|2016 Imported Cosmetics CFDA Registration Guide Concise Edition
Author: Beijing Tianjianhuacheng International Investment Consulting Co., LTD. Cosmetics Registration Department
The Definition of Cosmetics and Classification
1. What’s the definition of cosmetics in China?
Tianjianhuacheng: In China, as “Cosmetic Health Supervision Regulations” refers to the application of cosmetics spraying, sprinkling or other similar methods, impose on the human body (skin, hair, nail means, lips, etc.) in order to achieve a clean, maintenance, landscaping, exterior modification and change, or amendment to the human body order, for the purpose of maintaining the well-being daily chemistry products.
2. What’s classification of cosmetics in China?
Cosmetics can be divided into two parts,
Special Cosmetics refer to those substance used for hair nourishment, hair-dye, hair perm, hair removing, breast massage, body-building, deodorant, fading cream and anti-sunburn lotion, total nine functions.
Normal Cosmetics means those cosmetics which used for hair care, nail care, skin care, perfumes and make-ups.
About Approval Certificate and Applicant
3. What qualification the company needed for CFDA registration?
Tianjianhuacheng: The applicant of imported cosmetics should be the cosmetics manufacture company. The applicant of new raw materials of imported cosmetics should be the manufacturer of the new raw materials or the products manufacture company.
The same applicant should authorize a responsible company in China, which has legally registered and has independent legal personality in China, to responsible for the cosmetics CFDA registration in China.
The products should be allowed to be free sold and manufactured in local country (region).
4. What’s the form of imported cosmetics approval certificate?
Tianjianhuacheng: Standard form of imported special cosmetics approved certificate is special cosmetics, J********, and an imported normal cosmetic is normal cosmetics, J********. The first four characters are the year of approval, and the last four characters are the order of the registration, start from 0001 at the year.
5. What’s the expiry date of the imported cosmetics approval certificate?
Tianjianhuacheng: The expiry date of cosmetics approval certificate (registration certificate) is four years.
When apply for the extension of the certificate, should apply four months before the expiry date of the certificate.
About the authorities involved in cosmetics registration
6. Which authorities involved in imported cosmetics registration?
Tianjianhuacheng: Cosmetics registration, mainly involved with four authorities: 1. Testing institutions qualified by CFDA 2. Administrative acceptance service center of CFDA 3. Evaluation center 4. Administrative approval department
7. What are the qualified cosmetics testing institutions in China?
Tianijanhuacheng: Now, the number of testing institutions qualified by CFDA is 27 (including human body testing institutions), and the imported can choose them according to their own situations.
About imported cosmetics registration/filing process and periods
Tianjianhuacheng: Now, the imported normal cosmetics approval process is filing system, while the special one is registration system. The process of these are almost the same, the difference is the special cosmetics registration needs to have a technique evaluation by specialists in CFDA, so generally speaking, the special cosmetics usually takes more period than normal cosmetics.
1. Imported normal cosmetics CFDA registration process: filing the power of attorney about responsible company in China, sample testing, registration applying, form review, technique review, issue certificate and so on.
2. Imported special cosmetics CFDA registration process: filing the power of attorney about responsible company in China, sample testing, registration applying, technique evaluation, issue certificate and so on.
9. How long will the imported cosmetics registration take?
1. Imported normal cosmetics
According to Tianjianhuacheng experience, the registration of normal cosmetics can be finished in 3-6 months, and receive the registration certificate.
1. The registration time of normal cosmetics, the process can be divided into 2 parts, the testing time and evaluation time:
（1）Sample testing. Sample testing time for different functions: a. the normal hair use: 35 days; b. normal skin care/makeup: 60 days (If let Tianjianhuacheng help to arrange for the testing, generally the time can be decreased 20-40 days).
（2）CFDA evaluation. Imported normal cosmetics can be submitted for approval at any time, the total time is about 25 working days.
Total time of normal cosmetics: =（1）+（2），about 4 months total.
2. Imported special cosmetics
According to Tianjianhuacheng experience, imported special cosmetics registration can be finished in 6-12 months,
As same as the normal cosmetics, the registration parts can be divided into testing and evaluation time,
（1）Sample testing. a. perm: 60 days; b. fading, anti-sunburn, deodorant, hair removing, hair-dye: 80 days; c. bodybuilding, breast massage, hair, nourishment: 150 days.（the registration time can be shorten if let Tianjianhuacheng arrange the procedure）
（2）CFDA evaluation. CFDA evaluation time: The evaluation meeting held once in a month.
The total time of imported special cosmetics =（1）+（2）, the total registration time is 6-12 months.
(Notice: a. Before the testing, there will be authorization letter filing, if the documents are fully prepared, it won’t take much time, so this time is not included. b. There will be administrative approval and certificate making progress after passing the technique evaluation, because at this time, we can confirm whether this product has been approved or not, so this part of time is not included either.)
Tianjianhuacheng: The preparation of registration documents directly effects the registration periods. If the documents are provided in accordance with the related laws and requirements, the juries have no or a few opinions of the products, and accelerate the registration period. If the registration agency lacks of experience, it may take longer time on documents preparation period, even fail on the registration.
About the imported cosmetics filing/registration fee
10. How much is the imported cosmetics registration?
Cost of imported normal cosmetics registration
Tianjianhuacheng：The necessary fee are: 1. Sample testing fee 2. Notarization fee and translation fee. And the CFDA evaluation fee has been canceled since 2009.01. The fees are listed as below:
（1）Sample testing fee: different from areas, Beijing, Shanghai, and Guangzhou generally cost 4000-8000 RMB, mostly 5800 RMB
（2）Third party fee：The notarization and translation fee of the documents, generally different in areas, as Beijing, one product is about 1000 RMB
The total fee is （1）+（2）
2. Cost of imported special cosmetics registration
Tianjianhuacheng：The necessary fee has two parts as well, 1. testing fee 2. third party fee and evaluation fee
（1）Sample testing fee：The testing fee of special cosmetics is higher than normal ones, and because different functions and testing agencies, the cost can be different. Beijing, Shanghai and Guangzhou, for example, about 15000-38000 RMB. Like body building and breast massage are 26800 RMB; hair nourishment is 31800 RMB, because they have the human body testing fee. Besides, some additional tests may be done, like sunscreen cream usually has patch test, SPF and PA+++ test and the costs are calculated individually. .
（2）third party fee：
The same like the normal cosmetics.
The total fee is （1）+（2）
Tianjianhuachen: The detail of above fee can be found on our website (www.zhuceabc.cn), or call us: 86-010-51664481, 84828042, or 400-657-8487 (long distance fee free) to consult our cosmetics department. Please don’t fully trust some agencies’ low quotes, and charge more unreasonable price during the registration process.
About the documents and related requirements in CFDA registration/filing
11. Which documents needed to be submitted in cosmetics registration/filing?
Tianjianhuacheng：According to the newest polices：
1. Apply for imported normal cosmetics filing, should submit following documents：
Application form for registration
Chinese name of the product and its nomenclature;
Product quality control requirements
Product original package (include label, instruction); if has special package for Chinese market, its required as well (include label, instruction)
Testing report and related materials from a cosmetics testing institution approved by CFDA
Safety assessment of the possible safety risk materials in the products
Copy of power of attorney from registration company in China, and the company license of registration company with stamps.
The statement of the raw materials related to the mad cow disease
Free sales certificate in producing country (area) or manufacturing country (area)
Other documents may be helpful for inspection
Manufacturing description and diagram
Technical requirements of the products–paper and electronic editions
And attached with a sealed sales sample needed by testing agencies confirmed by CFDA
2. When apply for imported special cosmetics, the documents are almost the same as the normal ones, but the functions are hair nourishment, body building and breast massage, the company should provide related scientific literature reference of the functional raw materials.
(Tianjianhuacheng: Applicant needs to be very careful about the documents preparation, the CFDA is very strict about the forge of the documents, and if find there is a forge in the documents, it will not be allowed to be applied in a whole year.) Id the company needs some guides, please contact with Tianjianhuacheng cosmetics department.
Imported cosmetics registration/filing FAQs
12. What tests are necessary during the cosmetics registration?
Tianjianhuacheng: According to cosmetics administrative acceptance testing regulations, generally speaking, cosmetics usually need to do microorganism test, sanitary chemical test, pH value test, toxicology test, body safety and functional test. The testing period can be 2-4 months, while some special functions need to do human trials, then the time will be longer.
13. Apply by oneself or ask for an agency?
Tianjianhuacheng: Whether a company needs an agency is depended on the company itself. Generally speaking, if a company has no requirements of time or has professional staffs, it can apply by himself.
But if the company wants to capture the market, save time or has never applied before, we suggest the company can ask for a professional agency for help. One experienced agency usually can help the enterprise avoid detours, save time and money, like the company not in Beijing, the travel expense is a large amount of money.
Tianjianhuacheng: Now the agencies have varying qualities, especially some new agencies which are lack of experience, some companies use cheap price to cheat customers, use the leak in contracts and ask for unnecessary money from company during the registration, so companies need to be careful.
14. How to choose an agency?
To evaluate whether an agency is worth of choosing, here are some suggestions:
1. Whether this company has been industry and commerce registered.
2. The amount of registered capital and credit level.
3. Working place and staff size.
4. If the company can provide successful cases.
5. Find the word of mouth and credit records of the agency.
6. Don’t fully trust the successful rate.
7. The best method for a company is to visit the agency. Through the face to face communication, we believe you can have an accurate idea.
The head office of Tianjianhuacheng is in Beijing, and until now, we have helped hundreds of company register successfully. We have representative offices in Japan, America, South Korea, Eastern Europe and so on.
This are only part of the article, to find more information about the cosmetics registration, please visit http://www.zhuceabc.cn, or http://www.medfda.com
Epilogue: Beijing Tianjianhuacheng International Investment Consulting Co., Ltd. first launched “health related products registration guidance” since 2002, which including health food, cosmetics, disinfection products, medical instruments and so on, and this article is one of them. Again, DON’T COPY. When reproduce, please note the author and we refuse any kind of reproduce by the company of the same trade. Our company reserves all legal rights. And if a company wants to find whether the article is copied or not, please visit our website, http://www.zhuceabc.cn