SDS Section 15 (Tabs "15.1 Regulatory")
Quick start
On Tab 15.1, you identify health and safety rules, regulations, and statutory chemical lists that pertain to the product or to its ingredients. The regulatory items you include should be relevant to the jurisdictions (country, province, state, etc.) of your product users.
This section is optional for US-OSHA and Health Canada, but is required for EU/EEA and GB.
Regulations table
Regulations table.
Existing table contents
The Regulations table may already contain listings for the components that you added on Tab "3 Composition", or for the SDS product itself. The program automatically copied these items from the Regulations table in the Substances section, for each component and/or for the product itself.
Each listing may include the chemical name and (where available) the CAS number, in the “Applicability” column. Some listings may contain supplemental information concerning how a chemical came to be listed, or may present warnings relevant to the chemical.
Rebuilding the table
You might consider rebuilding the Regulations table if chemical regulatory lists have changed since you last worked on this SDS, and you have imported these lists into the program [File menu -> Imports-exports and utilities -> Review imports… (button)].
1. Click on the Interim save button (disk icon, lower right; shortcut: [Ctrl]-s) to preserve any work you’ve done since opening this SDS.
2. Highlight all rows in the Regulations table ([Ctrl]-a).
3. Click on the Delete button (trash can icon) to remove all rows (shortcut: [Ctrl]-[Backspace]).
4. Click on the Update button (circling arrows icon) to re-create regulations from the chemicals listed in Component table.
5. Check the contents of the newly-created rows, revising the text as necessary for clarity.
6. Click on the Add button if desired to manually enter other regulations or lists you know to be relevant. (You can also click on the Regs or the [R]esearch button to perform online research.)
7. Click on one of the flag buttons to indicate the geographical region for the SDS. Based on the codes in the “Region” column, the program will move relevant regulations to the top of the table, and mark others as “Omit” so that they won’t appear on the SDS. (For regions not covered by a flag button, [Alt]-click on the “Omit” column header instead, and select the region code to be included from the header menu.)
8. If you will be creating a non-English SDS: Click in the first (“No.”) column of the first row to highlight the row, and then click on the column header marked “Regulation (click translate)” to convert the English-language contents into non-English text. Repeat these steps for the “Applicability (click translate)” column. Then repeat this sequence for the other rows, one at a time.
9. If you don’t like what you’ve created, click on the Cancel button to close the SDS, without having saved any changes to the Regulations table.
Next steps
Next, click on the “15.2 Regulatory” 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”).[1]
· 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 15 (Tab "15.1 Regulatory") — details
NOTE: The UN, EU, and Health Canada guidance appearing below applies to both Tabs "15.1 Regulatory" and "15.2 Regulatory".
Contents
Copying preferences for regulations
Regulatory items order of appearance
A4.3.15 SECTION 15: Regulatory information
A4.3.15.1 Safety, health and environmental regulations specific for the product in question
SECTION 15: Regulatory information
15.1 Safety, health and environmental regulations/legislation specific for the substance or mixture
15.2 Chemical safety assessment
Item 15: Regulatory Information (header required; content optional):
I. Regulations table
Editing regulatory items
Edit the "Regulation" and "Applicability" columns as needed by clicking into the respective cells for the new row. You can also edit the "Regulation (click translate)" and "Applicability (click translate)" columns for use with a non-English version of the SDS.
To translate the contents of the two English-language columns, highlight the row and click on the respective "click-translate" column headers.
To insert a carriage return within an individual cell in the table, use the [Ctrl]-[Return] keystroke.
Copying preferences for regulations
You can customize the way the program automatically copies regulations for components from the Substances section. For instance, you might prefer using a slightly different name for the regulation, or omitting some details from the “Applicability” column.
Options for how regulations are copied into the SDS [File -> Preferences -> Other settings (tab) -> SDS (section)].
Clicking on the Regulation name substitutions button in Preferences reveals a two-column table, where the first column indicates the regulation name as it appears in the Substances section. The second column permits you to enter the corresponding regulation name as you wish it to appear on the SDS.
Regulation name replacement table (Preferences).
The “Regulation applicability lines to copy” preference allows you to cut off the content copied from the “Applicability” column in the Substance regulations table, after a specified number of embedded carriage returns (use [Ctrl]-[Return] to embed carriage returns in table cells).
For instance, if an applicability listing appears in the Substance regulations table as:
Chemical name: HEXANEDIOIC ACID
CAS number: 124-04-9
Listing note: E-environmental hazard.
…and you have selected “2” as the number of lines to copy, then only the first two lines will appear in the SDS regulations table:
Chemical name: HEXANEDIOIC ACID
CAS number: 124-04-9
If there are no embedded carriage returns in the text, or there are fewer than the number of carriage returns you specify in Preferences, then the program will copy all of the content from the Substance “Applicability” column to the SDS.
These copying preferences will not “stick” for future program sessions unless you click on the Save button to close Preferences. If you need to revise the Regulations table for all entries on a particular SDS, click on the Update button, described below.
Button and column actions
Add (button)
The preferred way to add new regulatory listings is to enter components on Tab “3 Composition”, and then allow the program to automatically add the associated regulations here.
To instead add regulations manually, click on the Add button. You then select a regulation, rule, or similar item from the pop-up menu. Or you can add an unlisted regulation, by selecting "Add New regulation".
Any item(s) that you add using this button will not be linked to the components on Tab “3 Composition”. You can identify unlinked regulations because they appear in plain black text. Linked regulations appear in blue text, and include the name of the component in the “Link” column, at far right in the table.
"Add" button pop-up menu. A menu item at the bottom of the list permits customization or a return to the default items ("Customize regulation list and preferred sort…").
Update (button)
Click on the Update button if you wish to regenerate the list of regulatory items for each of the components on Tab "3 Composition", plus any that are associated with the SDS product itself. The Update button action will not regenerate entries that you created manually with the Add button.
If there are existing regulation listings, the program will offer to mark the "Omit" box for each of them, prior to starting. Then, if any of the regulatory items that the program generates exactly matches an existing listing, the program will un-check the "Omit" box in the existing listing row.
Following the update, the rows that still have an "Omit" box checked were not found, and should be evaluated for relevance; there may not be a purpose for them remaining in the table.
If you wish to replace the entire list without preserving any existing items, you can highlight all existing items and delete them ([Ctrl]-A to highlight all items, then [Ctrl]-[Backspace] to delete), and then click on the Update button. In this case, none of the manually-added entries will reappear.
Flags (button bar)
Clicking on one of these flags will cause the program to include regulations on the SDS only for that particular region (the code in the “Region” column). The program will exclude regulations from other regions by checking the “Omit” boxes for those regulations.
For example, if you click on the European Union flag, the program will exclude all regulations with region codes other than "EU" by checking their “Omit” boxes. The program will then sort the entire list so that the omitted items appear at the bottom of the list.
The flag buttons also take into account any components that you have already omitted on Tab "3 Composition”, by checking the “Omit” boxes for the regulations associated with the omitted components.
Also note that:
· Clicking on the US flag button will cause the program to include both "US"-coded regulations and regulations having no codes (presumed to be US-related).
· The dual Canada-US flag button will include regulations pertaining to both countries (for region codes "US", "CA", and with no code entry).
· Clicking on the "x" button will remove all "Omit" check marks and re-sort alphabetically.
· You can [Alt]-click on the "x" button to have the program attempt to complete rows with missing codes in the “Region” column.
Omit (column)
In place of or in addition to using the flag button bar, you can also manually mark one or more regulatory items for omission from the generated SDS.
To omit individual regulatory items, check the box in the "Omit" column. The text should turn a light gray color for each row so marked.
To omit a group of regulatory items that are, say, in another geographic region, enter a code representing that region in the "Region" column[2], for each applicable row. Then click on the "Omit" column header to display a pop-up menu, and select the region code to exclude. You can enter any appropriate code(s) for this purpose; for example, you could assign "CSM" to all cosmetic regulations, and then exclude them by selecting "CSM" from the "Omit" column header.
Selecting a region to exclude from the generated SDS. The region code should be entered for excludable rows into the "Region" column of the Regulatory table. To exclude more than one region, hold down the [Shift] key while selecting the next region code to exclude.
To omit items for any component that is marked for omission on Tab "3 Composition", click on the "Omit" column header, and select "Omit if component omitted in Section 3" from the pop-up menu.
NOTE: You cannot use the "Omit if component omitted in Section 3" option if you have merged regulations together on this tab, using the Merge if same button. (discussed next), or if you manually created the listing here using the Add button. If regulations have been merged on this tab, they no longer retain a link back to a component.
Merge if same (button)
You might have more than one listing for the same regulatory item. For example, three product components could each appear as chemicals on the Pennsylvania Right To Know list, resulting in three rows for the Pennsylvania list. You might want to merge these rows, so that you will have only one row for the Pennsylvania Right To Know list. There are two methods:
1. Merge separate listings for the same regulation (preferred technique) — Rather than clicking on the Merge regulatory items button here, instead check this box in the SDS generation options dialog, immediately before generating the SDS.
Merging regulation listings during SDS generation (from the "Select SDS generation options…" dialog). This technique happens on the fly, and thus does not affect the original regulation listings.
With this approach, the program will merge regulations together "on the fly", so that the original regulatory items (and their order on this tab) remain the same. However, you cannot customize the order of the regulations on the generated SDS; they will always be alphabetized.
2. Merge if same (button on this tab) — Click on the Merge if same button, at top right on the form. The program will collect the component names from the separate rows, and place them together in the "Applicability" column of a new, single row.
In this example, the "Merge if same" button placed acetic acid and sodium bisulfite together, because they both appear on the same chemical list.
Once the SDS record is saved, the Merge if same result is not reversible; the merged row no longer has a link back to the original components. Therefore, you can no longer use the "Omit if component omitted in Section 3" option (discussed previously).
Regulatory items order of appearance
There are two options for rearranging the order of listed regulatory items on the generated SDS:
Individually
Highlight a row, and then use the Up or Down buttons to the left of the table, to move the row up or down. Repeat for other rows as needed.
As a group
Click on the "Regulation (click to reorder)" column header, and select a re-order option.
"Regulation…" column header pop-up menu.
Regulation header menu options
· Alphanumeric / reverse alphanumeric — Arranges by regulation name.
· Region — Arranges by alphanumeric order of the codes in the "Region" column. (You can use any codes you wish in this column.)
· National then state-province-territory — Arranges by jurisdiction. If the program cannot match one or more of the listed regulatory items by region, then it will place them after the ones it does recognize.
· Preferred (advanced option) — Places the regulations into a custom order that you define. Use this option if the other options are not suitable.
NOTE: You can achieve the same effect simply by re-ordering the regulatory items individually, with the Up and Down buttons. The difference here is that you retain the preferred order for the next time that you want to sort a Regulatory items table.
Preferred order customization (advanced option)
Define the preferred order by selecting "Customize regulation list and preferred order…" from the column header menu. The program will display a dialog containing the current choices for regulatory items in the Add menu.
"Edit regulations menu and preferred sort order…" (dialog).
Drag the regulations up or down to change the priority with which the program will re-order the regulatory items in the table. You can also add new regulations to the menu. Click on the OK button to dismiss the dialog.
Next, click on the "Regulation…" header again and select "Preferred". The program will rearrange the listed items in the Regulations table to conform to that order.
Exception to re-ordering the Regulations table
The generated SDS will retain the order of listings in the Regulations table, unless you have chosen to merge regulations together at generation time ("Merge separate listings for the same regulation" on the "Select SDS generation options…" dialog). In this case, the merged regulations will appear in alphabetical order.
II. OSHA guidance
From: “OSHA Brief: Hazard Communication Standard: Safety Data Sheets”, https://www.osha.gov/Publications/OSHA3514.html. NOTE: This section is optional under OSHA regulations.
This section identifies the safety, health, and environmental regulations specific for the product that is not indicated anywhere else on the SDS. The information may include:
· Any national and/or regional regulatory information of the chemical or mixtures (including any OSHA, Department of Transportation, Environmental Protection Agency, or Consumer Product Safety Commission regulations)
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.
A4.3.15 SECTION 15: Regulatory information
Describe any other regulatory information on the substance or mixture that is not provided elsewhere in the SDS (e.g. whether the substance or mixture is subject to the Montreal Protocol[16], the Stockholm Convention[17] or the Rotterdam Convention[18]).
A4.3.15.1 Safety, health and environmental regulations specific for the product in question
Provide relevant national and/or regional information on the regulatory status of the substance or mixture (including its ingredients) under relevant safety, health and environmental regulations. This should include whether the substance is subject to any prohibitions or restrictions in the country or region into which it is being supplied.
Footnotes:
[16] - Montreal Protocol means the Montreal Protocol on Substances that Deplete the Ozone Layer, as either adjusted and/or amended.
[17] - Stockholm Convention means the Stockholm Convention on Persistent Organic Pollutants.
[18] - Rotterdam Convention means the Rotterdam Convention on the Prior Informed Consent Procedure for Certain Hazardous Chemicals and Pesticides in International Trade.
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.
SECTION 15: Regulatory information
This section of the safety data sheet shall describe the other regulatory information on the substance or mixture that is not already provided in the safety data sheet (such as whether the substance or mixture is subject to Regulation (EC) No 1005/2009 of the European Parliament and of the Council of 16 September 2009 on substances that deplete the ozone layer [22] Regulation (EC) No 850/2004 of the European Parliament and of the Council of 29 April 2004 on persistent organic pollutants and amending Directive 79/117/EEC [23] or Regulation (EC) No 649/2012 of the European Parliament and of the Council of 4 July 2012 concerning the export and import of dangerous chemicals [24]).
15.1 Safety, health and environmental regulations/legislation specific for the substance or mixture
Information shall be provided regarding relevant Union safety, health and environmental provisions (for example, Seveso category/named substances in Annex I to Council Directive 96/82/EC [25]) or regarding the national regulatory status of the substance or mixture (including the substances in the mixture), including advice on action that should be taken by the recipient as a result of these provisions. Where relevant the national laws of the relevant Member States which implement these provisions and any other national measures that may be relevant shall be mentioned.
If the substance or mixture covered by this safety data sheet is the subject of specific provisions in relation to the protection of human health or the environment at Union level (such as authorisations given under Title VII or restrictions under Title VIII) these provisions shall be mentioned. Where an authorisation granted under Title VII imposes conditions or monitoring arrangements to a downstream user of the substance or mixture, they shall be provided.
15.2 Chemical safety assessment
This subsection of the safety data sheet shall indicate whether the supplier has carried out a chemical safety assessment for the substance or the mixture.
Footnotes:
[22] Regulation (EC) No 1005/2009 of the European Parliament and of the Council of 16 September 2009 on substances that deplete the ozone layer (OJ L 286, 31.10.2009, p. 1).
[23] Regulation (EC) No 850/2004 of the European Parliament and of the Council of 29 April 2004 on persistent organic pollutants and amending Directive 79/117/EEC (OJ L 158, 30.4.2004, p. 7).
[24] Regulation (EU) No 649/2012 of the European Parliament and of the Council of 4 July 2012 concerning the export and import of hazardous chemicals (OJ L 201, 27.7.2012, p. 60).
[25] OJL10,14.1.1997, p.13.
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.
Item 15: Regulatory Information (header required; content optional):
As per subsection 4(2) of the HPR, the content of the specific information elements may be omitted as long as the item number and heading appear on the SDS. If provided, this section offers information on the safety, health and environmental regulations, made within or outside Canada, specific to the product in question.
[rev. 4.24.2024]
[1] This shortcut is equivalent to clicking on the Help button on the entry form, and selecting “Background for this section”.
[2] If you cannot see the "Region" column, and you have upgraded to this version of SDScribe™, it may be over at the extreme right. Re-open the SDS while holding down the [Shift] key, to reset default column order.