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 or fax 010-63098758. It is the first time for CFDA to amend this old REGULATION after it was issued by MOH in 1989.


REGULATIONS CONCERNING THE HYGIENE SUPERVISION OF COSMETICS (Decree No.3) is the first cosmetics statute in China. This includes 6 chapters and 35 clauses.




I: General Principles


- Definition of cosmetics

II: Hygiene Supervision of Cosmetics Production


- Requirements for the sanitary certificate of cosmetics manufacturer
- Definition of new cosmetic ingredient
- Scope of special use cosmetics

III: Hygiene Supervision of Cosmetics Business


- Identification of illegal cosmetics
- Requirements for advertisement and publicity

IV: Supervisory Body and Duty for the Hygiene of Cosmetics


- The official and lab are not allowed to participate in the production and sale of cosmetics
- Medical unit should report the case of adverse effect to local MOH.

V: Penalty



VI: Additional Principles




The revised version of REGULATIONS CONCERNING THE HYGIENE SUPERVISION OF COSMETICS covers 7 chapters and 86 clauses.




i. Definition of cosmetics

  1. Daily used industrial chemicals which can be spread on the outer surface of human body (e.g. skin, hairs, nails. lips etc) for the purpose of cleaning, deodorizing, providing skin care, beauty and make up by way of smearing, spraying or other similar means.
  1. Products which can be spread on the outer surface of human body((e.g. skin, hairs, nails. lips etc), teeth and oral mucosa for the purpose of cleaning, protecting, beautifying, decorating and keeping in good condition by way of smearing, spraying or other similar means.

ii. Management of new cosmetic ingredient

  1. Pre-market approval by MOH;
  2. Each company can produce, import or use approval ingredient once approved.
  1. Pre-market approval by CFDA;
  2. Approval ingredient without the risk of safety will be added into the IECIC list after 4 years.

iii. Scope of special use cosmetics

  1. Hair growth, hair dye, hair perm, deodorization, depilation, fitness, breast shaping, anti-freckle and sunblock.
  1. Hair dye, hair perm, whiteness, sunblock and other products with high level of safety risk.

iv. Management of special use cosmetics

  1. Can be manufactured once approved by MOH.
  1. Can be produced and imported once approved by CFDA;
  2. Accredited local FDA can undertake the review work of some types of special use cosmetics.

v. Management of non special use cosmetics


  1. Online record-keeping in FDA at provincial or municipal level;
  2. The company can carry out the activity of import and sale without receiving any official notice of failed record keeping within 20 working days after format review.
  3. Site reviews conducted by provincial or municipal FDA for remaining documents within 3 months after the record keeping of domestic cosmetics

vi. Alteration registration


  1. Available for approval products of which ingredient, formula, production process or use method is changed completely. Otherwise, only record-keeping needed for the change not related to the content.

vii. Valid date of registration certificate


  1. Valid for 5 years.
  2. Renewal of certificate applied 6 months in advance before expiry date

Viii. Requirement of applicant for the registration or record keeping of cosmetics


  1. The legal representative of Chinese company appointed by foreign enterprise as an agent to be responsible for the registration or record keeping of cosmetics.
  2. The agent not only responsible for the authenticity of submitted materials but also for the quality and safety of cosmetics sold in mainland China

ix. Assessor of safety assessment report


  1. The safety assessment report has to be reviewed and signed by the specific assessor or third party.

x. Mandatory standard


  1. Available to search for public.

xi. Sanitary certificate of cosmetics manufacturer

  1. Issued by the provincial or municipal MOH;
  2. Valid for 4 years.
  1. Issued by FDA;
  2. Valid for 5 years.

xii. Management of cosmetics sold via E-commerce


  1. The operator of online store has to be registered in real name with the third -party platform of e-commerce.
  2.  The platform undertaking the compensation if the real name, address and contact info could not provided to the victims

xiii. Management of cosmetics having quality issue


  1. Recalling cosmetics placed on the market
  2. Stop production

xiv. Management of claiming


  1. The efficacy claiming should be supported by the testing or evaluation data;
  2. The claiming like “efficacy has never been verified” is required to be labeled for products without supporting documents of efficacy test.
  3. The qualification certificate of lab and testing reports should be searched for public in the CFDA designated website

xv. Monitoring of adverse effect


  1. The manufacturer and operator of cosmetics should monitor the adverse effect in the process of production and operation.

xvi. Inspection abroad


  1. Site inspection available to the foreign manufacturers of imported cosmetics if needed.

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.


Contact Us

  • CIRS China
    Hangzhou CIRS Co. Ltd (CIRS China)
    11F Building 1, Dongguan Hi-Tech Park, 288 Qiuyi Road, Binjiang District, Hangzhou 310052, China
    Tel: +86-571 8720 6555 | Fax: +86-571 8720 6533