A Brief Analysis of the Filing of Imported Non-special Use Baby Cosmetics

The market entry threshold for imported baby cosmetics has always been very high, resulting in a limited number of baby cosmetics brands spreading to the Chinese market. The market entry threshold for imported baby cosmetics was estimated to be lowered when the administrative license application of imported non-special use cosmetics was changed to filing management. However, judging from the data so far, it's backfiring. Overall, the pace of approval for baby cosmetics in China is not expected to increase.

1. Current status of approval of imported non-special use baby cosmetics

The personal care division of CIRS searched for the keywords, infant, baby, child, etc., in the Chinese name of products. Furthermore, a summary was made of the amount of non-special use baby cosmetics approved and filed by the former CFDA and the current local MPAs in the past ten years. Considering some products have multiple keywords in their Chinese names, we only count them once in the data of "baby" or "infant"

1.1  The quantity of CFDA approved imported non-special use baby cosmetics from 2010 to 2018

From 2010 to 2018, the competent authority for approval of imported non-special use baby cosmetics was the former CFDA. Keywords containing child, infant, baby, girls and boys, figure 1 shows detailed data.

Figure. 1 The quantity of CFDA approved imported non-special use baby cosmetics from 2010 - 2018

In 2010, the approved quantity of imported non-special use baby cosmetics was relatively high totaling 63. However, in 2011, the CFDA focused on tightening the application of baby cosmetics. As a result, the number of approvals through keyword searches was zero. In February 2012, a draft Guidelines on the Notification and Review of Children Cosmetics was published with the official version being released in October. The number of approved baby cosmetics in this year was also very low. In 2017 and 2018, a total of 58 and 68 baby cosmetics were approved, respectively, and there were also products registered by local MPA in these two years. In addition, using "whole family" or "family" as a search keyword, over 60 imported non-special use cosmetics could be found. These included body wash and hair wash products, some possibly registered and sold as baby cosmetics.

1.2  The quantity of local MPA approved imported non-special use baby cosmetics.

From 2017, local Medical Product Administration’s (MPAs) took over the management and supervision of the registration/filing of imported non-special use baby cosmetics.

Figure 2 shows the quantity of imported non-special use baby cosmetics approved by local MPAs that contain keywords including child, infant, nursing, baby, babe and girls.

Figure. 2 The quantity of local MPA approved imported non-special use baby cosmetics from 2017 - 2019

In 2017, the filing of imported non-special use cosmetics was opened to the Pudong district only, resulting in only 6 baby cosmetics filed, most of enterprises still chose to register with CFDA and this phenomenon was not changed in 2018. The main reasons are as follows: since November 10, 2018, the imported non-special use cosmetics registration system has been adjusted to the national unified filing system and the CFDA no longer accepts the related administrative license applications. However, after the decentralization, various local MPA have different review requirements, enterprises are more cautious under the new policy than before. In 2019, the number of registered non-special use baby cosmetics reached 101, while the total number of registered non-special use cosmetics for all categories exceeded 15,700.

2. Filing requirements of imported non-special use baby cosmetics

Although the number of registered products exceeded 100 in 2019, by the end of February 2020, only 12 products were "approved" based on passing both format and technical review. In addition, the technical review results of 63 products have not been issued yet and the sales of 7 products have been suspended (but 4 of them have passed technical review after submitting supplementary information). The other products were required to supplement the information once within 30 days but the follow-up the technical review results have not been issued yet.

2.1 The basic rules and regulations

In addition to the general cosmetic regulations, children cosmetics filing materials also need to meet the requirements of Guidelines on the Notification and Review of Children Cosmetics. The document specifies that children cosmetics refer to those used by children of 12 and under. It requires the product formula design principles based on safety considerations (including the overall analysis report of the product formula), the selection principles and requirements of raw materials, the production process, quality and safety control and other information. The packaging should include the Chinese name and descriptive terms indicating it’s explicitly applicable to children where it is easily seen. For baby cosmetics, warning words such as "should be used under adult supervision" should be marked on the product label under product instructions.

In addition, the Safety and Technical Standards for Cosmetics also has corresponding provisions on various indicators of children's cosmetics. According to the requirements  of  microbiological tests, the total number of bacterial colonies in baby's cosmetics should not be greater than 500 CFU/mL or 500 CFU/g. Chapter 3.7 of the general requirements for cosmetics safety also made it clear that in addition to satisfying the normal cosmetic safety requirements, the raw materials, formulation, manufacturing process, use method and quality and safety control of children cosmetics should also meet the specific requirements to ensure the safety of the product. Target users should be clearly indicated on the label. There are also some additional requirements for children cosmetics in the list of banned and restricted ingredients and applicable preservatives as shown in table 1.

Table 1. Requirements for the use of restricted ingredients in children's cosmetics

Restricted ingredients
No.	INCI  Name	Restrictions  and requirements	Instructions on label
1	Boric acid, borates and tetraborates（Except as listed in the list of  prohibited ingredients）	Products for use by children under  three years old are not allowed	Do  not use for children under 3 years of age; Do not use when skin is peeled or  irritated
2	Salicylic acid	Except shampoo, cannot be used in  products for children under 3 years old	Do not use  for children under 3 years of age*
3	Strontium chloride		Not suitable for children
4	Calcium hydroxide, lithium  hydroxide, thioglycolic acid and its salts, thioglycolates, sulfides of  alkali metals, sulfides of alkali earth metals, strontium hydroxide,  potassium hydroxide (or sodium hydroxide)		Keep away from touch of children**
5	Talc: hydrated magnesium silicate		Powdered  products for children under 3 years of age: keep the powder away from the  child's mouth and nose
Allowed preservatives
1	Iodipropargyl butyl aminoformate	Not to be used in products used by  children under 3 years of age (except bath products and shampoos)	Do not use  for children under 3 years of age***
2	Salicylic acid and its salts	Not to be used in products used by  children under 3 years of age (except bath products and shampoos)	Do not use  for children under 3 years of age*
3	Silver chloride deposited on  titanium dioxide	Not to be  used in products used by children under 3 years of age

* Needs to mark only if the product can be potentially used by children under 3 years of age and is in prolonged contact with skin.

** Some categories of cosmetics need to be marked here.

*** Needs to mark only if the product can be potentially used by children under 3, except for bath products and shampoos.

2.2 Common Q&A

From 2017 to 2019, the two most common comments in the technical review results of existing imported non-special use baby cosmetics filing cases were:

2. The raw material hazard identification is not accurate.

4. The safety basis for the effect of perfume used on children is insufficient.

Raw material selection for baby cosmetics is subject to more requirements than adult cosmetics. The Guidelines on the Notification and Review of Children Cosmetics emphasizes that cosmetic materials with a certain history of safe use should be selected, and the materials made by the use of genetic technology, nanotechnology should not be encouraged. These methods are required to understand the source, composition, impurities, physical and chemical properties, scope of application, safety dosage, precautions and other relevant information of the raw materials used in the formula. Therefore, when dealing with the risk assessment of raw materials, it is better to comprehensively consider raw material characteristics, safety dosage, scope of application, precautions, etc. In order to mask the odor of some raw materials or give them a pleasant smell to appeal to children, some companies will consider adding flavors in the product. However, the amount of perfume used and the risk of sensitization should be analyzed when dealing with filing of baby cosmetics.

The personal care division of CIRS has been providing technical support for baby cosmetics filing and has obtained many approvals from the former CFDA, as well as helping many enterprises to handle the filing work under the current pre-filing supervision policy. The verification data shows that half of the filing of imported non-special baby cosmetics were handled by the professional team of CIRS group. A free webinar of Filing Requirements of Imported Infant Care Cosmetics under New Filing System will be held by CIRS on March 27th where we will share our experience on filing in recent years.

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