CFDA's Explanations to Formula Modification Requirements during the Transitional Period of STSC

CFDA’s notification relating to transitional measures for implementing Safety and Technical Standards for Cosmetics on June 1 stipulated that if there is a change of formula for domestic special use cosmetics and all imported cosmetics approved already, modification application form, revised formula, description and diagram of the production process, packaging design and safety assessment report (for risk-concern substance) shall be submitted before Dec 1st 2016. After a technical review, CFDA will renew the license (keeping the previous license number) for qualified products. Unqualified products will require submission of safety-related documents.

During a CFDA internal training course, Qi Liubin Director of Cosmetic Registration Department explained that the safety-related documents include testing reports. Therefore, it is unnecessary for companies to submit testing reports in the first phase of applying modification. Testing reports are only required to supplement provided CFDA find products unsafe after the technical review. In such case, a majority of companies can exempt from conducting testing, which will cut their costs and reduce the risk of missing the deadline as generally two months is needed to obtain a testing report in China.

Qi further clarified that if the formula adjustment is only replacing a newly defined prohibited ingredient / an ingredient (except sunscreens and hair dyes) exceeding the newly defined limit with another ingredient in the positive lists, testing reports are exempted. For sunscreens and hair dyes, only physical and chemical testing reports require submission. If the revised formula uses a new permitted ingredient other than preservatives, sunscreens, colorants and hair dyes, regular full testing reports are mandatory.

Other good news for cosmetic companies is that a fast online channel to submit formula modification has been launched, which will close on December 1 2016. Its launch is to ensure that all companies can smoothly complete the transition and won’t suffer suspending production.