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

1. Procedure
Safety Data Sheet (SDS) and Labels SOP
Part Number: NNNNNSOP
Revision: draft
Effective Date: _
Contents
1. Purpose............................................................................................................... 5
2. Scope.................................................................................................................. 5
3. 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..........................................................................................................22
Date Printed: 9/28/2012 Page 1 of 186

2. Procedure
Safety 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)........................................57
Date Printed: 9/28/2012 Page 2 of 186

3. Procedure
Safety 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............61
4. Regulations ....................................................................................................... 62
5. Sample Safety Data Sheet (SDS)..................................................................... 63
6. Resource Table: Preparation Resources (Other sources/link not listed in the
following screen shots) Document/Link................................................................. 67
SDS Sections 1- 16................................................................................................................. 67
Other Links............................................................................................................. 72
7. GHS Labels Sample Format.............................................................................. 73
8. 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................................................................ 80
9. Other Guidance and Notes................................................................................ 80
10. Hazard Statements Table................................................................................ 81
GHS Hazard Statements General Notes................................................................................. 83
Other EU Hazard Statements..................................................................................................84
11. Precautionary Statement Table....................................................................... 84
12. Derivation of the Mixture Classification........................................................... 94
13. EPA Outline of the Six Steps for Hazardous Waste Determination................94
14. Classification Criteria, H-criterion, under LoW and DPD................................ 95
15. 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)............................................................................... 97
16. Intermediate Translation Table LoW to CLP................................................... 98
H9 Waste Types (Infectious)................................................................................100
17. United Nations Classification Recommendation on Transport of Dangerous
Goods.................................................................................................................. 100
18. Glossary........................................................................................................ 101
19. Table 2 – Incompatible Chemicals............................................................... 154
20. Hazardous Waste Identification (RCRA Subtitle C)...................................... 155
More GHS Labeling Sample.................................................................................................157
21. Notes from SDS Compiler’s Guide Updated August 2010.pdf (183 pages)..158
First Aid Notes......................................................................................................................158
Spillage Disposal Guide........................................................................................160
22. Globally Harmonized System of Classification & Labelling of Chemicals (GHS)
164
New GHS Combination Phrases ..........................................................................................166
Abbreviations........................................................................................................................167
23. Labeling and Storing of Chemicals at ........................................................... 168
Allowed Substances..............................................................................................168
Labeling of Chemicals.......................................................................................... 168
Labeling of Non- Substances................................................................................168
24. Labeling and Other Forms of Warning.......................................................... 168
25. Biological Waste Labeling............................................................................. 170
26. Employee Training Program Sample............................................................ 170
Date Printed: 9/28/2012 Page 3 of 186

4. Procedure
Safety Data Sheet (SDS) and Labels SOP
Part Number: NNNNNSOP
Revision: draft
Effective Date: _
27. MSDS Request Letter Sample...................................................................... 172
28. Hazardous Waste Tag................................................................................... 173
29. Container Labeling........................................................................................ 173
30. NFPA (NATIONAL FIRE PROTECTION ASSOCIATION) 704M SYSTEM. .174
31. MSDS and Labeling Guideline Summary at ................................................. 175
32. Notes on GHS Labels and Symbols.............................................................. 177
33. GHS Symbols................................................................................................ 177
34. 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..................................................................................182
35. Other Exposure Routes ................................................................................ 182
36. Sample Chemical Summary of Phenobarbital Drug...................................... 183
37. 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..................................................................................................... 186
Date Printed: 9/28/2012 Page 4 of 186

5. Procedure
Safety 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. Procedure
Safety 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 imposed
Date Printed: 9/28/2012 Page 6 of 186

7. Procedure
Safety 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. Procedure
Safety 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. Procedure
Safety 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. Procedure
Safety 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. Procedure
Safety 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. Procedure
Safety 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. Procedure
Safety 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. Procedure
Safety 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. Procedure
Safety 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 sensitization
Date Printed: 9/28/2012 Page 15 of 186

16. Procedure
Safety 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
• OSHA's Hazardous Chemicals in Labs Fact Sheet (270 K PDF download).
• OSHA's 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. Procedure
Safety 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. Procedure
Safety 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 material
Date Printed: 9/28/2012 Page 18 of 186

19. Procedure
Safety 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. Procedure
Safety 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 and
Date Printed: 9/28/2012 Page 20 of 186

21. Procedure
Safety 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
2002
Date Printed: 9/28/2012 Page 21 of 186

22. Procedure
Safety 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. Procedure
Safety 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. Procedure
Safety 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. Procedure
Safety 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. Procedure
Safety 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 Gases
Date Printed: 9/28/2012 Page 26 of 186

27. Procedure
Safety 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, mist
Date Printed: 9/28/2012 Page 27 of 186

28. Procedure
Safety Data Sheet (SDS) and Labels SOP
Part Number: NNNNNSOP
Revision: draft
Effective Date: _
Category 5
LD50 between 2000 and 5000 (oral or skin/dermal)
For gases, vapours, dusts, mists, LC50 in the equivalent range of the oral and dermal LD50
(i.e.,between 2000 and 5000 mg/kg bodyweight). See also the additional criteria:
• Indication of significant effect in humans
• Any mortality at Category 4
• Significant clinical signs at Category 4
• Indication from other studies
GHS Criteria for Skin Corrosion and other hazard class
(See ghs osha comparison.pdf file)
An SDS is not needed when (per OSHA’s 29 CFR 1910.1200)
• SDSs are one of the tools of hazardous communication standard. In its statement of
purpose – 29 CFR 1910.1200 (a) (1) – the regulation clearly states that, “This
transmittal of information is to be accomplished by means of comprehensive hazard
communication programs, which are to include container labeling and other forms of
warning, material safety data sheets and employee training.” So, SDSs are just one
form of communication. Other things, like container labels, are important too, and
many items that are regulated by other government agencies do not require separate
SDSs.
• 29 CFR 1910.1200 (b) goes into detail about what kinds of chemicals are exempt from
this rule. For example, 1200 (b) (4) applies to facilities where employees handle
chemicals in sealed containers but do not open them under normal conditions (such as
in warehouses or even retail sales). These facilities must keep copies of SDSs they
receive with hazardous shipments and must obtain an SDS for any hazardous chemicals
received without one if an employee requests it. But if no SDS is received and no
employee requests it, facilities are not required to have one on file.
• Pesticides, insecticides, fungicides and rodenticides do not require labeling under 29
CFR 1910.1200. These labels are regulated by EPA instead of OSHA.
• Chemicals and chemical mixtures defined in the Toxic Substances Control Act (15
USC 2601 et seq.) are exempt. Like the pesticides, they are regulated by EPA.
• Foods, food additives, color additives, drugs, cosmetics, medical and veterinary devices
and their ingredients are exempt. These items are regulated by the U.S. Food and Drug
Administration, rather than OSHA.
• Beverage alcohols including wine and malt beverages are exempt. These items are
regulated under the Bureau of Alcohol, Tobacco, and Firearms.
• Consumer product or hazardous consumer substance is exempt. These items are
regulated by the Consumer Product Safety Commission.
• Agricultural and vegetable seeds are exempt. These are regulated by the U.S.
Department of Agriculture.
• 12 categories of hazardous chemicals to which the regulation does not apply:
 Hazardous waste (regulated by EPA)
 Hazardous substance (EPA again)
 Tobacco or tobacco products
 Wood or wood products
 Articles not of a fluid or particle nature
Date Printed: 9/28/2012 Page 28 of 186