Governor Gavin Newsom further expanded California’s regulation of chemicals in personal care products by signing AB 2762 and SB 312 on September 30, 2020.
Commencing on January 1, 2025, AB 2762 prohibits manufacturing or selling any cosmetics containing as an intentionally added ingredient 24 specified chemicals. Many of these 24 chemicals are commonly employed in manufacturing and packaging or as processing aids or preservatives and include: methylene glycol, formaldehyde, mercury and phthalates, such as dibutyl phthalate and diethylhexyl phthalate (DEHP). The list also includes emerging chemicals such as perfluorooctanoic acid (PFOA) and perfluorooctane sulfonate (PFOS). While AB 2760 includes no numerical de minimis levels exempt from the ban, products may contain “technically unavoidable trace quantities” which “stem … from impurities of natural or synthetic ingredients, the manufacturing process, storage or migration from packaging.” Based on prior experience, California is likely to interpret this exception narrowly.
Given long reformulation horizons for some products, entities need to start planning now to comply with the AB 2760 ban. While some business may attempt to limit unreformulated product sales in California (e.g., labeling a product “Not for Sale in California”), this strategy can be extremely difficult to execute in light of modern distribution and sale chains. While enforcement mechanisms are not specified in the bill itself, the Office of the Attorney General can enforce all state laws.
SB 312 is the Cosmetic Fragrance and Flavor Ingredient Right to Know Act of 2020. Effective January 1, 2022, SB 312 requires manufacturers selling cosmetic products in California to report certain (deemed) hazardous fragrance and flavor ingredients to the Department of Public Health’s (DPH) Safe Cosmetics Program. DPH releases that information to the public through the Safe Cosmetics Database. DPH also describes the health hazards associated with the reported ingredients. While SB 312 does not ban any chemicals for which reporting is required, the law creates an incentive to reformulate because citizen enforcers under Proposition 65 (The Safe Drinking Water and Toxic Enforcement Act of 1986) and personal injury plaintiffs can review the DPH website for litigation targets.
California justifies SB 312 because it deems federal efforts insufficient and has determined residents are entitled to information on known or potential “carcinogens, reproductive toxicants, asthmagens, neurotoxicants, allergens, and other chemicals of concern” in cosmetics. Similar to federal law, “cosmetic products” are broadly defined as “an article for retail sale or professional use intended to be rubbed, poured, sprinkled, or sprayed on, introduced into, or otherwise applied to the human body for cleansing, beautifying, promoting attractiveness, or altering the appearance.” SB 312 thus covers both consumer and professional use products.
SB 312 is likely to impose logistical challenges. The ingredients that require reporting are determined by reference to 22 different lists, all of which will require monitoring. Some of these lists are maintained by foreign jurisdictions (e.g., Canada and the European Union) or are obscure to many, such as the “chemicals identified on Part A of the List of Chemicals for Priority Action prepared by the Oslo and Paris Conventions for the Protection of the Marine Environment of the North-East Atlantic.” Reporting is required for each of the over 900 Proposition 65 listed chemicals. Many of the lists are updated on a non-routine basis, so monitoring efforts will be continual.
It’s important to note that SB 312 recognizes only limited trade secret protection for ingredients subject to reporting. SB 312 specifically provides that “[a] fragrance ingredient or a flavor ingredient that is included in a designated list … does not constitute a trade secret.”
Because SB 312 imposes “only” reporting obligations and does not impose bans on content limitations on cosmetic products, DHS will be confident that federal preemption will not limit application of the law. However, given DHS controls the Safe Cosmetics Program website and plans to include information beyond just ingredient content, possible challenges can arise, perhaps based on statements DHS includes regarding the hazards associated with any given ingredient. Many ingredients on the designated lists are subject to ongoing health hazard assessments by federal authorities including the Food and Drug Administration (FDA) and U.S. Environmental Protection Agency (EPA). It is unclear whether DHS will in all cases timely update and correct its own website to reflect federally determined hazard evaluations or even changes in the 22 designated lists.
The recent activity in California may preview future federal developments. In the absence of federal regulation, it is not uncommon for states to begin applying individualized requirements. Examples include nutrition information on restaurant menus and labeling for bioengineered foods Currently, the FDA applies relatively limited standards to cosmetics. The FDA may soon face increased pressure to regulate cosmetics due to growing public concern — whether scientifically justified or arising from uncontrolled social media pressure — regarding ingredients in personal care products.