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California’s Safe Cosmetics Website Lists Products With Ingredients Suspected to Cause Cancer or Reproductive Harm

Beveridge & Diamond, P.C., February 13, 2014

California’s Safe Cosmetics Program (“SCP”) recently launched a new public disclosure website to fulfill the mandate of the California Safe Cosmetics Act of 2005 (“the Act”).  The site shows the names of products reported by the manufacturer to contain chemicals listed under the SCP as known or suspected carcinogens or reproductive toxicants.  Additionally, because public disclosure regarding the presence of listed chemicals under the Safe Cosmetics Program may have implications under Proposition 65, manufacturers that are required to report for the purposes of the Safe Cosmetics Act should ensure they are also compliant with Proposition 65. 

The California Safe Cosmetics Act

The California Safe Cosmetics Act requires cosmetic manufacturers to disclose to the California Department of Health (“CDPH”) a list of products sold in California that contain any ingredients known or suspected to cause cancer, birth defects, or other reproductive toxicity.[1]  The Act applies to companies with annual aggregate sales of cosmetic products of one million dollars ($1,000,000) or more, including sales within and outside of California.  “Manufacturer” is defined under the Act to mean any person whose name appears on the label of a cosmetic product pursuant to the requirements of Section 701.12 of Title 21 of the Code of Federal Regulations.  Notably, the scope of required reporting to the State includes any ingredient added to the product for the purposes of fragrance or flavoring and any chemical identified on a product label by the phrase “and other ingredients” that is considered a trade secret.  Companies subject to reporting under the Act were initially required to submit all reportable cosmetic products by December 15, 2009 and must report any applicable chemicals for all new products and formulations on a continuous basis.

While the Safe Cosmetics Program appeared to languish for a number of years due to minimal staffing and funding, the Program has taken significant action in recent months.  On August 1, 2013, the SCP produced a list of chemicals known or suspected to cause cancer or reproductive toxicity in order to assist companies in meeting their reporting obligations.  On January 13, 2014, the SCP launched a publicly available, searchable cosmetic product database that allows users to research products by brand name or chemical ingredient to access information about the listed chemicals they contain and how exposure to these chemicals can affect health.  While products containing trade secret ingredients listed under the program must report to the State under the Act, the SCP does not publicly list the identities of the trade secret protected ingredients in the product database.  Instead, the product is simply listed as containing one or more reportable chemicals, identified as “trade secret” rather than by the specific ingredient name.  See https://www.safecosmeticsact.org/search/chemical-profile.aspx.

Although the Safe Cosmetics Act empowers the CDPH to conduct investigations and report its findings to the state’s Office of Environmental Health Hazard Assessment, the primary goal of the Act is to gather information on hazardous and potentially hazardous ingredients in cosmetic products and to make such information easily accessible to the public.  Manufacturers that fail to report under the Act may face both civil and criminal penalties.  Violations of the Act are punishable by civil penalties of up to $1,000 per day.  Criminal penalties for failure to report include up to one year in prison, a fine of not more than $1,000 (or $10,000 if intent to mislead), or both. Moreover, the applicable enforcement provisions allow the Attorney General or any district attorney to bring an action for penalties or an injunction on behalf of the CDPH, hence enforcement is not solely dependent on the time and resources of the CDPH.

The Relationship to Proposition 65

California’s Proposition 65 law, passed by voter initiative in 1986, prohibits any person in the course of doing business from exposing another person to a Proposition 65 listed chemical without first providing a clear and reasonable warning.  The State maintains the list of chemicals known to the State of California to cause cancer, reproductive toxicity, or other reproductive harm (the “Proposition 65 list”).  Because the ingredients that must be reported under the Act are also likely to be listed under Proposition 65, companies that sell cosmetics subject to the Safe Cosmetics Act should ensure that they also meet applicable Proposition 65 warning requirements.

Proposition 65 authorizes civil penalties and, like the Safe Cosmetics Act, conveys relatively broad enforcement authority.  Like the Act, enforcement of Proposition 65 can be undertaken by the Attorney General or a district attorney.  Proposition 65 also allows lawsuits to be brought by any person acting “in the public interest” provided certain requirements are met. Proposition 65 includes civil penalties of up to $2,500 per day for each violation, however, the vast majority of Proposition 65 lawsuits are brought by plaintiffs’ attorneys and NGOs and are settled rather than litigated.  Cal. Health & Safety Code § 25249.7(b)(1); see also California Attorney General page for private enforcement action reporting at https://oag.ca.gov/prop65

Manufacturers Should Take Care to Ensure Compliance with Both Laws

Manufacturers should take time to ensure that they have completed the required reporting under the Safe Cosmetics Act and assess whether any products sold or offered for sale in California require a Proposition 65 warning.  Manufacturers whose products contain reportable ingredients that are trade secrets should be aware that they are not exempt from the reporting requirements of the Act.

Beveridge & Diamond’s Chemicals, Products & Nanotechnology team advises clients in California and worldwide on product-regulatory issues impacting cosmetics and personal care products.  If you have questions regarding how the California Safe Cosmetics Act may affect your business, please contact Laura Duncan (Principal) at (415) 262-4003, lduncan@bdlaw.com; Gary Smith (Principal) at (415) 262-4045, gsmith@bdlaw.com; or Sara Vink (Associate) at (202) 789-6044, svink@bdlaw.com.  

Key Links:

Guidance List of Chemical Agents Known Or Suspected to Cause Cancer, Birth Defects, or Other Reproductive Harm: http://www.cdph.ca.gov/programs/cosmetics/Documents/chemlist.pdf 

California SCP Product Database: https://www.safecosmeticsact.org/search/

California SCP Cosmetics Companies Page: http://www.cdph.ca.gov/programs/cosmetics/Pages/CosmeticsCompanies.aspx

Current Proposition 65 List:

http://oehha.ca.gov/prop65/prop65_list/Newlist.html



[1] “Ingredient” has the same meaning under the Safe Cosmetics Act as the term is defined in 21 Code of Federal Regulations (“CFR”) section 700.3(e) (i.e., any single chemical entity or mixture used as a component in the manufacture of a cosmetic product).  “Incidental ingredients” as defined in 21 CFR section 701.3(l), do not need to be reported.  Incidental ingredients include those that are present in a cosmetic at insignificant levels and that have no technical or functional effect in the cosmetic, such as:  (1) Substances that have no technical or functional effect in the cosmetic but are present by reason of having been incorporated into the cosmetic as an ingredient of another cosmetic ingredient; or, (2) Processing aids, including substances that are added to a cosmetic during the processing of such cosmetic but are removed from the cosmetic in accordance with good manufacturing practices before it is packaged in its finished form; substances that are added to a cosmetic during processing for their technical or functional effect in the processing, are converted to substances the same as constituents of declared ingredients, and do not significantly increase the concentration of those constituents; and/or substances that are added to a cosmetic during the processing of such cosmetic for their technical and functional effect in the processing but are present in the finished cosmetic at insignificant levels and do not have any technical or functional effect in that cosmetic.

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