China Food and Drug Administration issued revised ‘Decree on Cosmetic Supervision and Management’ for public comments on November 8^th, 2014.

The previous Decree which was named as ‘The Hygiene Supervision Over Cosmetics’ issued in 1990 has many problems, which caused the actual implementation is actually apart from it. After years’ planning, the revised version is now finally issued.

Based on long-term experience and understanding, Randis will share key points of the revised Decree.

1．The definition of cosmetics

The new Decree defines the cosmetics as ‘products applied on surface of human body (skin, hair, nails, lips, etc.), tooth and oral cavity mucous membrane by means of smearing, spraying or other similar methods to clean, protect, beautify, decorate and keep them under good conditions’. After its official implementation, toothpaste will be managed formally as cosmetics, and collutorium which is already popular will also be included.

2．Four cosmetics raw material list

The new Decree defines four lists: Forbidden Cosmetics Raw Material list, Restricted Cosmetics Raw Material List, Allowed Specific Cosmetics Raw Material List and List of Cosmetics Raw Material Already Used in China. Among which Allowed Specific Cosmetics Raw Material List is put forward the first time, which is in accordance with the management philosophy of new cosmetics raw material management for the future.

3．Cosmetic new raw material

Based on the current predicament of cosmetics new raw material’s examination and approval, management and approval of new cosmetics raw materials will be changed. This is reflected in the draft Decree, and approved new cosmetics raw materials will need to go through a 4-year observation period. If no safety problems are discovered in between, the approved new cosmetics raw material will be supplemented into the List of Cosmetics Raw Material Already Used in China.

4．Decentralization of Cosmetics Approval

The draft Decree rules SFDA is responsible for approval of Special cosmetics, while SFDA can authorize provincial FDA to be responsible for certain special cosmetics’ approval. None-special cosmetics only need to complete the reporting formalities at provincial FDA before the cosmetics are put onto the market.

5．Enhancement of risk assessment requirement

At present, risk assessment requirement for cosmetics is ‘to provide risk assessment information for risky materials possibly existed in the products'. The draft Decree requires risk assessment information for the product. The wording differences may mean enhanced risk assessment requirements.

6．Prolongation of certificates’ validity period

The validity period is prolonged from currently 4 years to 5 years, and the renewal renewal application should be submitted 6 months in advanced (currently 4 months).

7．Definite time limit for renewal and approval

The draft Decree rules that (S)FDA should make decision for the renewal application before the certificate’s expiration date, otherwise the renewal application is regarded as ‘agreed’. Imported non-special cosmetics can be imported if rejection is not received from FDA within 20 days from the reporting date. ‘No rejection within the defined timeline means acquiescence’ is very rare to appear in regulations.

8．Refined market supervisions

The draft Decree requires that that concentrated market platform owner, sales counter lessor, exhibition organizer as well as internet transaction platform provider assume management responsibility. Social groups or other organizations or individuals assume joint responsibilities for their recommended cosmetic products in advertisements.

9．Enhanced punishment

Punishment upto 10 times value of illegal cosmetics could be faced, and relevant responsible people will be prohibited from cosmetics business for 5 years. The company’s cosmetics registration will not be accepted for 5 years.

While, officials say it may take a relatively long time for the new Decree to be enacted. Two to three years will be already an optimistic estimates.

Related link:

SFDA solicit public opinion on ‘Cosmetic Health Supervision Regulations’ draft for comment

‘Cosmetic Health Supervision Regulations’ draft for comment