The food additive calcium formate may be safely used in the manufacture of complete swine and poultry feeds in accordance with the following prescribed conditions:

(a) The additive is manufactured by the reaction of butyraldehyde, formaldehyde, calcium hydroxide, and formic acid in water followed by purification and dried to produce a powder consisting of not less than 99.0 percent calcium formate (CAS 544-17-2). The additive meets the following specifications:

(1) The additive consists of minimum 30.5 percent calcium and minimum 68.5 percent formate.

(2) Trimethylolpropane (TMP) not to exceed 125 parts per million.

(b) The additive is used or intended for use as a feed acidifying agent, to lower the pH, in complete swine or poultry feeds at levels not to exceed 1.2 percent of the complete feed.

(c) To ensure safe use of the additive, formic acid and formate salts from all added sources cannot exceed 1.2 percent of complete feed when multiple sources of formic acid and its salts are used in combination.

(d) To ensure safe use of the additive, in addition to the other information required by the Federal Food, Drug, and Cosmetic Act, the label and labeling shall contain:

(1) The name of the additive.

(2) Adequate directions for use including a statement that calcium formate must be uniformly applied and thoroughly mixed into complete feeds and that the complete feeds so treated shall be labeled as containing calcium formate.

(3) Cautions for use including this statement: Caution: Follow label directions. Formic acid and formate salts from all added sources cannot exceed 1.2 percent of complete feed when multiple sources of formic acid and its salts are used in combination.

(e) To ensure safe use of the additive, in addition to the other information required by the act and paragraph (d) of this section, the label and labeling shall contain:

(1) Appropriate warnings and safety precautions concerning calcium formate.

(2) Statements identifying calcium formate as a possible severe irritant.

(3) Information about emergency aid in case of accidental exposure as follows.

(i) Statements reflecting requirements of applicable sections of the Superfund Amendments and Reauthorization Act, and the Occupational Safety and Health Administration's (OSHA) human safety guidance regulations.

(ii) Contact address and telephone number for reporting adverse reactions or to request a copy of the Safety Data Sheet (SDS).

[88 FR 87671, Dec. 19, 2023]