If Your Cosmetics Use Fragrance or Flavor, this New California Legislation May Affect You

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California cemented its status as the nation’s leader of cosmetics legislation when it passed the Cosmetic, Fragrance and Flavor Ingredient Right to Know Act of 2020 (“CFFIRKA”). Effective January 1, 2022, California’s newest cosmetic reporting law requires cosmetic companies to publicly disclose all fragrance and flavor ingredients in their products that are found on one of 22 “designated lists”. CFFIRKA supplements the state’s Safe Cosmetics Act (SCA), which for more than a decade has required companies to report to the California Department of Public Health (CDPH) Safe Cosmetics Program whether any of their cosmetic products contain chemicals known or suspected to cause cancer or reproductive toxicity. Now, the reporting requirements extend to fragrances and flavor ingredients that may pose health hazards.

Many cosmetic products contain fragrances or ingredients that give products flavor. In enacting CFFIRKA – a first-of-its-kind consumer “right-to-know law”, the state was concerned that some fragrance and flavor ingredients may have negative health effects, especially to those who are frequently exposed, such as salon workers. Thus, the new law is intended to provide the public with knowledge about the use of such fragrances and flavor ingredients in both retail and professional-use cosmetics, so consumers and workers can determine whether and how to mitigate their exposure.

Each entity whose name appears on the label of a cosmetic product must comply with CFFIRKA, which means companies such as distributors and importers may also have reporting obligations. CFFIRKA requires disclosure if a cosmetic product sold in California contains fragrance and/or flavor ingredients included on one or more of the 22 designated lists identified in California Health and Safety Code Section 111792.6. Among others, the lists include those chemicals on California’s Proposition 65 list as well as chemicals classified by other federal and state agencies and international bodies. The ingredients on the 22 designated lists are subject to change as each list is revised, requiring companies to pay special attention to such changes. All cosmetic products with reportable ingredients sold in California after January 1, 2022, regardless of date of manufacture, must be reported under this mandate. However, there is no requirement under CFFIRKA to make changes to product labels.

Additionally, cosmetic companies must disclose specific “fragrance allergens” if the allergens are present at or above 0.01 percent (100 parts per million) in rinse-off cosmetic products, or at or above 0.001 percent (10 parts per million) in leave-on cosmetics products. The subset of CFFIRKA reportable ingredients called “fragrance allergens” have distinct reporting requirements, and must be reported regardless of their intended purpose in the product (i.e. they must be reported even if they are not used to impart scent or counteract odor). In addition to disclosing the reportable fragrance, flavor, or allergen ingredients, businesses must also disclose each ingredient’s Chemical Abstracts Services (CAS) number, the Universal Product Code (UPC) of the cosmetic product that includes the ingredient, and whether the cosmetic product is intended for professional or retail cosmetic use.

Information reported by companies under CFFIRKA (as well as under the SCA) is made publicly available through the CDPH’s Safe Cosmetics Database, which is available at https://cscpsearch.cdph.ca.gov/search/publicsearch. To date, more than 90,000 cosmetic products have been reported to the CDPH.

Conkle Kremer & Engel attorneys stay current on regulatory and legal developments that affect the cosmetics business.

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California’s SB 574 and AB 495 Would Expand Regulation of Cosmetics Labeling and Ingredients

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California has always led the way when it comes to regulating cosmetic products, and bills recently introduced by Senator Connie Leyva (Senate Bill No. 574 or SB 574) and Assemblymembers Al Muratsuchi and Buffy Wicks (Assembly Bill No. 495 or AB 495) is in keeping with California’s reputation as a trailblazer in the cosmetics regulatory space.

SB 574, the “Toxic Fragrance Chemicals Right to Know Act of 2019”

SB 574, the “Toxic Fragrance Chemicals Right to Know Act of 2019,” was introduced last month. It would require cosmetic manufacturers, starting July 1, 2020, to disclose whether any of their cosmetic products contains a toxic fragrance or flavor ingredient.

Fragrance or flavor ingredients that appear on any one of 27 “designated lists” would be subject to public disclosure. The designated lists include chemicals listed as known to cause cancer or reproductive toxicity pursuant to California’s Proposition 65; chemicals classified by the European Union as carcinogens, mutagens or reproductive toxins; chemicals included in the European Union Candidate List of Substances of Very High Concern; and Group 1, 2A or 2B carcinogens identified by the International Agency for Research on Cancer (IARC) among many others.

Existing law – the California Safe Cosmetics Act of 2005 (“Safe Cosmetics Act”) – requires cosmetic manufacturers to disclose to the California Department of Public Health (CDPH) Safe Cosmetics Program whether any of their cosmetic products contain chemicals known or suspected to cause cancer or reproductive toxicity. The Safe Cosmetics Act’s list of reportable ingredients is compiled from a more far limited set of five designated lists. This self-reported information, in turn, is publicly available through the CDPH’s Safe Cosmetics Database.

While the Safe Cosmetics Act does not exempt fragrances and flavorings from being reported, the reportable chemicals in those cases are often identified simply as “trade secrets.” The proposed legislation would require the disclosure of the identities of the reportable chemicals or ingredients, but for trade secret purposes, would not require the weight or amount of a fragrance or flavor ingredient to be disclosed or any disclosure of how the fragrance or flavor is formulated. In addition, a manufacturer would not have to disclose any fragrance or flavor ingredients that are not found on any of the 27 designated lists. It is important to note that SB 574 as proposed would not ban or otherwise regulate the use of any fragrance or flavor ingredients.

AB 495, the “Toxic Free Cosmetics Act”

AB 495, also introduced in February 2019, would amend both California’s Sherman Food, Drug and Cosmetic Law and the Safe Cosmetics Act.

California’s Sherman Food, Drug and Cosmetic Law prohibits the manufacture, sale, delivery, holding or offer for sale of adulterated cosmetics. AB 495 would greatly expand the definition of an “adulterated cosmetic” to include cosmetics that contain specific ingredients. Any cosmetic that contains lead or asbestos or any of the following 13 intentionally added ingredients – without regard to the amount or exposure levels – would be banned from sale in California:

  • Butylparaben
  • Carbon black
  • Dibutyl phthalate
  • Diethylhexyl phthalate
  • Formaldehyde
  • Formaldehyde releasers
  • Isobutylparaben
  • Isopropylparaben
  • Mercury and related compounds
  • Per- and Polyfluoroalkyl substances (PFAS)
  • Propylparaben
  • Toluene
  • Triclosan

The bill would also amend the Safe Cosmetics Act by requiring referrals to be made to the Department of Justice for any sale of adulterated cosmetics, as well as any violation of the Safe Cosmetics Act.

If passed, the legislation would have the effect of requiring companies doing business anywhere in the United States to reformulate their cosmetics to remove these ingredients, effectively creating a nationwide ingredient ban. The bill comes as the FDA confirmed that cosmetic products sold in 2017 by Claire’s and Justice tested positive for asbestos.

It has become clear that California’s leadership position on cosmetic regulation has effectively driven changes in cosmetic products and labeling throughout the United States. Conkle, Kremer & Engel will continue to follow and update these important developments affecting the cosmetics industry.

Update on AB 495 as of April 9, 2019

Efforts to pass AB 495 have temporarily stalled.  On April 9, 2019, the Assembly’s Environmental Safety and Toxic Materials Committee postponed a scheduled vote to move the bill to the Assembly Health Committee due to lack of support.  The bill is not expected to be brought back again until next year. It is anticipated that the bill will be in a revised form when reintroduced.  Conkle, Kremer & Engel will continue to monitor the developments of AB 495.

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Safe Cosmetics Act Database to Go Public in 2014: Watch for More Lawsuits

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In a previous blog post, we referred to the Safe Cosmetics Act as a “sleeper” because it has been in existence for several years but has been little noticed and seldom used.  That is likely to change in 2014.

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.

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California Safe Cosmetics Act of 2005: A Sleeper That May Awake in 2014

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California has a well deserved reputation for extraordinary efforts to protect consumers.  While the goals behind the regulations may be laudable, California’s many requirements impose enormous burdens on companies doing business in the state, often with questionable public benefit.  Proposition 65 is a familiar example of a regulation that requires elaborate warnings, but does not actually regulate the use of any chemicals.

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.

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