GENERATING SAFETY DATA SHEETS FORSUBSTANCES AND MIXTURES ACCORDING TOTHE LATEST REACH AND CLP REQUIREMENTS

Updating SDS according to the latest requirements ofREACH and CLP

Lucia Bellmann, DOW Austria GmbH, 24 & 25 Nov. 2011

REACH AND CLP IN RUSSIA AND CIS – 24 & 25 November 2011, Moscow, Russia

Updating SDS according to the latestrequirements of REACH and CLP

•Introducing new changes and deadlines for submitting SDS

•Outlining changes to the SDS that CLP Regulation requires

•Providing SDS along the supply chain

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Updating SDS according to the latestrequirements of REACH and CLP

•Introducing new changes and deadlines for submitting SDS

•Outlining changes to the SDS that CLP Regulation requires

•Providing SDS along the supply chain

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From the EU SDS Directive to the new 453/2010 Regulation

Arts 31 & 32 andAnnex II of REACH provides thenew provisions for the SDS:- inversion of sections 2 and 3 (based onGHS)- addition of e-mail address of thecompetent person responsible for theSDS (section 1)- for non-classified components,description of the reason for theirinclusion in section 3.

Directive 2001/58/EC

REACH Regulation1907/2006

REACH Regulation453/2010

amending for thesecond time Directive91/155/EEC definingand laying down thedetailed arrangementsfor the system ofspecific informationrelating to dangerouspreparations…andrelating to dangeroussubstances inimplementation ofArticle 27 of CouncilDirective 67/548/EEC(safety data sheets)

European Harmonization

LOW HIGH

Two new Annexes with differentTiming for substances andmixtures

CLP Regulation1272/2010

The Regulatory Framework

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In a nutshell the amendment includes:• 3 articles defining the timing and the scope• new REACh Annex II

• which includes 2 annexes (Annex I and Annex II)• changes in the structure of the SDS• inclusion of CLP Classification and Label elements

The text of the legislation can be downloaded from here:http://eur-lex.europa.eu/LexUriServ/LexUriServ.do?uri=OJ:L:2010:133:0001:0043:en:PDF

Meeting the deadlines forSubstances

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Meeting the deadlines forMixtures

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To sum up:

• The CLP Regulation provides the new rules on how to classify theproducts

• The REACh regulation provides the new requirements for SDS

• “REACh compliant SDS” or “CLP compliant SDS”…. all mean the samething: the SDS in European Economic Area must be in accordance with thecriteria outlined in Regulation 453/2010 (an amendment to the REACHregulation), this includes having the C&L of substances in accordance withCLP criteria

• Such an SDS may or may not have an Exposure Scenario (ES).

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Updating SDS according to the latestrequirements of REACH and CLP

•Introducing new changes and deadlines for submitting SDS

•Outlining changes to the SDS that CLP Regulation requires

•Providing SDS along the supply chain

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1.Identification of the substance / preparation and of the company/undertaking

2.Hazards identification

3.Composition/information on ingredients

4.First-aid measures

5.Fire-fighting measures

6.Accidental release measures

7.Handing and storage

8.Exposure controls/personal protection

9.Physical and chemical properties

10.Stability and reactivity

11.Toxicological information

12.Ecological information

13.Disposal considerations

14.Transport information

15.Regulatory information

16.Other information

THE old STRUCTURE of the EU SDS

16 headings mandatory

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THE new STRUCTURE of the EU SDS

SECTION 1: Identification of the substance/mixture and of thecompany/undertaking1.1. Product identifier1.2. Relevant identified uses of the substance or mixture and uses advisedagainst1.3. Details of the supplier of the safety data sheet1.4. Emergency telephone numberSECTION 2: Hazards identification2.1. Classification of the substance or mixture2.2. Label elements2.3. Other hazardsSECTION 3: Composition/information on ingredients3.1. Substances3.2. MixturesSECTION 4: First aid measures4.1. Description of first aid measures4.2. Most important symptoms and effects, both acute and delayed4.3. Indication of any immediate medical attention and special treatmentneededSECTION 5: Fire-fighting measures5.1. Extinguishing media5.2. Special hazards arising from the substance or mixture5.3. Advice for fire-fightersSECTION 6: Accidental release measures6.1. Personal precautions, protective equipment and emergencyprocedures6.2. Environmental precautions6.3. Methods and material for containment and cleaning upSECTION 7: Handling and storage7.1.Precautions for safe handling7.2.Conditions for safe storage, including any incompatibilities7.3.Specific end use(s)SECTION 8: Exposure controls/personal protection8.1.Control parameters8.2.Exposure controlsSECTION 9: Physical and chemical properties

9.1.Information on basic physical and chemical properties9.2.Other informationSECTION 10: Stability and reactivity10.1. Reactivity10.2. Chemical stability10.3. Possibility of hazardous reactions10.4. Conditions to avoid10.5. Incompatible materials10.6. Hazardous decomposition productsSECTION 11: Toxicological information11.1. Information on toxicological effectsSECTION 12: Ecological information12.1. Toxicity12.2. Persistence and degradability12.3. Bioaccumulative potential12.4. Mobility in soil12.5. Results of PBT and vPvB assessment12.6. Other adverse effectsSECTION 13: Disposal considerations13.1. Waste treatment methodsSECTION 14: Transport information14.1. UN number14.2. UN proper shipping name14.3. Transport hazard class(es)14.4. Packing group14.5. Environmental hazards14.6. Special precautions for user14.7. Transport in bulk according to Annex II of MARPOL73/78 and the IBC CodeSECTION 15: Regulatory information15.1. Safety, health and environmental regulations/legislation specific for thesubstance or mixture15.2. Chemical Safety AssessmentSECTION 16: Other information

16 headingsmandatory+ 48 sub-headingsmandatory+ES when required

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Key changes:• New format• Email address of “person” responsible for SDS• Uses. Distinction between “Identified uses” and“Uses advised against”• New identifiers (chemical name, etc.)• For products associated with REACh substances:- REACh registration number(s)

- Identification consistent with REACh dossier

Old format New format

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Old format New format

Risk phrases plus other adverse effects Seenextslide

Substances

Key changes:• new format• Substances:

Classification as per DSD & CLP criteria Label elements with pictograms as per CLP criteria only

• Mixtures: Classification as per DPD criteria or (CLP&DPD) Label elements as per DPD criteria or CLP (if the mixture has been already classified according to CLP)

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Substances

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Mixtures

- Classification inaccordance withDSD/DPD

- Labeling inaccordance withDSD/DPD (in section2.2)

- At this point in time,neither CLPclassification in DOWSDS nor CLP label infoon DOW labels

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Key changes:• new format• Registration number when available or comment when not available• Substances & mixtures

Classification as per DSD & CLP criteria Registration number(s) (only base number)

Old format

New format

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Section name Key changes Consistency check with ES

SECTION 4: First aid measures Format changes + newsub-headers

No

SECTION 5: Firefighting measures Format changes No

SECTION 6: Accidental releasemeasures

Format changes yes

SECTION 7: Handling and storage Format changes + newsub-header:Specific end uses

yes

From section 4 to…7

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Key changes:• new format• DNELs & PNECs

Old format New format

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Section name Key changes Consistencycheck with ES

SECTION 9: Physical and chemical properties Format changes + mandatory additionalproperties

No

SECTION 10: Stability and reactivity Format changes No

SECTION 11: Toxicological information Format changes + summarized evaluationof the CMR properties - Consistency withCSR needed

No

SECTION 12: Ecological information Format changes + PBT/ vPvB assessments+ Consistency with CSR needed

No

SECTION 13: Disposal considerations Format changes Yes

SECTION 14: Transport information Format changes No

SECTION 15: Regulatory information Format changes + indicate if CSA has beencarried outLabelling info has been moved to section2

No

SECTION 16: Other information Format changes + Full text of H-statements No

From section 9 to…16

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When attachment of Exposure Scenarios to the SDS is required

The text of the law: (Article 31(7) of REACH)

“Any actor in the supply chain who is required to prepare a chemicalsafety report according to Articles 14 or 37 shall place the relevant exposurescenarios (including use and exposure categories where appropriate) in anannex to the safety data sheet covering identified uses and including specificconditions resulting from the application of Section 3 of Annex XI.”

In practice?

-If the substance is subject to registration AND is produced/imported inquantities of 10 tonnes or more per year AND meets the criteria forclassification as dangerous…the exposure assessment must be carried out

ES – an example

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ES – an example

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ES – an example

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Updating SDS according to the latestrequirements of REACH and CLP

•Introducing new changes and deadlines for submitting SDS

•Outlining changes to the SDS that CLP Regulation requires

•Providing SDS along the supply chain

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Under REACH, the SDS is:

the main information tool down the supply chain the basic input for the risk assessment in workplaces

The Supply Chain Communication

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SDS

Specific use

Directive2001/58/EC

REACHprovisions

+ ES + RMM+ Identified Uses

PBT, PNEC, DNEL, etc

CLPprovisions

New SDS

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REQUIREMENT TO SUPPLY SDS

•An SDS must be provided if• substances and preparations are classified as dangerous, according to CLP for

substances and 1999/45/EC for preparations• the substance is persistent, bioaccumulative and toxic (PBT) or very persistent and very

bioaccumulative (vPvB) in accordance with Annex XIII of the REACH Regulation• the substance is included in the candidate list of substances which may be subjected to

authorization, established according to Article 59(1)• preparations are not classified as dangerous but contain

» at least 1 substance posing human health or environmental hazard in a concentration of=>1% by weight for non-gaseous preparations and =>0.2% by volume for gaseouspreparations

» at least 1 PBT or vPvB substance at a concentration =>0.1%» a substance for which there are Community workplace exposure limits (or National OELs)

• For product stewardship reasons, The Dow Chemical Company decided to go beyondthe requirements of the legislation and to create and supply SDS for ALL the products itplaces on the market.

BusinessBusiness

• SDS deliveredper order

• Archive of SDS(electronic inDow website)

ArchiveDocuments

DeliverDocuments

• Determineevaluations

• Completeevaluations

• Populateproperty tree

• Create draftdocument

• Send forBusinessApproval

• Translations

• Activate

• Qualify data

• Completeentry ofcollected datainto system

SDS Involved SupportSDS Involved Support FunctionsFunctions

AnalyzeData

StoreData

CreateDocuments

CustomerCustomerServiceService

ArchiveArchiveCenterCenter

CollectSubstance

Data

• Compositionbased onprocedures

• StandardCollection Form

The SDS work process involves Product Stewardship, Expertise and support function activities,maintaining a steady dialogue throughout the process.

SDS at DOW – the high level view

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An internal IT system allows automatic distribution of SDSs to all customers

Basic features: Languages: the system allows to deliver SDSs in the official languages of each jurisdiction Customer type: there are a number of Customer Types relevant to the distribution of DowSDSs

Product Purchasers; SDS Requestors; Customer Designated SDS Recipients;Customer Consignees, etc.

Publically available information• All country versions on the “Safety Data Sheets & Product Finder” Dow websitehttp://www.dow.com/webapps/msds/msdssearch.aspx• Upon request the Dow Customer Information Group (CIG) will send the most up to dateSDS - CIG website: http://www.dow.com/assistance/index.htm

SDS at DOW – SDS Distribution

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External sources of information

http://eur-lex.europa.eu/en/index.htmThe official site for EU laws

http://echa.europa.eu/home_en.asp

The European Chemical Agency (from here links to REACh and CLP)FAQ about REACH (v. 23 June 2011): http://echa.europa.eu/reach/reach_faq_en.aspFAQ about CLP (v. 09 September 2011): http://echa.europa.eu/clp/clp_help/clp_faq_en.asp?fuseaction=home.faqGuidance on the compilation of safety data sheets (v. 07 September 2011):http://guidance.echa.europa.eu/public-2/getdoc.php?file=sds_en

GHS UNECE official site

http://live.unece.org/trans/danger/publi/ghs/ghs_welcome_e.html

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Notice: No freedom from infringement of any patent owned by Dow or others is to beinferred. Because use conditions and applicable laws may differ from one location toanother and may change with time, Customer is responsible for determining whetherproducts and the information in this document are appropriate for Customer's use and forensuring that Customer's workplace and disposal practices are in compliance withapplicable laws and other government enactments. The product shown in this literaturemay not be available for sale and/or available in all geographies where Dow isrepresented. The claims made may not have been approved for use in all countries. Dowassumes no obligation or liability for the information in this document. References to “Dow”or the “Company” mean the Dow legal entity selling the products to Customer unlessotherwise expressly noted. NO WARRANTIES ARE GIVEN; ALL IMPLIED WARRANTIESOF MERCHANTABILITY OR FITNESS FOR A PARTICULAR PURPOSE AREEXPRESSLY EXCLUDED.