New Cosmetics raw materials in the international cosmetics industry emerge endlessly, but since the implementation of the old regulations in China in 1989, the number of new raw materials that have been approved can be used in cosmetics are very small. Only 10 ingredients are approved during the last 30 years. Therefore, the research and development of raw materials by local companies have long been disadvantaged to compete and join the international markets. Foreign cosmetics ingredients enterprises also spent massive time and cost to get the approval of the products.
The situation could be improved significantly by the new cosmetics regulations that will be implemented on January 1, 2021. It strengthens the control of raw materials by risk levels and makes it easy and smooth to manage for low-risk ingredients. At the same time, it also encourages more companies engaged in the production of raw materials to increase investment, form a sustainable virtuous circle between raw materials and products, and expand the space for innovation in the industry.
According to the newly released “Regulations for the Registration and Filing of New Cosmetic Ingredients (Draft for Comment)”, I will bring you the key points that you need to pay attention to for the new cosmetics ingredients.
- What is the new raw material for cosmetics?
The natural or artificial raw materials used in cosmetics for the first time in China are new raw materials for cosmetics. According to the level of risk, it should be registered or filed separately before it can be used in cosmetics.
The current standard is mainly based on IECIC 2015. ” Inventory of Existing Cosmetic Ingredients in China (2015 Edition), which contains only 8783 ingredients in total.
2. The classification management of new cosmetic raw materials
2.1 Ingredients Types
The ingredients usually include chemical synthesis, plants, animals, minerals, biotechnology sources, and nano-materials.
Nano-materials: At present, China has neither defined nano-materials nor formulated relevant management regulations, and is in a regulatory blind zone. The specification refers to the EU regulations and gives the definition of nanomaterials (referring to insoluble and non-biodegradable artificial materials with at least one dimension in the three-dimensional structure in the size of 1 to 100 nanometers or composed of them as basic units.), “Specifications 》Specific data requirements are put forward for its preparation process, quality control standards, and safety evaluation data.
Biotechnology source materials: biotechnology (including genetic engineering, cell engineering, fermentation engineering, enzyme engineering and protein engineering). In view of the high risk of such materials, some oligopeptides, peptides, etc. may have drugs (such as growth factors) belonging The biological activity of it is beyond the scope of cosmetic raw materials. The “Specifications” put forward specific data requirements for the raw material data requirements of biotechnology sources, such as research reports, preparation processes, quality control standards, and safety evaluation data.
Natural raw materials: refers to derived from natural substances (plants, animals, minerals). Natural raw materials should be from a single source, that is, multi-based original animals and plants should be declared as a single species.
When the purity of a single ingredient extracted from plants is ≥80%, it shall be registered or filed according to the name of the ingredient.
3. Filing and Registration
After an ingredient is classified as high risks and low risks raw materials based on functions, the registration process will be different. For the high-risk ingredient such as anti-corrosion, sun protection, coloring, hair dyeing, freckle and whitening functions ingredients, it will be required to register at NMPA. For low risk ingredient, it only necessary to do the filing to the NMPA system.
The key difference between filing and registration is the review process of the application period.
After the application dossiers are well prepared and submitted to NMPA, the NMPA experts will take only 5 work days to review the materials and to complete the filing process but for high risk concern ingredients, it will be taking at least 133 working days to review and get the registration done.
Another difference may affect to ingredients company is the high risks ingredient usually will be involved more testing such as efficiency testing and toxicological testing. Such testing will take more testing time and money invest in the process.
4. 3 years supervision period
After the registration process has been completed, NMPA will grant the application company 3 years’ privilege to use the ingredients in cosmetics in China. But within the 3 years, the company shall take responsibility for the safety of the new ingredient and keep reports to NMPA for customer use feedback, post-market surveillance, and monitoring the side effects if any.
At the end of 3 years trial, NMPA will review the safety of the ingredients based on the supervision materials and decide whether the ingredients shall be added into IECIC or reject the ingredients to be used into cosmetics anymore.
5. Registration and filing information requirements
- New cosmetic raw material registration or filing application form
- Research report
- Manufacturing process
- Stability
- Quality control standard
- Safety assessment information
- Functions Evidence
- Technical requirements of
- Comparative report
- Samples
- Responsible Agent Materials (If necessary)
- Other materials that are helpful for administrative licensing.
5. What kinds of ingredients will be easier to be registered since 2020?
- Intended to be used for antiseptic, sunscreen, coloring, hair dyeing, freckle whitening, hair loss prevention, acne, anti-wrinkle, anti-dandruff, and antiperspirant functions.
- Sufficient evidence can be provided to prove that the raw material has a safe use history of more than three years in overseas.
- Can provide sufficient evidence to prove that it has a safe edible history of new cosmetic raw materials.
- Stable polymer structure that the average molecular weight is greater than 1000 Daltonan and less than 1000 daltons molecular weight of oligomer content of less than 10%
- The international evaluation authority has concluded that New raw materials are safe for use in cosmetics by the safety evaluation. It should submit the original and complete translations of the evaluation report, evaluation process, evaluation conclusions and laboratory qualification analysis, and other relevant materials.
Reference:
Inventory of Existing Cosmetic Ingredients in China (2015 Edition)
