ghs update impact on msdss and labels - sata point/spring 2011/mike...ghs update impact on msdss and...

GHS UpdateImpact on MSDSs and Labels

SATA Spring MeetingMarch 24, 2011

Mike P. MoffattNexreg Compliance

Nexreg Compliance Inc.http://[email protected](866)361-3032

http://www.nexreg.com/�

mailto:[email protected]�

Coverage

- Basics of GHS- Lessons from Other Jurisdictions- U.S. and Canada

- Leaving Out- Adding

- Timelines and To Dos.




What is GHS?

- U.N. Initiative: Globally Harmonized System of Classification and Labelling of Chemicals (GHS)

- Harmonized- Classification Criteria- Safety Data Sheets (SDSs)- Label Elements




Building Block Approach

Purple Book – Revision 3 (Living Document)- 3 Haz Groups: Health, Physical, Enviro.- 28 classes (10 H, 16 P, 2 E)- Categories (under class)

e.g. Ph: Flammable Aerosol, Category 2




Building Block Approach

- 2 Signal Words (Danger, Warning)- 72 ind., 17 comb. Hazard Statements- 105 ind., 33 comb. Precautionary Statem.- Standardized 16 section SDS- 9 Pictograms (non-transport)




Worldwide ProgressAdopted in:- Japan - Russia- Taiwan - China- New Zealand - South Africa- Korea - Brazil- EU Compliance Dates:

- Substances: Dec 1, 2010- Mixtures: June 1, 2015




Experience So Far- Far more harmonization of classification

(caffeine problem)- Country level issue (omissions/additions)- Use of ‘National Inventories’- EU SDS Format 453/2010GHS Neither Completely Global Nor

Harmonized: http://bit.ly/ghsvideo


http://bit.ly/ghsvideo�



North American Situation

Consider both U.S. and Canada.

- U.S. further ahead. Canada taking more of a ‘wait and see’ approach.




Canada – HazCom Standards

- 5 different HazCom standards- WHMIS (Industrial)- Consumer Products- Pest Control Products- Explosives- TDG (Transport)




North American Progress

Industrial Labeling / Safety Data Sheets- U.S. Proposed Rule on Sep. 30, 2009

- US Federal Register 74:50279-50549 - Hearings in March 2010: DC, Pittsburgh- Final rule expected August 2011

- Canada: CCOHS White Papers & Webinars




Likely GHS Omissions- U.S.: Omitted Hazard Categories

- Acute Toxicity Cat. 5 (Oral, Dermal & Inhl.)- Skin Corrosion/Irritation Cat. 3- Aspiration Haz. Cat. 2Note: These were also omitted from EU CLP, however

show up in other implementations (Oral Cat 5. in China, New Zealand, Brazil, etc.)

- Canada: Likely to follow suit.




Likely GHS Omissions

- Entire Enviro. Hazard Group omitted from OSHA (U.S.) and WHMIS (Can) adoption.- Jurisdictional Issue

- Could appear in other N.A. adoptions (e.g. pest control products)




Likely GHS Additions

- Both U.S. and Canada likely to add classes.

- U.S. – Possible Classes- Combustible Dust - Simple Asphyxiants (would not require a

pictogram)




Likely GHS Additions- Both U.S. and Canada likely to add

classes.- Canada

- Biohazardous Infectious Material (Class D3 –would use GHS modified version of existing pictogram)

- Water reactive substances (Part of Class F. May be in GHS Rev. 4)





- U.S.- No other major additions likely, though Safety

Data Sheets will continue to contain other regulatory info (Prop 65, etc.)

- Adoption of both 16 Section SDS and GHS standard label likely.

- May need to include CAS Nos. on label (not a GHS requirement)





- Canada: Many existing features of WHMIS likely to be retained, including:- Name ‘WHMIS’- WHMIS Concentration Ranges- Three year expiry date for SDSs.- Reference to SDS on Label- Hatched WHMIS Border on Label! (Possibly)




Consumer Products- U.S. CPSC: Interagency Working Group on

Harmonization- Canada CCCR: Consumer Chemical Sector

Working Group

Progress quite slow. GHS adoption not expected in near future.




Harmonization- Likely no Canada & U.S. official inventories.- Key: Will Can/US allow EU (453/2010) layout?- If both Canada and U.S. do not drop additional

categories, a single SDS to cover Can/US/EU should be possible, so long as the additional classes covered (EU – Enviro, Can – D3 etc.)

- Remember to also include other necessary state/country level regs (Prop 65, etc.)




Timeline Proposals- U.S.: Full compliance 3 years after publication.

(August 2011-2014?)- Canada proposing 2 years.- No staggered phase in date for pure-

substances vs. mixtures.- BIG PROBLEM- Lots of industry feedback – this may change.- How to classify mixtures without substance level

classifications?




Ten Action Items to Start Today1. Become familiar with: PURPLE BOOK

GHS Purple Book - Rev. 3http://bit.ly/ghs-rev-3


http://bit.ly/ghs-rev-3�



Ten Action Items to Start Today2. Learn More About U.S. and Canadian

GHS Adoption:

US Federal Register 74:50279-50549http://bit.ly/us-ghs-pdfWHMIS After GHS Book ($15)http://bit.ly/whmisghsbook


http://bit.ly/us-ghs-pdf�

http://bit.ly/whmisghsbook�



Ten Action Items to Start Today3. Designate an employee to be

responsible for GHS transition.




Ten Action Items to Start Today4. Develop and cost out plan to author

new SDSs and labels for company.- Software and databases- Training and hiring regulatory officers- Outsourcing




Ten Action Items to Start Today5. Ensure printing equipment can print

pictograms on SDSs and labels with proper shade of red.




Ten Action Items to Start Today6. Develop and cost out plan to train non-

regulatory personnel on GHS. (Training will be mandatory under legislation)




Ten Action Items to Start Today7. Get involved with Canadian government, to

reduce potential implementation costs and non-harmonized elements, including:- Non-requirement of WHMIS hatched border- Allow use of 453/2010 SDS format- Longer time-line for implementation- No red pictogram requirements- Staggered timelines for subs/mixtures!




Ten Action Items to Start Today8. Since no staggered dates for substance/

mixtures, need to obtain substance level classifications ASAP for components in products.

- EU companies have until Dec 1, 2010 to have compliant CLP SDSs for substances. As well, must propose “provisional classifications” for 140,000 REACH pre-registered components.

- Use EU info as basis for classifying mixtures.




Ten Action Items to Start Today9. Examine classifications for products. Are any

symbols/warning text going to be problematic for marketing claims? If so, can product be reformulated slightly to have it entered into a less severe hazard category (or have it fall out of hazard class entirely?)




Ten Action Items to Start Today10. Examine classifications for products. Are

any symbols/warning text going to be problematic for marketing claims? If so, but product cannot be reformulated and hazard category seems unreasonable, consider having product tested (e.g. in vitro testing) if applicable. In many classes test data ‘trumps’ ingredient based classification rules.




Any Questions?




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