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Confidential Business Information

Confidential business information (CBI) generally refers to technical information on a product or its manufacturing process that has economic value and that is usually known only to the producer. General names used to hide component’s names are called Trade Secret Names (TSN).


In the case of an ingredient that is in a substance or mixture and is displayed in section 3 TSN can be used to hide:

  1. the chemical name of the ingredient,
  2. the CAS registry number or any other unique identifier of the ingredient, and
  3. the concentration or concentration range of the ingredient.

Solvay's approach is to never use TSNs for components with OEL (Occupational Exposure Limits) or classified as CMR (Cancerogenic, Mutagenic or Reproductive toxicity).

Links of interest


RegionCountryCan we hide chemical name?Can we hide CAS?Any restrictions?Process*Any fees?
North America Canada YesYes
P F
Mexico YesYes
P
USA YesYes
P
South America

Argentina

Brazil

YesYes

P (A)

P (B)


REST OF SA YesYes


EUROPE (REACH)
YesYes R
F
EMEA Russia YesYes


Turkey YesYes R
F
O ceania Australia YesYes R

New Zealand YesYes R

Asia China YesYes
P
Korea YesYes R

Malaysia YesYes
P
Singapore YesYesR

Taiwan YesYes R

Thailand YesYes R

Vietnam YesYes
P

*Process - does it requires to have an extra actions to use TSNs



North America

Canada


Hazardous ingredients are required to be disclosed on Canada SDS. To keep them trade secret, an application (HMIRA Claim) must be submitted to Health Canada (in force from 2013). The Agency will review SDSs for compliance and can issue Advice Documents, Orders, etc.

Not required for:

  • Environmental hazardous substances
  • Samples intended for research and development
  • Articles

Important

  • Cost is $1839.60 CDN
  • Claim is valid for 3-years ; can be renewed

Mexico

When some information related to the composition is omitted for industrial secret, it must be inserted an informative phrase of this condition as “industrial secret” , or “confidential information held” or “Confidential information”.

Important

Regulatory agency approval is not required.

USA

If TSNs are used in section 3, after table a Trade secret statement is required. Information must be made available to health professionals in emergency situations and in non-emergency situations, but requests must be in writing. If the hazardous chemical or a component has a PEL (Permissible Exposure Limits) or TLV (Threshold Limit Values) , this must be reflected on the MSDS.

Important

Regulatory agency approval is not required. Decision is left to the manufacturer/supplier.

Links to Regulations


South America

Argentina, Brazil

When some information related to the composition is omitted for industrial secret, it must be inserted an informative phrase of this condition as “industrial secret” , or “confidential information held” or “Confidential information” .

Important

Regulatory agency approval is not required.

REST OF SOUTH AMERICA

Countries: Chile; Colombia; Costa Rica; Dominican Republic, Panama, Peru & Venezuela

There are no applications needed to be filled or any statement added in section 3. TSN can be used if components have no OEL or are classified as CMRs.

Links to Regulations


Europe

Trade secret name can be used if:

  • the substance has not been assigned a Community workplace exposure limit;

  • the manufacturer, importer or downstream user can demonstrate that the use of the alternative chemical name meets the need to provide enough information for necessary health and safety precautions to be taken in the workplace and the need to ensure that risks from handling the mixture can be controlled;

  • the substance is classified exclusively as one or more of the following hazard categories:

    • any of the physical hazard categories

    • Acute toxicity, Category 4;

    • Skin corrosion/irritation, Category 2;

    • Serious eye damage/eye irritation, Category 2;

    • Specific target organ toxicity – Single exposure, Category 2 or 3;

    • Specific target organ toxicity – Repeated exposure, Category 2;

    • Hazardous to the aquatic environment – Chronic, Category 3 or 4.

Important

Cost is set to 4000€ for 1 substance up to 5 mixtures + 500€ for an additional 10 mixtures with the same substance.




EMEA

Russia

There are no applications needed to be filled or any statement added in section 3. Trade secret name can be used if components have no OEL or are classified as CMRs.

Turkey

Requests for use of an trade secret name or alternative chemical name under Article 26 may be granted only where:

  • the substance has not been assigned a Community workplace exposure limit; and

  • the manufacturer, importer or downstream user can demonstrate that the use of the alternative chemical name meets the need to provide enough information for necessary health and safety precautions to be taken in the workplace and the need to ensure that risks from handling the mixture can be controlled; and

  • the substance is classified exclusively as one or more of the following hazard categories:

    • any of the hazard categories (Explosives; Flammable gases; Flammable aerosols; Oxidizing gases; Gases under pressure; Flammable liquids; Flammable solids; Self-reactive substances and mixtures; Pyrophoric liquids; Pyrophoric solids; Self-heating substances and mixtures; Substances and mixtures which in contact with water emit flammable gases; Oxidizing liquids; Oxidizing solids; Organic peroxides; Corrosive to metals;

    • Acute toxicity, Category 4;

    • Skin corrosion/irritation, Category 2;

    • Serious eye damage/eye irritation, Category 2;

    • Specific target organ toxicity – Single exposure, Category 2 or 3;

    • Specific target organ toxicity – Repeated exposure, Category 2;

    • Hazardous to the aquatic environment – Chronic, Category 3 or 4.

The alternative name request should be made to the Ministry online system with the necessary documents and only Turkish importers can make this application.

Important

Fees need to be paid to the Ministry.

Links to Regulations


Oceania

Australia

Generic names may be used in an SDS if the identity of an ingredient is genuinely commercially confidential, and if:

  • the ingredient is in any of the following health hazard categories:

    • Acute toxicity - Category 4 (oral, dermal, inhalation);

    • Aspiration hazard - Category 1;

    • Serious eye damage/eye irritation - Category 2/2;

    • Skin corrosion/irritation - Category 2;

    • Specific target organ toxicity (single exposure) - Category 3.

  • the ingredient does not cause the correct classification of the hazardous chemical to include any other hazard class or category, and

  • an exposure standard for the ingredient has not been established.

New Zealand

Generic names may be used in an SDS if the identity of an ingredient is commercially confidential, and if:

  • (A) the ingredient causes the correct hazard classification of the hazardous substance to include any of the following hazard classifications:

(I) acute toxicity Category 4 (oral, dermal or inhalation):

(II) skin irritation Category 2:

(III) eye irritation Category 2:

(IV) specific target organ toxicity – single exposure Category 3:

(V) aspiration hazard Category 1; and

  • (B) the ingredient does not cause the correct hazard classification of the hazardous substance to include any hazard classification other than those referred to in subparagraph (A); and
  • (C) the identity of the ingredient is confidential information; and
  • (D) a prescribed exposure standard (as defined in the Health and Safety at Work (Hazardous Substances) Regulations 2017) has not been established.

Last update:

Links to Regulations


Asia

China

The real name and CAS numbe r of the component may be omitted depending on the specific circumstances of the need for confidentiality, but the associated hazards shall be included in the relevant section of the SDS.

Korea

To claim Confidential Business Information (CBI) , companies must submit substitute chemical names and concentration information as well as supporting data to the MoEL for approval.

Harmful chemical substances that may cause serious health hazards to workers, i.e.

  • prohibited substances;
  • substances requiring permission;
  • hazardous substances subject to management;
  • harmful factors subject to measurement of the work environment;
  • hazardous factors subject to a special health examination
  • hazardous chemicals under K-REACH are not eligible for CBI claims.

Upon the MoEL’s review, whether approved or disapproved, companies must provide the information on their MSDS. The information (e.g. approval number and expiration date) of the approval are to be indicated in Section 3 on the MSDS.

*Enforcement date of the standard is January 16th of 2021.

Malaysia

The CBI shall be consistent with the following general principles:

  • For information otherwise required on labels or SDS, CBI claims shall be limited to the names of chemicals, their identifiers, and their concentrations in mixtures. All other information shall be disclosed on the label and/or SDS, as required;

  • Where CBI has been withheld, the label or SDS shall so indicate; and

  • CBI shall be disclosed to the Director-General of Occupational Safety and Health upon request. The confidentiality of the information received is protected under Section 67 of OSHA 1994.

Singapore

In section 3 information on chemical hazards must be provided.
Generic names may be used in an SDS if the identity of an ingredient is genuinely commercially confidential, and if:

  • the ingredient is not any of the following health hazard categories:
Hazard ClassHazard CategoryConcentration

Carcinogenic

Category 1

≥ 0.1%

Germ cell mutagenicity

Category 1

≥ 0.1%

Reproductive toxicity

Category 1

≥ 0.1%

STOT, single exposure

Category 1

≥ 1.0%

STOT, repeated exposure

Category 1

≥ 1.0%

Skin corrosion

Category 1

≥ 1.0%

Serious eye damage

Category 1

≥ 1.0%

Respiratory Sensitization

Category 1

≥ 0.1%

Acute Toxicity

Category 1 to 3

≥ 0.1%

  • Or have PEL values as listed in the First Schedule of Workplace Safety and Health (General Provisions) list .

*This information is a summary of SS 586 : Part 3 regulation. Full text is available for charge only

Taiwan

It is possible to use TSN without requesting CBI claim :

  • Is hazardous for the environment and gives environmental classification for the whole product.

It is possible to use TSN without requesting CBI claim :

  • Is hazardous for environment and gives environmental classification for whole product

It is possible to use TSN business has been submitted CBI claim to Taiwan authority:

  1. Acute toxicity categories 4.

  2. Skin corrosion/irritation category 2.

  3. Serious eye damage/irritation category 2A.

  4. Specific target organ toxicity - single exposure category 2.

  5. Specific target organ toxicity - repeated exposure category 2.

  6. Aspiration toxicity cat 1

Withholding Safety Data Sheet content as confidential is prohibited if components are classified as:

  1. Acute toxicity categories 1, 2 or 3.

  2. Skin corrosion/irritation category 1.

  3. Serious eye damage/irritation category 1.

  4. Respiratory or skin sensitizer.

  5. Germ cell mutagenicity.

  6. Carcinogenicity.

  7. Toxic to reproduction.

  8. Specific target organ toxicity - single exposure category 1.

  9. Specific target organ toxicity - repeated exposure category 1.

Thailand

It is possible to use TSN without requesting a CBI claim . Importers must disclose full composition for DIW (Department of Industrial Works) per B.E. 2558 form, if they import more than 1 000 kilograms per year.

Vietnam

Organizations and individuals producing or importing chemicals have to send a classification and labeling of chemicals and materials related to the Chemicals Agency before 15 (fifteen) working days from the date of the chemical in use and circulation in the market. Information considered as confidential business, organization or individual must notify the Department of Chemical chemicals before putting into use, circulation in the market and to the implementation with other agencies as required.

More questions? Ask them in our Discussion board or contact SDS Authoring team .

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