The bright Qian Zejia with research for Bird & Bird

We are very proud that one of the brightest students from our Law Summer Program 2017 shared with us her research.

Qian Zejia compared the market access requirements and regulations for cosmetics and dietary supplements in China and Poland (as a country part of the EU). She was an intern in the international Law firm Bird & Bird in Poland and impressed everyone. Not only that she achieved great development in the traineeship, but also succeeded to write two academic articles. One of them we share with you below.

Enjoy the reading.


Market Access Requirements for Cosmetic Products and Dietary Supplements - Comparison of Regulations in China and Poland /EU

Zejia (Sloan) Qian Warsaw office Bird&Bird Trainee

Table of Contents

 

Part 1: Cosmetic Products 2

  1. Sources of law regarding cosmetic products 2
  2. Legal definitions of cosmetic products 2

III. Safety of cosmetic products 2

  1. Application for cosmetic products approval 3
  2. Supervision of cosmetic products 8
  3. Liability and sanctions for the unlawful marketing (market introduction) of cosmetic products 8

VII. Rules governing the unlawful advertising of cosmetic products 8

Part 2: Dietary Supplements 9

  1. Sources of law regarding dietary supplements 9
  2. Legal definitions of dietary supplements 9

III. Safety of dietary supplements 9

  1. Registration and recordation of dietary supplements 10
  2. Supervision of dietary supplements 14
  3. Liability and sanctions for unlawful marketing (market introduction) of dietary supplements 14

VII. Rules governing unlawful advertising of dietary supplements 15

Part 1: Cosmetic Products

  1. Sources of law regarding cosmetic products

In China, the Regulation on Cosmetics Hygiene Supervision (hereinafter “Regulation”),the Detailed Rules for the Implementation of Regulations on Cosmetics Hygiene Supervision (hereinafter “Detailed Rules”), and the Safety and Technical Standards for Cosmetics are the main legal basis for regulation over cosmetics production and distribution.

The Regulation stipulates general provisions of cosmetics control, which are supplemented by the Detailed Rules. The Safety and Technical Standards for Cosmetics include different national standards and requirements of cosmetics, such as limits on restricted substances.

  1. Legal definitions of cosmetic products

Article 2 of the Detailed Rules explains the definition of “cosmetics”, which refer to “those chemical products applied daily on the surface of any part of the human body (such as skin, hair, nails and lips) by smearing, spraying or other similar methods to keep the body clean, to get rid of undesirable odours, to protect the skin, to make up the face enhance appearance”.

In China, cosmetics are categorised into two types: special-use cosmetics and non-special-use cosmetics. Regulation over special-use cosmetics is stricter due to its high potential to harm consumers. The Ministry of Health of the People's Republic of China introduces a clear definition and a detailed interpretation of special-use cosmetics in both Article 10 of the Regulation and Article 56 of the Detailed Rules to better supervise it.

In 2013, the China Food and Drug Administration (further as “CDFA”) published the Notice on the Adjustment to Relevant Matters Concerning the Registration and Recording of Cosmetics, in which it stipulates that whitening cosmetics are officially categorised as fading creams due to their similar function and attributes. Under this circumstance, more dossiers are now required for an approval of whitening cosmetics production and distribution. Regulations on whitening cosmetics advertisement changed as well, which forbids cleaning or covering cosmetics to claim their function of whitening skin.

  • Safety of cosmetic products
  • Legal requirements

In Chapter 1 of the Safety and Technical Standards for Cosmetics, both general and specific safety requirements are stipulated in part 3. Basically, all cosmetics are required to pass necessary safety tests, safety risk evaluation, and they shall fulfil relevant product safety standards.

In addition, enterprises shall ensure that the amount of restricted substances included in the formula is within the national limit. Sources, quality, and specifications of cosmetic materials are required to be available to each and every consumer. Requirements of labels and packages are also specified in Chapter 1: they shall never contaminate the product, and all cosmetics for children shall follow stricter rules of labelling and testing.

  • Reporting obligation (adverse effects)

Enterprises have the obligation to state possible adverse effects in the identification marks of cosmetics under Article 15 of the Regulations on Cosmetics Identification Marks. For cosmetics that may harm consumer’s health or safety, information including remarks, warnings (in Chinese), and specifications shall be clearly stated in the identification marks.

  • Sanctions

Sanctions for enterprises that fail to state possible adverse effects are stipulated in both the Regulations on Cosmetics Identification Marks (Article 26) and the Product Quality Law of the People's Republic of China.(Article 27 and 54)

For products that can easily harm a consumer’s personal or property if not appropriately used, if enterprises failed to add either a warning sign or specifications (in Chinese) to the identification marks, they will be punished by a fine of less than 30% of the value of such illegal products and have all illegal income confiscated in the worst situation. Such enterprises will be given a chance to correct their irregularities before sanctions are imposed on them.

  1. Application for cosmetic products approval

Under the Detailed Rues, enterprises are required to apply for administrative approval of initial imported cosmetics. The approval of such application is decided by the CDFA. An approval document and the number of such approval will be offered to the applicant if all stipulated standards are met. Approved cosmetics will still have to be inspected at the port when entering China. The approval will be valid for 4 years.

For approved cosmetics, the enterprise will only need to renew the approval, which means that the enterprise shall apply for renewal 4 to 6 months ahead of the approval expiry date. In cases where the applicant fails to renew the approval, the products will be treated as not being approved.

Please note that an approval document is only valid for the specific production enterprise, importing country, and cosmetics that are stated on the document. Foreign distributors and their representatives shall apply for another approval under relevant regulations.

  • Steps for an approval application

There are 5 steps for the approval application, most of which are about material preparation.

Step 1: Check whether the product is defined as cosmetics under the Chinese law. 

Step 2: Make sure all ingredients are in accordance with the regulations.

According to the applicable provisions (Article 2.2-2.2.3) in part 3 under Chapter 1 of the Safety and Technical Standards for Cosmetics, usage and dosage of restricted substances and special substances such as preservatives, sun screens, colorants, and hair dyes shall fulfil requirements listed in the charts in Chapter 2. Materials listed in the chart of banned substances shall never be used.

  If an enterprise wishes to use materials that are neither listed in the Safety and Technical Standards nor approved by the CDFA, it must apply for administrative approval. The applicant can be the producer of either the material or the relevant cosmetics.

[Table1. Administrative Approval Application for New Cosmetic Ingredients]

Fees

No charge.

List of application documents

  • Application form for new cosmetic ingredients administrative approval;
  • R&D reports;
  • Descriptions and diagrams of the production process.
  • Raw materials quality and safety control requirements;
  • Toxicological & safety evaluation data;
  • Copies of certificate of entrustment and business licenses of recorded units responsible for administrative approval in China; copies must be stamped with official seal
  • Additional information that may be useful for administrative approval; attach a sample for review

Approval procedures

  • Accepted by the CFDA Administrative Acceptance Service Centre (A decision of acceptance or rejection is made within 5 days.)
  • Technical review (within 90 days)
  • Decision of administrative examination and approval (Normally a decision is made within 20 days from receipt of the technical review result, but a ten-day extension is possible.)
  • Delivery (within 10 days after the decision is made)

*The time frame counts on working days, excluding legal holidays.

Step 3: Appoint a Chinese Agent.

Although the requirement of appointing a Chinese Agent is not stipulated in either the Detailed Rules or the Regulations, both the Service Guide for Approval of Imported Special-use Cosmetics and the Service Guide for Approval of Imported Non-special-use Cosmeticsrequire for a Chinese agent.

Both Service Guides stipulate in Article 7 that the production enterprise shall authorise an enterprise registered in China to be responsible for the application. In cases where the approval is applied for cosmetics made of new raw materials, production enterprises of both the new raw materials and the cosmetics can be the applicant.

When appointing a Chinese agent, the applicant's letter of authorization should be notarised at the CDFA. The letter of authorization should be offered by the applicant and signed by a representative of the Chinese agent.

After the notarisation of the signature, the letter of authorization should be recognised by the Chinese Embassy in the applicant's country. If the letter of authorization is in a language other than Chinese, a Chinese version will be needed.

There is no time limit for such authorisation, but the notarisation is valid for four years, so it is recommended that the authorisation last more than 4 years. After submitting the letter of authorisation, the applicant can then register its Chinese agent on the CDFA's official website. Normally, it takes 5 days for CDFA to check all the information, after which it offers an account and code to the Chinese agent.

Step 4: Send samples to a CDFA-accredited testing institution.

Fees and time frames for sample tests may differ from institution to institution, but there is no extreme difference. According to the data on the Shanghai Institute for Food and Drug Control's website, it normally takes more than 25 days and less than 60 days to test non-special-use cosmetics, and it costs more than approx. PLN 1,181 and less than approx. PLN 3,866. For special-use cosmetics, it normally takes more than 60 days and less than 80 days, and it costs more than approx. PLN 3,758 to approx. PLN 11,275.

Step 5: Prepare all dossiers and submit them to the CDFA.

  • Institution responsible for approval

The CDFA is the authority that processes cosmetics import applications. Such application should be sent to the CFDA Administrative Service Centre.

  • Documentation for initial imported cosmetics

[Table2. Required Documents for Initial Imported Cosmetics]

Initial imported special-use cosmetics

Initial imported non-special-use cosmetics

  1. Application form for administrative approval of imported special-use cosmetics
  2. Rationale for nomenclature of the product’s Chinese name
  3. Product formulas
  4. Descriptions and diagrams of the production process
  5. Product quality and safety control requirements
  6. Original package (including product labels and product brochures); Package design intended specifically for the Chinese market shall be submitted (including product labels and product brochures)
  7. Testing report issued by CFDA-accredited testing institutions and related dossier
  8. Safety evaluation data of the product’s potential safety hazards
  9. For application of products for hair growth, fitness, breast enhancement, the scientific literature for effective ingredients and rationale for use shall be submitted
  10. Copies of certificate of entrustment and business licenses of recorded units responsible for administrative approval in China; copies shall be stamped with official seal
  11. Letter of commitment ensuring that the cosmetic materials and sources of materials are in line with the requirements concerning the restriction and prohibition of substances from BSE-affected high risk areas
  12. Documents proving production and sales of the product in the producing country (region) or country (region) of origin
  13. Additional information that may be useful for administrative approval
  14. Text version and electronic version of the product technical requirements.Attached with 1 sample of marketed product sealed by designated test institutions.
  15. Application form for administrative approval of imported special-use cosmetics
  16. Rationale for nomenclature of the product’s Chinese name
  17. Product formulas
  18. Product quality and safety control requirements
  19. Original package (including product labels and product brochures); Package design intended specifically for the Chinese market shall be submitted (including product labels and product brochures)
  20. Testing report issued by CFDA-accredited testing institutions and related dossier
  21. Safety evaluation data of the product’s potential safety hazards
  22. Copies of certificate of entrustment and business licenses of recorded units responsible for administrative approval in China; copies shall be stamped with the official seal
  23. Letter of commitment ensuring that the cosmetic materials and sources of materials are in line with the requirements concerning the restriction and prohibition of substances from BSE-affected high risk areas
  24. Documents proving production and sales of the product in the producing country (region) or country (region) of origin
  25. Additional information that may be useful for administrative approval
  26. Descriptions and diagrams of the production process
  27. Text version and electronic version of the product technical requirements.Attached with 1 sample of marketed product sealed by designated test institutions.
  • Fees

No charges.

  • Length of procedure

Procedures and time frame of approval can be found in both the Notice on Administrative Approval of Initial Imported Special-use Cosmetics and the Notice on Filing of Initially Imported Non-special Use Cosmetics.

[Table3. Time Frame of Procedures (1)]

Initial imported special-use cosmetics

Initial imported non-special-use cosmetics

Procedures

Time frame

Procedures

Time frame

Acceptance

A decision of acceptance or rejection is normally made within 5 days following receipt of the application dossier, but it also depends on whether all dossiers are submitted and whether there are errors in such dossiers.

Acceptance

A decision of acceptance or rejection is normally made within 5 days following receipt of the application dossier, but it also depends on whether all dossiers are submitted and whether there are errors in such dossiers.

Technical review

The process is normally completed within 90 days. If the applicant asks for a re-examination after receiving a decision of disapproval, the process is then extended.  

Decision of administrative examination and approval

Normally within 20 days after receipt of the technical review conclusions, but a ten-day extension is possible when a decision cannot be made in 20 days.

Decision of administrative examination and approval

Normally within 20 days after receipt of the technical review conclusions, but a ten-day extension is possible when a decision cannot be made in 20 days.

Delivery

The CDFA delivers relevant certificates within 10 days following a decision of administrative approval.

Delivery

The CDFA delivers relevant certificates within 10 days following a decision of administrative approval.

*The time frame counts on working days, excluding legal holidays.

  • Appeal procedure from the examination of the application

For initial imported special-use cosmetics, the result of a technical review can be challenged by the applicant. The applicant can ask for a re-examination after receiving a decision of disapproval.

In the case of incomplete dossiers or errors, the applicant will not be given a decision of disapproval directly. Where in the application dossier, there are errors that can be corrected on the spot, the applicant shall be allowed to make the corrections on the spot. Where the application dossier is incomplete or does not meet the statutory format, the applicant shall be informed of all the supplements and amendments to be made once and for all, on the spot or within five days.

If there are further complaints, the applicant can refer to the Department of Legal Affairs in the CDFA Bureau of Investigation and Enforcement.

  1. Supervision of cosmetic products

Inspection will be conducted to enterprises and individuals import cosmetics from time to time. Under Article 16 of the Regulation, it is stipulated that all imported cosmetics are subject to inspection by the State Bureau of Import and Export Commodities Inspection, and only those cosmetics pass the inspection are allowed to be imported.  In addition, non-scheduled inspection will be conducted under Article 32 of the Detailed Rules, according to which wholesalers shall be inspected at least once a year and retailors shall be inspected at least once in two years.

  1. Liability and sanctions for the unlawful marketing (market introduction) of cosmetic products

Chapter 5 of the Regulations and Chapter 7 of the Detailed Rules contain information about penalties for illegal imports.

In Article 26 of the Regulation, it is stipulated that those who import or sell imported cosmetics have not been approved or examined shall be having their goods and illegal earnings confiscated and by a fine of from 3 to 5 times their illegal profits. According to Article 31, such enterprises or individuals shall also compensate for consumer's loss if any of them is harmed physically or poisoned because of violation of provisions in this Regulation.

Under Article 49 from the Detailed Rules, confiscated imported cosmetics that have not been approved or inspected will still be allowed to be sold if they pass inspection and the enterprise goes through relevant formalities. In cases where such cosmetics are made of banned materials, they will be destroyed under supervision.

  • Rules governing the unlawful advertising of cosmetic products

The Advertising Law of the People's Republic of China includes general provisions of all advertisements, and several provisions in the Regulation also govern cosmetics advertisements.

In Article 14 of the Regulation, it is stipulated that content about exaggerative effectiveness, guarantee in the name of other people, misleading information about efficacy, and advertising medical efficacy shall not be included in cosmetics advertising. Those who conduct these illegal advertising will be given a sanction by the administrative department for industry and commerce under Article 28 of the Regulation.

Part 2: Dietary Supplements

  1. Sources of law regarding dietary supplements

In China, the Measure for the Administration of the Registration and Recordation of Dietary Supplements (hereinafter the ''Measure''), the Food Safety Law of the People's Republic of China (hereinafter ''Food Safety Law''), and the Regulations on the Implementation of the Food Safety Law of the People’s Republic of China (hereinafter ''Implementation Regulations'') are the main legal basis for regulation of dietary supplements.

The Food Safety Law and the Implementation Regulations are laws regulating all aspects of food safety, and the Measure is stipulated by the CFDA to supervise registration and recordation of dietary supplements.

  1. Legal definitions of dietary supplements

A definition of "dietary supplements" was first introduced in 2005 in Measures for the Administration of the Registration and Recordation of Dietary Supplements (for trial implementation) (expired), but no such definition is included in the Measures after the expiry of the trial version.

According to Article 2 of the expired version, "dietary supplements" refer to the kind of food that is alleged to have specific health-care functions or the kind of food that people consume for the purpose of vitamin or mineral supplement. They are made for specific groups of people to consume and help with human-body functions. They are not produced for treatment of diseases, and should not cause any acute, sub-acute or chronic harm.

  • Safety of dietary supplements
  • Legal requirements

Safety of dietary supplements is regulated by the Food Safety Law and the Implementation Regulations. A safety evaluation is mandatorily required for dietary supplements under the Food Safety Law, in which Article 17 stipulates that the Health Administrative Department of the State Council shall organise such evaluations and form a committee composed of experts in different fields.

Another requirement under the Service Guide for Registration and Recordation of Dietary Supplements for such products is that applicants for imported supplements registration and recordation shall submit a safety demonstration report on their products. Such safety demonstration report should include usage basis or raw materials and supplementary materials, scientific basis of the formula, synergy, and dosage, analysis and comment of safety evaluation reports, and a comprehensive description about formula, suitable and unsuitable users, usage and dosage, and warnings.

  • Reporting obligation (adverse effects)

In Article 2 of the Measures for the Administration of the Registration and Recordation of Dietary Supplements (for trial implementation) (expired), the CFDA stipulated that dietary supplements ''shall not cause any acute, sub-acute or chronic harm''.

In addition, under Article 54 of the Measure, for dietary supplements which are unsuitable for certain groups, applicants for registration or recordation shall state the situation in the label and specifications, which will then be inspected by the CDFA.

  • Sanctions

Sanctions for enterprises that produce or distribute pre-packaged food, food additives, and genetically modified food whose label or specifications are not in accordance with the provisions are stipulated in Article 125 of the Food Safety Law.

Such enterprises will be punished by having their illegal earnings and products confiscated, and a fine will also be imposed on them according to the value of illegal products they produce or distribute. The fine can be between approx. PLN 2,673 and approx. PLN26,729 if the value of such products is less than approx. PLN 5,346. If such value exceeds approx. PLN 5,346, a fine of 5 to 10 times the value of such products will be imposed. Their tools, appliances, materials, and other items for the purpose of illegal production or business may be confiscated as well. Enterprises which produce or distribute food or food additives with flawed labels or specifications which will not affect food safety or mislead consumers will be ordered to correct these irregularities; but for those who refuse to correct such irregularities, they will be punished by a fine of up to approx. PLN 1,070.

  1. Registration and recordation of dietary supplements
  • Scope and subject of registration and recordation

The scope of registration is stipulated in Article 9 of the Measure, under which dietary supplements made of new raw materials that are not included in the List of Raw Materials for Dietary Supplements and initial imported dietary supplements shall be registered at the CDFA, but dietary supplements for the purpose of supplementing vitamin, mineral, and other nutritious substances are excluded from this scope. Under Article 11 of the Measure, applicants for such registration shall be foreign production enterprises of listed dietary supplements.

For recordation, the scope is stipulated in Article 45, under which dietary supplements made of raw materials that are included in the List of Raw Materials for Dietary Supplements and initial imported dietary supplements for the purpose of supplementing vitamin, mineral, and other nutritious substances shall be recorded at the CDFA. Under Article 46 of the Measure, applicants for such recordation shall be foreign production enterprises of listed dietary supplements.

  • Institution responsible for registration and recordation

The CFDA is the authority that processes dietary supplements import applications. Such application should be sent to the CFDA Administrative Service Centre.

  • Documentation for registration and recordation

[Table4. Required Documents for Registration and Recordation]

Registration

Recordation

All materials required for registration are stipulated in Articles 12 and 13 of the Measure. Please see the following list:

  1. Application chart for dietary supplements registration, and legal liability undertaking for reality of materials submitted.
  2. Copy of the applicant’s subject registration certificate.
  3. Product development report, including developers, time of development, development process, proving data from experiments above medium size, proving report for safety, health-care function, quality of both non-listed materials and the product, and technical requirements based on comprehensive research and development.
  4. Product formula materials, including the names and dosage of raw materials and supplementary materials, production processes, and quality standards; when necessary, the usage basis of raw materials, descriptions on the parts used, certificates of inspection conformity, and variety appraisal reports.
  5. Materials on production processes, including a diagram and description of the production processes together with key process control points and description.
  6. Materials of safety and health-care functions evaluation, including testing materials of safety and health-care function of non-listed raw material or product, evaluation materials of consumer feedback, testing reports on the effective ingredients or symbolic ingredients, hygiene, stability, strain identification, strain virulence, etc. of the product, as well as testing reports involving , inter alia, dopes, ingredients of illegal drugs.
  7. The category, name, relevant standards of packaging materials in direct contact with the dietary supplements.
  8. Draft of labels and specifications, and search materials proving that the generic names in the name of the product are not the same as the names of any registered drug.
  9. Three samples of minimum unopened sales package.
  10. Other relevant materials.
  11. Qualification proving document issued by the competent government department or legal service agency in the country (region) of manufacture that the registration applicant is the overseas manufacturer of the dietary supplement available on the market.
  12. Documents proving that the product has been marketed more than one year in the producing country (region), which shall be notarized by notary institutions of the producing country (region) and confirmed by the Chinese Embassy in the country.
  13. Technical regulations or standards related to the dietary supplement that are adopted by the country (region) of manufacture or the relevant international organizations.
  14. Physical samples of the packaging, labels and specifications of the product available on the market of its country (region) of manufacture.
  15. Where registration matters are to be handled by the resident representative office of an overseas registration applicant in China, the Registration Certificate of the Resident Representative Offices of Foreign Enterprises in China and the photocopies thereof shall be submitted. Where an overseas registration applicant authorizes an agency within China to handle registration matters, a notarized original of the power of attorney and a photocopy of the business license of the authorized agency shall be submitted.

All materials required for recordation are stipulated in Articles 12, 13, 48, and 49 of the Measure. Please see the following list:

  1. Application chart for dietary supplement recordation, and legal liability undertaking for reality of materials submitted.
  2. Copy of the applicant’s subject registration certificate.
  3. Technical requirements materials.
  4. The testing report issued by qualified testing institutions which proves fulfilment of all technical requirements.
  5. Other materials that prove safety and health-care function of the product.
  6. Product formula materials, including the names and dosage of raw materials and supplementary materials, production processes, and quality standards; when necessary, the usage basis of raw materials, descriptions on the parts used, certificates of inspection conformity, and variety appraisal reports.
  7. Materials on production processes, including a diagram and description of the production processes together with key process control points and description.
  8. Materials of safety and health-care functions evaluation, including testing materials of safety and health-care function of non-listed raw material or product, evaluation materials of consumer feedback, testing reports on the effective ingredients or symbolic ingredients, hygiene, stability, strain identification, strain virulence, etc. of the product, as well as testing reports involving inter alia, dopes, ingredients of illegal drugs.
  9. The category, name, relevant standards of packaging materials in direct contact with the dietary supplements.
  10. Draft of labels and specifications, and search materials proving that the generic names in the name of the product are not the same as the names of any registered drug.
  11. Qualification proving document issued by the competent government department or legal service agency in the country (region) of manufacture that the registration applicant is the overseas manufacturer of the dietary supplement available on the market.
  12. Documents proving that the product has been marketed more than one year in the producing country (region), which shall be notarized by notary institutions of the producing country (region) and confirmed by the Chinese Embassy in the country.
  13. Technical regulations or standards related to the dietary supplement that are adopted by the country (region) of manufacture or the relevant international organizations.
  14. Physical samples of the packaging, labels and specifications of the product available on the market of its country (region) of manufacture.
  15. Where registration matters are to be handled by the resident representative office of an overseas registration applicant in China, the Registration Certificate of the Resident Representative Offices of Foreign Enterprises in China and the photocopies thereof shall be submitted. Where an overseas registration applicant authorizes an agency within China to handle registration matters, a notarized original of the power of attorney and a photocopy of the business license of the authorized agency shall be submitted.
  • Fees

No charge.

  • Length of procedure

For registration, all procedures and the time frame is stipulated in Articles 14, 15, 16, 19, 20, 21, 22,24,25,26, and 28 of the Measure. For recordation, the relevant provision is Article 50.

[Table5. Time Frame of Procedures (2)]

 

Registration

Recordation

Acceptance

The applicant shall be informed as soon as a decision of acceptance or rejection is made. Where the application dossier is incomplete or does not meet the statutory format, the applicant shall be informed of all the supplements and amendments to be made once and for all on the spot or within five days. Such supplements and amendments shall be finished within three months. After receipt of such corrected materials, the time will be recalculated.

After receipt of materials by the food and drug administrative departments, a recordation shall be made on the site if such materials fulfil all the requirements; if not, the applicant shall be informed of all the supplements and amendments to be made once and for all.

Inspection and verification

The relevant authority shall then deliver all materials to the review body within three weekdays.  In cases where the review body find on-site inspection or verification necessary, such review shall be finished within 60 weekdays. Under specific circumstances, the process can be extended for 20 weekdays. The inspection body shall finish the on-site inspection and submit its report to the review body within 30 weekdays after being informed to conduct such an inspection. The verification body shall finish the verification and submit its report to the review body within 60 weekdays after being appointed by the review body. However, the time frame of on-site inspection and verification for initial imported dietary supplements has to be decided on the situation of such foreign enterprises.

Technical review and administrative review

Those applicants who have doubts on the decision of rejection by the review body shall ask the review body for a technical review or an administrative review within 20 weekdays since receipt of the decision. The review body shall reply within 30 weekdays, and then submit s comprehensive report to the CDFA. The CDFA shall review the whole process and make the decision of registration within 20 weekdays.

Delivery

Within 10 days from the date of decision making of administrative approval, the CFDA Administrative Service Centre shall deliver the decision to the applicants.

*The time frame counts on working days, excluding legal holidays.

  • Appeal procedure from the examination of the application

Under Article 29 of the Measure, if the applicants for registration do not agree with a decision of rejection, they can apply for an administrative reconsideration in written form, or they can bring up administrative litigation in the court.

No information of the recordation appeal procedure has been included in the Measure.

  1. Supervision of dietary supplements

The provisions governing supervision and management of dietary supplements are set out in Chapter 6 of the Measure. Under Article 67, it is stipulated that the CFDA shall revoke enterprises' registration when they fail to renew such registration, or when there is proof based on development of science to show the potential safety risks of dietary supplements. Under Article 68, the food and drug administrative departments shall revoke recordation when recordation materials are false, or when there are safety issues in production technique or formula. According to Article 70, those registration applicants who conceal facts or submit false materials will be given a warning, and they will not be allowed to register the relevant dietary supplements in one year.

  1. Liability and sanctions for unlawful marketing (market introduction) of dietary supplements

Unlawful market introduction of dietary supplements is governed by Article 124 and 129 of the Food Safety Law. 

In Article 124, it is stipulated that those who produce or distribute dietary supplements without registering in accordance with relevant provisions will be punished by having their illegal income and food or additives that are produced or distributed illegally confiscated. Their tools, appliances, materials, and other items for the purpose of illegal production or business may be confiscated as well. In addition, a fine of between approx. PLN 2,673 and approx. PLN26,729 will be imposed on such enterprises if the value of such products is less than approx. PLN 5,346. If such value is more than approx. PLN 5,346, a fine of 10 to 20 times the value of such products will be imposed. For serious cases, approval document of such enterprises will be revoked.

Under Article 126, those who fail to record imported dietary supplements in accordance with relevant provisions will be given a warning and be ordered to correct such irregularities; for those who refuse to correct their irregularities, a fine of more than approx. PLN 2,673 and less than approx. PLN 26,729 will be imposed. For serious cases, such enterprises will be ordered to stop production or distribution until their approval document is revoked.

  • Rules governing unlawful advertising of dietary supplements

Provisions regulating dietary supplements advertising are stipulated in the Advertising Law of the People's Republic of China. In Article 18, it is specified that assertion or guarantee on efficacy and safety, mention of functions in preventing or curing diseases, claiming or implying the advertised commodity is essential for ensuring health, comparison with drug or other functional food, endorsement, and other content prohibited by laws and regulations shall not be included in advertisements. Such advertisements shall also not be published by radio, television, newspaper and audio/video publishing house and Internet information providers by means of presenting health knowledge under Article 19. Such advertisements shall also not be published in mass media aimed at minors according to Article 40.

For supervision of dietary supplements advertising, it is stipulated in Article 46 that an approval from the relevant authority is required before the publishing of such advertisements.

 

The bright Qian Zejia with research for Bird & Bird