CFDA Review Experts Reiterate Important Cosmetic Registrations Requirements

Takehome: Former CFDA (now SAMR) review experts emphasized several cosmetic registration requirements.

During a recent training course hosted by the SAMR on Cosmetic registration in Beijing, officials and technical review experts delivered lectures on registration work results. The experts also offered advice on vital requirements derived from analyzing unapproved cases. According to Liu Baojun, the head of Cosmetic Division, Chinese Herbology Protection Review Committee, there are two guiding principles determining the result of an application, product safety and procedural legality. The first principle requires that applicants shall ensure product safety as substantiated through sufficient supporting material, professional competency and verification by accredited 3rd party institutions while the other principle requires compliance with standard legal procedures and complete and authentic documentation. Numerous cosmetic enterprises do not receive “Approval” due to failure to meet these requirements. Based on the overall analysis of the common problems extracted from non-approval cases, the review experts reiterate several important requirements:

In terms of Procedures for Application

• There is time limit stipulated to supplement registration dossiers. Supplementation or perfection of dossiers shall be accomplished within the prescribed date.
• In the process, applicants are forbidden to modify errors without permission. Once discovered the application will be immediately rejected. The only solution is to inform CFDA initiatively and wait for experts' feedbacks.
• Enterprises receiving "disapproval" for the first application shall give a written explanation and specify why when going through the reapplication procedure.
• Enterprises only have one chance to apply for product name changing, if the second application still does not conform to the naming standard, it will be rejected.
• Applicants are prohibited to abuse "Second Review". "Second Review" presupposes that experts make mistakes during an initial review.

In terms of Contents of Dossiers

1. Dossiers for application shall be complete and clear, corresponding to the required items given by CFDA.

2. Compliance Requirements for the submitted Dossiers:

» Ingredients:

1. It is required to provide the documents of supply relationship between trade companies and production enterprises.
2. It is prohibited to use human cells, human tissues or other human-derived products as cosmetic ingredients.

» Technology：

1. It is required to have cooling operations when there are heating steps in the product and process report.
2. It is required to mark the specific parameters of heating and cooling temperatures in the product and process report.

» Quality and safety control:

1. It is required to mark the expiration date on the products; besides, relevant testing reports shall be submitted to prove it.
2. It is required to unify the Chinese language and English language descriptions of product color.

» Inspection report：

1. It is required to provide relevant multiple skin irritation test reports for mask products.
2. It is required to provide the original copy (shall ensure its integrity and reliability) of testing reports from overseas laboratories for imported products.

» Efficacy：

1. It is required to submit valid testing reports and scientific documents on functional components to ensure efficacy for hair growth, slimming and breast beauty products.
2. It is required to provide corresponding translations of efficacy testing report for imported products.

» Claim and labeling:

1. Claims on the original packaging shall conform to Chinese cosmetic definition since the review of imported product starts from the original packaging.
2. Not only words but also designs, symbols, numbers and other contents that imply specific functions etc. shall conform to requirements.
3. It is prohibited to use terminology which exaggerates efficacy or function
4. It is prohibited to use plant name on the labels if it does not appear in the ingredient list.
5. It is prohibited to use homophones and traditional Chinese characters on the labels.
6. It is required to provide additional instructions for skin care products, explaining the definition of "so-and-so skin" when claim "suitable for so-and-so skin".
7. If the imported product claims "medicinal" on the labeling, it is required to submit an explanation, informing experts that there exists corresponding regulations allowing the claims in the country of origin.
8. Warning Instructions:

① Children products must be labeled with "Under Adult Supervision".

② Household skin care products which claim "Suitable for All Family Members" will be reviewed as children products; Otherwise, they shall claim "Not suitable for children" to avoid stricter review.

3. Translation:

• Chinese translations shall accurate and professional.
• The translated version and the original text shall correspond.
• The original content shall be represented fully and faithfully.
• All foreign languages (excluding items that must use foreign characters, such as overseas addresses, URLs, registered trademarks, patent names, SPF, PFA or PA, UVA, UVB, etc.) shall be translated into standard Chinese. Furthermore, an additional explanation of untranslated contents shall be submitted.
• It is required to provide original packing and corresponding translation of imported products even if enterprises specially design a package for the Chinese market.

4. All duplicates shall be clear and recognizable and the same as the original copy.

• It is prohibited to do handwriting or manual modification on the submitted dossiers.
• It is required to print on the white paper in A4 size, instead of on the waste paper.