China Opens a New Draft of Amendments to Hygiene Supervision of Cosmetics Regulation 1989 to Public Consultation

Takehome: 2018 Draft revisions of Hygiene Supervision concerning Cosmetics Regulation modifies the competent authority, cosmetic definition scope and liability subjects and etc. compared with the 2015 draft.

According to our inside sources, after 3-year wait, the latest revision to China's overarching cosmetic regulation has finally been worked out. A new draft which will hopefully be the last version before promulgation has been released to industry associations for their comments.

Compared to the previous draft released in 2015, the new version rather than being a massive overhaul instead offers subtle refinements to the previous specifications and includes:

1. The change of competent authority. The newly-established China National Drug Administration (CNDA) (a subordinate division of SAMR) undertakes responsibilities previously designated to CFDA and will be responsible for the formulation of cosmetic standards, registration management, supervision management and other related duties.

2. The extension of cosmetic definition scope. The new draft deletes the expression of “any external part of human body” indicating that the scope of cosmetics has been extended. Notably, soaps intended solely for cleanliness are outside the scope of this regulation. 

3. The addition of requirements for Oral hygiene cosmetics. Oral hygiene cosmetics only require compliance with national or industrial standards such as GB 8372-2017 Toothpaste, GB 22115-2008 and GB 29337-2012 instead of registration or filing. Efficacy claims (such as “anti-caries”, “inhibit plaque” and ect.) of these products are permitted to be used provided adequate standard-based evaluation data supports the claims.

4. The implementation of classified management for cosmetic new ingredients. Ingredients with high risk such as new preservatives, sunscreens, colorants, hair dyes, whitening agents shall register with CNDA and obtain approval, while ingredients with low risk only require filing certificates. Additionally, the new ingredient without safety problems before the expiry of 3-year observation period will be included in IECIC.

5. The change of subjects of duties. Stakeholders with filed or registered products are responsible for the recall of substandard cosmetics. Where cosmetic manufacturers or operators have found that the cosmetics are harmful to human health resulting from quality defects and other reasons, they shall immediately inform relevant stakeholders of recall requirements and also aid in the process.

6. The change of labeling requirements. Imported cosmetics can either directly use Chinese language labels or choose to affix Chinese translated labels over the original one. While in 2015 version, only the former practice is allowed.

7. The change of punishment clauses. Stipulations on punishments associated with non-compliance involving the use of ingredients which have not been filed/registered have changed been reclassified as a serious illegal act (previously only considered "general illegal act" analogous to difference between a felony vs misdemeanor). 

Cosmetic stakeholders with any suggestions (e.g. addition of cruelty-free alternatives, imported goods requirements etc.) or comments can send to us ([email protected]) before Aug 25. We will sort your suggestion and submit them to authorities on your behalf.