Nexreg - SATA Presentation - Sept. 2011

14 Regulatory Issues of Interest
SATA Fall Meeting
September 30, 2011
Mike P. Moffatt
Nexreg Compliance
Nexreg Compliance Inc. http://www.nexreg.com [email_address] (866)361-3032

1. 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

1. 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

1. 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: http://bit.ly/ghsvideo

1. 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.)

1. 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?

2. GHS in Mexico
Voluntary standard : NMX-R-019-SCFI-2011
No English translation (yet)
‘ Partially equivalent to 3 rd edition of GHS’
Adapted to reflect existing national regulations
Takeaway: Cannot just use an SDS from Spain in Mexico. Need to include information from NOM-004-SCT2-1994 and NOM-018-STPS-2000.
http://bit.ly/mexico-ghs

3. GHS Worldwide Progress
Adopted in:
Japan - Russia
Taiwan - China
New Zealand - South Africa
Korea - Brazil
EU Compliance Dates:
Substances: Dec 1, 2010
Mixtures: June 1, 2015

4. GHS Revision 4
Two new hazard categories:
Chemically unstable gases (e.g. acetylene)
Non-Flammable Aerosols
New Label Arrangement
Corrosive to Metals, but not Skin/Eyes – Left off of Consumer Labels
Needs to Be Implemented in National Laws
http://bit.ly/ghsrev4

5. GHS/CLP SDS Guidance Doc
“… provides information on issues to consider when compiling an SDS, details of the requirements for information to be included within each Section… and transition periods for implementation of these changes. It also gives general information on for which substances and mixtures SDSs needs to be provided and by whom.”
100+ Pages – HIGHLY RECOMMENDED
http://bit.ly/clp-guidance

6. 20 New EU SVHCs
- Interested parties are invited to comment on the proposals by October 13, 2011.
- Interested parties are invited to comment on the proposals by October, 13 2011. 53 substances on the Candidate List. Inclusion imposes new information requirements on suppliers of preparations and articles containing the substances.
http://bit.ly/svhc20

6. 20 New EU SVHCs
19 classified as carcinogenic and/or toxic for reproduction.
Includes chemicals used in vehicle coatings: Potassium hydroxyoctaoxodizincatedi-chromate , Pentazinc chromate octahydroxide.
http://bit.ly/svhc20

7. Canada: CEPA Batches
Canada’s Chemical Management Plan
Public Consultation: Publication of final decision after screening assessment of substances - Batches 6, 8 and 11.
Consultation ends: November 11, 2011
http://bit.ly/cepa-batches

8. Canada: CCPSA – June 2011
New recall powers by Health Canada.
Mandatory incident reporting along supply chain
Two days on incident determination to report
Difficulty: Definition of incident loose/vague
Already seeing over-reporting
http://bit.ly/ccpsapresent

9. Canada: Automotive Aerosol Recalls & Canada Customs
Health Canada working with Canada Customs to inspect automotive chemicals going from U.S. to British Columbia
Issue: Distributor ignoring difference between WHMIS and CCCR.
Problem 1: Long delays for some products to enter country.
Problem 2: Flagged product/companies experiencing furtther delays

10. CCCR vs WHMIS - Letter
Industrial-labeled products being stopped by Canadian Customs and investigated to see if they are being sent to retail stores.
Retail stores being investigated for selling as consumer products, when they should not be.
Solution : Include a letter with each shipment. Products will clear customs faster and companies will avoid further investigations.

11. Canada: CCCR Recalls
Sept – Pourable Real Flame Gels (Flam)
Sept – Goo D-solv-r (Aspiration)
Sept – Citrus Degreaser (Aspiration)
Aug – Aerosol Paint (Symbols)
Aug – Aerosol Cleaners (Symbols)
Aug – Orange TKO (Aspiration)
Jun – Pourable Real Flame Gels (Flam)
Jun – Lubricant (Flam)

12. Canada: Limonene @ 10%
CCCR: Must determine the appropriate sub-category for the product …in the following order of precedence:
(a) human experience data pertaining to the toxic product;
… (d) in the case of a toxic product that poses an aspiration hazard, the properties set out in subsection 34(5).
34(5)e: a hydrocarbon with a composition of at least 3 carbon atoms but not more than 13.

13. Next Potential Issue: Aerosol Dusters
Health Canada rapidly changed position on D-Limonene /Aspiration Hazard issue. Now makes up 1/3 rd of CCCR recalls.
Next potential issue: Aerosol products that are flammable only in certain orientations.
Intent of regulations vs. testing-aparatus
Health Canada insider: Pretending the issue does not exist. But will they forever?

14. Canada: Pet Care Products Under CCCR
June 2011, Health Canada notified industry that pet shampoos, etc., would now fall under CCCR, 2001 rather than Cosmetics Regulations
IMPLICATIONS:
Labels need to be altered to fit CCCR
Pet products subject to CCPSA

Any Questions? Nexreg Compliance Inc. http://www.nexreg.com [email_address] (866)361-3032

Nexreg - SATA Presentation - Sept. 2011

by Nexreg Compliance on Oct 01, 2011

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Nexreg - SATA Presentation - Sept. 2011 — Presentation Transcript