Labeling and Consumer Protection

Guidance for Proprietary Substances

1. Multipurpose GRAS (21 CFR, Part 182, Subpart B) or appropriate GRAS such as sequestrant or anti-caking agents (21 CFR, Part 182, Subparts C and G)
2. Substances permitted for use in animal feed and drinking water listed in Title 21, Parts 573 and 584
3. Prior sanctioned materials
4. Defoaming agents listed in Title 21 Section 173.340 (a)(1) and (a)(2)

1. No longer require evaluation
2. Still subject to labeling requirements and other restrictions that apply to the use of any flavoring
3. Inspectors may use manufacturer’s letter of guaranty as indication of compliance with FDA requirements

1. Formulated with FD&C certified colors - Title 21 Part 74 Subpart A Foods or color additives exempt from certification - Title 21 Part 73 Subpart A Foods
2. Drying agents and diluents that are generally recognized as safe (GRAS) – Title 21 Section 73.1. Specifically, may use water, dextrose (corn sugar), isopropyl alcohol, ethyl alcohol, shellac, and acetone. If a company wants to use another diluent that is listed in Title 21, Section 73.1, they need to obtain clearance from the Food and Drug Administration (FDA).
3. Green inks are used to mark carcasses and parts derived from horses, mules, and other equines
4. Multipurpose GRAS 21 CFR, Part 182, Subpart B

1. Acceptable substances are listed in Title 9, Section 424.21 (c)

1. Acceptable substances are listed in Title 9, Section 424.21 (c)

1. Acceptable substances are listed in Title 9, Section 424.21 (c)

1. Acceptable substances are listed in Title 21, Section 173.315. Substances in the section for washing sugar beets are not acceptable.
2. Label must include the common or chemical name for each ingredient and directions for use adequate to insure compliance with the regulations.

1. Only preflushed animal casings packed in salt or a salt and glycerine solution, or those GRAS (Title 21, Parts 182 and 184) may be used without additional flushing provided they are found to be clean and otherwise acceptable and are thoroughly rinsed with potable water before use.

1. Acceptable substances are listed in Title 9, Section 424.21(c)

1. Acceptable substances are listed in Title 9, Section 424.21(c)

1. May contain edible oils such as corn oil, cottonseed oil, and soybean oil. Mineral oil complying with Title 21, Section 172.878. GRAS substances (Title 21, Parts 182 and 184), and first paragraph of 173.340.

1. Preparations containing dimethylpolysiloxane and other substances cleared for use under Title 21, Sections 173.340(a)(1) and (a)(2), along with other substances generally recognized as safe, (Title 21, Parts 182 and 184).

1. Preparations containing hydrogen peroxide or other substances generally recognized as safe (Title 21, Parts 182 and 184).

1. Acceptable substances are approved food/feed additives, certified color additives, GRAS materials (21 CFR, Parts 573, 584, 182, 184, 73, and 74), or other substances cleared by the FDA Bureau of Veterinary Medicine.

1. Acceptable substances are listed in Title 9, Section 424.21(c)

 

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