The China State Council announced to adjust administrative approval procedures through publishing Guo Fa  No. 24 on 19 April 2016. In the circular, it calls for a stop to the administrative approval process for non-special cosmetics imported for the first time. Guo Fa  No. 24 was announced to be effective till 21 December 2018.
On 10 January 2017, a notice regarding the pilot implementation of registration process for importation of non-special cosmetics in the Pudong New Area of Shanghai (hereafter referred to as “Circular No.7”) was issued by the China Food and Drug Administration, together with the General Administration of Quality Supervision, Inspection and Quarantine.
In succession, the two departments jointly issued another official document– Procedures for the registration process for importation of non-special cosmetics in Pudong New Area of Shanghai (Provisional) (hereafter referred to as “Procedures”), which details the specific operating methods and information requirements relevant to the registration process.
Both “Circular No.7” and the “Procedures” are announced to be implemented from 1 March 2017, and would be effective till 21 December 2018.
“Circular No.7” clarifies that:
- From 1 March 2017 to 21 December 2018, a registration process shall be implemented (in place of the administrative approval process) for non-special cosmetics imported to ports in the Pudong New Area of Shanghai (the registered address of the responsible Chinese legal entity) for the first time. Cosmetics-import enterprises and their domestic responsible person (a party responsible for the importation and operation of the cosmetics and liable for products’ quality and safety) shall handle registration process for non-special cosmetics before the importation.
- The registration process for non-special cosmetics imported for the first time is executed through the registration system; the importation cannot be carried out until a registration certificate has been obtained from that system.
- In the event that an enterprise needs a subsequent importation of cosmetics already registered in the registration system from ports outside the Pudong New Area, the registered information shall be deregistered and an administrative approval shall be obtained before the importation, in accordance with active Regulations on the Supervision of Cosmetics Hygiene.
- The China Food and Drug Administration shall, together with the Entry-Exit Inspection and Quarantine Bureau, strengthen their coordination and cooperation to ensure a timely circulation of the quality and safety information, and crack down on illegal behaviours and actions with related departments. The China Food and Drug Administration (in charge of implementing registration process management) shall inform the Entry-Exit Inspection and Quarantine Bureau (responsible for the management of import inspection, quarantine and supervision) with timely information related to registered information to facilitate the Bureau in its verification.
“Procedures” stipulates that the responsible Chinese legal entity can register with a user name and submit relevant electronic information in the registration system of the Shanghai Food and Drug Administration. After the successful uploading of electronic information, related physical documents need to be sent to the Shanghai Food and Drug Administration for the purpose of record-keeping. The Shanghai Food and Drug Administration shall execute supervision and inspection on the registered information within 3 months upon the registration date, with focus on the ingredients, processing technique, inspection items and security risk assessment of the products. When necessary, spot supervision and inspection are required.
“Circular No.7” and “Procedures” clarified that after 1 March 2017, there is no longer a need for domestic enterprises registered in the Pudong New Area to file and obtain administrative approval from the China Food and Drug Administration (“State administrative approval process”) when importing non-special cosmetics for the first time from ports in the Pudong New Area. They can distribute the cosmetics nationwide with filing serial numbers obtained from the Shanghai Food and Drug Administration (“Shanghai registration process”) when both electronic information and physical documents are examined and approved. Compared to the State administrative approval process, the Shanghai registration process facilitates enterprises to shorten the time to put products into the market by setting technical examinations of the submitted information after product launch.
It should be noted that the Shanghai registration process is only applicable to enterprises satisfying all the following conditions:
- Registered in Pudong New Areao
- Import products from ports in Pudong New Areao
- Non-special cosmetics imported for the first time
The Shanghai registration process embodies the reform measures of the central government to simplify pre-approval measures, and to enhance on-going supervision. This process sets higher requirements for the responsible Chinese legal entity, who shall be responsible for the quality and safety of the products. As a consequence, the responsible Chinese legal entity should take the potential quality and safety problems of their products into consideration before deciding to utilise the Shanghai registration process.
The main differences between the two processes are summarised by KPMG as follows:
||Administrative approval process||Registration process|
|Department in charge||China Food and Drug Administration||Shanghai Food and Drug Administration|
|Registration location of the responsible Chinese legal entity||Unlimited||Pudong New Area|
|Port of entry||Nationwide ports||Ports in Pudong New Area|
|Technical examination of the submitted information||Before granting approval||Within 3 months upon the registration|
|Valid term of certificates||4 years||Not specified in the current regulations|
|Process to be adopted in case the products would no longer be imported||No requirement||Registered information shall be deregistered|
Cosmetics-import enterprises registered in the Pudong New Area are suggested to understand more about the new development and adopt the Shanghai registration process, which helps to shorten the time to launch products to the market. For those who are not registered in the Pudong New Area and want to enjoy the preferential policy, a feasibility study regarding benefits of this policy should be evaluated.