On May 27th, China’s National Medical Products Administration (NMPA) released a draft of its Administrative Measures for Registration of Non-Special Purpose Cosmetics for public input. These new measures suggest a number of changes in the current version of these regulations, also known as GSYJX [2011] No.181. At the same time, policies that went into effect on November 10, 2018 subject imported non-special purpose cosmetics to a unified registration procedure. This registration procedure replaced the previous approval-based approach and the pilot registration program in free trade zones.
Unified Management and Control of Domestic and Imported Products
The new measures are intended to strengthen the registration process for non-special purposes cosmetics. The regulations are divided into 30 articles and 5 chapters, covering general provisions, product registration, registration administration, monitoring and inspection, and supplementary provisions. Article 2 of the regulations’ first chapter explicitly puts imported and domestic cosmetics under the same registration scheme.
The new measures also spell out the different roles and responsibilities of regulatory authorities. The drug regulatory authority under the State Council will be responsible for registration administration of imported products, while provincial, autonomous region, and directly-control municipality drug regulatory authorities will handle locally produced products and some imported products. These local authorities will be responsible for post-registration monitoring and supervision. Before products are launched or imported, they must be registered with the appropriate authority.
Detailed Administration Rules for Imported Non-Special Purpose Cosmetics
In the past, registration of imported non-special purpose cosmetics had been governed by Shanghai Pudong New Area’s Administrative Work Procedure for Registration of Imported Non-Special-Purpose Cosmetics (Interim) and applicable registration application guidelines. Shanghai is one of the first cities to implement the pilot registration program. Now, this new legislation explicitly defines administrative rules for registration of imported non-special purposes cosmetics.
The new regulations stipulate that overseas entities that seek to registration their products must set up a representative office within China or designate a corporate entity within China as its legally appointed representative to handle the registration of any non-special purpose cosmetics products. The local representative will create a review process for the overseas applicant and review and verify that the product complies with applicable requirements in China. Any imported products that don’t comply with such regulations or mandatory national standards will be banned.
The representative for the overseas registrant must verify that it continues to produce or import the registered process via an online registration platform on an annual basis. If a product is no longer produced or imported, it’s registration will be cancelled.
Under the new regulations, imported products need to submit certifications issued by cosmetics regulators or trade associations in their place of origin. These certifications should include the quality management system or best manufacturing practices of the supplier and confirmation of the launch and sale of the product in its country or region of origin. If a product is specifically manufactured for the Chinese market and lacks these documents from its country of origin, then it should submit similar data and certification based on tests conducted for Chinese consumers.
Review of Regulation Documents Will Be More Rigorous
The new regulations increase the scope of the documentation required to register new products. In addition to previous product formula, product packaging, and product inspection reports, applicants now need to submit information on the applicant (e.g. name, address, contact information, and local representative), the producer, the product names (foreign and Chinese names), an photo of the product manual, product standards, and a product safety risk assessment. In cases where documentation is not compliant, the applicant or local representative will be notified and asked to amend the application. If the application lacks complete or adequate inspection and testing reports or if the product cannot meet safety or quality requirements, then the sales of the product in China will be suspended.
If the production of the product is outsourced, then the outsourcing supplier will need to complete the relevant product registration information the online registration platform after the product has been registered. If the outsourced supplier changes or no longer manufacturers the product, then it should update the online registration records in a timely manner.
In the past, imported products have been exempt from toxicology testing if its technical requirements meet Chinese regulations and if its risk assessment confirmed the safety of the product. However, the new regulations stipulate that no toxicology test exemptions will be granted for products are used for children or infants, products that use new materials that have not been included in the list of permissible cosmetic materials, or cases where the local representative has been targeted for monitoring, investigated, or penalized for quality or safety-related offenses during the past three years.
New Quantitative Classification System
The new regulations also affect how products are sold. Any product sold as a set or bundle can not be divided into sub-products or individual pieces for sale.
The new regulations also stipulate new treatment for offshore duty-free goods. These duty-free policies are focused on Hainan, now the fourth largest offshore duty-free region. Under the new regulations, duty-free retailers are responsible for the quality and safety of registered products that they import and sell. The provincial drug regulator in the duty-free location shall be responsible for handling post-registration inspection and enforcement.
The new regulatory framework also includes a new quantitative classification administration system for the registration of non-special purpose cosmetics in China. This means that drug regulators will give the applicant or its local representative a quantitative rating based on its quality management system, registered product, and inspection results. Product inspection will be conducted on a random basis post product launch. The frequency and prioritization of inspection will focus on products with low quantitative ratings.
“The National Medical Products Administration is guiding and regulating the development of companies with more efficient supervision,” acclaims some seasoned insider, “The release of the New Measures marks a major reform in the administration of the registration of non-special purpose cosmetics products.”
Learn more about China’s latest cosmetics industry regulations from China Beauty Expo.
Comments