China Makes Significant Changes to the Overarching Cosmetic Regulation

On July 20th 2015, the Legislative Affairs Office of China State Council promulgated the second version of the draft Regulation concerning Supervision and Administration over Cosmetics for public consultation. The period of public consultation will end on August 20th. China State Council is responsible for the issuance and implementation of this overarching cosmetic regulation. This round of consultation could be a rare chance (maybe the last chance before its issuance) for all stakeholders to give comments and make requests.

Compared to the previous draft released last November, this draft contains more significant changes to the management of cosmetics and ingredients. It thoroughly amends the classification of cosmetics and the registration requirements of new cosmetic ingredients and refines the labelling requirements and manufacturing management.

Cosmetic Classification Scope Changed

For almost 26 years Chinese authorities have divided cosmetics into non-special use cosmetics and special-use cosmetics . In this draft China has changed the classification and categories of cosmetics falling under these categories . In the draft cosmetics are regulated as general cosmetics and special cosmetics. Special cosmetics include:

• Hair dye products
• Hair perming products
• Whitening products
• Sunscreens
• Other special cosmetics deemed by the CFDA

The draft defines general cosmetics as all other cosmetics not classified as special cosmetics. The CFDA is responsible for formulating and publishing the cosmetic categories inventory and will also adjust the scope of special cosmetics based on the monitoring of cosmetics adverse reaction and R&D outcomes.

According to our inside information, breast beauty products and slimming products are likely to be managed as pharmaceutical products.

New cosmetic ingredients with high risk require approval while other new ingredients only require record filing

According to the draft, new preservatives, sunscreens, colorants, hair dyes, whitening agents and other high risk ingredients require domestic manufacturers or China agents of imported cosmetics  to apply for approval prior to use.

For other new ingredients, domestic manufacturers or China agents of imported cosmetics only need to file a record with the CFDA within 30 working days before use, submitting related dossiers in accordance with the corresponding requirements prescribed by the CFDA. Within 10 working days as of the approval or successful record filing the CFDA will publish the relevant information to the public. Any organization and personnel are able to raise objections. Where an objection is raised and deemed relevent, the CFDA will withdraw the approval. The applicants of approved new cosmetic ingredients shall report the usage and safety information to the CFDA every half a year for 3 years.

It should be noted that the 4 year observation period for approved new ingredients is no longer used in this draft and the CFDA will issue a positive list which includes preservatives, sunscreens, colorants, hair dyes, whitening agents and other high risk ingredients allowed to be used in cosmetics apart from the prohibited ingredient inventory and the restricted ingredient inventory.

CFDA amends labelling requirements to faciliate industry compliance

Stricter labelling requirements prescribed in the first version causedinternational stakeholders considerable concern. The biggest controversy relates to proposed prohibition on the use of over-labeling. The draft stipulates that any form of relabeling, over-labeling, or other modification of original labeling is strictly forbidden. In this case, foreign suppliers must redesign original labels in Chinese specifically for the China market. Based on this situation the corresponding requirements are now amended. The new draft stipulates that imported cosmetic with over-labels in Chinese shall comply with related requirements of production quality control and are also required to supply supporting documentation at the time of application for approval or record-keeping.

Another change to labelling requirments relates to the mandatory indication of efficacy. According to the first version, the efficacy validation must be conducted by testing institutes and that testing reports are also needed. Under the new draft only relevant literature and research data are required, however the manufacturer must take full responsibility for any efficacy claims.

Regulations concerning the Supervision and Administration over Cosmetics (draft)

CFDA details the registration/filing documents and standardizes the technical review procedures

Compared to the inexplicit requirements in the previous draft, this draft makes clear provisions on what documents shall be submitted when applying for approval and record-keeping. The following documents shall be provided:

• Name, address and contact information of applicant
• Name, address and contact information of manufacturer
• Product name
• Imported cosmetics: product formula (domestic cosmetics: a full list of ingredients)
• The national standard or company standard adopted
• Testing report
• Safety assessment dossiers and related qualification documents of safety assessor
• Sample manuscript of label and specification
• Other documents

The CFDA also closes a loophole for imported cosmetics. The applicant shall submit certifications relating to manufacturing quality control of the overseas manufacturers. Besides, supporting documents which prove those products have been put into market in the country (region) where those products are manufactured or originally made shall also be submitted.

Furthermore, the CFDA standardizes the technical review procedures. It is regulated that the registration/filing documents will be transferred to the technical review center within 3 working days as of the acceptance of the documents. The technical review center will complete the review and give comments within 90 working days.

Other changes are as follows:

• CIQs are responsible for the inspection of imported cosmetics. Unqualified imported cosmetics are prohibited to be imported.
• Third-party ecommerce platforms bear less responsibility, only requiring management and implementation of  a registration system