Confidential Business Information
Depending on the country, the use of Trade Secret Names (TSN) may be subject to certain limitations and considerations. See the resume in the following table.
Some specificities considering the region/country:
Great Britain
It can be requested the use of an alternative chemical name if all three of the following requirements are met:
- You are a GB-based manufacturer, importer or downstream user (M/I/DU), or a NI-based M/DU supplying qualifying NI goods (QNIG) directly to the GB market
- The substance (ingredient in the mixture) meets the criteria in Article 24 and Section 1.4 of Annex I of the GB CLP Regulation
- You can demonstrate that including the name of the substance on the label or SDS would put the confidential nature of your business at risk
Where granted, the alternative name can be used on the label and in the SDS for mixtures placed on the GB market.
The GB alternative name CANNOT be used for mixtures placed on the EU market.
HSE is responsible for administering requests for alternative chemical names in GB. This page offers more information on this provision and provides guidance for GB-based M/I/DU and NI-based M/DU who place mixtures on the GB market.
Article 24 and Section 1.4 of Annex I of the GB CLP Regulation provides detailed criteria and procedures for the application to use an alternative chemical name.
Application Submission: An application must be submitted to the Health and Safety Executive (HSE) in GB, including:
- Justification for the use of an alternative name.
- Evidence that the substance meets the criteria for confidentiality.
- Information on the hazards of the substance and how the alternative name will still allow for appropriate risk management.
Hazard Categories: The substance must be classified exclusively in 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.
Approval: The HSE will review the application and, if approved, will allow the use of the alternative chemical name in the Safety Data Sheet (SDS) and labeling.
Important Considerations:
Fees: There may be fees associated with the application process, and these should be checked with the HSE.
Compliance: It is crucial to ensure that all other relevant regulations and guidelines are followed to maintain compliance.
North America
Canada
Hazardous ingredients are required to be disclosed on Canada SDS. To keep them as a 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
- The HMIRA claim has a cost associated.
- Claim is valid for 3 years ; can be renewed.
USA
If TSNs are used in section 3, 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.
South America
Rest of South America countries
Regulatory agency approval is not required.
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 and they are not classified as CMRs.
Oceania
Asia
Korea
Complete amendment of OSHA (Jan. 2019) and its decrees (Dec. 2019):
The changed MSDS policy was enforced since January 16, 2021 including new obligations like MSDS submission and CBI claim for specific components
CBI claims for Confidential Business Information:
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.
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.
Requirements
- MSDS of product
- Full composition of product
- Supporting materials to prove that the target chemical is a trade secret
- Secrecy of the information;
- Competitive or economic advantage conferred on the owner by the information
- Reasonable efforts by the owner to maintain secrecy of the information
- Substitute name and concentration range of target chemical
- Information of health/environmental and physical hazards of target chemicals
- Other documents announced by MoEL
*R&D chemicals can omit 3) and 6)
Validity period:
5 years (extendable every 5 years)
Processing period
More than 2~3 months (1 months for R&D products)
Fees
Basic fee 70k KRW + 40k KRW*number of CBI components (maximum 270k KRW)~200EUR
Substances not subject to CBI claims
- (under the K-OSHA) Harmful Substances Prohibited from Manufacturing, Harmful Substances Required Permission for Manufacture, Controlled Hazardous Substances, Controlled Substances Subject to Environment Monitoring, Controlled Substances Subject to Health Examination
- (under the K-REACH) Toxic Substances, Authorization Substances Restricted Substances, Prohibited Substances
Tricky Point:
Information disclosed in an SDS from another country cannot be kept confidential in Korea.
Economic value must be submitted, even if only approximate.
CBI conditions_ All three conditions must be met :
- Non-publicity
Who knows the information, both inside and outside the company.
Whether it's legally disclosed elsewhere.
- Confidentiality Management
Measures taken to protect the information.
Difficulty for others to access it.
- Economic Value
Advantage to competitors if disclosed.
Investment made to develop the information.
If an Article contains Special control substances, we need to get CBI approval for ALL concealed substances in Chapter 3.
Thailand
For non-hazardous chemical products imported into Thailand, a statement from the supplier is sufficient. There is no need to disclose the full composition.
For hazardous chemical products, It is possible to use TSN without requesting a CBI claim, but DIW usually requires notifiers to disclose their product composition 100%. Importers must disclose full composition for DIW (Department of Industrial Works) per B.E. 2558 form, if they import more than 1t hazardous substances per year.(1, 2, 3)
For imported products, foreign suppliers may consider using a local third-party agent to submit all info on behalf of importers to protect confidential business info.
Exemption could be applied if the person has already been granted a permit for production, import or export of hazardous substances, a permit for the possession of the particular hazardous substance could be exempted.
Hazardous Substance type 4 used for R&D could be exempted.
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