Throughout 2024, the Office of Information and Regulatory Affairs (OIRA) has made significant changes to the timeline for implementing essential cosmetic regulations resulting from the Cosmetic Modernization Regulation Act of 2022 (MoCRA) . These provisions seek to update the safety, quality, and labeling standards for cosmetic products available in the U.S. market.
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MoCRA: Details of the Regulations Under Review
The first revision of the timelines was announced in the Spring Unified Agenda for Regulatory and Deregulatory Actions published in July 2024. This document highlighted some initial delays in the regulatory process. Further extensions were announced in December 2024 with the release of the Fall Unified Agenda, affecting the publication schedule of several key rules, including those related to fragrance allergen labelling, the use of formaldehyde, and testing methods for identifying the presence of asbestos in cosmetic products containing talc.
This timeline adjustment not only reflects the technical complexity of these regulations, but also the need to give cosmetic companies sufficient time to implement the necessary changes to their operational and compliance processes.
Test methods for detection of asbestos in talc-based products
The regulation seeks to establish uniform and reliable testing protocols to identify the presence of asbestos in talc-based cosmetics. The detection of this substance has been a cause for concern due to its potential health risks, which has prompted a more rigorous approach to its control.
Original proposed date : December 2023
Spring Agenda Review : July 2024
New target date : December 2024
Mandatory labelling of fragrance allergens
This rule aims to provide transparency in the labelling of certain allergenic compounds present in fragrances, so that consumers can make informed decisions regarding their health and safety.
Original proposed date : June 2024
Spring Agenda Review : October 2024
New target date : January 2025
Good Manufacturing Practices (GMP) for cosmetic facilities
In order to ensure that cosmetic products are produced under controlled and safe conditions, this regulation establishes a set of guidelines on their production, storage and distribution.
Original proposed date : December 2024
Fall Agenda Review : October 2025
Ban on formaldehyde and its releasers in hair straightening products
The ban on the use of formaldehyde and substances that release it in hair products responds to the risks that these compounds pose to health, particularly in straightening treatments that involve frequent exposure to toxic fumes.
Original proposed date : October 2023
Spring Agenda Review : September 2024
New target date : March 2025
Implications and Challenges for the Cosmetics Sector
These timeline changes offer the cosmetics industry additional scope to adapt its processes to new regulatory requirements. However, they also represent a significant challenge, as manufacturers will need to review their production practices, adjust their product labelling and ensure compliance with strict quality standards.
From a business perspective, compliance with these new regulations will be crucial not only to avoid sanctions, but also to maintain consumer confidence in cosmetic products. The new regulations are expected to foster greater transparency and security in the market, which could strengthen the competitiveness of those companies that manage to adapt effectively.
Recommendations for Compliance
Since these dates are still subject to possible changes, it is highly recommended that companies closely follow FDA updates . Being prepared for regulatory compliance from an early stage could be a competitive advantage, as well as minimizing the risk of supply chain and product marketing disruptions.
Key areas that companies should focus on include:
Review and adaptation of labelling : Especially with regard to the disclosure of fragrance allergens.
Manufacturing Process Improvement : Ensuring that facilities comply with Good Manufacturing Practices defined by the FDA .
Implementation of new safety tests : Particularly those related to the detection of hazardous substances such as asbestos.
Ultimately, these regulations seek to improve the safety of cosmetic products, promote transparency towards consumers and raise quality standards throughout the industry.
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