Children's Cosmetics: Obligations for Foreign Stakeholders in the Chinese Market

After 3-year study and internal discussion, as well as the 8-month public consultation, the "Guidance on Application and Review of Children's Cosmetics" was finally released by the CFDA (China Food and Drug Administration) in October, 2012 and came into effect since February 1st this year. It regulates the standard of cosmetics for children of 12 years including the definition, formula, toxicity, package, etc.. Considering the population of children under 14 is over 220 million in China (Source from State Statistics Bureau), and the cosmetics market targeting children is estimated to hit  9.263 billion CNY in 2016 with a 17% annual increase (Source from Euromonitor), this guidance is crucial for the companies competing for their share in China's children cosmetics market.

It is currently only a guidance document with no corresponding obligations for industry. However  CFDA's cosmetic evaluation expert committee has been reviewing notifications based on this document since last year, which resulted in rejection or reconsideration of most of notifications, which were quite common among the imported non special-use children cosmetics.

This phenomenon could be the result of intrinsic "disadvantages" of imported cosmetics:

1. Based on the CFDA policy on imported cosmetics, the "no CFDA permit, no market" principle prevails for both special-use and non-special use imported cosmetics. Compared with China domestic non special-use cosmetics which are allowed to be notified 2 months after being placed on the market, oversea cosmetics are at a disadvantage.

2. The main oversea country/region, like EU, US, Japan, Korean, has different or no standards for children cosmetics. In EU, both the current directive(76/768/EEC) or the coming regulation (1223/2009/EC) has special provisions on microbiological quality and restricted ingredients in cosmetics for children under 3 or 6 years (different age range in China), while other countries mentioned above do not have regulation specifically addressed for children cosmetics. Therefore, the possibility exists that the original formula designed by overseas companies would be unacclimatized in China--containing the ingredients which raise concerns of expert committee of CFDA.

Furthermore, at least 3 new requirements are mentioned in the guidance.

1. Formula & Ingredients

The newly adopted guidance demands the cosmetics manufacturers to submit an overall formula analysis report, in which each ingredient should be evaluated in terms of safety. According to the example presented in the guidance, the limitation value of China "Hygiene Standard for Cosmetics", certain ingredient standard published by CFDA and CIR literature could be referred to.

The key principle of formula design is to keep it as simple as possible, the use of fragrance, colorant, preservative and surfactant should be limited. Functional ingredients of whitening, freckle eliminating, acne treatment, depilation, hidroschesis, deodorization, hair nurturing, hair perming, body shaping, breast caring are prohibited (sun screening is allowed) and genetic or nano technologies are not recommended. CFDA has not provided a "positive ingredients" list for children's cosmetics, claiming it is scientifically inappropriate to make such a list.

The ambiguous clause in the guidance put the industry, both Chinese and oversea cosmetics manufacturers, in a dilemma.Common sense has it that it is quite difficult to avoid any preservative in cosmetics and sometimes to achieve a desired effect, 2 or more kinds of preservatives need be applied. Ironically, one children cosmetics containing 3 kinds of preservatives (22 ingredients in total) has just been approved by CFDA, confirmed by Mr. Xu, the evaluation expert, also the main editor of this guidance during the CFDA official training in April, 2013. Apparently, the question of what is the "passing line" or is there a unified evaluation standard was raised by many attendees of the training, with no conclusion being drawn.

Plant sourced ingredient is also controversial at the current stage, affected companies find it quite difficult to demonstrate the safety and necessity of use.

2. Hygiene & Toxicity standard

The Children Cosmetics and the ingredients used should meet the relevant requirements in "Hygiene Standard for Cosmetics" 2007. The products for children should be non-irritant to the skin and eyes, non-phototoxic and non-allergic and the total plate count of Children Cosmetics should be lower than or equal to 500 CFU/g.

Besides, the oversea companies should also pay attention to the revision of this "Hygiene Standard for Cosmetics". CFDA has revised part of the standard in December 2012, and renamed it as "Safety technical Standard for Cosmetics" (draft). The limitation of lead and arsenite will be changed from 40mg/kg to 10 mg/kg, and from 10 mg/kg to 4mg/kg, respectively, closed to the standard adopted in EU and US.

3. Package and Label

The package and label of all kinds of cosmetics from overseas company need be redesigned in Chinese. Regarding the children cosmetics, it should clearly indicate "designed for Children" on the package, and mark "Should be used under adult supervision" on the label (and product specification).

It is inappropriate that some companies may print or advertise "pure natural" or "non safety risk" on the package, because chemical synthesized ingredients are inevitably used in most cases.

To solve the challenges faced by oversea children cosmetic manufacturers, the formula and the ingredients are the heart of the problem. The less ingredients used, the more opportunity to be approved. However, without a clear instruction, companies could only assess the product formula based on the few lines in the guidance and their own failing experience. If the formula is complicated and risky to be notified directly, the last resort is to modify the formula, redesign for China market or suspend certain product for now. The problem of regulatory transparency needs to be taken care of to avoid the business impediments.

Reference Link

Guidance on Application and Review of Children's Cosmetics (with english translation available)