[Source: National Law Review] On June 11, 2020, the California Assembly passed the Toxic-Free Cosmetics Act, Assembly Bill (A.B.) 2762 [1], by a bipartisan vote of 54-0. If enacted by the Senate, the law would be the first in the United States to ban twelve ingredients, including mercury and formaldehyde, from beauty and personal care products sold in California due to toxicity concerns.
Although there are state regulations aimed at protecting cosmetics users, the prohibition on toxic chemical additives in cosmetics has fallen short of what bill proponents maintain is necessary to ensure the safety of consumers. Out of the more than 10,000 chemicals used to formulate beauty and personal care products, the federal Food and Drug Administration (“FDA”) has prohibited or restricted eleven. [2] In contrast, the European Union (“EU”) prohibits or restricts the use of nearly 1,400. [3]
By prohibiting the sale of cosmetic products with specified chemical ingredients, the California Legislature has found that the proposed Toxic-Free Cosmetics Act would “protect[] Californians against harmful chemicals in cosmetic products they use every day.” [4]
Current Law Governing Cosmetics
There are two existing state laws that govern cosmetics – the Sherman Food, Drug and Cosmetic Law (“Sherman Law”) [5] and the California Safe Cosmetics Act of 2005 (“Safe Cosmetics Act”). [6]
The Sherman Law broadly defines “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 appearance.” [7] It prohibits the manufacture, sale, delivery, holding, or offer for sale of any adulterated cosmetic; adulterating any cosmetic is also prohibited. [8] A cosmetic is adulterated if it “bears or contains any poisonous or deleterious substance that may render it injurious to users.” [9] Often, adulteration in the context of cosmetics refers to tampering with a product after it leaves the manufacturer’s control. [10] The Sherman Law is administered by the California Department of Public Health (“CDPH”). [11]
The Safe Cosmetics Act requires manufactures of cosmetic products sold in California to submit a list to the CDPH of all of its cosmetics sold in the state that contain chemical ingredient identified as causing cancer or reproductive toxicity. [12] CDPH maintains an active, searchable database with all of the data collected from manufacturers under the Cosmetics Act. [13] As of May 2020, 613 companies reported 75,279 products. [14] Notably, however, CDPH does not have any enforcement authority over these manufacturers and thus cannot compel compliance. [15]
At the federal level, the Food, Drug & Cosmetic Act requires that cosmetics produced or distributed for retail sale to consumers for personal care must include an ingredient declaration on the label of each package. [16]
Proposed Law Banning 12 Ingredients as Toxic
The Toxic-Free Cosmetics Act intends to ban specified intentionally added ingredients from cosmetics sold in California. As drafted, proposed section 111663 of the Health and Safety Code states that effective January 1, 2025, “no person or entity shall manufacture, sell, delivery, hold, or offer for sale in commerce any cosmetic product that contains any of the following intentionally added ingredients [17]:”
- Dibutyl phthalate;
- Diethylhexyl phthalate;
- Formaldehyde;
- Paraformaldehyde;
- Methylene glycol;
- Quaternium-15;
- Mercury;
- Isobutylparaben;
- Isopropylparaben;
- m-Phenylenediamine and its salts;
- o-Phenylenediamine and its salts; and
- Specified long-chain per- and polyfluoroalkyl substances (PFAS) and their salts. [18]
According to the legislative findings, the listed ingredients are some of the most well-known carcinogens, reproductive toxicants, and endocrine disruptors; all of these substances have been banned by the EU. [19]
The proposed law also includes an exception for cosmetic products made through manufacturing processes that were intended to comply with the law but contain a “technically unavoidable trace quantity” of one of the twelve ingredients and that trace quantity “stems from impurities of natural or synthetic ingredients, the manufacturing process, storage, or migration from packaging.” [20] Such trace quantities will not cause the cosmetic product to be in violation of the law.
Purpose of the Toxic-Free Cosmetics Act
The California Legislature has found that the proposed Toxic-Free Cosmetics Act will address a number of policy issues:
- Fill the regulatory gap in cosmetics safety: Neither the federal FDA nor the CDPH require premarket safety testing, review, or approval of cosmetic products. [21] Under state and federal law, cosmetics and their ingredients are not required to be approved before they are sold to the public and the FDA does not have authority to require manufacturers to file health and safety data on cosmetic ingredients or to order a recall of dangerous cosmetic products. [22]
- Address public health concerns: Cosmetic products are used by children and adults alike as part of daily beauty and cleansing routines, including on sensitive areas like the face, eyelids, and lips. Ensuring that these products are safe and do not include toxic ingredients is essential to protecting all cosmetics users. Of particular concern are pregnant women and new mothers who have a high likelihood of exposing fetuses and young nursing children to toxic substances through their use of cosmetic products. [23]
- Attain consistency with European Union regulations: In 1976, the EU adopted a Cosmetics Directive to create uniform safety standards for cosmetics. Under the Directive, EU regulation No 1223/2009 establishes rules for all cosmetic products available on the market. [24] The proposed law intends to enact a prohibition on toxic ingredients in cosmetics that is consistent with the approach of EU’s regulation, although the EU regulates a broader category of cosmetics. [25]
Implications of COVID-19
The timeline and scope of the Toxic-Free Cosmetics Act has been amended as a result of the California Legislature’s findings regarding coronavirus disease 2019 (“COVID-19”). The original bill was introduced in the legislature in February 2019, over a year before the World Health Organization declared the outbreak of COVID-19 a public health emergency of international concern. Amendments to the Act were approved in Assembly on May 18, 2020, reflecting the drastic implications of the coronavirus pandemic and representing the legislature’s priority in ensuring the state is expending adequate resources on preventing the further spread of the virus.
First, the proposed law includes an effective date of January 1, 2025. Although the original bill included an earlier effective date – January 1, 2022 – the California Assembly found that the companies that will be directly affected by the proposed law are “currently reeling” from the impacts the coronavirus pandemic has had on the economy and the shift in consumer product needs. [26] In fact, as both individual consumers as well as hospitals and healthcare centers have been purchasing more disinfectants to prevent the spread of the virus, many cosmetics companies have refitted their factories to increase production of these products. [27] The California Assembly found that the abrupt manufacturing shift combined with the economic slowdown support extending the start date for the prohibition by three years. [28]
Second, the proposed law does not authorize CDPH to prohibit additional chemicals beyond those specifically listed. The original bill included a provision allowing for CDPH to identify chemicals – that are already forbidden by the EU in Regulation No. 1223.2009 and after a stakeholder process – to ban according to proposed law. Although the California Assembly recognized that exposure to toxic chemicals can impair immune systems and preventing unnecessary exposure to such chemicals in consumer products can protect public health, it found that such an authorization would only add unnecessary pressure on CDPH to perform duties unrelated to the coronavirus pandemic. [29]
State of Play
The Toxic-Free Cosmetics Act was recently passed from the California Assembly to the Senate on June 11, 2020. The legislation is set to be heard by policy and fiscal committees in the Senate before August 2020.
[1] The bill was introduced by Assembly members Al Muratsuchi, Bill Quirk, and Buffy Wicks in February 2019 and is coauthored by Assembly member Bloom and cosponsored by Black Women for Wellness, Breast Cancer Prevention Partners, Environmental Working Group, and the California Public Interest Research Group.
[2] U.S. Food and Drug Administration, Prohibited & Restricted Ingredients in Cosmetics (current as of Nov. 3, 2017), available at https://www.fda.gov/cosmetics/cosmetics-laws-regulations/prohibited-restricted-ingredients-cosmetics.
[3] A.B. 2762, 2019-2020 Leg., Reg. Sess. (Cal.), at 3 (Assembly Committee Third Reading as Amended, June 11, 2020) (“Assembly Analysis”).
[4] A.B. 2762, 2019-2020 Leg., Reg. Sess. (Cal.), at 3 (Assembly Committee on Environmental Safety and Toxic Materials, May 14, 2020) (“Committee on Environmental Safety and Toxic Materials”).
[5] See Health & Saf. Code § 109875 et seq.
[6] Id. at § 111791 et seq.
[7] Id. at § 109900 (“The term ‘cosmetic’ does not include soap.”).
[8] Id. at §§ 111700, 111705.
[9] Id. at § 111670.
[10] Committee on Environmental Safety and Toxic Materials at 3.
[11] Health & Saf. Code § 110045.
[12] Id. at § 111792(a).
[13] Id. at § 111792(e); see CDPH, California Safe Cosmetics Program Product Database (last visited Jun. 29, 2020), available at https://safecosmetics.cdph.ca.gov/search/.
[14] Committee on Environmental Safety and Toxic Materials at 3.
[15] Id.
[16] 21 C.F.R. § 701.3(a).
[17] See California Legislative Information, AB-2762 Cosmetics: safety (2019-2020) (amended May 18, 2020), available at https://leginfo.legislature.ca.gov/faces/billCompareClient.xhtml?bill_id=201920200AB2762&showamends=false (“A.B. 2762 (May 18, 2020)”). The term “ingredient” means any single chemical entity or mixture used as a component in the manufacture of a cosmetic product, as that term is defined in Section 111791.5(d) of the Health and Safety Code.
[18] The PFAS substances prohibited by the proposed law include: (i) Perfluorooctane sulfonate (PFOS); heptadecafluorooctane-1-sulfonic acid; (ii) Potassium perfluorooctanesulfonate; potassium heptadecafluorooctane-1-sulfonate; (iii) Diethanolamine perfluorooctane sulfonate; (iv) Ammonium perfluorooctane sulfonate; ammonium heptadecafluorooctanesulfonate; (v) Lithium perfluorooctane sulfonate; lithium heptadecafluorooctanesulfonate; (vi) Perfluorooctanoic acid (PFOA); (vii) Ammonium pentadecafluorooctanoate; (viii) Nonadecafluorodecanoic acid; (ix) Ammonium nonadecafluorodecanoate; (x) Sodium nonadecafluorodecanoate; (xi) Perfluorononanoic acid (PFNA); (xii) Sodium heptadecafluorononanoate; (xiii) Ammonium perfluorononanoate. See A.B. 2762 (May 18, 2020).
[19] Committee on Environmental Safety and Toxic Materials at 3-4.
[20] See A.B. 2762 (May 18, 2020).
[21] Assembly Floor Analysis at 2.
[22] Id. at 2; see also, U.S. Food and Drug Administration, FDA Authority Over Cosmetics: How Cosmetics Are Not FDA-Approved, but Are FDA-Regulated (current as of Jul. 24, 2018), available at https://www.fda.gov/cosmetics/cosmetics-laws-regulations/fda-authority-over-cosmetics-how-cosmetics-are-not-fda-approved-are-fda-regulated.
[23] Assembly Floor Analysis at 2.
[24] Id. at 3.
[25] The EU’s regulation No 1223/2009 defines “cosmetic product” as “any substance or mixture intended to be placed in contact with the external parts of the human body (epidermis, hair system, nails, lips and external genital organs) or with the teeth and the mucous membranes of the oral cavity with a view exclusively or mainly to cleaning them, perfuming them, changing their appearance, protecting them, keeping them in good condition or correcting body odors.” Id.
[26] Committee on Environmental Safety and Toxic Materials at 4.
[27] Id.
[28] Id.at 4-5.
[29] Id. at 5.
By: Olivia Molodanof
National Law Review, Volume X, Number 182
June 30, 2020
