For Europe to request for the use of an alternative chemical name

(to protect confidential business information) under the REACH regulation is associated with a fee.

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  EMEA EMEA

  EMEA

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    Great Britain Great Britain

    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 Regulationprovides 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.

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    Ukraine Ukraine

    Ukraine

The adoption of the Globally Harmonized System of Classification and Labelling of Chemicals (GHS) versions 5, 6, and 7 in Ukraine brings about specific regulations and requirements for the classification, labeling, and safety data sheets (SDS) of chemicals.

Regarding the use of trade secret names to hide chemical names and CAS numbers, GHS does allow for the protection of confidential business information (CBI), including trade secrets, under certain conditions. 

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    Russia Russia

    Russia

There are no applications needed to be filled or any statement added in section 3. Trade secret names can be used if components have no OEL and if they are not classified as CMRs.

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    Turkey Turkey

    Turkey

Requests for use of a 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.

Fees need to be paid to the Ministry.

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  North America North America

  North America

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    Canada Canada

    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.

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    Mexico Mexico

    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.

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    USA USA

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.

supplier.

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  South America South America

  South America

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    Argentina, Brazil Argentina, Brazil

• • Argentina, Brazil

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

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    Rest of South America countries Rest of South America countries

    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.

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  Oceania Oceania

  Oceania

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    Australia Australia

• • 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.

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    New Zealand New Zealand

    New Zealand

Generic names may be used in an SDS if the identity of an ingredient is commercially confidential, and if (1):

• (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. 

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  Asia Asia

  Asia

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    China China

    China

The real name and CAS number 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.

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    Korea Korea

    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

1. MSDS of product
2. Full composition of product
3. Supporting materials to prove that the target chemical is a trade secret 
1. Secrecy of the information; 
2. Competitive or economic advantage conferred on the owner by the information 
3. Reasonable efforts by the owner to maintain secrecy of the information
4. Substitute name and concentration range of target chemical
5. Information of health/environmental and physical hazards of target chemicals
6. 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 :

1. Non-publicity

Who knows the information, both inside and outside the company.

Whether it's legally disclosed elsewhere.

1. Confidentiality Management

Measures taken to protect the information.

Difficulty for others to access it.

1. 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.

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    Malaysia Malaysia

    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. Theconfidentiality of the information received is protected under Section 67 of OSHA 1994.
  
  

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    Taiwan Taiwan

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It is possible to use TSN without requesting CBI claim if :

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

It is possible to use TSN if 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:

• Acute toxicity categories 1, 2 or 3.
• Skin corrosion/irritation category 1.
• Serious eye damage/irritation category 1.
• Respiratory or skin sensitizer.
• Germ cell mutagenicity.
• Carcinogenicity.
• Toxic to reproduction.
• Specific target organ toxicity - single exposure category 1.
• Specific target organ toxicity - repeated exposure category 1.

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    Vietnam Vietnam

    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.

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    Singapore Singapore

    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:

• 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

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    Thailand Thailand

    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.