ghs update impact on msdss and labels - sata point/spring 2011/mike...ghs update impact on msdss and...
TRANSCRIPT
GHS UpdateImpact on MSDSs and Labels
SATA Spring MeetingMarch 24, 2011
Mike P. MoffattNexreg Compliance
Nexreg Compliance Inc.http://[email protected](866)361-3032
Coverage
- Basics of GHS- Lessons from Other Jurisdictions- U.S. and Canada
- Leaving Out- Adding
- Timelines and To Dos.
Nexreg Compliance Inc.http://[email protected](866)361-3032
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
Nexreg Compliance Inc.http://[email protected](866)361-3032
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
Nexreg Compliance Inc.http://[email protected](866)361-3032
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)
Nexreg Compliance Inc.http://[email protected](866)361-3032
Worldwide ProgressAdopted in:- Japan - Russia- Taiwan - China- New Zealand - South Africa- Korea - Brazil- EU Compliance Dates:
- Substances: Dec 1, 2010- Mixtures: June 1, 2015
Nexreg Compliance Inc.http://[email protected](866)361-3032
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
Nexreg Compliance Inc.http://[email protected](866)361-3032
North American Situation
Consider both U.S. and Canada.
- U.S. further ahead. Canada taking more of a ‘wait and see’ approach.
Nexreg Compliance Inc.http://[email protected](866)361-3032
Canada – HazCom Standards
- 5 different HazCom standards- WHMIS (Industrial)- Consumer Products- Pest Control Products- Explosives- TDG (Transport)
Nexreg Compliance Inc.http://[email protected](866)361-3032
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
Nexreg Compliance Inc.http://[email protected](866)361-3032
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.
Nexreg Compliance Inc.http://[email protected](866)361-3032
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)
Nexreg Compliance Inc.http://[email protected](866)361-3032
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)
Nexreg Compliance Inc.http://[email protected](866)361-3032
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)
Nexreg Compliance Inc.http://[email protected](866)361-3032
Likely GHS Additions
- 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)
Nexreg Compliance Inc.http://[email protected](866)361-3032
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)
Nexreg Compliance Inc.http://[email protected](866)361-3032
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.
Nexreg Compliance Inc.http://[email protected](866)361-3032
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.)
Nexreg Compliance Inc.http://[email protected](866)361-3032
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?
Nexreg Compliance Inc.http://[email protected](866)361-3032
Ten Action Items to Start Today1. Become familiar with: PURPLE BOOK
GHS Purple Book - Rev. 3http://bit.ly/ghs-rev-3
Nexreg Compliance Inc.http://[email protected](866)361-3032
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
Nexreg Compliance Inc.http://[email protected](866)361-3032
Ten Action Items to Start Today3. Designate an employee to be
responsible for GHS transition.
Nexreg Compliance Inc.http://[email protected](866)361-3032
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
Nexreg Compliance Inc.http://[email protected](866)361-3032
Ten Action Items to Start Today5. Ensure printing equipment can print
pictograms on SDSs and labels with proper shade of red.
Nexreg Compliance Inc.http://[email protected](866)361-3032
Ten Action Items to Start Today6. Develop and cost out plan to train non-
regulatory personnel on GHS. (Training will be mandatory under legislation)
Nexreg Compliance Inc.http://[email protected](866)361-3032
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!
Nexreg Compliance Inc.http://[email protected](866)361-3032
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.
Nexreg Compliance Inc.http://[email protected](866)361-3032
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?)
Nexreg Compliance Inc.http://[email protected](866)361-3032
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.
Nexreg Compliance Inc.http://[email protected](866)361-3032
Any Questions?
Nexreg Compliance Inc.http://[email protected](866)361-3032