CFDA Clarification on the Work Program of Record-keeping for First Imported Non-Special Use Cosmetics in Shanghai Pudong New Area

O n 23 Feb, CFDA issued an official clarification on the Work Program of Record-keeping for Imported Non -special Use Cosmetics in Shanghai Pudong New Area (Click here for more details of the record-keeping system). The clarification consists of 8 points. Details are as below.

1. Background

Work Program of Record-keeping for Imported Non-special Use Cosmetics in Shanghai Pudong New Area is drawn up based on 3 important files.

• State Council’s Reply to Carry out Overall Program of Pilot Reform regarding Licensing Separation in Shanghai (State Council No. 222, 2015) in Dec 2015.
• A Decision regarding Temporary Adjustment of Administrative Regulations and Approval Matters Stipulated on State Council Documents in Shanghai Pudong New Area (State Council No. 24, 2016) in Apr 2016.
• A Notice regarding Pilot Implementation of Record-keeping for Imported Non-special Use Cosmetics in Shanghai Pudong New Area (Notice No.7 2017, CFDA and AQSIQ)

2. Scope

From 1 Mar, 2017 to 21 Dec, 2018, record-keeping process can be adopted by non-special use cosmetic products firstly imported at Shanghai Pudong New Area according to the above Work Program. But the domestic responsible entity has to be registered in Shanghai Pudong New Area.

3. Difference Between the Domestic Responsible Entity in Shanghai Pudong New Area for Record-keeping and the Chinese Responsible Person for Declaration under CFDA Registration

Chinese responsible person for declaration is an independent legal entity appointed by oversea cosmetic manufacturer. It is responsible for cosmetics registration. An oversea cosmetic manufacturer has only one Chinese responsible person for declaration.

Domestic responsible entity is a corporate legal person appointed by oversea cosmetic manufacturer which is registered in Shanghai Pudong New Area. It is in charge of both importing and operating of the products, and of the products’ safety and quality. One oversea manufacturing company can appoint several domestic responsible entities based on the needs for sales and marketing. However, the scope of authorization should be different. The same product should not be authorized to multiple responsible entities.

4. Main Difference Between the Current Regulatory Regime of Imported Non-Special Use Cosmetics and the Pilot Record-keeping System Launched in Shanghai Pudong New Area

The pilot system is an innovative way of product management on the basis of not affecting the surveillance requirements for the safety of products.

All the documents required for record-keeping are the same as that of CFDA registration except the exemption of sealed testing sample. Moreover, the security obligations such as testing and safety assessment that should be performed by enterprises are the same.

The way of product management is changed from pre-market approval to on- or post- market surveillance. Domestic responsible entity can carry out business activities once fulfilling the record-keeping in terms of requirements of Work Program. Nevertheless, the overseas manufacturing companies and/or domestic responsible entities will be rectified and/or punished under the law by competent authority if having any activities in violation of regulations and laws.

5. The Settlement of Disqualified Products that have already been Recorded

During the process of record-keeping, materials will be reviewed. The review work covers whether the products are subject to the scope of record-keeping, completeness and form of record information. For unqualified dossiers, the domestic responsible entity should be informed without any delay with the reasons thereof.

In the stage of technical review after record-keeping, (i) If any documents are deemed not compliance with regulation, but the products are still judged to be safe for use, the domestic responsible entity should be required to provide relevant supporting documents as supplement materials within 30 days. (ii) If the safety of the products cannot be judged from the submitted documents, the domestic responsible entity should be informed to provide relevant documents as supplement, and the importation and sale of that specific product should be suspended until the dossiers are in compliance with the regulations. (iii) Having safety issues of products/or any activities in violation with regulations and laws, the related products should be removed from the market and recalled.

6. How to Obtain the Record-keeping Certificate?

The hard copy of record-keeping certificate will not be issued. Instead, the electronic version of record-keeping certificate will be generated automatically through the online recording system. Moreover, the certificate will be actively opened to public on CFDA official website, whereupon the domestic responsible entity can download and print the electronic record-keeping certificate by themselves. The record-keeping number should be indicated on the Chinese label.

7. Which one to Choose, CFDA Registration or Record-keeping in Shanghai Pudong New Area when the Work Program is Available for the First Imported Non Special Use Cosmetics?

Both the registration with CFDA and record-keeping in Shanghai Pudong New Area are available when the Work Program is applicable to first imported non special use cosmetics. However, same product has to be imported under same management system (CFDA registration or record-keeping in Shanghai Pudong New Area).

For recorded products in Shanghai Pudong New Area, if they have to be imported from other ports outside Pudong New Area afterwards, the existing record-keeping certificate should be cancelled before they get registered under CFDA.

The products registered in CFDA can be imported from Pudong port within the validity period of license. However, if the CFDA license is expired and enterprises fail to apply for extension or cancelation of the license, the record-keeping in Shanghai Pudong New Area is applicable. If the products have ever been rejected by CFDA, they are not allowed to be imported under new record-keeping system.

8. Relevant Arrangements after the Pilot Implementation

The record-keeping process is different from the formal registration process because record-keeping certificate does not involve expiration and certificate extension.

According to the State Council No. 24, 2016, the pilot implementation is valid until 21 st Dec, 2018. After that, CFDA will make a summary, draw on the experience of the implementation, propose amendments and improve relevant regulations, and hence to popularize the regulations nationwide in time.

CIRS Comments

1. There is a big difference between domestic responsible entity and Chinese responsible person for declaration. A foreign manufacturer can have several domestic responsible entities based on its business needs. But only one Chinese responsible person for declaration is required for CFDA registration. On the other hand, and the Chinese responsible person for declaration is in charge of product registration while the domestic responsible entity will be in charge of not only record-keeping but also the product quality and safety.
2. Dossier requirements, including required testing in CFDA designated labs, of the record-keeping are the same as that of the CFDA registration. As a result, animal testing is mandatory for imported non special use cosmetics recorded in Shanghai Pudong New Area.
3. It will be more stringent for on-or post-market surveillance under new record-keeping system. Once the dossiers are not sufficient to prove product safety, the import and sale of the products will be suspended. In case having safety issue of the product or illegal activities, the products will be recalled from the market.
4. The new record-keeping system is not available for the products unapproved by CFDA.
5. The record-keeping certificate un der the new system does not have an expiration date. The pilot stage of the new record-keeping system will last from 1 Mar 2017 to 21 Dec 2018.

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Source: http://www.sda.gov.cn/WS01/CL1789/169871.html