Methylisothiazolinone (MIT) is having a rough go of it in the European Union. The preservative, used in a variety of products, including rinse-off products like shampoos, has been accused of causing skin rashes. EU regulators decided that makers of rinse-off products can no longer use MIT above a level of 0.0015%, down from 0.01%.
It’s a sign of the increasing degree of regulatory cosmetovigilance we should expect to see in various markets, as more and more countries embrace a wider range of cosmetic and personal care products. That, over time, usually leads to greater scrutiny and regulation.
In the case of cosmetovigilance, a term that’s actually applied to regulatory standards for cosmetics in the EU, it’s a public health policy aimed at detecting any adverse effects of cosmetic products, and preventing those effects by taking appropriate measures. But the involvement of manufacturers aren’t limited strictly to formulation guidelines.
EU regulations expect the manufacturer, not just governing bodies or consumers, to monitor and report on the health impacts of products after they’ve reached the market as part of a system of regular evaluation and potential safety re-assessment that might entail recalls, market withdrawals and more.
In the U.S., more (potential) FDA oversight
In the U.S., the 1938 Federal Food, Drug, and Cosmetic Act (FD&C Act) encompasses products such as skin moisturizers, lipsticks, perfumes, nail polishes, eye and facial makeup, shampoos, hair colors, toothpastes, deodorants and more, and the ingredients that go into them. But its intent is to prevent “adulterated or misbranded” products from reaching the market. There’s been no real regulatory hurdle for cosmetic products (except for color additives) in going to market.
That may change. In 2016, Senators Dianne Feinstein and Susan Collins proposed the Personal Care Products Safety Act to give the FDA additional authority to regulate the safety of beauty products, something the FDA doesn’t currently do.
Up until now, manufacturers were expected to self-police the safety of beauty and cosmetic products. Surprisingly, the industry is on board with the legislation, with support from companies including Estée Lauder, L’Oréal, Johnson & Johnson, the Honest Company, Juice Beauty, Revlon, Procter & Gamble, and Unilever.
Part of that support owes to the fact the industry and legislators have worked together in creating the bill, which would create a more workable regulatory environment for all concerned and would supersede stricter state statutes such as California’s strict reporting regulations around ingredients like phthalates and other compounds considered toxic or potentially carcinogenic.
Senator Feinstein’s comments on the changes are, “From shampoo to lotion, everyone — women, men, children — uses personal-care products every day. Despite the universal use of these products, none of their ingredients have been independently evaluated for safety. This puts consumers’ health at risk and we urgently need to update the nearly 80-year-old safety rules.”
If the bill becomes law, it will finally give consumers and the industry an actionable framework for protecting everyone’s interests. But it’s also an example of how legislation and regulation around cosmetics and beauty product are on the rise worldwide.
Global marketing faces local laws
Developed markets have more transparent and streamlined regulatory processes, but that may not hold in developing countries. As companies enter these markets, they’re faced with the complexity and cost of complying with local laws that, while often patterned on EU legislation, may have a number of variations that affect product classification, dossier/document preparation and more.
Companies that want to market at scale across multiple borders are adopting regulatory intelligence models that help them cost-effectively mitigate the costs and risks involved in compliance by keeping all stakeholders, including formulators, continually aware of local rules and guidelines that affect their products.
As the demand for cosmetic and beauty products continues to surge, along with consumer demand for natural products that are ethically sourced and produced, understanding the trends and dynamics of market-by-market regulation will grow increasingly important even as those rules and guidelines get more and more common – and potentially more complex.
