California’s Cosmetic Animal-Testing Ban Not A Brick Wall, But Proceed With Caution

Animal testing permitted for ingredients in Europe with purposes beyond cosmetics is not necessarily something that would forfeit products’ marketability in California under its Cruelty-Free Cosmetics Act. However, industry should seek guidance on the law’s interpretation from the state’s attorney general.

Industry would be well-served to seek guidance from the California Attorney General on compliance with the state’s recently enacted Cruelty-Free Cosmetics Act, but the statute isn’t necessarily a death knell for cosmetic ingredient innovation.

In an Oct. 16 interview, Greg Sperla, an attorney in DLA Piper’s Sacramento, Calif. Office, said he believes the enforcement provisions of SB 1249 – signed into law by California Governor Jerry Brown at the end of September – “are pretty watered down.”

However, much of the legislation’s bite depends on how its exemptions are interpreted, and the California AG’s read of those terms should be industry’s first-line resource, he said.

SB 1249 prohibits the marketing of any cosmetic product in California that was “developed or manufactured using an animal test that was conducted or contracted by the manufacturer, or any supplier of the manufacturer, on or after January 1, 2020.” (Also see "California Passes Cruelty-Free Cosmetics Act: Now Friendlier To Industry, Still A Legal Minefield " - HBW Insight, 3 Sep, 2018.)

District and city attorneys are authorized to enforce the statute’s provisions and collect penalties from non-compliant entities.

The law was designed with NGO influence to shut down animal testing of new cosmetic ingredients, given that industry stopped testing finished cosmetics on animals decades ago and engages in the practice now only in limited contexts, including the assessment of new ingredients in the absence of viable alternative methods. (Also see "ECHA: Non-Animal Tests For Complex Toxicity Endpoints Not 'Foreseeable'" - HBW Insight, 29 Nov, 2017.)

However, SB 1249 exempts animal testing conducted to comply with the requirements of a foreign regulatory authority, ostensibly including the European Chemicals Agency, which administers the EU’s Registration, Evaluation, Authorization and Restriction of Chemicals (REACH) program.

According to the European Commission, animal testing to comply with REACH across all human health endpoints can be used to support the safety of a cosmetic ingredient in the EU, notwithstanding the Cosmetics Regulation’s animal-testing prohibitions, as long as the ingredient has uses outside of the cosmetics sector, or was developed for such versatility. (Also see "Cosmetic Ingredient Innovation In An Increasingly Cruelty-Free World; Is It Possible?" - HBW Insight, 26 Oct, 2018.)

So the same animal testing that can support ingredients in Europe with multiple purposes (including cosmetic applications) without triggering the cosmetics testing ban can be performed after 2020 without necessarily jeopardizing cosmetics’ marketability in California.

There’s a catch, however. The California statute specifies that data from such testing cannot be relied upon to substantiate cosmetic safety.

That said, California law, like the Federal Food, Drug and Cosmetic Act, does not specify safety tests required for cosmetic products. Cosmetics must be safe for consumer use, but it’s left to manufacturers’ discretion how that threshold is met.

What’s to say that manufacturers can’t take solace in the safety assurance provided by animal testing in Europe while relying formally, outwardly, on alternative, non-animal calculations – however experimental – to satisfy California’s hazily sketched requirements?

It could be a risky gambit, but some anticipation of this possibility seems already to be baked into the California legislation, which was heavily revised in industry’s favor in the run-up to its passage.

As enacted, SB 1249 exempts regulatory-required animal testing undertaken for non-cosmetic purposes, including in foreign jurisdictions, while barring these studies’ use as substantiation for cosmetics safety.

It dictates, however, that “a manufacturer is not prohibited from reviewing, assessing or retaining evidence from an animal test conducted pursuant to this paragraph.”

Sperla, who authored a Sept. 12 insights post on California’s cruelty-free cosmetics law, refers industry stakeholders to guidance published by the California AG’s office to support compliance with the Transparency in Supply Chains Act.

That legislation mandated disclosure of manufacturer’s efforts (or lack thereof) to eliminate slavery and human trafficking from their supply operations.

The California AG’s guidance in that instance is an example of the kind of perspective that could benefit cosmetics industry players subject to the Cruelty-Free Cosmetics Act, he says.

Time is of the essence though. The Transparency in Supply Chains Act of 2010 was enacted the following year and went into effect Jan. 1, 2012, and the California AG didn’t issue its guidance until 2015.

Companies also should be aware of FDA’s position on unvalidated alternative testing methods as they strive to navigate California’s new prohibitions.  (Also see "FDA Guarded On California Animal-Testing Ban’s Implications For Federal Cosmetics Compliance" - HBW Insight, 26 Oct, 2018.)