As EU chemical regulations grow more precautionary and politically driven, U.S. states like California continue to follow Europe’s lead, posing compliance challenges for indie beauty brands. Eoghan Gallagher outlines the risks, stresses the need for early-warning systems and strong supplier processes, and explains how his new consultancy and law firm aim to support small and mid-sized companies navigating this shifting landscape.
In the European Union, a confluence of factors is making cosmetic ingredients increasingly vulnerable to regulatory restrictions and bans—changes that promise to influence policies at the U.S. state level as well.
“The attack on ingredients is coming from all different sides,” noted attorney, regulatory consultant and Independent Beauty Association Board Member Eoghan Gallagher. “Sometimes it’s justified. Other times something gets flagged as hazardous, and then no one defends it and it becomes banned forevermore.”
Recent updates to the EU’s Classification, Labeling and Packaging (CLP) Regulation are driving greater scrutiny of cosmetic ingredients, while the EU Green Deal and its Chemicals Strategy for Sustainability (CSS) are promoting a shift toward regulating substances based on hazard profiles rather than exposure risks.
At the same time, the EU’s Cosmetic Products Regulation, which includes pathways for banning CLP-classified hazardous substances, is undergoing revision to align with Greal Deal principles.
“There’s a goal to basically eliminate hazardous materials and ingredients in the EU by the year 2050,” said Gallagher. “So it’s huge. But what is ‘hazardous’? For that matter, what’s not?”
He continued, “The EU, historically, has had great mechanisms and structures in place to validate or prove the safety of ingredients—a really scientific-based approach.”
However, in recent years that science-based foundation has eroded in the face of political pressures. “It just lends itself to deleting more and more chemicals and banning more and more stuff,” Gallagher said.
The EU’s increasingly precautionary leanings pose concerning implications for cosmetics brands in the U.S., where states have been taking ingredient safety cues from the EU and legislating their own restrictions accordingly.
In Gallagher’s discussions with legislators and staffers in California, they have expressed unbroken confidence in conforming to EU regulations.
“I tried to explain to them, the EU is dealing with its own political pressures. You can’t just 100% trust exactly what the EU is doing, especially when they’re doing something and you have no idea why. You have to have your own basis for why you’re banning materials—it can’t just be because the EU is doing it,” Gallagher said.
Where Will Impacts Be Concentrated?
In 2023, the European Commission adopted new hazard classes within the CLP Regulation to better address emerging scientific concerns, including:
- Endocrine disruptors (EDs) for human health and the environment;
- Persistent, bioaccumulative and toxic (PBT) substances; and
- Persistent, mobile and toxic (PMT) substances.
“The endocrine disruptors—that hasn’t even hit where it’s going. But already, before any of the new CLP hazard classifications came into being, in anticipation of the new goals and targets, ECHA [European Chemicals Agency] and the EU were using existing mechanisms to really ramp up hazard classifications in the fragrance industry. Fragrance materials really are feeling it first because there’s so much data available on those materials,” said Gallagher.
Notably, the Research Institute on Fragrance Materials (RIFM), whose independent safety assessments inform standards set by the International Fragrance Association (IFRA) for fragrance use globally, touts its proprietary database as the world’s largest repository of toxicology data, literature, and general information on fragrance and flavor raw materials.
Staying Ahead of the Curve
Gallagher has over 20 years of experience in this space, including as former Senior Director, Global Regulatory Affairs, Registration and ESG, at Interparfums, Inc.
As a growing number of ingredients are flagged and routed for review, visibility and strategic planning are critical. “You need to have a way to understand what’s coming ahead of time – an advanced warning system. And, two, you need to make sure that your processes and systems are equipped from end to end with an adequate change management process,” Gallagher said.
“If you don’t have strong relationships with your suppliers, and you don’t have contracts set up in a way where you’re getting all the documentation that you need about all the different raw materials used in your products, then you might run into a problem. You really need to set those processes up ahead of time.”
Cost-Effective Compliance
Gallagher acknowledged that the cost of managing complexity and staying compliant can be inhibitive for many startups and small brands, especially across international markets with shifting regulatory targets.
“It’s a catch-22 because it may seem like you can’t afford to be compliant, and you can’t afford not to be compliant. Because when they get you, they get you. But there are ways to do it where you don’t have to break the bank,” Gallagher said.
To address this, Gallagher offers two parallel services:
- Gallagher Beauty Compliance Strategies, a New York-based regulatory consulting firm; and
- The Law Offices of Eoghan Gallagher, based in Irvine, CA, which handles regulatory risk assessment and product compliance, commercial contracts and vendor agreements, claims review and substantiation, and market entry and cross-border legal considerations.
“I work with clients to align legal compliance with their values, making law and regulation a strategic advantage—not a barrier,” Gallagher says.
Between the two businesses, “The idea is for startups and rapidly growing cosmetic brands to have the ability to choose which service would best serve suit their needs.”