(Originally posted Dec 13, 2017; last updated on July 20, 2022)
In some jurisdictions it is possible to withhold information from a Safety Data Sheet that identifies product recipes or other proprietary details which, if revealed to others, could be detrimental to your business interests. The UN GHS specification, European Union (EU/EEA) regulations, and Canadian regulations refer to company-proprietary details as Confidential Business Information (CBI). US-OSHA regulations use the term specific chemical identity as it pertains to substances or product ingredients.
This post summarizes the requirements for withholding confidential information from SDSs in the USA, Canada, EU/EEA, and Korea.
USA (US-OSHA)
For the US, the Hazard Communication Standard (HCS, or "HCS 2012") allows you to claim a trade secret for chemical name(s), other specific identification of a hazardous chemical, or the exact percentage (concentration) of substance(s) in a mixture (29 CFR 1910.1200(i)1). You can make this claim without prior approval from OSHA, although you should be prepared to justify the claim if asked to do so. Additional requirements for claiming trade secrecy include:
A statement in SDS Section 3 (Composition) that you have made a claim of trade secrecy, indicating that the specific chemical identity and/or percentage of composition is being withheld as a trade secret.
The SDS must still include the properties and effects of the hazardous chemicals for which you are withholding the chemical identity and/or concentration.
You must disclose the specific chemical identity and concentration in cases of medical emergencies, medical treatment for exposed individuals, workplace monitoring, and the evaluation of suitable protective equipment to prevent harmful exposures. The HCS identifies specific circumstances and requirements for persons requesting the information.
If you intend to withhold the actual percentage of composition for one or more hazardous ingredients, you can replace the actual concentration with a concentration range that includes the actual value. Or you can use inequality symbols (less than or greater than a stated value).
However, if you already use concentration ranges to represent actual ingredient levels, due to batch-to-batch product variations, or where the SDS covers a group of "substantially similar mixtures", then you cannot enlarge the concentration ranges to avoid revealing the actual concentration range.
You should have a concentration or concentration range for each hazardous ingredient. You cannot use a value of zero, have a concentration range that includes zero, or omit the concentration entirely.
OSHA provided additional comments on withholding concentrations in a 2017 letter interpreting the standard. Additionally, in its 2021 notice of proposed rulemaking (NPRM), OSHA indicated that it may allow the use of Canadian prescribed concentration ranges.
SDScribe™ has a Component table in SDS Section 3 (Composition), where each row represents an ingredient, stabilizer, impurity, or other component of the product which (at its concentration in the product) contributes to the hazards associated with the product as a whole. (As an option, you can also include non-hazardous items, and/or hazardous items present below thresholds levels in the product.)
SDS Section 3, Component table with Trade Secret statement field below.
The "C" button menu can generate suggested trade secret statements.
For the HCS, you omit the specific chemical identity of a hazardous ingredient by checking a "name withheld" box for the ingredient row. When generating the SDS, the program will replace the ingredient name with the phrase "Component x (trade secret)*", where "x" is the position of the ingredient in the table. You can use the trailing asterisk (*) on this phrase to reference the trade secret claim statement, which is located just below the Component table.
The Component table also contains minimum and maximum percentage columns, for specifying the concentration range for each ingredient. If you plan on using an actual concentration for an ingredient (i.e., you are not withholding the actual concentration), then use only one of the columns (minimum or maximum) for the concentration value.
Because SDS Sections 8 (Exposure-protection), 11 (Toxicological), 12 (Ecological), and 15 (Regulatory) may also contain references to specific chemical names of ingredients, the program offers an option to substitute "Component x" for the actual chemical names in these sections, when you generate the SDS. When SDS generation is complete, ensure that you proofread these sections. The program won't distinguish between, say, "sodium hydroxide" and "sodium hydroxide carbonate" in the text of these sections – your SDS might contain references to "Component 3 carbonate". You may also need to manually remove references to CAS numbers, EC numbers, or other chemical identifiers.
Planning for multiple markets
Generally, the US has the most permissive regulations regarding trade secrecy claims on safety data sheets. Taking full advantage of these provisions may be problematic for companies with multi-national product distribution, however, since ingredients and/or concentrations withheld on a US SDS may need to appear on SDSs in other countries or regions. Thus US customers may be dissatisfied if they find better information on non-US SDSs for the same product.
Canada (Health Canada)
Canada regulates CBI claims under its Workplace Hazardous Materials Information System (WHMIS 2015) regulations. You can read more about the specific provisions for withholding CBI here.
As with the US-OSHA HCS regulation, WHMIS 2015 permits you to withhold:
The chemical identity of an ingredient, substance, or material (including impurities and stabilizing solvents).
Actual concentration or concentration range.
The names of any toxicological study that identifies the ingredient, substance or material.
Employers can also withhold a "product identifier" (chemical name, trade name and/or other means of identification for the product itself); and information that could be used to identify a supplier.
Instead of using "Component x (trade secret)*" as a substitute for the actual chemical name of an ingredient (as with US-OSHA in the HCS), you must use a generic chemical identity (GCI). The GCI should be descriptive of the chemical structure and "important radicals" of the ingredient, so that the GCI can be related to the hazards of the product as a whole. For example, you might use "Alcohol" as a substitute for "propanol" or "t-butyl alcohol".
Concentration for an ingredient can be expressed as a range (minimum to maximum) which contains the actual value or actual concentration range. Unlike the HCS requirements, WHMIS 2015 allows you to omit concentration entirely, substituting a phrase like "Proprietary*" instead.
To withhold confidential information, you must file a claim for exemption with Health Canada. The agency charges a processing fee for the claim application. You must include the GCI you plan to use (if any) for each ingredient.
When Health Canada determines that the application is complete, it issues an HMIRA registration number and a claim filed date under the Hazardous Materials Information Review Act (HMIRA). Once you receive the HMIRA number, you can issue the Safety Data Sheet.
Health Canada will subsequently either approve or request changes to your claim. Prior to approval, Health Canada can still require you to make changes to your CBI claim, or (ultimately) to deny the claim. You have a limited time to make the requested changes on the Safety Data Sheet.
Each ingredient that has a replacement name (GCI) or a concentration substitution should refer to the HMIRA registration number and claim filed date (or the claim approval date, if Health Canada has granted the claim).
In SDScribe™, you enter the HMIRA registration number, the claim filed date, and (if Health Canada has approved the claim) the claim granted date in SDS Section 1 ("Identification").
Location for the HMIRA registration number, claim field date, and claim granted date, on Tab “1 Identification” of the SDS entry form. The “Show more” button (top right, not shown in this illustration) must be pressed to display these fields.
The Composition table has an "Alternative/generic name" column for the generic name (GCI) of an ingredient. When present, the text in this column replaces the specific chemical name, unless the "name withheld" box is checked.
To omit the concentration of an ingredient, leave the minimum and maximum concentration columns in the Component table at zero, and do not include any "less than", "greater than", etc. modifiers (e.g., "<, <=, =, >, >=") in the adjacent columns. You would then add a phrase like "Proprietary*" in a note column, after the maximum concentration column.
Each ingredient (row) in the Component table for which CBI withholding applies should reference a statement (use the "Trade secret statement..." field below the table). The statement should contain the HMIRA registration number and the claim filing date (or the claim approval date, if available). The example which Health Canada uses in their fact sheet is "* HMIRA RN: 3333 – Decision Granted Date January 1, 2021".
Prescribed concentration ranges
Canada offers another option for withholding actual ingredient concentrations when they fall within specified ranges. This option does not require submission or prior approval from Health Canada, provided that you are not also planning to use generic chemical names.
A discussion of these ranges appears in a separate post, “Canada and prescribed concentration ranges”.
European Union/European Economic Area (ECHA)
Similarly to the Canadian regulations, the European Classification, Labelling and Packaging regulations permit the use of an alternative chemical name for ingredients in mixtures, to replace the specific chemical identity of the ingredient.
The EU requires that you file a request to use an alternative chemical name for one or more ingredients, with the European Chemicals Agency (ECHA). You file the claim online, at the agency's web portal (REACH-IT). The claim filing process also involves creating an account there, if you don't have one already. The ECHA charges a processing fee.
Once fee payment is received, the ECHA will respond to the request within six weeks, indicating whether your choice of alternative chemical name(s) is acceptable. However, they can modify or withdraw their approval at a later date, subject to an appeals process.
The requirements for using an alternative name include:
The ingredient must not have a community workplace exposure limit from the European Agency for Safe and Health at Work.
The ingredient 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 alternative chemical name must provide adequate information on the nature of the ingredient for handlers to take suitable health and safety precautions.
Unlike either the HCS or the WHMIS 2015 regulations, the EU CLP regulation does not provide a mechanism to file a CBI claim for ingredient concentrations.
South Korea (MoEL)
The Republic of Korea now requires manufacturers and importers of hazardous chemicals to submit safety data sheets to the Ministry of Employment and Labor (MoEL) for approval prior to product distribution. Non-Korean entities should use an “Only Representative” in Korea for this purpose.
Upon approval, the MoEL issues a serial number that must be included on the upper portion of the first page of the SDS. (SDScribe™ now provides an “SDS no.” field that can be used for this purpose; the “SDS no.” field can appear in the header of all pages.)
“SDS no.” field (upper right), on Tab “1 Identification” of the SDS entry form.
Companies wishing to claim trade secrecy for hazardous ingredients above threshold levels must obtain prior approval by submitting an application for non-disclosure to the MoEL web portal.
The application should provide the specific chemical identity and concentration for the proposed CBI ingredient(s); the hazard classification(s) for the product and for the CBI ingredient(s); the reasons for requesting CBI; and should demonstrate that the ingredient(s) are not carcinogenic, mutagenic, or reproductive toxicants (non-CMR; certain other toxic/controlled chemicals are also excluded from eligibility).
Once the application is approved, the MoEL will issue an authorization number that is valid for five years, with an additional five years available on application for an extension. The authorization number should appear in SDS Section 3. In SDScribe™, you may wish to include this number in the “Trade secret statement…” field, below the Composition table.
Original post Dec 13, 2017. Minor revisions 12.14.2017, 3.25.2020. Corrections/revisions 8.17.2021 for US-OSHA concentration ranges. Additions/revisions 7.20.2022 for South Korea, EU/EEA, and US-OSHA.