California set to ban an additional 26 chemicals from cosmetics

Regulatory background

• Cosmetic ingredients in California are governed by the Federal Food, Drug & Cosmetic Act (FD&C Act), which provides that cosmetics produced or distributed for retail sale to consumers for their personal care are required to bear an ingredient declaration (21 CFR 701.3).
• California’s Health and Safety Code (HSC), Sherman Food, Drug, and Cosmetic Laws incorporates the labeling requirements established under the FD&C Act and generally prohibits the sale of falsely advertised, adulterated or misbranded food and cosmetics in California.
• California’s HSC defines a “ cosmetic” as “any article, or its components, intended to be rubbed, poured, sprinkled, or sprayed on, introduced into, or otherwise applied to, the human body, or any part of the human body, for cleansing, beautifying, promoting attractiveness, or altering the appearance.” The term cosmetic does not include soap. Additionally, it is unlawful for any person to adulterate a cosmetic or to receive in commerce any adulterated cosmetic or to deliver or offer for delivery an adulterated cosmetic.
• California’s definition of ingredient is the same as defined at the federal level which is, any single chemical entity or mixture used as a component in the manufacture of a cosmetic product (21 CFR 700.3(e)).
• California’s Safer Consumer Products (SCP) law directs the Department of Toxic Substances Control (DTSC) to establish a process to identify and evaluate chemicals of concern in consumer products and their potential alternatives. The SCP Regulations define a candidate chemical as a chemical that exhibits a “hazard trait and/or an environmental or toxicological endpoint” and is found on one or more of the authoritative lists specified in section 69502.2(A), or listed by DTSC using the criteria specified in section 69502.2(B). Those authoritative lists include numerous lists related to the chemicals known to cause cancer and/or reproductive toxicity that are listed under the HSC section 25249.8 of the California Safe Drinking Water and Toxic Enforcement Act of 1986, the European Union’s (EU) Regulation on the Registration, Evaluation, Authorization of Chemicals (REACH, 1907/2006), and the EU’s Classification, Labeling, and Packaging Regulation (CLP 1272/2008), among others.
• “Hazard traits are intrinsic properties of a chemical that may contribute to adverse effects in humans, animals, or in ecological communities.” The SCP Regulations also refer to the Green Chemistry Hazard Traits defined in the California Code Of Regulations, Title 22, Division 4.5, Chapter 54.
• In September 2020, California enacted legislation (AB 2772) amending the HSC to prohibit the intentional addition of 11 chemicals and 13 PFAS substances and their salts to a cosmetic product. The legislation prohibits any person or entity from manufacturing, selling, delivering, holding, or offering for sale in commerce any cosmetic product that contains any of several specified intentionally added ingredients except under specified circumstances. The ban will become effective on January 1, 2025.

Bill to ban additional chemicals and PFAS in cosmetics

• Assembly bill 496 (AB 496) was first introduced on February 7, 2023, by Assemblymember Laura Friedman and coauthored by Assemblymember Alex Lee. It was passed by the Assembly on September 8, 2023.
• AB 496 would amend the same section of the HSC (108980) to prohibit a person or entity from manufacturing, selling, delivering, holding or offering for sale in commerce any cosmetic product that contains any of the following 26 intentionally added ingredients:
  • Lily aldehyde (CAS RN 80-54-6)
  • Acetaldehyde (CAS RN 75-07-0)
  • Cyclohexylamine (CAS RN 108-91-8)
  • Cyclotetrasiloxane (CAS RN 556-67-2)
  • Phytonadione (CAS RN 84-80-0)
  • Sodium perborate (CAS RN 15120-21-5)
  • Styrene (CAS RN 100-42-5)
  • Trichloroacetic acid (CAS RN 76-03-9)
  • Tricresyl phosphate (CAS RN 1330-78-5)
  • Vinyl acetate (CAS RN 108-05-4)
  • 2-Chloracetamide (CAS RN 79-07-2)
  • Allyl isothiocyanate (CAS RN 57-06-7)
  • Anthraquinone (CAS RN 84-65-1)
  • Malachite green (CAS RN 569-64-2)
  • Oil from the seeds of Laurus nobilis L. (CAS RN 84603-73-6)
  • Pyrogallol (CAS RN 87-66-1)
  • C.I. disperse blue 1 (CAS RN 2475-45-8)
  • Trisodium nitrilotriacetate (CAS RN 5064-31-3)
  • The following boron substances:
    • Perboric acids: (Sodium salt (CAS RN 11138-47-9), Sodium salt, monohydrate (CAS RN 12040-72-1), Sodium perborate monohydrate (CAS RN 10332-33-9)
    • Boric acid (CAS RNs 10043-35-3 and 11113-50-1)
    • Borates, tetraborates, octaborates, and boric acid salts and esters, including all of the following:
      • Disodium octaborate anhydrous (CAS RN 12008-41-2)
      • Disodium octaborate tetrahydrate (CAS RN 12280-03-4)
      • 2-Aminoethanol, monoester with boric acid (CAS RN 10377-81-8)
      • 2-Hydroxypropyl ammonium dihydrogen orthoborate (CAS RN 68003-13-4)
      • Potassium borate, boric acid potassium salt (CAS RN 12712-38-8)
      • Trioctyldodecyl borate
      • Zinc borate (CAS RN 1332-07-6)
      • Sodium borate, disodium tetraborate anhydrous; boric acid, sodium salt (CAS RN 1330-43-4)
      • Tetraboron disodium heptaoxide, hydrate (CAS RN 12267-73-1
      • Orthoboric acid, sodium salt (CAS RN 13840-56-7)
      • Disodium tetraborate decahydrate; borax decahydrate (CAS RN 1303-96-4)
      • Disodium tetraborate pentahydrate; borax pentahydrate (CAS RN 12179-04-3)
  • C.I. disperse blue 3 (CAS RN 2475-46-9)
  • Basic green 1 (CAS RN 633-03-4)
  • Basic blue 7 (CAS RN 2390-60-5)
  • 3(or5)-((4-(benzylmethylamino)phenyl)azo)-1,2 -(or1,4)-dimethyl-1H-1,2,4-triazolium and its salts (CAS RNs 89959-98-8 and 12221-69-1)
  • Basic violet 4 (CAS RN 2390-59-2)
  • Basic blue 3 (CAS RN 33203-82-6)
  • Basic blue 9 (CAS RN 61-73-4)
• However, if a cosmetic product made through manufacturing processes contains a technically unavoidable trace quantity of an ingredient listed above, and that trace quantity stems from impurities of natural or synthetic ingredients, the manufacturing process, storage, or migration from packaging, that trace quantity shall not cause the cosmetic product to be in violation of this prohibition.
• The ban for the intention inclusion of any of these substances in cosmetic product would become effective on January 1, 2027.

Next steps

• AB 496 will be sent to the governor for his signature or veto. Once signed it will officially amend California’s HSC. The bills do not provide penalties for violations of these new provisions, nor does section 108980 of the HSC.
• Both Bill AB 2771 which was signed into law and AB 496 amend the HSC to not only ban these intentionally-added chemicals and PFAS in cosmetics, but also “holding” cosmetics with these intentionally-added substances after the effective dates. A definition of the term “hold” is absent from both of these bills. This calls into question whether this bill could extend to transporters, purchasers, or other intermediaries such as those importing cosmetics through California for sale in a different state. According to a 2022 report by California’s Legislative Analyst’s Office, California ports process about 40 percent of all shipping container-based imports. If holding was deemed to include the pass-through of these products to other states, this could cause critical supply chain issues for cosmetic products arriving at California ports.

To contact the author of this analysis, please email Patricia Iscaro.
To contact the editor of this analysis, please email Scott Stephens.

Key documents and dates

• • • Assembly bill 496 (AB 496)
    • Assembly bill 2771 (AB 2771)
    • California’s Health and Safety Code (Section 108980)
    • Federal Food, Drug & Cosmetic Act (21 CFR 701.3).