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U.S. requirements for confidentiality of ingredients in SDS

Posted Date:2025/1/21

Safety Data Sheet (SDS), also known as chemical safety technical specification, is one of the important compliance documents in chemical management. The third part of the SDS deals with ingredient information, which includes provisions for commercial confidentiality. The following are U.S. regulations regarding the commercial confidentiality of ingredient information:

(i)Trade secrets.

(1)The chemical manufacturer, importer, or employer may withhold the specific chemical identity, including the chemical name, other specific identification of a hazardous chemical and/or the exact percentage (concentration) or concentration range of the substance in a mixture, from section 3 of the safety data sheet, provided that:

(i)The claim that the information withheld is a trade secret can be supported;

(ii)Information contained in the safety data sheet concerning the properties and effects of the hazardous chemical is disclosed;

(iii)The safety data sheet indicates that the specific chemical identity and/or concentration(i)or concentration range of composition is being withheld as a trade secret;

(iv) If the concentration or concentration range is being claimed as a trade secret then the safety data sheet provides the ingredient's concentration as one of the prescribed ranges below in paragraphs (i)(1)(iv)(A) through (M) of this section.

(v)The prescribed concentration range used must be the narrowest range possible. If the exact concentration range falls between 0.1% and 30% and does not fit entirely into one of the prescribed concentration ranges of paragraphs (i)(1)(iv)(A) to (G) of this section,a single range created by the combination of two applicable consecutive ranges between paragraphs (i)(1)(iv)(A) and (G) of this section may be disclosed instead,provided that the combined concentration range does not include any range that falls entirely outside the exact concentration range in which the ingredient is present.

(vi)Manufacturers may provide a range narrower than those prescribed in (i)(1)(v).

(vii) The specific chemical identity and exact concentration or concentration range is made available to health professionals, employees, and designated representatives in accordance with the applicable provisions of this paragraph (i) of this section.