Protection of Trade Secrets– Confidentiality of Mixture Components in SDS and Labels

Exporting chemicals to EU countries requires the provision of labels and Safety Data Sheets (SDS). Manufacturers, importers, and downstream users in the EU often worry that disclosing all components of a mixture on the label or SDS might lead to the leakage of trade secrets. Therefore, it may be necessary to use alternative chemical names to protect confidentiality and intellectual property rights.

Under the CLP Regulation, the use of alternative chemical names for mixtures must meet the following criteria:

1. The EU has not established workplace exposure limits for the substance;
2. The use of an alternative chemical name can provide sufficient information to take necessary health and safety precautions in the workplace and ensure that the risks arising from the processing of the mixture can be controlled;
3. The substance is specifically classified under one or more of the following hazard categories:

1. Physical hazards as mentioned in Part 2 of Annex I to the CLP Regulation;
2. Acute toxicity, Category 4;
3. Skin corrosion/irritation, Category 2;
4. Serious eye damage/eye irritation, Category 2;
5. Specific target organ toxicity – single exposure, Category 2 or 3;
6. Specific target organ toxicity – repeated exposure, Category 2;
7. Hazardous to the aquatic environment – acute hazard, Category 3 or 4.

According to the requirements of the CLP Regulation, a fee is required to use alternative chemical names. The amount usually depends on the size of the company and the number of mixtures involved in the request. Additionally, the alternative chemical name cannot be applied for by a "third-party representative" or a "sole representative."

Under the CLP Regulation, the use of alternative chemical names is subject to a fee. The amount typically depends on the size of the company and the number of mixtures covered by the request. In addition, alternative chemical names cannot be requested by a "third-party representative" or a "sole representative."

In accordance with the requirements of the regulatory provisions, ECHA charges a standard fee of €4,000 for requests to use an alternative chemical name for a substance in up to 5 mixtures. If the applicant is an SME (as defined in Regulation 2003/361/EC), ECHA applies a reduced fee as follows:

Table 1: Reduced Fees for SMEs for Substances in Up to 5 Mixtures

For the use of an alternative chemical name for a substance in additional mixtures, an additional fee shall be charged for every 10 additional mixtures as follows:

Table 2: Fees for Every 10 Additional Mixtures Using Alternative Chemical Names

The date on which ECHA receives the payment shall be deemed the date of receipt of the request for an alternative chemical name for the substance. Payment shall be made in euros. Payment should only be made after ECHA has issued an invoice. Payment must be transferred to ECHA's bank account, and each payment must include the invoice number in the reference field. Any overpayment will be refunded and may not be offset against future payments.

The EU requirements for applications for alternative chemical names for substances are relatively stringent. However, for general mixtures, components that are not classified under GHS and do not have occupational exposure limits in the EU do not need to be disclosed on the SDS or label. For components with a GHS classification, if they do not have an occupational exposure limit in the EU, do not have specific requirements such as special concentration limits, and their concentration is below the EU's general threshold values, they may also be omitted from the SDS or label.

Table 3: EU General Threshold Values