Beginning in 2020, the sale of new cosmetic formulations or ingredients that are tested on animals will be prohibited in California, subject to a few narrow exceptions, under the recently passed Senate Bill 1249 (2017), also known as the California Cruelty-Free Cosmetics Act, when Governor Jerry Brown signs the bill into law, as is expected.
Cosmetic companies are now considering how they will adjust their development processes within the two-year timeframe. The considerations include analyzing what ingredients, if any, may still fall into exemptions created by SB 1249 and by the EU's Cosmetic Regulation, and, if applicable, adjusting marketing claims concerning animal testing, including so-called "cruelty-free" claims.
California's new rules will be mostly, but not entirely, consistent with EU rules that took effect in 2013. Most notably, the EU rule, which binds all EU member states, does not prohibit animal testing to comply with the EU's Registration, Evaluation, Authorisation and Restriction of Chemicals regulation (REACH). The European Chemical Agency clarified in 2014 that ingredients with non-cosmetic uses may be developed using animal testing to verify REACH requirements for all endpoints, including human health.
The final bill, authored by State Senator Cathleen Galgiani and sponsored by an assortment of interest groups, passed without opposition after last-minute amendments to previous versions opposed by industry. The 11th-hour modifications did not substantively alter the key provisions – a general prohibition on animal testing for cosmetics starting in 2020 and the grant of investigatory authority to California prosecutors – but cosmetic companies should take note of several important changes.
First, sales of a finished cosmetic or cosmetic ingredient will be permissible if they were sold in California or tested on animals before 2020, even if the product or ingredient is manufactured after that date. The amendments subject only new cosmetic products and new ingredients to the animal testing ban.
Second, similar to trade secret protections under the existing California Safe Cosmetic Program, product information disclosed to enforcement authorities by cosmetic companies will be treated as confidential.
Third, the law provides a sell-through period of 180 days for cosmetic inventory "found to be in violation" of the new law.
Additionally, the legislation creates narrow exemptions for animal testing that is:
- required by a federal or state agency for an ingredient that is in wide use and cannot be replaced, so long as there is no viable alternative method and the purpose is to address a documented health problem
- conducted to comply with a foreign government, so long as no evidence derived from the test was relied upon to substantiate the safety of the cosmetic sold in California
- required by Chapter V of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. section 351 et seq.) or
- conducted for noncosmetic purposes in response to a requirement of a federal, state, or foreign regulatory authority, if no evidence derived from the test was relied upon to substantiate the safety of the cosmetic sold in California by the manufacturer.
The California Attorney General's Office and local prosecutors are authorized to enforce the statute through civil litigation and investigative subpoenas. The AG's office sometimes issues guidance to industry on new legislation, (eg, with the Transparency in Supply Chains Act of 2010), but it may be a year or more before the AG's Office provides clarity regarding several areas of potential dispute in this new law. What products precisely are in "wide use," which ingredients are irreplaceable, and whether the requirements of REACH fall within the "foreign government" exemption, among other questions left open by the statute, may thus become the subject of litigation after the prohibition goes into effect on January 1, 2020.
Finally, regarding "Cruelty-Free" or "Not Tested on Animals" claims on cosmetic labels, the FDA has said that "the unrestricted use of these phrases by cosmetic companies is possible because there are no legal definitions for these terms." With the adoption of SB 1249, that may no longer be the case. Furthermore, such claims may recede in perceived importance. Thanks to the dominance of California in the marketplace, and thus the influence of California laws and regulations, far more cosmetics sold not just in California but nationwide are likely to be "cruelty-free" starting in 2020, at least as defined by SB 1249. Therefore, a reevaluation of such marketing, and the litigation risks it raises, may also be a prudent response to the legislation for some companies.
Find out more by contacting your DLA Piper attorney or either of the authors.