China Children Cosmetics Regulations

In China Children cosmetics refer to cosmetics produced specifically for children from age 0-12 years old (including infants). The majority of children cosmetics are classified as non-special use cosmetics except for sunscreens which are special use cosmetics. Some functional products such as whitening products, hair dyes are usually not approved as children cosmetics.

Like adult cosmetics, children cosmetics sold in China must be notified or registered according to the "Provisions on Cosmetics Administrative License Application" and "Hygienic Standard for Cosmetics" (click here to see the required dossiers). For the purpose of standardizing the notification/registration and technical review for children cosmetics, CFDA released "Guidance on Application and Review of Children's Cosmetics" on Oct 12 2012. It outlines that the following documents are additionally required for children cosmetics:

• Document on formula design principles (including the formula overall analysis report)

• Document on ingredients selection principles and related requirements

• Documents of processing techniques and quality control

Formula

The design of children products formula must follow certain principles:

1. The number of categories of ingredients adopted should be kept to a minimum level.

2. The use of fragrance, colorant, preservative and surfactant shall be restricted as long as it is sufficient to maintain the effectiveness, and at the same time pay attention to the potential adverse effects.

3. The formula of children's cosmetics should not contain the ingredients with the function of whitening, freckle eliminating, acne treatment, depilation, hidroschesis, deodorization, hair nurturing, hair perming, body shaping, breast enlargement, etc.

4. The ingredients selected should have a certain period of safe use, ingredients manufactured through genetic technology, nanotechnology are not recommended.

5. The information of all the ingredients in the formula including source, composition, impurity, physicochemical property, scope of use, safe use amount, precautions, etc. should be known and filed for future inspection.

The formula overall analysis report submitted should be complete and analyze the ingredients in the formula from the perspective of safety. For "ingredients with a certain history of safe use", the analysis report shall indicate the dosage of ingredients in the formula.

Safety

Companies shall study and evaluate the safety of children cosmetics based on the formula design principles and from the aspects of the selection of ingredients, the processing technique and quality control, etc. They shall also conduct risk assessment s on the safety of ingredients used in children cosmetics. Companies shall focus on assessing the safety of some specific ingredients such as fragrance, organic solvent, cationic surfactant and transdermal accelerator, taking the use purpose (e.g. rinse off or leave on) into consideration.

For example, compared to anionic, nonionic and amphoteric ionic surfactant, cationic surfactant is more toxic. So when using a cationic surfactant in a leave-on children product, companies must consider the necessity to use such an ingredient. Use of another less toxic ingredient facilitates CFDA approval.

Labeling

Children cosmetics are subject to the following additional requirements:

• The Chinese name or visible packaging shall clearly express that the product is suitable for use by children.

• The products used by children should print on the product label (including product instruction) the warnings sentences such as "should be used under adult supervision".

• Cosmetics without clear indication for use by children shall not bear any images of children or imply in any way that these are children cosmetics on the packages.

Testing

Like adult cosmetics, children cosmetics must be tested in the CFDA approved testing institutions. The testing items shall comply with the "standard of the inspection for cosmetics administrative license". In addition, the children cosmetics shall be non-irritant to the skin and eyes, non-phototoxic and non-allergic. The total bacteria count of children cosmetics shall be no more than 500 CFU/Ml or 500 CFU/g.

Re-evaluation

Based on the characteristics of children cosmetics, the CFDA may arrange re-evaluation on the safety of the approved/filed children cosmetics. If the re-evaluation results show that new safety risks may exist, existing approval will be revoked.