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Cosmetics Registration in California and the FDA's Electronic-only Drug Registration
By: David C. Steinberg, Steinberg & Associates
Posted: September 29, 2009, from the October 2009 issue of Cosmetics & Toiletries.
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Flavors and fragrances: If a chemical on the ingredient disclosure list is part of a fragrance or flavor, the state requires manufacturers to register it under the law as they would any other chemical on the list. Manufacturers will need confirmation and the amount of each such chemical from the supplier company. The only chemical on the list that can be used in flavors and fragrances is acetaldehyde.
Instructions and definitions: Definitions2 and instructions3 can be found online. Generally, information that should be submitted includes: the name of the company and any other names under which the company conducts business; the corporation name; the company’s Web site; indication of whether the company is public or private; the company’s business address; representation of how the company is labeled on the product; the company’s contact information; the submitter’s information; the name of the product; the brand name; the name of the manufacturer; the product’s intended use; the list of chemicals that require reporting; and the concentration of the chemicals in the finished product. This represents a challenge, especially for ingredients like titanium dioxide. Pure titanium dioxide is never used and is not an item of commerce. Nano-sized (if they exist) and micro-sized pigments typically have stabilizers and occasionally coatings. These stabilizers often are closely guarded trade secrets and nearly impossible to identify. What is the submitter to do in such cases? Lie and report the amount the manufacturer included? Perhaps it is better to overestimate than underestimate.
Chemicals that must be filed: If a manufacturer has used any of the chemicals listed as potentially causing cancer or reproductive toxicity, the products containing them must be reported. This list4 consists of 783 chemicals; however, the most common ingredients found in cosmetics include: butylated hydroxyanisole (BHA), which is on the Prop 65 list but rarely used; black 2 or carbon black, an FDA batch-certified color; cocamide DEA; methyl alcohol, since it is a denaturant in SD alcohol 1, 3-A, 30; retinol and retinyl esters, with the most common being acetate and palmitate; and titanium dioxide. Less common cosmetic ingredients include: acetaldehyde, used in fragrances; 4-amino-2-nitrophenol, used in hair dyes; prycatechol; dibutyl phthalate; ethyl acrylate; glycol, known by its chemical name ethylene glycol; formaldehyde, but only as the anhydrous gas; lead acetate; spironlactone; sulindac; talc that contains asbestiform fibers; and toluene, previously found in nail polishes.
Creating an account: Accounts, user names and passwords can be obtained online.5 After this information is obtained, the account holder may log in and fill out the form. Instructions are provided on Pages 12–27.6
California has finally released the forms needed for manufacturers to comply with the California Safe Cosmetics Program. It also has published the list of chemicals that, if used in cosmetic products, require registration with the state.