Federal Level: MoCRA
This law, enacted by Congress under the Appropriations Bill, put a lot of pressure on FDA and the deadline for getting the electronic submission portal up and running was not reasonable.
On Nov. 1, 2023, (less than 60 days before the due date of Dec. 29), the FDA issued this statement (bolding added for emphasis):
“[The] industry will soon be able to use “this platform” for cosmetics, as well as drug registration and listing submissions. Stay tuned for implementation of FDA Direct, the latest FDA submission tool for drugs and cosmetics with a new look and menu structures. For more details on the cosmetics platform see: FDA Issues Draft Guidance on Registration and Listing of Cosmetic Product Facilities and Products.”1
One week later, on Nov. 8, the FDA issued a compliance guidance stating that the FDA will not enforce the facility registration and product listing requirements under MoCRA until July 1, 2024. Despite this change, the author advises those affected to still register and submit as soon as possible, assuming the portal is live by time of publication.
California
AB 496: In California, Assembly Bill (AB) 496 issues a ban on certain chemicals. It was enacted on Oct. 8, 2023.2This bill is an add-on to AB 2762, which was signed into law Sept. 30, 2020 and contains a laundry list of chemicals.
The banned list from AB 2762 is effective as of Jan. 1, 2025 while the banned list from the more recent AB 496 is effective on Jan. 1, 2027.
Notably, there is no sell through, meaning products containing an ingredient from the banned list must be off the shelf by Jan. 1 of the applicable year. The common chemicals found in cosmetics to be banned by these bills include the following.
Banned on Jan. 1, 2025:
- Quaternium 15;
- Isobutylparaben and
- Isopropylparaben.
Banned on Jan. 1, 2027:
- Lilial (Butylphenyl Methylpropional);
- Cyclotetrasiloxane; and
- Phytonadione.
Colorado
SB 253: In Colorado, standards for products that are represented, marketed or advertised in the state as being compostable went into effective on Aug. 7, 2023.3 Products that make these claims must comply with ASTM D6400.
Effective July 1, 2024, a producer will be prohibited from representing a product as compostable unless the product has received certification by a recognized, independent, third-party verification body stating the product is as such. Specific labeling standards were set to ensure the product is easily recognizable as compostable: 1) at the point of sale, 2) at the end use of the product and 3) at a public sorting facility.
Effective Jan. 1, 2024, marketing or advertising a non-compostable product using a) tinting, b) color schemes, c) labeling, d) images or e) words that are required for certified compostable products is prohibited. This includes labeling, images or words that could reasonably be anticipated to mislead consumers about the product’s compostability.
Furthermore, non-certified plastic products are prohibited from using any words, labeling or images that imply the plastic product will eventually break down, fragment, biodegrade or decompose in a landfill or other environment. Upon the request of any person, a producer must provide information and documentation demonstrating its compliance with any applicable standards.
Minnesota
HF 2310: The state of Minnesota issued a restriction on lead and cadmium – 90 ppm for lead and 75 ppm for cadmium. This is not the most restrictive limit (see Washington State regulations), so it should not be a concern for the cosmetics industry. However, the need to be aware of varying restriction levels is problematic at best.
New York
AB 619: New York legislation now prohibits mercury, stating no person shall sell or offer for sale any cosmetic product or personal care product containing mercury, other than in trace amounts allowed by the FDA as unavoidable under conditions of good manufacturing practice – or if necessary for use as a preservative in the absence of an effective and safe nonmercurial preservative substitute. This measure should not be a concern for the industry, it merely adds to the burden of keeping track of state restrictions.
AB 8630: The state of New York also prohibited the distribution and sale of cosmetics and personal care products containing mercury and mercury compounds. Here, mercury is defined to mean elemental mercury Hg, mercuric iodide, mercury oxide, mercurous chloride, ethyl mercury, phenylmercuric salts, ammoniated mercury, amide chloride of mercury, mercury sulfide or cinnabaris, or mercury iodide. The prohibition was effective on June 1, 2023 – and once again, this is not a real concern for the industry but it is good to be aware of varying restrictions.
Oregon
HB 3043: The state of Oregon issued an update to the Toxic-Free Kids Act, which goes into effect on Jan. 1, 2024.4 The brand name and model are now required as part of the manufacturer’s reporting information, effective on Jan. 1, 2025. In addition, manufacturers may continue to sell products containing High Priority Chemicals of Concern for Children's Health (HPCCCH) for three years if they have submitted a hazard assessment. After three years, another hazard assessment must be submitted, or the product withdrawn from the market.
SB 546: Also in Oregon, specific chemicals have been prohibited (see below list) and high priority chemicals requiring reporting to the state have been identified. The effective date is Jan. 1, 2024.
This bill is particularly concerning as there is no time to formulate out the affected ingredients and there is no sell through period, although most of the listed chemicals are not used by the cosmetics industry. Bullets one and three below, however, are worth noting.
The prohibited chemicals are:
- Ortho-phthalates, so be sure fragrances do not contain diethyl phthalate;
- Perfluoroalkyl and polyfluoroalkyl substances;
- Formaldehyde (CAS Registry Number 50-00-0) and formaldehyde-releasing agents;
- Methylene glycol (CAS Registry Number 463-57-0);
- Mercury and mercury compounds (CAS Registry Number 7439-97-6);
- Triclosan (CAS Registry Number 3380-34-5);
- m-Phenylenediamine and its salts (CAS Registry Number 108-45-2); and
- o-Phenylenediamine and its salts (CAS Registry Number 95-54-5).
Furthermore, lead or lead compounds are limited to 10 ppm – not unreasonable but something to be aware of. OTC drug products that make cosmetic claims are also covered by this law.
The bill requires the Oregon Authority to create a list of high priority chemicals and review it every three years.4 The list created can include:
- A chemical or class of chemicals on the list of high priority chemicals of concern.
- A chemical or class of chemicals identified by a state agency, another state, a federal agency or an accredited research university, or by other information deemed authoritative by the Oregon Health Authority on the basis of credible scientific evidence, as known to:
- Harm the normal development of a fetus or child or cause other developmental toxicity;
- Cause cancer, genetic damage or reproductive harm;
- Disrupt the endocrine system;
- Damage the nervous system, immune system or organs or cause other systemic toxicity;
- Be persistent, bioaccumulative and toxic; or
- Be very persistent and very bioaccumulative as determined by the authority by rule.
Manufacturers of cosmetic products sold in the state must list it on their website if they have high priority chemicals in their products over the de minimis level.
Texas
HB 2194: The Made in Texas bill is patterned after the “Made in USA” criteria and requires all or virtually all significant parts of a product to originate in Texas. It requires the comptroller to develop a labeling program and applicable logo.5
Washington
HB 1047: The state of Washington also prohibited given chemicals (see below), effective on July 23, 2023, and issued a limit on lead at 1 ppm, which will go into effect on Jan. 1, 2025.6 The bill requires the Department of Ecology to identify formaldehyde releasers and establish a list with stiff penalties for violation.
This bill is most concerning of all. The 1 ppm lead limit is not feasible for most color cosmetics. Industry associations are doing their best to work with Washington regulators to have this modified.
The chemicals prohibited are the usual suspects:
- Ortho-phthalates;
- Perfluoroalkyl and polyfluoroalkyl substances;
- Formaldehyde and chemicals determined by the department to release formaldehyde;
- Methylene glycol;
- Mercury and mercury compounds;
- Triclosan;
- m-phenylenediamine and its salts; and
- o-phenylenediamine and its salts.
Conclusion
The above changes in regulations only account for one year. State-to-state, there is much to keep track of, so organizations are highly advised to implement an action plan.
In addition, this article only covered chemical bans and labeling – a variety of bills on Extended Producer Responsibility have been introduced that cosmetic companies should be aware of to plan for compliance. The struggle is ongoing. It will be interesting to see what 2024 brings.
References:
1. U.S Food and Drug Administration (Nov. 8, 2023). Recent News and Updates. Available at https://www.fda.gov/cosmetics/cosmetics-news-events
2. Assembly Bill No. 496. . (Oct. 10, 2023). California Legislative Information. Available at https://leginfo.legislature.ca.gov/faces/billNavClient.xhtml?bill_id=202320240AB496
3. Senate Bill 23-253. (May 17, 2023). Available at https://leg.colorado.gov/sites/default/files/2023a_253_signed.pdf
4. House Bill 3043 (June 21, 2023). 82nd Oregon Legislative Assembly. Available at https://olis.oregonlegislature.gov/liz/2023R1/Downloads/MeasureDocument/HB3043
5. House Bill No. 2194 (Sept. 1, 2023). Available at https://capitol.texas.gov/tlodocs/88R/billtext/html/HB02194F.htm
6. Substitute House Bill 1047 (July 23, 2023). Available at https://lawfilesext.leg.wa.gov/biennium/2023-24/Pdf/Bills/Session%20Laws/House/1047-S.SL.pdf?q=20231101215521
