The Safe Cosmetics Act was enacted in 2005 and became effective January 1, 2007. Businesses manufacturing cosmetics sold in California were required to make their initial report to the California Department of Public Health by December 15, 2009. Reporting must be made on a continuous basis, such as when formulation changes add a “suspect” chemical to an existing cosmetic product. The Safe Cosmetics Act is so little-known that many manufacturers may have missed the reporting requirements, or complied as to some products but failed to update their reporting as product formulations changed. So far, those omissions have rarely had any significant impact on manufacturers, but that is likely to start changing now.
The relative quietude may change in 2014 because by December 31, 2013 the CDPH must make a publicly accessible database available on its website containing all of the information collected pursuant to the Safe Cosmetics Act. The information included in the database could be used by enterprising Prop 65 bounty hunters searching for products that contain chemicals that are subject to the warning requirements of Prop 65. And the failure to report required information timely or accurately may be the basis for future unfair competition lawsuits by private parties, including consumers and competitors.
As a harbinger of the potential consequences for manufacturers, in January 2012 the California Attorney General’s Office announced the first law enforcement action taken under the Safe Cosmetics Act against a manufacturer of “Brazilian Blowout” products. But the manufacturer’s failure comply with the Safe Cosmetics Act’s reporting requirement was only one of many business acts and practices alleged to violate California’s Unfair Competition Law. The Attorney General also alleged violations of California’s False Advertising Law and Proposition 65. The end result was a consent judgment that required the manufacturer to pay $300,000 in attorneys’ fees and costs and an additional $300,000 civil penalty for violation of Prop 65. The manufacturer was also subject to numerous injunctions, including a requirement that it report in compliance with the Safe Cosmetics Act. Private claimants such as Prop 65 bounty hunters are likely to take notice of the newly available information and any failures to comply.
Conkle, Kremer & Engel stays up to date on regulatory compliance matters to provide continued expert legal guidance to clients. Conkle, Kremer & Engel has decades of experience representing clients in the personal care products and cosmetics industry, and understand the unique regulatory compliance concerns facing manufacturers, distributors and retailers.
There are many other examples, including a “sleeper” called the Safe Cosmetics Act. Enacted in 2005, the Safe Cosmetics Act was heralded by its supporters as a landmark law that would protect the health of millions of Californians who use cosmetics. In reality, the Safe Cosmetics Act is just another glorified reporting statute, requiring manufacturers of cosmetic products sold in California to file with the California Department of Public Health (CDPH) reports of information that is already on product ingredient labels.
But the Safe Cosmetics Act takes the idea of the consumers’ “right to know” to an extreme by imposing a precautionary rather than risk-based approach. Unlike Prop 65, the Safe Cosmetics Act requires manufacturers to report use of chemicals that are not just “known” to cause cancer or reproductive harm, but also chemicals that are “suspected” to cause cancer or reproductive harm. In addition, the Safe Cosmetics Act does not recognize any “safe harbor” levels for reporting – any amount of a “suspect” chemical must be reported. Finally, cosmetic products that contain a reportable chemical must be reported regardless of whether the likely mode of exposure to the chemical by use of the product differs from the route of exposure identified by the authoritative scientific body as a pathway likely to cause cancer or reproductive harm. For example, a chemical that has only been identified as “suspected” of causing cancer or reproductive harm when ingested must be reported even if it is contained in a skincare product.
In future blog posts, we’ll address why the Safe Cosmetics Act could become much more significant to personal care products manufacturers beginning in 2014, the risks of liability to manufacturers posed by the Safe Cosmetics Act, and how manufacturers can know if their products contain the regulated chemicals. At Conkle, Kremer & Engel, we help our clients meet compliance requirements, despite constantly changing state and federal laws. With proper counseling, clients can avoid potential liability and minimize disruption to their businesses.
CK&E’s presentation about legal regulatory issues for personal care product companies doing business in California included an overview of the California Organic Products Act (COPA), Proposition 65 (California’s Safe Drinking Water and Toxic Enforcement Act) and California’s Green Chemistry Initiative including the new Safer Consumer Products Regulations. Conkle, Kremer & Engel’s materials from the BIW event, including the “Navigating Civil Regulatory Issues” presentation and its “Resource Guide for Regulatory Compliance,” are available for download on CK&E’s Regulatory Compliance web page.
Co-presenter Donald Frey, an industry veteran, regulatory expert and product development and innovation consultant, presented on key regulatory issues from the business perspective, including how to effectively deal with regulators. Mr. Frey has generously agreed to share his presentation, available for download here.
Among the questions and answers covered after the presentation were the addition of titanium dioxide (airborne, unbound particles of respirable size) to the Proposition 65 list of chemicals, responsible entities for purposes of compliance with the Safer Consumer Products Regulations, and the determination of organic ingredients under the National Organic Program standards.
Conkle, Kremer & Engel attorneys are frequent speakers at events of interest to the beauty industry due to their expertise in representing manufacturers, distributors, suppliers, retailers and salons in all aspects of their business, including the challenges of regulatory compliance.
CK&E will be speaking on legal regulatory issues for personal care product companies doing business in California, including California Organic Products Act (COPA), Proposition 65 (California’s Safe Drinking Water and Toxic Enforcement Act) and California’s Green Chemistry Initiative.
Co-presenter Donald Frey is an industry veteran and a product development and innovation consultant of Frey Consulting. Mr. Frey will present on key regulatory issues from the business perspective, including how to effectively deal with regulators.
Beauty Industry West is a non-profit industry trade organization that educates and provides resources and a networking platform for companies and entrepreneurs who want to develop their own personal care and beauty brands.
Conkle, Kremer & Engel has decades of experience in the personal care industry. Our attorneys are pleased to participate in trade organizations like Beauty Industry West and to share their experience with members of the industry.
The SCP regulations are the first step in implementing California’s Green Chemistry Initiative. The goal of the SCP regulations is to accelerate the manufacture and use of safer versions of products in California by: (1) establishing a process to identify and prioritize chemical ingredients in consumer products that may be considered “chemicals of concern,” and (2) establishing a process for evaluating chemicals of concern and their potential alternatives, to determine how best to limit exposure to or to reduce the level of hazard posed by chemicals of concern.
The SCP regulations apply to all consumer products that contain a “Candidate Chemical” and are sold, offered for sale, distributed, supplied, or manufactured in California. The regulations do not apply to food, pesticides, dangerous prescription drugs and devices, dental restorative materials or medical devices. There are currently 1,060 “Candidate Chemicals” that DTSC believes have hazard traits or environmental or toxicological effects.
The DTSC has already released its list of “Initial Candidate Chemicals” that will receive DTSC’s priority attention. Toluene, formaldehyde and bisphenol A are among the 164 “Initial Candidate Chemicals” that DTSC will consider to identify the “priority products” that DTSC will address first.
Conkle, Kremer & Engel’s lawyers stay current on the latest developments, and guide the firm’s clients through the thicket of expanding regulatory issues affecting their businesses. Watch for our next post on Green Chemistry, identifying the chemicals that can make your product a candidate to be a “priority product” for the DTSC.