Description
This guidance represents the Food and Drug Administration's (FDA's) current thinking on this topic. It does not create or confer any rights for or on any person and does not operate to bind FDA or the public. You can use an alternative approach if the approach satisfies the requirements of the applicable statutes and regulations.
Scope & Applicability
Product Classes
2The primary product category addressed in the guidance; Safety of nanomaterials in cosmetic products; safety assessment of cosmetic products using nanomaterials; Subject of EU Directive 2003/15/EC and Council Directive 76/768/EEC
Products intended for human use requiring color additive declaration.
Regulatory Context
Attributes
1must accurately identify or describe the basic nature of the food
Related CFR Sections (5)
- 21CFR101.22§ 101.22 Foods; labeling of spices, flavorings, colorings and chemical preservatives.
- 21CFR701.3§ 701.3 Designation of ingredients.
(a) The label on each package of a cosmetic shall bear a declaration of the name of each ingredient in descending order of predominance, except that fragrance or flavor may be listed as fragrance or flavor. An ingredient which is both fragrance and flavor shall be designated by each of the functionsRead full regulation →
- 21CFR73.2087§ 73.2087 Carmine.
(a) Identity and specifications. The color additive carmine shall conform in identity and specifications to the requirements of § 73.100 (a)(2) and (b)(2) .Read full regulation →
- 21CFR101.4§ 101.4 Food; designation of ingredients.
- 21CFR73.100§ 73.100 Cochineal extract; carmine.
(a) Identity.Read full regulation →
Related Warning Letters (10)
- 2025-09-30
CGMP/Food/Prepared, Packed or Held Under Insanitary Conditions/Adulterated
Hans Bakery Inc. d/b/a Andersen’s Bakery
- 2025-06-24
Food Labeling/Misbranded
Revolution Foods, PBC
- 2025-06-03
CGMP/Hazard Analysis/Risk-Based Preventive Controls for Food/Adulterated
One Roof LLC
- 2024-12-03
CGMP/Manufacturing, Packing or Holding Human Food/Adulterated/Insanitary Conditions
Mena Food Group, LLC
- 2024-11-26
Food Labeling/Misbranded
Stew Leonard’s Holdings LLC
- 2024-10-15
CGMP/Food/Prepared, Packed or Held Under Insanitary Conditions/Adulterated
Alfred Louie, Inc.
- 2024-10-01
CGMP/Food/Prepared, Packed or Held Under Insanitary Conditions/Adulterated
NRS Enterprises, Inc. d/b/a Sunflour Bakery
- 2024-06-25
Food Labeling/Misbranded/False and Misleading
Bimbo Bakeries USA, Inc.
- 2024-06-11
Acidified Foods/Prepared Packed or Held Under Insanitary Conditions
Midwest Foods, LLC
- 2024-05-14
Food Labeling/Misbranded
California Bread Co.
See Also (8)
- CPG Sec 555.250 DRAFT: Major Food Allergen Labeling and Cross-contact (Status: Draft)
- Guidance for Industry: Safety of Nanomaterials in Cosmetic Products (Status: Final)
- Guidance for Industry: Registration and Listing of Cosmetic Product Facilities and Products (Status: Final)
- CPG Sec 585.850 Sweet Potatoes - Sirup Pack (Status: Final)
- CPG Sec 567.100 Antipasto, Common or Usual Name (Status: Final)
- Guidance for Industry: Questions and Answers Regarding Food Allergen Labeling (Edition 5) (Status: Final)
- Draft Guidance for Industry: Labeling of Plant-Based Alternatives to Animal-Derived Foods (Status: Draft)
- Guidance for Industry: The Seafood List FDA’s Guide to Determine Acceptable Seafood Names (Status: Final)