Covalo Blog

Biotech Innovation in Cosmetics Brings New Regulatory and Technical Challenges

Written by Seongmin (Mike) Sohn - REACH24H KOREA | Nov 27, 2024

Biotechnology is revolutionizing the beauty industry by enabling the creation of high-efficacy, sustainable, and ethically produced ingredients. Leveraging biological processes such as microbial fermentation and marine-based technology, biotech eliminates the dependency on animal sources and minimizes environmental impact. More and more companies are leading this transformation by combining cutting-edge R&D, sustainable manufacturing practices, and collaborative innovation. Biotech allows for the production of cruelty-free, vegan ingredients like lab-grown collagen and hyaluronic acid, aligning with consumer demands for sustainability and personalization. As the industry faces challenges such as climate change and resource scarcity, biotechnology offers resilient solutions that stabilize supply chains, reduce environmental footprints, and ensure the future of beauty remains both innovative and sustainable.

However, as biotech ingredients redefine the boundaries of the cosmetics industry, they also introduce a complex landscape of regulatory, technical, and communicational challenges. Here, we explore how these challenges are reshaping the industry and what solutions may lie ahead.

Regulatory Challenges

 

Safety Assessment

Biotech ingredients often require the development of new safety testing protocols to meet regulatory standards. Current methodologies designed for traditional ingredients may not adequately address the unique properties of biotech components, necessitating more comprehensive and innovative approaches to ensure consumer safety. For example, bio-engineered peptides, which claim to reverse skin's biological age, require robust safety testing to ensure they do not cause allergic reactions or long-term toxicity.

Traditional safety protocols may not adequately address the complexities of biotech ingredients. Regulators may demand new toxicological and dermal absorption studies, which can significantly extend the product development timeline and increase costs. As new biotechnologies pursue the improvement of skin penetration or stronger efficacy compared to the conventional products, relevant health risks may arise, and finding the physiological pathways and detailed evaluations for consumer safety will likely prove to be a difficult task.

Labeling Requirements

The emergence of novel biotech ingredients raises questions about labeling standards. Regulators may require updates to labeling guidelines to ensure that product claims and ingredient disclosures are clear, accurate, and reflective of the product’s biotech origins.

Recent trends like Exosome-based products carry unique mechanisms of action that require precise labeling to educate consumers about their function and benefits. Current cosmetic labeling frameworks may not capture the nuances of biotech mechanisms. Regulators might introduce new guidelines to ensure transparency, such as mandating detailed descriptions of biotech-derived components. Labeling is highly important as it relates to scope of safety and efficacy, which also leads to consumer perception and education.

In the long run, regulators are challenged to set the right guidelines to ensure the proper labeling of biotech ingredients and products according to the technical classification. In addition, clearly defining which information should be provided to the authorities, to the end-user group, and which safety information should be prepared to prevent infringing a proper Intellectual property, etc., and should be considered as a whole.

Ingredient Classification

As biotech-derived ingredients blur the line between cosmetics and pharmaceuticals, regulators face the challenge of developing new classification categories. This ambiguity can create delays in product approval and complicate market entry, especially for products that claim therapeutic benefits or similar of a kind. One of good examples is Microbiome formulations, like those leveraging probiotics, often straddle the line between cosmetics and therapeutic products. Both authorities and industry can face difficulties categorizing these products. Misclassification can delay approvals or lead to compliance issues, particularly in regions with strict boundaries between cosmetics and pharmaceuticals (e.g., EU and U.S.).

Technical Challenges

 

Scalability

Scaling biotech ingredients from lab-scale production to commercial manufacturing poses significant hurdles. Ensuring consistency, efficacy, and quality at higher volumes is critical, yet inherently challenging due to the sensitivity of biological processes as for cutting costs for manufacturing plays a crucial part in bio-engineering product.

Producing biosynthetic squalane could be a good example at scale with a high level quality. Scaling biotech production requires advanced bioreactors and optimized processes. Companies need to invest in infrastructure and skilled experts, driving up initial costs and potentially slowing down market entry.

Stability

Maintaining the efficacy and shelf life of biotech-derived active ingredients in various formulations is another key challenge. Biotech ingredients are often highly sensitive to environmental factors such as temperature, light, and pH, requiring careful formulation and packaging solutions.

Ensuring the long-term stability of biotech actives often necessitates specialized formulations, such as encapsulation techniques, which can complicate production and increase costs.

Formulation Compatability

Integrating biotech ingredients with existing cosmetic bases and preservative systems can be complex. These new ingredients must interact seamlessly with traditional components to deliver the desired consumer experience without compromising stability or effectiveness.

For example, plant-based glycogen may interact with preservatives, affecting product efficacy and safety. Another good example is a microbiome formulation which is not allowed to actually put a live microorganism in a final product due to quality standard compliance. So, technically, this microbiome formulation would not include microbiome, making it incomplete.

Incorporating biotech ingredients into existing formulations requires rigorous testing to prevent adverse interactions. Formulation scientists must evaluate compatibility with emulsifiers, stabilizers, and other components, adding complexity to the R&D process.

Consumer Communication

 

Education

Consumer education is vital to the success of biotech cosmetics. Brands must clearly articulate the benefits, safety, and sustainability of biotech ingredients to gain consumer trust and dispel misconceptions.

Stem cell-derived actives are often misunderstood by consumers who associate them with ethical concerns. So often Brands need to invest in consumer education campaigns to demystify biotech innovations, emphasizing their safety, efficacy, and sustainability. This can help overcome skepticism and build trust and also avoiding wrong perceptions on positive features or absolute criticism.

Transparency

In an era of "biotechwashing," where claims of innovation may not always be substantiated, transparency is crucial. Companies must provide verifiable information about ingredient origins, production processes, and testing methodologies to build credibility.

To counter this, companies must implement robust transparency measures, such as third-party certifications and clear ingredient disclosures, ensuring consumers understand the origins and benefits of the ingredients. Of course, this can only be obtained through scientific research and attempts to find the actual value of a new innovation.

How should the cosmetics industry respond to these challenges? 

 

Manufacturing Processes

Biotech innovations require upgrades to manufacturing facilities to accommodate new production methods. From fermentation tanks to advanced purification systems used to make a biotech-derived bisabolol, companies must invest in infrastructure capable of supporting biotech-derived ingredients.

Quality Control

The complexity of biotech ingredients requires rigorous quality control systems to ensure consistency and purity. This includes developing new testing methods tailored to the specific properties of these ingredients. Again, as an example, ensuring the purity of exosome-based products requires advanced quality control systems that can detect impurities at a molecular level.

Conclusion: The Path Forward

The convergence of biotechnology and cosmetics is transforming the industry, offering unprecedented opportunities to create effective, sustainable, and personalized products. However, to fully realize this potential, the industry must address the regulatory, technical, and communicational challenges inherent to biotech innovation. Collaboration between regulators, scientists, and industry stakeholders will be key to navigating this evolving landscape and ensuring that biotech cosmetics meet the highest standards of safety, efficacy, and consumer trust.

Regulators and industry stakeholders must work together to develop frameworks that support innovation while ensuring safety and transparency. Companies should prioritize investments in scalable, stable production systems and robust quality control methods. Lastly, transparent and educational marketing can bridge the gap between biotech innovation and consumer acceptance.

Need additional help or advice around regulations when it comes to biotech innovations? Check out REACH24H's website here to learn about their services.

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