministrativefirmwithestablishedprocesses,contracts,andLoAs

•CLPClassification:In-housechemicalassessmentbasedondefinedCLPthresholds(withinregu-lation)ORThirdPartyassessmentbasedontestingresults

•CLP Notification: Importer of record/manufacturer provides information to Third party forcompletionandsubmissionofdossierontheirbehalf



ASSENTCOMPLIANCE

COMMON INduSTRy PRACTICES – REACHconsorTiums and cosTs

Industry Consortium SAS FOR REACH

Information Letter 4

Member Companies

Albemarle Europe, AZ Electronic Materials GmbH, BASF SE, Cabot Corp., CP Kelco / Huber Engineered

Materials, Evonik Degussa GmbH, Grace GmbH & Co. KG, IQESIL S.A., PPG Industries Chemicals, PQ Corporation,

Rhodia Operations S.A.S., Süd-Chemie AG, Wacker Chemie AG, Zeochem AG

July 2010 Dear SIEF members, With this SIEF Information Letter the SASFORREACH consortium (“Consortium”) would like to inform all SIEF members about the next steps in the REACH registration process for Synthetic Amorphous Silica (EINECS # 231-545-4), consisting of

(i) Silica, amorphous, pyrogenic (fumed), crystalline-free (CAS#:7631-86-9, 112945-52-5);

(ii) Silica gel, precipitated silica, crystalline-free (CAS#: 7631-86-9, 112926-00-8). The Consortium has meanwhile finalized the documents for the SIEF members who want to register Synthetic Amorphous Silica as described in the previous SIEF Information Letters and on the homepage of the Consortium [http://www.reach-sas.org/]. For this purpose, the Consortium has prepared the following documents:

1. NDA (Non-disclosure agreement) 2. LoA agreement 3. Cost calculation

1. NDA The NDA is available on the homepage (pdf) http://www.reach-sas.org. There are two separate versions available, one for producers/importers and one for Only Representatives (“OR”) and/or Third Party Representatives (“TPR”). Please print out and complete the appropriate document. Important notes for OR’s/TPR’s: - Please complete one NDA for each and every client represented by you (incl. the UUID and pre-registration code). - Please also identify in your response the respective tonnage band applicable for each client represented by you. PLEASE DO NOT PROVIDE INFORMATION REGARDING ACTUAL TONNAGES PRODUCED/IMPORTED BY YOUR CLIENT. Please fax the signed NDA to Dr. Knoell Consult, Fax: +49-214-20658201, after receiving the NDA we will prepare the agreement(s) for you.

Industry Consortium SAS FOR REACH

Information Letter 4

Member Companies

Albemarle Europe, AZ Electronic Materials GmbH, BASF SE, Cabot Corp., CP Kelco / Huber Engineered

Materials, Evonik Degussa GmbH, Grace GmbH & Co. KG, IQESIL S.A., PPG Industries Chemicals, PQ Corporation,

Rhodia Operations S.A.S., Süd-Chemie AG, Wacker Chemie AG, Zeochem AG

2. LoA Agreement The price for the letter of access to the joint registration dossier for Synthetic Amorphous Silica (“LoA”) depends on the tonnage band for which a registration is made:

> 1000 t/a: €200,000 100 - 1000t/a: €180,000 10 - 100t/a: €50,000 1 - 10t/a: €30,000 The price calculation is explained in detail in the document ‘Cost Calculation SASFORREACH’, also available on the homepage http://www.reach-sas.org. Please bear in mind that every study/action which is listed in the cost calculation document was necessary for the successful registration of Syynthetic Amorphous Silica, thus the price of the letter of access is not negotiable. Likewise, the LoA agreement defining the terms and conditions under which a letter of access will be issued is a standard document. As the Consortium expects less than 20 potential registrants to join the joint submission for Synthetic Amorphous Silica in the highest tonnage band, no rebate in case of additional buyers is planned. The Consortium will ensure full compliance with applicable REACH and other EU legislation. After receipt of payment for the LoA, the lead registrant will provide purchasers of a LoA with a complete registration package, including a Letter of Access to the technical part of the dossier (parts 4 – 13), a prepared template for the company-specific part of the dossier (parts 0 – 3, except confidential business information), and the Chemical Safety Report. With kind regards For the SASFORREACH Consortium Patrick Wellmann Dr. Knoell Consult, Leverkusen

• bePrepared –Consortiums and/or LRs need tocommunicateanddetail costing toanymembers,these costs canbequitehighas theyhave initial-ly been determined based on pre-registrants andmembers at themomentof calculation aswell as“expected”testinganddatagatheringcosts

• GoodCommunication – itwill be vital to havegood,clearunderstandingofalltheconsortium/LRcommunicationsand, inkind, toclearlycommu-nicatebacktothem…especiallytoproperlydeter-mineyourspecificcosts.



ASSENTCOMPLIANCE

HOw CAN ASSENT HELP? consulTing services•ManagethecompliancetoROHS,REACH,CLPandotherEnvironmentalstandards

•Ensurecompliancewithregulatoryagenciesandcomplianceregulations

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ASSENTCOMPLIANCE

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ASSENTCOMPLIANCE

QuESTIONS?PleasesubmityourquestionsinwritingusingtheQ&Atoolalongthetopmenutoolbar.

AnyquestionsnotaddressedduringtheQ&Aportionofthiswebinarwillbeaddressedinprivatecorrespondenceafterthewebinar.

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