MSDS SDS labelling SOP GHS of classification labelling of chem

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GHS CLP REACH current regs on labeling and class of chemicals MSDS 160 pages with 60 pages of glossary contact motherhealth@gmail.com conniedello buono for MSDS authoring using current regs or standards

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MSDS SDS labelling SOP GHS of classification labelling of chem

  1. 1. ProcedureSafety Data Sheet (SDS) and Labels SOP Part Number: NNNNNSOP Revision: draft Effective Date: _Contents1. Purpose............................................................................................................... 52. Scope.................................................................................................................. 53. Procedure............................................................................................................ 6 Creating or re-authoring an SDS per GHS standard.................................................................6 Update and Monitoring.............................................................................................................6 Monitoring................................................................................................................ 7 Hazard Classification................................................................................................................7 Copies of SDS...........................................................................................................................8 EU and GHS Classification...................................................................................................... 8 Other Rules in SDS Preparation............................................................................................... 8 Author and Users...................................................................................................................... 9 CLP and GHS........................................................................................................................... 9 GHS Label elements.................................................................................................................9 EC, USA, CANADA and UN Identification, Classification and Labelling of Chemicals.....11 Writing Labels........................................................................................................................ 12 Suppliers and Employers Responsibilities..............................................................12 GHS Symbols and Elements and Regulatory Changes on Labelling.....................12 Label Requirements................................................................................................12 GHS Pictograms/Symbols...................................................................................................... 13 Signal Words...........................................................................................................13 GHS Hazard Statements......................................................................................... 13 Hazard Symbols and Pictograms............................................................................14 Examples of Pictogram Description and their Hazard Classes...............................14 Precautionary Statements........................................................................................14 Hazard and Precautionary Statements.................................................................... 14 Product Identifier.................................................................................................... 15 Other GHS Guidance and Annexes........................................................................ 15 Standardized Rules of Precedence to group a product to more than one class.......15 GHS Health and Environmental Hazard Classification Criteria.............................15 What is new with CLP?.......................................................................................... 16 OSHA References...................................................................................................16 Description of Hazardous Material on Shipping Papers.........................................17 Hazardous Materials at .......................................................................................... 17 Select Carcinogens..................................................................................................18 WHMIS Classes or Classifications.........................................................................18 Hazardous Substances with Toxic Effects on Specific Organs include.................19 Chemical Safety Report (CSR) and SDS................................................................................19 Records................................................................................................................................... 19 REACH Note.......................................................................................................................... 19 Language.................................................................................................................................19 Not classified as Hazardous under CLP .................................................................................20 Downstream Users..................................................................................................................20 Downstream Legislation......................................................................................................... 20 Hazard Communication..........................................................................................................22Date Printed: 9/28/2012 Page 1 of 186
  2. 2. ProcedureSafety Data Sheet (SDS) and Labels SOP Part Number: NNNNNSOP Revision: draft Effective Date: _ Supplier Responsibilities ....................................................................................................... 22 Summary of SDS Changes According to REACH.................................................................23 What is new in REACH Safety Data Sheet?.......................................................................... 24 SDS Audit Checklist...............................................................................................................24 Classification and Labeling ....................................................................................................25 GHS/CLP Classification General Notes................................................................. 25 Table 1. Hazard Classes of the Proposed EU Regulation .....................................................26 GHS Criteria for Acute Toxicity.............................................................................................27 GHS Criteria for Skin Corrosion and other hazard class (See ghs osha comparison.pdf file).........................................................................................28 An SDS is not needed when (per OSHA’s 29 CFR 1910.1200)............................................ 28 SDS Exclusions per WHMIS .................................................................................29 An SDS is not required for (per Japan Regulatory Bodies)....................................................29 ANSI....................................................................................................................................... 30 GHS New Hazard Classifications...........................................................................................31 Changes to Supplier Labels.................................................................................................... 31 EU Labels................................................................................................................................31 SDS Form Completion and Content Summary.......................................................................31 Identify the hazards.................................................................................................31 Generic SDS Form..................................................................................................31 Newly Revised SDS................................................................................................32 When new SDS are issued on a chemical, they will be compared to previous data sheets on file and any changes will be noted and changes will be made to the labels of the chemical containers accordingly............................................................................................................32 Controlled Substances.............................................................................................32 SDS Organization (HCS/OSHA/GHS , minimum information for an SDS)..........32 Section 10: Stability and Reactivity........................................................................37 Completing the SDS Form (with examples)...........................................................................39 Section 1. Product and Company Identification....................................................39 Section 2. Hazard Identification............................................................................ 40 Section 3. Composition/Information on Ingredients...............................................42 Section 4. First Aid Measures.................................................................................44 Section 5. Firefighting Measures........................................................................... 44 Section 6. Accidental Release Measures............................................................... 47 Section 7. Handling and Storage.............................................................................47 Section 8. Exposure Controls/Personal Protection................................................. 48 Section 9. Physical and Chemical Properties..........................................................49 Section 10. Stability and Reactivity........................................................................50 Section 11. Toxicological Information...................................................................51 Section 12. Ecological Information....................................................................... 52 Section 13. Disposal Considerations.....................................................................53 Section 14. Transport Information..........................................................................53 Section 15. Regulatory Information.......................................................................56 Example: Section 15. Regulatory Information (NaOH)........................................57Date Printed: 9/28/2012 Page 2 of 186
  3. 3. ProcedureSafety Data Sheet (SDS) and Labels SOP Part Number: NNNNNSOP Revision: draft Effective Date: _ Section 16. Other Information................................................................................ 57 Exposure Scenarios, ESs (Annex).......................................................................... 59 Table A Hazard Category and SDS Template Guide............................................................ 59 Table B Composition/Information on Ingredients (CLP Labels)...........................................61 Table B1 Composition/Information on Ingredients (DPD Labels).........................................61 Table C. Concentration Limits and Hazard Class/Category per (EC) No 1272/2008............614. Regulations ....................................................................................................... 625. Sample Safety Data Sheet (SDS)..................................................................... 636. Resource Table: Preparation Resources (Other sources/link not listed in thefollowing screen shots) Document/Link................................................................. 67 SDS Sections 1- 16................................................................................................................. 67 Other Links............................................................................................................. 727. GHS Labels Sample Format.............................................................................. 738. Translation Table under Regulation (EC) No 1907/2006.................................. 76 TRANSLATION Table Translation between classification in accordance with Directive 67/548/EEC and Regulation (EC) No 1907/2006 (ANNEX VII)...........76 Translation Table between Risk Phrases................................................................ 809. Other Guidance and Notes................................................................................ 8010. Hazard Statements Table................................................................................ 81 GHS Hazard Statements General Notes................................................................................. 83 Other EU Hazard Statements..................................................................................................8411. Precautionary Statement Table....................................................................... 8412. Derivation of the Mixture Classification........................................................... 9413. EPA Outline of the Six Steps for Hazardous Waste Determination................9414. Classification Criteria, H-criterion, under LoW and DPD................................ 9515. Determination Scheme for the Classification of Waste................................... 95 Identifying Waste with the European Waste Catalogue (EWC).............................................96 Waste Classification................................................................................................................97 European Waste Catalogue (EWC 2002)............................................................................... 9716. Intermediate Translation Table LoW to CLP................................................... 98 H9 Waste Types (Infectious)................................................................................10017. United Nations Classification Recommendation on Transport of DangerousGoods.................................................................................................................. 10018. Glossary........................................................................................................ 10119. Table 2 – Incompatible Chemicals............................................................... 15420. Hazardous Waste Identification (RCRA Subtitle C)...................................... 155 More GHS Labeling Sample.................................................................................................15721. Notes from SDS Compiler’s Guide Updated August 2010.pdf (183 pages)..158 First Aid Notes......................................................................................................................158 Spillage Disposal Guide........................................................................................16022. Globally Harmonized System of Classification & Labelling of Chemicals (GHS) 164 New GHS Combination Phrases ..........................................................................................166 Abbreviations........................................................................................................................16723. Labeling and Storing of Chemicals at ........................................................... 168 Allowed Substances..............................................................................................168 Labeling of Chemicals.......................................................................................... 168 Labeling of Non- Substances................................................................................16824. Labeling and Other Forms of Warning.......................................................... 16825. Biological Waste Labeling............................................................................. 17026. Employee Training Program Sample............................................................ 170Date Printed: 9/28/2012 Page 3 of 186
  4. 4. ProcedureSafety Data Sheet (SDS) and Labels SOP Part Number: NNNNNSOP Revision: draft Effective Date: _27. MSDS Request Letter Sample...................................................................... 17228. Hazardous Waste Tag................................................................................... 17329. Container Labeling........................................................................................ 17330. NFPA (NATIONAL FIRE PROTECTION ASSOCIATION) 704M SYSTEM. .17431. MSDS and Labeling Guideline Summary at ................................................. 17532. Notes on GHS Labels and Symbols.............................................................. 17733. GHS Symbols................................................................................................ 17734. Standards (Pesticides and other Toxics)....................................................... 178 ACRONYMS AND TERMS................................................................................178 Comparison of EPA and IARC Classification Systems for Evidence of Carcinogenicity...181 LD50 of Active Ingredients..................................................................................18235. Other Exposure Routes ................................................................................ 18236. Sample Chemical Summary of Phenobarbital Drug...................................... 18337. Hazardous to the Aquatic Environment (Chapter 4.1 GHS)..........................184 21 CFR part 809 (Labeling of In-vitro Diagnostic Products For Human Use) Notes on Reproductive Toxicity Hazard..............................................................................................184 Developmental Toxicity Assessment per 21 CFR part 809..................................................185 Special Labeling per 21 CFR part 809..................................................................................186 Methyl alcohol ( methanol ) .................................................................................186 Ethylene glycol..................................................................................................... 186Date Printed: 9/28/2012 Page 4 of 186
  5. 5. ProcedureSafety Data Sheet (SDS) and Labels SOP Part Number: NNNNNSOP Revision: draft Effective Date: _ 1. Purpose This procedure provides guidance in the preparation and update of all SDS and labels for each hazardous substance or mixture manufactured by CDD Fremont. The SDS Forms/ Templates use the GHS SDS format to allow continuous improvement for chemical hazard communication consistent in all countries such as EU, Canada, USA and other countries. This procedure details the SDS and label format in compliance with applicable laws such as CLP () and GHS (Globally Harmonized System of Classification and Labelling of Chemicals). This SDS and labels procedure lists: • New classification rules and hazard classes per GHS, new label requirements, new hazard symbols/pictograms, new SDS format • Labeling procedure • hazard communication programs and SOPs 2. Scope • Safety Data Sheets (SDS) should be produced for all substances and mixtures which meet the harmonized criteria for physical, health or environmental hazards under the GHS Note: An SDS should be provided based on the following generic cut-off /concentration limits: ≥ 1% for acute toxicity, skin corrosion/irritation, serious damage to eyes/eye irritation, respiratory/skin sensitization, mutagenicity category 2, target organ toxicity (single & repeat) exposures, and hazardous to the environment; and ≥ 0.1% for mutagenicity category 1, carcinogenicity and reproductive toxicity. • The SDS should be produced for all mixtures which contain ingredients that meet the criteria for carcinogenic, toxic to reproduction or target organ toxicity in concentrations exceeding the cut-off limits for SDS specified by the criteria for mixtures. Note: An SDS is required for mixtures which contain acutely toxic substances or substances toxic to the aquatic environment in concentrations equal to or greater than 1 %. • All hazardous substance or mixture manufactured by CDD Fremont shall comply with the GHS, REACH and ANSI regulatory standards as noted in the appropriate 16 sections of the SDS Form. • The SDS provides a mechanism for transmitting appropriate safety information on substances and mixtures where:  A substance meets the criteria for classification as hazardous according to CLP (the European version of GHS).  A mixture meets the criteria for classification as dangerous according to the Dangerous Preparation Directive (DPD) 1999/45/EC.  A substance is persistent, bio-accumulative and toxic (PBT) or very persistent and very bioaccumulative (vPvB) according to the criteria given in Annex III of REACH.Date Printed: 9/28/2012 Page 5 of 186
  6. 6. ProcedureSafety Data Sheet (SDS) and Labels SOP Part Number: NNNNNSOP Revision: draft Effective Date: _ 3. Procedure Creating or re-authoring an SDS per GHS standard 1. Identify the substance or mixture and its contents. 2. Use Tables B (per DPD) and B1 Hazard Label - CLP Annex 6 excel files containing lists of hazard classification for each substance (including concentration limits, CAS and EC numbers) according to DPD and CLP/GHS regulations. 3. Based on the substance and hazard class identified in steps 1 and 2, select the SDS Template from Table A, Hazard Category and SDS Template Guide and complete Sections 1 to 16 of the SDS form. 4. Complete all the SDS Sections including Transport and Regulatory to list limitations based on concentration limits and hazard class and other supporting data (see Resource Table section for links and sources of data). 5. Only inner packages should be labeled with GHS symbols and product identifier per GHS. Harmful chemicals/mixtures with signal word Warning must not be labeled with H and P statements until 125 ml or 125 g according to GHS regulation. 6. The Regulatory department shall ensure that all hazardous substances and mixtures shall have documented and approved SDS following the SDS Form Templates. 7. Open a PCO request to document any changes (training required) and when approved, provide a pdf copy and translation in French (or other languages when applicable). Note: Hazardous substances and mixtures are listed in the National Toxicology Program (NTP) Annual Report on Carcinogens (latest edition) or have been found to be a potential carcinogen in the International Agency for Research on Cancer (IARC) Monographs (latest editions) or by OSHA. Hazard vs Risk A hazard is an inherent (built-in) property of a material. Risk is the extent to which that material can cause harm. You can reduce or remove risks associated with a hazardous material, but you cannot remove the underlying hazard itself (unless you get rid of the hazardous material). For example, gasoline is hazardous, but it does not have a significant risk provided that proper use and storage precautions have been taken. Update and Monitoring Each approved SDS shall be updated without delay on the following occasions: • as soon as new information which may affect the risk management measures or new information on hazards becomes available • once an authorization has been granted or refused • once a restriction has been imposedDate Printed: 9/28/2012 Page 6 of 186
  7. 7. ProcedureSafety Data Sheet (SDS) and Labels SOP Part Number: NNNNNSOP Revision: draft Effective Date: _ Monitoring • The RA Dept is responsible for obtaining the SDS, reviewing them for completeness, and maintaining the data sheet system. • In the review of incoming data sheets (for raw materials from suppliers) and update/archive/creation of SDS for products, if new and significant health/safety information becomes available, this new information is passed on immediately to the affected employees and downstream users by additional training sessions, web site, and other means of communication. • Legible SDS copies for all hazardous substances to which employees of this company may be exposed are kept in (list all locations). • SDSs are readily available for review to all employees in their work area and during each work shift. If SDSs are missing or new hazardous substance(s) in use do not have SDSs, or if an SDS is obviously incomplete, please contact (person/position, RA Dept) immediately, and a new SDS will be requested from the manufacturer/supplier and/or update of current SDS from RA dept for products. • If we are unable to obtain the SDS from the vendor within 25 calendar days of the request, we will either call our local Cal/ OSHA compliance office or write to: Division of Occupational Safety and Health Deputy Chief of Health and Engineering Services P. O. Box 420603 San Francisco, CA 94142-0603 Hazard Classification • Classify, label and package substance or mixture according to CLP which has already been classified according to DSD/DPD (see Table B1). Note: Since all revised SDS will be issued before 1 June 2015, both the DSD/DPD (see Table B1) classifications and the new CLP (see Table B) classifications, including any specific concentration limits or M-factors for substances will be included. Note: According to 1999/45/EEC, if a mixture contains corrosive substances with R35 or R34 and below the concentration limits for a classification of the mixture as corrosive, such substance can contribute to the classification of the mixture as IRRITANT with R41 or R36 risk phrase (see EC 1999 45 dangerous preparations pdf file). • Review any new knowledge on hazards when they become available. Review Sections 9, 11 and 12 for consistency. What do you need to update? Any new or revised classification, including any changes of specific concentration limits or M-factors for substances, should be included in Section 2 (Hazard Identification), Section 3 (Composition / Information on Ingredients) and your new labeling in Section 15 (Regulatory Information) of your Safety Data Sheet. Issue Date and Date Last Changed (see Section 16) shall be completed and noted in each page of the SDS. Note: The information required for labels and SDS is required if a product meets the criteria for a hazard class and category.Date Printed: 9/28/2012 Page 7 of 186
  8. 8. ProcedureSafety Data Sheet (SDS) and Labels SOP Part Number: NNNNNSOP Revision: draft Effective Date: _ Copies of SDS • Copies of SDSs for all hazardous substances to which employees of Scientific may be exposed are kept in the SDS folder for the hazardous materials being used in their respective areas. • The Regulatory Department is responsible for obtaining and maintaining all SDSs for the company. • If an SDS is missing or obviously incomplete, a new SDS will be requested from the manufacturer/supplier and/or the Regulatory Department. _____(OSHA) will be notified if a complete SDS is not received. • SDSs are available to all employees in their work area for review during each work shift. • If an SDS is not available or new hazardous substance(s) in use do not have a SDS, contact a supervisor immediately. EU and GHS Classification • EU is moving ahead and has adopted GHS. Substances by Dec 1st 2010. Mixtures by June 2015. New hazard communication rules called the “Classification, Labelling and Packaging” (CLP). Transition period of two years. • GHS uses a building block approach, which allows law makers to adopt any or all of the hazard classes and categories applicable to their target population. Classifying products according to GHS methods and criteria is similar to that of the transport sector. Classification will require a “weight of evidence” evaluation where all available, relevant data must be reviewed by the supplier. A single well-conducted study may be sufficient to classify. Note: CLP includes all of the hazard classes of the UN GHS. As CLP also builds on the previous system of classification and labelling, consisting of DSD and DPD, also the EU category of danger ‘hazardous to the ozone layer’ is taken up in CLP. Hazard classifications UN GHS hazard categories not in CLP: Acute toxicity Cat. 5 for the classification of flammable aerosols Flammable liquids Cat. 4 Flammable liquids with a flash point ≤ 93ºC are used • Suppliers will need access to skilled personnel to conduct comprehensive literature searches, evaluate the quality of data, draw conclusions and document the rationale for their conclusions. Other Rules in SDS Preparation • The basic requirement for a supplier to transmit an SDS to the customer at the time of (first) sale will not change. • WHMIS will retain the rule requiring an SDS to be updated at least every three years, and whenever new hazard information about the product becomes available. • Suppliers are advised to ensure that their SDSs are prepared by persons who understand SDS content rules and the technical data included on them. • Document the references used for each SDS, at least for internal use.Date Printed: 9/28/2012 Page 8 of 186
  9. 9. ProcedureSafety Data Sheet (SDS) and Labels SOP Part Number: NNNNNSOP Revision: draft Effective Date: _ • The SDS shall be made accessible during each work shift to all employees. Note: All regular/contractor and newly hired employees in the Operations and Manufacturing departments shall receive an SDS training. Author and Users • The completed SDS Form by the trained author shall be made available in pdf and print format to all downstream users: re-importer, retailer and producer of articles. • , as the chemical manufacturer or importer, shall ensure that distributors and employers are provided an appropriate SDS with their initial shipment and with the first shipment after an SDS is updated. • , as the employer, shall have the responsibility to transform the information into suitable formats to manage risks at the specific workplace and access must be given to its workers and their representatives. • The completed SDS form shall be completed by a trained SDS author. CLP and GHS CLP is different to the current directives: • It sets criteria for both transport and supply and use • It defines further hazard classes and categories • It uses partly other criteria and other cut-offs • It uses a different approach for mixtures • It changes some labelling elements GHS includes some categories which are not part of the current EU system. CLP does not carry over those categories: • Flammable liquids Category 4 • Acute Toxicity Category 5 • Skin corrosion/irritation Category 3 • Aspiration hazard Category 2 • Acute aquatic toxicity Category 2 • Acute aquatic toxicity Category 3 It takes over the current Annex I of DSD and Title XI (Classification and Labelling Inventory) of the REACH Regulation. The CLP Regulation maintains the current level of protection by including EU “left-overs” not yet covered by the GHS. • Ozone depletion (Annex I Part 5) • Additional labelling requirements in Annex II:  EUH014 [R14] reacts violently with water  EUH066 [R66] repeated exposure may cause skin dryness or cracking GHS Label elements • Symbols (hazard pictograms) convey health, physical and environmental hazard information, assigned to a GHS hazard class and category. • Signal Words: "Danger" or "Warning" is used to emphasize hazards and indicate the relative level of severity of the hazard, assigned to a GHS hazard class and category. • Hazard Statements or standard phrases are assigned to a hazard class and category that describe the nature of the hazard (they replace the R-phrases). The actual phrase (not the code GHSNNN or HNNN or PNNN) should appear on the labels and the SDS.Date Printed: 9/28/2012 Page 9 of 186
  10. 10. ProcedureSafety Data Sheet (SDS) and Labels SOP Part Number: NNNNNSOP Revision: draft Effective Date: _ • GHS Hazard statements include Precautionary statements: prevention, response, storage, disposal. They are prescribed by class and category with new statements such as: May cause drowsiness or dizziness. May be harmful if swallowed and enters airways.Date Printed: 9/28/2012 Page 10 of 186
  11. 11. ProcedureSafety Data Sheet (SDS) and Labels SOP Part Number: NNNNNSOP Revision: draft Effective Date: _ EC, USA, CANADA and UN Identification, Classification and Labelling of Chemicals Definition of Data Components in Labels UN RTDG EC USA CANADA Format: Format: Format: Format: Size of labels Minimum label None defined Supplier Label: must appear on all varies with dimensions are controlled products received at work- transport mode defined for places; required information must be set different package aside from sales information; surrounded capacities; by WHMIS must be printed in contrasting contrasted danger colours with texts in English and French. symbols and Workplace Label: must appear on all background (black products produced in a workplace or or yellow transferred to other containers by the background) employer; may appear in placard form on products received in bulk. Data elements Data elements: Data elements: Data elements: are not 1.Chemical identity 1.Chemical identity Supplier label: mandated. The 2. Hazard symbol 2. Supplier - product identifier UN RTDG label and indication of identification - supplier identification defines hazards danger 3. Appropriate - reference to existing SDS by the use of 3. Risk phrases hazard warnings - hazard symbols symbols, colours 4. Safety phrases Employer must and for containers over 100 ml: and danger 5. Supplier ensure that labels - risk and safety phrases warning words identification (full and other forms of - first aid measures for specific address and tel no) warnings are in Workplace label: hazards 6. CA number English. - product identifier (explosives, 7. Wording EEC - information for the safe handling of the radioactive, Label where ANSI Standard Z products corrosive, etc) appropriate or 129.1.1988 defines - reference to existing SDS GHS Label acceptable - may contain MHMIS hazard symbols Placarding of precautionary and other pictograms transport units is phrases and Chemical name may be replaced by defined, hazard symbols. generic name or number in case of including form, or use GHS hazard products covered by provisions on minimum size statements. exemption for confidential business and colour of information. placards. Link: http://www.ilo.org/legacy/english/protection/safework/cis/products/safetytm/classify.htm Note: EEC number is also the CAS #Date Printed: 9/28/2012 Page 11 of 186
  12. 12. ProcedureSafety Data Sheet (SDS) and Labels SOP Part Number: NNNNNSOP Revision: draft Effective Date: _ Writing Labels Suppliers and Employers Responsibilities Suppliers retain the duty to provide the prescribed labels for their products. Employers would continue to be responsible for labels required within their workplaces. GHS Symbols and Elements and Regulatory Changes on Labelling There are two types of Labels for hazard communication: Supplier labels for controlled products that are sold to the customer, to be used in workplaces. Workplace labels for certain controlled products at the customer’s workplace. Note: Alternative means of providing workers with the information contained in GHS labels are needed usually where hazardous chemicals are transferred from an original supplier container into a workplace container or system, or where chemicals are produced in a workplace but are not packaged in containers intended for sale or supply. Label Requirements • Product Identifier (hazardous ingredients may be required) • Supplier Identifier – Specifies the name, address, and telephone number of the supplier • Hazard symbols/pictograms (square set at a point) – Pictures to identify the hazards of a product • Hazard statement – Standardized wording to describe the hazards of a product, e.g., “flammable liquid and vapour” • Precautionary statements (prevention, storage and disposal) – Recommended measures to minimize or prevent adverse effects, e.g., “keep away from open flames” • Precautionary statements (response) • Reference to SDS (retained) • Signal word (Danger or Warning) Note: WHMIS border and reference to the SDS are required on WHMIS supplier labels that are not included in GHS. Label Content Depends on Class and Category Product X Product Y (Cat. 1) (Cat. 2) Danger Warning Extremely flammable aerosol Flammable aerosol • The Product Identifier used on a label must match the identifier on the SDS. It is a name which uniquely identifies the product. GHS criteria also state that the Product Identifier may include the chemical identity of the substance, or the hazardous ingredients if the product is a mixture.Date Printed: 9/28/2012 Page 12 of 186
  13. 13. ProcedureSafety Data Sheet (SDS) and Labels SOP Part Number: NNNNNSOP Revision: draft Effective Date: _ • The Supplier Identifier must also appear on the label showing the name, address and telephone number of the manufacturer or supplier. • The GHS hazard pictograms, signal word and hazard statements should be located together on the label. • All labels (MSDS, Package Insert and other technical/marketing documents) shall comply with the requirements as defined in 21 cFR part 809 (Labeling of In-vitro Diagnostic Products For Human Use). GHS Pictograms/Symbols Go to http://www.unece.org/fileadmin/DAM/trans/danger/publi/ghs/pictograms/ for GHS pictograms. Signal Words They indicate the severity of a hazard. Depending on the category within a hazard class, the signal word will be: Danger – to indicate a severe hazard Warning – to indicate a lower serverity hazard No signal word – for certain classes and categories, a signal word will not be shown on the label. GHS Hazard Statements They are text descriptions of a product’s hazards and are assigned to a hazard class and category to describe the nature/degree of the hazards. Suppliers are required to use standardized hazard statements on their labels, according to hazard class and category of each product. Hazard statements form part of the Globally Harmonized System of Classification and Labelling of Chemicals (GHS). They are intended to form a set of standardized phrases about the hazards of chemical substances and mixtures that can be translated into different languages. As such, they serve the same purpose as the well-known R-phrases, which they are intended to replace. Hazard statements are one of the key elements for the labelling of containers under the GHS, along with: • an identification of the product • one or more hazard pictograms (where necessary) • a signal word – either DANGER or WARNING – where necessary • precautionary statements, indicating how the product should be handled to minimize risks to the user (as well as to other people and the general environment) • the identity of the supplier (who might be a manufacturer or importer) Each hazard statement is designated a code, starting with the letter H and followed by three digits. Statements which correspond to related hazards are grouped together by code number, so the numbering is not consecutive. The code is used for reference purposes, for example to help with translations, but it is the actual phrase which should appear on labels and safety data sheets.Date Printed: 9/28/2012 Page 13 of 186
  14. 14. ProcedureSafety Data Sheet (SDS) and Labels SOP Part Number: NNNNNSOP Revision: draft Effective Date: _ Hazard Symbols and Pictograms • shall decide the symbols to be displayed on a label once the product has been classified accordingly. GHS uses nine different symbols. Symbols are specified for each hazard class and category. Hazard symbols provide a graphical description of product hazards. • Pictograms display the symbol plus other graphical elements, such as a border, background pattern or color that conveys specific information. In GHS pictograms, all symbols are displayed within a square set at a point. In some cases, more than one hazard symbol/pictogram applies to a specific class depending on the category or type. • With GHS, some supplier labels will not have a hazard symbol/pictogram for certain categories such as: Explosives 1.5, 1.6 Organic Peroxides type G Skin corrosion/irritation category 3 Flammable gases category 2 Self-reactive substances/mixtures type G Flammable liquids category 4 Acute toxicity category 5 Serious eye damage/irritation cat 2B Toxic to reproduction affects on or via lactationHazardous to the aquatic environment Acute Category 2 and 3; Chronic category 3 and 4 Examples of Pictogram Description and their Hazard Classes Description Hazard Classes Skull and crossbones Acute toxicity (high hazard categories) Gas cylinder Gas under pressure Explosion Explosive (high hazard categories), self-reactive substances/mixtures Flame with an O Oxidizing gases/liquids/solids Environment Hazardous to the aquatic environment (high hazard categories) Precautionary Statements These statements include measures aimed at preventing or minimizing adverse effects of the product (see Precautionary Statement Table). They include safe practices for storage, handling and use of the product. Example: Keep away from heat/sparks/open flames/hot surfaces – No smoking. Hazard and Precautionary Statements • For the lists of Hazard and Precautionary statement per UN 2011 document, see Annex 3 codification of hazard statements UN 2011 pdf file. • For precautionary statements, remove duplicates and select the most protective statements when they are similar.Date Printed: 9/28/2012 Page 14 of 186
  15. 15. ProcedureSafety Data Sheet (SDS) and Labels SOP Part Number: NNNNNSOP Revision: draft Effective Date: _ Product Identifier • A product identifier should be used on a GHS label to match the product identifier used on the SDS. “ Where a substance or mixture is covered by the UN Model Regulations on the Transport of Dangerous Goods, the UN proper shipping name should also be used on the package. • The label for a substance should include the chemical identity of the substance. For mixtures or alloys, the label should include the chemical identities of all ingredients or alloying elements that contribute to acute toxicity, skin corrosion or serious eye damage, germ cell mutagenicity, carcinogenicity, reproductive toxicity, skin or respiratory sensitization, or Target Organ Systemic Toxicity (TOST), when these hazards appear on the label. Other GHS Guidance and Annexes http://www.unece.org/fileadmin/DAM/trans/danger/publi/ghs/ghs_rev03/English/06e_an nex2.pdf Annex 1: Allocation of label elements Annex 2: Classification and labeling summary tables Annex 3: Codification of hazard statements, codification and use of precautionary statements and examples of precautionary pictograms Annex 4: Guidance on the preparation of Safety Data Sheets (SDS) Annex 5: Consumer product labeling based on the likelihood of injury Annex 6: Comprehensibility testing methodology Annex 7: Examples of arrangements of the GHS label elements Annex 8: An example of classification in the GHS Annex 9: Guidance on hazards to the aquatic environment Annex 10: Guidance on transformation/dissolution of metals and metal compounds in aqueous media Standardized Rules of Precedence to group a product to more than one class To determine label content, suppliers will follow standardized rules of precedence. Some symbols (health-related) or signal words may not be shown according to these rules. GHS rules of precedence for health hazards would result in a label with: • skull and crossbones symbol only • signal word “Danger” only • hazard statements for BOTH classes/categories • other mandatory label elements – product identifier, supplier identifier, precautionary statements Note: GHS hazard pictogram, signal word and statements should be located together on the label. GHS Health and Environmental Hazard Classification Criteria • Acute toxicity • Skin corrosion/irritation • Serious eye damage/eye irritation • Respiratory or skin sensitizationDate Printed: 9/28/2012 Page 15 of 186
  16. 16. ProcedureSafety Data Sheet (SDS) and Labels SOP Part Number: NNNNNSOP Revision: draft Effective Date: _ • Germ cell mutagenicity • Carcinogenicity • Reproductive toxicity • Specific target organ • Aspiration hazard Category 1 Danger Oral LD50=5 mg/kg bodyweight, or• Dermal LD50=50 mg/kg bodyweight, or• Inhalation (gas) LC50=100 ppm, or• Inhalation (vapour) LC50=0.5 mg/l, or• Inhalation (dust/mist) LC50=0.05 mg/l? What is new with CLP? • Aquatic Toxicity: freshwater and marine species toxicity data • Bioaccumulation: using a higher cut-off value of log Kow > 4 and BCF > 500 is intended to identify substances with a potential to bioconcentrate • Rapidly degradable vs readily degradable • Declassification from chronic categories 2 and 3 (NOECs > 1 mgL) • Classification Categories Acute Category 1 96 hr LC50 (for fish) < 1 mg/l when classifying substances as Acute Category 1 and/or Chronic Category 1, it is necessary at the same time to indicate an appropriate M-factor. Note: A substance or mixture need not be classified when it can be shown by conclusive experimental data from internationally acceptable test methods that the substance or mixture is not biologically available (GHS). Hazard Classification by Total Weight of Evidence For others, classification of a substance or a mixture is made on the basis of the total weight of evidence. This means that all available information bearing on the determination of toxicity is considered together, including the results of valid in vitro tests, relevant animal data, and human experience such as epidemiological and clinical studies and well documented case reports and observations. When it is clear that the mechanism or mode of action is not relevant to humans, the substance or mixture should not be classified. OSHA References • OSHAs Hazardous Chemicals in Labs Fact Sheet (270 K PDF download). • OSHAs page on toxic and hazardous substances including recognition, evaluation, controls, standards and more. • Appendix E of the HazCom standard has some useful guidelines for employer compliance with the standard. • Risk and Hazard: How They Differ (PDF file), by CEFIC - the European Chemical Industry Council. • Hazard vs Risk at the DEHP Information Center. • Communicating Risks and Benefits: An Evidence-Based User’s Guide at the US FDA.Date Printed: 9/28/2012 Page 16 of 186
  17. 17. ProcedureSafety Data Sheet (SDS) and Labels SOP Part Number: NNNNNSOP Revision: draft Effective Date: _ Description of Hazardous Material on Shipping Papers (49 CFR 173 - HRM US DOT Hazard Class and Definition ; Pipeline and Hazardous Materials Safety Admin., DOT 172.202) The shipping description of a hazardous material on the shipping paper must include: 1. Identification number prescribed for the material 2. Proper shipping name prescribed for the material. 3. Hazard class or division number prescribed for the material. Except for combustible liquids, the subsidiary hazard class(es) or subsidiary division number(s) must be entered in parentheses immediately following the primary hazard class or division number. In addition: (i) The words ‘‘Class’’ or ‘‘Division’’ may be included preceding the primary and subsidiary hazard class or division numbers. (ii) The hazard class need not be included for the entry ‘‘Combustible liquid, n.o.s.’’ (iii) For domestic shipments, primary and subsidiary hazard class or division names may be entered following the numerical hazard class or division, or following the basic description. Packing group in Roman numerals, as designated for the hazardous material Note: Class 1 (explosives) materials, self-reactive substances, organic peroxides and entries that are not assigned a packing group are exempted from this requirement. The packing group may be preceded by the letters ‘‘PG’’ (for example, ‘‘PG II’’) Dangerous goods of all classes other than UN Hazard Classes 1, 2, 6.2, and 7 have for packing purposes been divided among three groups according to the degree of danger they present: - great danger: Packing Group I - medium danger: Packing Group II - minor danger: Packing Group III 4. Except for transportation by aircraft, the total quantity of hazardous materials covered by the description must be indicated (by mass or volume, or by activity for Class 7 materials) Hazardous Materials at The following materials are defined as hazardous for the purposes of this SOP: 1. Biological materials in the BSL-2 Category, or greater. 2. Chemicals listed as Select Carcinogens and Regulated Carcinogens. (See http://www.dir.ca.gov/Title8/5191.html for the Cal/OSHA criteria for select carcinogens) 3. Chemicals listed as Reproductive Toxins. (See http://www.oehha.org/prop65/prop65_list/Newlist.html#files for a list of reproductive toxins and carcinogens identified under California Proposition 65 ) 4. Chemicals listed as Toxic or Highly Toxic. (See http://www.osha.gov/pls/oshaweb/owadisp.show_document? p_table=STANDARDS&p_id=1 0100 for OSHA guidance on identifying Highly Toxic Chemicals) 5. Flammable chemicals in excess of one (1) liter by volume, or any amount of violently air reactive or water reactive chemicals. 6. Corrosive chemicals in concentrations of one (1) molar or greater.Date Printed: 9/28/2012 Page 17 of 186
  18. 18. ProcedureSafety Data Sheet (SDS) and Labels SOP Part Number: NNNNNSOP Revision: draft Effective Date: _ 7. Known significant skin or eye irritants. Note: Irritants also include chemicals/mixtures with pH values of less than 5 and higher than 9. Note: This list is to be used as a guideline. It does not supersede Cal/OSHA regulations or accepted safe work practices for specific materials. PPE and other safety measures, as appropriate, must be used to protect workers from any and all known hazards that are present in all work-related activities Select Carcinogens Select carcinogens are any substance which meets one of the following: 1. It is regulated by OSHA as a carcinogen; or 2. It is listed under the category, "known to be carcinogens," in the Annual Report on Carcinogens published by the National Toxicology Program (NTP) (latest edition);or 3. It is listed under Group 1 ("carcinogen to humans") by the International Agency for Research on Cancer Monographs (IARC)( latest editions); or 4. It is listed in either Group 2A or 2B by IARC or under the category, "reasonably anticipated to be carcinogens" by NTP. WHMIS Classes or Classifications WHMIS (Workplace Hazardous Materials Information System) uses classifications to group chemicals with similar properties or hazards. The Controlled Products Regulations specifies the criteria used to place materials within each classification. There are six (6) classes although several classes have divisions or subdivisions. Each class has a specific symbol to identify the hazard quickly. The classes are: • Class A - Compressed Gas • Class B - Flammable and Combustible Material  Division 1: Flammable Gas  Division 2: Flammable Liquid  Division 3: Combustible Liquid  Division 4: Flammable Solid  Division 5: Flammable Aerosol  Division 6: Reactive Flammable Material • Class C - Oxidizing Material • Class D - Poisonous and Infectious Material  Division 1: Materials causing immediate and serious toxic effects  Subdivision A: Very toxic material Subdivision B: Toxic material  Division 2: Materials causing other toxic effects - Subdivision A: Very toxic material Subdivision B: Toxic material - Division 3: Biohazardous Infection Material • Class E - Corrosive material • Class F - Dangerously reactive materialDate Printed: 9/28/2012 Page 18 of 186
  19. 19. ProcedureSafety Data Sheet (SDS) and Labels SOP Part Number: NNNNNSOP Revision: draft Effective Date: _ Note per DPD: If the Non-dangerous preparation (NDP) contains > or = 1% for non gaseous preparations and > or = 0,2% for gaseous preparations of at least: one dangerous substance or a substance with EU exposure limits at workplace, an SDS with "proportionate information" should be made and delivered at request. If the NDP is only affected by the Annex V of the DPD and contains a percentage of a dangerous substance or a substance with EU exposure limits at workplace, smaller than those described above, no SDS will be required. Note: Materials which fall under WHMIS follow the Transportation of Dangerous Goods Act and Regulations while they are in transport (shipment). Hazardous Substances with Toxic Effects on Specific Organs include • Hepatotoxins – i.e., substances that produce liver damage, such as nitrosamines and carbon tetrachloride • Nephrotoxins – i.e., agents causing damage to the kidneys, such as certain halogenated hydrocarbons • Neurotoxins – i.e., substances which produce their primary toxic effects on the nervous system, such as mercury, acrylamide and carbon disulfide • Agents which act on the hematopoietic system – e.g., carbon monoxide and cyanides which decrease hemoglobin function and deprive the body tissues of oxygen • Agents which can damage lung tissue – e.g., asbestos and silica Chemical Safety Report (CSR) and SDS The information in the SDS for the substance must be consistent with that provided in the CSR as well as with that provided in the registration dossier. Records as a supplier of a substance or mixture is responsible for the content of the SDS that cannot be claimed as confidential and updates are given free of charge to downstream users. Records of the SDS shall be kept for at least 10 years after the last manufacture, import, supply or use of the substance or mixture. REACH Note REACH requires you to assemble and keep available all the information necessary to carry out your duties under REACH for a period of at least 10 years after you last manufactured, imported, supplied or used a substance or mixture. You should submit this information or make it available without delay upon request to the Member State Competent Authority/ies where you are established or to the Agency (REACH Article 36) Language The SDS shall be supplied in an official language of the Member State(s) where the substance or mixture is placed on the market.Date Printed: 9/28/2012 Page 19 of 186
  20. 20. ProcedureSafety Data Sheet (SDS) and Labels SOP Part Number: NNNNNSOP Revision: draft Effective Date: _ Not classified as Hazardous under CLP Labeling on the Packaging of the Substance or Mixture not classified as hazardous under CLP but dangerous under DPD (not for public use) must have an SDS available and supplied upon request with the following information in its packaging: Per DPD: “Safety Data Sheet available for professional user on request” (see Dangerous Preparations Directive 1999/45/EC, Annex V, Part C, no. 1). Per CLP: “Safety Data Sheet available on request”(see CLP Annex II, point 2.10, text EUH210). Downstream Users Downstream users can request for the SDS where hazardous substances or mixtures are offered or sold to the general public. Downstream Legislation Provisions under Community legislation other than CLP (downstream legislation) may be triggered by the classification of the substance or mixture. The corresponding acts/laws are: • Registration, evaluation, authorisation and restriction of chemicals (REACH) • Regulation (EC) No 1907/2006 of 18 December 2006 • Control of major-accident hazards involving dangerous substances (Seveso II) • Council Directive 96/82/EC of 9 December 1996 • Plant protection products Council Directive 91/414/EEC (PPPD) of 15 July • Biocidal products Directive 98/8/EC (BPD) of 16 February 1998 • Chemical agents at work Council Directive 98/24/EC of 7 April 1998 • Carcinogens and mutagens at work Directive 2004/37/EC 29 April 2004 • Young people at work Council Directive 94/33/EC of 22 June 1994 • Pregnant and breastfeeding women at work Council Directive 92/85/EEC of 19 October 1992 • Health and safety signs at work Council Directive 92/58/EEC of 24 June 1992 • Cosmetic products Council Directive 76/768/EEC of 27 July 1976 • Toy safety Council Directive 88/378/EEC of 3 May 1988 as amended by Directive 93/68/EEC • Detergents Regulation (EC) No 648/2004 of 31 March 2004 • Eco-label award scheme Regulation (EC) No 1980/2000 of 17 July 2000 • Aerosol dispensers Council Directive 75/324/EEC of 20 May 1975. CLP Article 14 (2c) takes account of the Aerosols Directive Article 8 (1a) • Limitation of emissions of volatile organic compounds Council Directive 1999/13/EC (VOCD) of 11 March 1999 and Directive 2004/42/EC of 21 April 2004 • Ambient air quality assessment and management Council Directive 1996/62/EC of 27 September 1996 • Export and import of dangerous chemicals Regulation (EC) No 689/2008 of 17 June 2008 • Hazardous waste Council Directive 91/689/EC of 12 December 1991, including Commission Decision 2000/532/EC of 3 May 2000 • Batteries and accumulators Council Directive 91/157/EEC of 18 March 1991 • End-of-life vehicles Directive 2000/53/EC of 18 September 2000 andDate Printed: 9/28/2012 Page 20 of 186
  21. 21. ProcedureSafety Data Sheet (SDS) and Labels SOP Part Number: NNNNNSOP Revision: draft Effective Date: _ • Waste electrical and electronic equipment (WEEE) Directive 2002/96/EC of 27 January 2002Date Printed: 9/28/2012 Page 21 of 186
  22. 22. ProcedureSafety Data Sheet (SDS) and Labels SOP Part Number: NNNNNSOP Revision: draft Effective Date: _ Hazard Communication SDS for pure substances shall include the classification according to 1272/2008 from Dec 1, 2010 until Jun 1, 2015 Sec 2 and Sec 3 shall show both old and new classification SDS for mixtures shall show the classification according to 1272/2008 from Jun 1, 2015 (Sections 2 and 3 of the SDS) • If classified under 1272/2008 before Jun 2015: Sec 2 must show product classification from both systems (1272/2008 and 1999/45/EC) • Section 3 must show substance classification from both systems (1272/2008 and 67/548/EEC) • CLP classification (sections 2 and 3) includes: Hazard statements, Hazard classes and categories • Section 15 must show the “old” label (67/548/EEC and 1999/45/EC) as long as used and the CLP (1272/2008) label when used Supplier Responsibilities • Suppliers must prepare an SDS for each controlled product. • Content of the SDS must comply with regulatory requirements (GHS, CLP). • SSDSs must be available to customers in English and French. • Suppliers must transmit SDSs to their customers. • SDS Updates are communicated to users: Distribution of updated SDS are only necessary when there are important changes in the SDS, that concerns the information on the dangerous properties and precautionary measures, e.g. new classifications or relevant and more detailed information in the different Headings. • The supplier can have one SDS prepared for other mixtures with very similar formulation, for instance different colours (nuances) and the components that make up the difference in the similar formulations do not modify the dangerous properties of the preparation. • As a supplier, you need to provide a safety data sheet in the following cases:  A substance (and from 1 June 2015 a mixture) classified as hazardous according to CLP.  A mixture classified as dangerous according to the Dangerous Preparations Directive (until 1 June 2015).  A substance that is persistent, bioaccumulative and toxic (PBT) or very persistent and very bioaccumulative (vPvB), as defined in REACH (AnneIII), or  A substance is included in the candidate list of substances of very high concern.Date Printed: 9/28/2012 Page 22 of 186
  23. 23. ProcedureSafety Data Sheet (SDS) and Labels SOP Part Number: NNNNNSOP Revision: draft Effective Date: _ Summary of SDS Changes According to REACH • The risk management measures for the identified uses with regard to human health and the environment are to be summarized in Sections 8 and 7. This includes consumer related measures communicated to a downstream user producing consumer preparation or articles. Also the relevant Derived No-Effect Levels (DNELs) and Predicted No-Effect Concentrations (PNECs) should be presented here. • The information on physicochemical properties, toxicology and eco-toxicology in the SDS is to be updated in line with the information requirements of Annex VI to XI of the REACH Regulation. • The results of the PBT and vPvB assessment are to be presented in Section 12. The information on uses advised against in Section 16 of the SDS may need to be updated depending on the outcome of the manufacturer’s Chemicals Safety Assessment (CSA). • Where Exposure Scenarios (ES) are developed as a result of conducting a chemical safety assessment in accordance with Article 14 of the REACH Regulation they must be annexed to the SDS and thereby be appropriately passed down the supply chain. The information on uses of the substance in section 1.2 of the SDS must be consistent with the short titles of the ES in the annex, indicating which uses are covered by the ES. Note: Where the information in an ES that becomes available does not affect the risk management measures and the ES contains no new information on hazards, the SDS does not have to be updated. • Since REACH includes a requirement to include the waste disposal considerations into the manufacturer’s chemicals safety assessment, section 13 of the SDS may need to be updated with substance specific waste management advice as contained in the ES. • It is important to note that now SDSs are additionally required for substances assessed to be PBTs (Persistent, Bioaccumulative and Toxic) or vPvBs (very Persistent and very Bioaccumulative), for substances included in the candidate list for potential inclusion in Annex IV of the REACH Regulation, as well as for mixtures containing any of these substances. • For further details on the obligation to provide an SDS, please consult the Guidance on information requirements and chemicals safety assessment (part G) (http://guidance.echa.europa.eu/docs/guidance_document/information_requirem ents_en.htm) and the Guidance on registration (http://guidance.echa.europa.eu/docs/guidance_document/registration_en.pdf). In addition, the Guidance for downstream users (http://guidance.echa.europa.eu/docs/guidance_document/du_en.pdf). Provides an overview on the new information in an SDS.Date Printed: 9/28/2012 Page 23 of 186
  24. 24. ProcedureSafety Data Sheet (SDS) and Labels SOP Part Number: NNNNNSOP Revision: draft Effective Date: _ What is new in REACH Safety Data Sheet? The following sections of the SDS Section 1: Identification of substance or mixture and company: • Registration No. is required (when available) • Identified uses of the substance/mixture is added • E-mail address of competent person is needed Note: Korea requires an emergency contact info of supplier based in Korea Section 2: Hazards identification: • Distinguish between mixtures that are and are not hazardous • Mention other hazards that do not result in classification (e.g., dustiness, ozone depletion) • Classification as in Title V CLP and DSD (see note) Section 3: Composition & information on ingredients: • All substances classified as hazardous or those with OELVs or PBT/vPvB need to be reported Section 7: Handling and storage: • Where CSR required, information to be consistent with Exposure Scenario (ES) • Under "Handling" include measures to protect environment • New section on "Specific uses" Section 8: Exposure controls/personal protection (If CSR is required): • DNELs and PNECs for substance shall be provided • Summary of Risk Management Measures(RMM) shall included for identified uses as set out in ES Section 11, 12: Toxicological information and Ecological information • Summaries of toxic tests and ecological tests need to be provided Section 15: Regulatory information: • Indicate if CSA has been carried out • Indicate if substance subject to authorization/restriction Section 16: Other information: • Full text of R phrases (hazard statements) to be listed • Upon revision, indicate information added/deleted/revised Note: From 1 December 2010 until 1 June 2015, substance shall be classified in accordance with both 67/548/EEC (DSD) and CLP regulation. ?? SDS Audit Checklist • Do chemical manufacturers and importers have an SDS for each hazardous chemical produced or imported into the United States? • Do employers have an SDS for each hazardous chemical used? • Is each SDS in at least English? • Does each SDS contain at least the: Identity used on the label? Chemical and common name(s) for single substance hazardous chemicals? For mixtures tested as a whole: (1) Chemical and common name(s) of the ingredients which contribute to the known hazards?Date Printed: 9/28/2012 Page 24 of 186
  25. 25. ProcedureSafety Data Sheet (SDS) and Labels SOP Part Number: NNNNNSOP Revision: draft Effective Date: _ (2) Common name(s) of the mixture itself? For mixtures not tested as a whole: (1) Chemical and common name(s) of all ingredient which are health hazards (1 percent concentration or greater), including carcinogens (0.1 percent concentration or greater)? (2) Chemical and common name(s) of all ingredients which are health hazards and present a risk to employees, even though they are present in the mixture in concentrations of less than 1 percent or 0.1 percent for carcinogens? Chemical and common name(s) of all ingredients which have been determined to present a physical hazard when present in the mixture? Physical and chemical characteristics of the hazardous chemical (vapor pressure, flash point, etc.)? Physical hazards of the hazardous chemical including the potential for fire, explosion, and reactivity? Health hazards of the hazardous chemical (including signs and symptoms and medical conditions aggravated)? Primary routes of entry? OSHA permissible exposure limit (PEL)? The American Conference of Governmental Industrial Hygienists (ACGIH) Threshold Limit Value (TLV)? Other exposure limit(s) (including ceiling and other short term limits)? Information on carcinogen listings (reference OSHA regulated carcinogens, those indicated in the National Toxicology Program (NTP) Annual Report on Carcinogens and/or those listed by the International Agency for Research on Carcinogens (IARC))? Classification and Labeling • A substance or a mixture fulfilling the criteria relating to physical hazards, health hazards or environmental hazards shall be classified in relation to the respective hazard classes and hazard categories. Where applicable, it is differentiated on the basis of the route of exposure or the nature of the effects. Further assigned are one or more hazard statements corresponding to each hazard category. • A substance or mixture classified as hazardous needs to be labeled. To each classification, label elements are assigned. These may comprise a hazard pictogram, a signal word, hazard statements and precautionary statements for prevention, response (in case of spillage or exposure), storage and/or disposal. Further supplemental hazard information may apply to maintain the level of protection of current EU law (e.g., EUH208 - “Contains (name of sensitizing substance: May produce an allergic reaction.”). The regulation further provides principles of precedence for the hazard pictograms, hazard statements and precautionary statements to avoid duplication or redundancy. • The following example shows the classification of TPGDA under the new legislation (Table 1). The classification is obtained from table 3.1 of Annex VI of the proposed GHS regulation for substances listed in Annex I of 67/548/EEC. Further included are the resulting label elements, except of applicable precautionary statements. For TPGDA, two pictograms and one signal word apply (reachonline: http://www.reachonline.eu/REACH/EN/REACH_EN/articleVI.html) . GHS/CLP Classification General Notes • The GHS has several health hazard endpoints, e.g., mutagenicity and target organ systemic toxicity, that do not exactly correspond to the HCS (OSHA) hazards.Date Printed: 9/28/2012 Page 25 of 186
  26. 26. ProcedureSafety Data Sheet (SDS) and Labels SOP Part Number: NNNNNSOP Revision: draft Effective Date: _ • In general the major difference between the HCS and the GHS is untested mixtures. • OSHA has a single 1% cut-off value for all health hazards, except carcinogens at 0.1%. These cut-off values require labels, MSDSs, and disclosure of hazardous components. In the GHS cut-off values for mixtures vary by endpoint. • The GHS cut-off values for labeling, MSDSs and disclosure can be different. • The GHS acute toxicity and irritant hazard determinations for mixtures have more steps. • For substances previously classified under the HCS, existing data should be accepted when these substances are classified under the GHS. Table 1. Hazard Classes of the Proposed EU Regulation 1 Physical Hazards 2. Health Hazards 2.1 Explosives 3.1 Acute Toxicity 2.2 Flammable Gases 3.2 Skin Corrosion / Irritation 2.3 Flammable Aerosols 3.3 Serious Eye Damage / Eye Irritation 2.4 Oxidizing Gases 3.4 Respiratory or Skin Sensitization 2.5 Gases under Pressure 3.5 Germ Cell Mutagenicity 2.6 Flammable Liquids 3.6 Carcinogenicity 2.7 Flammable Solids 3.7 Reproductive Toxicity 2.8 Self-reactive Substances and Mixtures 3.8 Specific Target Organ Toxicity – Single Exposure 2.9 Pyrophoric Liquids 3.9 Specific Target Organ Toxicity – Repeated Exposure 2.10 Pyrophoric Solids 3.10 Aspiration Hazard 2.11 Self-heating Substances and Mixtures 2.12 Substances and Mixtures which in contact with water emit flammable GasesDate Printed: 9/28/2012 Page 26 of 186
  27. 27. ProcedureSafety Data Sheet (SDS) and Labels SOP Part Number: NNNNNSOP Revision: draft Effective Date: _ Environmental Hazards 2.13 Oxidizing Liquids 4.1 Hazardous to the Aquatic Environment 2.14 Oxidizing Solids 2.15 Organic Peroxides Additional EU Hazard Class 2.16 Corrosive to Metals 5.1 Hazardous for the Ozone Layer Note: Some of these classes or categories thereof do not exist in the current EU system but are added aiming at consistency with Dangerous Goods legislation (e.g. gases under pressure, corrosive to metals, etc.). According to the ‘Building Block Approach’, the following GHS Hazard Categories are not part of the proposed EU regulation: • Flammable Liquids Category 4 • Acute Toxicity Category 5 • Skin Corrosion / Irritation Category 3 • Aspiration Hazard Category 2 • Acute Aquatic Toxicity Category 2 • Acute Aquatic Toxicity Category 3 GHS Criteria for Acute Toxicity Substances of this hazard class are assigned to one of five toxicity categories on the basis of LD50 (oral, dermal) or LC50 (inhalation): Category 1 LD50 < 5 mg/kg bodyweight (oral) LD50 < 50 mg/kg bodyweight (skin/dermal) LC50 < 100 ppm (gas) LC50 < 0.5 (mg/l) (vapour) LC50 < 0.05 (mg/l) (dust,mist) Category 2 LD50 > 5 and < 50 mg/kg bodyweight (oral) LD50 > 50 and < 200 mg/kg bodyweight (skin/dermal) LD50 > 100 and < 500 ppm (gas) LD50 > 0.5 and < 2.0 (mg/l) (vapour) LC50 > 0.05 and < 0.5 (mg/l) (dust, mist) Category 3 LD50 > 50 and < 300 mg/kg bodyweight (oral) LD50 > 200 and < 1000 mg/kg bodyweight (skin/dermal) LC50 > 500 and < 2500 ppm (gas) LC50 > 2.0 and < 10.0 (mg/l) (vapour) LC50 > 0.5 and < 1.0 (mg/l) (dust, mist) Category 4 LD50 between 300 and less than 2000 mg/kg bodyweight (oral) LD50 between 1000 and less than 2000 mg/kg bodyweight (skin/dermal) LC50 between 2500 and less than 5000 ppm (gas) LC50 between 10.0 and less than 20.0 (mg/l) (vapour) LC50 between 1.0 and less than 5.0 (mg/l) (dust, mistDate Printed: 9/28/2012 Page 27 of 186

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