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Mandatory Reporting Deadline Approaching Under California’s Safe Cosmetics Program

Beveridge & Diamond, P.C., July 30, 2009

Cosmetic manufacturers, packers and distributors must soon report to the California Department of Public Health (CDPH) if any of their products sold in California contain a chemical ingredient identified as causing cancer or reproductive toxicity.  This requirement was established by the California Safe Cosmetics Act of 2005 (the Act),[1] and requires certain reports by October 15, 2009.  The Act applies to any cosmetic product subject to regulation by the federal Food and Drug Administration[2] and sold in California on or after January 1, 2007.  Persons named on a product label pursuant to 21 C.F.R. § 701.12 (including product manufacturers, packers and distributors, generally referred to herein as “cosmetic companies”) are required to report if their aggregate sales of cosmetic products within and outside of California total one million dollars or more.

A list of chemicals subject to reporting under the Act is available here.  The list includes all Proposition 65-listed chemicals plus chemicals identified by other authoritative scientific bodies including the National Toxicology Program (NTP), the International Agency for Research on Cancer (IARC), and the U.S. Environmental Protection Agency (EPA).[3]  The list currently contains 783 chemicals and includes several common cosmetic ingredients such as titanium dioxide and phthalates.  CDPH plans to review and update the list annually.

Cosmetic companies reporting under the Act must include the name of the listed chemical, its Chemical Abstract Service (CAS) number, and the product or products in which the chemical is contained.  There is no de minimis threshold for reporting under the Act, and unlike federal law, the Act does not include exemptions for chemicals used as fragrances or flavoring.[4]  Chemical ingredients determined to be trade secrets (e.g., those chemicals listed on a product labels as “other ingredients”) must be reported if they are listed chemicals under the Act, although their identities will not be disclosed by CDPH.  Incidental ingredients that are present in a cosmetic at insignificant levels and that have no technical or functional effect do not need to be declared under the Act.[5]

The California Safe Cosmetics Program launched an online system for reporting under the Act on June 15, 2009.[6] Click here to access the Program's webpage. Cosmetic companies subject to reporting under the Act must submit information for all reportable cosmetic products by October 15, 2009.  For any new products that become subject to reporting after that date, cosmetic companies will have one month to report.  CDPH is requiring filings for all reportable products sold in California on or after January 1, 2007, even if the product is no longer being manufactured.  CDPH plans to post an online list of non-confidential product data for consumers.  CDPH will not release the identities of any product ingredients claimed as trade secrets, but it will flag the associated products as containing a reportable ingredient.

Beveridge & Diamond, P.C. has a broad environmental practice including representation of consumer products companies with regard to chemical regulation (such as Proposition 65, California Green Chemistry, the federal Toxic Substances Control Act, EU REACH, nanotechnology), consumer product safety laws, market access, and transactional issues.  For additional information or guidance regarding the California Safe Cosmetics Program, please contact Gary Smith (gsmith@bdlaw.com) or Laura Duncan (lduncan@bdlaw.com).


[1] California Health & Safety (H&S) Code §§ 111791 - 111793.5.

[2] The Federal Food, Drug, and Cosmetic Act defines cosmetics as “articles intended to be rubbed, poured, sprinkled, or sprayed on, introduced into, or otherwise applied to the human body or any part thereof for cleansing, beautifying, promoting attractiveness, or altering the appearance,” including articles for use as components of cosmetics but excluding soap.  21 U.S.C. § 321(i).

[3] See California H&S Code § 111791.5(b).

[4] This may present compliance difficulties for companies that do not know the full chemical composition of their products (e.g., fragrances obtained from other suppliers).

[5] See 21 C.F.R. § 700.3(l) for additional details and examples of incidental ingredients.

[6] Although the Act took effect on January 1, 2007, there was no mechanism for companies to report until the electronic system came online in June 2009.

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