| To specify the children (including infants and young children, hereinafter referred to as “children”) cosmetics application and technical review, and based on “cosmetics health norms”, “regulation of cosmetics administrative acceptance” and other regulations, formulate this guideline.
1. The scope of this application
(1). This guide is suitable for the application and evaluation of children’s cosmetics. Children’s cosmetics refer to the cosmetics used by the children under the age of 12.
2. Principles of formulation
(2). Should minimize the types of raw materials.
(3). When choose fragrance, colorant, preservative, and surfactant, on the premise of effectiveness, should insist on the principles of no or less use of them, and at the same time, pay close attention to their possible adverse reactions.
(4). Children’s cosmetics should not have the ingredients for such as whitening, spot removing, acne removing, hair removing, hidroschesis, deodorant, hair tonic, perm, bodybuilding, breast beauty and so on.
(5). Should choose the raw materials which have safety usage history, and does not encourage to use genetic technology and NT to prepare the raw materials.
(6). Should understand the source, composition, impurities, physical and chemical properties, applicable scope, safety suing amount, notice and other relevant information and reference.
3. Safety
(7). Applying enterprise should do the safety research and evaluation to the children’s cosmetics, and ensure that the product is safe.
(8). Applying enterprises should have security risk assessment of the children’s cosmetics in accordance with the characteristics of children,
(9). Combine with the usage method of the products (for instance, whether need to rinse after using), enhance the risk assessment of raw materials, like fragrance, ethanol and other organic solvent, cationic surfactant and TPEa
4. Applying
(10). If the enterprise expresses the cosmetic is for children’s use, and then enterprise can apply in accordance with the related laws in “regulation of cosmetics administrative acceptance”; if the cosmetic is not clearly express for children’s use, and there cannot be the design of package and other forms or hints to display it’s children’s cosmetics.
(11). As children’s cosmetics applying documents, should include the principles of formulation design which based on the security considerations ( including formula overall analysis report), principles and requirements of raw materials chosen, manufacturing technology and quality control, etc.
(12). Formula overall analysis report should analysis based on the safety evaluation. For the convenience of applicant, this guideline provides the reference sample of the principles of children’s cosmetics formula design (including formula overall analysis report). See the attachment.
5. Evaluation
(13). Evaluate the integrity, rationality and scientific of the documents submitted:
The application documents should be complete and conform to the relevant requirements;
The name and package of the products should have the words which clearly express that this is the children’s cosmetics;
For children’s use product, the label of the product (including the instruction) should have the warning words, like “must be used under adult supervision”;
Children’s cosmetics and its raw materials must comply with “cosmetics health norms”;
The testing of children’s cosmetic must comply with “cosmetics administrative licensing inspection specification”. Product should have no skin and eye irritation, phototoxic, and allergic to children;
The bacterial colony of children’s cosmetic is no higher than 500 CFU/mL or 500 CFU/g;
According to the product, the principles of formula design (including formula overall analysis report), the principles and requirements of raw materials chosen, manufacturing technology and quality control should illustrate scientifically and reasonable, besides, these should be the same as other information (such as label, formula, technology etc.);
The content of formula overall analysis report should be complete, and attached with raw materials analyzing. And those involved in the limited materials in “cosmetics health norms” should illustrate by combining with the relevant restrictions.
(14). If there are problems in the documents, specialists will give detailed opinions according to the relevant policies and scientific evidence of cosmetics regulation.
(15). According to the characteristics of children’s cosmetics, CFDA will have the second time review to the children’s cosmetic which has already been approved.
(16). Domestic normal children’s cosmetics registration, applicant should submit the documents as this guideline’s requirements.
(17). CFDA will take responsibility to explain this guideline, and this guideline will implement since February 1st, 2013.
Attachment: Principles of children’s cosmetics’ formula design (including formula overall analysis report). Sample.
Attachment
Principles of Children’s Cosmetic’s Formula Design (including Formula Overall Analysis Report)
Sample
1. Ingredients example
XXX Baby Moisturizer Ingredients Formula
| NO. |
Ingredients |
Content (w%) |
Purpose |
| 1 |
WATER |
74.6 |
Solvent |
| 2 |
GLYCERIN |
6.0 |
Humectants |
| 3 |
OLEA EUROPAEA (OLIVE) FRUIT OIL |
6.0 |
Emollient |
| 4 |
SQUALANE |
5.0 |
Emollient |
| 5 |
CETYL ALCOHOL |
3.0 |
Emollient |
| 6 |
DIMETHICONE |
2.0 |
Emollient |
| 7 |
POLYSORBATE 60 |
1.5 |
Emulsifier |
| 8 |
SORBITAN STEARATE |
0.8 |
Emulsifier |
| 9 |
PHENOXYETHANOL |
0.5 |
Preservative |
| 10 |
SODIUM CARBOMER |
0.4 |
Thickener |
| 11 |
TOCOPHERYL ACETATE |
0.2 |
Antioxidant |
NOTICE: The above formula is only reference example about the principles of formula design (include formula overall analysis report)
2. Example of the principles of formula design
This formula selects safe, moderate and high purity cosmetic raw materials, and use as less as possible kinds of materials and additives (except water).
The basic function of this product is nourishing and moisturizing, and the formula does not contain additive ingredients which exceed these functions (except necessary emulsifier, stabilizer and so on).
The selected raw materials have been strictly tested, and ensure the testing result conform to relevant specification indicators.
This formula does not have raw materials, like fragrance, coloring etc. which can cause adverse reactions.
3. Example of formula overall analysis
NO.1-6 raw materials in the formula have been chosen based on the purpose of nourishing and moisturizing.
NO.2 raw material glycerin is commonly used as polyhydric alcohols moisturizer in cosmetics. The purity of glycerin in this formula is more than 98%, the content of impurity diethylene glycol is less than 0.05%. Relevant indicators are higher than “requirements of glycerin as raw material in cosmetic” issued by CFDA. Glycerin in this formula is 6% and at the safety using amount range.
No.3 OLEA EUROPAEA (OLIVE) FRUIT OIL is derived from natural plants, it’s safe and edible, and also it has been used in cosmetics for many years and has no restrictions in cosmetics. The content is 6% in the formula.
NO.4 SQUALANE is natural composition in human sebaceous, and according to the America CIR, it is safe used in cosmetics, ad the maximum safety usage amount is 31%. Content in this formula is 5%.
NO.5 CETYL ALCOHOL, the CIR considers it is safe in cosmetic’s use, the maximum safety usage amount is 50% and here is 3%.
NO.6 DIMETHICONE has been used in cosmetics for many years, and has stable chemical properties. CIR’s maximum safety dosage is 24% while the amount in this formula (2%) should be safe.
NO.7,8 They are common nonionic emulsifier in cosmetic, and it is necessary material to form cream. The contents of POLYSORBATE 60 and SORBITAN STEARATE are low and they are 1.5% and 0.8%. And CIR considers it is safe when used in cosmetics and the maximum safety content as raw material is both 25%.
We noticed that the POLYSORBATE 60 and SORBITAN STEARATE could have residual DIOXAN, so we did risk assessment about the possible risk materials, and the result of risk assessment can be found in the risk assessment documents.
NO.9 PHENOXYETHANOL is preservative in cosmetics. Its limit content in “Cosmetics Health Standard” is 1% and here is 0.5%, which is far more less than limit amount.
We noticed that there may be PHENOL and DIOXAN residual risk problems, so we did the risk assessment about the possible risk materials, and the evaluation results can be found in the risk assessment documents.
NO.10 SODIUM CARBOMER has many years of usage history as thickener in cosmetics. Carbomer 940 in this formula has been neutralized by alkali and do not need to neutralization when using. Maximum usage amount of carbomer 940 considered by CIR is 2% and in this formula, 0.4% is much lower than this value.
NO.11 It is common antioxidant ingredient in cosmetic, and its main function is to prevent the oxidation and rancidity of the grease. In this formula, the content is 0.2%, which number is much lower than the America CIR required amount, 36%. So it should be safe in this formula.
In conclusion, through the overall analysis of the materials, this formula should be safe in children’s cosmetic.
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