Imported Health Food Registration Procedure Complete Guidebook

时间： 2022-03-03 作者：来源：

导读： Imported Health Food Registration Procedure Complete GuidebookAuthor: Beijing Tianjianhuacheng International Investment Consulting C

Imported Health Food Registration Procedure Complete Guidebook

Author: Beijing Tianjianhuacheng International Investment Consulting Co., Ltd. Health Food Department

This guidebook is aiming to provide friendly guide for those Chinese corporation and foreign enterprise who wants to imported health food to China.

Since 2002 Tianjianhuacheng has pioneered “health related products registration guide” series articles, including health food, cosmetics, disinfection products and medical instruments. This article is one of this series. Again we strictly warn counterparts: DO NOT COPY. Our purpose is communicated with other enterprises in these areas, but we have no obligation to train other counterparts. And we can welcomed those non-commercial reprint, and please keep the author and the information in the articles if reprint. Our company retains all legal rights.

How to identify if the article is copied:

1. If sign his name. Tianjianhuacheng original article mainly issued with authors name. (For example, health food declaration guide author: HAN xin), or signed with our department’s name (generally “health food department”, “health food registration department”, “health products department” and so on). But copier generally do not have the courage to sign his name, mostly sign his company’s name;

2. Check the title. The guidance series articles which officially issued by our company, generally use “strategy”, “guidebook”, “ guide” and so on, before us there is no other company use this form.

2. If it is complete. Generally copier cut part of the articles, and it is cannot become a complete article. Of course there is one which copy total articles from us and changed the title and ending, please judge with next statement.

3. If it is series. Since 2002, Tianjianhuacheng has issued incluing health food, cosmetics, disinfection products series guide articles one after the other (each series contain several articles, for example health food series has imported nutrient supplements, 27 kinds functions of health food and other 30 articles; cosmetics has imported normal products, special and homemade special and total 10 articles; several disinfection products, water involved products and medical instruments related articles.), and updated with the yearly policies (please visit our website www.zhuceabc.cn to read the newest articles, and abroad we recommend the website www.zhuceabc.com). But the copier only copy one or two of the articles, and the one which has been copied most are the “imported cosmetics declaration guide” and “health food declaration guide”.

State again: We are welcome academy and business communication, but we despise the those who lack of creation and copy other company’s work for their own benefits.

Beijing Tianjianhuacheng International Investment Consulting Co., Ltd.

Core tips：

1. All health food (whatever homemade or import), it must apply for record to MOHC the Minister of Health of the People’s Republic of China (specific management department: Food Licensing Department, SFDA), region department has no rights to approve;

2.Chinese health food can be divided into nutrients supplement and functional health food, among them the functional health food can be classified in 27 kinds, and there are big differences among the two types and 27 functions, even very big differences, besides the imported products and homemade products has a big differences. So if only can make sure of the function of the products then the company can give responsible budget.

3.Chinese official has canceled health food’s medical function, any products which announced having medical function please register in medicine; since 2000 China has canceled “health medicine”, now the health food can only have healthy function, called as “J******”, which is the “little blue hat”, and can only be the products which enter into month. External products please apply for cosmetics, medical instruments or drugs.

4.The applying of health food registration is not submit the documents to SFDA directly, but it need to have the test. And after the products pass the test then it can be submitted to SFDA. (It seems not be a question, but since there were customers ask about this, so we list it here).

5.The fee of health food registration is calculated individual, which means the company has to apply if the name is different, and not only need to provide one certificate for one brand or a series products (some special products can have special applying). And this one is important, because many applicants ask about this question.

6.The expiry date of health food approval certificate is five years, and after years the approval need to be re-registered (extend), and Chinese will not charge for the re-registration.

Approval certificate: The first step to enter into Chinese market

As the constant openness of Chinese market and since China joined into WTO, many foreign (iincluding HK, Macau and TW) looking good of Chinese huge health food market, and many health food wants to enter into China. But if the foreign health food wants to enter into Chinese market, it has to be approved by Chinese ministry of health and get the approval certificate “health food approval certificate” (hereinafter approval certificate) which issued by SFDA, then this products can be allowed into China. The products cannot enter into if not get the approval certificate. The products without the approval certificate cannot be sold in Chinese mainland. Otherwise it will be strictly punished. So applying health food approval certificate “J********” is the first step to enter into Chinese market.

1. What is health food, how to classify?

Tianjianhuacheng: In China, health food is: has been approved by SFDA and allowed to be sold and manufactured, and announced having specific health function (27 kinds) or the purpose of replenishes vitamins and minerals, which is suitable for special groups, and have regulate body function, and not aiming for cure disease, and cannot have any acute, sub acute or chronic dangers to human body.

Health food can be classify as two kind: one is functional health food, the other is nutrient supplement.

（1）Functional Health Food, means the health food which has one or multiple of the functions below.

27 Kinds of Functions of Health Food which approved by CFDA

Enhancing immune systems, Sleep improvement, Alleviating physical fatigue, Enhancing anoxia endurance, Irradiation hazard protection, Increasing bone density, Assisting liver protection against chemical injury, Alleviating eye fatigue, Eliminating skin pigmentation, Eliminating acne, Improving skin ability to retain moisture, Improving skin oil content function, Assisting blood lipids reduction, Assisting blood sugar reduction, Anti-oxidative function, Assisting memory improvement, Alleviating lead excretion, Improving throat-clearing function, Assisting blood pressure reduction, Facilitating milk secretion , Assisting weight control, Improving child growth, Improving nutritional anemia, Regulating gastrointestinal flora, Facilitating digestion (regularity), Facilitating bowel movement, Protection of gastric mucosa

（2）Nutrients supplements, means those which is aiming replenish vitamins and minerals and not aiming to provide energy. Its function is to replenish the lack of dietary supply, and decrease the danger of some chronic degenerative diseases because lack of these nutrients.

Tianjianhuacheng prompt: In the future, new SFDA new registration may begin record management to the nutrients supplement; and it may delete some functions, and some functions may increase functional tests, and allowance function range and principles of evaluation may adjust at any time. So we suggest applicant should choose reliable health function to apply, and applicant should not just pursue for multiple and new functions.

2. What is the process of imported health food declaration?

Tianjianhuacheng: Imported legal health food manufacture enterprise can apply for health food approval certificate, and this product need to be sold for more than one year in manufacture country (region), and when declare, it should entrust domestic business office or Chinese domestic agency to do declaration business. Products first need to have project testing in national qualified institutions, and then apply for CFDA for registration, after CFDA accept the first time evaluation, and it will re-test on the qualified testing institution, and then transfer the documents to CFDA. Then the evaluation center will organize specialists meeting to start technology evaluation to products’ formula, production technology, testing and so on, and then it will give opinions. After the opinions published, applying enterprise should proceed products documents added, modification, at last, the products which comply with CFDA related requirements and waiting for the approval of CFDA, if there are serious problems the products will not be approved by CFDA.

3. How long is the health food approval certificate period?

Tianjianhuacheng: In abroad, health food generally put on record, there is no need to declaration, so it will not take much cost and time. But in China, it use registration system to manage, so there are large differences. The health food approval certificate period is closely related to products declaration functions, so the declaration time is about 1-2 years, so the period is depends.

Tianjianhuacheng: Foreign company should confirm which function the company wants to apply if the products want to enter to Chinese market, then each budget can be relative accuracy.

Health food registration period mainly reflect in following aspects:

1. Testing period

Testing programs that needed on imported health food declaration: safety test (toxicology), functional test, stability test, hygiene test, function/iconic ingredients qualification test. The hygiene, stability, and functional ingredients test usually takes 4 months; safety test and animal function test usually takes 5-6 months. Human trials usually take 3-5 months. So in a word, theoretically if it doesn’t need to have human trials, the tests period is usually 8-10 months, and if it needs human trials, the period is about 12-14 months.

2. Evaluation period

SFDA evaluation center’s evaluation meeting generally has once each last third of the month (except the month which has Spring Festival, the National Day or other special vacation day). The evaluation center will evaluate after 85 working days of SFDA accept company’s declaration, and have products documents total technology evaluation, and provide evaluation opinions. Enterprise will have 5 months to submit and provide additional documents, after evaluation waiting for state administrative approval opinions.

3. Influence of documents preparation

The documents preparation will influence the time of declaration. If the documents comply with the requirements and related laws of CFDA, then the jury will have fewer opinions, and the documents supplement will be faster, so it will be faster to get CFDA approval, otherwise the registration period will be longer.

Tianjianhuacheng prompt: if the entrusted agency is lack of experience, it may take too much time on documents preparation.

4. Effects of the evaluation policies

Imported health food registration work is according to the related regulations and technique requirements of ”Food Hygiene Law of the People’s Republic of China”, “Provisions for Health Food Registration” and so on.

Tianjianhuacheng prompt: The official will issue some new policies, the enterprise should know its requireements, or it will extend the registration period.

The approximately registration period can be referenced as below:

Item			Period budget
Item			Period budget
Products classification	①Nutrients supplement		10-15 months
	②Functional health food	Enhancing immune systems, Sleep improvement, Alleviating physical fatigue, Enhancing anoxia endurance, Irradiation hazard protection, Assisting liver protection against chemical injury	18-24 months
		Alleviating eye fatigue, Eliminating skin pigmentation, Eliminating acne, Improving skin ability to retain moisture, Improving skin oil content function	20-30 months
		Increasing bone density, Assisting blood lipids reduction, Assisting blood sugar reduction, Anti-oxidative function, Assisting memory improvement, Alleviating lead excretion, Improving throat-clearing function, Assisting blood pressure reduction, Facilitating milk secretion , Assisting weight control, Improving child growth, Improving nutritional anemia, Regulating gastrointestinal flora, Facilitating digestion (regularity), Facilitating bowel movement, Protection of gastric mucosa	30-36 months

* The above period is just estimate time, and not have notary and translation time.

* Other details please refer to our website Tianjianhuacheng original “health food declaration guidance”, or call Tianjianhuacheng for more information: 010-51664481-8001 or 8008.

4. What is the cost of the imported health food registration?

Tianjianhuacheng: The cost of applying health food approval certificate has a deep relationship with the applied function, its main cost is official charge (testing fee, re-test fee and evaluation fee), translation and notary fee and agency fee these three parts. Among them the evaluation fee has been canceled since 2009.01.01; if the enterprise apply by herself, the agency fee can be ignored; the testing fee is from 50-300 thousand RMB, and the re-test fee is generally from about 5-10 thousand RMB. The below table can be reference for the enterprise:

Item			Cost budget（RMB, ten thousand）	Notice
Testing fee	①Hygiene study, stability, functional ingredients test		5-7	All products must have this test
	②Safety (toxicology) test		7-13	Nutrient supplement can do not have this test
	③Functional test	Enhancing immune systems, Sleep improvement, Alleviating physical fatigue, Enhancing anoxia endurance, Irradiation hazard protection, Assisting liver protection against chemical injury	5-10	Subject to the actual fee
		Alleviating eye fatigue, Eliminating skin pigmentation, Eliminating acne, Improving skin ability to retain moisture, Improving skin oil content function	25-30
		Increasing bone density, Assisting blood lipids reduction, Assisting blood sugar reduction, Anti-oxidative function, Assisting memory improvement, Alleviating lead excretion, Improving throat-clearing function, Assisting blood pressure reduction, Facilitating milk secretion , Assisting weight control, Improving child growth, Improving nutritional anemia, Regulating gastrointestinal flora, Facilitating digestion (regularity), Facilitating bowel movement, Protection of gastric mucosa	30-40
	④Stimulants test		1	Alleviating physical fatigue, Assisting weight control, Improving child growth must have this test
⑤Re-test fee			0.5-2	All products must have this test
Evaluation fee			0.8	Has canceled since 2009.1.1
⑥Others		Agency fee, translation fee and notary fee	Depends

* The total declaration fee of each product =①+②+③+⑤, some function need to plus ④, imported products declaration need to plus translation fee and notary fee in ⑥ (generally one product is about 2 thousand RMB). If the enterprise entrust other agency to declare, it should plus the agency in ⑥.

* Other details please refer to our website Tianjianhuacheng original “health food declaration guidance”, or call Tianjianhuacheng for more information: 010-51664481-8001 or 8008.

Tianjianhuacheng prompt: Because the testing standards is changing in recently, and the testing fee maybe increase.

Entrust agency to declaration it will save the travel fee and time of go and back to Beijing, so it will save the economic cost of the enterprise.

So it is not hard to find, the registration work is a long time work ,which has the high requirements of enterprise’s time and economic cost, sp ant enterprise which wants to have the plan of declaration, it must consider of these situation and have a reasonable plan.

5. How to accelerate the CFDA registration process?

Tianjianhuacheng: The time of health food’s CFDA registration is mainly depended on these factors: evaluation, testing, policies and documents preparation. The time of first two factors are hardly to be shorten, and because of the different policies in different time, so the mainly factor that we need to be focused is the documents preparation.

The documents preparation has big effects on the declaration period, and companies can control this part. If the documents are well-prepared, evaluation specialists will have fewer opinions, and then applicant only need bit modifications of the documents if necessary. But if there are many problems in the documents, the applicant may take a longer time to modify the documents, so the registration time will be longer. Besides, evaluation specialists may have questions and ask for some more testing reports and related literature reference of new technologies, and it may lengthen the registration period.

So if a company wants to shorten the registration time, it must arrange the time in each stage reasonable, and try to fully prepare the registration documents. But on the other hand, the policies may change all the time, and it may still influence the CFDA registration.

Tianjianhuacheng: The working principle of our agency is doing the basic jobs at the very beginning: review ingredients before the testing, check every document before submit the documents, correct the problems which may happen and avoid the problems modification during the registration.

6. Registration period of health food is too long, how to import into as soon as possible?

Tianjianhuacheng: There is no need to registration if imported to China as normal food, only need to have Chinese label filing then can imported into, and it only takes 2-3 months. But not all products can be applied as normal food. If your products must emphasize some kind of health function, or the using materials is not on the allowed range of national normal food, or the form of the products is not normal product’s form, then the products must applied as health food.

If you cannot ensure whether your product belongs to normal food or health food, you can take samples, formulas and instructions to consult with professional declaration agency, they have a lot of registration experience and can basically help you to decide whether this product need to be registered as health food. Or you can take these documents to related customs to consult, if it belongs to normal food it can be imported in, if not, you have to registration.

7. What is the valid date of the CFDA certificate? What should the applicant do before the valid?

Tianjianhuacheng: The valid date of approval certificate is five years, and if the company needs to extend the certificate, the applicant should submit the re-register three months before the valid date.

8．Can we apply for multiple functions? Can we apply for the function other than the 27 allowed functions?

Tianjianhuacheng: YES. According to the related laws, “health food administrative methods” (interim) (bureau order No.19) issued by CFDA in 2004.04.30, the same products have no strict to apply for numbers of functions, and can apply for the new functions besides of the 27 published functions.

When applicant applies for the new function, applicant should do the animal and human body tests by themselves, and provide the function research report to the testing institution. The product research report should include the research idea, function filter process and expecting effects; the function research report should include the function name, applying reasons, functional testing methods and evaluation results. If the company cannot proceed animal or human test, it must illustrate the reasons and provide related documents on the functional report.

Tianjianhuacheng: We recommend one product don’t have more than two functions, and different functions need to have some sorts of connections, otherwise it is hard to pass. Besides, apply for the new function is VERY hard to provide documents accepted by CFDA, so the risk is very high.

9. What need to be noticed when apply nutrient supplements?

Tianjianhuacheng: Nutrient supplements only limited on vitamins and minerals supplement, and the types of vitamins and minerals should comply with the regulates of “vitamins, minerals types and dosage”, and cannot have other biological activity that reach functional dosage. The auxiliary materials should only aiming to meet the manufacture technology demands or change product’s color, odor, and taste.

If the suitable groups are adults, its vitamins and minerals daily recommend intake should comply with the requirements of “vitamins, minerals types and dosage”; if the suitable groups are pregnant women, nursing mothers and under age 18, its vitamins, minerals daily intake amount should control in between 1/3-2/3 of Chinese this supplement recommend intake (RNIs or AIs) of the special group.

If the supplement has three or more vitamins or minerals, and it can be called with multiple vitamins or minerals supplement can be called as multiple vitamins or minerals supplement.

And besides, the nutrient supplement cannot apply for health function at the same time.

10. Which government involved in health food declaration?

Tianjianhuacheng: Imported health food declaration mainly refers to these following four authorities:

1. Testing authority: Now imported health food registration must proceed in Institute of Nutrition and Food Safety, China Disease Prevention and Control Center.

Tianjianhuacheng prompt: Chinese Center for disease prevention and control is official authority, the price is transparency, please do not trust some agencies’ malice offer.

2. The acceptance office: The acceptance work of imported health food is responsible by SFDA administrative acceptance center. They take the responsible for the form evaluation, and for those which are comply with the form requirements have acceptance, and for those which are not meet the requirements and let the applicant make the corrections, and it also responsible to arrange the lab test and sampling test and then arrange the products evaluation meeting. In addition, it takes the responsible for the imported products approval certificate change, transfer and re-registration acceptance work.

3. Specialists evaluation committee: SFDA health food evaluation center responsible for the meeting, and organize specialists to have the technology evaluation to the products.

4. Administrative department: SFDA registration bureau will have technology evaluation to the products, if the products comply with the related laws, then SFDA will give approval to the products.

11. What tests need to be done during the health food registration?

Tianjianhuacheng: generally speaking, normal products need to have safety test (toxicology), functional test (including animals test/human tests), stability test, hygiene test, functional/key function identify test. According to the functions and the characteristics, it may need the hormones test, stimulant test, bacteria test and the raw materials identification test.

As for the nutrient supplement, there is no need to have function tests. If the raw materials belong to the “Vitamins and Minerals Compound List”, and the related manufacture process and quality standards confirm to Chinese related laws, generally it is no need to provide safety toxicology testing report.

Hygiene test is the test of the physical and chemical properties and microbiological index tests of the health food, such as heavy metal, pesticide residue, disintegration time, pH value, microbiological value and so on.

Stability test is the test of whether health food is stability on the valid date, and the tests are the same as the hygiene test. Generally, the test is accelerated stability test placed in 38℃ and 75 humidity in one, two and three months, then have tests of each required index.

Safety test is the test of the toxicology of the product. According to the different ingredients of the product, toxicology test subject can be different. Normal products need to have stage 1 and 2 tests, while others may need to have deeper test or 90 days eating test.

Function test means the test of the product’s announced functions according to CFDA qualified testing methods. According to the different functions of the products, it may need to have animal function test or human body test.

Before 2013, the imported health food can be only proceed in Food supervision and inspection institute, Chinese Center for Disease Control and Prevention. In 2013, SFDA has issued 2013 NO.9 notice “SFDA about choose China Food and Drug Inspection Institute as SFDA qualified testing institutions (NO.9)”, which increase China Food and Drug Inspection Institution, Beijing Drug Inspection Institution, Chinese center for Disease Control and Prevention, Tianjin Drug Inspection Institution, and other departments, total 10 departments as SFDA qualified health food registration testing institutions.

12. Is the product still need to be tested again if already tested before?

Tianjiahuacheng: Some companies will present: do we still need to have the test in domestic if the product already has the test before? It depends on how you had the test. If you have the test on Chinese Center For Disease Control and Prevention, according to ministry of health “health food test and evaluate Technical Specification” (2003 edition) and related Chinese national standards about the continuous three batches sample testing, ad the report issued date should be in two years, then it can be used; otherwise it must have each test again.

13. Can series health food use a same approval certificate?

Tianjianhuacheng: Series health food means the raw materials and auxiliary materials are the same but tastes or colors are different. Series health food brand name, general name and attribute name should be the same, and after the attribute name indicate the different tastes and colors. Since 2010.05.01, CFDA would give series health food one approval certificate, and use a same approval number. Applying for series health food approval certificate can use a group of products to apply. And series products is no need to have toxicology evaluation test and functional evaluation test (need to provide testing report copies of the original products), but its testing methods, evaluation index and judgment standards should comply with current stipulates.

In addition, for that health food which has same function, same material but different dosages should apply as different products.

14. What documents needed to be provided on imported health food registration?

Tianjianhuacheng：imported health food registration should provide following documents:

1．Application form of imported health food registration

2．Copies of applicant legal registration confirmation documents

3．Provide the catalogue to confirm that the applied health food’s general name is different from registered drugs

4．Guarantee that the applicant’s patent not result in infringement

5．Provide the confirmation documents of the label

6．Products research report

7．Products formula and its basis; raw materials and auxiliary materials and the formula basis

8．Functional/iconic ingredients, contents and testing methods of functional/iconic ingredients

9．Manufacture process chart and its detailed description and related research documents

10．Products quality standards and compile description

11．Category, name, quality standards and selection basis of package materials that directly contact

12．Testing report and its related documents issued by testing institution

13．Sample of product’s label and instruction

14．Other documents that may helpful for products review

15．Sample

Besides it need to provide the following documents：

1．GMP confirmation documents issued by related authorities in manufacture country (region).

2．If abroad company allow resident offices of foreign to do the renewal business, it should provide the copy of the “registration certificate of resident offices in China of foreign enterprises”; if abroad company entrusts agency in China to deal with renewal business, it should provide the original copy of power of attorney and the copy of business license of the agency.

3．Confirmation certificate that the products have been sold more than one year in manufacture country (region).

4．Manufacture country (region) or international organizations’ related products standards

5．Samples of package, label, and instruction used in manufacture country (region).

15. What requirements of the confirmation documents about imported health food registration？

1. Requirements of confirmation certificate that comply with local GMP

（1）If the applicant entrust overseas company to manufacture, the manufacture company on confirmation documents should be the entrusted manufacture company, meanwhile it should provide the power of attorney about the entrusted manufacture.

（2）The confirmation documents should have the name of the issuing authority, name of the product, name of the manufacture company and the date of issuing this documents.

（3）The authorities which issuing the confirmation certificate should be the competent department or industry association of the manufacture company’s country.

2. Requirements of the power of attorney

（1）The power of attorney should have the name of the issuing company, name of the entrusted company, name of the entrusted registration products, entrusted events and the issuing date of the power of attorney.

（2）The entrust party who issuing the power of attorney should be exactly the same as the applicant.

（3）The entrusted party entrust other agency to manage registration business again, it should provide original copy of approved certificate and its Chinese translation, and the translation should be notarized notary public in Chinese mainland.

3. Requirements of the manufacture and sales confirmation

（1）Confirmation certificate should have the name of the authority which issuing the certificate, name of the applicant, name of the manufacture company, name of the products and the date of issuing the certificate.

（2）The confirmation certificate should clearly indicate that this product comply with related regulates and standards in this country (region), and from what time it allowed to be produced and sold in this country (region). If the product is only allowed to be manufactured but not allowed to be sold in this country (region), then this product cannot apply for registration.

（3）The authority which issue this confirmation documents should be the government competent department or industry association.

（4）This confirmation certificate should have been confirmed by notary public in manufacture country (region) and Chinese embassy in this country.

Besides please pay attention to following matters:

1．Names of the product, applicant, manufacture company, agency (Chinese and English names) should be coherence.

2．Confirmation certificate, power of attorney should be original, and it should use manufacture country (region)’s official language, it needs to be confirmed by notary public in country (region) and Chinese embassy in this country.

3．If the confirmation certificate and power of attorney have expiry date, it should be used before expiry date.

4．Confirmation certificate and power of attorney should have the seals of the company or signature of legal representative (or his entrust person).

5．Confirmation certificate and power of attorney should be translated into Chinese, and notarized by notary public in Chinese mainland. If the original copy is in both Chinese and English, then it doesn’t need to be translated or notarized in domestic. If cannot provide the original copy, then it should notary the copy and original are the same.

Tianjianhuacheng prompt: company shouldn’t afraid the inconvenience of the documents preparation, then let the agency help to prepare, and the state is very strict to the fraud, if the documents have been found the fraud, it won’t allowed to be declared in one year.

16. Requirements of the name of the health food

Tianjianhuacheng: Each product can only have one name, and the name should be consisted by trade name, generic name and attribute name, a series product must have the same trade name and generic name. Generally speaking, company should use the main raw material as the products’ name, and use scientific and standard name of raw material, but words numbers are no more than 10. The product cannot express or implied the words like treatment, such as “efficient, quick results, and XX generation” these exaggerate words; cannot use the words of human organs; cannot use people’s name and address (except for the registered brand); cannot use the name of special group; cannot use the letter, pinyin, number, symbols and others; cannot use the name of approved registered medicine name.

17. What’s the requirements of the raw materials and auxiliary materials about health food ingredients?

Tianjianhuacheng: Applying for imported products, the raw materials and auxiliary materials and dosage must comply with Chinese related laws. One reason that many foreign products cannot achieve national approval is the formula doesn’t comply with Chinese laws, such as use the raw materials that don’t allowed in China, raw and auxiliary materials don’t comply with Chinese hygiene standards, and these factors lead to the fail of products testing and fail of formula evaluation.

SFDA published raw materials and auxiliary materials which can be used on health food, ministry of health published or approved raw materials and auxiliary materials which can be used on normal food, new resource food and normal food manufacture, these materials can be used in health food as raw materials and auxiliary materials. The use and approval of health food’s raw materials and auxiliary materials temporarily execute according to “ministry of health raw materials and auxiliary materials further normalized health food raw materials management notice” (health law administrative issue [2005] NO.51).

Wild animals and plants, fungi and probiotics, nucleic acids, amino acids chelate, using microbial fermentation production directly, melatonin, soy lecithin, aloe, ants, wine as a carrier, chitin, superoxide dismutase (SOD), animal ingredients, rhodiola, pollen, spirulina, caulis dendrobii, nutrient supplements, these kind health food should comply with CFDA administrative notice [2005] NO.202 documents (“ about print and issue “nutrients supplements declaration and evaluation regulations (interim) and 8 related regulations notification””) this related specification to executive.

In addition, the company cannot use creatine and bear bile powder as raw materials on health food, also CFDA temporally not accept and approve the application which has metallothionein as raw material on health food.

Tianjianhuacheng prompt: Most common problem of imported health food is formulaproblem, which means a lot amount of formulas, frequently not comply with Chinese related regulations, which mainly centred on using of raw materials and auxiliary materials and form of compsition. So when products begin registration testing, it should have first examination of the formula.

18. What are the requirements of manufacture technique on health food registration?

Tianjiahuacheng: Health food manufacture technique should be reasonable.In addition, it still need to notice:

1. The raw material are exacts, freeze dried powder and other semi-finished product, it should provide relevant extract and freeze-dried manufacture process, quality standards and testing report.

2. Apply separation and purifying technology with macroporous adsorptive resin to manufacture health food should comply with “Apply separation and purifying technology with macroporous adsorptive resin to manufacture health food declaration and evaluation regulations (interim)”.

3. The finished product manufacture technology should provide main steps, technical parameters (such as times, temperature, pressure, time, solvent name and concentration, specification of filter material, numbers of screen cloth, sanitation clean class of manufacture environment, etc.)

19. Are the products can be sold after the company achieves the approval certificate? How much is the health food involves tariff?

Tianjianhuacheng: After achieve the health food approval certificate the company can have clearance of goods, commercial inspection, customs will ask you to provide “approval certificate” and verify. After the product has the approval certificate, the first time imported in and clearance, it should have Chinese label filing in China Entry-exit Inspection and Quarantine Bureau (CIQ) in local and apply “hygiene license” in CIQ, then the product can enter into Chinese market.

The tariff of the imported health food is 20%, VAT (value added tax) is 17%, and consumption tax is 30%.

20. How to change the content of imported health food approval certificate?

Tianjianhuacheng: The content on imported product approval certificate change, it should apply for the changing to CFDA. And the applicant should be the holder of the health food approval certificate.

The matters allowed to be changed including: change consumption, shelf life, decrease the range of suitable crowds, increase the range of unsuitable crowds, change matters needing attention, increase functional items; change products specification, quality standards, manufacture company change its manufacture place in China; change the name of the product, change the name of the applicant/or address, change the domestic declaration agency and other filing business.

Matters which are not allowed to be changed: the functional name of the health food on approval certificate, raw (auxiliary) materials, technology, edible methods, increase the range of suitable crowds, decrease the range of unsuitable crowds and others which may influence the safety and function.

After states accept the changing business, generally it will give opinions in 50-60 working days.

Tianjianhuacheng prompt: in the future, CFDA new registration method will not allow the change of edible amount.

21. Is the health food approval certificate can be transferred?

Tianjianhuacheng: health food approval certificate transfer is the product technology transfer, means the holder of the health food approval certificate, give full powers of products manufacture and sales power and production technology to other health food manufacture company, and the habit of together to applying new health food approval certificate for the transferee. And the health food approval certificate can be transferred.

Transfer form：

（1）Domestic transfer: imported health food approval certificate can be transferred to Chinese domestic health food manufacture company, and the transferee must comply with Chinese “health food GMP”.

（2）Abroad transfer: can be allow applicant transfer to abroad manufacture company, manufacture country (region) should allow the transferee’s manufacture and sales of this product, and the transferee should comply with local related manufacture GMP.

It is needed to point out that: change domestic declaration agency belongs to the change filing business, and does not belong to transfer.

Basic requirements of transfer:

The transfer and transferee should sign effective transfer contract, and this contract and related confirmation documents should be notarized by official and confirmed by embassy.

Transferee should manufacture three continuous batches samples, and have functional/iconic ingredients, hygiene studies and stability tests.

As for product’s ingredients, manufacture process, quality standards and others may refer to the safety of the products and these content cannot be changed.

After state accept the change of transfer business and it will generally gives opinions in 50-60 working days.

Tianjianhuacheng prompt: in future SFDA new registration methods may forbid the imported health food approval certificate transfer.

22. What if the approval certificate lost or damaged?

Tianjianhuacheng: It can apply for post-register if the approval certificate lost or damaged, before the applying, company should publish lost or damage announcement in country public-issue official newspaper.

23. What is imported food and cosmetics Chinese label filing, how to declare?

Tianjianhuacheng: Imported food Chinese label, is before imported food come into Chinese mainland market and before complete approval certificate registration, and local entry-exit inspection and quarantine bureau evaluate Chinese information post on products origin package (details can refer to “food label administrative regulations” (CFDA order NO.102)). According to general administration for quality supervision and inspection and quarantine (AQSIQ) 2006 NO.44 notification regulation, imported food, cosmetics label should comply with Chinese laws and regulations and mandatory standards regulations; exported food, cosmetics label must comply with imported country/region requirements. Imported health food belongs to special food, and its Chinese label refers to food label regulations to executive. Since from 2006.April 1^st, each AQSIQ began to test all imported and exported food, cosmetics labels, and only pass the test and get filing then the products can be imported. Since 2006 April 1^st,AQSIQ issued “about adjust imported and exported food, cosmetics label evaluation system notification”, imported and exported food, cosmetics label evaluation and inspection & quarantine together, do it will not have pre-evaluation. After imported and exported food and cosmetics pass the test of AQSIQ of different area, and issuing the mark of “label has been qualified” in testing confirmation documents according to the laws, and then the products can be imported into. AQSIQ has inspection & quarantine on imported and exported food and cosmetics, including evaluation, testing and checking, it all have flat fee of inspection & quarantine, and it will not charge additional label evaluation fee.

Tianjianhuacheng prompt: Tianjianhuacheng can help the company with label filing, and we have other guidance information to issue about imported health food, cosmetics and food Chinese label filing business. Please follow our website,：http://www.zhuceabc.cn (domestic), http://www.zhuceabc.c om (abroad)

24. Is confirmed products’ Chinese and English names (brand) consider about the brand corresponding protection?

Tianjianhuacheng: When abroad health food enterprise apply “imported health food approval certificate” it should submit products’ Chinese name, according to SFDA “health food nomenclature regulations (interim)”, and product’s name should consist by brand name, general name and attribute name. Among them, “brand name” is enterprise’s brand, but SFDA doesn’t care about the submitted “brand name” has been registered in China, so it may bring some potential risk: if the enterprise get approval certificate successfully, your package, including the “brand name” will be showed on the approval certificate, and if your brand has not been registered in China, there will be the risk that this brand name registered by other company, if the brand has been registered by other company, the products need to re-name. If so, not only the package and promotion materials of the products need to be changed, more importantly, you have to apply for the change of name to SFDA again, and the changing time take about 3 months, of course it will bring troubles to the company and increase the cost. If you do not change the approval certificate of the re-registered brand, then you actual name of the sales product is different from the name on the approval certificate, and it is not allowed. So we strongly recommend apply for trademark registration to trademark office of the State Administration For Industry & Commerce of the People’s Republic of China before apply for registration, and if checked there is no one use the brand, according to “applying come first”, this brand can be basically belong to you. According to international brand registration classification, the health food trademark declaration can be classified as No.5 kind and No.30 kind. Of course, it wont influence the approval certificate declaration if not register the trademark.

Tianjianhuacheng prompt: Tianjianhuacheng can be entrusted to apply trademark registration, please pay attention on our website: http://www.zhuceabc.cn (domestic), http://www.zhuceabc.c om (abroad)

25. If the company registered the same domain name to the product’s English name?

Tianjianhuacheng: The domain name on the Internet is very limited (whether it is international or abroad domain name), because there can be only one domain name, which is unique, and cannot be repeated, first register first served. For example, when you visit www.zhuceabc.cn, its connection content is unique. From the business, the domain address has been called as “enterprise’s website trademark”. On the global area, there is case about some companies cost billion dollars to buy domain address, so if you think highly of the brand of the product, you must apply for the domain name corresponding to enterprise or products’ name.

Tianjianhuacheng prompt: Tianjianhuacheng can be entrusted to apply for the domain name, and can help you build a satidfication enterprise’s website.

26. Apply by oneself or ask for an agency?

Tianjianhuacheng: Whether an enterprise 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. Middle and large scale enterprises can build its registration department, and I know some middle or large scale enterprise has its own law department, specialized in products registration.

But if the enterprise wants to capture the market, save time or has never applied before, we suggest the company can ask for a professional agency for help. Because if an enterprise wants to apply, first it needs to build its special technical department, and usually the registration of one product takes more than half a year, and some special one takes about one year, it is difficult for a small enterprise to support the registration through the products development. Besides, the policies of registration changes all the time, the understanding of policies is important. At the main time, 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 enterprise, so enterprises need to be careful.

Advantages of an agency：

 Save time

（1）Has professional staffs, who have good experience in registration process, and can arrange the procedure more reasonable.

（2）Familiar to the testing institutions, arrange the testing time reasonable, shorten the testing period.

（3）Familiar to the related laws, avoid extension because of violation.

（4）Has registration experience and specialists group, evaluate the registration documents, complete the documents and decrease the possibility of review and testing period.

 Save money

（1）If the documents are incomplete, enterprise needs to complete the documents as requirements and its brings the extra travel expenses.

（2）Tianjianhuacheng has more than 10 years experience, the success rate is high, decrease the re-testing and review possibility.

（3）Save the money of travel expenses, entertainment expenses and other unexpected expenses.

 High successful rate

（1）Agency has abundant registration experience, do familiar to the related laws.

（2）Has professional specialists group and consultants, can avoid critical mistakes.

 Save energy

Because the registration process and documents arrangement have been done by agency, registration enterprise can save time and energy, and put the energy in products planning, to make the products express its economic effects.

27. How to choose an agency?

Tianjianhuacheng: How to choose a good registration agency? I have seen many enterprises fail in registration because let an unprofessional agency to act the registration.

To evaluate whether an agency is worth of choosing, here are some suggestions:

1. Whether this company has been industry and commerce registered, and only the business license is not enough, you had better check it by yourself. Because many agencies are in Beijing, please refer to Beijing administration for industry and commerce (http://www.hd315.gov.cn) website, you can find the formal industry on the “industry information checking system”. The Organization Code Certificate and Tax Registration Certificate are important as well. Besides, you can check the credit rating of the industry, and whether it has “A” credit rating like Tianjianhuacheng.

2. The amount of registered capital. Tianjianhuacheng registered capital is 1 million.

3. Whether the agency has fixed working office. The working office can reflect the power of the industry.

4. Successful cases. If an industry cannot provide successful cases, it means the industry is lack of experience. Tianjianhuacheng has 10 years registration experience, has helped hundreds of companies’ registration, and build a long relationship with most of them. For further information, please visit http://www.zhuceabc.cn/gs/ShowArticle.asp?ArticleID=46814 to find some of our customers.

5. Website. Search on the website, whether the industry has some bad feedbacks and if industry website updated recently. These can reflect whether the industry working regularly.

Tianjianhuacheng: Rank on website cannot reflect truly of an industry, because one industry can get a high rank with money. (one search engine has done this before and already been reported by public)

Of course, Tianjianhuacheng suggests it is better for a company to visit the industry. Through the face to face communication, we believe you can have an accurate idea.

28. Is a hundred percent successful rate believable?

Tianjianhuacheng: it is true that every registration company wants to find an agency which has a hundred percent successful rate. But from our experience, it is impossible. The key is the product itself, and good agency is better on the documents edited and compiled, decrease the possibility of review. And please notice that until now, China has no official registration agency.

At last, here are two advices needed to be reiterated:

(1). Please don’t believe in “relation” completely. The key is still the registration documents preparation. And as long as problems happen, the so-called “relation” cannot help you to pass the evaluation. So when you choose the agency, the key considerations are the professional compile and edit abilities.

(2). Please don’t believe in the low price completely. Some agencies use low price to attract customers, but we suggest you have to consider it carefully if the quote is unreasonable. Because prepare documents and pre-approval documents need to spend money, and it is hard to believe the agency would take it seriously if the charge is barely afford the cost. Anyway, even the agency charge high, it may not take it seriously, so we suggest the registration company finds some information and understand the registration process at the beginning of the registration.

Epilogue

Since 1^st June 2009, “Food Safety Law of People’s Republic of China” issued, according to this, SFDA made new “health food supervision and management regulations (interim)” (edition for opinions) and “health food registration management affairs” (for opinions”, and ask for the opinions from the public. In future, the new regulation is more strictly, and adds many new details, and it is expected to be harder to registration in the future, besides the fee will increase. Now the new regulations are not complete, so we don’t know when it will proceed, but we guess it will be soon. So Tianjianhuacheng suggest company which want to apply please focus on the new policies, and pay close attention to SFDA official website and our websites: http://www.zhuceabc.cn (domestic), http://www.zhuceabc.c om (abroad). And know the registration polices and regulations in time.

The above information is welcomed to communicate with the author: Email：zhuceabc@zhuceabc.com，qq：281613376、915369983，Wechat：1801335159

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