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://[email protected] (866)361-3032

http://www.nexreg.com/

mailto:[email protected]

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 453/2010GHS Neither Completely Global Nor

Harmonized: http://bit.ly/ghsvideo


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 3rd 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


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 AerosolsNew Label Arrangement- Corrosive to Metals, but not Skin/Eyes – Left

off of Consumer LabelsNeeds to Be Implemented in National Lawshttp://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


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.






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


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 1/3rd 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?


Technology

Nexreg - SATA Presentation - Sept. 2011