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.
The definition of baby care cosmetics
The specific requirements on baby care cosmetics
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.
² Labeling requirements: Marking “Use under adult supervisions”.
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.
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
- Using less ingredients based on the effect of products is achieved.
- The content of fragrance, colorant, preservative and surfactant should be less or no.
- The cosmetic ingredients 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.
- The genetic or nano materials are not encouraged to use.
- Not using ingredients banned for baby care cosmetics in terms of Hygienic Standard for Cosmetics (2007).
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.