By: Vanessa K. Fulton and Daniel Dwyer
On September 30, 2020, California Governor Gavin Newsom signed into law two pieces of legislation related to cosmetics products: the Cosmetic Fragrance and Flavor Ingredient Right to Know Act (SB 312) and the Toxic-Free Cosmetics Act (AB 2762). The Cosmetic Fragrance and Flavor Ingredient Right to Know Act (“Right to Know Act”), effective on January 1, 2022, requires companies to disclose to the State the presence of certain ingredients in cosmetic products, while the Toxic-Free Cosmetics Act, effective in 2025, prohibits the manufacture, sale, or distribution of cosmetics products with certain ingredients. Together, the acts make several key changes to the existing California cosmetic regulation framework.
Similar to California’s Safe Cosmetics Act of 2005, the Right to Know Act requires disclosure of fragrance and flavor ingredients that appear on specified lists. However, the Right to Know Act significantly increases number of specified lists from four to twenty-seven. The Right to Know Act also adds requirements for disclosure of certain fragrance allergen ingredients depending on the amount of the fragrance allergen and the product type (rinse-off or leave-on). Additionally, the Right to Know Act changes the treatment of ingredients identified as trade secrets. While both the Safe Cosmetic Act and the Right to Know Act require cosmetic companies to disclose ingredients identified as trade secrets, the Right to Know Act now requires the identity of these ingredients to be publicly available.
The Toxic-Free Cosmetics Act also expands on California’s current requirements by prohibiting the manufacture, sale, or distribution of cosmetics products with certain specified ingredients. Current California law only prohibits cosmetic products if they are considered “adulterated” under federal law and the Sherman Food, Drug, and Cosmetic Act. Now, products with any of the ingredients specified in the Toxic-Free Cosmetics Act are also prohibited. California’s intent is to prohibit the same intentionally added ingredients as are prohibited in the European Union.
Below is a summary of each act:
Cosmetic Fragrance and Flavor Ingredient Right to Know Act, SB 312
- Effective January 1, 2022, SB 312 (to be codified at California Health & Safety Code Section 111792.6) requires certain cosmetic product companies (identified below) to report to the State Department of Public Health: (1) use of fragrance and flavor ingredients that appear on a list designated by the State (at any levels); and (2) use of certain fragrance allergens present in specific concentrations.
- The requirements apply to the entity included on the cosmetic label pursuant to 21 CFR 701.12, which could be the manufacturer, packer, or distributor.
- Regarding the fragrance and flavor ingredients:
- The designated list of fragrance & flavor ingredients comes from 22 separate sources, including lists from: California, Washington state, U.S. Federal agencies, European governments and organizations, and an international organization. Section 111792.6(a)(2).
- If ingredients are added to any of the lists identified in the law, companies will have six months after the revised list is either adopted or becomes effective (whichever is later) to report the presence of the newly-added ingredient to the State. Section 111792.6(b)(3)(A).
- The State Department of Health is required to create an electronic mailing list that will provide updates on when ingredients are added to any of the lists identified in the law. The electronic mailing list is voluntary – meaning companies will need to sign up to receive the mailing list. Section 111792.6(b)(3)(B).
- Regarding the fragrance allergens:
- The fragrance allergens are listed in EU cosmetic regulations, specifically Annex III of the EU Cosmetics Regulation No. 1223/2009. Section 111792.6(b)(1)(B).
- The reporting requirements only apply to fragrance allergens present at certain concentrations, and the concentration amount varies depending on whether the product is “rinse-off” or “leave-on.” Id.
- For “rinse-off” products, fragrance allergens must be disclosed if present at a concentration at or above 0.01 percent (100 parts per million).
- For “leave-on” products, fragrance allergens must be disclosed if present at a concentration at or above 0.001 percent (10 parts per million).
- The law also requires reporting of the following additional information: whether the products are intended for professional or retail use, the CAS number for each ingredient or allergen, and the UPC for the cosmetic product. Section 111792.6(b)(1)(C)-(E).
- In an effort to protect trade secrets, the law also specifies that it does not require companies to disclose the weight or amount of an ingredient, or the disclosure of any ingredients that do not appear on the specified lists. Section 111792.6(b)(2)(A).
Toxic-Free Cosmetics Act (AB 2762)
- Effective January 1, 2025, AB 2762 (to be codified at California Health & Safety Code Section 10890) prohibits any person or entity from manufacturing, selling (or offering for sale), delivering, or holding any cosmetic product that contains certain specified “intentionally added ingredients.”
- A list of the prohibited ingredients is included below.
- All the ingredients appear to be already prohibited by the European Union. Indeed, AB 2762 states that the intention is to enact a prohibition similar to the EU.
- The law defines “ingredient” by reference to definitions in federal regulations, 21 CFR 700.3(e), 701.3(l). “Ingredient” means any single chemical entity or mixture used as a component in the manufacture of a cosmetic product and does not include incidental ingredients that are present in a cosmetic at insignificant levels and that have no technical or functional effect in the cosmetic. Examples of incidental ingredients include certain ingredients with no technical or functional effect incorporated through another ingredient and certain processing aids. 21 CFR 701.3(l).
- The law contains an exception for products that contain a “technically unavoidable trace quantity” of a prohibited ingredient. Section 10890(b).
- The law does not define “unavoidable” or “trace.”
- The prohibited ingredients are:
- (1) Dibutyl phthalate (CAS no. 84-74-2).
- (2) Diethylhexyl phthalate (CAS no. 117-81-7).
- (3) Formaldehyde (CAS no. 50-00-0).
- (4) Paraformaldehyde (CAS no. 30525-89-4).
- (5) Methylene glycol (CAS no. 463-57-0).
- (6) Quaternium-15 (CAS no. 51229-78-8).
- (7) Mercury (CAS no. 7439-97-6).
- (8) Isobutylparaben (CAS no. 4247-02-3).
- (9) Isopropylparaben (CAS no. 4191-73-5).
- (10) m-Phenylenediamine and its salts (CAS no. 108-45-2).
- (11) o-Phenylenediamine and its salts (CAS no. 95-54-5).