CFDA Revised the REGULATIONS CONCERNING THE HYGIENE SUPERVISION OF COSMETICS and Consulted Public Comments on the Draft Version
Original Article by April Guo from CIRS
CFDA issued the revised version of REGULATIONS CONCERNING THE HYGIENE SUPERVISION OF COSMETICS on 8th Nov 2014 and consulted public comments. The deadline is 24th Nov 2014. You may submit comments to CFDA via written letter, email xuxy@sda.gov.cn or fax 010-63098758. It is the first time for CFDA to amend this old REGULATION after it was issued by MOH in 1989.
Background
REGULATIONS CONCERNING THE HYGIENE SUPERVISION OF COSMETICS (Decree No.3) is the first cosmetics statute in China. This includes 6 chapters and 35 clauses.
Chapter |
Clause |
Note |
I: General Principles |
1-4 |
- Definition of cosmetics |
II: Hygiene Supervision of Cosmetics Production |
5-12 |
- Requirements for the sanitary certificate of cosmetics manufacturer |
III: Hygiene Supervision of Cosmetics Business |
13-16 |
- Identification of illegal cosmetics |
IV: Supervisory Body and Duty for the Hygiene of Cosmetics |
17-23 |
- The official and lab are not allowed to participate in the production and sale of cosmetics |
V: Penalty |
24-32 |
n/a |
VI: Additional Principles |
33-35 |
n/a |
Comparison
The revised version of REGULATIONS CONCERNING THE HYGIENE SUPERVISION OF COSMETICS covers 7 chapters and 86 clauses.
Item |
Old REGULATION |
New REGULATION |
i. Definition of cosmetics |
|
|
ii. Management of new cosmetic ingredient |
|
|
iii. Scope of special use cosmetics |
|
|
iv. Management of special use cosmetics |
|
|
v. Management of non special use cosmetics |
n/a |
|
vi. Alteration registration |
n/a |
|
vii. Valid date of registration certificate |
n/a |
|
Viii. Requirement of applicant for the registration or record keeping of cosmetics |
n/a |
|
ix. Assessor of safety assessment report |
n/a |
|
x. Mandatory standard |
n/a |
|
xi. Sanitary certificate of cosmetics manufacturer |
|
|
xii. Management of cosmetics sold via E-commerce |
n/a |
|
xiii. Management of cosmetics having quality issue |
n/a |
|
xiv. Management of claiming |
n/a |
|
xv. Monitoring of adverse effect |
n/a |
|
xvi. Inspection abroad |
n/a |
|
CIRS’ Comments
According to the revised version of REGULATIONS CONCERNING THE HYGIENE SUPERVISION OF COSMETICS, you should know:
- Oral care products including toothpaste and mouth wash will be regarded and managed as cosmetics in terms of revised definition;
- CFDA will refer to 3 basic principles to manage cosmetics:
- Cosmetic manufacturer and operator are responsible for the quality and safety of cosmetics
- Self-regulation in cosmetics industry
- Social supervision - 4 years protection for the applicant of new cosmetic ingredient registration.
- CFDA will regulate the detailed category of special use cosmetics based on the level of safety risk;
- Pre-market approval for imported non special use cosmetics will be changed into pre-market record keeping in the near future;
- Despite provincial or municipal FDA will be in charge of the record keeping of imported non special use cosmetics, CFDA Review Center of Food Supplement will perform the technical review as well so as to keep the evaluation standard identical.
- The valid date of registration certificate will be changed from 4 to 5 years.
- The registration procedure will be simplified for approval products when the ingredient, formula or production process is changed;
- The safety assessment report required for product registration will not be limited in the evaluation of risk substance in the future;
- Site inspection with respect to the sanitary condition of production will not be mandatory for the registration of domestic special use cosmetics;
- A qualified assessor of safety should have a professional background of medical science, pharmacy, nursing or a certain period of working experience;
- The government shall be involved in the supervision of cosmetics sold via E-commerce;
Actually, the revised version of REGULATIONS CONCERNING THE HYGIENE SUPERVISION OF COSMETICS is more similar to European cosmetics regulations. From the regulatory point of view, it might be good news for foreign companies, as the regulation will be easier to understand. However, it will be a great challenge for the Chinese agent including especially for the distributor or consulting firm.
Source:
http://www.sda.gov.cn/WS01/CL0781/108920.html
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