About protecting confidential compositional information in Material Safety Data Sheets MSDSs

What is a Material Safety Data Sheet (MSDS or SDS)?
In the US the Hazard Communication Standard (HCS) and in the rest of the World it is required that the chemical manufacturer, distributor, or importer provide Material Safety Data Sheets (MSDSs or SDSs) for each hazardous chemical to users to communicate information on these hazards. The SDS has 16 sections which include information such as:

  • The properties of each chemical;
  • The physical, health, and environmental health hazards; 
  • Protective measures;
  • Safety precautions for handling, storing, and transporting the chemical.
How to protect confidential business information in MSDSs?
The Globally Harmonized System GHS has given different competent authorities capabilities to make their own provisions to protect confidential business info in MSDSs or on labels as along as such provisions do not compromise the health and the safety of workers and consumers. In some regions and countries, withholding confidential business info in SDSs or labels even requires prior approval from local competent authorities. In this article, we have summarized the information disclosure requirements in major countries that have adopted GHS.
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About the United Nations Global Harmosided System UN GH

The UN GHS Purple Book is a guidance document published by the United Nations on the Globally Harmonized System of Classification and Labelling of Chemicals (GHS). The UN GHS Purple Book:

  • Defines physical, health and environmental hazards of chemicals and harmonizes classification criteria;
  • Standardizes the content and format of chemical labels and Safety Data Sheets.
Given the expanding international market in chemical substances and mixtures, to help protect people and the environment, and to facilitate trade, the United Nations (UN) has therefore developed a Globally Harmonized System (GHS) of classification and labelling of chemicals.
In PART 1  INTRODUCTION of the UN GHS Purple Book: Globally Harmonized System of Classification and Labelling of Chemicals (GHS) Eighth revised edition publised by the United Nations in 2019 is highlighted:

"1.1.1.6 (j) in relation to chemical hazard communication, the safety and health of workers, consumers and the public in general, as well as the protection of the environment, should be ensured while protecting confidential business information, as prescribed by the competent authorities."

"1.4.8 Confidential business information 1.4.8.1 Systems adopting the GHS should consider what provisions may be appropriate for the protection of confidential business information (CBI). Such provisions should not compromise the health and safety of workers or consumers, or the protection of the environment. As with other parts of the GHS, the rules of the importing country should apply with respect to CBI claims for imported substances and mixtures. 1.4.8.2 Where a system chooses to provide for protection of confidential business information, competent authorities should establish appropriate mechanisms, in accordance with national law and practice, and consider: (a) whether the inclusion of certain chemicals or classes of chemicals in the arrangements is appropriate to the needs of the system; (b) what definition of “confidential business information” should apply, taking account of factors such as the accessibility of the information by competitors, intellectual property rights and the potential harm disclosure would cause to the employer or supplier's business; and (c) appropriate procedures for the disclosure of confidential business information, where necessary to protect the health and safety of workers or consumers, or to protect the environment, and measures to prevent further disclosure. 1.4.8.3 Specific provisions for the protection of confidential business information may differ among systems in accordance with national law and practice. However, they should be consistent with the following general principles: (a) For information otherwise required on labels or safety data sheets, CBI claims should be limited to the names of chemicals, and their concentrations in mixtures. All other information should be disclosed on the label and/or safety data sheet, as required; (b) Where CBI has been withheld, the label or chemical safety data sheet should so indicate; (c) CBI should be disclosed to the competent authority upon request. The competent authority should protect the confidentiality of the information in accordance with applicable law and practice; (d) Where a medical professional determines that a medical emergency exists due to exposure to a hazardous chemical or a chemical mixture, mechanisms should be in place to ensure timely disclosure by the supplier or employer or competent authority of any specific confidential information necessary for treatment. The medical professional should maintain the confidentiality of the information; (e) For non-emergency situations, the supplier or employer should ensure disclosure of confidential information to a safety or health professional providing medical or other safety and health services to exposed workers or consumers, and to workers or workers' representatives. Persons requesting the information should provide specific reasons for the disclosure, and should agree to use the information only for the purpose of consumer or worker protection, and to otherwise maintain its confidentiality; (f) Where non-disclosure of CBI is challenged, the competent authority should address such challenges or provide for an alternative process for challenges. The supplier or employer should be responsible for supporting the assertion that the withheld information qualifies for CBI protection."

In ANNEX 4 GUIDANCE ON THE PREPARATION OF SAFETY DATA SHEETS (SDS) is highlighted:

A4.3.3 SECTION 3 – Composition/information on ingredients Identify the ingredient(s) of the product in this section. This includes identifying impurities and stabilizing additives which are themselves classified and which contribute to the classification of the substance. This section may also be used to provide information on complex substances. NOTE: For information on ingredients, the competent authority rules for Confidential Business Information (CBI) take priority over the rules for product identification. When applicable, indicate that confidential information about the composition was omitted.

 Occupational Safety and Health Administration OSHA in the USA

The Occupational Safety and Health Administration OSHA clearly explained in this letter The purpose of Material Safety Data Sheets. | Occupational ... the reasons for disclosing the hazards in Material Safety Data Sheets MSDSs.

About the disclosure of confidential information in MSDSs (or SDS´s) by OSHA in the USA

According to OHSA’s hazard communication standards, the following info must be disclosed in MSDSs and on labels:
  • The chemical and common name(s) of all ingredients which have been determined to be health hazards, and which comprise 1% or greater of the composition, except that chemicals identified as carcinogens shall be listed if the concentrations are 0.1% or greater; and,
  • The chemical and common name(s) of all ingredients which have been determined to be health hazards, and which comprise less than 1% (0.1% for carcinogens) of the mixture, if there is evidence that the ingredient(s) could be released from the mixture in concentrations which would exceed an established OSHA permissible exposure limit or ACGIH Threshold Limit Value, or could present a health risk to employees; and,
  • The chemical and common name(s) of all ingredients which have been determined to present a physical hazard when present in the mixture;

Chemical name, substance identification number and exact weight percentage belong to trade secrets if the claim that the information withheld is a trade secret can be supported. Prior approval from OSHA is not required. All hazards must be disclosed. If confidential business info is claimed and withheld from SDSs, they must be indicated as trade secrets in SDSs.

Summary

3Dresyns is committed to disclose the properties of its products; their physical, health, and environmental hazards; protective measures; safety precautions for handling, storing, and transporting to ensure their appropriate safe handling and usage, as well as to provide all the know health & safety precautionary statements, and labelling of pictograms for proper risk and hazard assessment, prevention, mitigation, and communication.

On the other hand, 3Dresyns cannot disclose the chemical compositions since they have been withheld as trade secret to protect 3Dresyns intellectual property.

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