Different Types of Ingredients and When They Must Be Reported

The California Safe Cosmetics Act of 2005 (CSCA) and the Cosmetics Fragrance & Flavor Ingredient Right to Know Act of 2020 (CFFRIKA) both require companies to report products containing specific toxic ingredients to the California Department of Public Health (CDPH). CSCP has compiled those ingredients into the Reportable Ingredient List (Excel). The following definitions and guidance are intended to help companies understand how to report some products and ingredient types that may require clarification. More information about these laws is available on the CSCA and CFFIRKA Compliance Information page.

• Ingredient
  
• Fragrance Ingredient
  
• Flavor Ingredient
  
• Fragrance Allergen
  
• Naturally Occurring Chemicals
  
• Incidental Ingredient
  
• Cosmetic-Drugs or Over-the-Counter (OTC) Drugs
  
• Titanium Dioxide
  
• Carbon Black and Carbon Black Extracts
  
• Crystalline Silica
  
• Aloe Vera
  

Ingredient¹ is defined as any single chemical entity or mixture used as a component in the manufacture of a cosmetic product. There is an exception in the law for incidental ingredients—see definition below.

Fragrance ingredient² is any intentionally added substance or complex mixture of aroma chemicals, natural essential oils, and other functional ingredient or ingredients for which the purpose is to impart an odor or scent, or to counteract an odor.

Flavor ingredient² is any intentionally added substance or complex mixture of aroma chemicals, flavor chemicals, natural essential oils, and other functional ingredient or ingredients for which the purpose is to impart a flavor or taste, or to counteract a flavor or taste.

Fragrance allergens are reportable under CFFRIKA, but unlike fragrance ingredients defined above, they must be reported regardless of their intended purpose in the product, i.e. they must be reported even if they are not used to impart scent or counteract odor. Fragrance allergens must only be reported when present in a rinse-off cosmetic product at a concentration at or above 0.01 percent (100 parts per million) or in a leave-on cosmetic product at a concentration at or above 0.001 percent (10 parts per million).

Naturally occurring chemicals that are constituents of an intentionally added ingredient must be reported if they are on the Reportable Ingredients List. For example, beta-myrcene is in some essential oils and must be reported if so.

Incidental ingredients³ do not need to be reported if they are present in a cosmetic at insignificant levels or trace amounts. Incidental ingredients are:

• Substances that have no technical or functional effect in the cosmetic but are present by reason of having been incorporated into the cosmetic as an ingredient of another cosmetic ingredient.
• Processing aids, which are as follows:
• Substances that are added to a cosmetic during the processing of such cosmetic but are removed from the cosmetic in accordance with good manufacturing practices before it is packaged in its finished form.
• Substances that are added to a cosmetic during processing for their technical or functional effect in the processing, are converted to substances the same as constituents of declared ingredients, and do not significantly increase the concentration of those constituents.
• Substances that are added to a cosmetic during the processing of such cosmetic for their technical and functional effect in the processing but are present in the finished cosmetic at insignificant levels and do not have any technical or functional effect in that cosmetic.

Cosmetic Drugs or Over-the-Counter (OTC) Drugs: According to the U.S. Food and Drug Administration, some products meet the definitions of both cosmetics and drugs under federal law (the Federal Food, Drug and Cosmetic Act). CSCA and CFFIRKA apply to any cosmetic product subject to regulation by the federal Food and Drug Administration.⁴ Examples of products that meet both definitions and must be reported are:

• Lip balms that moisturize or have a color tint
• Anti-dandruff shampoos
  
• Antiperspirants with deodorant
  

Titanium dioxide is reportable due to its listing by IARC⁵ as a possible human carcinogen. The IARC listing is based on sufficient evidence of carcinogenicity in experimental animal studies, i.e., evidence that animals exposed to airborne respirable particles of titanium dioxide developed lung cancer. Titanium dioxide is also listed under Prop 65⁶ as “titanium dioxide (airborne, unbound particles of respirable size).” Companies need only report products with titanium dioxide that can potentially be present as airborne, unbound particles of respirable size, including products that are in powder form, pressed powders, aerosols, and other products that are inhalable.

Carbon black is reportable due to its listing by IARC⁷ as a possible human carcinogen. The IARC listing is based on sufficient evidence of carcinogenicity in experimental animal studies, i.e., evidence that animals exposed to airborne respirable particles of carbon black developed lung cancer. Carbon black is also listed under Prop 65⁸ as “Carbon black (airborne, unbound particles of respirable size).” Companies need only report products with carbon black that can potentially be present as airborne, unbound particles of respirable size, including products that are in powder form, pressed powders, aerosols, and other products that are inhalable.  

Carbon black extracts are also reportable due to being listed by IARC as a possible human carcinogen. The IARC listing is based on sufficient evidence of carcinogenicity in experimental animal studies, i.e., evidence that animals dermally or subcutaneously exposed to carbon black extracts developed tumors. Companies must report all products containing carbon black extracts. 

Crystalline silica in the form of quartz, cristobalite, and cristobalite dust is reportable due to its listing by IARC⁹ as a human carcinogen. The IARC listing for crystalline silica is based on sufficient evidence of carcinogenicity in humans, i.e., crystalline silica causes lung cancer. Crystalline silica is also listed under Prop 65¹⁰ as "Silica, crystalline (airborne, unbound particles of respirable size)." Companies need only report products with crystalline silica that can potentially be present as airborne, unbound particles of respirable size, including products that are in powder form, pressed powders, aerosols, and other products that are inhalable.

Whole leaf extract of aloe vera is reportable due to its listing by IARC¹¹ as a possible human carcinogen. Aloe vera is also listed under Prop 65¹² as “Aloe Vera, Non-decolorized Whole Leaf Extract.” Decolorized whole leaf extract of aloe vera has been filtered to remove cancer-causing chemicals naturally found in the aloe vera plant. Companies need only report products with non-decolorized (unfiltered) whole extract of aloe vera.

¹ Subdivision (e) of Section 700.3 of Part 700 of Chapter 1 of Title 21 of the Code of Federal Regulations, as referenced in California Health and Safety Code Section 111791.5, subdivision (d).

² California Health and Safety Code Section 111792.6. 

³ Subdivision (l) of Section 701.3 of Part 701 of Chapter 1 of Title 21 of the Code of Federal Regulations, as referenced in California Health and Safety Code Section 111791.5, subdivision (d).

⁴ California Health and Safety Code Section 111792, subdivision (a).

⁵Carbon Black, Titanium Dioxide, and Talc: IARC Monographs on the Evaluation of Carcinogenic Risks to Humans Volume 93.

⁶Prop 65 listing for titanium dioxide. 

⁷Carbon Black, Titanium Dioxide, and Talc: IARC Monographs on the Evaluation of Carcinogenic Risks to Humans Volume 93.

⁸Prop 65 listing for carbon black.

⁹Arsenic, Metals, Fibres, and Dusts: IARC Monographs on the Evaluation of Carcinogenic Risks to Humans Volume 100C.

¹⁰Prop 65 listing for crystalline silica. 

¹¹IARC monograph on aloe vera (PDF, 4.4MB).

¹²Prop 65 list for aloe vera.

Email SafeCosmetics@cdph.ca.gov for more information.