Bilgiye hızlı erişim:
The year 2025 marks a period of major transformation for the cosmetics industry, as outlined in the Spring 2025 Unified Agenda released by the U.S. Food and Drug Administration (FDA). These updates, introduced under the Modernization of Cosmetics Regulation Act (MoCRA), aim to strengthen safety, transparency, and traceability across the sector.
The new regulations require cosmetic manufacturers to reassess their formulations, labeling, and production standards. So, what changes can the cosmetics world expect under MoCRA?
→ Restrictions on Formaldehyde and Its Derivatives
The FDA has proposed restrictions on the use of formaldehyde and formaldehyde-releasing ingredients, particularly in hair straightening products.
This step aims to reduce health risks such as respiratory irritation, skin sensitivity, and allergic reactions among consumers.
The new regulations will require manufacturers to reformulate products and seek safer alternative ingredients. Initially planned for March 2025, the proposal is now expected to be published in December 2025.
Another significant change is the requirement to clearly identify fragrance allergens on product labels.
This practice, long established in the European Union’s cosmetic regulations, is now being introduced to the U.S. market.
It will enable consumers to make more informed purchasing decisions by being aware of ingredients that may cause allergic reactions. The proposal is expected to be submitted in May 2026.
Under MoCRA, the FDA will make Good Manufacturing Practices (GMP) mandatory for all cosmetic manufacturers.
This regulation will require production facilities to maintain hygiene, staff training, traceability, and quality control in accordance with international standards.
For brands, this represents an important step in strengthening both manufacturing safety and product integrity.
Cosmetic products containing talc have been under public scrutiny in recent years due to the risk of asbestos contamination.
The new regulations mandate asbestos testing and standardization of testing methods for talc-based products.
This measure will not only boost consumer confidence but also require stricter raw material quality control from brands.
A proposed rule was published in December 2024, with the final rule expected in March 2026.
The FDA’s 2025 plan represents more than just stricter regulations—it offers an opportunity for cosmetic brands to adopt a safer, more sustainable, and transparent manufacturing approach.
From now on, brands must:
Reassess their formulations
Update their labeling strategies
Document their GMP systems
Enhance traceability throughout the supply chain
This transformation will play a critical role not only in regulatory compliance but also in building consumer trust and enhancing brand reputation
The changes brought by MoCRA redefine the principles of safety, transparency, and quality in the cosmetics sector.
For manufacturers, these developments represent not just a compliance requirement but also an opportunity to improve processes, reduce risks, and increase competitiveness in the global market.
The FDA Spring Unified Agenda is not merely a list of regulations — it is a call for standardization and accountability across the cosmetics industry.
For brands, the time has come to prepare for the future based on reliability, sustainability, and consumer confidence.
Stay informed about the latest developments in the industry and our company by subscribing to our e-newsletters.