Josephine Zhou

REACH24H Consulting Group, China

Determine if your products is a cosmetic in China

The first thing is to determine that whether your product is a cosmetic. You can refer to definition which is clarified below. The definition is important for products which are at the borderline between cosmetics and other product types,such as wet wipes. Because the distinction makes products undergo very different regulatory requirements.

Article 2 of China’s overarching cosmetics law “Regulations concerning the Hygiene Supervision over Cosmetics 1989” defines cosmetic product as industrially produced chemical product subject to daily use, which are intended to be placed in contact with any external parts of human body(skin, hair system, nail, lips and oral cavity) by spreading,rubbing, spraying, sprinkling etc., with the purpose of cleansing, correcting body odors, protecting function or changing their appearance.

It should to be noticed that teeth and mucous membranes of the oral cavity, such as toothpastes, are currently not within the scope of cosmetics, but they will be included in the future according to the second draft of “Regulations Concerning the Supervision and Administration over Cosmetics”.

Classify cosmetics

Once you assure your product is a cosmetics, you should check the classification of your cosmetics. In China,cosmetics are generally classified into two categories:special use cosmetics and non-special use cosmetics (Table 1).This classification is important because it determines which importing approach your cosmetics can apply for:

Table 1. Cosmetic classification and entry approach

For importing special use cosmetics, it is required to register the product with CFDA. The registration procedure means stricter pre-market review, and it includes generally 4 steps: 1) assign a responsible agent in China; 2) check the compliance of formula, label and claim; 3) arrange product testing; 4) submit dossiers for technical review. Special use cosmetics must get approval from pre-market review before entering Chinese market, and the whole procedure will take approximately half year.

For importing non-special use cosmetics, the policy has a tendency to subject to filing management. But the regulation requirement is currently under an interim period. Non-special use cosmetics imported from Shanghai Pudong Port can apply for filing management, which only takes about 5 days to get market entry approval; when imported from other ports in China, your non-special use cosmetics should undergo registration like special use cosmetics do.

Appoint a responsible agent or a responsible person

When you know which category your product belongs to, you can arrange the proper approach to import your product into China. If overseas enterprises desire to fulfill entry approval procedures, they have to entrust a local responsible agent/person to complete the registration/filing on behalf of them.

Specifically, to fulfill registration procedures, overseas company should appoint a responsible agent to represent it deal with factual steps. A responsible agent could be a subsidiary based in China, an importer or a third party.While to fulfill filing management in Shanghai for nonspecial use cosmetics, overseas company should appoint a responsible person to fully take the responsibility of operation of the product in China. Not only completing filing procedures, the responsible person should be in charge of product safety and quality. A responsible person should be a Shanghai local legal entity.

Check whether ingredients are allowable, limited or prohibited

After assigning Chinese representatives, you should make fully preparation to let your product approved for entry. You have to firstly reassure all your ingredients used in your product are aligned with ingredients standard.China release ingredients standard by issuing inventory,negative list and positive list. All the ingredients used in cosmetics should be listed on Inventory of Existing Cosmetic Ingredients in China, otherwise the ingredient will be regarded as new ingredient and require registration.Cosmetics can’t apply ingredients in List of Substances Prohibited in Cosmetic Product, and can conditionally use ingredients on restricted used lists. Table 2 outlines the nine inventories encompassing regulated ingredients.

Table 2. Chinese inventories for cosmetic ingredients

Prepare and submit the pre-market application dossier

If all your ingredients are in compliance with the requirements, you can prepare to submit required dossiers. It is mandatory to fill out online as well as submit hard-copy to relevant organs (CFDA or local FDA). For registration, e-submission is only applicable for parts of the dossiers including the information on the formulation and technical requirement, and for filing management all materials requires an e-copy. Dossiers required for registration and filing are different. Table 3 is a detailed list for all documentations for registration and filing management respectively.

Table 3. Application dossiers required for non-special used and special used cosmetics

Label and claim your products

CFDA provides two options for labeling imported cosmetics: 1) the original upon with Chinese translation,2) confirm with national labeling standards and use a Chinese commercial label and package.

Label refers to the combination of words, numbers,figures or instructions which appear on the container or packing. The following information must be included in the Chinese label:

Product name—the Chinese product name generated according to the Cosmetic Naming Rule;

Address of producer—the name and address of the oversea manufacturer;

Country of origin—the country of origin must be indicated on the Chinese label;

Approval ID number—the ID number on the approval acknowledgment, representing the product type, approved date and sequence number, such as manufacture production license number, special cosmetic registration number, nonspecial cosmetic filing number;

List of ingredients—all the ingredients with concentration over 1.0% must be identified with Chinese INCI name;

Date of production and durability—combination of product date and period after manufacturing (such as 6 months), or the batch number and date of minimum durability (such as 2013-12-31);

Particular precautions for use—warning and condition of use for products containing restricted substances (e.g.Dichloromethane, which should be indicated, while the max concentration is less than 0.5%) or special use cosmetics (e.g. hair dye);

Storage condition and use instruction—should be provided if necessary for safety assurance;

Other—the local distributor or wholesaler can be identified as well.

Other notes on labeling

Language—original label can be remained by attaching the Chinese label, and the simplified Chinese is official required, plus necessary traditional Chinese or other language characters.

Small packaging—as to the product with nominal content less than 15 g or 15 mL, where it is not practical to print warning, ingredients and product use information on the packing or container itself, a leaflet, label or card should be provided containing the related information,and making reference through necessary words on the label, such as “find the ingredients on the leaflet inside”.

Labeling nanomaterial—this new obligation under EU Cosmetic Regulation is not required in China; however, the application dossier should specify the nano property for some ingredients, such as ZnO for baby products.

Labeling inspection—CFDA is responsible for the labeling review prior to marking, is China Inspection and Quarantine Bureau (CIQB) is in charge of the labeling assessment prior to custom clearance, and Administration of Quality Supervision (AQS) inspects the labels of inmarket products.

In 2014, CFDA had issued a draft of “Administrative Measures on Cosmetics Labeling” to adjust information on the label. Though it has not been actually implemented,some enterprises may take the measure as reference. The new requirements for label should include the following information:

-Product name;

-Name and address of manufacturer;

-Actual production and processing place;

-Cosmetics manufacturing enterprise license number and product standard number;

-Approval number or record number;

-List of all ingredients;

-Shelf-life;

-Net content;

-Other information.

CFDA promulgated special rules and guidelines on the product claimed name on the Chinese label. Medicinal or therapeutic function claims are prohibited along with inclusion of misleading information. The general principle is that industry can’t claim the functions or features which the products do not possess. Local expertise will be necessary for balancing compliance with Chinese claim requirements and the addressing the interests of manufacturers who rely on the added value derived from inclusion of certain claims in their marketing strategies.

Pre-market approval

All the imported cosmetic products are subject to the pre-market evaluation carried out by CFDA.Acknowledgement of approval marks the first successful step for exporting. The following information will be present on the approval document:

ID number—indicating the product type, special or ordinary, approval year and sequence number;

Product and producer name—both the Chinese and original name;

Product type—indicating the type of special cosmetics,such as anti-spot cosmetics;

Country of origin—country name and producer address;

Responsible agent—the name and address of responsible agent;

Approval date—marking the starting point of 4-year valid period of approval acknowledgement and refresh application should be submitted in 4 months prior to the expired date.

CIQ inspection

For each shipment of cosmetic product, the local importer or its agent should apply for the CIQ inspection carried out by the local offices, such as Shanghai CIQ. The inspection process includes on-site examination of the label or package, sampling or testing based on the outcome of on-site examination and other findings, and finally the issuance of the CIQ Certificate, which is the ultimate requirement for custom clearance.

In-market surveillance

CFDA and AQSIQ (Administration of Quality Supervision, Inspection and Quarantine) will carry out the in-market surveillance under their own authorities, such as the plant on-site inspection for hygienic condition and good quality management system, product contamination investigation and sampling from the supermarket or cosmetic stores as well, furthermore, the State Administration for Industry and Commerce (SAIC) will monitor the advertising activities of commercial cosmetic product.

[1] Regulations Concerning the Hygiene Supervision over Cosmetics, 1989.

[2] Regulations Concerning the Supervision and Administration over Cosmetics (draft version).

[3] Safety and Technical Standard for Cosmetics 2015.

[4] Requirements for Application and Acceptance of Administrative Licensing for Cosmetics, 2009.

[5] Guidance of Filing Management for First Import Non-special Use Cosmetics through Shanghai Pudong, 2017.

[6] Requirements for Cosmetic Administrative Licensing Testing,2010.

[7] Administrative Measures on Cosmetics Labeling (draft version).

[8] GB 5296.3-2008 General Labeling for Cosmetics, 2009.

[9] Guide to the Naming of Cosmetics, 2010.

[10] Inventory of Existing Cosmetic Ingredients in China, 2015.

[11] Administrative Measures on Inspection and Quarantine of Import and Export Cosmetics, 2012.

[12] GB 5296.3-2008 Instruction for Use of Consumer Products —General Labeling for Cosmetics.