This year in China, there has been a groundbreaking progress in the registration of raw materials in the field of synthetic biology.
Why is that? Because in the field of food ingredients, there has been a new registration for HMO (Human Milk Oligosaccharides), making it the first case in the field of new varieties of food additives. Although there hasn’t been a breakthrough in genetically modified microorganisms synthesizing new food ingredients yet, I believe it’s only a matter of time. In the realm of cosmetic ingredients, there have already been registrations for synthetic biology-related materials.
Next, I’d like to discuss with everyone the process and requirements for registering new cosmetic ingredients.
The registration process for new cosmetic ingredients involves four steps
Regarding synthetic biology and the registration of new materials, some regions in China have introduced numerous supportive policies this year. While these policies may constitute only a small part of the overall industrial development support, they are nonetheless an essential component.
Since the implementation of the new regulations, the “Cosmetic Supervision and Management Regulations,” on January 1, 2021, and the launch of the new material filing system on May 1, 2021, a total of 102 cosmetic new material filings have been approved (as of November 23). Unfortunately, there are still no registered cosmetic new materials in the registration category, awaiting breakthroughs. It is believed that in the future, new materials for whitening and hair dyeing will emerge.
Let’s take a look at the sources of these 102 cosmetic new materials. The majority comes from chemical materials, with polymers being the most prominent within the chemical category. Polymers, especially those with high molecular weights, can exempt some toxicity tests, reducing the overall testing period. As a result, they have a higher registration and filing volume. Later, I’ll also share when it’s possible to skip animal testing and when it can be reduced to evaluate the safety of materials and whether they can be registered and enter the market compliantly.
When preparing a material that has undergone pilot testing, has stable quality standards, and is ready to be applied in the cosmetics field, you can check if the material is listed in our “Catalog of Used Cosmetic Ingredients.” This is a preliminary assessment, and if it’s not listed, it’s likely that you need to apply for the registration of a new cosmetic material.
The first step is to determine the entity applying for the registration of the new cosmetic material
Research and development companies typically have multiple entities, and the entity responsible for introducing the new material to the market becomes the registrant. For overseas companies, there needs to be a domestic responsible company to establish the corresponding safety risk monitoring and evaluation system. Simultaneously, account permissions for the filing system must be activated to ensure the safety and compliance of the material during the safety monitoring period.
The second step involves testing the new cosmetic material
Testing primarily focuses on two dimensions: safety verification and efficacy verification. Safety verification should be the most crucial aspect of the application, including the stability of the material’s own quality standards. When conducting stability testing for the material, the main goal is to demonstrate under what storage conditions and for how long the material can meet the quality standards.
From the filing perspective, at least one batch of influencing factor experiments should be conducted to identify factors affecting the storage of the material. For instance, high temperatures may lead to changes in the quality of the material. Additionally, at least three batches of accelerated experiments should be performed, typically using single-factor accelerated experiments by increasing the temperature to speed up the chemical reactions, characterizing the material’s shelf life through short-term accelerated experiments. The most scientific way to characterize the shelf life of a material is through long-term stability tests.
In reality, all three types of experiments are necessary, but during the initial filing stage, the first two types are sufficient.
There are also toxicity tests and efficacy tests for the material. For example, the European Union prohibits animal testing for cosmetic ingredients, presenting certain barriers and difficulties for some overseas materials. Efficacy tests for the material generally include in vitro studies, skin models, human experiments, etc. For a new material, it is essential to verify its efficacy from multiple dimensions.
Furthermore, a structural confirmation report for the material is required. This report is mainly for single-component materials, where structurally clear materials need structural confirmation. In other words, the substance to be declared should be the actual substance itself, and even plant-based materials require species identification.
The third step is to submit the filing materials and complete the filing process
The filing materials are relatively simple in terms of the overall framework, including research and development reports, preparation processes, quality standards, safety evaluations, and technical requirements.
During the filing stage, the current timeframe has significantly increased compared to before the implementation of the new regulations. In the 31 years from the implementation of the health regulations in 1990 to before the implementation of the new regulations, including cosmetic new materials approved by the health department and our food and drug supervision bureau, there were only around 14. Now, there are over 100.
How long does the filing process currently take? After submitting the documents, feedback is generally provided within 5 working days, and it may take one or two filings to get approval. This stage is already very efficient, making it an excellent time for new material filings.
The fourth step is the three-year monitoring period
Of course, filing does not mean that the National Medical Products Administration has approved the material. During the three-year monitoring period, the entity applying for the filing still bears the responsibility for the safe use of the material. When applying the material to products, it is crucial to ensure consistency with the filing materials. For example, if the filing states that the production process is based on synthetic biology, the corresponding strains used in production must be consistent with the filing information.
During the monitoring period, attention should also be paid to the intended use and safe usage amount of the material. For instance, when filing, some materials may be designated as skin protectants, and when using them in products, there may be some areas of ambiguity on how to declare their use. In the current situation, it is advisable to adhere to the characteristics of the material itself, avoiding making claims that go beyond its scope, such as claiming it to be a whitening or anti-wrinkle agent.
At HONGMAOKANG, we are dedicated to providing comprehensive consulting services for NMPA Cosmetic Registration/Filing. Our expertise ensures a seamless process, guiding you through the intricate steps of material assessment, regulatory compliance, and safety documentation preparation. With a commitment to excellence, we strive to facilitate your journey in achieving successful cosmetic registrations and filings, making regulatory compliance an accessible and efficient experience for your cosmetic products.
