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  • Writer's pictureDaniel Jiménez

EU Cosmetic Regulation Changes: Amendments to Annexes II, III, and V


In an era where consumer safety and product quality stand at the forefront of regulatory measures, the European Commission has once again set new benchmarks in the cosmetics industry. With the recent publication of Regulation (EU) 2024/996 on March 4th, a significant stride has been made towards ensuring the highest standards of consumer health and environmental safety.


This groundbreaking regulation introduces critical amendments to Annexes II, III, and V of Cosmetic Regulation No. 1223/2009, specifically targeting the use of certain ingredients in cosmetic products.


These changes, primarily influenced by the latest scientific insights from the Scientific Committee on Consumer Safety (SCCS), address substances ranging from skin conditioners and UV filters to preservatives, each with its unique role and potential impact on both users and the environment.



EU Cosmetic Regulation: Update and Key Changes
EU Cosmetic Regulation: Update and Key Changes


Official Publication of the European Commission


On March 4th, the European Commission published Regulation (EU) 2024/996, which regulates the use of vitamin A, Alpha-Arbutin, and Arbutin, as well as certain substances with possible endocrine-disrupting properties in cosmetic products: 4-Methylbenzylidene Camphor (4-MBC), Genistein, Daidzein, Kojic Acid, Triclocarban, and Triclosan.


These ingredients are known for their skin conditioning and depigmenting function, UV filter, and preservative function respectively.

 

This Amendment is based on the latest scientific recommendations of the Scientific Committee on Consumer Safety (SCCS), which implies modifications to Annexes II, III, V, and VI of Cosmetic Regulation No. 1223/2209.

 

Key Points


The recent amendments to Annexes II, III, and V within the European Commission's Regulation (EU) 2024/996 mark a pivotal moment for the cosmetic industry, emphasizing a commitment to safety, innovation, and environmental stewardship. These key points serve as a compass for manufacturers, guiding the inclusion, restriction, and permissible use of various substances in cosmetic products. By adhering to these updated regulations, companies are not only ensuring compliance but also aligning with the evolving expectations of consumers who prioritize health, safety, and sustainability in their beauty choices. This introductory overview of the annexes lays the foundation for a deeper exploration of each section, offering insights and advice on how to navigate the complexities of cosmetic regulation in today's market.


Annex II: Prohibited substances

 

Navigating the landscape of prohibited substances in cosmetic products is paramount for manufacturers aiming to maintain compliance and uphold consumer trust. The inclusion of 4-Methylbenzylidene Camphor (4-MBC) in Annex II serves as a potent reminder of the evolving regulatory environment, driven by advancements in scientific research and consumer safety standards.


Companies must adopt a proactive approach, regularly reviewing and updating their ingredient lists to align with the latest regulations. Implementing robust ingredient screening processes and investing in research and development can aid in identifying safe and innovative alternatives that meet efficacy and safety criteria without compromising product quality.


This not only ensures regulatory compliance but also positions brands as responsible and consumer-centric in the competitive cosmetics market.


The UV filter 4-Methylbenzylidene Camphor (4-MBC) (CAS No. 36861-47-9 / 38102-62-4) has been included by removing its entry from Annex VI of the Regulation. The following transitional periods are established for its implementation:

 

  • Products containing this substance will not be allowed to be placed on the market after May 1, 2025.

  • Products containing this substance will not be marketed after May 1, 2026. 



Annex III: Restricted substances


The regulation of restricted substances underscores the nuanced balance between leveraging the beneficial properties of certain ingredients and mitigating potential risks. For cosmetic companies, this translates into a meticulous assessment of formulation concentrations, usage conditions, and labeling requirements. Staying informed about the specific restrictions and permissible thresholds is critical. Companies should consider leveraging advanced analytical methods and consulting with regulatory experts to ensure their products meet the stringent safety standards set forth in Annex III. Furthermore, transparency with consumers about ingredient safety and adherence to regulatory guidelines can enhance brand credibility and consumer confidence in a brand's commitment to safety and quality.



Annex III: Restricted substances
Annex III: Restricted substances


Annex V:  Allowed Preservatives


The preservatives listed in Annex V represent a carefully vetted group of substances deemed safe for use within specified limits. For cosmetic manufacturers, this list is a valuable resource for formulating products that are not only effective but also compliant with safety regulations. However, with the growing consumer demand for products free from certain preservatives and the rise of clean beauty trends, companies are encouraged to innovate in preservation techniques. Exploring natural and alternative preservatives that meet regulatory approval while satisfying consumer preferences can be a significant differentiator in the market. Additionally, staying abreast of ongoing research and potential future amendments to Annex V is essential for maintaining compliance and anticipating shifts in consumer expectations and regulatory landscapes.


Annex V:  Allowed Preservatives
Annex V:  Allowed Preservatives

These modifications aim to guarantee the safety and quality of cosmetic products on the European market, in line with the latest scientific research on safety and health.

 

With our expertise in consulting sector and technology solutions, we can help companies ensure compliance and stay competitive in an ever-changing marketplace. If you need more information, please do not hesitate to contact us.

We will glad to help you.

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