US Regulatory Compliance Forums

Transcription

1 US Regulatory Compliance Forums Christina Widodo November 12, 2015

2 HazCom 2012 Are we done yet?

3 Agenda GHS Deadlines Canada GHS Global GHS updates

4 UN Purple Book 6 th Revised Edition

5 GHS New 6 th Revised Edition Sept (publicly available) New Hazard Classes Desensitized Explosives (4 categories with new H & P phrases) Pyrophoric Gases (new hazard class with new H& P Phrases) Revision STOT SE Cat 3 Refinement Aspiration Category Revisions (Revises category 1 & 2) Aquatic Toxicity - M-factor adjustments

6 GHS New 6 th Revised Edition Small Packaging labels Front page / back page - Product identifier - Hazard pictogram(s) - Signal word - Supplier identification (name, address & telephone number of the company) Inside page(s) - Signal word - Hazard and precautionary statements - Other information (e.g. directions for use, information required by other regulations, etc.)

7 GHS New 6 th Revised Edition SDS changes - Section 9 Restructure - A new order format for Section 9 Physical and Chemical Properties. - Caution: Change will depend on each authority as each may specify its own format. 6 th edition 5 th edition Physical state; Colour; Odour; Melting point/freezing point; Boiling point or initial boiling point and boiling range; Flammability; Lower and upper explosion limit/flammability limit; Flash point; Auto-ignition temperature; Decomposition temperature; ph; Kinematic viscosity; Solubility; Partition coefficient: n-octanol/water (log value); Vapour pressure; Density and/or relative density; Relative vapour density; Particle characteristics Nanomaterials Physical state; Colour; Odour; ph Melting point/freezing point; Boiling point or initial boiling point and boiling range; Flash point; Evaporation rate Flammability Lower and upper explosion limit/ flammability limit; Vapour pressure Vapour density Solubility Partition coefficient: n-octanol/water Auto-ignition temperature; Decomposition temperature; Viscosity

8 GHS Deadlines

9 GHS Implementation Overview 29 Jan 2013 Jul 2013 Mar Jan Jun 2015 Mid Mar 2015 April 2015 Jul Dec Jan Mar Jan Jul Jan Jan Jun ID: Single substances Ecuador VN: Single substances EU: Mixtures SG: Single substances & mixtures (suppliers) PH: Single substances & mixtures (employers) US (Distributors) VN: Mixtures PH: Suppliers of chemicals on CCO and PCL lists US (Employers) SG: Mixtures (users) Australia PH: Suppliers of high volume chemicals ID: Mixtures PH: Suppliers of chemicals on IATA or IMDG list Canada Mexico Taiwan Malaysia PH: other mixtures Argentina

10 2015 GHS Timeline January 1 Mid March June 1 December 1 January 26 April 17 July 1 Suppliers & employers - All: Taiwan (4 th ed.) Only employers All: Philippines ( latest ed.) Distributors All: United States (3 rd ed.) Labeling of mixtures: Brazil (3 rd ed.) Suppliers & employers - All: Malaysia (3 rd ed.) Manufacturers & importers Substances: Brazil, European Union, Korea, Thailand, Vietnam, (3 rd ed.); Indonesia (4 th ed.) All: Abu Dhabi, China, Russia & Uruguay (4 th ed.); Ecuador, S. Africa (2 nd ed.), Japan (1 nd or 3 rd ); Taiwan (phase I to III) Singapore (4 th ed.) Manufacturers & Importers: All: Users Substances: Manufacturers, importers & employers : All: Brazil, Serbia, & United States (3 rd ed.) Substances: Turkey (3rd ed.) Mixtures: European Union (3 rd ed.)

11 Future GHS Compliance Timeline 1 Jan Mar Mar Apr Jun Jan Mar Dec Jun 2017 Oct Jan 2019 GHS reporting when > 1 ton: Malaysia (3rd ed.) Manufacturers & importers Mixtures: Vietnam (3 rd ed.) Manufacturers, importers & employers Mixtures: Turkey (3rd ed.) Manufacturers & importers All: Japan (3rd ed.) Cyanide, PCBs, Asbestos, Mercury, Lead, ODS: Philippines Manufacturers, importers & employers : Substance: Argentina (5th ed.) Manufacturers & importers All: Australia (3rd ed.); Japan (4 th ed.) High volume chemicals: Philippines Mixtures: Argentina (5 th Ed) Manufacturers & importers Mixtures: Thailand (3rd ed.) Manufacturers & importers Mixtures: Uruguay Fully compliant: Philippines CANADA Manufacturers, importers & employers Mixtures: European Union (product already on shelf) Mexico

12 Canada GHS

13 Latest from Health Canada Hazardous Products Regulations; a.k.a. WHMIS 2015 Based on the 5 th Rev. GHS and the U.S. HazCom 2012 Effective Feb. 11, 2015 Major deadline: June 1, 2017 Bilingual GHS label/sds HMIRR applies to trade secrets 13

14 Latest from Health Canada Published guidance documents on variances between the U.S. and Canada Provincial governments still working on their workplace label requirements Most common compliance error on the repeal of the 3 year (M)SDS revision requirement - (New) HPR SDSs do not need the 3-yr revision - (Old) CPR MSDSs still do during the transition period 14

15 Canada GHS - SDS Require the manufacturers to inform their customers of significant new information immediately. - Such notification does not have to be in a new SDS or label but transmission must indicate the new information and date upon which the new information became available. Revised SDSs must be provided within 90 days.

16 Canada GHS Analysis of the final regulations What, when and who? Classification Label Safety Data Sheet (SDS)

17 Canada GHS Analysis of the Final Regulations

18 Canada GHS What to comply with? Amended Hazardous Products Act (HPA) Hazardous Products Regulations (HPR) replacing Controlled Products Regulations (CPR) Amended Hazardous Materials Information Review Regulations WHMIS 1988 WHMIS 2015

19 Canada GHS When to comply? *In addition, employers will be able to use any products that comply with the CPR requirements and that are already within the workplace as of December 1, 2018, until June 1, 2019.

20 Canada GHS Who should comply? Current WHMIS requirements for suppliers, employers, and workers stay the same. Suppliers: Initial supplier identifier : the name, address and telephone number of manufacturer; or importer of the hazardous product who operates in Canada Manufacturer : a supplier who, in the course of business in Canada, manufactures, produces, processes, packages or labels a hazardous product and sells it.

21 Canada GHS Who should comply? Employers: Required to establish education and training programs for workers exposed to hazardous products in the workplace. Employers must also make sure that the products are labeled, and an MSDS is present for each product and readily available.

22 Canada GHS Who should comply? Workers: Required to participate in the training programs and to use the information to help them work safely with hazardous materials. They may also inform employers when labels on containers have been accidentally removed or if the label is no longer readable.

23 Canada GHS Classification Updates Adopting the 5 th Rev. of GHS and HazCom 2012 Repeal the WHMIS Ingredient Disclosure List - New smaller prescribed classification list in Sch. 4 (39 entries) Separating hazards not otherwise classified (HNOC) into two categories: - Health and Physical (HHNOC and PHNOC) HNOCs will require labeling

24 Canada GHS Classification Caveats Adopting the 5 th Rev. of GHS and HazCom However, SDS classifications based on the 3 rd Rev. of GHS or HazCom 2012 (e.g. Aerosol classifications) - Labelling requirements based the 5 th Rev. of GHS? CPR Ingredient Disclosure List Repealed Quebec s Guidance WHMIS Classifications (CSST/SRT) is being updated - Updates made throughout 2015

25 Canada GHS - Classification Physical Hazard Classes & Health Hazard Classes Physical hazard classes GHS 16 classes No provision on Explosives Pyrophoric Gases Simple Asphyxiants Aligns with HazCom 2012 except: Combustible Dusts PHNOC

26 Canada GHS - Classification Health hazard classes 1. Acute toxicity: Category Skin corrosion/irritation: Category 1 (A-C) and Category 2 3. Serious eye damage/eye irritation: Category 1, 2A, 2B 4. Respiratory or skin sensitization: Category 1A, 1B 5. Germ cell mutagenicity: Category 1A, 1B, 2 6. Carcinogenicity: Category 1A, 1B, 2 7. Reproductive toxicity: Category 1A, 1B, 2 and effects via lactation 8. Specific target organ toxicity-single exposure: Category Specific target organ toxicity-repeated exposure: Category Aspiration hazard: Category 1

27 Canada GHS - Classification Health hazard classes (cont d) Dangerously Reactive Material Acute Toxicity hazard class Tiered approach to mixture classification (i.e. bridging principles) HHNOC Keep Biohazardous Infectious Materials ( BIM ) class - Criteria from Risk Group 2, Risk Group 3 and Risk Group 4 under the Human Pathogens and Toxins Act - New 9-heading appendix to the SDS - Not harmonized with the HazCom 2012

28 Canada GHS - Labeling GHS format label requirements - No more hatched border label and reference to MSDS - Red borders on GHS pictograms - Signal word, H/P statements - Durable and legible - Distributor may provide its contact info - Importer may retain the foreign supplier info if for importer use

29 Canada GHS - Labeling Label requirements (cont d) - Both English and French to appear - Supplemental element required: percentage of ingredients in a mixture of unknown acute toxicity; supplemental H statements for water-activated toxicants - Rules of precedence for signal word and pictograms - H/P statements can be combined - Inapplicable P statements can be omitted but not H statements - Labels must be updated within 180 days with new info

30 Canada GHS - Labeling

31 Canada GHS - Labeling Bulk shipment exemption e.g. bulk oil (more than 450 liters) Small container label Less than 100 ml: exempt from P/H statements Two exemptions retained: Inner container label visible through the outer container; outer with DG transportation label

32 Canada - Labeling WHMIS workplace label - Secondary containers, bulk product containers, storage tanks, employer-produced products - Minimum info required: Product name, safe handling procedures, and reference to the MSDS Regulated at provincial level - Alberta, British Columbia, Manitoba, New Brunswick, Newfoundland and Labrador, Nova Scotia, Ontario, Prince Edward Island, Quebec, and Saskatchewan

33 Canada GHS Safety Data Sheet 1. Identification 2. Hazard(s) identification 3. Composition/information on ingredients 4. First-aid measures 5. Fire-fighting measures 6. Accidental release measures 7. Handling and storage 8. Exposure controls/personal protection 9. Physical and chemical properties 10. Stability and reactivity 11. Toxicological information 12. Ecological information* 13. Disposal considerations* 14. Transport information* 15. Regulatory information* 16. Other information, including date of preparation or last revision * Optional

34 Canada GHS - SDS Notable SDS requirements: 16 standardized GHS headings with items optional For a mixture, disclose the chemical name and concentration or concentration range of all ingredients that present a health hazard even if no toxicity data is available For supplier identifier in Section 1 of SDS, retain the information requirement of initial supplier

35 Global GHS Updates

36 GHS Edition Harmonization? 6th 5 th N/A Canada Mexico Argentina Note: * Indonesia reviewing GHS version * EU & New Zealand 5 th ed. - draft regulation pending ** Philippines latest but listed categories align with 3 rd edition ** South Africa refers to 1 st edition but is more aligned with 2 nd edition 4 th 3 rd China, Japan, Taiwan Indonesia*, Singapore European Union, Abu Dhabi, Brazil, Russia, Uruguay Australia, Korea, Malaysia, New Zealand*, Philippines**, Thailand, Vietnam Turkey, Serbia, Switzerland, United States 2nd South Africa**, Ecuador

37 Mexico GHS Mexican Official Standard, NOM 018-STPS-2015 Published: Oct. 9, 2015 Adopts 5 th Revised Edition of the UN Purple Book NMX-R-019-SCFI-2011 (Valid) Authorizes GHS in Mexico Transitional Period 3 years (following its publication in the Mexican Official Gazette (DOF) (Oct. 2018) NOM 018-STPS-2000 (Mandatory Non-GHS Standard) NOM 018-STPS-2014 (Voluntary GHS Standard)

38 GHS Updates Argentina Resolution 3359/2015 (Sept. 29, 2015) 5 th Revised Edition Substances: April 15, 2016; Mixtures: Jan. 1, 2017 Uruguay Substance: Jan.1, 2013; Mixtures: Jan.1, 2018 Brazil GHS labeling of mixtures delayed until Dec 1, 2015 (SDS requirement remains unchanged) Substances: April 15, 2016; Mixtures: Jan. 1, 2017

39 GHS Updates EU REACH Regulation 1907/2006/EC (Art. 31, Annex II SDS) Amended by Regulation 453/2010/EU (Annex II) Regulation 2015/830/EU (May 2015) (5 th Rev.Ed) June 1, 2015 For examples:» "Other hazards" Addition of a note to be included in case of dust explosion hazards;» "Extinguishing media" Addition aiming at the means to prevent dust explosions, etc.

40 GHS Updates EU CLP Regulation 1272/2008/EC Draft of 8 th ATP (June 2015) (5 th Rev.Ed) Amendments to all seven annexes:» New, alternative method for the classification of oxidizing solids» Changes to the provisions on classification for skin corrosion/ irritation and serious eye damage/ irritation, and aerosols» Amendments to several precautionary statements Adoption: expected in the fourth quarter of 2015 Application of changes 18 months after their entry into force (i.e. 20 days after publication in the EU Official Journal) June 1, 2017 (SDS, re-labeling, re-packaging) mixtures placed on the market before June 1, 2015

41 GHS Updates China Notice No (Classification List) [based on Hazardous Chemicals Catalogue] Sept. 2, 2015 (4 th Rev. Ed) Taiwan CNS (revised to align with 4 th Rev.Ed) (Jan. 2015) Jan. 1, 2017 (all hazardous chemicals must be GHS compliant)

42 GHS Updates Japan GHS Labeling Guidance (JCIA) (Aug. 2015) Effective date: June 1, Precautionary Statements - Recommendations on P statements selection 2. Chemical name display (voluntary now) - ISHL chemicals subject to labeling requirements ONLY - However, chemical names that are required to have labeling must be displayed on the SDS Korea Updating GHS Standards and guidance to align with UN 4 th Rev. Ed.

43 GHS Updates Japan JCIA Labeling Guidance

44 GHS Updates Australia Model Work Health and Safety (WHS) Regulations (3 rd Rev.Ed.) Guidance on the Classification of Hazardous Chemicals under the WHS Regulations January 1, 2017 (GHS is mandatory) New Zealand Dec. 2014: EPA issued a draft Notice Changing the current HSNO system to GHS (calling for 5 th Rev. Ed. adoption) Public comment (End of 2015/ early 2016) Industry: 6 th Rev. Ed. / align with Australia Target: Starting in 2017

45 GHS Updates Thailand Implemented GHS for chemicals (under Ministry of Health) Substances: March 19, 2016 Mixtures: March 19, 2019 Singapore (2008) 4 th Rev. Ed (2014) Single substance & mixtures: July 1, 2015 (manufactures/suppliers/ importers) Mixtures: July 1, 2016 (users)

46 GHS Updates Indonesia (2009) 4 th Rev.Ed Single substance: July 12, 2003 Mixtures: Dec. 31, 2016 Philippines (2009) Latest edition Employers: March 2015 Manufacturers/importers:

47 GHS Updates Vietnam (2010) 3 rd Rev. Ed Single substance: March 30, 2014 Mixtures: March 30, 2016 MARD s Circular 21/0215/TT-BNNPTNT (June 2015) [Implemented GHS for Pesticides] (Labeling: Aug. 1, 2020)

48 Thank You

49 Thank you! Christina Widodo Director, Regulatory Research