Chinese Cosmetic Regulation: Latest Developments and Potential Changes

Takehome: Chemlinked participated in a training course hosted by the SAMR (takes over responsibilities previously designated to CFDA) on cosmetic registration and learned the recent and upcoming regulatory changes. SAMR outlined the work plan for the next several months, including highlighting its continuing efforts to streamline administration and delegate authority to provincial departments. Regulations are being revised to align with these overriding goals.

A training course hosted by the former CFDA on cosmetic registration was held in Beijing on May 8 – 11. Officials from the former CFDA and technical review experts delivered lectures to report registration work results and give advice on key requirements for cosmetic registration (See CL News). The experts also used case studies involving registration application rejections to illustrate common problems encountered by cosmetic manufacturers or companies applying for registration. ChemLinked participated in the training and learned the latest developments and potential regulatory changes.

The key work of 2018

According to Liu Baojun, the head of Cosmetic Division (SAMR), major regulatory goals in 2018 include:

• Endeavor to amend Regulations Concerning the Hygiene Supervision over Cosmetics.
• Support the pilot reforms of imported non-special use cosmetics in 10 FTZs.
• Innovate and improve government approval services. SAMR plans to delegate the applications of renewing or modifying approved products to provincial departments. SAMR also intends to control the number of non-special use cosmetic registrations and concentrate on special use cosmetics.
• Work on assessment and improvement to the database of review experts.
• Simplify the procedures of review and approval to improve efficiency.

Potential Regulatory Changes

♦ 4 Regulations are under revision

Officials from the former CFDA disclosed that the current focus of SAMR is institutional reform and the amendment of Regulations Concerning the Hygiene Supervision over Cosmetics which could be published by the end of the year.

Qi Liubin, CFDA's former Cosmetics Division director, stressed the significance of two exposure drafts, Classification Standards of Cosmetics and Guidelines for the Evaluation of Cosmetic Efficacy Claims. Qi stated that SAMR is about to set up a coding system to classify cosmetics on the basis of functional claims, target application area, product types and target users. Once published, a product excluded from this list will be classified as a new product and will be reviewed by SAMR accordingly.

Guidelines for the Evaluation of Cosmetic Efficacy Claims is still being drafted by SAMR. Currently they have worked out the first batch of permitted claim terminology, but have not released any information about these claims.

According to Xu Liang, director of Beijing Daily Chemicals Institute, SAMR is likely to release the 2016 edition of Catalogue of Standard Chinese Name of International Cosmetic Ingredients. SAMR will increase the number of ingredients from 15649 to over 22000. However, the release date is not yet clear.

♦ Other discussed issues

Qi also points out that SAMR might establish an enterprise credit rating system and manage these enterprises in accordance with their credit score.

There are also potential changes in store for filing of domestic non-special use cosmetics. Conventionally, provincial SAMR departments conduct supervision and inspection within 3 months after filing and strengthen in-process and post-marketing surveillance. This system mostly emphasizes the responsibilities of manufacturers, with no specific requirements for downstream parties. SAMR therefore intends to strengthen supervision on downstream links in the supply chain (after manufacturing), including distributors and retailers thus ensuring more comprehensive product lifecycle stewardship.

Giving authorities false information particularly false identification will also result in issuance of a public warning on the official website instructing a legal representative to appear within 1 month to verify identity. If a relevant person does not appear within a month the enterprise will have their online account frozen and if there is no appearance within 3 months, the account and all the filing information will be deleted.

Furthermore, concerning the filing of imported non-special use cosmetics, SAMR may address the following issue: conditions and obligations of domestic responsible person and the feasibility of importing products in the different location from original filing place.