Shanghai FDA Issues New Hygiene Permit

On 5 August, Shanghai Food and Drug Administration released a renewed Measure regarding hygiene permit for cosmetic manufacturers located within its jurisdiction. Compliance with the measure is required as of its date of issuance.

The measure will remain valid for the next five years and applies to the application, issuance, extension, change and complementary issuance of hygiene permit as well as its supervision and management.

Regarding the issuance of hygiene permits there are several noteworthy stipulations:

1. Relevant proof materials must be prepared in order to justify the use of a documentation proving the legality of manufacturing sites. Most notable is the requirements to submit documentation for facilities that are still under construction.

2. to apply for a hygiene permit, the applicants must prepare the following material including:

  1) application paper (as specified in Annex 2 issued along with the measure)

  2) copy of the applicant’s commercial operation license

  3) identity and proof of the legal representative

  4) legal proof materials used for cosmetic manufacture site

  5) blueprints of the manufacture site, product inventory, diagram for production technology procedure, main production facility and the list of inspection instruments as well as materials regarding their use

  6) air quality in the workshop, production procedure and testing report of the water for manufacture use

  7) materials regarding organization of hygienic management and its institution

  8) the list of employees and health check status, hygiene management personnel and certificate proof materials of inspection personnel

  9) other materials required in accordance with relevant law, regulation and orders

Regarding extension, change and supplementary complementary issuance of hygiene permit, stakeholders should be aware that:

1. the validity period for a hygiene permit of cosmetic manufacturer is four years

2. in order to extend the validity period of the permit, the company must apply for extension to FDA three months before the current permit expires

3. several materials must be provided by cosmetic companies applying for extension of hygiene permit, including:

 1) the materials required in above-mentioned 9 materials for application of hygiene permit

 2) approval paper of the hygiene permit of corresponding special use product or proof of record-keeping of domestic non-special use cosmetic  

 3) the original copy of the last hygiene permit

 4) any change in the instruction materials regarding manufacture site layout and facilities of the previously approved project

 5) other materials required by relevant law, regulation and measures

*Click to See Reference Document