Since the pilot program of the import non-special filing system in 2017, the total number of imported non-special cosmetics has been reached 34,270 products, but only about 200 infants and children’s products been approved, less than 0.6% in total. But on the bright side is that the registration of children’s cosmetics is quite difficult but it is not impossible.

I have worked in several successful cases to help brands to register children’s cosmetics in China. I would like to share with you my experiences with analyzing the current laws and regulations of children’s cosmetics in China. And also give suggestions on how you can design your baby/infant/children cosmetics in compliance in China.

China Children’s Cosmetics Regulatory Requirements-“Guidelines for the Application and Evaluation of Children’s Cosmetics”

In China, there are special regulations for children’s cosmetics, namely the “Guidelines for the Application and Evaluation of Children’s Cosmetics”, which were released in October 2012. After the release, the number of successfully registered children’s cosmetics, especially imported children’s cosmetics, is very small.

⏩Scope of application: cosmetics used by children from 0 to 12 years old will be categorized as Children’s cosmetics.

Note: The claims on the labels such as “for family use, children’s pictures”, etc. may be regarded as Children’s cosmetics.

⏩Additional Documents for registration: Except for the normal registration documents of adult cosmetics, there are additional materials are required.

1. Formula design principles of children’s cosmetics

2. The overall analysis report of the formula *

3. The selection principles and requirements of raw materials

4. Production Process and quality control, etc.

Note: The overall analysis report of the formula requires a safety analysis of each raw material and its dosage similar to EU CPSR.

Example of ingredients analysis: No. 6 raw material polydimethylsiloxane has been used in cosmetic formulations for many years, and its chemical properties are stable. The US CIR commented that its maximum safe dosage in cosmetics is 24%, so it should be safe to use forthe ingredients dosage is 2% in this formula.

Roger: Failure to provide sufficient evidence for the safety of raw materials is a common reason for the failure of the filing of children’s cosmetics.

There are only 8783 types of cosmetic raw materials used in China. Not every raw material is suitable for children’s cosmetics. Among them, there are relatively few raw materials that can have a sufficient safety basis. Generally, the data sources recognized by the NMPA recognized institutions include CIR, SCCS, etc.

⏩Product safety requirements:

● The safety of children’s cosmetics should be researched and evaluated to ensure product safety. It should carefully perform the safety evaluation of Children cosmetics based on the use types of the product (such as whether to rinse after use) to strengthen the safety of fragrances, ethanol, and other organic solvents, cationic surfactants, and skin penetration enhancers use in the products.

● The total number of colonies should not be greater than 500CFU/mL or 500CFU/g;

● There should be no skin and eye irritation, no phototoxicity, and no allergic reaction.

⏩Formulation Suggestions:

Principle: The types and numbers of raw materials used in the formulation should be minimized as much as possible.

● When selecting flavors, colorants, preservatives, and surfactants, the principle is to use less or even don’t use on the basis of effectiveness, and it should be paid attention to the possible adverse reactions.

● Children’s cosmetics formulations should not use ingredients that have functions such as whitening, freckle removal, acne removal, hair removal, antiperspirant, deodorant, hair growth, hair dyeing, perming, bodybuilding, and beauty breast. The above claims are all belongs to the special cosmetics category, so It also means Children cosmetics almost not be registered as special cosmetics except for sunscreen products. 

● Cosmetic raw materials with a certain history of safe use should be selected, and the use of raw materials prepared by genetic technology and nanotechnology is discouraged.

● The source, composition, impurities, physical and chemical properties, the scope of application, safe dosage, precautions and other relevant information of the raw materials used in the formula should be known and available for reference.

⏩Labeling Suggestions:

● The Chinese name of the product or the visual surface of the package should indicate the products applicable to children;

● Should put the warning term: “should be used under adult supervision.”

Case Study about Children Cosmetics Registration

I sorted out 10 review opinions of typical failure of children’s cosmetics registration from the NMPA Database as follows:

Case 1: The formula contains flavors and pigments “CI 15985, CI 14700“. It does not provide sufficient basis for adding these ingredients and the explanation of the necessity, as well as the conclusions of toxicological research and its literature (including toxicology Research report on experimental data and conclusions) and other materials.

Case 2: In the formula, MACADAMIA INTEGRIFOLIA seed oil and sunflower (HELIANTHUS ANNUUS) seed oil did not provide the basis for evaluating the safe dosage for use in cosmetics, nor calculate and provide the daily exposure of these two raw materials and Basis for infants weight calculation. The Chinese label of the product is not marked with warning words such as “should be used under adult supervision” as required.

Case 3: Did not analyze the necessity of using and rationality of each ingredients, such as of p-hydroxyacetophenone, bisabolol, carbomer, etc.

Case 4: The product packaging adopts the cartoon image”Little Penguin Pok Lele”. It is suspected of children’s cosmetics. The packaging should be designed in accordance with relevant Chinese regulations and registered as Children cosmetics.

Case 5: The foreign name of the product is “Little Body Moisturizing Lotion“. Please clearly indicate the warning word on the Chinese label: This product is not a cosmetic for children.

Case 6: The formula design principles of children’s cosmetics did not provide cyclopentadimethylsiloxane and did not provide the quality specification certificate containing cyclotetrasiloxane (D4) control indicators.

Case 7: The name of the product was changed from “boy” to “child”, the applicable population has changed, and no special and effective description has been made.

Case 8: Assessment of safety risk substances: The raw material formula“carbomer” may bring in the harmful solvent “benzene”. Please provide the quality specifications of the raw material, and make a safety evaluation analysis for this ingredient in the overall analysis report.

Case 9: Potassium sorbate is a preservative, which has not been analyzed according to the “Cosmetics Safety Technical Standards”.

Case 10: The safety assessment of the fragrance does not meet the requirements, and the ratio analysis certificate issued by the fragrance manufacturer that may contain allergenic fragrance components (26 EU allergens) in the fragrance is not provided.

In conclusion, the main problems are that the formulation design principles do not meet the requirements and the raw material safety basis is insufficient. Highly suggest that the safety of the raw materials and their dosage are fully considered when the product formula is designed.

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.

1. 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?

1. Intended to be used for antiseptic, sunscreen, coloring, hair dyeing, freckle whitening, hair loss prevention, acne, anti-wrinkle, anti-dandruff, and antiperspirant functions.
2. Sufficient evidence can be provided to prove that the raw material has a safe use history of more than three years in overseas.
3. Can provide sufficient evidence to prove that it has a safe edible history of new cosmetic raw materials.
4. 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%
5. 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)