Outline:
- The three key date for the implementation of the new regulations
- The definition of children’s cosmetics
- Allowed efficacy claims of children’s cosmetics
- Labeling requirements for children’s cosmetics
- The product implementation standards of children’s cosmetics products
- Children’s cosmetics safety requirements
- Formula Design Principles
- Children’s toothpaste Management
On October 8, the National Medical Products Administration (NMPA) issued the latest regulations on children’s cosmetics: “Regulations on the Supervision and Administration of Children’s Cosmetics.” The implementation of this regulation will bring new challenges to the market access of children’s cosmetics. CosmeticsBridge has summarized the key points of the registration of children’s cosmetics new regulations.
1. The three key dates for the implementation of the new regulations
| Date | Details |
| January 1, 2022 | Implementation”Children’s Cosmetics Supervision and Administration Regulations” for the labeling requirements |
| May 1, 2022 | Children’s cosmetics that new applications for registration or Notification must follow the new label requirements of the children’s regulation. |
| Before May 1, 2023 | Children cosmetics that already applied for registration or Notification before May 1, 2022 shall complete the new regulation compliance before May 1, 2023, in accordance with the new regulations labeling requirement. |
2. The definition of children’s cosmetics
According to Article 3 of the “Children’s Regulations”, Children’s cosmetics refer to cosmetics that are suitable for children under the age of 12 (including 12 years old) and have the functions of cleansing, moisturizing, body conditioning, and sun protection. Labels like “applicable to the whole population”, “use by the whole family” and other words or use trademarks, patterns, homophones, letters, Chinese pinyin, numbers, symbols, packaging, etc. to imply that the product users include children’s products in accordance with the management of children’s cosmetics. ——–At present, adult products are often seen on the market is implied that the products are applicable for children. Such brands should special attention to this regulation now.⚠️.
3. Allowed efficacy claims of children’s cosmetics
According to the “Rules for Classification of Cosmetics and Classification” that came into effect on May 1 this year, the users of children’s cosmetics can be divided into infants and children. The corresponding age groups and efficacy claims are shown in the table below. It must be noted that common claims such as repair and nourishment are not within the scope of the efficacy claims of infant products.
| The user population | Efficacy claims |
| infants and young children(0 to 3 years old, including 3 years old) | are limited to cleansing, moisturizing, hair care, sun protection, soothing, and taming |
| Children(3 to 12 years old, including 12 years old) | Are limited to cleaning, makeup remover, moisturizing, and beauty Retouching, fragrance, hair care, sun protection, repair, soothing, and refreshing |
4. Labeling requirements for children’s cosmetics
① No words such as “food grade” or “edible” or food-related patterns shall be marked.
② Children ‘s cosmetics logo: Mark the children’s cosmetics logo specified by the NMPAon the display surface of the sales package (the logo has not yet been released). Non-children’s cosmetics shall not be marked with the children’s cosmetics logo.
③ Warning Terms: Cosmetics for children should use “attention” or “Warning” as the introductory phrase, marked in the sales package visible surface ” should be used under adult supervision“.
④Encourage anti-counterfeiting technology: Encourage cosmetics registrants and filing person to use anti-counterfeiting technology on the label to facilitate consumers to identify and choose legal products.
5. The product implementation standards of children’s cosmetics products
Encourage cosmetic registrants and filling person to formulate children’s cosmetics that are stricter than mandatory national standards and technical specifications. According to the “Cosmetics Safety Technical Specification” (2015 Edition), the total number of colonies in children’s cosmetics is required to be ≤500 CFU/g or CFU/ml, which is stricter than that of adult products ≤1000 CFU/g or CFU/ml.
6. Children’s cosmetics safety requirements
Children’s cosmetics should pass safety assessments and necessary toxicological tests for product safety assessments. That is, there is no way to exempt animal testing during the pre-marketing registration process of children’s cosmetics. When the cosmetics registrants and filing person conduct safety assessments of children’s cosmetics, they shall consider the physiological characteristics of the children in the aspects of hazard identification and exposure calculation.
The inspection items required for the filing and registration of children’s cosmetics should be in accordance with the “Regulations for Cosmetics Registration and Filing Inspection Work”, and the results of toxicological testing can be determined in accordance with the “Guidelines for the Application and Evaluation of Children’s Cosmetics”. The products should have no skin and eye irritation, no phototoxicity, no allergic reaction.
7. Formula Design Principles
For children’s cosmetics, formula design principles are a unique requirement for the filing and registration of children’s cosmetics, and it is also a difficult point in the filing and registration process.
The new rules stipulate this principle is similar to the “Guidelines for the Declaration and Review of Children’s Cosmetics”, requiring the formula design of children’s cosmetics should follow the principle of safety first, the principle of essential efficacy, and the principle of minimal formulation:
(1) Cosmetics with long-term safe use history should be selected for raw materials, it is not allowed to use new raw materials that are still in the monitoring period, and raw materials from genetic technology and nanotechnology. If there is no alternative raw materials and must be used in the products, the reasons should be explained and the safety of children’s cosmetics should be evaluated;
(2) It is not allowed to use raw materials for the purpose of freckle whitening, acne removal, hair removal, deodorization, anti-dandruff, hair loss prevention, hair dyeing, perming, etc. If the raw materials that may have the above-mentioned effects are used for other purposes, they shall be Necessity and evaluation of the safety of the use of children’s cosmetics;
(3) Children’s cosmetics should be evaluated in terms of the safety, stability, function, compatibility and other aspects of the raw materials, combined with the children’s physiological characteristics, to evaluate the scientificity and necessity of the raw materials used, especially fragrances. Flavors, colorants, preservatives and surfactants and other raw materials.
CosmeticsBridge suggestion: the nano-level sunscreen ingredients zinc oxide and titanium dioxide are not recommended for children’s sunscreen products. Genetically modified vegetable oils are also not to be used in children’s cosmetics.
8. Children’s toothpaste
The Regulation clealy indicate that children’s toothpaste shall be managed according to the”Children’s Regulations”. Which means highly chance that the children’s toothpaste shall be required to do the notification as children cosmetics. We believe the under composing regulation of toothpaste management shall be reveal more details of the management.
