2019 Annual Summary of Imported Non-special Use Cosmetics Filing in China

Filing is a critical market entry prerequisite confronting stakeholders importing cosmetics in China. In the past year, the number of filed imported non-special use cosmetics grew considerably, driven by a series of favorable policies including the acceleration of customs clearance, the reduction in tariffs, and the proposal of a new filing management scheme.

1. 2019 Filing Data

According to the filing data publicized on China National Medical Products Administration's (NMPA) online filing information query system, a total of 15684 products were filed in 2019. 60% of these products were OEM manufactured.

With regard to the place of origin, South Korea accounted for the overwhelming majority, followed by France, America, and Japan. Notably, there is also a significant proportion of Chinese enterprises that commissioned overseas manufacturers to make their products overseas. These products were also considered as imported products.

(Data Source: NMPA, CNPHARM)

With regard to the technical review, the pass rate in Zhejiang, Guangdong Province, and Shanghai Municipality was comparatively high. The average once-off pass rate of the technical review was close to 58%.

(Data Source: NMPA, CNPHARM)

With regard to filing category, lipsticks, masks, and essences were the top 3 products in terms of the number of products filed. In the skincare segment, the products are more diversified, indicating trends towards greater product segmentation to meet the evolving demands of niche consumer groups.

(Data Source: NMPA, CNPHARM)

2. Tips for Cosmetic Enterprises to Complete Filing: Q&A

"Cosmetic Classifications"

Q1: Are baby cosmetics categorized as general cosmetics or functional cosmetics? How about cosmetics for pregnant and breastfeeding women?

 A1: The cosmetics used for baby, pregnant, and breastfeeding women are categorized as special use cosmetics and will require registration.

Q2: If intimate hygiene products are not classified as cosmetic products, what is their classification?

A2: Intimate hygiene products are classified as sanitary disinfection products or medicines based on their functions.

“Responsible Person”

Q1: What are the responsibilities of the responsible person in China?

A1: The responsible person shall be responsible for all issues related to cosmetic filing, importation, sale, and the safety and quality of all products filed under their name.

Q2: Can an RP select a third party to undertake importation?

A2: Yes, RP can add consignees in the online filing system when importing cosmetics. After a consignee is selected, products can be imported not only from the port where the RP is located but also from the ports where the consignees are located.

Q3: Can the RP (entity) be a non-commercial entity (without import/export activity)?

A3: No, RP must be a business entity registered in China. So RP must be the importer. Usually, international enterprise selects their distributor as the RP or alternatively, where applicable, the international enterprise can use their China mainland business. 

Q4: Can the contact details of the RP be outside China?

A4: No. The contact person must be able to be contacted in mainland China. When you apply for a filing account, the telephone number and fax number must be inputted in the filing system. The authorities will contact this number to ensure the number is reachable. If they call you and there is no answer (3 chances are given), they may freeze the account of this RP.

Q5: Do we have to start a filing process with the new Responsible Person?

A5: Once the previous administration licenses for non-special use cosmetics expire, it is mandatory to conduct import filing of these products, and a new domestic responsible person shall be authorized.

“Filing Dossiers”

Q1: Which documents are needed for filing? For example, administrative and technical data? Free sale certificate? The requirement for quality and safety control? Technical requirements? Report for lab tests?

A1: Please refer to our Cosme-list for a detailed checklist of documents needed to compile filing dossiers.

Q2: Can filing documents be in English, or should they be translated to Chinese?

A2: All filing documents written in languages other than Chinese must be accompanied by their Chinese translations. The translations should be placed before the corresponding foreign-language materials.

Q3: What are the registration requirements for baby cosmetics?

A3: The total bacteria count of children cosmetics shall be no more than 500 CFU/ml or 500 CFU/g.

In regard to the design principle of children cosmetics, the number of ingredients used should be kept to a minimum level. The use of fragrance, colorant, preservative, and surfactant should be minimized. The safety limit of raw materials should be included in the CIR report. For more details, please refer to the Guidance on Application and Review of Children's Cosmetics, which specifies the documentation and review requirements for children cosmetics.

“Filing Process”

Q1: How long is the process for filing cosmetic products in China?

A1: It will take 4-6months for non-special use cosmetics. Based on our experience, we can complete the filing in 3 months if everything goes really smoothly.

Q2: For a non-special cosmetic product, what procedure should we follow to update a product formula? Can we cancel the e-filing document?

A2: If you change or update your formula, then the updated product will be regarded as a new product, and you have to re-file it. Yes, the e-filing document can be canceled as you request.

Q3: We have some licenses from the old system for non-special use cosmetics. Are they still valid: what is the process if we want to change the Responsible Agent for these products?

A3: As per China's new filing policy, the approved registration certificate is still effective for importing the product within its validity period, and there is no need to modify RA. Once the previous administration licenses for non-special use cosmetics expires, it is mandatory to undertake import filing of these products, and a new domestic responsible person shall be authorized. For more information, please consult our technical experts.

“Packaging”

Q1: What do you have to do when there is a packaging change for a previously registered non-special use cosmetic product?

A1: Change of a package of a non-special use cosmetic only requires an update of the new package information on NMPA ‘s online filing system. After this, stakeholders should submit relevant paper documents to NMPA or provincial MPA. There is no need to re-file this product.

Q2: What documents are required if a natural ingredient content claim is made on the product label (e.g., 98% natural ingredients)

A2: We need the Certificate of Analysis (COA) of this ingredient to prove the claim is natural-origin. As long as authenticity can be proved, the claim is allowable.

“Testing”

Q1: Do imported cosmetics still require animal testing?

A: For now, it’s still required. However, according to the new draft of Administration Measures for Filing of Non-Special Use Cosmetics, imported non-special use cosmetics will probably be eligible for exemptions from mandatory animal testing.

Q2: Is it required to submit all packaging artwork (each capacity, limited editions,) with pictures during online filing with Shanghai MPA? Is it mandatory to submit samples? If yes, is it required for all contents, and how many products are needed?

A2: If your products have different packaging, it is necessary to submit all the packages online. It’s not mandatory to submit sample products, but when it comes to the testing, samples that are consistent with the commercial products shall be sent to the testing labs. As for the quantity, we need to review your products, and that will be handled case by case.

Q3: Regarding the phototoxicity tests and stability tests for products containing more than 0.5% of UV filters: does the 0.5% mean the sum of all UV filters, or is the limit fixed at 0.5% per UV filter?

A3: It means that the sum of all chemical sunscreen agents (titanium dioxide and zinc oxide are not included) used in non-sunscreen cosmetics (except for perfumes and nail polish products) should be less than 0.5%.

“Post-market Surveillance”

Q1: What is post-market surveillance? What will happen if the filing information submitted and the product inspected during post-market inspections do not conform?

A1: Under the new filing system, provided you pass the format review and get the filing e-certificate, it is possible to import your cosmetics in China. After this the market regulators will inspect the product on the market to ensure compliance. The technical review will be carried out within three months after that. If the review expert thinks the dossiers submitted are incomplete, then supplementary documents can be submitted. If there is non-conformity between the actual products on the market and the product filing info, and this difference impacts the safety or quality of the product, then product recall, and further rectifications will be required.

Q2: What’s the difference between the pre-market administrative review and post-market technical review? What items will be reviewed?

A2: Administrative review mainly focuses on the format of the dossiers. For filing, authorities will only review:

1) Whether the product falls within the scope of filing (imported non-special use);

2) Whether the filing information is complete;

3) Whether the filing information conforms to the prescribed format. The technical review mainly focuses on the safety documents, for example, whether the formulation complies with Chinese regulations, whether the manufacturing process is consistent with the formula and whether the labeling claims are compliant.

Q3: After the filing process, are there only three months of technical review? We have been told that the process will be much longer (maybe 2 or 3 years during which we won't be able to change anything on the products including packaging)

A3: Generally, the technical review time is three months, but in practice, this time can vary depending on the capacities of the province/city in which the product is filed. For example, the technical review period of products filed in Shanghai may take nine months or more. Yes, the information, including Chinese product name, packaging can't be modified before the issuance of technical review results, which can only be modified after passing the review.