GHS Substance Classifications for SDS Authoring & Labels. Paul Lloyd

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1 GHS Substance Classifications for SDS Authoring & Labels Paul Lloyd

2 Need for Substance Classifications Required if individual substances are sold Essential requirement for classifying mixtures in absence of test data for mixture 3E Generate automated output is dependent on substance classifications Display of component substance classifications is mandatory for EU SDS s for mixtures

3 Classification Sources Poll How do you get substance classifications? Obtain test data for all classes and select the most appropriate Use the classifications automatically generated by 3E Generate Use classifications from vendor SDS s Use classifications from regulatory lists

specified criteria Availability of data In-house expertise,

4 Approaches to Classification Theoretical requirement Based on comparing physical, chemical and toxicological data against specified criteria Availability of data In-house expertise, particularly with regard to GHS criteria Interpretation of data Very time consuming

5 Approaches to Classification Automated classification utilizing information from databases By default, must be conservative and take most severe toxicological values and /or authority classification Data does not provide the whole story, generally numeric with no qualification. Limit tests are particularly problematic Data may be misreported, particularly when taken from secondary sources. LD50 of 5.1 g/kg is very different to 5.1 mg/kg

6 1-methoxy 2- propanol CAS

GHS Classification LD50 >1840 mg/kg means LD50 could be 1840.

7 GHS Classification LD50 >1840 mg/kg means LD50 could be mg/kg Applying the relevant criteria mg/kg is <2000 mg/kg therefore Category 4

8 1-methoxy 2- propanol CAS

9 GHS Classification Hence LD50 >1840 mg/kg should not be used as basis for classification All other LD50 data is >5000 mg/kg Therefore, most appropriate conclusion is Not classified

10 Approaches to Classification Classifications from Vendor SDS s Reliability Conflicting information from different suppliers Coverage of all GHS classes and categories, particularly if taken from non domestic format SDS s or if your product is to be exported May be best option for substances with variable composition (ethoxylated fatty alcohols, petroleum products etc.)

11 Approaches to Classification Utilizing existing classifications from Regulatory Lists Which list? Reliability Substances without existing classifications Acceptability Regulators and Marketplace

12 Global Supply Poll Do you supply outside of the EEA? What classification do you use? EU Regulation (EC) 1272/2008 [CLP] classification only Global GHS classification Country specific classifications

13 Methyl propyl ketone (CAS ) Acute toxicity (inhalation) classification EU CLP Annex VI Not listed China SAWS Category 3 (toxic if inhaled) Japan NITE Category 3? REACH Registration database Not Classified

14 Changes to Lists Japan NITE 2006 Japan NITE 2015

15 Questionable Data

16 REACH Registration Dossier

17 GHS Classification Hence LC50 >25.5 mg/l can be considered reliable Therefore, most appropriate conclusion is: Not classified However, before quoting that value consider: Is it copyright and are you entitled to print it?

18 Classification Lists

19 Authority Lists Listing Approx. # Entries Status Canada HPR Schedule 4 40 Mandatory for Canada China SAWS 3300 Mandatory for China EU CLP Annex VI 4500 Mandatory for EU Korea MOE 900 Mandatory for Korea Korea NEMA 1080 Mandatory for Korea New Zealand HSNO CCID 4900 Mandatory for New Zealand Malaysia ICOP 230 Mandatory for Malaysia Serbia Decree No. 48/2014, Table Mandatory for Serbia Turkey SEA Annex VI 4500 Mandatory for Turkey Australia HSIS 4500 Advisory Canada Quebec WHMIS CSST/SRT 2400 Advisory Korea KOSHA 6500 Advisory Japan JAISH 370 Advisory Japan NITE 2900 Advisory South Africa SANS 670 Advisory Taiwan CLA 3300 Advisory Taiwan OSHA 6000 Advisory

20 Classifications for Methanol Hazard Class Flammable Liquid Acute Tox oral Acute Tox dermal Acute Tox inhal Eye damage/irritation Reproductive toxicity STOT SE STOT RE EU Annex VI Korea MOE Korea KOSHA Japan NITE China SAWS Taiwan CLA * * 3 3 3* A 1B 1B ,3(H335) 1,3 (H336)

21 Other Lists ECHA REACH Registered Substances Database Information from REACH registration dossiers ECHA Classification and Labelling Inventory

22 Pros and Cons of Lists EU CLP Annex VI Widely recognized Hazard classes other than those with classification need to be assessed Basis of many is unknown / hard to trace Does not cover all GHS categories China SAWS Covers majority of GHS categories Basis of classifications not available

23 Pros and Cons of Lists Korea MOE Does not cover all GHS categories Basis of classification hard to find Taiwan CLA Covers majority of GHS categories Basis of classification hard to find Classifications tend to be conservative

24 Pros and Cons of Lists Japan NITE Basis of classification available Often very conservative classifications Occasional misinterpretations of GHS criteria Korea KOSHA Dubious quality / little expert judgment Access to original data / basis for classification problematic

25 Pros and Cons of Lists EU REACH Dossiers Supporting data available Large number of substances Not all GHS categories covered Not an official classification, multiple classifications for same CAS number in some cases Quality is variable dependent on Registrant Supporting data may be copyright protected

26 Other Sources Independent comprehensive reviews EU Risk Assessment OECD SIDS Initial Assessment Reports US EPA Toxicological Assessments Australian NICNAS Reports Industry group recommendations Oil Industry Concawe, API Petroleum HPV Test Group Gases European Industrial Gases Association Oleo Chemicals APAG

27 Summary of Pitfalls Missing classifications (Building blocks) - Example: Flammable liquid 4 Inappropriate classifications failing to reflect specific authority interpretations - Examples: carcinogenicity of Quartz, Ethyl benzene Classification algorithms are sensitive to seemingly minor inaccuracies - Example: Impact of not classified verses classification not possible in acute toxicity calculations

28 Summary of Pitfalls Unnecessary over-classification impacting labeling, shipping and customer perception Can you support the classification if challenged by customers or regulators?

29 How Verisk 3E Can Help BASE CHEMICAL LIBRARY Developed to help support the chemical regulatory compliance and authoring needs of clients Consists of substances identified by CAS number and fully classified by Verisk 3E s expert team

30 How Verisk 3E Can Help BASE CHEMICAL LIBRARY GHS classifications for all global GHS Authorities Including relevant set of Physical/Chemical, Toxicological and Eco-toxicological data Content structured for import into 3E Generate Data utilized as the input for automatic mixture level classification algorithms

31 Thank You! Q & A

Observations: UN Global List Pilot Project versus Published GHS Classifications

Observations: UN Global List Pilot Project versus Published GHS Classifications Darlene Susa-Anderson March 28, 2017 1 Published GHS Classifications Australia 4803 Canada 1253 China 2903 EU 4623 Indonesia