Specifications on Imported Non-Special Use Cosmetics Filing Documents Review in Shanghai

On Nov. 9, 2018, China National Medical Products Administration (NMPA) officially announced that registration of first imported non-special use cosmetics will be entirely replaced by filing management nationwide from Nov. 10. Due to the novelty of the new system, authorities in provinces throughout China lack practical experience, prompting both authorities and enterprise alike to turn their attention to Shanghai’s Medical Products Administration, which was the first authority tasked with administrating pilot filing work starting on March 1st, 2017.

On Dec 14, 2018, Shanghai Medical Products Administration (SMPA) released and implemented Specification for initial Imported Non-Special Use Cosmetics Filing Documents Review. SMPA Technical Review Department collected more than 10,000 opinions from the former CFDA in the past 2 years. Combined with experiences gained from implementation of the pilot filing system in Shanghai. SMPA then organized the preparation of Technical Review Specifications with a view to standardizing filing document review.

This specification is of great reference value for stakeholders filing imported non-SUC and is likely to be the reference document guiding development of what will be the  gold standard going forward i.e. Administrative Measures on Filing for Non-Special Use Cosmetics (still in the process).

Compared with the previous filing specification, the requirements have become clearer, more stringent and more specific. This article will offer an in-depth interpretation of this specification. The key points are summarized into 3 aspects, Chinese label, product formula and testing report.

Chinese Label

Novel product name's meaning must be explained on Chinese label

With the rapid commercialization of cosmetic R&D outcomes, cosmetics utilizing novel delivery methods, shape, physical state etc. are becoming popular. In order to reduce consumer misunderstanding and protect consumer rights, the name of novel cosmetics products is required to explain the meaning on the Chinese label, such as jelly mask, sherbet.

Explain the foreign letters or symbols in Chinese product name

Based on Chinese cosmetic naming regulations, all foreign letters or symbols including trade mark in the product Chinese name need to be explained in Chinese product naming statement as well as Chinese label, except for some conventional words, like Vitamin C and BB cream.

Taiwanese cosmetic products need to pay attention to cosmetic packaging

For Taiwan (China) products, neither R.O.C nor the date marked as (AD year/month/day) on the original package will be allowed. It is necessary to provide designed packaging after deleting R.O.C and date marked as AD year/month/day.

Illegal words in original packaging

Product’s original packaging containing some simple or traditional Chinese words which are medical terminology, "药用"(Medicinal) and "医药"(Medicine) are not allowed. These words are prohibited as stipulated by relevant Chinese cosmetic naming regulations. For imported products which contain this terminology, the prohibition can be circumvented by providing a disclaimer (using simplified mandarin Chinese) on the label or instruction which states that the product is compliant with regulations/laws in the country of origin and cannot be used as medicines. This requirement will be especially enforced for Cosmetics made in Taiwan and Japan (these 2 countries/regions’ cosmetic categories include medical cosmetics and quasi-drugs).

Fragrance allergens should be marked on Chinese label

According to EU Cosmetic Directive 2003/15/EC, for the EU cosmetics, if any of the following 26 allergens exceed 0.001% in leave-on products or 0.01% in rinse-off products, they must be marked on the Chinese label.

Previously, there was no need to label fragrance allergens for imported cosmetics in China. Under new regulatory compliance requirements, China now aligns with EU requirements, and imported cosmetics in China are also required to mark fragrance allergens on Chinese label if original packaging is marked.

26 Fragrance allergens:

Product Formula

3 prohibited ingredients:

Although Caprylhydroxamic Acid, Tropolone and Colloidal Silver are listed in IECIC 2015, SMPA clearly states that products that contain these ingredients will be considered unsafe. The ingredients are also excluded in the list of permitted preservatives in cosmetic product of Safety and Technical Standards for Cosmetics 2015. Please recheck if your products contain these 3 ingredients.

EGF (Epidermal Growth Factor) is banned in China

Biologic agents and small peptide molecules like EGF are strictly forbidden for use in cosmetics in China. Products which contain oligopeptide-1 (a synthetic peptide of similar peptide chain length, sequence and molecular weight to EGF) in their formulation, shall issue a specification demonstrating the amino acid composition and provide supporting documents of source.

Snail Secretion Filtrate —— Uncertain Safety

In recent years, snail treatment has become popular in beauty salons and snail secretion filtrate popular in many cosmetics. SMPA clearly stated that based on safety considerations, products containing snail secretion filtrate will be refused China market entry. 

Specify presence of CARBOMER (polyacrylic acid) in baby products

Special attention should be paid to baby products that contain carbomer and its derivatives (such as Potassium Carbomer / Sodium Carbomer or TEA-Carbomer). The potential for presence of high risk substances such as benzene or trichloromethane must be identified during product safety assessment report.

Testing Report

Cross compatibly of registration/filing testing data – Duplication of testing not required

Imported non-SUC (including products entrusted by domestic enterprises to be produced by oversea enterprises) that have finished testing to generate the data required for an administration license (registration) but have not submitted the application to NMPA, will not be required to conduct repeat testing under updated requirements but are required to submit the following 2 statements:

(1) Responsible person should issue a statement of the product submitted for filing is the same as the one which applied for registration.

(2) Previous Responsible agent should issue an agreement on using testing reports for filing.

*Please contact us at [email protected] if translations of Technical Review Specification are needed.