MoCRA was the first major statutory change to the Federal Food, Drug, and Cosmetic Act (FDCA) regarding the regulation of cosmetics since the FDCA’s enactment in 1938. Since the passing of December 2022, the industry has been in a scramble getting their regulatory houses in order. New regulations in the beauty industry have been coming faster than many can keep up with. From state level regulations in the US and new legislation in the UK and EU, there are no signs of slowing down. Compliance and regulation are foundational blocks of building a successful brand. Adhering to regulations is not optional, regardless of how big or small your brand is.

EcoMundo was born from a vision to provide companies with expert guidance in the complex field of chemical and cosmetic product regulations. Founded over 15 years ago, the company quickly gained recognition thanks to its team of specialists in regulatory affairs, toxicology, and ecotoxicology. By combining technical expertise with technological innovation, EcoMundo has established itself as a leader in compliance management, helping businesses navigate international regulations, reduce their time to market, and ensure the safety of their products. Today, EcoMundo continues to grow, with a strong presence in North America, Europe, and Asia.

BeautyMatter caught up with Alexander Detre, Chief Executive Officer at EcoMundo USA & Canada.

EcoMundo has been an invaluable resource for many brands in the industry as they are navigating MoCRA. Can you share a bit about how you work with brands and the role you play? 

As a trusted partner, we support many brands navigating MoCRA. We work closely with our clients to ensure full compliance with these new regulations, offering a hands-on approach that simplifies what can often seem like an overwhelming process. We went through something similar during Brexit, so we were well-prepared for the scale of work that MoCRA would entail. For years, we've been notifying companies for the EU and UK markets, and MoCRA, in comparison, is a lighter version of product notification.

Our toxicologists and regulatory staff understand that accurate data collection is the cornerstone of compliance. We help brands gather the necessary information to create robust safety substantiation documents, conduct thorough labeling reviews, and facilitate product registrations. This allows us to provide not only regulatory support but also strategic guidance to help brands bring their products to market with confidence. Our goal is to ease the regulatory burden on our clients so they can focus on innovation and growth, knowing that their compliance is in good hands.

What sets you apart from your competitors?  

EcoMundo stands out for its international expertise across 60+ countries and its proactive approach to regulatory changes. Our team of toxicologists, chemists, and regulatory professionals not only ensures compliance but also provides tailored, hands-on support to meet each brand's unique needs. What truly sets us apart is our ability to offer both expert services and software solutions. Unlike many competitors who focus on one or the other, our Cosmetic Factory platform allows brands to manage formulations while our regulatory experts guide them through compliance.

On the MoCRA front, what are the early learnings or things you are encountering that we should know about? 

Not understanding why we have regulations and why it’s important to ensure products are safe for consumers and the environment. While brands understand the logic of regulations that protect consumers and the environment, there is a disconnect around the complexity of why regulations need to be so complex.

There is also confusion for companies entering the EU market from the UK or the US, as well as entering the US market from the EU. While there are similarities, regulations for Responsible Person (RP) requirements and safety substantiation are slightly different.

For the EU, RP can be a third party and safety substantiation is a full Cosmetic Product Safety Report (CPSR). For the US market, RP can only be a brand, distributor, or packer and safety substantiation are toxicology risk assessments (TRA) at best. We believe the US FDA is easing into a stricter regulation process for cosmetics, and today it starts with TRAs.

Regulatory for many independent brands is usually entirely or partially outsourced. What are the common pain points you help solve? 

Data collection on raw materials is one of the biggest challenges. Many brands struggle when their suppliers don’t provide the necessary documentation for product compliance. Additionally, frequent regulatory changes often require formula or labeling updates, which can lead to significant costs. For independent brands, managing these changes is particularly difficult, as the financial impact can be much harder to absorb compared to larger companies.

What do you do next?

Our relationships with RM suppliers and a sound data collection process allows us to get the necessary ingredient information for product compliance and take that burden off the plate of brands. We step in with our strong relationships with raw material suppliers and an efficient data collection process to secure the necessary ingredient information. Beyond that, we manage everything from safety documentation, to labeling reviews, to product registrations, taking the entire regulatory burden off the brand's plate. This ensures full compliance while allowing brands to focus on innovation and growth. EcoMundo has a strong presence in North America, Europe, and Asia, all key markets in the global beauty ecosystem.

What are some of the top regulatory changes working their way through various governing bodies that should be on people's radar?

On the international front, we are closely monitoring several key developments:

Extended Producer Responsibility (EPR): While some countries have implemented EPR regulations, many more are in the process of passing similar laws.

Allergen Declaration: In 2023, the EU introduced Regulation (EC 2023/1545), adding new allergens to the existing list of 24. Canada updated its regulations in 2024 to align with the EU, while the US under MoCRA is expected to release a draft on allergen declarations by October 2024.

In the EU specifically:

Titanium Dioxide: The Scientific Committee on Consumer Safety (SCCS) published its final opinion in May 2024, raising concerns over the genotoxicity of most grades of titanium dioxide used in oral and inhalable cosmetic products, with exceptions for two nano grades (RM09 and RM11). This could have a significant impact on products like lipsticks and toothpaste.

Vitamin A Restrictions: In 2024, restrictions on retinol, retinyl palmitate, and retinyl acetate will enter into force with their addition to Annex III of the EU Cosmetic Regulation.

Key deadlines:

November 1, 2025: Cosmetic products containing restricted substances that don’t comply with regulations cannot be placed on the market.

May 1, 2027: These products cannot be available for sale if noncompliant.

IFRA 51: New fragrance composition standards take effect in 2024, introducing tighter restrictions and specifications.

Misleading Claims Directive: This EU directive, aimed at protecting consumers from unfair practices, will be adopted by March 27, 2026.

There are instances where brands are either unaware or make a calculated business decision around regulatory compliance. What are the potential ramifications of noncompliance? 

While brands make business decisions around compliance for a myriad of reasons, they may fly under the radar for a while. However, this becomes increasingly difficult as a brand scales.

Noncompliant products are easy targets for the FDA, FTC (regarding unsubstantiated claims), and bounty hunters. These can lead to public warning letters, recalls, fines, and lawsuits. In the case of bounty hunters, there are law firms that specialize in targeting brands they believe are large enough to pursue but small enough to lack the financial resources to litigate, or that have a precedent of settling. Dealing with these situations requires resources and bandwidth, but they also carry the risk of "going viral" and causing significant reputational damage to the brand.

Where in the process of launching a business, product, or entering a new market should regulatory come into the equation and planning?

Regulatory needs to be part of your start-up costs. It should be a key expense line in projections, and compliant products must be considered as part of product life cycle cost planning.

If your start-up funding includes VCs or investment funds, then global product planning comes into play, along with which cosmetic product compliance process you follow. If you have smaller amounts but enough to impact a market, then choosing a market where the compliance process is accepted in other regions is a good start as well.

 If your start-up funds include savings and support from friends and family, then don’t try to dominate the world. Pick a compliance process that is simpler and cheaper, and dominate that market segment before going into the next.

If regulatory compliance is left as an afterthought or the plan is to deal with it later, reformulation, relabeling, and claims adjustments may become a reality. This scenario will explode your budget across the board, lead to delays, and result in opportunity costs, along with the financial requirements to become compliant and the potential loss of confidence from investors.

This year, we have seen a rush to market by brands that have reached a scale to hire bankers to explore their options. How important is having your regulatory house in order, and what should brands think about?

Having your regulatory house in order is crucial for risk evaluation and can significantly impact the valuation of your business. It helps avoid costly issues such as reformulations, relabeling, and claims adjustments, which are often uncovered during due diligence by bankers or investors. Ensuring regulatory compliance strengthens a brand’s reputation, signifying clean labels and accurate claims, which enhances the brand’s market position and consumer appeal. Moreover, brands with pending regulatory issues, or facing potential lawsuits from noncompliance, may see their valuation drop and could struggle to secure investment. Investors expect transparency and minimal risk; a solid regulatory foundation provides them with the confidence they need to invest.

We have begun to see AI and technology penetrate and disrupt the old way of doing things across the value chain of beauty, including the regulatory arena. What are your thoughts on these changes?

The rise of AI is both an exciting and challenging development. While many regulatory tech platforms are emerging, EcoMundo takes a different approach by combining advanced technology with expert human oversight. AI has undoubtedly shortened barriers to entry, and while it’s a powerful tool, it still requires experts to ensure that the solutions being built are accurate and effective. For us, it's about finding the right balance between automation and the critical expertise our team brings to the table.

In the regulatory world, data is everything. AI can be incredibly useful in processing large volumes of information, but it's still the quality of the input data that determines the outcome—good data in, good results out. We’re not just focusing on the tech itself but also on how we can guide brands through these changes by ensuring that the data they rely on is accurate and complete. Innovation is definitely on the horizon, and we’re embracing AI to enhance our processes, but the human element remains essential to navigating regulatory complexities.

What would keep you up at night if you were a brand owner or manufacturer in this regulatory climate? 

One of the biggest concerns would be ensuring I have the right people guiding me through the complexities of both local and global regulatory requirements. With constant changes in regulations across different regions, from MoCRA in the US to evolving EU standards, it's critical to have a knowledgeable team that can stay ahead of these updates. Not having the right expertise can lead to compliance issues, product delays, or even costly recalls. It's essential to have confidence in the people and processes in place to navigate these regulations effectively, ensuring the brand’s reputation and business growth are not at risk.