Options for Supplying Information Downstream - The Extended Safety Data Sheet Wayne Smith, BCF Eastwood Hall, Nottingham Wednesday 30 March

The SDS 2

Requirements for SDSs : Article 31 of REACH (EC) 1907/2006 Annex II REACH Updated Annex II May 2010 (EC) 453/2010 More content obligatory, previously just recommended Information in SDS must be consistent with ES

Timescales New SDS from 1 December 2010 Existing SDS until 30 Nov 2012 CLP-based SDS for mixtures by 1 Jun 2015 (guidance to come) – unless classify early

When is it a new SDS? Update without delay - Section-1: change in emergency telephone number 2: change in C&L of substance/mixture (inc CLP classn), if more severe 3: change/addition of a component which is/becomes CMR (CLP Cat. 1A/1B, DSD 1 or 2), PBT/vPvB, N;R50/53, or SVHC 8: change in RMMs - PPE, engineering or emission control (if more stringent), or new OEL 14: change in transport classification (exc technical names) 15: granting/refusal of an authorisation or application of a restriction to a substance Annex - mixture : complete set of ESs for all risk-determining substances or if a safety assessment is revised (or attached for the first time) and contains new relevant information on risk management measures

Minor Changes Examples : Change in layout Section 2 and 3: deletion of DPD and DSD classifications after 1 June 2015 Section 3: registration number available for one or more components Section 8: change in OEL value and/or PNEC for a substance in the mixture Annex: availability of exposure scenario(s) for one or more substances in the mixture (not affecting RMMs) Other changes with no effect on the PPE, engineering or emission controls.

SDS Supply Not needed for products to general public, unless requested (but needs sufficient info on label) In official language of MS supplied in Free On paper or electronic Can download from website with alert and proof of receipt To named individual or job title with request to pass on Keep records – 10 years Version control/changes identified By competent person

SDS Sections 1.Identification of the substance/mixture 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: Handling 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 Main and Sub-sections mandatory

What is an extended safety data sheet 9

What is an Extended SDS SDS + ES(s) = ESDS or Extended SDS – Not eSDS – Existing requirement for SDS not changed – The content off the SDS is set by REACH Annex II – revised May 2010 – may have one or more exposure scenarios (ES) attached – SDS may be longer due to new REACH Annex II – Supply ESDS in an official language of MS The main body of the SDS contains information relevant to all users

How to produce an ESDS 11

Check consistency between ESs and SDS – Sections 7, 8, 12, 13 Add info from substance ESDS to mixture SDS – Substance registration number in Section 3 – PNECs and/or DNELs in Section 8 – Any PBT/vPvB substances in Section 12 Same substance different suppliers? – Pass on all variations or – Use expert judgement (liability?) 12 Option 1 Forward Substance ESs

As separate, composite ES or Include in body of SDS – Same information, different format 13 Option 2 and 3 Prepare Mixture ES

Compile list of RMs in mixture Breakdown to substances Ignore those not relevant – Exposure/emission routes not relevant – Below REACH concentration thresholds – No registration number (but check significant info) Identify lead substances Use DPD+ method if have a number of substances 14 Prepare Mixture ES

Exposure scenarios for mixtures 15

16 DPD+ Method ABCDEFG MixtureBreakdown mixtureOverall compositionVapour Pressure (hPa at 25°C) Components%Substances% % Resin solution A Acrylic Polymer5.00Acrylic Polymer5.00< Ethyl Acetate } Ethyl Acetate 103 Resin solution B Ethyl Acetate Vinyl Polymer12.50Vinyl Polymer12.50< Cyclohexane4.50 } Cyclohexane Cyclohexane25.5Cyclohexane25.50 n-hexane2.50n-hexane2.50n-hexane Naphtha hydro-treated light Naphtha hydro-treated light Naphtha hydro-treated light Exercise - Identify relevant RMs and list substances

17 DPD+ Method ABCDEFG MixtureBreakdown mixtureOverall compositionVapour Pressure (hPa at 25°C) Components%Substances% % Resin solution A15.00 Acrylic Polymer5.00Acrylic Polymer5.00< Ethyl Acetate10.00 } Ethyl Acetate Resin solution B37.00 Ethyl Acetate20.00 Vinyl Polymer12.50Vinyl Polymer12.50< Cyclohexane4.50 } Cyclohexane Cyclohexane25.5Cyclohexane25.5 n-hexane2.50n-hexane2.50n-hexane Naphtha hydro-treated light Naphtha hydro-treated light Naphtha hydro-treated light Identify relevant RMs and list substances

DPD+ Method SubstanceConc. In the prep.(%) Vap. Pressure (hPa) InhalationDermal R/H Phrases Conc. thresh. (%) LSI R/H Phrases Conc. thresh. (%) LSI From Col EFrom Col F From Col G Col 3 x Col 2 / Col 5 Col 2/ Col 8 Ethyl acetate R67 25R6620 Cyclohexane R R n-hexane R48/20 R62 R R38 R48/20 R Naphtha hydro-treated light R R66201 Acrylic Polymer 5.00< 10-6 Vinyl Polymer 12.50< 10-6 Exercise - Identify lead substances 1

DPD+ Method Identify lead substances SubstanceConc. In the prep.(%) Vap. Pressure (hPa) InhalationDermal R/H Phrases Conc. thresh. (%) LSI R/H Phrases Conc. thresh. (%) LSI From Col EFrom Col F From Col G Col 3 x Col 2 / Col 5 Col 2/ Col 8 Ethyl acetate R R Cyclohexane R R n-hexane R48/20 R62 R R38 R48/20 R Naphtha hydro-treated light R R66201 Acrylic Polymer 5.00< 10-6 Vinyl Polymer 12.50< 10-6

DPD+ Method Substance Conc. In the prep. (%) Vap. Pressure (hPa) Eyes IngestionAquatic R/H Phrase s Conc. thresh. (%) LSIR/H Phras es Conc. thres. (%) LSI R/H Phras es Conc. thres. (%) LSI From Col E From Col F From Col G Col 2/ Col 11 Col 2 x Col 14 Col 2/ Col 17 Ethyl acetate R3620R65 Cyclohex ane R65 R50/ n-hexane R65 R51/ Naphtha htl Acrylic Polymer 5.00< 10-6 Vinyl Polymer 12.50< 10-6 Identify lead substances 2

DPD+ Method Identify lead substances Substance Conc. In the prep. (%) Vap. Pressure (hPa) Eyes IngestionAquatic R/H Phrase s Conc. thresh. (%) LSIR/H Phras es Conc. thres. (%) LSI R/H Phras es Conc. thres. (%) LSI From Col E From Col F From Col G Col 2/ Col 11 Col 2 x Col 14 Col 2/ Col 17 Ethyl acetate R R65 Cyclohex ane R65 R50/ n-hexane R65 R51/ Naphtha htl Acrylic Polymer 5.00< 10-6 Vinyl Polymer 12.50< 10-6

The following substances have to be considered for generation of the mixture ES: – Inhalation: cyclohexane, n-hexane, ethyl acetate and hydro treated naphtha. Reasoning: 82.5% are classified R67 (additive) generating an overall LSI of 361 – Dermal: n-hexane and cyclohexane. Reasoning: dermal irritation R38 concerns both substances and is additive. Note: for n-hexane, the specific threshold in Annex I takes precedence over the default value associated with R38 (20) – Eyes: Ethyl acetate, eye irritant R36 – Ingestion: no lead substance. R65 has only to be considered if the mixture viscosity is below the threshold of 7 mm²/s at 40°C. – Environment: the LSI of cyclohexane (120) is much larger than the others. No additive effects are foreseen. Note: if the product contains any substances classified as: – - Cat 1,2,3 CMR – - dermal or respiratory sensitiser – The ES for these substances should be also be taken into account for consideration of the mixture ES 22 Conclusions

Communicating downstream 23

Passing on Information This can be done in several ways : – Forwarding to customers the ES of each substance without consolidation – Preparing a new ES by consolidating the received ES of substances and annexing it to the SDS of the mixture – Extracting from the received ES all relevant information on RMMs and OCs, summarizing and including them in the related sections of the SDS of the mixture for professional users On the label for mixtures sold to the public

Which option and when to use it? Simply forwarding is simple for mixture with a very limited number of dangerous substances. However: – It doesn’t take into account dilution effects by non-dangerous components – The information on RMMs and OCs in the SDS of the mixture might not be consistent with those of the pure substance(s) in the original ES Different classification Different risks

Which option and when to use it? If the mixture is an end-product used under different conditions the best option might be to prepare several new consolidated exposure scenarios – Taking into account the various conditions of use – Indicating specific RMMs Scaling possibilities can be adapted to each use in the various ES – if you want to help your customer

Which option and when to use it? If the mixture is used as a component in a formulation down the supply chain, forwarding both – a consolidated ES and – the substances ESs helps the following actor in identifying and including relevant information in his own SDS/ESDS If scaling possibilities exist they can be found in the original ES of the substances allowing consolidation by customer

The XML standard

The XML Standard Goal: an electronic exchange standard for exposure scenario information in the supply chain Release 1.0 (available via Cefic website) for M/ICefic website – Further development needed to meet needs of DUs  Release 1.1 Co-operation between DUCC/Cefic/VCI and software providers Output will be an open standard – No intellectual property rights for lead IT partners Reconcile with ECHA (e.g. alignment with other tools) – ECHA is informed/invited to meetings, but not in lead

The XML Standard REACH Experts resolving outstanding issues e.g. – DPD+ requirements – New sub-group to consider multiple substances – Comparisons of current draft XML with “real-life” ES received by DUs

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