Many cosmetics companies are familiar with the need to comply with California Proposition 65 regulations for their products, but are you aware of the the over-arching and new regulations that apply to cosmetics sold in California? The California Safe Cosmetics Act of 2005 (CSCA) requires manufacturers, packers, and/or distributors of cosmetic products to report to the California Department of Public Health (CDPH) all products sold in California, which contain ingredients known or suspected to cause cancer, birth defects, or other reproductive harm (as well as certain environmental toxins). This is established based on numerous "designated lists" published by various authorities. For some chemicals, any presence of the chemical (like 1,4-dioxane) triggers reporting requirements. These can be submitted to the CDPH via its online portal. Small businesses with less than $1 million of annual aggregate sales of cosmetic products are exempt from this reporting requirement. More recently, the Cosmetic Fragrance and [...]
The US FDA has published new information regarding the MOCRA facility registration and product listing requirements, including: screenshots/overview of the electronic submission portal ("Cosmetics Direct") [this is not online yet, expected in October] how to obtain a "FDA Establishment Identifier (FEI)" for your business (which will be required prior to registering your facility through "Cosmetics Direct" [this can be done now] drafts of the electronic/paper forms (can be used but electronic submissions are highly encouraged) request for comments from stakeholders on the above. If your company requires any assistance in getting ready for these MOCRA requirements, please reach out directly! RegTox can support your MOCRA requirements: obtaining FEI facility and product listing agent support
The US FDA has recently published an additional draft guidance document called "Registration and Listing of Cosmetic Product Facilities and Products: Guidance for Industry" as it relates to the cosmetic regulation overhaul under MOCRA. Although companies around the world are eagerly awaiting details about how to comply with MOCRA for their products sold on the US marketplace, there is still much to learn! The FDA stated that the electronic facility registration and product listing portal will only be available in October (there will be a paper format as well). Until then companies can assess whether they are eligible for any exemptions (i.e., small business, etc) and prepare by compiling relevant information for The guidance otherwise, provided definitions, exemptions, and a Q&A format explanation of some of the requirements. Stay tuned for further MOCRA guidance updates!
Within the Consolidated Appropriations Act, 2023 that was passed by the US Congress on December 29, 2022, under Subtitle E, it included the "Modernization of Cosmetics Regulation Act of 2022" (MoCRA), which creates new legal requirements for cosmetic companies and new authority for the US FDA. This Act is expected to provide greater FDA oversight and tracking of cosmetics. Key points in brief: (Definitions: "responsible person" = manufacturer, packer, or distributor of a cosmetic product whose name appears on the label; "facility" = site of manufacturing or processing but not including entities involved solely in one or more of: labeling, packaging, holding, distributing). Facility Registration (Sec. 607(b)): each facility that manufacturers or processes cosmetics for sale in the US, including foreign facilities, must register with the Secretary within 1 year of enactment (by Dec. 29, 2023) and renewed every other year (biennially). Foreign entities must have a US agent on [...]
If your company manufactures any type of cleaning product and sells it into California, then you likely have already heard about the "California Cleaning Product Right to Know Act of 2017" ("the Act"). If not, here is a general summary to bring you up to speed! This Act requires manufacturers of certain types of cleaning products to disclose the presence of certain chemicals on the company's website, as well as on product labels. The website disclosure part of the Act is effective now for products sold on or after January 1st, 2020. The product label disclosure part of the Act becomes effective next year on January 1st, 2021. Essentially, companies need to check whether the ingredients in their products are listed on any of the 22 "designated lists" prescribed in the Act (state, federal, and international chemical databases). This Act applies to "designated products", including (see Act for full definitions): Air care [...]