SDS Section 2 (Tab "2 Hazards")
Quick start
In this section, you identify the hazards of the product as a whole. GHS classification of hazards appears in the Hazard table, which is the central focus of this tab.
Þ Start on this section only if you have already worked on Tab “1 Identification”, Tab “3 Composition”, and Tab “9 Phys-chem props”.
Þ Fields and other items that are “required” — recommended to generate a substantially complete SDS — have burgundy titles or applicability notes on the entry form.[1]
Þ For general guidance, refer to the Managing help box, below.
1. GHS version (button) — Click on the GHS version button to select the version of the GHS standard that you plan to use for this SDS.
· By default, the version may already be set to “US”. If your product is for the US market, then you may want to use either this GHS version or the “US21” version (the US-OSHA Hazard Communication Standard for 2024, which went into effect on July 19, 2024[2]).
· If you are unsure which version to select, click on the “GHS version” link (just to the left of the button), for access to UN regional and country lists in your web browser.
2. Class acc to (“Classification according to”; field with drop-down menu) — If you wish to indicate a different regulatory statute or standard for GHS classification (other than one that the program selects), you can specify it here. For example, Mexico currently aligns its regulations with UN GHS revision 5, but has its own set of implementing regulations ("NOM-018-STPS-2015"), which you may want to use on the generated SDS instead of "UN GHS revision 5".
The “Zoom” button (magnifying glass icon) to the right of the field enables you to enter the regulation in another language, for use on a non-English SDS.
3. No GHS hazards (check box) — If you are reasonably sure that the product has no hazards that would result in GHS classification, then you may want to consider checking this box. In this case, the program will not incorporate Hazard table entries into the generated SDS. You can still enter non-GHS hazard information in the field, "Other hazards (not resulting in classification)", below the Hazard table.
For a product checked "No GHS hazards", you can skip the instructions below for creating Hazard table entries.
4. If you have already determined the GHS classifications for the product (from test data or from “bridging” principles), then skip to manual entry of the classifications, below.
Otherwise, click on the Suggestions button:
The program will display a “Suggestions…” dialog containing an analysis and recommendations report (the "Suggestion report"). A summary of the recommendations appears at the top of the report, with details further down.
“Suggestions...” dialog, displaying the top part of the Suggestion report.
5. If the Suggestion report includes GHS health classification recommendations:
(The recommendations appear under the heading, “Suggested health hazards”, at the top of the report.)
· Click on the Add health hazards button to add them to the Hazard table. The program should add one or more rows to the table, under the “Classifications” table tab:
Hazard table, “Classifications” table tab.
· If the Suggestion report does not indicate any health classification recommendations, click on the Close button. You can add classifications manually in the next step.
6. Determine whether there are any additional classifications relevant to the product (which are not already listed in the Hazard table). In particular, you may know of physical or environmental hazards of your product. Physical and environmental recommendations won’t be included in the Suggestion report.
· Click on the Multi-select button, and select "Any GHS classifications" from the button menu. The program will display a “Multi-select” dialog, listing available hazard classifications for the GHS of the SDS.
“Multi-select” dialog, for choosing among hazard classifications for a selected GHS version.
· Scroll through the list of classifications, and click on any that you think should be added. You can [Shift]-click or [Ctrl]-click to select more than one row. You can also use the “Find text” (quick search) box to narrow the list.
i. If you selected any rows, click on the Paste selected button. The dialog will close, and the selected classifications will appear in the Hazard table.
ii. The US and US21 versions of the GHS standard do not include environmental classifications. If you are using either US version and want to include environmental classes, click on the “Classifications shown for GHS” button at lower left on the Multi-select dialog, and select one of the other versions (for example, UN revs. 3-9, EU, or GB).
iii. Because you can select and paste classifications from just one GHS version at a time, you will need to reopen the dialog to paste additional classification(s) from another GHS version.
iv. If you don’t find any classifications that you want to add, click on the Cancel button to close the Multi-select dialog.
v. If you would like to select (or view) GHS classifications that are associated with the components, click again on the Multi-select button, and select "Component GHS classifications".
Multi-select dialog, "Component GHS classifications" option.
7. On the other hand, if you did select one or more GHS classifications to add to the Hazard table, then click on the Regenerate button (rotating arrows icon).
"Regenerate" options dialog.
8. Accept the default settings on the “Select hazard items…” dialog. Click on the OK button. The program will place the H-/P-statements and pictograms normally associated with the selected hazard classifications into the Hazard table.
"Regenerate" confirmation dialog.
9. Click on the Check button on the confirmation dialog to determine if there are any significant concerns or anomalies. For example, you might have H-statements, P-statements, and/or pictograms that are redundant and should not be used together (the Check button on the SDS form itself also performs this same function.)
10. Other hazards (not resulting in classification) (required if other hazards exist) — If the product has hazards that are not covered by GHS classifications for the product as a whole, describe them here.
· Examples include incidental release of air contaminants, and risks of dust explosion, suffocation, and freezing (refer to the UN guidance on "Other hazards...").
· For EU/EEA and GB SDSs, additionally identify other potential hazards (cross-sensitization, odor/taste, and ozone; refer to the second paragraph of the EU guidance on "Other hazards").
· For EU/EEA and GB SDSs, additionally indicate whether the product is persistent, bioaccumulative or toxic (PBT), or very persistent and very bioaccumulative (vPvB) under the criteria of EU REACH Annex XIII.
· For EU/EEA SDSs, additionally identify products (and components at or above 0.1 percent concentration in mixtures) that:
· Are persistent, bioaccumulative or toxic (PBT), or very persistent and very bioaccumulative (vPvB).
· Appear on the Candidate List of Substances of Very High Concern (SVHC) for Authorization, based on having endocrine disrupting properties.
· Meet the criteria for endocrine disruption in either of two regulations: (EU) 2017/2100 and (EU) 2018/605.
11. “For mixtures with ingredient(s) of unknown acute toxicity…” (required for CA, CA22, US, US21 when applicable) — A statement of unknown acute toxicity may be appropriate if one or more ingredients of unknown acute toxicity are present at or above a cut-off concentration of 1 percent. If you check-marked one or more items in the Component table (Tab “3 Composition”) as “Ac tox unkn”, then read these details (below).
12. Next, click on the “4.1 First aid” tab.
Managing help
· If this help window opened automatically when you started the program, then you have automatic help turned on. To change automatic help, click on the “Auto-help is” on/off pushbutton, on this window.
· When automatic help is off, you can display or refresh this help window manually, by using the [Ctrl]-9 shortcut (“Background for this section”).[3]
· To get an overview:
o Take the Brief tour on how the SDS entry form works:
§ Entering SDS content
§ Navigating the form
§ Shortcuts and convenience features
§ Translation features
§ Generating the SDS and GHS labels
To start the tour, click on the Help button and select “Brief tour”.
o Watch the video on this tab (click on the Video button, if the label is in blue text).
o Navigate to Tab "1 Identification" and view or refresh the background help. Read the section, “Features common to most SDS form sections/tabs”.
· For brief tips, hover with your mouse over the object of interest.
· To get assistance on a particular field: Click into the field, then click on the Help button, and select “Guide this item” (shortcut: [Ctrl]-5).
· To get stepwise assistance for all areas on this tab: Click on the Help button and select “Guide this section” (shortcut: [Ctrl]-6).
· To learn additional details and requirements, including guidance from regulatory agencies (US-OSHA, UN, EU, and Health Canada) read the details section, below.
SDS Section 2 (Tab "2 Hazards") — details
Contents
Adding pictograms, H-statements, and P-statements individually
H- and P-statements requiring completion
Translation of Hazard table entries
Update (narrow rectangular button, no label, adjacent to the “GHS version” button)
Class acc to (field with drop-down menu)
Signal word (button and field with drop-down menu)
Regenerate (button with circular arrows)
Move (Up “^”, and down “v” buttons)
Other hazards (not resulting in classification) (field)
For mixtures with ingredient(s) of unknown acute toxicity, statement of percentage(s) (field)
Section 2: Hazard(s) Identification
A4.3.2 SECTION 2: Hazard identification
A4.3.2.1 Classification of the substance or mixture
A4.3.2.2 GHS label elements, including precautionary statements
A4.3.2.3 Other hazards which do not result in classification
2. SECTION 2: Hazards identification
2.1 Classification of the substance or mixture
Item 2: Hazard Identification:
I. Section 2 features
For information on items common to most areas of the SDS entry form, refer to the "Background for this section" item in the Help button menu, when viewing SDS Tab "1 Identification".
SDS entry form, “2 Hazards” tab, showing the Hazard table.
Hazard table
The Hazard table contains codes and phrases identifying the hazards and warnings associated with your product, within the GHS framework: classifications, pictograms, hazard (H-) statements, and precautionary (P-) statements. These items will appear on the generated SDS, and on generated GHS labels.
If you identify other hazards of the product that are not covered by standard GHS matrix of classifications, H-statements and P-statements, you can identify them in the Other hazards (not resulting in classification) field, discussed below.
Editing
The Hazard table has its own set of “table” tabs, for Classification, Pictograms, Hazard statements, and Precautionary statements.
Columns with a gray-and-white scheme are for display only. For example, on the table’s “Classification” tab, you cannot edit the “Description” column, because the GHS version of the SDS determines the content of the classification statement.
Color columns (beige and white) can be edited by clicking into individual cells. For example, the “Description (click translate)” column is editable, for use as a non-English translation of the “Description” column contents.
Adding GHS classifications
There are three basic ways of adding GHS classifications to the Hazard table:
· Clicking on the Suggestions button, and then using the “Suggestions...” dialog to insert recommended health hazard classifications;
· Selecting classifications from the Select one button (“Classifications” table tab); or
· Selecting classifications from the Multi-select button (“Classifications” table tab).
Each of these methods for adding GHS classifications can also automatically add the H-statements, P-statements, and pictograms that normally are associated with the classifications. Additionally, you can enter H-statements and P-statements and pictograms individually.
Suggestions (button)
Clicking on the Suggestions button generates a report on the screen (the "Suggestion report"). For health-related classification recommendations, the report considers:
· Component hazards, from the "Hazards 1" tab of the linked[4] Substance record;
· Component physical properties, from the "Phys-chem props" tab of the linked Substance record;
· Component acute toxicity estimate (ATE) measurements, from the "Toxicological table" tab of the linked Substance record (the numbers appearing above the table, rather than in the table itself);
· Component concentrations, from the “3 Composition” tab of the SDS; and
· Product physical properties, from the “9 Phys-chem props” tab of the SDS.
If you have already entered the product components and the product physical properties, clicking on the Suggestions button is the easiest way to complete the Hazard table.
The program will display a “Suggestions…” dialog containing a report with recommendations:
Suggestion report, for adding health-related classifications.
Clicking on the Add health hazards button will place the suggested health-related classifications into the Hazard table.
· The program makes classification recommendations using the classification descriptions of UN GHS rev. 7[5]. If you check the box, "Convert recommended classification(s) to the SDS GHS version, if needed/possible.", the program will convert the recommended classifications to the GHS version you have selected for the SDS, if possible and as needed. This box is checked by default.
· If you check the box, "Also add corresponding H-/P-statements, pictograms, and acute toxicity estimates (ATEs)", the program will add H-statements, P-statements, and pictograms appropriate for the selected GHS classification. It will also place the results of acute toxicity estimates for the mixture ("ATEmix") into the Acute toxicity field, on the "11.1 Toxicological" tab[6]. This box is checked by default.
· The program will enter a Signal Word above the table (“Warning” or “Danger”, depending upon whether “Danger” is associated with any of the health classifications the analysis recommends).
· The Suggestion report identifies potential physical and environmental hazards based on individual component characteristics, but does not make recommendations for the product itself. Typically, physical hazards require testing of the product as a whole, and environmental hazards require a review of existing studies or other expert evaluations.
· If you already have GHS classifications for the product that are based on either testing or bridging principles, then you should enter those classifications manually (using the Select one or Multi-select buttons), rather than using the Suggestions button.
Acute toxicity determinations
The Suggestion report recommends an acute toxicity classification for a mixture-type product using:
1) The concentrations of "relevant"[7] components, from the Hazard table on SDS Tab "3 Composition"; and
2) Either:
· Point values from a lookup table, based on the acute toxicity classifications for individual components, as entered on the "Hazards 1" tab of the linked Substance record for the component; or
· Measured toxicity values for the individual components (e.g., LD50, LC50), as entered on the "Toxicological table" tab of the linked Substance record
Component acute toxicity measurements (on the "Toxicological table" tab of the linked Substance record).
If measured values are present for a component, the program will use those values in preference to acute toxicity classifications.
The report calculates an acute toxicity point estimate for the product as a whole (ATEmix), using one of two equations:
· For components with unknown acute toxicity totaling less than 10 percent
ATEmix = 100 / ∑ (Ci/ATEi)
· For components with unknown acute toxicity totaling at or above 10 percent
ATEmix = (100-∑ Cunknown)/ ∑ (Ci/ATEi)
In these equations, Ci is the concentration for any individual component. Cunknown is the concentration of a component with unknown acute toxicity. ATEi is the toxicity point value or experimental measurement for a component. The report performs the calculations separately for the different routes of exposure (oral, dermal, inhalation of gas, inhalation of vapor, and inhalation of dusts-mists).
Lookup tables then enable the program to identify the appropriate acute toxicity classification for each route of exposure, from the calculated ATEmix values.
Where the Suggestion report has performed acute toxicity calculations of this type, the ATEmix values appear in the summary section at the top of the report. Details of the calculations, including intermediate values, appear further down, in the body of the report.
If the user checks the second box on the "Suggestions…" dialog ("Also add corresponding H-/P-statements, pictograms, and acute toxicity estimates (ATEs)"), the program will place the calculated ATEmix values into the Acute toxicity field, on the "11.1 Toxicological" tab.[8]
Select one (button)
When the “Classification” table tab is displayed, the Select one button permits you to manually add individual GHS classifications to the Hazard table.
You must be on the "Classifications" table tab to add GHS hazard classifications using the Select one button. The same button instead adds individual pictograms, hazard statements, or precautionary statements on the other, corresponding table tabs.
Adding a GHS hazard classification from the “Select one” button.
When you select a classification, the program will offer to add the H-statements, P-statements, and pictograms that are normally associated with the classification.
Add corresponding items dialog (after adding a GHS classification).
If you accept the offer, you should then see the corresponding H-statements, P-statements, and pictograms on the other Hazard table tabs. To insert the corresponding hazard items without first viewing the confirmation dialog, hold down the [Alt] key while double clicking on a classification from the Select one button menu.
Multi-select (button)
The Multi-select button presents either (1) a list of all classifications for available in the GHS version of the SDS; or (2) a combined list of GHS classifications for the individual components of the SDS.
You can add multiple classifications to the Hazard table, by clicking on the first one, then [Shift]-clicking or [Ctrl]-clicking on others (depending on whether or not the additional classifications are in adjacent rows).
“Multi-select” dialog, for choosing GHS hazard classifications.
You can narrow the list by searching on a phrase or partial phrase in the “Find text” quick search box (upper left). In the illustration, the user has typed “tox”, so only classifications containing that combination of letters will appear. When the “Include H, P statements and pictograms” box is checked, the program will add those items for the selected classifications, when you click on the Paste selected button.
It’s also possible to view/add classifications that are not part of the GHS version of the SDS. Clicking on the Classifications shown for GHS button (lower left) displays a pop-up menu of GHS versions. For example, if the GHS of the SDS is the US revision, but you want to add an “Aquatic Acute 1” classification, you would need to switch to another GHS version to find and paste that classification.
By selecting a different GHS version from the button menu, you are not changing the GHS version of the SDS itself. To add classifications from more than one GHS version, use the Paste selected button to add the selected classifications from the first GHS version, and then re-open the dialog to change to the other GHS version, and select relevant items.
Adding pictograms, H-statements, and P-statements individually
The techniques for adding GHS classifications (the Suggestions button, the Select one button, and the Multi-select button) allow you to automatically add the H-/P-statements and pictograms that are normally associated with the selected classification(s).
However, you can also add pictograms, H-statements, and P-statements individually, by going to the "Pictogram", "Hazard statements", and "Precautionary statements" table tabs, respectively. There you can click on the Select one button for adding these items.
Adding a hazard (H-) statement manually, on the “Hazard statements” table tab (Hazard table).
Double-click entry (H-/P-statements only)
For manually adding a single H-statement or a P-statement, you can also double click on an empty row in the table.
This action creates a new row, allowing you to directly enter an H-code or a P-code into a cell, and then tab or click away from the cell for the entry to register. If no empty rows are visible, you can [Alt]-double click on any row to create a new row. These options apply to H-statements and P-statements only, not to classifications or pictograms.
Adding a P-statement by double-clicking on a blank row, then entering the code. (For the “Hazard statements” and “Precautionary statements” table tabs only.)
If you enter an H- or P-statement code into the “Code (reorder)” column that the program recognizes, it will add the corresponding H- or P-statement text into the “Description” column.
Care should be exercised with the double-click entry technique, because it permits you to create your own H- and P- statements on an SDS.
H- and P-statements requiring completion
Editing is necessary for some standard H- and P-statements, which include portions for the user to complete. For example, the following P-statement contains both slash (/) characters and an ellipsis (...), to indicate that the user should make appropriate choice(s) for whom should be contacted:
P304+P312 IF INHALED: Call a POISON CENTER/doctor/.../if you feel unwell.
Customizing P-statements
More generally, it is also possible to customize P-statements from the File menu (File -> “Customize P-statements”). You can in fact create a library of custom statements that will apply to any SDS that you create.
Precautionary (P-) statements customization dialog.
This option is useful for P-statements specifying storage conditions (like P401) and disposal (like P501), where requirements vary for different products. You might have, say, five or six different custom P401 statements, indicating different storage requirements. Other useful applications include response-type P-statements like first aid treatments and fire fighting techniques.
In the upper list of the customization dialog, you can:
· Double-click; or
· Highlight, then click on the down arrow; or
· Click and drag
…a standard P-statement, to copy it from the upper list to the lower list. Then customize the description by clicking into the third column of the lower list (“Your customized precautionary (P-) statement”). You can also enter a translated description by clicking into the fourth column of the lower list (“Non-English, customized P-statement (click translate)”); or translate the third-column (English) description, by clicking on the header of the fourth column.
The next time you create or edit an SDS, if you click on the Select one button on the “Precautionary statements” tab, the customized P-statements will appear in the list, along with the standard P-statements. When you let the program select the appropriate H-/P-statements for the classification(s) that you have chosen, it will prompt you to select among available customized P-statements.
Translation of Hazard table entries
The “Description (click translate)” column holds non-English translations of hazard items (except for pictograms). There are three ways to place translated text into the column:
· Highlight one or more rows in the Hazard table, and select “Standard translation” from the “Description (click translate)” column header.
· Highlight one row in the Hazard table, and select “Custom translation using dialog” from the column header.
· Directly enter non-English text, by clicking into the “Description (click translate)” column.
Standard translation — Hazard classifications
Standard translation of hazard classifications converts the “Description” column contents (English text) into the target (non-English) language. It uses either (1) internal program resources; or (2) when internal resources are not available for a particular language, Custom translation groups (CTGs).
To make use of internal resources, the target language must have an asterisk (*) suffix in the language selection drop-down menu (top right on the SDS form). Because the program uses English text rather than codes to find translations, and the English text varies with different GHS versions, this type of translation may not work in some cases.
To make use of a Custom translation group, you must first create one for the desired language. From the File menu, select “Phase translations” and then click on the “Custom translation groups (CTGs)” tab. There, you can click on the Help button to obtain instructions on CTG creation.
Creating a Custom translation group (CTG). File (menu) -> “Phrase translations” -> “Custom translation groups (CTGs)” tab. SDScribe™currently includes Polish as an example CTG.
Standard translation — H- and P-statements
For a standard translation of H- and P-statements, the program reads the “Code (reorder)” column contents of each highlighted row, and uses the target language from the drop-down menu (top right on the SDS form).
Selecting “Standard translation” from the column header, to convert a hazard (H-) statement into another language for the highlighted row.
Standard translations for H- and P-statements are listed in the Phrase translation section of the program (File menu -> Phrase translations -> “GHS H-/P-statements and signal words” tab).
Standard translations for H- and P-statements, as listed in the Phrase translation section of the program (File menu -> Phrase translations -> “GHS H-/P-statements and signal words” tab).
Where more than one translation record is available for an H-statement or P-statement, you can designate your preferred translation by double-clicking to edit the Phrase translation record, and checking the "...prefer this one for use..." box.
Phrase translation entry form. Where more than one translation record is available for a given H- or P-code, check the box, “If there are other phrase records…” for the translation record you prefer to use.
In the Hazard table, if you want to choose from more than one H- or P-statement translations in the Phrase translations section (where more than one is available), hold down the [Alt] key while selecting “Standard translation” from the column header.
Custom translation and direct entry
Because the program uses GHS codes in the “Code (reorder)” column contents to find standard translations of H- and P-statements, it doesn’t know about (and won’t account for) revisions you may have made in the English “Description” column. In this case, you can either click into the relevant cell in the “Description (click translate)” column to directly enter the translated text, or use the “Custom translation using dialog” option.
For H- and P-statements, you can also add your own standard translation, by creating another Phrase translation record for a particular H- or P-code, and checking it as the one to use (the "...prefer this one for use..." box).
Fallback (on-the-fly) translation during non-English SDS or label generation
If the “Description (click translate)” column is empty for your Hazard table entries, the program will attempt to insert translated text at the time that you generate a non-English SDS or a non-English label. In the case of multiple H- and/or P-statement translations in the Phrase translation section, and without a preferred translation, the program will use the most recent translation. If a translation is not available, then the program will substitute English.
GHS version (button)
Use the GHS version button to select the GHS version/revision that you plan to use for the SDS. Your choice affects the hazard classifications and the associated H-/P-statements and pictograms that can be selected in the Hazard table. Different GHS versions may associate hazard classifications with different H-/P-statements, and/or pictograms.
Selecting a GHS version to use with the SDS.
Default GHS version for a new SDS
If you have selected a default GHS version in Preferences, then when you create a new SDS, the GHS version button initially displays the default you selected. If you have not selected a default GHS, then the program uses the US version. If you are upgrading from an earlier version of SDScribe™, then existing SDSs may not display a GHS (the button will be blank). A blank button indicates a GHS version of “4” (UN rev. 4).
Selecting a default GHS version, in Preferences.
GHS version for individual hazard items (“GHS vers” column)
Each classification, H-statement, and P-statement listed in the Hazard table also displays its own individual GHS version (the “GHS vers” column). Typically, the individual GHS version matches the GHS version for the SDS as a whole. However, you may have entered a hazard classification from another GHS version that cannot be switched to that of the SDS. Classifications from another GHS version appear in orange text.
“GHS vers” column, showing the GHS version used for each row. (Orange text indicates a hazard classification from another GHS version.)
Changing the GHS version of an existing SDS
If you switch to another GHS version, the program may ask whether it should also change the Class acc to drop-down menu (to the right of the GHS version button), to indicate a new regulatory framework (or UN GHS standard) for the SDS.
Request to change the "Classification according to" (Class acc to), above the Hazard table.
In addition, if the Hazard table already contains GHS classifications, H-/P-statements and/or pictograms, the program will present a dialog listing any existing items that are not already associated with the new GHS.
Dialog when switching from one GHS version to another. In this case, the user is switching from UN rev. “6” to "US".
The update may be as simple as changing the “GHS vers” column contents to the newly selected GHS version, if the description remains the same. Some hazard classifications have different descriptions in different GHS versions, so the program will attempt to update them.
Differences among GHS versions affecting conversion
Some GHS versions use a different set of P-statements for the same hazard classification, or include combination P-codes (e.g., “P370+P372+P380+P373”) that are available only as individual P-codes and statements in earlier GHS versions. In addition, some GHS versions also offer more or fewer hazard classifications than others. For these cases, the program might not be able to update some hazard items, and would leave these item(s) in an unconverted state. Unconverted hazard items will appear in orange text.
For example, suppose you selected a hazard classification of “Acute hazards to the aquatic environment (chapter 4.1)” while the GHS version for the SDS was UN rev. 4. Then you switched the GHS version of the SDS to US, which does not include environmental hazards. In this case, the program will not be able to convert the aquatic hazards classification to an equivalent in the US GHS version. Therefore, this classification will retain a GHS version of “4” in the "GHS vers" column, and will appear in orange text.
An option in the confirmation dialog allows you to “Delete and rebuild associated items”. If you check this box, the program will first delete all of the existing H-statements, P-statements, and pictograms, and then rebuild the list of these items to reflect the GHS version for each hazard classification. H-statements, P-statements, and pictograms that you may have added manually (and that are not normally associated with the classifications) will no longer be listed.
If you do not check the “Delete and rebuild associated items” box, the program neither adds new nor deletes existing pictograms, H-statements, and P-statements. In this case, the listed pictograms, H-statements and P-statements may not be the ones normally expected with the new GHS version.
Given the following conditions:
· You check the “Delete and rebuild associated items” box; and
· The “Classification” tab of the Hazard table has classifications from a different GHS version (they appear in orange text); and
· The program is unable to convert these classifications to the new SDS GHS version;
…then the “Hazard statements” and/or “Precautionary statements” tabs may contain unexpected listings (or may be missing expected listings), because the program will add H- and P-statements associated with the individual GHS version of each hazard classification, not the GHS version of the SDS itself. You can find unexpected or missing H- and P-statements using the Check button (discussed below).
You might decide not to update associated items if you have edited H- or P-statements extensively via direct entry into the Hazard table cells; the update will replace your custom descriptions with the standard descriptions.
GHS versions used in particular countries
The United Nations created the GHS specification, and issues new revisions biennially. Individual countries or groups of countries have adopted some portions of the specification and not others (the “building blocks” approach), and/or modified the specification.
For instance, some countries have:
· Aligned their statutes and regulations with different UN GHS revisions (e.g., 4th revision, 5th revision, etc.);
· Added custom hazard classifications that are not part of any UN GHS revision;
· Added non-standard hazard (H-) statements and pictograms;
· Removed some standard GHS hazard classifications;
· Not yet adopted or partially adopted GHS, but have implementation timelines; and/or
· Not yet adopted GHS, but accept GHS-format SDSs and/or labels on a voluntary basis.
Click on the underlined “GHS version” label (next to the GHS version button) to view two lists, of countries and of regions, that have aligned or intend to align their statutes and regulations with one or more GHS versions.[9] This action will direct your web browser to a United Nations website.
Other items
Update (narrow rectangular button, no label, adjacent to the “GHS version” button)
This button attempts to update Hazard table for inconsistencies with the currently-selected GHS version of the SDS. It works as if you had just changed the GHS version of the SDS, but without changing the GHS version.
Class acc to (field with drop-down menu)
Entering text here adds a statement to Section 2 of the generated SDS, in the form:
· "GHS classification in accordance with…” (for UN-format SDSs); or
· “Classification according to…” (for EU-ECHA format SDSs),
...where the legal or regulatory reference you’ve entered or selected appears immediately afterwards.
The program will remove square brackets that may be present as a prefix. For example, if you selected “[US] OSHA (29 CFR 1910.1200, 2012)” from the menu, then the program will use “GHS classification in accordance with OSHA (29 CFR 1910.1200, 2012)” on the generated SDS.
On the UN-format SDS, if there is no text in this field, then the program will skip the statement.
On the EU-ECHA format SDS, if there is no text, the program will default to the EU regulation:
· “Classification according to Regulation (EC) No 1272/2008 (CLP)”
On the EU-ECHA format SDS, the program will also add (in the label elements subsection):
· “Labelling according to Regulation (EC) No 1272/2008 [CLP]”
No GHS hazards (check box)
If you check this box, then none of the classifications, pictograms, H-statements or P-statements you may have added to the Hazard table will appear on the generated SDS form. Instead, the SDS form will indicate:
· "Not a hazardous substance or mixture" (for a UN-style SDS)
· "This product does not meet the criteria for classification in any hazard class according to Regulation (EC) No 1272/2008 on classification, labelling and packaging of substances and mixtures." (for an EU-ECHA style SDS, with “Regulation (EC) No 1272/2008” or with no regulation specified in “Class acc to”.).
· “This product does not meet the criteria for GHS classification in accordance with: <regulation or legal citation>” (EU-ECHA style SDS, with a regulation other than “Regulation (EC) No 1272/2008” specified in “Class acc to”).
Section 2 of the generated SDS, EU-ECHA format, no GHS hazards, with the “Class acc to” field set to “UN GHS revision 7”
Section 2 of the generated SDS, EU-ECHA format, no GHS hazards, with the “Class acc to” field empty. Section 2.3 (Other hazards) will include the same “This product does not meet…” statement, unless you have entered other text.
Section 2 of the generated SDS, UN format, no GHS hazards, with the “Class acc to” field empty.
If you enter information into the field, "Other hazards (not resulting in classification)", located below the Hazard table, then Section 2.3 in the generated SDS will include the information from that field, rather than the "Not a hazardous substance or mixture" statement.
Signal word (button and field with drop-down menu)
For GHS-classified products, the signal word should be either “Danger” or “Warning”, depending upon which GHS classifications you select.
Each individual classification has an associated signal word; you can see this by opening the Multi-select dialog (discussed previously) and examining the second column (“Signal word”). Do any of the classifications you selected have a signal word of “Danger”? If so, you should enter “Danger” for the product. In most other circumstances, the signal word should be “Warning”.
Some GHS classifications do not have a signal word; they would appear as “none” in second column of the Multi-select dialog. If all of your classifications had “none” as a signal word, then you would leave the signal word empty on the entry form.
The Signal word button immediately to the left of the field can enter the appropriate word for you into the field, provided that GHS classifications are already listed in the Hazard table. You can also use the Suggestions button to obtain a recommended Signal word, or click on the Regenerate button, discussed next.
Regenerate (button with circular arrows)
This button adds pictograms, H-statements, and P-statements consistent with the listed classifications in the Hazard table. The program will also select a signal word for the product, based on the most severe of the signal words associated with the individual classifications (either “Danger” or “Warning”).
This button is helpful if you have made manual changes to the classifications (adding or deleting), since the manual actions may result in lists of H-/P-statements and pictograms that are not fully consistent with the classifications.
Check (button)
This button performs a consistency check for items in the Hazard table. It does not make any changes.
· It identifies duplicate classifications, both identical and from the same “family”. An example of a family duplicate would be listings for both skin corrosion and skin irritation.
· It identifies classifications that have descriptions that are inconsistent with the GHS version for the SDS; and identifies classifications that are not part of the GHS version.
· It identifies H-statements, P-statements, and pictograms which are expected from the SDS GHS version and the listed hazard classifications, but which are missing.
· It checks for P-statements that are similar in effect, and if appropriate recommends discarding one or the other.
· It checks for GHS hazard items that are unexpected but nonetheless present.
· It checks for combinations of pictograms that are unadvisable or impermissible under US-OSHA regulations.
As noted earlier, there are circumstances where you might elect to include hazards that are not available in the GHS version you are using for the SDS. For example, you might include an aquatic toxicity classification that is listed for one of the UN GHS revisions, but which is not available under the "US" or “US21” versions.
Potential issues report (from clicking on the Check button).
Move (Up “^”, and down “v” buttons)
You can change the order of appearance for items in the Hazard table, by clicking once on the row to select it, and then using these buttons to move the row up or down, relative to the others. You can also click on the “Code (reorder)” column header to change the order of all items, with an alphanumeric sort of all listed items.
Delete (“trash can“, button)
Click to delete one or more items from the Hazard table. A pop-up menu will appear, offering the choices to “Delete selected hazard items”, “Delete all H-, P-stmts, and pictograms”, or to “Delete all hazard items”. To delete selected hazard items, the row(s) you wish to delete must be highlighted before you click on the button. You can highlight adjacent rows by [Shift]-clicking on them. To select non-adjacent rows, use a [Ctrl]-click for each added row.
General hazard statement (for items not regulated under SDS requirements, such as Articles) (field) –
Text entered into this area will appear at the top of Section 2 on the generated SDS, under the heading "General Hazard Statement".
Some products are specifically exempted from SDS requirements, such as manufactured articles under US-OSHA rules. However, you might still wish to create another type of SDS, a Product Safety Data Sheet (PSDS), to inform your customers of potential hazards of the product. In this case, check the Product Safety Data Sheet (PSDS) box, on tab “1 Identification” of the SDS form.
Here is an example paragraph that might be used in this field, for a metallic product:
Solid metallic products are generally classified as 'articles', and do not constitute a hazardous material in solid form under the definitions of the OSHA Hazard Communication Standard (29 CFR 1910.1200). Any articles manufactured from these solid products would be generally classified as non-hazardous. However, some hazardous elements contained in these products can be emitted under certain processing conditions, such as but not limited to: burning, melting, cutting, sawing, brazing, grinding, machining, milling, and welding. Products in the solid state present no fire or explosion hazard. Small chips, fines, and dust may ignite readily, though. The following classification information is for the hazardous elements that may be released during processing.
Other hazards (not resulting in classification) (field)
If the product has hazards that are not covered by GHS classifications for the product as a whole, describe them here. These might include (UN GHS 7 guidance):
· Release of air contaminants during hardening or processing;
· Dust explosion hazards;
· Suffocation;
· Freezing;
· Environmental effects such as hazards to soil-dwelling organisms.
To this list, for EU/EEA and GB SDSs, the EU guidance adds:
· Cross-sensitization;
· High potency for odor and taste;
· Photochemical ozone creation potential;
· Information on whether the product is persistent, bioaccumulative or toxic (PBT), or very persistent and very bioaccumulative (vPvB) under the criteria of EU REACH Annex XIII.
To this list, for EU/EEA SDSs, additionally identify products and components (at or above 0.1 percent concentration in mixtures) that:
· Are persistent, bioaccumulative or toxic (PBT), or very persistent and very bioaccumulative (vPvB).
· Appear on the Candidate List of Substances of Very High Concern (SVHC) for Authorization, based on having endocrine disrupting properties.
· Meet the criteria for endocrine disruption in either of two regulations: (EU) 2017/2100 and (EU) 2018/605.
Sample statements for this field might include:[10]
· "Substance meets the criteria for vPvB and PBT according to Regulation (EC) No 1907/2006, Annex XIII"
· "Substance identified as having endocrine disrupting properties according to Regulation (EU) 2017/2100"
For mixtures with ingredient(s) of unknown acute toxicity, statement of percentage(s) (field)
Enter a statement into this field for a Canadian or US-OSHA SDS if:
· The product is a mixture and has been GHS-classified as acutely toxic by one or more of the routes of exposure (oral, dermal, and/or inhalation); and
· The product classification is based on the concentrations and classifications of the ingredients of known acute toxicity (through the calculation of “Acute toxicity estimates”, or ATEs), and not on testing of the product as a whole; and
· You have marked one or more ingredients in the Component table (Tab “3 Composition”) as "Ac tox unkn" (as in "Acute toxicity unknown"); and
· These “unknown” ingredient(s) are individually present in the mixture at level(s) of one percent or greater; and
· The “unknown” ingredients could contribute to the acutely toxic classification of the product through the same route(s) of exposure as the product itself.
The statement should be of the form,
X percent of the mixture consists of ingredient(s) of unknown acute toxicity.
The "X" represents the total concentration of ingredients of unknown acute toxicity.
If there is more than one route of exposure for the product, then the statement should include the route of exposure with the highest sum of unknown ingredients contributing to one of the routes. You can also make individual statements for each route of toxicity, if there is more than one route. For example:
· X% of the mixture consists of ingredient(s) of unknown acute oral toxicity.
· X% of the mixture consists of ingredient(s) of unknown acute dermal toxicity.
· X% of the mixture consists of ingredient(s) of unknown acute inhalation toxicity.
For more information on the unknown acute toxicity statement, refer to:
· Appendix A to 29 CFR §1910.1200, Item A.1.3.6.2.3
· Appendix C to 29 CFR §1910.1200, Item C.3.3
· Appendix D to 29 CFR §1910.1200, Table D-1, "Minimum Information for an SDS", Item 2(e)).
· OSHA letter of interpretation, March 24, 2015
II. OSHA guidance
From: “OSHA Brief: Hazard Communication Standard: Safety Data Sheets”
Section 2: Hazard(s) Identification
This section identifies the hazards of the chemical presented on the SDS and the appropriate warning information associated with those hazards. The required information consists of:
1. The hazard classification of the chemical (e.g., flammable liquid, category).
2. Signal word.
3. Hazard statement(s).
4. Pictograms (the pictograms or hazard symbols may be presented as graphical reproductions of the symbols in black and white or be a description of the name of the symbol (e.g., skull and crossbones, flame).
5. Precautionary statement(s).
6. Description of any hazards not otherwise classified.
7. For a mixture that contains an ingredient(s) with unknown toxicity, a statement describing how much (percentage) of the mixture consists of ingredient(s) with unknown acute toxicity. Please note that this is a total percentage of the mixture and not tied to the individual ingredient(s).
For additional guidance on hazard identification, refer to Appendix C to Section 1910.1200 (Allocation of Label Elements).
III. UN guidance
From: United Nations (2017). Globally Harmonized System of Classification and Labelling of Chemicals (GHS), Seventh Revised Edition. https://unece.org/ghs-rev7-2017. United Nations. Reprinted with permission.
A4.3.2 SECTION 2: Hazard identification
This section describes the hazards of the substance or mixture and the appropriate warning information (signal word, hazard statement(s) and precautionary statement(s)) associated with those hazards. The section should include a brief summary/conclusion of the data given as described in A4.2.4.3.
A4.3.2.1 Classification of the substance or mixture
A4.3.2.1.1 This sub-section indicates the hazard classification of the substance or mixture.
A4.3.2.1.2 If the substance or mixture is classified in accordance with Parts 2, 3 and/or 4 of the GHS, generally the classification is communicated by providing the appropriate hazard class and category/subcategory to indicate the hazard (for example, flammable liquid Category 1 and skin corrosive, Category 1A). However, when classification is differentiated within a hazard class and results in unique hazard statements, then the classification should also reflect that differentiation. For example, the route of exposure differentiates the acute toxicity classification as follows: acute oral toxicity Category 1, acute dermal toxicity Category 1 and acute inhalation toxicity Category 1. If a substance or mixture is classified into more than one category in a hazard class that is differentiated, then all classifications should be communicated.
A4.3.2.2 GHS label elements, including precautionary statements
A4.3.2.2.1 Based on the classification, provide the appropriate label elements: signal word(s), hazard statement(s) and precautionary statement(s).
A4.3.2.2.2 Pictograms (or hazard symbols) may be provided as a graphical reproduction of the symbols in black and white or the name of the symbol, e.g. “flame”, “skull and crossbones”.
A4.3.2.3 Other hazards which do not result in classification
Provide information on other hazards which do not result in classification but may contribute to the overall hazards of the material, for example, formation of air contaminants during hardening or processing, dust explosion hazards, suffocation, freezing or environmental effects such as hazards to soil-dwelling organisms. The statement “May form explosible dust-air mixture if dispersed” is appropriate in the case of a dust explosion hazard.
IV. European Union guidance
From: "COMMISSION REGULATION (EU) 2020/878 of 18 June 2020, amending Annex II to Regulation (EC) No 1907/2006 of the European Parliament and of the Council concerning the Registration, Evaluation, Authorisation and Restriction of Chemicals (REACH)”. Official Journal of the European Union, 26.6.2020.
2. SECTION 2: Hazards identification
This section of the safety data sheet shall describe the hazards of the substance or mixture and the appropriate warning information associated with those hazards.
2.1 Classification of the substance or mixture
The classification of the substance or the mixture which results from the application of the classification criteria in Regulation (EC) No 1272/2008 shall be given. Where the supplier has notified information regarding the substance to the classification and labelling inventory in accordance with Article 40 of Regulation (EC) No 1272/2008, or has provided that information as part of a registration pursuant to this Regulation, the classification given in the safety data sheet shall be the same as the classification provided in that notification or registration.
If the mixture does not meet the criteria for classification in accordance with Regulation (EC) No 1272/2008, this shall be clearly stated.
Information on the substances in the mixture is provided under subsection 3.2.
If the classification, including the hazard statements, is not written out in full, reference shall be made to section 16 where the full text of each classification, including each hazard statement, shall be given.
The most important adverse physical, human health and environmental effects shall be listed in accordance with sections 9 to 12 of the safety data sheet, in such a way as to allow non-experts to identify the hazards of the substance or mixture.
2.2 Label elements
Based on the classification, at least the following elements appearing on the label in accordance with Regulation (EC) No 1272/2008 shall be provided: hazard pictogram(s), signal word(s), hazard statement(s) and precautionary statement(s). A graphical reproduction of the full hazard pictogram in black and white or a graphical reproduction of the symbol only may be substituted for the colour pictogram provided in Regulation (EC) No 1272/2008.
The applicable label elements in accordance with Article 25(1) to (6) and Article 32(6) of Regulation (EC) No 1272/2008 shall be provided.
2.3 Other hazards
Information shall be provided on whether the substance meets the criteria for persistent, bioaccumulative and toxic or very persistent and very bioaccumulative in accordance with Annex XIII, whether the substance was included in the list established in accordance with Article 59(1) for having endocrine disrupting properties, and whether the substance is a substance identified as having endocrine disrupting properties in accordance with the criteria set out in Commission Delegated Regulation (EU) 2017/2100 (3) or Commission Regulation (EU) 2018/605 (4). For a mixture, information shall be provided for each such substance that is present in the mixture at a concentration equal to or greater than 0,1 % by weight.
Information shall be provided on other hazards which do not result in classification but which may contribute to the overall hazards of the substance or mixture, such as formation of air contaminants during hardening or processing, dustiness, explosive properties which do not fulfil the classification criteria of part 2 Section 2.1 of Annex I to Regulation (EC) No 1272/2008, dust explosion hazards, cross-sensitisation, suffocation, freezing, high potency for odour or taste, or environmental effects like hazards to soil-dwelling organisms, or photochemical ozone creation potential. The statement “May form explosible dust-air mixture if dispersed” is appropriate in the case of a dust explosion hazard.
V. Health Canada guidance
From: "Technical Guidance on the Requirements of the Hazardous Products Act and the Hazardous Products Regulations, WHMIS 2015 Supplier Requirements", Cat.: H129-64/1-2016E-PDF. December 2016. ©2016, Her Majesty the Queen in Right of Canada, as represented by the Minister of Health. The acronym "HPR" refers to the Canadian Hazardous Products Regulations. The acronym "HCS 2012" refers to the (US) OSHA Hazard Communication Standard, as updated in 2012 for GHS compatibility.
For the most recent guidance (2024-04-29), search for “Item 2: Hazard identification” in Guidance on the WHMIS supplier requirements.
Item 2: Hazard Identification:
Note that in the HCS 2012, the heading for this item is “Hazard(s) identification”. This section identifies the hazards of the product and the information associated with those hazards. The information elements provided on the label related to hazard communication must be provided in this section along with some additional information. The required information consists of:
· The hazard classification of the product (e.g., Flammable Liquid - Category 1)
· Signal word (if applicable)
· Hazard statement(s) - May be combined (refer to subsection 3.2(3) of the HPR)
· The symbol(s) representing the hazard(s). Either the name of the symbol (e.g., skull and crossbones, flame) or the symbol itself may be used. The names of the symbols are set out in Column 1 of Schedule 3 of the HPR. Note that the pictogram(s) may be used instead of the symbol(s).
· Precautionary statements - May be combined or omitted where appropriate (refer to subsections 3.2(1) and (2) of the HPR)
· Supplemental label elements, if applicable, as specified in paragraphs 3(1)(e) and (f) of the HPR:
o Mixtures classified in the Acute Toxicity hazard class that contain ingredient(s) with unknown acute toxicity require a supplemental statement indicating what total percentage of the mixture consists of ingredients of unknown acute toxicity. The route of exposure should be included in the statement.
o Substances and mixtures which, in contact with water, release a toxic gas also require a supplemental statement. Further guidance is provided in the discussion of paragraphs 3(1)(e) and (f) of the HPR.
· Description of any other hazards known to the supplier (e.g., electrical conductance, radioactivity) which did not result in classification.
Classification of the hazardous product: Item 2(a) of Schedule 1 of the HPR (classification of the hazardous product) specifies that, for hazardous products classified in any HPR hazard class other than Physical Hazards Not Otherwise Classified (PHNOC) and Health Hazards Not Otherwise Classified (HHNOC) (Subpart 20 of Part 7 and Subpart 12 of Part 8, respectively), the SDS may disclose either:
o the exact name of the hazard class (as it appears in the HPR), along with the category or subcategory in which the hazardous product is classified, or
o a substantive equivalent of the hazard class name, along with the category or subcategory in which the hazardous product is classified.
Comparison to HCS 2012
This allowance for a substantive equivalent of the hazard class name recognizes that, in the HCS 2012, some hazard classes have a slightly different name. For example, if a hazardous product is classified in Self-Reactive Substances and Mixtures - Type B under the HPR, it would be acceptable to instead disclose “Self-Reactive Chemicals - Type B” under section 2 of the SDS, since the HCS 2012 refers to “Self-Reactive Chemicals”.
For hazardous products classified in PHNOC or HHNOC, the SDS must disclose either the classification (e.g., Health Hazards Not Otherwise Classified - Category 1) or a description of the hazard. This allowance for using a description of a hazard in lieu of the hazard class name is aligned with the HCS 2012, which requires a description of “any hazards not otherwise classified that have been identified during the classification process” (item 2(c) of Table D.1 of the HCS 2012).
[rev. 8.8.2024]
[1] Minimum SDS requirements vary with jurisdiction. In some cases, instead of a burgundy label, a field may include a note identifying particular jurisdiction(s) requiring it.
[2] There is a multi-year phase in for the changes that US-OSHA made to 29 CFR Part 1910 regulations, however. Manufacturers, importers, and distributors of substances have 18 months starting from May 20, 2024; they have 36 months for mixtures. During the phase-in period both the older and newer SDS and label requirements are valid.
[3] This shortcut is equivalent to clicking on the Help button on the entry form, and selecting “Background for this section”.
[4] A “linked” Substance record is one that is associated (1) with an SDS component (listed in the Component table) on Tab “3 Composition”; or (2) with the SDS itself. In this case, the discussion relates to components.
[5] Where relevant, the program will use cut-off concentrations that are based on the GHS revision of the SDS, however.
[6] The program does not insert ATEmix calculation results if the number falls beyond the lowest toxicity category. For example, an ATEmix of 18,000 for the oral toxicity route would not appear in the Acute Toxicity field of Tab "11.1 Toxicological", because the number is greater than 5,000, the upper limit of the lowest toxicity classification, Cat. 5.
[7] A "relevant" component for these calculations has in its linked Substance record an acute toxicity classification or measurement; and a concentration in the product at or above (1) 1 percent generally; or (2) 0.1 percent for component Acute toxicity Cats. 1 or 2 (or Cat. 3 for an EU-ECHA SDS); or any positive percent value, if the user has checked the No thresholds box on the "Toxicological table" tab.
[8] If an ATEmix value does not result in an acute toxicity classification, then it will not appear in the Acute toxicity field. For example, if the calculated ATEmix value for oral toxicity is 15,000, then it is beyond the lowest oral toxicity category (Cat. 5, at 5,000 points or below). Thus, the 15,000 value won't appear in the Acute toxicity field.
[9] We cannot attest to the accuracy of the lists. Regional and national regulations change regularly, so it’s best to check as you prepare an SDS for a new country. You may obtain more current information through a web search, such as “GHS version for Indonesia”, etc.
[10] Guidance on the compilation of safety data sheets, Version 4.0, December 2020. Helsinki: European Chemicals Agency (ECHA), 2020. Section 3.2, SDS Subsection "2.3 Other hazards".