Clarifying Compliance Requirements for Children Cosmetics in China

Takehome:

The scale of China's children cosmetics market is constantly expanding. Naturalness and safety are crucial factors shaping consumer purchasing decisions and markets. Regulatory requirements differ between children cosmetics and general cosmetics and these distinctions are likely to become further polarized as government develops stricter regulations to differentiate administration of adult cosmetics and children cosmetics. Children cosmetics are subject to more stringent requirements in terms of their safety indexes, permitted ingredients, labeling stipulations and overall documentation requirements. 

Regulations:

Children cosmetics in China are defined as "cosmetics produced specifically for children from age 0-12 years old (including 12)". Currently, there are two main regulations for the supervision of children cosmetics in China:

Children Cosmetics Enterprises' Obligation:

Note: products such as soaps, wipes and diapers do not need CFDA’s approval or filing in Pudong.

Comparison with imported adult cosmetics application documents:

There is no difference in procedures between domestic non-special use children cosmetics and adult cosmetics online filing, but certain safety indexes, documentation requirements and labeling stipulations are stricter. The same applies to imported children cosmetics application documents：

1. More documents. For instance, formula design principles based on safety considerations (including the overall analysis report of the formula), selection principle and requirements of ingredients, manufacturing technique, quality and safety control, etc.;

2. Stricter standard in microorganisms and toxicology;

3. The Chinese name or visible packaging surface should clearly express that the product is suitable for children use;

4. Products for children should print on the product label (including product instruction) the warnings such as "should be used under adult supervision" .

Ingredient Requirements for Children Cosmetics:

Ingredient selection:

• The number of categories of ingredients adopted should be kept to the minimum level

• Restrict the use of fragrance, colorant, preservative and surfactant to the minimum as long as it is sufficient to maintain efficacy/function

• 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. (Function of sunscreen is permitted);

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

Ingredient usage amount:

1. Refer to the safety reference values of domestic and foreign authoritative organizations;

2. If there is no safety reference value, refer to the indirect reference value, such as the limited amount of the same ingredients in food, or the toxicology data, etc.

Ingredient index

Special attention is paid to cosmetics used on children under 3 years old. Some ingredients are not allowed to be used in cosmetics produced for children under 3 years old.

Other child care products compliance requirements：

• Children’s toothpaste and oral rinses, in line with industry standards

• Children's toothbrush shall comply with the relevant provisions in GB 30002-2013

• Baby cleansing wet wipes and diapers shall be supervised in accordance with disposable hygiene products

• For antibacterial and mosquito-repelling products, compliance should be carried out according to the standard of disinfection product or public health pesticide.

Existing Problems and Future Trends:

"Standard for Cosmetic Classification (Draft)" was opened to public consultation in January 2018 and outlines that cosmetics will be differentially regulated based on target users. Special group such as infants and children have more sensitive skin than adults and are more susceptible to adverse reactions, allergic reactions and other negative impact. Children cosmetics research, manufacture and supervision will be treated differently from adults.

Although Safety and Technical Standards for Cosmetics sets different hygienic standards for children and adult cosmetics, the requirements for ingredients, especially some heavy metals, are basically the same as those for adults. Due to the physiological differences inherent in adults compared to children, clear limitations and requirements for children cosmetics ingredients are necessary.

Competent authorities are constantly tightening the control and supervision of children cosmetics, but there are no mandatory standards for children cosmetic ingredients. Mandatory standards and safety evaluation standards for children cosmetics ingredients are likely to be introduced in the future.