China Officially Accepts Domestic Non-special Use Cosmetics without Animal Testing

On 16 Dec, CFDA published the breaking adjustment of registration of domestic non-special use cosmetics and whitening products. Two separate rules, namely Requirements for Fling of Domestic Non-special Use Cosmetic Products and Requirements for Management on Whitening Products were released simultaneously to assist concerned companies to meet new regulatory moves.

Three dramatic changes could be summarized as below:

• The previous post-market filing requirements for non-special use cosmetics (such as shampoo and perfume) manufactured in China has been changed into pre-market online notification from 30 Jun 2014, which is similar to EU cosmetics management mode.
• Mandatory animal testing has been officially removed for domestic non-special use cosmetics. Although it is still unknown whether the policy shift will be extended to imported counterparts, it is a milestone for China on the way of modernizing its animal testing policy to align with the global trend of cruelty-free, which will no doubt invite more foreign cosmetic companies to start business in China. To evade animal tests, those in firm stance of selling cosmetic not tested on animals can either choose to directly establish factories in China or export cosmetic in bulk and have them packaged in China, on the conditions that evidence (by alternatives or existing animal testing data) prepared can sufficiently prove the safety of ingredients and finished products.
• Whitening products get re-classified as special use cosmetics and fall into the category of spot-removing products. From 30 June 2015, China will ban the manufacture and import of whitening products without the certificate for special use cosmetics.

Pre-market online filing of non-special use cosmetics produced in China

Step 1 The applicant should prepare a product information file containing the following information:

1. Formula
2. Sales packaging (including label and instruction)
3. Description of production process
4. Product technical requirements (according to Specification for Cosmetic Product Technical Requirements)
5. Testing reports
6. Copy of outsourcing agreement (for OEM products)

In case the product contains restricted ingredients listed in Hygienic Standard for Cosmetics 2007, the applicant must ask the ingredient supplier for quality and specification information.

Companies of infants’ and children’s cosmetics should keep on record the designing principles for formula (including the formula overall analysis report), the selecting principles of ingredients, the processing techniques and quality control requirements, according to the Guidance on Application and Review of Children's Cosmetics.

Step 2 The applicant should keep the product information file on record for further reference and notify 1. the formula and 2. the sales packaging to provincial FDA through an online portal. It is noted that for outsourced products both parties are subject to pre-market online notification of required info to provincial FDAs.

Step 3 The provincial FDA will check the compliance of notified info within 5 working days. For approved products, CFDA will release the basic info to the public.

Post-market surveillance of non-special use cosmetics produced in China

To ensure companies in compliance with regulations indeed, provincial FDAs will conduct post-market check on the authenticity of product info kept on file within 3 month after product filing. There will also be a regular check on products’ notified info every 4 years.   

Figure. The General Filing Procedure of Domestic Non-special Use Cosmetics

Increased requirements for whitening products

Since whitening products are categorized as special use cosmetics now, companies involved should follow the requirements for spot-removing products to fulfill the registration, which leads to more tests, longer duration and more cost. For whitening products already available on market, cosmetic companies are required to bridge the data gap by submitting more testing data and other missing information.

It is highlighted that applicants of whitening products providing only physical cover should register this kind of products according to registration rules for imported non-special use cosmetics since they present relatively lower risks to consumers.

Reference Links

• CFDA Circular No. 10-2013
• Requirements for Filing of Domestic Non-special Use Cosmetic Products (download in Chinese)
• Requirements for Management on Whitening Products (download in Chinese)