GHS Update Impact on MSDSs and Labels

Transcription

1 GHS Update Impact on MSDSs and Labels SATA Spring Meeting March 24, 2011 Mike P. Moffatt Nexreg Compliance

2 Coverage - Basics of GHS - Lessons from Other Jurisdictions - U.S. and Canada - Leaving Out - Adding - Timelines and To Dos.

3 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

4 Building Block Approach Purple Book Revision 3 (Living Document) - 3 Haz Groups: Health, Physical, Enviro classes (10 H, 16 P, 2 E) - Categories (under class) e.g. Ph: Flammable Aerosol, Category 2

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

6 Worldwide Progress Adopted in: - Japan - Russia - Taiwan - China - New Zealand - South Africa - Korea - Brazil - EU Compliance Dates: - Substances: Dec 1, Mixtures: June 1, 2015

7 Experience So Far - Far more harmonization of classification (caffeine problem) - Country level issue (omissions/additions) - Use of National Inventories - EU SDS Format 453/2010 GHS Neither Completely Global Nor Harmonized:

8 North American Situation Consider both U.S. and Canada. - U.S. further ahead. Canada taking more of a wait and see approach.

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

10 North American Progress Industrial Labeling / Safety Data Sheets - U.S. Proposed Rule on Sep. 30, US Federal Register 74: Hearings in March 2010: DC, Pittsburgh - Final rule expected August Canada: CCOHS White Papers & Webinars

11 Likely GHS Omissions - U.S.: Omitted Hazard Categories - Acute Toxicity Cat. 5 (Oral, Dermal & Inhl.) - Skin Corrosion/Irritation Cat. 3 - Aspiration Haz. Cat. 2 Note: 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.

12 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)

13 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)

14 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)

15 - U.S. Likely GHS Additions - 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)

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17 Likely GHS Additions - 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)

18 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.

19 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.)

20 Timeline Proposals - U.S.: Full compliance 3 years after publication. (August ?) - Canada proposing 2 years. - No staggered phase in date for puresubstances vs. mixtures. - BIG PROBLEM - Lots of industry feedback this may change. - How to classify mixtures without substance level classifications?

21 Ten Action Items to Start Today 1. Become familiar with: PURPLE BOOK GHS Purple Book - Rev. 3

22 Ten Action Items to Start Today 2. Learn More About U.S. and Canadian GHS Adoption: US Federal Register 74: WHMIS After GHS Book ($15)

23 Ten Action Items to Start Today 3. Designate an employee to be responsible for GHS transition.

24 Ten Action Items to Start Today 4. Develop and cost out plan to author new SDSs and labels for company. - Software and databases - Training and hiring regulatory officers - Outsourcing

25 Ten Action Items to Start Today 5. Ensure printing equipment can print pictograms on SDSs and labels with proper shade of red.

26 Ten Action Items to Start Today 6. Develop and cost out plan to train nonregulatory personnel on GHS. (Training will be mandatory under legislation)

27 Ten Action Items to Start Today 7. 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!

28 Ten Action Items to Start Today 8. 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.

29 Ten Action Items to Start Today 9. 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?)

30 Ten Action Items to Start Today 10. 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.

31 Any Questions?