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Some common questions for cosmetics registration

                   时间:2022-02-22 浏览:316
导读: 1. Chinese laws related to the cosmetics registration Regulations concerning the hygiene supervision over cosmetics(1990); Detailed Rules for the Implementation of the Regulation on the ……
1. Chinese laws related to the cosmetics registration

  • Regulations concerning the hygiene supervision over cosmetics(1990);
  • Detailed Rules for the Implementation of the Regulation on the Hygiene Supervision over Cosmetics(2005);
  • Hygienic Standard for Cosmetics(2007)
  • The Measures for the Administration of Hygiene License for Cosmetics (revised in 2010);
  • Guideline for Risk Evaluation of Substances with Possibility of Safety Risk in Cosmetics(2010);
  • Standard Chinese Names of International Cosmetics Ingredients Inventory (2010);
  • Cosmetics Technical Requirement Standard(2011);
  • Guidelines for the Registration and Evaluation of New Cosmetic Ingredient(2011);
  • AQSIQ Order No. 143 of 2011 – The Administrative Measures on the Inspection, Quarantine and Supervision of Chinese Imported & Exported Cosmetics (2011)

 

 

2. The definition of cosmetics and its classification

The word cosmetic derives from the Greek, meaning “skilled in ordering”, “skilled in ornament”. As the development and prosper of the society, cosmetics generally become a necessary in people’s life.

 

The definition of cosmetic in different countries is a little bit different. 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, maintence, landscaping, exterior modification and change, or amendment to the human body order, for the purpose of maintaining the well-being products.

 

Cosmetics can be divided into two parts,

Ordinary Cosmetics means those cosmetics which used for hair care, nail care, skin care, perfumes and make-ups.

Special Cosmetics refer to those substance used for hair nourishment, hair-dye, hair perm, hair removing, breast massage, deodorant, fading cream and anti-sunburn lotion.

 

 

3. How long will the imported cosmetics registration take?

According to Tianjianhuacheng experience, the registration of ordinary cosmetics can be finished in 4-6 months, and receive the registration certificate.

 

1. The registration time of ordinary 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 ordinary cosmetics can be submitted for approval at any time, the total time is about 25 working days.

Total time of ordinary cosmetics: =(1)+(2),about 4-6 months.

2. Imported special cosmetics registration time

According to Tianjianhuacheng experience, imported special cosmetics registration can be finished in 6-12 months,

 

As same as the ordinary 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 difference from the ordinary cosmetics is it needed to have specialists’ review meeting. The review meeting held once in a month. Materials applied before 10th in every month can enter into the review meeting. Generally, if there is no special modification requirement, license will be received in 1-2 months after the review meeting.

 

The total time of imported special cosmetics =(1)+(2), the total registration time is 6-12 months.

 

 

4. How much is the imported cosmetics registration?

1.      Cost of imported ordinary 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 ordinary 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, breast massage is 31800 RMB; hair nourishment is 35800 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 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)

 

Tianjianhuacheng:The detail of above fee can be found in our website, www.zhuceabc.cn,or call 86-010-51664481, 84828042, or 400-657-8487, and transfer to cosmetics department. Please notice some agencies malicious offer an unreasonable quota, and charge another unnecessary fee during the registration.

 

 

5. Which documents needed to be submitted in cosmetics registration? What requirements?

Tianjianhuacheng:As from the newest polices:

1. Apply for imported ordinary cosmetics filing, should submit following documents:

  • Application form for registration
  • Chinese name of the product and its nomenclature;
  • Product ingredients;
  • 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

And attached with a sealed sales sample needed by testing agencies confirmed by CFDA

 

Tianjianhuacheng: Documents needed of the imported special cosmetics are the same as the ordinary ones, but the hair nourishment, body building and breast massage, should submit scientific literature reference of the functional raw materials.

 

Requirements of registration documents:

1. The first time application should submit original copy of documents, and special cosmetics should submit 4 copies.

 

2. Apart from the testing report, notarization certificate, official approval document, and third party confirming document, the original copy of each should have stamps from applicant; imported cosmetics (new raw materials) original copy should have the stamps from Chinese responsible company.

 

3、Use A4 size paper to print, and use visible mark, and arrange them as requirements, and binding.

 

4、All documents (except foreign address、websites、register trademark、patent name、SPF、PFAor PA、UVA、UVB those must use English)should translated into Chinese, and attach the Chinese translation before the related English documents.

 

 

6. What documents need foreign companies provide?

Tnajianhuacheng:mainly two documents:

1. Manufacturing and sales certificate. Provide by local governments or associations of manufacturing or producing country. For those who cannot provide original copy, copy is acceptable, and the copy should confirmed by local Chinese embassy; certificate must have products name, name of manufacturing company, institution which issue certificate with stamps and signature, and issue date; the listed products name and manufacturing company name should be exactly the same;if it’s a authorized manufacture or others, the manufacturing company is different from application, applicant should offer explanation;multiple forms cosmetics which need to be used cooperatively can provide part if the manufacture and sales certificate; if the manufacture and sales certificate is in English, it should be translated into Chinese, and the translation needed to be notarized in Chinese notary public.

 

2. Power of attorney. The signature of power of attorney needs notary from third party, and the notarization of the translation. According to the requirements, every time of submitting the application, the power of attorney or copy of notary letter is needed, and state the application company’s name in written. The authorized signed content shouldn’t contain in power of attorney. Free manufacture and sales certificate, GMP, confirmation letter of different companies belong to the same unit, authorized manufacture contract. If these products are registration at the same time, one product can use original copy, while others can use copies, and state the name of the registration products in written; if these products don’t registration at the same time, one product can use original copy, while others need to provide copy of notary letter, and state the registration products in written.

 

 

7. What requirements of ingredients?

1. Use form that contain ingredients NO., INCI name (except Chinese products), standard Chinese name, content percentage, using purpose and others. Size is not smaller than 5.

2. Should provide name of all ingredients, the real content percentage, and indicate the content of effective ingredients (treated as 100% if not indicated); compound materials should applied as compound materials, and please indicate the content of each ( listed as percentage); some special situation, like have crystal water, it should have the instruction, and all raw materials are listed in descending order.

3. Raw materials (include ingredients in compound), and the name should refer to the INCI, if there are no name of INCI, refer to Chinese Pharmacopoeia, and the raw materials cannot use the brand name or common name. Except compound materials.

4. Colorant should provide the CI number on cosmetics health norms

5. Contain animals organs or blood extract, it should provide the resources of the raw materials, quality specification and the permitted use certificate.

6. As long as the ingredients has hydrocarbon from oil and coal tars (except single ingredient), should mark its CAS number.

7. “Cosmetics Health Norms” has the requirements of the restriction substance, it should submit the quality specification certificate from ingredients manufacture company.

8. Multiple forms products (one package contains multiple forms), like hair dying and perm, the ingredients should be listed individual.

9. Confirmation certificate from licensed testing agency, and make sure the confirmation date is the same as the accepted date.

10. As long as the products claim has the function for pregnancy and lactation women, children or baby, the registration should provide principles of production, like the report of its materials, why choose these materials, production procedure and related quality control.

 

Tianjianhuacheng:Our company will auditing the documents strictly, and we suggest after a company choose an agency, the company should ask the agency review the basic documents at the beginning in order to avoid the loss during the registration.

 

 

8. What the requirements of products’ quality control?

1. Color, odor, trait and other sensory index.

2. Microbiological (except those don’t need to exam), chemistry index.

3. Perm, hair removing, freckle removing and others which claim has the α-hydroxy acid or its content is more than ≥3%(w/w)should have pH index (except water-in-oil, powdery and others) and testing method.

4. Imported products should submit GMP (English documents and Chinese translation). If the GMP does not contain above information, then the quality control documents are needed.

5. Applicant should submit the commitment about the cosmetics hygiene regulation.

 

 

9. Requirements of products’ package

Tianjianhuacheng:The testing sample must be sealed and has instruction. If the product has no instruction because of small size, like lipstick, should submit related explanation. And the foreign language on the product should be translated into Chinese.

 

 

10. What tests will be done during the registration?

According to the official implementation and national standards, some of the following tests are necessary depend on the types of the cosmetics.

 

Tianjianhuacheng: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.

 

1. Microbiological test: bacterial colony, staphylococcus aureus and so on.

 

2. Sanitary chemical test: include Mercury, Plumbum, Selenium, nitrogen mustard, methanal and other limited or forbidden materials, and pH test and others.

 

3. Toxicology test: non-special cosmetics need to do the acute dermal hypersensitive test, eye irritation test and multiple dermal irritation tests.

 

Apart from the above testing, special cosmetics need to do dermal allergy test, dermal phototoxicity test, reverse mutation test, chromosome aberration test.

 

4. Safety evaluation of using the cosmetics on human body, and function evaluation for special cosmetics: Depend on different functions, other tests may be done as well, like human patch test, using on human body test, SPF, PA tests, waterproof performance test and so on.

 

 

11. Is the product still need to do testing in China if it has been tested in abroad before?        

Tianjianhuacheng:Generally speaking, imported products must have hygiene and toxicology testing in China, but if one cosmetic has SPF, PFA and PA tested already, registration company can provide abroad testing report, and with these documents below:

1) The testing institution, which issued the report, has been qualified, and it should submit the qualification certificate.

2) The testing institution, which issued the report, has not been qualified, and it should submit Good Clinical Practice, GCP or Good Laboratory Practice, GLP)

3) Other documents may help the registration.

4) As long as the testing report submitted at the first time, it should provide original copy or copy notarized by local industry association, Chinese Embassy or notary public.

5) Abroad laboratory’s testing report should be original copy, and if series products meet the requirements, at least one product provides its original copy while others only need to submit the copy ones, and attach with the instruction of applicant.

6) Use the abroad testing report, should submit confirmation letter that related to samples and testing report.

 

 

12. If the products are consigned to be manufactured, can we apply as well? How and what documents are needed?

Tianjianhuacheng:Yes. Except some basic documents, here are some others:

1) The consigned contract signed by consignor and consignee.

2) GMP of consigned manufacture company.

3) Confirmation letter of production qualification

Production qualification should meet the following requirements:

① Issued or approved by certificate authority. If cannot provide original copy, can provide copy and notarized by Chinese notary public or embassy.

② The name of the manufacture company and address must be exactly the same as the ones on application form.

 

In addition, if the manufacture company and the application company belong to a same enterprise, applicant can provide the confirmation letter which stated that they belong to a same enterprise and the quality warranty letter issued by the enterprise.

 

 

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