SDS Section 3 (Tab "3 Composition")
Quick start
In this section, you identify the chemical components of the product.
Þ Ensure that you have already entered information on Tab "1 Identification" before continuing here.
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. Substance/Mixture (radio buttons) — If yours is a substance-type product rather than a mixture-type product, click on the Substance button. (Mixture is the default selection when adding a new SDS record.)
2. For substance-type products:
2.1. The Link button at top right should appear as a “Linked” button, indicating that the SDS is already linked to a Substance record (from when you entered a CAS no. or a Subs. name, on Tab “1 Identification”). However, if the button still has a “Link” label, click on it and select “Link SDS to an existing Substance” from the menu. Choose an existing Substance record, or create a new one.
Linking a substance-type SDS to a Substance record.
2.1.1.If you link to an existing Substance record, the program may offer to copy over information concerning physical properties and hazards. Review the items and copy if appropriate.
2.2. Common name (1st); synonyms (field) — Skip for now. These names will appear in a similarly-named column in the Component table, after entering the substance as a new table row. If there is content in the field here, you can remove it.
2.3. Impurities/stabilizing additives (field) — If desired, enter the names and concentrations of any impurities, stabilizing additives and/or fillers. Or you can later create a separate row for each of these items in the Component table, and leave this field empty.
2.4. SCIs, M-factors, and/or ATEs (field) — Skip for now. This information, if available, will appear in a similarly-named column in the Component table, after entering the substance as a new table row. If there is content in the field here, you can remove it.
2.5. Nanoform characteristics (field) — Skip for now. This information, if available, will appear in a similarly-named column in the Component table, after entering the substance as a new table row. If there is content in the field here, you can remove it.
2.6. Formula and Molec. wt. (two fields) — Enter a chemical formula and/or the molecular weight of the product, if relevant.
3. Other statement(s) for Section 3 — Skip for now.
4. Component table — For mixture-type products: add a row for each component. For substance-type products: add a row for the substance itself. For either type product: you can also create individual rows for each impurity, filler, and stabilizing additive.
4.1. Add (button) — click to add a row.
4.2. Name (enter CAS, EC or name) (Component table column) — In the new row, enter a chemical name or other identifier (CAS, EC, UN/NA, or RTECS — including hyphens where appropriate). You can enter a partial name like “isopropyl”, and the program will search for matching Substance records that start with or exactly match “isopropyl”. To search for matching text anywhere within a name, like finding “boro” within “sodium borohydride” or similar, prefix the name with a wildcard asterisk (*), e.g., “*boro”.
Component table (partial view).
4.3. Click or [Tab] away from the cell where you entered the name, and allow the program to link the component to a Substance record. The program may prompt you to select among several potential matches, or (if it finds nothing) ask whether it should create a new Substance record.
Component table, linking a component to a Substance record by entering the name.
4.4. "Add associated items(s) for this component?" (dialog) — If the program prompts you, click on the Add associated items button.
Add associated items, after linking a component to a Substance record.
4.5. Min % / Max % (Component table columns) — For specifying an actual range of concentration (based on production variations), enter the minimum and maximum weight percent for the component. For a single concentration value, enter it in either the Min % or the Max % column; however, use the same column when entering other single-concentration components.
4.6. Min% dsp / Max% dsp (Component table columns) — For specifying a display range of concentrations that will appear on the SDS but which is wider than (surrounds) the actual concentration or actual concentration range, enter the minimum and maximum range values here. You would use this approach (where permitted) to preserve trade secrecy/confidential business information (CBI). Click in the header of the Min% dsp column to select a prescribed concentration range for Health Canada or US-OSHA SDSs; the program will insert the range end values into both columns. To use a display range, in most cases you will also need to insert a Trade secrecy claim statement below the Component table.
4.7. Add other product components — Repeat the steps above in this subsection (from the Add button) for each component, until you have entered all items. If you skipped adding impurities and stabilizing additives to the substance field (above), you can alternatively add rows for each of those items here.
4.8. The column that most closely represents the actual concentration values (Min % or Max %) should have a total close to 100 percent. For the purposes of this quick start, if neither column total is near 100 percent, you may want to adjust the concentrations in one of the columns so that it does.
5. Omit row (Component table column, optional task) — Click on the header for the Omit row column, and select “Suggest using max concentrations…” or “Suggest using min concentrations…”.
Clicking on the “Omit row” column header.
5.1. Select the “min” or “max” option depending upon which concentration column most closely represents the actual product recipe.
5.2. If the program warns that the concentrations do not total to 100 percent, click on the OK button to proceed anyway.
5.3. The program will display an “Omit analysis options…” dialog. Click on the OK button to continue.
Omit component analysis, options dialog.
5.4. The program will display an “Omit component(s) from the SDS - suggestions” dialog. Table rows in green text indicate proposed revisions. You can double-click on individual rows to view the details. If desired, select the green-text rows you wish to update by highlighting them, and then click on the Update highlighted button. Or click on the Update all button to make the proposed revisions for every green-text row.
“Omit component(s) from SDS – suggestions” dialog.
6. Omit haz (Component table column, optional task) — Check this box on any row, to omit its associated GHS hazard classifications and hazard (H-) statements from the generated SDS. The UN and US-OSHA GHS standards do not require component hazards to be listed on the SDS. EU regulations do require the listing of individual component hazards.[2]
7. Conc. Note, Name w/h, Alternative/generic name (Component table columns, optional) — These columns (and the Trade secrecy claim statement, below the Component table) relate to trade secrecy/confidential business information (CBI) claims. The provisions for withholding proprietary information on an SDS vary with the regulatory authority. For additional information, click on the column names (here) to read the details. You may also want to read a blog post, “Withholding confidential business information (CBI) from a safety data sheet”.
8. Next click on the “9 Phys-chem props” 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, starting immediately below.
SDS Section 3 (Tab "3 Composition") – details
Contents
Individual field and object descriptions
Mixture / Substance (radio buttons)
Common name (1st); synonym(s) (for substance-type products)
Impurities / stabilizing additives (for substance-type products)
SCLs, M-factors, and/or ATEs (for substance-type products, EU/EEA requirement)
Nanoform characteristics (substance-type products, EU/EEA requirement)
Formula / Molec. Wt. (substance-type products)
Other statement(s) for Section 3
Hazardous components (check box)
Component table (general comments)
Component table (main column listing)
Classif. Codes, H-codes (click to add new)
SCLs/M-facs/ATEs (required for EU/EEA when available)
SCLs/M-facs/ATEs (click translate)
Nanoform chars (required for EU/EEA if component substance is in nanoform)
Nanoform chars (click translate)
FDA actv purpose (click translate)
Alternative name (click translate)
Common name (1st); syn(s) (click-translate)
A4.3.3 SECTION 3: Composition/information on ingredients
PART A – SDS compilation requirements
3. SECTION 3: Composition/information on ingredients
Item 3: Composition/Information on Ingredients:
Disclosure of HHNOC [Health Hazard Not Otherwise Classified] ingredients on SDSs
I. Instructions for Section 3
· The discussion that follows uses the terms “component” and “ingredient” more-or-less interchangeably.
Overview
In this section you identify whether your product is fundamentally a mixture or a substance. For mixtures, generally you will need to list those components that contribute to the potential hazards of the product, and their concentrations.
Mixture vs. substance
The “3 Composition” tab will display differently depending upon which radio button you choose at the top of the form: “Mixture” or “Substance”.
Both the US-OSHA Hazard Communication Standard (HCS 2012) and the UN GHS Standard define a substance:
Substance means chemical elements and their compounds in the natural state or obtained by any production process, including any additive necessary to preserve the stability of the product and any impurities deriving from the process used, but excluding any solvent which may be separated without affecting the stability of the substance or changing its composition.
And define a mixture:
Mixture means a combination or a solution composed of two or more substances in which they do not react.
By default, when you create a new SDS, the program initially assumes that the product is a mixture rather than a substance. As a result, certain fields that are mostly relevant to substances will be hidden on this tab. If, however, you click on the Substance radio button, the program will reveal the hidden fields.
Appearance of the SDS Composition tab for a product that is a mixture (the default choice).
Appearance of the SDS Composition tab for a product that is a substance (rather than a mixture).
Any information that you enter into these previously-hidden fields will appear on the generated SDS, whether or not you designate the product as a substance. Entry areas below, starting with "Other statement(s) for Section 3" and including the Component table, can be used for either substances or mixtures.
Individual field and object descriptions
Mixture / Substance (radio buttons)
Indicate whether the product is a mixture or a substance. Refer to Mixture vs. substance, above.
If you select "Substance", then the generated SDS will have a subsection label of “3.1 Substances”. If you select "Mixture", then the SDS will have a subsection label of “3.2 Mixtures”.
Common name (1st); synonym(s) (for substance-type products)
(Visible only when the “Substance” button is selected)
For substance-type products, enter a common name and/or chemical synonyms for the product. Conventionally, the common name (if any) should be the first item listed. You can separate the names using carriage returns or semicolons. Avoid using commas, because chemical names frequently contain commas.
The Component table has a column with the same name as this field. If you add the product itself as a row in the Component table, then the program may repeat the common names there as well, leading to redundant information on the generated SDS. Avoid this situation by entering the information in only one place; if you add a Component table row for the product, then remove any common names/synonyms already present here.
Impurities / stabilizing additives (for substance-type products)
(Visible only when the “Substance” button is selected)
For substance-type products, identify GHS-classified impurities, fillers, and/or stabilizers that are present in the product, and which contribute to the classification of the product as a whole.
Impurities and stabilizers can also be entered as individual rows in the Component table. If you decide to list them there, you would not list them here as well.
Impurities and stabilizers do not, in themselves, cause a product to be considered as a mixture. However, if hazardous impurities and/or stabilizers are part of a product that is already a mixture, then add these items as rows in the Component table, rather than here.
SCLs, M-factors, and/or ATEs (for substance-type products, EU/EEA requirement)
(Visible only when the “Substance” button is selected)
For substance-type products, if the product has specific concentration limits (SCLs), multiplying factors (M-factors), and/or acute toxicity estimates (ATEs), then specify them here.
The Component table has a column with a name similar to this field (“SCLs/M-facs/ATEs”). If you add the product itself as a row in the Component table, then the program may repeat the SCLs, M-factors, and ATEs in that column as well, leading to redundant information on the generated SDS. Avoid this situation by entering the information in only one place; if you add a Component table row for the product, then remove any information already present here.
Specific concentration limit
A specific concentration limit (SCL) is an EU regulatory threshold for a GHS-classified substance that is sufficient to classify a mixture containing the substance for the same hazard. It is used in place of a generic cut-off concentration (for any substance with the same hazard class).
SCLs appear in the EU table of “harmonised entries” (Annex VI of Regulation (EC) No 1272/2008), for specific chemicals. For example, 3-(3-biphenyl-4-yl-1,2,3,4-tetrahydro-1-naphthyl)-4-hydroxycoumarin (CAS No. 56073-07-5) has three SCL values, one of which is "STOT RE 1; H372: C ≥ 0,02 %”. The EU generic cut-off concentration for the presence of an STOT RE 1-classified substance in a mixture is 1 percent. Because the SCL value (at 0.02 percent) is lower, however, the threshold for STOT RE 1 classification for a mixture containing this substance would instead be the SCL value.
Multiplying factor (M-factor)
Multiplying (M-) factors are used for substances (components) with GHS classifications of "Aquatic acute 1" or “Aquatic chronic 1", to determine:
1. A cut-off concentration for inclusion of a component in the aquatic toxicity calculations of the mixture. For example, a component with an "Aquatic acute 1” classification and an M-factor of 10 would have a cut-off value of (0.1/10), or 0.01 percent, whereas 0.1 percent is the normal EU cut-off concentration for "Aquatic acute 1”.
2. The aquatic toxicity classification for the mixture as a whole, based on weighted concentrations of the Category 1 components. For example, a component with "Aquatic acute 1" toxicity and an M-factor of 10, with a concentration in the mixture of 2 percent (w/w) would contribute (2 x 10) = 20 percent toward a 25-percent tier for the mixture as a whole to have an "Aquatic acute 1” classification.
Like SCLs, multiplying factors also appear in the EU table of harmonised entries for specific chemicals.
Acute toxicity estimate (ATE)
The acute toxicity estimate for a substance is the dose or concentration that causes death in a studied population of organisms (e.g., LD50 for oral and dermal routes, LC50 for inhalation). Numeric values for ATEs can be entered in fields located above the Toxicological table in a Substance record ("Toxicological table" tab). Some ATEs also appear in the EU table of harmonised entries for specific chemicals.
Acute toxicity estimates (ATEs), in a Substance record.
Acute toxicity estimates for components can be used to estimate the ATE for a mixture (ATEmix), enabling classification of mixture itself for acute toxicity. The program performs these calculations when you click on the Suggestions button (Tab “2 Hazards” on the SDS, for a mixture-type product).
Nanoform characteristics (substance-type products, EU/EEA requirement)
(Visible only when the “Substance” button is selected)
For substance-type products, if the product contains nano-sized particles (nanomaterials), then characterize them here.
The Component table also has a column with a name similar to this field (“Nanoform chars”). If you add the product itself as a row in the Component table, then the program may repeat the nanoform characteristics there as well, leading to redundant information on the generated SDS. Avoid this situation by entering the information in only one place; if you add a Component table row for the product, then remove any information present here.
If the substance is already registered under the EU REACH regulations,[4] and the registration includes nanoform characteristics, then those characteristics should be entered. (The characteristics to be included are described in Annex VI of REACH.)
If the substance is not registered under EU REACH regulations but contains nanoparticles, then enter particle characteristics that have an impact on safety.
Nanomaterials and nanoforms
Nano-sized particles (nanomaterials) have at least one dimension that is less than 100 nanometers (10-7 m). They exist in nature as well as in synthesized (engineered) products.
Annex VI of REACH defines a nanoform as,
“...a form of a natural or manufactured substance containing particles, in an unbound state or as an aggregate or as an agglomerate and where, for 50 % or more of the particles in the number size distribution, one or more external dimensions is in the size range 1 nm-100 nm including also by derogation fullerenes, graphene flakes and single wall carbon nanotubes with one or more external dimensions below 1 nm.”
Nanoform characterization for a substance containing nanomaterials is based on properties such as
· Size distribution
· Shape/morphology
· Chemical surface treatments
· Specific surface area of the particles.
Separating the particles into nanoform “sets” enables evaluation of the individual sets for toxicological and ecological impacts. The European Chemicals Agency (ECHA) has provided nanoform registration guidance documents that detail the methods and results needed for characterization.
A substance may exist both in nanoform and in non-nanoform conditions (with and without nanomaterials present).
Formula / Molec. Wt. (substance-type products)
(Visible only when the “Substance” button is selected)
Enter the chemical formula and molecular weight of the product, if known.
Other statement(s) for Section 3
(The information appears above the Component table in the generated SDS, and has no subsection label.)
If further explanation is desirable concerning the composition or hazards of the product or its components, enter it here.
For example, you might explain an apparent anomaly, such as the product being a mixture but having no items listed in the Component table. Or you might call attention to items you’ve listed for reasons that may not be clear to a reader, such as:
· You are intentionally including all components, whether potentially hazardous or not;
· Components are present above specific concentration limits (SCLs), as listed in the EU table of harmonised entries;
· Persistent, bioaccumulative and toxic (PBT) or very persistent, very bioaccumulative (vPvB) components are present at or above a 0.1-percent cut-off concentration (on the SVHC list or the PBT assessment list;
· Endocrine disrupting components are present at or above a 0.1-percent cut-off concentration (on the SVHC list or the ED assessment list;
· Components are present above a 0.1-percent cut-off concentration that appear on the candidate list of substances of very high concern for authorisation (SVHC list);
· Components are present that have (European) Union workplace exposure limits;
· Components are present that create a health, and/or environmental hazard at their level(s) of concentration in the product, despite not being classified; or despite not exceeding a generic cut-off concentration normally applied to a specific GHS hazard classification/category.
Hazardous components (check box)
Check this box if you would like the word "Hazardous" to prefix the word "Components" as the title above the component listing, in Section 3 of the generated SDS.
Some of the components in a mixture may not be considered hazardous, either because they have no GHS hazard classification or because they are present at too low a concentration to affect the mixture as a whole. If you (perhaps in the spirit of full disclosure) decide to list unclassified components, you may want the label over the list to be "Components" rather than "Hazardous components". In this case, leave this box unchecked.
Component table (general comments)
Component table, “Quick” column view.
In this table you list the individual components of a mixture-type product. For a substance-type product, you would list the substance itself. In either case, you can also add impurities, fillers, and stabilizing additives, each as individual rows.
Table column headers with burgundy text indicate that the content is recommended to generate a substantially complete SDS. Column headers with titles that are underlined perform tasks when you click on them, such as rearranging the rows, checking/un-checking boxes in the rows, or language translation.
The columns that have a beige-and-white color scheme are enterable, whereas the columns with a gray-and-white scheme are non-enterable, for display only. When you want to select a row without editing a cell, either click on the row in a gray-and-white column, or [Ctrl]-click anywhere in the row.
The most straightforward way to add a new component is to click on the Add button (shortcut: [Ctrl]-[Shift]-n).
The table below summarizes editing options for the Component table. The "Single-click mode…" setting in Preferences determines which options are available (the first column in the table). By default, single-click mode is enabled, so the top row is relevant to most users.
Editing content in the Component table
Preferences: “Single-click mode when editing tables” (check box in Preferences)
Edit a cell (must be a beige-and-white column)
Add a row
(a new component)
Remove row(s)
Update/refresh
(update a row to match the same content in its linked Substance record*)
Yes (default)
Click into the cell.
· Click on the Add button; or
· Right-click and select “Add a component to the list”; or
· Double click on an empty row; or
· [Alt]-double click on a gray-and-white column of any row.
· [Ctrl]-click on any row(s) to be removed; and
· Click the remove (“-”) button; or
· Right-click and select “Remove component”.
· Double click on a gray-and-white column in the row to be updated; or
· Right click on a row and select “Refresh components”; or
· Select (highlight) a row and click on the Update button (“Update selected”).
No
Click once into the cell, pause approx. 1 second, and click again (“slow click”).
· Click on the Add button; or
· Right-click and select “Add a component to the list”; or
· Double click on an empty row; or
· [Alt]-double click on any row.
· [Ctrl]-click on any row(s) to be removed; or
· Click the first row, then [Shift]-click adjacent rows or [Ctrl]-click any other row(s); and
· Click the remove (“-”) button; or
· Right-click and select “Remove component”.
· Double click on a gray-and-white column in the row to be updated; or
· Right click on a row and select “Refresh components”; or
· Select (highlight) a row and click on the Update button (“Update selected”).
* The update will not replace content of a cell if the linked Substance record has no content for the cell.
Component table (main column listing)
The following discussion assumes that you have selected Quick as the column view, as shown in the illustration above.
No. (display only)
This column simply represents the row number (order of appearance) for the components in the table.
To move an individual row up or down, highlight the row and then use the "^" and "v" buttons to the left of the table. You can also reorder (sort) all rows by clicking on the column header.
Rearranging (sorting) the rows (components) in the table.
Components can be entered in any order. However, on the final (generated) SDS, the components should appear from highest to lowest concentration: select either "Reverse Min% sort" or "Reverse Max% sort" from the column header, depending upon which concentration column is the most accurate reflection of the actual concentration.
When using the Component table for a substance-type product, enter the substance name as the first row in the Component table. You can then add impurities, fillers, stabilizers, solvents, etc., as additional rows.
GHS (display only)
This column indicates whether a component has GHS hazard information, either in the "Classif. codes, H-codes (click to add new)" column or in the linked Substance record. Key to contents:
· Yes — The "Classif. codes, H-codes (click to add new)" column has content for this row, indicating that classifications and hazard statements for the component will appear on the generated SDS.[5]
· Avail — GHS classifications are listed for the linked Substance record, but the information hasn’t been copied into the Component table. It will not appear on the generated SDS. However, you can copy over the GHS classification codes and hazard (H-) statement codes by right clicking on the row, and choosing “Update component” from the contextual menu.
· No — The "Not GHS Classified" box is checked on the “Hazards 1” tab of the linked Substance record.
· TBD (“to be determined”) — There are no GHS classifications listed on the linked Substance record.
· /no lnk — The component is not linked to a Substance record.
· No lnk — The component does not have a valid link to a Substance record.
If you edit the linked Substance record (for example, by adding GHS hazard classifications), the “GHS” column will not update itself automatically. To refresh the “GHS” and other display-only columns, right click on any row and select “Refresh the display”.[6]
Name (enter CAS, EC, or name)
This column is the basis on which the program links a component to a matching record in the Substances section of the program.
Enter the CAS registry number, the EC number, the beginning portion of the chemical or substance name, or the full chemical name of the component. Entering a CAS or EC number is likely to find fewer Substance records than a chemical name, which makes selecting the right record easier. For a CAS or EC number, ensure that you insert the hyphen separators in the correct locations.
After you click or [Tab] away from the cell, the program will:
· Link the component with a matching record in the Substance section of the program; or
· Prompt you to select among Substance records (when it finds more than one matching record); or
· Prompt you to add a new Substance record (when it finds no matching Substance records).
When you link the component with an existing Substance record, the program may fill some of the other columns for the row:
· Common name (1st); synonym(s)
· CAS, EC, and Index numbers
· INCI names, CSPA dictionary name, FDA name
· Classif. Codes, H-codes
· SCLs/M-facs/ATEs
· Nanoform chars (nanoform characteristics)
Copying associated items from the linked Substance record
Associated items related to the component may be available in the linked Substance record. These items go into other sections of the SDS:
· Exposure levels — to the Exposure limits table on the “8.1 Exposure-protection” tab
· Regulations — to the Regulations table on the “15.1 Regulatory” tab
· Special hazards — “5 Firefighting” tab
· Hazardous decomposition products — “10 Stability-reactivity” tab
· Incompatible materials — “10 Stability-reactivity” tab
· Toxicity[7] — 11.1, 11.2, and 11.3 “Toxicological” tabs
· Ecological toxicity — “12 Ecological” tab
If associated items are available, the program will present a dialog (“Add associated item(s) for this component?”) offering to copy items to other sections of the SDS. You can select among the available items by checking one or more boxes:
Add associated items, after selecting a Substance record for linkage with a row in the Component table.
For paragraph-style content like incompatibilities, firefighting, etc., the program will first ensure that the content to be copied from the Substance is not already located somewhere within the target field on the SDS.
Multiple instances of the same component
A chemical can only appear once in the Component table. If you try to add the same component more than once, the program will offer to add a concentration that you specify to the concentration that is already listed.
“Add to existing component” dialog, when user attempts to add the same component more than once.
Selecting a Substance record to add that is itself a mixture (the “Formulator” dialog)
If you select a Substance record which itself is a mixture, then the program will present the Formulator dialog, in which it separates the Substance into its own component chemicals, and proposes to add these chemicals individually to the product.
“Add mixture components?” (Formulator dialog)
You must indicate the “Concentration in product”, which is the weight percentage of the Substance you selected to add. For example, if the total concentration of the other items in the Component table is presently at 95 percent and you are adding the final item, you would probably want to enter 5 percent.
Multiple-level mixtures
If one or more of the components of the Substance record you selected are also mixtures, then the program will in turn separate those mixtures into their components. The Formulator dialog will display additional breakdown levels, and the calculated result of adding new components and/or adding to existing components.
Copying associated items from linked Substance records
Associated items related to the components added using the Formulator may be available in the linked Substance records. These are items that go into other areas of the SDS.
At the bottom of the Formulator dialog, there are three options for copying associated items to the SDS.:
· “If an ingredient to be added as a new component has Substance-linked exposure levels, add them to Section 8”
· “If an ingredient to be added as a new component has Substance-linked regulations, add them to Section 15”
· “Append relevant content from component Substance fields into the equivalent sections of the SDS”
The “Append” option affects the following areas of the SDS:
o Special hazards — “5 Firefighting” tab
o Hazardous decomposition products — “10 Stability-reactivity” tab
o Incompatible materials — “10 Stability-reactivity” tab
o Toxicity[8] — 11.1, 11.2, and 11.3 “Toxicological” tabs
o Ecological toxicity — “12 Ecological” tab
The program will only copy the related content from the linked Substance record when it is not already present in the target location on the SDS.
Withholding the name of a component
Some regulatory jurisdictions allow the SDS to withhold the true chemical names of components, pursuant to a claim of trade secrecy or confidential business information (CBI). In these cases, you would still include the true names of all components in this column, but either check the “Name w/h” column, or enter a less specific name in the “Alternative/generic name” column. The choice would depend on the regulations of the jurisdiction to which you are distributing the product. For example, for US-OSHA, you would use the "Name w/h" approach, but for Canada and the EU/EEA, you would use the "Alternative/generic name".
NOTE: Using an alternative or generic name requires prior approval for Canada and the EU/EEA.
CAS no.
This column holds the Chemical Abstracts Services (CAS) Registry number for the component. The program may have entered a CAS automatically, when you linked the component to a Substance record.
The program will not verify the accuracy of any changes you make to this column, and will not revise the information in the linked Substance record.
If you wish to change the component to a new substance, you should enter new information into the "Name (enter CAS, EC, or name)" column; or delete the row and add it to the table again.
Updating a component to match the linked Substance record
To update a component to match the linked Substance record, double click on it. Or right click on the row and select "Update component". You can also select (highlight) the row and click on the Update button (rotating arrows icon, below the Add button).
Updating a row in the Component table, with information from the linked Substance record.
Concentration (“<>”, “Min %”, “<>”, “Max %”, “Conc. basis”, “Conc. note”, “Min% dsp”, “Max% dsp”; 8 columns)
Use these columns to specify a concentration or a concentration range of the component in the product. Where regulations require an exact percentage, you can place that number in either the “Min %” column or the “Max %” column, and leave the other percentage columns at zero. Where the regulations allow you to specify a range of concentration, you can use both the “Min %” and “Max %” columns as the lower and upper extent of the range.
If either of the “Min% dsp” or “Max% dsp” columns contain a positive value, then the contents of both of these two columns will appear instead of the “Min %” and “Max %” column values, in Section 3 of the generated SDS. This feature allows you to specify a range of concentration that is larger than (but includes) the actual concentration or concentration range.
Not all jurisdictions allow you to use a “masking” concentration range to withhold the actual concentration or actual concentration range on the SDS; refer to the discussion in Component concentration ranges and regulatory issues, below.
Clicking on the “Min%” or the “Min% dsp” column header when a table row is highlighted enables you to insert a prescribed concentration range, to be used in the respective minimum and maximum columns.
As an option, you can also use a modifier expression like “less than” (<), “greater than” (>), “less than or equal to” (<=), etc. in the modifier columns (titled "< >") that precede both the “Min %” and “Max %” columns.
If either the “Min %” or the “Max %” column for a component has a value of zero (0) percent, then the numeral zero (“0”) will appear on the generated SDS only if you precede it with one of the modifier expressions. The "=" modifier does not itself print when paired with a zero value, but forces a zero value itself to print.
The modifier expressions also apply to the “Min% dsp” and “Max% dsp” columns, when at least one of them contains a positive value.
The “Conc. basis” column allows you to specify whether the concentration or concentration range is based on weight or volume. This information is for display purposes only; calculations and evaluations of component hazards and whether to omit a component from the SDS assume a weight-percent basis.
The “Conc. note” column enables you to add a suffix to a concentration or concentration range. It is useful for claims of confidentiality (trade secrecy/confidential business information), as you can use a phrase like "Proprietary*" or even a simple asterisk (“*”), to indicate the concentration(s) for which you are claiming trade secrecy. (The asterisk would refer the reader to the contents of the “Trade secret statement…” field, located immediately below the Component table.)
The following table provides examples of entered concentration values and how they will appear on the generated SDS.
<>
Min %
<>
Max %
Conc. basis
Conc. note
Min% dsp
Max% dsp
Resulting concentration, SDS Section 3
0
<
90
Weight
0
0
< 90% (weight)
=
0
<
90
Weight
0
0
0 - < 90 % (weight)
32
40
Weight
0
0
32 – 40 % (weight)
32
40
30
50
30 – 50 %
2
4
Volume
0
0
2 - 4 % (volume)
0
0
Weight
Proprietary*
0
0
Not specified, Proprietary*
<
20
Weight
0
0
< 20 % (weight)
<
20
Weight
18
22
18 - < 22 % (weight)
0
>=
50
Weight
0
0
>= 50 % (weight)
Sample component concentration entries and how they will appear on the generated SDS.
Evaluating component concentrations
(the Suggestions button)
SDScribe™ has a Suggestions button on the "2 Hazards" tab, which analyzes product components and makes recommendations for possible GHS classifications of the product.
The program considers each component concentration, and the GHS hazard classifications from the component’s associated Substance record. It then suggests possible GHS hazard classifications for the overall product.
If you have entered both lower and upper concentrations into the Min % and Max % columns in the Component table, then the Suggestions analysis will use the upper concentration. In general, the hazard classification process for the SDS should consider the most hazardous concentration likely to occur for each component in the product.
If a component concentration is less than 1 percent ("<1%"), then the Suggestions analysis will assume a value of 0.99 percent for the calculations; if the concentration is less than 0.1 percent ("<0.1%"), then the analysis will use 0.099 percent.
Component concentration ranges and regulatory issues
United States
US-OSHA SDS requirements currently allow you to specify a range of concentration:
· Where there is batch-to-batch variability in the actual concentration.
· Where the SDS covers a group of "substantially similar mixtures".
· When you have made a claim of trade secrecy for a component, to withhold an actual concentration or an actual concentration range of the component in the mixture.[9] You can use a prescribed concentration range or a smaller range, as long as it includes the actual concentration or actual range of concentrations.
There is no provision to omit concentration entirely; you cannot specify a zero value for component concentration, or include zero in a range of values.
Claiming trade secrecy does not require a claim submission to OSHA or receiving a prior approval from OSHA.
Canada – HMIRA claims
Canada generally requires you to specify the actual component concentration or actual concentration range on the SDS.
However, the Hazardous Materials Information Review Act (HMIRA) enables you to specify a larger range of concentration for each trade-secret ingredient; or to omit the concentration entirely.
To do so, you must file a claim of Confidential Business Information (CBI) with Health Canada. Your submission would include the proposed concentration range. (The claim can also include proposed generic component name(s), to substitute for the actual component names.)
Upon receipt of a claim that it deems to be complete, Health Canada supplies an HMIRA number and the claim filing date, both of which must appear on the SDS (you can enter these items on the “1 Identification” tab). If Health Canada eventually approves the claim, then you must also indicate the date of approval on the SDS. If Health Canada does not approve the claim, then you must either appeal the decision or revise your SDS within a time period that the agency or appeals board specifies.
To have a component concentration appear on the SDS as “Not specified” in SDScribe™, set both the minimum and maximum concentration of the component to zero. You may also want to enter a phrase like “Proprietary*” or “Trade secret*” in the “Conc note” column (discussed below), where the asterisk refers to a claim statement that you place into the “Trade secret statement…” field.
Canada and US-OSHA — Prescribed concentration ranges
Another option for a Canadian SDS (and now also for a US-OSHA SDS) is to use prescribed concentration ranges, where the actual component concentration or concentration range fits within one of the “prescribed” ranges:
Prescribed concentration ranges for components of mixtures (Canada)
a) 0.1 to 1 %
b) 0.5 to 1.5 %
c) 1 to 5 %
d) 3 to 7 %
e) 5 to 10 %
f) 7 to 13 %
g) 10 to 30 %
h) 15 to 40 %
i) 30 to 60 %
j) 45 to 70 %
k) 60 to 80 %
l) 65 to 85 %
m) 80 to 100 %
You can then use the prescribed range on the SDS, rather than the actual concentration or concentration range.
You can select a prescribed range for a component by first clicking on the Component table row, and then clicking on the header of either the “Min %” or the “Min% dsp” column (depending on where you want the range to be entered) to display/select the range from a drop-down menu.
Selecting a prescribed concentration range from the drop-down menu, after clicking on the “Min% dsp” column header.
The range will then appear in the “Min% dsp” and “Max% dsp” columns.
In addition, if an ingredient concentration or concentration range is between 0.1 and 30 percent, but does not fall entirely within a single prescribed range, you can combine two adjacent ranges, using the lower concentration from the lower range, and the upper concentration from the upper range, to define the new concentration range.
The prescribed ranges option would not apply if the actual lower and upper concentrations are outside the range of two adjacent, prescribed ranges.
The use of prescribed ranges does not require a claim submission to Health Canada for confidential business information.
However, you cannot use generic names for one or more components with this option; generic component name use requires that you file a claim with Health Canada.
For either Canada or the US, the SDS must also include a trade secret statement, indicating that the actual concentration or concentration range is being withheld as a trade secret.
EU/EEA and GB
European Union regulations allow the use of concentration ranges, provided they reflect actual variability in the product composition. The EU does not permit the use of concentration ranges to mask an actual concentration or actual concentration range, for purposes of claiming confidential business information.
South Korea
Except for certain regulated hazardous or prohibited chemicals, South Korea allows for the use of concentration ranges that are as much as 20 percent above/below the actual component concentration. However, the manufacturer must first submit a CBI claim (application for non-disclosure) to the Ministry of Employment and Labor (MoEL), prior to submitting the SDS for approval. Upon approval, the MoEL issues an authorization number valid for 5 years, which should appear in Section 3 of the SDS.[10]
Classif. Codes, H-codes (click to add new)
This column contains codes for hazard classifications and hazard (H-) statements, separated by semicolons. These codes represent the hazards posed by the component, initially as listed in the linked Substance record. If you edit the contents manually, be sure that you use the exact hazard classification code or H-statement code; and separate the individual codes with semicolons.
Unless you check the box in the Omit haz column, the contents in this column will appear with its associated component on the generated SDS.
If you enter custom text that the program does not recognize, it will simply pass it on, to be used directly in the generated SDS.
To facilitate the entry of hazard items, you can also click on the column header, and the program will display a dialog of hazard classes and H-statements. Click, [Shift]-click, or [Ctrl]-click to select the hazard item(s) that you want copied into the cell. You must select (highlight) exactly one row in the Component table before clicking on the column header.
Adding hazard classifications for a listed component, by clicking on the “Classif. codes…” column header. The classifications listed will depend on the GHS revision selected for the SDS.
Omit row (check box column)
Checking a box in this column will cause the program to entirely omit the component from Section 3 when it generates the SDS. There will not be an alternative name, generic name, “name withheld”, or any other type of notice — the component simply won't be listed.
You might check this box if:
o You know that the component is non-hazardous. It doesn’t meet criteria for GHS classification, and poses no additional health or environmental hazards; or
o For each of its GHS classifications, the component:
o Has a concentration below the generic cut-off concentration for classifying the product as a whole (for classifications in which cut-off concentrations are applicable); and
o Has a concentration below any specific concentration limit (SCL) for the product and the GHS hazard classification (if one exists); and
o Does not present a health or environmental risk (depending on the classification) below the cut-off concentration.
Checking this box does not remove references to the omitted component that might exist in other sections. For example, you might check the “Omit row” box for ammonium thiosulfate on the “3 Composition” tab, but still have an exposure limit for ammonium thiosulfate on the “8.1 Exposure-protection” tab.[11] Similarly, you might have added a sentence or two regarding eye damage from ammonium thiosulfate, on the “11.1 Toxicological” tab. You must remove those references manually.
Suggestions for components that can be omitted (“omit analysis”)
There are two “suggestion” options available when you click on the header for this column, which can assist you in determining whether to check the “Omit row” box for a component:
· Suggest using min concentrations: Analyzes each component based on its minimum concentration in the product ("Min %" column).
· Suggest using max concentrations: Analyzes each component based on its maximum concentration in the product ("Max %” column)
Omit component suggestions, activated by clicking on the “Omit row” column header, Component table.
Omit component suggestions, options dialog.
To determine whether a component might be suitable to omit, the program attempts to evaluate the following conditions. If any of these conditions are applicable to the component, then the program will recommend that the component appear on the SDS (it should not be omitted).
1. A component is above a generic cut-off concentration for its GHS health and/or environmental classifications.
o Some generic cut-off concentrations are lower when the GHS version of the SDS is set to “EU” or “GB”, compared to the UN settings (3, 4, 5, etc.).
o To perform this evaluation, the “Not GHS classified” box for the linked Substance record must not be checked.
The “Not GHS classified” box, “Hazards 1” tab of a linked Substance record, must not be checked to evaluate generic cut-off concentrations for a component with GHS hazard classifications.
2. A component has one or more acute toxicity estimate values entered (oral, dermal, etc.), on the “Toxicological table” tab of its linked Substance record.
3. A component is check marked as having unknown acute toxicity on the “Toxicological table” tab of its linked Substance record (one or more of the “Unkn” boxes is checked).
Acute toxicity estimate values and unknown acute toxicity checkboxes, “Toxicological Table” tab of the linked Substance record, for an SDS component.
4. A component has one or more acute toxicity estimates entered in the “Specific conc. limits and M-factors (EU CLP)” field, on the “Hazards 1” tab of its linked Substance record.
5. A component has one or more specific concentration limits (SCLs) or multiplying factors (M-factors), in the “Specific conc. limits and M-factors (EU CLP)” field, on the “Hazards 1” tab of its linked Substance record.[12]
“Specific conc. limits and M-factors (EU CLP) field, “Hazards 1” tab of the linked Substance record for an SDS component. This example has three SCL listings and two M-factors (one is slightly off the bottom of the window).
6. A component has one or more (European) Union workplace exposure limits, in the Exposure limits table, on the “Exposure-protection 1” tab of its linked Substance record. (The “Source” column entry for the row(s) must be “EU/OSHA”.)
Union workplace exposure limit, “Exposure-protection 1” tab of the linked Substance record for an SDS component.
7. A component that is present at a concentration of 0.1 percent or higher, and appears on the EU Substances of Very High Concern (SVHC) Candidate List, for reasons of:
o Endocrine disruptive properties; or
o Persistent, bioaccumulative, and toxic (PBT); or
o Very persistent and very bioaccumulative (vPvB); or
o Some other reason.
SVHC listing for a component, “Hazards 2” tab of the linked Substance record.
“Omit analysis” results
The program will display an “Omit component(s) from SDS – suggestions…” dialog, in which each component appears as a row in the table. Rows with green text indicate that the program suggests a change (from “omit” to “do not omit”, or vise-versa, for the component). Rows with black text do not require a change to the component “omit” status.
“Omit component(s) from SDS – suggestions” dialog.
You can double-click on a row to view the current “omit” status, recommended setting, concentration in the product, hazard classification(s), and rationale for the recommended setting. Buttons at the bottom of the form enable you to update highlighted rows with green text, or all rows with green text.
Omit component suggestions, summary dialog. User has double-clicked on the row for sodium bisulfite to view the details.
It is important understand the rationale provided for each “omit” suggestion, and weigh the parameters in light of their relevance for your product’s intended distribution. For example, endocrine disrupting properties for components over 0.1 percent concentration trigger reporting requirements in the EU/EEA, but may not be considerations elsewhere.
Additionally, the program currently identifies components with SCLs and M-factors, but does not actually compare component concentration in the product with these parameters. Barring other factors, a component with a concentration that is below both the generic cut-off and an SCL may warrant omission.
Component concentration levels can impact the “omit” suggestions. If actual component concentrations in the product are much lower than those listed on the SDS (in jurisdictions that allow actual concentrations to be replaced with ranges, for preserving confidential business information), then more components may need to be listed: The presumption is that the highest concentrations in the range you provide dictate the reporting requirements.
Omit haz (check box column)
Checking this box for a row will cause the program to omit GHS classifications and hazard (H-) statements for the component on the generated SDS. This option is not the same as Omit row; the component will still appear in Section 3 of the SDS.
UN and US-OSHA SDS guidance do not specify the inclusion of GHS classifications and hazard statements for components. However, the EU/EEA SDS specifications do require this information, or an explanation if it is not provided (Annex II of REACH, Section 3.2):
3.2.3. For the substances indicated in subsection 3.2, the classification of the substance according to Regulation (EC) No 1272/2008, including the hazard class(es) and category code(s) as provided in Table 1.1 of Annex VI to that Regulation as well as the hazard statements which are assigned in accordance with their physical, human health and environmental hazards, shall be provided. The hazard statements do not need to be written out in full in this section; their codes shall be sufficient. In cases where they are not written out in full, reference shall be made to Section 16, where the full text of each relevant hazard statement shall be listed. If the substance does not meet the classification criteria, the reason for indicating the substance in subsection 3.2 shall be described, such as ‘non-classified vPvB substance’ or ‘substance with a Union workplace exposure limit’.
Here, “substance” refers to the components of a product that is a mixture.
Because the inclusion of classifications and H-statements takes up space on the SDS for a mixture containing many components, we recommend checking the Omit haz box, except in the case of an SDS destined for the EU/EEA and GB regions.
Common name (1st); synonym(s)
Here you can edit existing synonyms for the component, or add new ones. Conventionally, the first name listed should be the common name of the chemical. This column may already contain synonyms from when you linked the component to a Substance record, in the “Name (enter CAS, EC, or name)” column.
As noted earlier, a separate, Common name (1st); synonym(s) field for substance-based SDSs is located above the Component table. To avoid redundant information,
· For mixture-type SDSs, complete this column for each component. Leave the Common name (1st); synonym(s) field above the Component table empty; or
· For substance-type SDSs where you plan to use the Component table, complete this column for the first (substance) row and optionally any additional impurity/stabilizer/filler rows. Leave the Common name (1st); synonym(s) field above the Component table empty; or
· For substance-type SDSs where you do not plan to use the Component table, complete the Common name (1st); synonym(s) field above the Component table.
Suppressing synonyms on the SDS
The "Select SDS generation options…" dialog, which appears just before you generate the SDS, has an option that you can select by checking a box: “Omit component synonyms”. Additionally, selecting the "Compact format" option automatically checks the “omit” box as well.
Option to omit component synonyms on the “Select SDS generation options…” dialog.
For detailed information on these and other options for generating the SDS, refer to the background information on the “Build SDS” tab.
Ac tox unkn (display only)
Indicates if the acute toxicity of a component is unknown, for one or more routes of exposure (oral, dermal, and/or inhalation).
Unknown acute toxicity can be edited from the linked Substance record: Right click on the row and select “Show linked Substance” from the contextual menu (the program may prompt you to save your work on the SDS first). Once you are editing the Substance record, navigate to the “Toxicological table” tab.
Acute toxicity unknown (“Unkn” check boxes located above the Toxicological Table), in the linked Substance record for a component.
SVHC reason (display only)
Content in this column indicates that the component is listed on the EU Substances of Very High Concern (SVHC) Candidate List, and the content represents the reason(s) for being listed.
The displayed information resides in (and can be viewed or edited from) the linked Substance record: Right click on the row and select “Show linked Substance” from the contextual menu (the program may prompt you to save your work on the SDS first). Once you are editing the Substance record, navigate to the “Hazards 2” tab.
The SVHC information does not appear in Section 3 of the generated SDS. However, an SVHC listing may trigger an EU/EEA requirement to include the component on the SDS if present at a concentration at or above 0.1 percent — even if the component does not contribute to a GHS classification for the product as a whole.
SVHC listing for a component, “Hazards 2” tab of the linked Substance record.
SCLs/M-facs/ATEs (required for EU/EEA when available)
If the component has specific concentration limits (SCLs), multiplying factors (M-factors), and/or acute toxicity estimates (ATEs), then specify them here.
As noted earlier, a separate, SCLs, M-factors, and/or ATEs field for substance-based SDSs is located above the Component table. To avoid redundant information,
· For mixture-type SDSs, complete this column for each component. Leave the SCLs, M-factors, and/or ATEs field above the Component table empty; or
· For substance-type SDSs where you plan to use the Component table, complete this column for the first (substance) row and optionally any additional impurity/stabilizer/filler rows. Leave the SCLs, M-factors, and/or ATEs field above the Component table empty; or
· For substance-type SDSs where you do not plan to use the Component table, complete the SCLs, M-factors, and/or ATEs field above the Component table.
For additional information concerning SCLs, M-factors, and ATEs, refer to the discussion under the SCLs, M-factors, and/or ATEs field, above the Component table.
SCLs/M-facs/ATEs (click translate)
Enter the non-English specific concentration limits (SCLs), multiplying factors (M-factors), and/or acute toxicity estimates of the component, to be incorporated into a non-English SDS.
Click on the column header to display the translation dialog, for converting the English-language contents of the “SCLs/M-facs/ATEs” column into the desired language.
Nanoform chars (required for EU/EEA if component substance is in nanoform)
If the component contains nano-sized particles (“nanoparticles” or nanomaterials), then characterize them here.
If the substance is already registered under the EU REACH regulations,[13] and the registration includes nanoform characteristics, then those characteristics should be entered. The characteristics to be included are described in Annex VI of REACH.
If the substance is not registered under EU REACH regulations but contains nanoparticles, then enter particle characteristics that have an impact on safety.
A discussion of nanomaterials and nanoforms appears above.
As noted earlier, a separate Nanoform characteristics field for substance-based SDSs is located above the Component table. To avoid redundant information,
· For mixture-type SDSs, complete this column for each component that contains nanoparticles. Leave the Nanoform characteristics field above the Component table empty; or
· For substance-type SDSs where you plan to use the Component table, complete this column for the first (substance) row, if the substance contains nanoparticles, and any additional impurity/stabilizer/filler rows that contain nanoparticles. Leave the Nanoform characteristics field above the Component table empty; or
· For substance-type SDSs where you do not plan to use the Component table, if the substance contains nanoparticles, complete the Nanoform characteristics field above the Component table.
Nanoform chars (click translate)
Enter the non-English nanoform characteristics of the component, to be incorporated into a non-English SDS.
Click on the column header to display the translation dialog, for converting the English-language contents of the “Nanoform chars” column into the desired language.
My (display only)
A heart symbol in this column indicates that the box “My item” in the component’s linked Substance record is checked; it’s one of your “preferred” substances.
Saf (display only)
Indicates whether the component has an EPA Safer Choice rating. A product carrying a Safer Choice label indicates to potential buyers that EPA scientists consider its ingredients to be safe for human health and the environment, without sacrificing overall product performance. Individual ratings for components appear as symbols in this column:
· Full green circle — ingredient of low concern
· Half green circle — ingredient expected to be of low concern
· Yellow triangle — ingredient has some hazard issues
· Gray square — ingredient is not acceptable
· No symbol — no information (no evaluation is available)
Gsl (display only)
Indicates the component's status (if any) regarding Green Seal verification as a raw material.
Key to abbreviations:
· vC — verified concentrate
· vF — verified formula
· vP — verified parent roll
· vR — verified raw material
· vO — verified other (there should not be any listings of this type)
Cos (display only)
Indicates the European Union cosmetic ingredient (COSING) status for the component. The European Commission maintains an online database of chemicals (CosIng) relevant to cosmetic formulation, based on European Commission regulations and directives. In general, there are three allowed categories for cosmetic components, one restricted category, and one banned category. The symbols in this column are:
· Green spray bottle — allowed components (ingredients, fragrances, colorants, preservatives, and UV filters)
· Yellow spray bottle — restricted components (subject to concentration limits and/or other limitations)
· Red spray bottle — banned components
· No symbol — no information on relevance to cosmetics
P65 (display only)
Indicates whether the component is a listed chemical under California Proposition 65 (“Prop. 65”), which "protects the state's drinking water sources from being contaminated with chemicals known to cause cancer, birth defects or other reproductive harm, and requires businesses to inform Californians about exposures to such chemicals". The symbols in the column are:
· Yellow triangle with exclamation point — component currently listed under Prop. 65
· Blue question mark — component is itself a mixture, which may or may not have ingredients listed under Prop. 65
· No symbol — not currently listed under Prop. 65 (although it may have been de-listed at some point)
Pfl (display only)
Indicates whether the component appears on one or more lists of per- and polyfluoroalkyl substances maintained by regulatory agencies. If the Regulations table for the linked Substance record contains one or more entries where the regulation name contains the letters “pfas”, then this column will display a green “F” symbol inside a rectangle.
Index no.
This column represents the identifier code for the component from Column 1 of Table 3.1, the EU table of harmonised entries, Regulation (EC) No 1272/2008. The program may have entered the code when you linked the component to a Substance record.
You can enter, add to, or replace an existing value. However, the program will not verify the accuracy of your edits, and will not revise the information in the associated Substance record.
EU REACH
This column represents the component’s 18-digit registration number under the EU REACH regulation. If you have registered the component with the European Chemicals Agency (ECHA), then enter the registration number for this component.
REACH (Registration, Evaluation, Authorisation and Restriction of Chemicals) concerns the production and use of chemicals within the EU. Manufacturers and importers of certain substances above 1 metric ton per year must submit a dossier of safe product use, hazard, exposure, risk, and labeling data to the European Chemicals Agency (ECHA).
When you link this component to a record in the Substances section of the program, if the Substance record includes an EU REACH registration number, then it will enter the number here. If you change the EU REACH number on the linked Substance record, the EU REACH number here will not automatically update from the Substance, but you can update the row.
You can enter, edit, or replace a value in this column. However, the program will not verify the accuracy of your edits.
UK REACH
If you have registered this component with the UK Health and Safety Executive (HSE), then enter the 18-digit UK REACH registration number.
Any Great Britain-based entity (in England, Scotland, and/or Wales) intending to manufacture or import a substance into Great Britain at or above one metric ton per year must submit a registration to UK HSE for that substance. "Grandfathering" provisions are available for a certain period of time, to those who hold EU REACH registrations for the same substances.
When you link this component to a record in the Substances section of the program, if the Substance record includes a UK REACH registration number, then it will enter the number here. If you change the UK REACH number on the linked Substance record, the UK REACH number here will not automatically update from the Substance, but you can update the row.
You can enter, edit, or replace a value in this column. However, the program will not verify the accuracy of your edits.
Name w/h
Checking this box will substitute the specific name from the "Name (enter CAS, EC, or name)" column with a placeholder name, "Component x (trade secret)" in the generated SDS. The "x" represents the row number in the Component table (e.g., "Component 3 (trade secret)" for the third listed component). Additionally, the program will omit the CAS number, EC number, and synonyms for the component.
This option is available when you claim trade secrecy under the US-OSHA standards (29 CFR 1910.1200(i)). A trade secrecy claim does not require pre-approval from OSHA. However, you should be prepared to support the claim if asked to do so.
You have the option of withholding the:
"…specific chemical identity, including the chemical name, other specific identification of a hazardous chemical, or the exact percentage (concentration) of the substance in a mixture, from the safety data sheet…" (29 CFR 1910.1200(i)(1).)
You must state on the SDS that the specific chemical identity and/or concentration are being withheld as a trade secret. The Trade secret statement... field (directly below the Component table) serves this purpose.
Trade secrecy notwithstanding, the specific chemical identity and actual concentration must be disclosed to health professionals in certain situations. Also, you must still identify the hazardous properties associated with the component (the contents of the Classif. codes, H-codes… column in the Component table).
Component name substitutions in other SDS sections
The box in the Name w/h column can optionally replace references to the component name in Sections 8, 11 and 12 of the generated SDS. On the "Select SDS generations options…" dialog (appearing just prior to SDS generation), you must check the box, "Substitute for chemical names claimed as trade secrets…" As in Section 3, the name should then appear in these other sections as "Component x (trade secret)".
For detailed information on these and other options for generating the SDS, refer to the background information for the “Build report” tab.
FDA columns - general
The columns (listed below) that have names starting with "FDA" are incorporated into an FDA Drug Facts label. They do not appear on the generated SDS.
The US Food and Drug Administration (FDA) requires over-the-counter (OTC, non-prescribed) drugs and drug-cosmetic products to have Drug Facts label, consisting of active ingredients (active for drug effects only), inactive ingredients, product uses, directions for use, and warnings.
For additional details, click into a cell in the column of interest, and open the Guide window (Help button -> "Guide this item"). You may also want to read the background help on the "FDA label" tab (Help button -> "Background for this section").
FDA name
This column is for the established name of this component, to be used on an FDA Drug Facts label. The established name may be obtained from one of the following sources, in order of preference:
· FDA administrator-designated name (21 CFR 701.30), for specific substances only;
· The International Nomenclature of Cosmetic Ingredients (INCI) name;
· The United States Pharmacopeia – National Formulary (USP-NF) name;
· The Food Chemicals Codex name;
· The common name, or (in the absence of all previous names):
· A chemical name, generally in IUPAC format.
FDA name (click translate)
Enter the non-English established name of this component, to be used on a non-English FDA Drug Facts label.
FDA actv purpose
Enter the purpose for a component that is an active ingredient, to be used on an FDA Drug Facts label.
Entering text here places the component in the "Active ingredients" section of the Drug Facts label. Components with no entry in this column will appear in the "Inactive ingredients" section of the label.
If you are unsure of what purpose to use, you can perform an FDA active ingredient search for other products containing this component; or a SpecialChem search for suppliers of the component.
FDA actv purpose (click translate)
Enter the non-English purpose for a component that is an active ingredient, to be used on a non-English FDA Drug Facts label. This column serves the same purpose as the "FDA active purpose" column, but in another (non-English) language.
FDA potency
For a component that is an active ingredient, enter the strength of the ingredient (relevant to the prescribed dose unit of the product) or the concentration (for products with no dose).
· For products taken orally by the dose, use units of measure that are relevant to the dose units.
As an example, suppose that the recommended dose for an acetaminophen-containing cough syrup is two 5-ml teaspoonfuls every four hours, and the potency of the ingredient in the product is 160 mg per 5-ml teaspoonful.
If you enter "160 mg" in the "FDA potency" column, acetaminophen will appear in the active ingredients list (Drug Facts) as "Acetaminophen 160 mg".
Later, on the "FDA label" tab, you will enter a suffix for the "Active ingredients" title: "5-ml teaspoonful". This suffix will cause the title to become "Active ingredients (in each 5-ml teaspoonful)".
· For products like topical ointments that have a recommended dose, the potency should be in grams per gram of product.
· For products like topical ointments or therapeutic shampoos that have no recommended dose, use the proportion of the ingredient in the product mixture. As an example, a lip balm might contain "White petrolatum 38.5%" and "Avobenzone 2.5%" as active ingredients.
· As a convenience, you can copy concentration information from the "Min %" and/or "Max %" columns by highlighting one or more rows and then clicking on the "FDA potency" column header. Caution should be used with this approach, however, because the Drug Facts box should contain a single concentration value rather than an outer range of values.
FDA may contain
Occasionally you might need to replace one ingredient with another that has similar properties, based on its availability or because you are dealing with a different supplier. Checking this box will place a statement at the end of the list of inactive ingredients. Depending on whether there are one or more ingredients so marked, the note will be:
· (For one ingredient): "* may contain this ingredient"
· (For more than one ingredient:) "* contains one or more of these ingredients"
FDA color
For inactive ingredients that are color additives, check the box in the "FDA color" column. Designation as a color additive allows the program to list the ingredient in Drug Facts box after the other ingredients that are listed.
FDA w/h
For inactive ingredients that you have claimed as confidential (trade secrets), check this box.
· Confidential ingredients do not appear as individual items in Drug Facts. Instead, they appear collectively in one statement at the end of the inactive ingredient list: "…and other ingredients".
· You must obtain approval by submitting a claim to the FDA.
Notes (do not appear on SDS)
This column is strictly for your own use. The contents do not appear anywhere on the generated SDS. You might enter notes to jog your memory about where the component originated: for example, if some of the components are themselves ingredients in other materials, as might occur after using the Formulator. If you are using concentration ranges for purposes of withholding confidential business information, you could enter the actual concentration or concentration ranges here.
Alternative/generic name
Some regulatory authorities outside of US-OSHA permit the use of a less specific name in place of the true chemical name for a component, for Section 3 of the SDS. The permission to do so would be in conjunction with your claim of trade secrecy, for components that are proprietary to your business.
If you have permission to use an alternative/generic name, then enter the name in this column.
For example, suppose the actual component name is "tert-Butyl alcohol", and you select "Tertiary alcohol" as the generic name. The program will list the component as "Tertiary alcohol" in Section 3 of the generated SDS. You should also enter an asterisk or other annotation in the “Conc. note” column, to reference your claim of trade secrecy/confidential business information (which you would place in the Trade secret statement... field, below the table).
Considerations
· For US-OSHA regulations, you should check the “Name w/h” column instead of using an alternative/generic name; skip this column.
· For regulatory agencies using this approach, ensure that the "Name w/h" box is not checked; otherwise, the generated SDS will exhibit the default behavior for substitute names (e.g., "Component 1 (trade secret)", "Component 2 (trade secret)", etc.).
· An entry into this column does not replace the true chemical name in the “Name (enter CAS, EC, or name)” column; you should maintain the true chemical name in that column.
· The program can optionally replace references to the component name in Sections 8, 11 and 12 of the generated SDS. On the "Select SDS generations options…" dialog (appearing just prior to SDS generation), you must check the box, "Substitute for chemical names claimed as trade secrets…” As in Section 3, the alternative/generic name should then appear in these other sections.
o In Section 8, the replacement occurs in the Exposure limits table (on the "8.1 Exposure-Protection" tab). For Section 11, the replacement can occur in one or more of the text fields among the three tabs ("11.1 Toxicological", "11.2 Toxicological", or "11.3 Toxicological"). Similarly, for Section 12, the replacement can occur in one or more of the six text fields on the "12 Ecological" tab.
o Care should be exercised with name substitution in these other sections. You must proofread the substitutions in these sections after generating the SDS, because the program is not able to differentiate partial chemical names from complete names. Further, it will not recognize and then substitute for synonyms of the name.
Agencies/jurisdictions for alternative names
Both Canada and the EU allow the use of generic/alternative name substitutions for components. Unlike US-OSHA, however, they require you to file a claim for exemption from using specific chemical identifiers. The request must include the component name(s) that you propose to use.
Canada
In Canada, you must file a claim for exemption with Health Canada, to preserve Confidential Business Information (CBI) by withholding specific chemical identit(ies) and/or concentrations of one or more components. The agency charges a processing fee for the claim.
When Health Canada deems your application to be complete, it issues an HMIRA registration number and claim filed date under the Hazardous Materials Information Review Act (HMIRA). You can then enter the registration number and filing date on the first tab ("1 Identification"). If Health Canada subsequently approves your claim, enter the approval date on the same tab.
After submission of the CBI claim, Health Canada can still require you to make changes, or (ultimately) to deny the CBI claim. You must then revise the SDS within a time frame specified by the agency or an appeals board.
EU/EEA
The EU requires that you file a request to use a generic name for one or more components, with the European Chemicals Agency (ECHA). You file the claim online, at the agency's web portal. This process also involves creating an account there, if you don't have one already. If the ECHA does not respond to the request within six weeks, then you can assume that your choice of generic chemical name(s) is acceptable. The ECHA charges a processing fee.
For the ECHA to approve the request, the component must not have a community workplace exposure limit from the European Agency for Safe and Health at Work. The component must fall exclusively into one or more of the following hazard classifications:
· Any physical hazard
· Acute toxicity, Cat. 4
· Skin corrosion/irritation, Cat. 2
· Specific target organ toxicity - single exposure (STOT-SE), Cat. 2 or 3
· Specific target organ toxicity - repeated exposure (STOT-RE), Cat. 2
· Hazardous to the aquatic environment, chronic, Cat. 3 or 4
The ECHA also requires that the generic chemical name provide adequate information on the nature of the component for handlers to take suitable health and safety precautions.
Alternative name (click translate)
This column functions in the same manner as the "Alternative/generic name" column, but for a non-English SDS form. If you leave this column empty, then a non-English SDS will use the English generic name, from the "Alternative/generic name" column. Clicking on the column header will cause the program to display the translation dialog, to translate the contents of the "Alternative/generic name" column into another language.
Name (click translate)
This column is for the name of the chemical in a non-English language. You can enter the name manually, or click on the header to translate the English name in the previous column. When you generate a non-English SDS, the program will use this chemical name, if it is available.
Common name (1st); syn(s) (click-translate)
Edit existing synonyms or add new ones in a non-English language, as specified in the upper-right corner of the SDS form. Clicking on the column header when a row is selected allows you to use the translation dialog as an assist for this purpose, provided that an Internet connection is available.
INCI name(s)
Lists one or more names established under the International Nomenclature for Cosmetic Ingredients (INCI) system for the component. The Personal Care Products Council oversees the system. The US, Canada, and EU countries generally require the use of INCI names in the ingredient listings for personal care products.
When the "Use INCI name" box (above the Component table) is checked, the program will attempt to substitute an INCI name for the chemical name, after you enter a CAS number or other identifier into the "Name (enter CAS, EC or name)" column. If more than one INCI name is available for a component, the program will use the first INCI name it finds.
To revise the entries in the "Name (enter CAS, EC, or name)" column to show INCI names, check the "Use INCI name box" and then right-click on the Component table, selecting "Refresh all components" from the contextual menu.
CSPA dict. name
Lists the name of the component as it appears in the Consumer Product Ingredients Dictionary, from the Household & Commercial Products Association. The dictionary is a source for standardized ingredient names. Use of these names fulfills naming requirements under California SB 258, the Cleaning Product Right to Know Act of 2017.
You can use the CSPA dictionary name on the generated SDS, provided you have that name entered in the Synonym table of the linked Substance record.
Right-click on the component row here and select "Show linked Substance". In the Synonym table, add the CSPA dictionary name as a new entry (of type "CSPA dictionary"), if one doesn't already exist. Check the box in the "Use" column of the Synonym table, to indicate that you want to use the CSPA dictionary name as the preferred name. Returning to the SDS component table, click on the Update button (choose either "Update selected" for the highlighted row, or "Update all").
Category (display only)
Indicates the component’s category, if any, from the linked Substance record ("Identification" tab of the Substance entry form).
Category selection, on the Substance entry form.
EC no.
This column represents European Community (EC) number associated with the component. Like the CAS number, the EC number is unique for a particular substance. It represents the merging of three earlier lists,
· European Inventory of Existing Commercial Chemical Substances (EINECS list)
· European List of Notified Chemical Substances (ELINCS)
· No Longer Polymers (NLP) list
You can enter, add to, or replace an existing value. However, the program will not verify the accuracy of your edits, and will not revise the information in the associated Substance record.
M min, M max (2 columns)
These two columns indicate the minimum and maximum molarity of the component in the product. The use of molarity to express the concentration of the component in the product mixture assumes that the product is a dilute aqueous solution.
After entering molarity, you can highlight the component row, then right click to calculate the weight percentage to place in the “Min %” or “Max %” column. To perform this calculation, the program needs the component molecular weight from its linked Substance record (“MW” on the “Phys-chem props” tab), as well as the specific gravity or density (in SI units) of the product (“Density or Sg” field, on the “9 Phys-chem props” tab of the SDS).
Selecting “Set min pct from min molarity”; i.e., calculating the component concentration (w/w) from the molarity, and placing it into the “Min %” column.
Component table controls
Add (button)
Adds a new row to the Component table. The initial name of the (unlinked) component will be "New chemical". Click into the cell to replace the name with the desired CAS registry number, EC number, or chemical name.
You can also add a new row to the Component table by double clicking on a blank row, or [Alt]-double clicking on any row (refer to Editing content in the Component table).
^ and v (buttons)
Changes the order of appearance for components in the list. Click once on a row to select (highlight) it, and then use these buttons to move the row up or down.
Update (button with circular arrows)
"Update" button, with menu.
"Update" button, confirm request dialog.
Dialog, "Update" completed.
Revises selected (highlighted) or all components from their linked Substance records for chemical name, INCI name, identification numbers, acute toxicity, synonyms, and hazard classifications. If the linked Substance record has no contents in a particular field, then the program will not overwrite existing content in the corresponding row.
Checking the "Update supplemental items" box causes the program to update information in other SDS locations based on the individual components' properties, such as exposure levels, applicable regulations, incompatibilities, etc.
The update function is also available by right clicking on a row in the table.
Import-Export (button with horizontal arrows)
Transfers listed components into or out of the program. You can import components from a tab-delimited (“.txt”) file; export components with their associated exposure level information; or export components with their associated toxicity information. The exports are in comma-separated values (“.csv”) format, which is compatible with most spreadsheet programs.
Import-Export button options, Component table.
Delete ("trash can" button)
Removes one or more rows from the table. You must have one or more rows selected (highlighted) to use this function.
Column lock control ("slider" at bottom left on table)
“Freeze” one or more columns on the left, while you scroll horizontally through the remaining columns on the right. Works similarly to a spreadsheet program.
Zoom (magnifying glass icon, upper-right)
View/edit the contents of alphanumeric cells in a larger area (the zoom dialog), similar to the zoom feature on alphanumeric fields. Click once on the cell that you wish to view or edit, and then on this button. If you click on a cell that is non-editable, or which is a yes/no (Boolean) or a numeric field, then the program will present an error message. Because spell checking does not work on table cells, you can use the zoom feature instead to check spelling on these items.
A/A (button pair, upper right)
Enlarge or reduce the font size in the component table.
Slide control (upper right)
Enlarge or reduce the height of the rows.
Trade secret statement, if a specific chemical identity or exact percentage has been withheld (field, beneath Component table)
If you plan to make a claim of trade secrecy/confidential business information for component identities and/or component concentrations, then place a statement here to indicate the nature of the claim and the regulation/statute under which you are making the claim.
To claim trade secrecy for component names and/or for actual concentration under the US-OSHA Hazard Communication Standard (HCS 2012) or Health Canada claim submission process, you must indicate on the SDS that you have made the claim. For Canadian SDSs, you should indicate which component(s) the claim covers.
For the ECHA request process, a trade secrecy statement on the SDS is optional, but is recommended in case an inspector questions the accuracy of your work.
A Compose button (located just above the field) gives you the option of generating a sample claim statement procedurally, for US-OSHA, Health Canada, or the ECHA, in English, French, Italian or Spanish. If relevant information is missing for the claim, the program will inform you of what item(s) may require attention.
For additional discussion relevant to claims of trade secrecy, refer to the Name w/h, the Alternative/generic name, and the Conc. note columns, above.
We cannot guarantee the accuracy of the statement for any particular situation; you must verify its appropriateness. Other countries and other jurisdictions may have their own requirements for trade secrecy claims that these statements might not cover.
II. OSHA guidance
From: “OSHA Brief: Hazard Communication Standard: Safety Data Sheets”, https://www.osha.gov/Publications/OSHA3514.html.
This section identifies the ingredient(s) contained in the product indicated on the SDS, including impurities and stabilizing additives. This section includes information on substances, mixtures, and all chemicals where a trade secret is claimed. The required information consists of:
Substances
· Chemical name.
· Common name and synonyms.
· Chemical Abstracts Service (CAS) number and other unique identifiers.
· Impurities and stabilizing additives, which are themselves classified and which contribute to the classification of the chemical.
Mixtures
· Same information required for substances.
· The chemical name and concentration (i.e., exact percentage) of all ingredients which are classified as health hazards and are:
· Present above their cut-off/concentration limits or
· Present a health risk below the cut-off/concentration limits.
· The concentration (exact percentages) of each ingredient must be specified except concentration ranges may be used in the following situations:
o A trade secret claim is made,
o There is batch-to-batch variation, or
o The SDS is used for a group of substantially similar mixtures.
Chemicals where a trade secret is claimed
· A statement that the specific chemical identity and/or exact percentage (concentration) of composition has been withheld as a trade secret is required.
III. UN guidance
From "Globally Harmonized System of Classification and Labelling of Chemicals (GHS)", 7th Ed., by Secretariat, United Nations Economic Commission for Europe (UNECE). ©2017, United Nations. Reprinted with the permission of the United Nations.
A4.3.3 SECTION 3: Composition/information on ingredients
Identify the ingredient(s) of the product in this section. This includes identifying impurities and stabilizing additives which are themselves classified and which contribute to the classification of the substance. This section may also be used to provide information on complex substances.
NOTE: For information on ingredients, the competent authority rules for Confidential Business Information (CBI) take priority over the rules for product identification. When applicable, indicate that confidential information about the composition was omitted.
A4.3.3.1 Substances
A4.3.3.1.1 Chemical identity of the substance
The identity of a substance is provided by its common chemical name. The chemical name can be identical to the GHS product identifier.
NOTE: The “common chemical name” may, for example, be the CAS name or IUPAC name, as applicable.
A4.3.3.1.2 Common name(s), synonym(s) of the substance
Common names and synonyms should be provided where appropriate.
A4.3.3.1.3 CAS number and other unique identifiers for the substance
The Chemical Abstract Service (CAS) registry number provides a unique chemical identification and should be provided when available. Other unique identifiers specific to a country or region, such as the European Community (EC) number could be added.
A4.3.3.1.4 Impurities and stabilizing additives which are themselves classified and which contribute to the classification of the substance
Identify any impurities and/or stabilizing additives, which are themselves classified and which contribute to the classification of the substance.
A4.3.3.2 Mixtures
A4.3.3.2.1 For a mixture, provide the chemical identity, identification number (within the meaning of A4.3.3.1.3) and concentration or concentration ranges of all hazardous ingredients, which are hazardous to health or the environment within the meaning of the GHS, and are present above their cut-off levels. Manufacturers or suppliers may choose to list all ingredients, including non-hazardous ingredients.
A4.3.3.2.2 The concentrations of the ingredients of a mixture should be described as:
(a) exact percentages in descending order by mass or volume; or
(b) ranges of percentages in descending order by mass or volume if such ranges are acceptable to the appropriate competent national authority.
A4.3.3.2.3 When using a proportion range, the health and environmental hazard effects should describe the effects of the highest concentration of each ingredient, provided that the effects of the mixture as a whole are not available.
NOTE: The “proportion range” refers to the concentration or percentage range of the ingredient in the mixture.
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.
NOTE: Regulation (EC) No. 1272/2008 (referenced herein) incorporated the GHS system into the EU hazardous material regulatory framework.
PART A – SDS compilation requirements
3. SECTION 3: Composition/information on ingredients
This section of the safety data sheet shall describe the chemical identity of the ingredient(s) of the substance or mixture, including impurities and stabilising additives as set out below. Appropriate and available safety information on surface chemistry shall be indicated.
3.1. Substances
The chemical identity of the main constituent of the substance shall be provided by providing at least the product identifier or one of the other means of identification given in subsection 1.1.
The chemical identity of any impurity, stabilising additive, or individual constituent other than the main constituent, which is itself classified and which contributes to the classification of the substance shall be provided as follows:
(a) the product identifier in accordance with Article 18(2) of Regulation (EC) No 1272/2008;
(b) if the product identifier is not available, one of the other names (usual name, trade name, abbreviation) or identification numbers.
The specific concentration limit, the M-factor and the acute toxicity estimate for substances included in Part 3 of Annex VI to Regulation (EC) No 1272/2008 or determined in accordance with Annex I to that Regulation shall be indicated, if available.
If the substance is registered and it covers a nanoform, the particle characteristics that specify the nanoform, as described in Annex VI, shall be indicated.
If the substance is not registered, but the safety data sheet covers nanoforms, the particle characteristics of which have impact on the safety of the substance, those characteristics shall be indicated.
Suppliers of substances may choose to list in addition all constituents including non-classified ones. This subsection may also be used to provide information on multi-constituent substances.
3.2. Mixtures
The product identifier, the concentration or concentration ranges and the classifications shall be provided for at least all substances referred to in points 3.2.1 or 3.2.2. Suppliers of mixtures may choose to list in addition all substances in the mixture, including substances not meeting the criteria for classification. This information shall enable the recipient to identify readily the hazards of the substances in the mixture. The hazards of the mixture itself shall be given in section 2.
The concentrations of the substances in a mixture shall be described as either of the following:
(a) exact percentages in descending order by mass or volume, if technically possible;
(b) ranges of percentages in descending order by mass or volume, if technically possible.
When using a range of percentages, if the effects of the mixture as a whole are not available, the health and environmental hazards shall describe the effects of the highest concentration of each ingredient.
If the effects of the mixture as a whole are available, the classification determined from this information shall be included under section 2.
Where the use of an alternative chemical name is permitted in accordance with Article 24 of Regulation (EC) No 1272/2008, that name can be used.
3.2.1. For a mixture meeting the criteria for classification in accordance with Regulation (EC) No 1272/2008, the following substances (see also Table 1.1) shall be indicated, together with their concentration or concentration range in the mixture:
(a) substances presenting a health or environmental hazard within the meaning of Regulation (EC) No 1272/2008, if those substances are present in concentrations equal to or greater than the lowest of any of the following:
(i) the generic cut-off values set out in Table 1.1 of Annex I to Regulation (EC) No 1272/2008;
(ii) the generic concentration limits given in parts 3 to 5 of Annex I to Regulation (EC) No 1272/2008, taking into account the concentrations specified in the notes to certain tables in part 3 in relation to the obligation to make available a safety data sheet for the mixture upon request, and for aspiration hazard (Section 3.10 of Annex I to Regulation (EC) No 1272/2008) ≥ 1 %;
(iii) the specific concentration limits given in Part 3 of Annex VI to Regulation (EC) No 1272/2008;
(iv) if a M-factor has been given in Part 3 of Annex VI to Regulation (EC) No 1272/2008, the generic cut- off value in Table 1.1 of Annex I to that Regulation, adjusted using the calculation set out in Section 4.1 of Annex I to that Regulation;
(v) the specific concentration limits provided to the classification and labelling inventory established under Regulation (EC) No 1272/2008;
(vi) one tenth of the specific concentration limit for a substance classified as skin sensitiser or respiratory sensitiser with a specific concentration limit;
(vii) the concentration limits set out in Annex II to Regulation (EC) No 1272/2008;
(viii) if an M-factor has been provided to the classification and labelling inventory established under Regulation (EC) No 1272/2008, the generic cut-off value in Table 1.1 of Annex I to that Regulation, adjusted using the calculation set out in Section 4.1 of Annex I to that Regulation;
(b) substances for which there are Union workplace exposure limits which are not already included under point (a);
(c) providedthattheconcentrationofanindividualsubstanceisequaltoorgreaterthan0,1%,substancesthat meet any of the following criteria:
— substances that are persistent, bioaccumulative and toxic or very persistent and very bioaccumulative in accordance with the criteria set out in Annex XIII,
— substances included in the list established in accordance with Article 59(1) for reasons other than the hazards referred to in point (a) of this subsection such as endocrine disrupting properties,
— substances identified as having endocrine disrupting properties in accordance with the criteria set out in Delegated Regulation (EU) 2017/2100 or Regulation (EU) 2018/605.
Table 1.1
List of hazard classes, hazard categories and concentration limits
for which a substance shall be listed as a substance in a mixture in subsection 3.2.1
Hazard class and category
Concentration limit (%)
Acute toxicity, category 1, 2 and 3
≥ 0,1
Acute toxicity, category 4
≥ 1
Skin corrosion/irritation, category 1, categories 1A, 1B, 1C and category 2
≥ 1
Serious damage to eyes/eye irritation, category 1 and 2
≥ 1
Respiratory sensitiser category 1 or category 1B
≥ 0,1
Respiratory sensitiser category 1A
≥ 0,01
Skin sensitiser category 1 or category 1B
≥ 0,1
Skin sensitiser category 1A
≥ 0,01
Germ cell mutagenicity category 1A and 1B
≥ 0,1
Germ cell mutagenicity category 2
≥ 1
Carcinogenicity category 1A, 1B and 2
≥ 0,1
Reproductive toxicity, category 1A, 1B, 2 and effects on or via lactation
≥ 0,1
Specific target organ toxicity (STOT) – single exposure, category 1, 2 and 3
≥ 1
Specific target organ toxicity (STOT) — repeated exposure, category 1 and 2
≥ 1
Aspiration toxicity
≥ 1
Hazardous to the aquatic environment — Acute, category 1
≥ 0,1
Hazardous to the aquatic environment — Chronic, category 1
≥ 0,1
Hazardous to the aquatic environment — Chronic, category 2, 3 and 4
≥ 1
Hazardous for the ozone layer
≥ 0,1
3.2.2. For a mixture not meeting the criteria for classification in accordance with Regulation (EC) No 1272/2008, substances present in an individual concentration equal to or greater than the following concentrations shall be indicated, together with their concentration or concentration range:
(a) 1% by weight in non-gaseous mixtures and 0,2 % by volume in gaseous mixtures for:
(i) substances which present a health or environmental hazard within the meaning of Regulation (EC) No 1272/2008; or
(ii) substances for which Union workplace exposure limits have been assigned;
(b) 0,1% by weight for substances that meet any of the following criteria:
— substances that are persistent, bioaccumulative and toxic in accordance with the criteria set out in Annex XIII,
— substances that are very persistent and very bioaccumulative in accordance with the criteria set out in Annex XIII,
— substances included in the list established in accordance with Article 59(1) for reasons other than the hazards referred to in point (a) of this subsection such as endocrine disrupting properties;
— identified as having endocrine disrupting properties in accordance with the criteria set out in Delegated Regulation (EU) 2017/2100 or Regulation (EU) 2018/605;
(c) 0,1 % of a substance classified as skin sensitiser category 1 or 1B, respiratory sensitiser category 1 or 1B, or carcinogenic category 2;
(d) 0,01 % of a substance classified as skin sensitiser category 1A or respiratory sensitiser category 1A;
(e) one tenth of the specific concentration limit for a substance classified as skin sensitiser or respiratory sensitiser with a specific concentration limit;
(f) 0,1 % of a substance classified as toxic to reproduction categories 1A, 1B or 2, or with effects on or via lactation.
3.2.3. For the substances indicated in subsection 3.2:
— the classification of the substance according to Regulation (EC) No 1272/2008, including the hazard class (es) and category code(s) as provided in Table 1.1 of Annex VI to that Regulation as well as the hazard statements and supplemental hazard statements, shall be provided. The hazard statements and the supplemental hazard statements do not need to be written out in full in this subsection; their codes shall be sufficient. In cases where they are not written out in full, reference shall be made to section 16, where the full text of each relevant hazard statement shall be listed. If the substance does not meet the classification criteria, the reason for indicating the substance in subsection 3.2 shall be described, such as “non-classified vPvB substance” or “substance with a Union workplace exposure limit”.
— the specific concentration limit, the M-factor and the acute toxicity estimate for the substance in Part 3 of Annex VI to Regulation (EC) No 1272/2008 or as determined in accordance with Annex I to that Regulation shall be indicated, if available.
— if the substance as used in the mixture is in nanoform and is as such registered or addressed by the downstream user chemical safety report, the particle characteristics that specify the nanoform, as described in Annex VI, shall be indicated. If the substance as used in the mixture is in nanoform but is not registered or addressed by the downstream user chemical safety report, the particle characteristics which have impact on the safety of the mixture, shall be provided.
3.2.4. For the substances indicated in subsection 3.2 the name and, if available, the registration number, as assigned under Article 20(3) of this Regulation, shall be given.
Without affecting the obligations of downstream users laid down in Article 39 of this Regulation, the part of the registration number referring to the individual registrant of a joint submission may be omitted by the supplier of the mixture provided that:
(a) this supplier assumes the responsibility to provide the full registration number upon request for enforcement purposes or, if the full registration number is not available to him, to forward the request to his supplier, in line with point (b); and
(b) this supplier provides the full registration number to the Member State authority responsible for enforcement (hereinafter referred to as the enforcement authority) within seven days upon request, received either directly from the enforcement authority or forwarded by his recipient, or, if the full registration number is not available to him, this supplier shall forward the request to his supplier within seven days upon request and at the same time inform the enforcement authority thereof.
The EC number, if available, shall be given in accordance with Regulation (EC) No 1272/2008. The CAS number, if available, and the IUPAC name, if available, may also be given.
For substances indicated in this subsection by means of an alternative chemical name in accordance with Article 24 of Regulation (EC) No 1272/2008, the registration number, EC number and other precise chemical identifiers are not necessary.
(For further guidance on the compilation of safety data sheets, refer to the handbook: "Guidance on the compilation of safety data sheets", Version 4.0, European Chemicals Agency (ECHA), December 2020. ©2020, European Chemicals Agency.)
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.
Item 3: Composition/Information on Ingredients:
This section identifies the hazardous ingredient(s) (as defined in subsection 1(1) of the HPR), including impurities, stabilizing solvents and stabilizing additives, contained in the product. The required information consists of:
For a hazardous product that is a substance or material:
o Chemical name *
o Common name and synonyms*
o Chemical Abstracts Service (CAS) registry number and any unique identifiers*
o The chemical name of the impurities, stabilizing solvents and stabilizing additives known to the supplier which are themselves classified in any health hazard class and which contribute to the classification of the material or substance*
* Unless a CBI [Confidential Business Information] claim to protect the required information element has been filed or granted under the HMIRA [Hazardous Materials Information Review Act]. In this case, replacement information must appear on the SDS (refer to the discussion of section 5.7 of the HPR).
The requirement to disclose common names and synonyms for the substance or material includes the obligation to disclose other names by which the substance or material is commonly known in the work place. It is not expected that a long list of common names and synonyms would be provided.
For a hazardous product that is a mixture:
The following information is required for each ingredient in the mixture which is, by itself, classified in any health hazard class and is present at or above the cut-off/concentration limit that is designated for the category or subcategory in which it is classified, or is present in the mixture at a concentration which, in accordance with subsection 2.5(1) of the HPR, results in the mixture being classified in any health hazard class:
· Chemical name*
· Common name and synonyms*
· CAS registry number and any unique identifiers*
· Concentration*
* Unless a CBI claim to protect the required information element has been filed under the HMIRA. In this case, replacement information must appear (refer to the discussion of section 5.7 of the HPR).
The requirement to disclose common names and synonyms for each hazardous ingredient includes the obligation to disclose other names by which the ingredients are commonly known in the work place. It is not expected that a long list of common names and synonyms would be provided.
Concentration disclosure: If the concentration or the actual concentration range of an ingredient is expressed as a percentage, the units used to calculate the percentage must be provided, as required by section 4.3 of the HPR.
Section 4.5 of the HPR sets out a provision whereby, under specified circumstances, the SDS must disclose the actual concentration range of an ingredient in a mixture. Further guidance on the disclosure of ingredient concentrations and concentration ranges on SDSs is provided in Appendix 3 to this chapter (Guidance on the Disclosure of Ingredient Concentrations and Concentration Ranges on Safety Data Sheets). For the ingredients that are present in a range of concentrations in a mixture, the information provided on the SDS must correspond to the data available for the most hazardous concentration of the ingredient, as required by section 4.4 of the HPR.
Concentration limits – equivalent or higher concentration: Subsection 2.5(2) of the HPR sets out a provision whereby, if an ingredient is present in a mixture at a concentration equal to or greater than the concentration limit for a particular category or subcategory of a health hazard class, but evidence based on established scientific principles demonstrates that the ingredient does not present the associated health hazard at that concentration, then the mixture need not be classified in that category or subcategory of the health hazard class based on the assessment of this ingredient. (Note that other ingredients in this mixture may result in the mixture being classified in the same health hazard class).
Therefore, in a situation where subsection 2.5(2) of the HPR applies, the ingredient need not be disclosed in section 3 of the SDS, unless the ingredient is required to be disclosed for another reason.
Disclosure of HHNOC [Health Hazard Not Otherwise Classified] ingredients on SDSs
Information relating to the HHNOC ingredient, including its chemical name and concentration or concentration range, must be disclosed on the SDS under item 3(2) of Schedule 1 of the HPR for any mixture that contains an ingredient classified in HHNOC at a concentration of 1% or more.
[rev. 5.27.2024]
[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] Annex II, Section 3 (Subsection 3.2, “Mixtures”) of EU REACH regulations.
[3] This shortcut is equivalent to clicking on the Help button on the entry form, and selecting “Background for this section”.
[4] “REACH” is the Registration, Evaluation, Authorisation and Restriction of Chemicals, Regulation (EC) No 1907/2006. It is the basic framework for chemical regulation in the EU. REACH is distinct from the EU chemical labelling and packaging regulations (EU CLP), which also includes an Annex VI (“Table of harmonised entries in Annex VI to CLP”).
[5] The “Omit haz” column/box for the row must not be checked.
[6] The “Refresh the display” menu option only redraws display-only information for a row, to reflect any changes that may have occurred elsewhere. By contrast, the “Update component” option can replace content in component fields.
[7] By default and for historical reasons, the program will not copy content from the Other information field, on the “Toxicology 3” tab of the linked Substance record. You can change this setting in File -> Preferences -> Other settings, by checking the box, “Toxicity ‘Other info’ field copies from the Substance record to the SDS”.
[8] As noted previously, the program will not copy content from the Other information field on the “Toxicology 3” tab of the linked Substance. You can change this setting in File -> Preferences -> Other settings, by checking the box, “Toxicity ‘Other info’ field copies from the Substance record to the SDS”.
[9] Prior to the May 20, 2024 final rule on the Hazard Communication Standard, US OSHA did not permit the use of concentration ranges to withhold actual (narrower) concentration ranges; concentration ranges could only be used to withhold an individual (single) concentration. The final rule takes effect on July 19, 2024.
[10] The authorization number might be suitably placed in the “Trade secret statement…” field, below the Component table.
[11] However, the Exposure limits table on Tab “8.1 Exposure-protection” also has an “Omit” column. Clicking on the “Omit” column header reveals an option to “Omit if component omitted in Section 3”, which will set the “omit” options for each exposure limit according to the “Omit row” setting in the Component table. This setting is not dynamic: If you change the “omit” option for one or more Component table rows, you should also update the omit options for the Exposure limits table.
[12] The program does not, however, determine whether the component concentration in the product exceeds the SCL value(s); and it does not evaluate aquatic toxicity from the M-factor(s). The content in this field (from Annex VI of the EU CLP regulations) is not in a machine-readable format. SCLs and M-factors are part of the EU/EEA regulations framework.
[13] “REACH” is the Registration, Evaluation, Authorisation and Restriction of Chemicals, Regulation (EC) No 1907/2006. It is the basic framework for chemical regulation in the EU. REACH is distinct from the EU chemical labelling and packaging regulations (EU CLP), which also includes an Annex VI (“Table of harmonised entries in Annex VI to CLP”).