Tags: | CFDA | Cosmetics | Cosmetics | 食药监局 | 化妆品 | 化妆品 |

The inspection and labelling approval procedures concerning cosmetics and beauty products importing into the Chinese Market.

The responsibility of approving cosmetics and beauty product imports into China was previously shouldered by the Ministry of Health but has been taken over by the State Food and Drug Administration (SFDA) since 2008. The time required for the approval procedure is officially set at three to four months but in reality, it normally takes about nine months to a year as it involves such processes as inspection, acceptance of application, technical assessment, and granting of approval document for imports. Hence, Foreign companies applying for approval should plan well in advance.

To understand the import approval procedure, one must first be clear about the mainland's definition of cosmetics and beauty products, which are defined according to three standards. First of all, under the Hygienic Standard for Cosmetics (2007 edition), cosmetics cover all kinds of industrial chemicals for daily use which are spread on the outer surface of the human body (e.g. skin, hairs, nails, lips etc) for the purposes of cleaning, deodorizing, skin care, beauty and make-up.

Second, under the Instructions for Use of Consumer Products – General Labelling of Cosmetics (GB5296.3-2008), the definition of cosmetics and beauty products is similar to the above standard.

Third, based on the Administrative Provisions on Cosmetics Labelling issued in 2008 by AQSIQ, cosmetics also include products related to dental health, such as toothpaste and mouth rinse etc.

According to the approval documents issued by SFDA, cosmetics can be classified into two main categories. The first category is "non-special purpose cosmetics", which refers to cosmetics with no medicinal effects, such as hair care products (e.g. shampoo, conditioner, styling agent etc), skin care products (e.g. skin cleanser, skin toner, moisturizer etc), make-up (e.g. foundation, rouge, mascara etc), lip care products, nail care products and perfumes. For this category of cosmetics, the procedure involved is rather simple, the applicant only has to register with SFDA and obtain a Registration Credence of Imported Cosmetics for Non-Special Purpose.

The second category is "special purpose cosmetics", which refers to cosmetics for special purpose meeting the requirement for Chinese labelling in compliance with China's National Standard and includes products for hair growth, fitness (slimming), breast shaping (or enhancement), hair dye, hair perm, sun block, deodorizing, spots removal, hairs removal etc. For this category of products, application for approval and issue of the Health Certificate for Imported Cosmetics for Special Purpose is required. As a matter of fact, the time required and the complexity involved in applying for this health certificate are more or less the same as the registration credence, only that more inspections and tests are needed.

The first step of the whole application procedure is inspection. there are 14 authorised inspection centres under SFDA mainly responsible for performing tests on micro organism (five types), physical chemistry (i.e. heavy metals), toxicology, human safety, as well as efficacy assessment. Each product is required to provide more than 10 phials for the tests, with each phial measuring 20g or 20ml. The inspection centre under the company also performs tests on the ingredients of different formulae, e.g. tests for antibiotics and anti-dandruff agents. Where sun block products are concerned, the highest SPF value stipulated by the mainland is 30. Hence, products with an SPF of over 30 do not meet the labelling requirement. Also, the higher the SPF, the longer is the testing time and the higher the fee involved.

Generally speaking, the test report would be ready within 50 to 60 working days. As five-day work is in place on the mainland, this translates into about three months. The testing time for perfumes is shorter, about 25 to 60 days, while that for spot removing products or sun block products is longer, up to 180 days or about nine months.

After the tests have been performed, the applicant may go to the Application Acceptance Service Centre under SFDA to proceed with document review whereby the authority concerned will check to see if the description of the product is sufficient. The review procedure requires five to 10 days. After the review, the application is either accepted, rejected or suspended. If the application is rejected, the whole inspection and application procedure has to be conducted all over again. If the application is suspended, a rectification notice will be issued whereby supplementary documents are required to be submitted for further review.

If the application is accepted, it will be referred to the SFDA Assessment Centre for assessment of technical documents. Assessment of technical documents involves the checking of the inspection enterprise to see if there is any fraudulent misrepresentation. For example, if the documents state that the product "contains no preservative", assessment has to be made to see whether this statement is true. The technical assessment of imported cosmetics for non-special purpose normally takes 25 to 30 working days, while imported cosmetics for special purpose takes longer, about 30 to 100 working days.

To submit an application, the applicant should provide the following documents and note the points below:

1. Application form – application for import must be made by the manufacturer or brand holder and not the agent.
2. The formula of the product applied for must be disclosed and may not be kept secret on the grounds of confidentiality.
3. The efficacies of the product stated must be supported by proofs and evidences such as research reports and scientific journals.
4. For special purpose cosmetics, details of the production process have to be submitted.
5. The quality of the product must meet specific standards, e.g. quality requirements on micro organisms, heavy metals etc.
6. The language on the original packaging must be translated fully into Chinese. Also, certain wordings such as "whitening" and "spot removing" are not allowed, but wordings such as "anti-spot" are acceptable. Thus, in translation, the choice of words is important.
7. Certificates of production and sale in the country (region) of production of the product.
8. Letter of undertaking on the use of raw materials involving high risks (such as mad cow disease). Letters of undertaking made by the manufacturer pledging that the product contains no bovine or sheep ingredient are now acceptable.
9. Authorisation letter issued by the production enterprise to its responsible agency in China (if the authorisation letter is in a foreign language, it has to be translated and notarised by the China Notary).
10. A sealed intact product sample.

After completing the above steps, a batch approval document or registration certificate would be issued. When the goods are imported, Chinese labelling of the imported cosmetics is required. The purpose of the labelling is to let consumers know from the product packaging that the product has been approved. The certification number printed on the label may allow consumers to go online and check the genuineness of the product and the validity of the label. For products imported from foreign countries, the original packaging can be used but a label with Chinese translation must be affixed.

Import procedure includes application for commodity inspection and quarantine, random inspection, routine inspection, compliance inspection and labelling inspection. Routine inspection involves the inspection of the quantity, weight, specifications, packaging and hygiene condition of the product. Compliance inspection involves the checking of the content of the label, e.g. claims such as no artificial colouring, no preservatives etc, against the product. If the product fails any one of these inspections, it will be destroyed and prohibited from import.

Labelling inspection is conducted according to the format and content set out in the Instructions for Use of Consumer Products – General Labelling of Cosmetics. Its basic requirement is that in the description of the content of the product, no wordings or specialist medical terms that may cause misunderstanding (such as special effect, anti-allergy, germ killing, anti-inflammatory effect) may be used. The product description may not discriminate against or compare with other products. Also, it may not use languages or graphics which may mislead consumers (such as graphics implying body slimming). Lastly, the product description must use simplified Chinese characters but may use foreign languages simultaneously.