The Interpretation of the Difficulties in the Notification of Imported Baby Care Cosmetics

Since the implementation of The Guideline for the Notification and Examination of Baby Care Cosmetics (the Guideline) on 1st Feb 2013, less than 100 non-special use baby care cosmetic products were permitted to import into China by CFDA. Indeed, the imported special use baby care cosmetics were even few. One of the main reasons for the failed notification is that cosmetic enterprises have a poor understanding of the Guideline. With several successful notification experiences, CIRS cosmetic compliance team made an interpretation of the difficulties in the notification of imported baby care cosmetics.

1. Countries and regions have different regulatory requirements for baby care cosmetics

We can see from the below chart that China has specific requirements on several aspects of baby care cosmetics notification, including application documents, ingredients, microorganism and toxicology standards, and labels. But other countries may have different regulations, which caused many difficulties in the notification of baby care cosmetics for oversea enterprises. Therefore, foreign companies ought to make a pre-evaluation for the compliance of baby care cosmetics in China.

Nations	The definition of baby care cosmetics	The specific requirements on baby care cosmetics
EU	Cosmetics for Children under the age of 3.	² Ingredients requirements : CMR substances, endocrine disruptors, substances on annex XIV of EC 1907/2006 (REACH), allergen substances are all banned in baby care cosmetics. The usage of preservatives should be minimal effective concentration. ² Labeling requirements : including clear usage and attentions, ensuring the safety and avoiding misuse. ² Cosmetics safety assessment report : Have to conduct toxicological analysis for each ingredient.
U.S.	/	² Labeling requirements : Marking “Use under adult supervisions”.
Japan	/	² No specific requirements in the regulation, but the standards issued by the producers and industry association include that baby care cosmetics should be low irritation, easy cleaning, harmless if licked a little, etc.
China	Cosmetics for Children under the age of 12.	² More application documents required than adult use cosmetics. ² More stringent requirements on ingredients, formula and manufacturing technique. ² More stringent requirements on microorganism and toxicology standards ² ”Use under adult supervision” should be clear in the labels

2. The interpretation of difficulties in notification.

Point 1. Notification of imported baby care cosmetics requires more complicated documents than cosmetics intended for adult

The main documents that needed in the notification of imported adult cosmetics include： application form, Chinese name of the product and its nomenclature principle, formula, quality and safety control requirements, package, inspection report and relevant materials, safety assessment of risk substances，the copies of POA, letter of commitment which confirming that ingredients and its source are accord with forbidden or limited requirements of high-risk substances in mad cow disease epidemic area, certificates of Free Sale in original countries and regions, the brief introduction and diagram of production process, and both hard and soft copy of product technique requirements.

Except all above materials, additional documents needed in the notification of imported baby care cosmetics are formula design principle based on product safety (includes overall formula analyzing report), the principle and requirements of ingredients selection, etc.

Point 2. Based on product safety, enterprises should analyze the ingredients selection, product formula and production process.

Ingredients:

1. Using less ingredients based on the effect of products is achieved.
2. The content of fragrance, colorant, preservative and surfactant should be less or no.
3. The cosmetic ingre dients except sun block agents having the effects of whitening, spots removal, anti-acne, hair removal, hidroschesis, deodorizing, hair growth, hair dye, hair perm, fitness and breast shaping are unsuitable for baby care cosmetics.
4. The genetic or nano materials are not encouraged to use.
5. Not using ingredients banned for baby care cosmetics in terms of Hygienic Standard for Cosmetics (2007).

Product formula : Formula design principle is required. An example is shown in the Guideline for reference. Safety assessment should be conducted for the content of each ingredient used in cosmetics.

Production process : Combining manufacturing characteristics, enterprises should clarify how to control the quality during the manufacturing process from the perspective of ensuring the safety of baby care cosmetics,

Point 3. More stringent requirements on microorganism and toxicology standards

The inspection items of baby care cosmetics should strictly comply with the Inspection Standard for the Administrative Permit of Cosmetics. The total bacterial count should not be more than 500CFU/ml or 500CFU/g. Skin and eye irritation, phototoxicity, or allergy reactions are not allowed.

Point 4. Chinese labels and special package designed for Chinese market.

Imported cosmetics have to attach Chinese labels or use special package designed for Chinese market. The words of “suitable for kids” have to declare on the Chinese product name or package of baby care cosmetics. The warning words like “use under the supervision of adult” should be marked on the labels.

In general, CFDA will conduct strict technical examination for the completeness, rationality and scientificity of the application dossiers of baby cosmetics notification. Foreign companies ought to make a pre-evaluation for the compliance of baby care cosmetics in China, especially understanding if their ingredients, formula, manufacturing process and quality control are compliant with current Chinese cosmetic regulations.