China Reach Regulation for Various Sectors

On December 31, 2021, China’s National Medical Product Administration (NMPA) launched an online cosmetic ingredient submission platform. This platform, Cosmetic Ingredients Safety Information Registration Platform, will require companies handing existing cosmetic ingredients to submit information. The platform is created based the requirements of CASR (state council order No.727).  For foreign cosmetic ingredient manufacturers, they can create their own accounts to submit information, or authorize representative companies to submit ingredient information on their behalf.  

Cosmetics Raw Material manufacturers, domestic or overseas, are required to submit to the Cosmetic Ingredients Safety Information Registration Platform. Manufacturers can submit information by themselves, or they can appoint an authorized representative to submit and maintain ingredient safety information on their behalf. This applied to cosmetic raw materials regardless of its tonnage.  

This applies to two types of substances:  

1. Substance that are included in IECIC (Chemical Inventory, Inventory of Existing Chemical Substances Produced or Imported in China) but not listed in IECSC (Inventory of Existing Cosmetic Ingredients Produced or Imported in China)  

2. Substances that are listed in IECIC and IECSC.  

Basic information and manufacturing process  

1. Trade name  

2. Composition  

3. Basic properties  

4. Purpose of use 

5. Suggested percentage in cosmetics 

6. Restrictions on the use of raw materials  

7. Properties  

8. Physical and chemical properties  

9. Brief statement of the Manufacturing process  

Quality control requirements and characteristic indicators  

1. Identification method  

2. Quality and characteristics of ingredients  

Limit requirements for risky substances

1.  Heavy metal  

2. Microbiology indicators  

3. Pesticide residue risk  

4. Others  

Assessment conclusions of international authorities  

Brief description of the requirements for use in other industries  

Other issues to be explained  

The pesticide regulation in China is called Measures for the Administration of Pesticide Registration. The Measures came into force from the promulgation of the decree of the Ministry of Agriculture and Rural Affairs (MARA) on Aug. 1, 2017. The temporary pesticide registration permit that had been obtained prior to Jun. 1, 2017, would not be renewed; the application for pesticide registration that had not yet been approved would be processed in accordance with the relevant provisions of the Pesticide Management Regulations (PMR).

The PMR aims to better standardize pesticide registration behavior, it is to strengthen pesticide registration management to ensure the safety and effectiveness of pesticides.

Key summaries 

• Pesticides produced, traded, and used within the territory of the People's Republic of China shall obtain pesticide registration.
• The registration management of pesticides for overseas use only shall be stipulated separately by MARA.
• The pesticides that have not obtained the pesticide registration permit in accordance with the law shall be treated as fake pesticides.

Responsible unit

• MARA is responsible for the national pesticide registration management and organizing the establishment of a pesticide registration review committee to formulate pesticide registration review rules; the agency responsible for pesticide inspection to which it belongs is responsible for the specific work of national pesticide registration, which is The Institute for the Control of Agrochemicals, Ministry of Agriculture (ICAMA).
• The competent agricultural and rural departments of the provincial people's governments (hereinafter referred to as the provincial agricultural and rural departments) are responsible for accepting applications for pesticide registration within their respective administrative areas, reviewing the application materials, and providing preliminary review opinions. Its subordinate institution, provincial ICAMA, is also responsible for pesticide verification (hereinafter referred to as provincial pesticide verification institutions) assist in the specific work of pesticide registration.

New pesticides: refer to pesticides whose active ingredients have not been approved and registered in China, including new pesticide technical (parent drug) and new pesticide formulations.

Technical medicine: refers to the product obtained in the production process, which is composed of active ingredients and related impurities, and a small amount of additives can be added if necessary.

Parent drug: refers to the product obtained during the production process, which is composed of active ingredients and related impurities, and may contain a small amount of necessary additives and appropriate diluents.

Preparation: refers to the pesticide product in a stable state which is processed from the original pesticide (parent drug) and suitable auxiliary agents, or processed by biological fermentation, plant extraction and other methods.

Auxiliary: refers to any single component or multiple components added to pesticide products, other than active ingredients, that do not have pesticide activity and active ingredient functions, but can or help to improve or improve the physical and chemical properties of pesticide products substance.

The name of the pesticide should use the Chinese generic name of the pesticide or the simplified Chinese generic name, and the name of the botanical pesticide can be represented by the plant name plus the extract. The name of the directly used sanitary pesticide is expressed by the functional description word plus the dosage form.

The content of active ingredients and formulations of pesticides should be set in accordance with the principles of improving quality, protecting the environment, and promoting sustainable agricultural development.

The formulation of the preparation product shall be scientific, reasonable and convenient to use. Single preparation products of the same active ingredient and dosage form, with no more than three content gradients. The active ingredients of the mixed preparation shall not exceed two, and the active ingredients such as herbicides, seed treatment agents and pheromones shall not exceed three. For mixed preparations with the same active ingredients and dosage forms, the proportions shall not exceed three, and the total content gradients of the same proportions shall not exceed three. Pesticides with low active ingredient content for direct use without dilution or dispersion are classified separately.

If the specified adjuvant needs to be added during use, the corresponding test data should be submitted when applying for pesticide registration.

The dilution ratio or concentration of pesticide products should be matched with the application technology.

The specific requirements shall be formulated separately by MARA, and according to the toxicity and hazard of pesticide adjuvants, the list, and limit of prohibited and restricted adjuvants shall be announced and adjusted in a timely manner.

Pesticide manufacturers, companies exporting pesticides to China, or developers of new pesticides will need to apply for pesticide registration in China, depending on their roles there are different requirements apply.

Domestic applicants apply for pesticide registration to the local provincial agricultural and rural departments. Overseas enterprises submit pesticide registration applications to the Ministry of Agriculture and Rural Affairs.

Pesticide production enterprises: refers to domestic enterprises that have obtained pesticide production licenses.

• Enterprises exporting pesticides to China (hereinafter referred to as overseas enterprises): refers to enterprises that export pesticides produced overseas to China.

• New pesticide developers: refers to Chinese citizens, legal persons or other organizations that develop new pesticides within the territory of China.

  • For new pesticides jointly developed by multiple entities, one entity should be identified as the applicant, and other cooperative research institutions and relevant test samples should be specified; other subjects may not apply repeatedly.

The applicant shall submit the product chemistry, toxicology, efficacy, residues, environmental impact and other test reports, risk assessment reports, labels or instruction sheets, product safety data sheets, relevant documents, application forms, applicant qualification certificates, and materials Authenticity statement and other true, standardized, complete and valid application materials.

The registration test report should be issued by a registration test unit recognized by the MARA, or by a relevant overseas laboratory that has signed a mutual recognition agreement with relevant departments of the Chinese government; experiments and registration experiments of endemic biological species in China should be completed within the territory of China.

When applying for new pesticide registration, the registration application for new pesticide technical and new pesticide formulation shall be submitted at the same time, and pesticide standard products shall be provided.

Within 6 years from the date of new pesticide registration, if other applicants submit the data obtained by themselves or with the authorization and consent of the holder of the new pesticide registration permit to apply for registration, the application for new pesticide registration shall be applied.

MARA or the provincial agricultural and rural department shall deal with the application materials submitted by the applicant according to the respective following circumstances:

1. no pesticide registration is required: immediately inform the applicant that it will not be accepted;
2. an error occurs in the application information: the applicant is allowed to correct it on the spot;
3. the application materials are incomplete or do not conform to the statutory form: the applicant shall be notified on the spot or within 5 working days of all the contents that need to be supplemented and corrected.
4. the application materials are complete and conform to the statutory form, or the applicant submits all supplementary materials as required: accepted.

Review and decision will take at least 11 months. 

The provincial agriculture and rural departments shall, within 20 working days from the date of accepting the application, conduct a preliminary examination of the materials submitted by the applicant, put forward preliminary examination opinions, and submit them to MARA. If the applicant fails to pass the preliminary examination, the applicant may be notified in writing and explain the reasons as per the applicant's wishes.

After the MARA accepts the application or receives the application materials and preliminary review opinions submitted by the provincial agricultural and rural department, it shall complete the product chemistry, toxicology, efficacy, residue, environmental impact, label proofs, etc. within 9 months and submit the review comments to the Pesticide Registration Review Committee for review.

After receiving the technical review comments, the Pesticide Registration Review Committee will issue review comments in accordance with the pesticide registration review rules. After the application is accepted, the applicant may withdraw the registration application and re-apply after supplementing and improving the relevant information. At the same time, the MARA may also request the applicant to supplement the information according to the opinions of the Pesticide Registration Review Committee.

During the registration review and review period, the types of registration applications submitted by the applicant, as well as the technical requirements and approval procedures they follow, shall not be changed because other applicants have obtained pesticide registration permits during this period. If the new pesticide is approved, the new pesticide registration applications of other applicants that have been accepted can continue to be reviewed and reviewed in accordance with the new pesticide registration approval procedures, or the application can be withdrawn and a new registration application can be submitted.

MARA will make an approval decision within 20 working days from the date of receipt of the review comments. If the requirements are met, the pesticide registration permit will be issued; if the requirements are not met, the applicant will be notified and explain in writing.

The pesticide registration permit is uniformly printed by MARA and the pesticide registration permit is valid for 5 years. If the applicant wish to change the holder of the pesticide registration permit within the validity period of the pesticide registration permit, relevant certification materials should be submitted and application sent to MARA for a replacement of the pesticide registration permit; under any of the following circumstances, the holder of the pesticide registration permit should report Ministry application changes:

• the scope, method or dosage of pesticide use are changed;
• the components other than the active ingredients of pesticides are changed;
• the product toxicity level is changed;
• the content of active ingredients in the original drug product has changed;
• product quality standards are changed;
• there exists any other circumstances prescribed by MARA.

The extension of license will take at least 10 month.

If it is still necessary to continue to produce pesticides or export pesticides to China after the expiration of the validity period, an application for renewal shall be made 90 days before the expiration of the validity period. If the applicant fails to apply for renewal within the time limit, registration must be re-applied. MARA will review the application materials for registration renewal and make a decision on whether to extend the registration before the expiration of the validity period. If there are hidden dangers or risks in safety and effectiveness during the review, it will be submitted to the Pesticide Registration Review Committee for review.

Application for registration change or renewal must be submitted by the holder of the pesticide registration permit to the MARA, with the application form filled in and relevant information submitted. MARA shall complete the review of registration changes within 6 months, form review opinions, submit them to the Pesticide Registration Review Committee for review, and make an approval decision within 20 working days from the date of receipt of the review opinions. If the requirements are met, the registration change will be allowed, and the registration permit number and validity period will remain unchanged; if the requirements are not met, the applicant will be notified in writing and the reasons will be explained.

Provincial agricultural and rural departments should report monitoring and evaluation results to MARA in a timely manner.

• The holder of the pesticide registration permit shall collect and analyze the safety and effectiveness changes of pesticide products, product recalls, and accidents during production and use.
• For pesticide varieties that have been registered for more than 15 years, MARA will organize periodic evaluations based on changes in production use and industrial policies.
• If a registered pesticide is found to have serious harm or greater risk to agriculture, forestry, human and animal safety, agricultural product quality and safety, ecological environment, etc., MARA shall organize a pesticide registration review committee to review and revoke or change the corresponding pesticide registration according to the review results; to decide to disable or restrict the use and make an announcement when necessary.

Supervision and management

In any of the following circumstances, MARA or the provincial agricultural and rural department will not accept the application for pesticide registration; if it has been accepted, it will not be approved:

The authenticity, integrity or normativeness of the application materials does not meet the requirements;

• The applicant does not meet the qualification requirements specified in Article 13 of these Measures;
• The applicant is included in the list of seriously untrustworthy units stipulated by the relevant state departments and restricted from obtaining administrative licenses;
• The pesticides applied for registration belong to the pesticides whose production, operation and use are explicitly prohibited by the relevant state departments, or MARA will no longer register new pesticides according to law;
• The registration test does not meet the provisions of Articles 9 and 10 of the Regulations on the Administration of Pesticide;
• Other circumstances that should not be accepted or approved.
•  
  • If the applicant conceals relevant information or submits false pesticide registration materials and test samples, its application will not be accepted within 1 year; if the registration has been approved, the pesticide registration permit will be revoked, and its application will not be accepted within 3 years; the pesticide registration permit will be revoked applications will not be accepted within 5 years.
  •  

For those who submit false information and test samples, MARA will list the applicant's illegal information in the integrity file and publish it. In any of the following situations, MARA will cancel the pesticide registration permit and announce it:

• ​​​​​​​​​​​​​​​​​​​​​the validity period has not been extended;
• the holder of the pesticide registration permit has terminated according to law or is not qualified as a pesticide registration applicant;the pesticide registration information has been transferred according to law;
• other circumstances under which the pesticide registration permit should be cancelled.

Persistent Organic Pollutants (POPs), also referred to as “emerging contaminants”, include a range of chemical substances from diverse applications, ranging from medicines, personal care, household cleaning products, lawn care, agricultural products, among others.

The toxicity of POPs has been long investigated, and researchers found that these chemicals may have long-range mobility and long-lasting duration, leading to environmental contamination and pollution. POPs are often classified as Substance of Very High Concern (SVHC) with hormone disruption consequences, bioaccumulation and biomagnification through the food chain. The presence of POPs in the environment and in human health can lead to several complications, from mild effects to more serious consequences, for example, reproductive disruptions and immunological disorders.

Since POPs are not easily broken down, a characteristic that guarantees its continuation in the environment, the contaminant consequences are still being investigated. In other words, the emerging contaminants are mainly not from new pollutants that recently entered the environment. Instead, there is a good understanding of contaminants, but the consequences of their exposure are still being discovered.

Countries have created a set of rules and regulations to regulate, control, and mitigate POPs use and its effects on the environment and on human health. The essence of these legislations is to eliminate the production, trading, and use of such chemicals, including storage and waste management.

International effort in addressing POPs starts in the late 1990s. The initial protocol to address POPs was implemented in 1998, signing 16 chemicals to phase out according to previously established risk criteria. The Aarhus Protocol also impose parties to reduce their emissions below 1990 levels.

The Stockholm Convention is an international conference specifically for POPs proposed in May 2001 in Sweden (complementing the Aarhus Protocol), entering into force in 2004. Among the objectives, the Stockholm Convention aims to:

• Prohibit, eliminate, and restrict several POPs in the production, use, import, and export.
• Ensure that waste containing POPs is managed safely and in an environmentally sound manner.
• Promote tools for information exchange, public access, awareness and education, research, development and monitoring, reporting, and implementation of plans to fight POPs pollution.

The Stockholm Convention is considered the main international instrument to address POPs. Most countries adhere to the Stockholm Convention.

China signed the Stockholm Convention on its launch in 2001 and ratified the Convention in 2004. Since then, the initial list of 12 POPs listed in the Stockholm Convention entered the government agenda. For example, the Regulation for Pesticide Management, issued by the State Council in 1997 and amended in 2002, is a comprehensive law that strengthened the import and export, registration, production, utilization, management, and transportation of pesticides, especially those of POPs. The Regulation for Pesticide Management forbids enterprises or individuals to produce, utilize, or trade products such as Hexachlorobenzene (HCB), Bexachloridge (HCH), and Dichlorodiphenyltrichloroethane (DDT).

In 2007, the Chinese government issued the National Implementation Plan for the Stockholm Convention on Persistent Organic Pollutants, dividing the implementation goals by stages (2010, 2010-2015, and after 2015), by region, and type of industry. The overall objective, as expected, is to reduce or eliminate the environmental and health risks posed by the POPs through the effective implementation of several action plans.

• By 2010
  • Eliminate the production, use, import, and export of certain pesticide POPs
  • Control of PCBs used in PCBs-containing equipment in use
  • Reduce or eliminate releases of unintentionally produced POPs
  • Reduce or eliminate releases of POPs from stockpiles and wastes
• By 2015
  • Eliminate the use of PCBs in currently used equipment containing PCBs
  • Reduce or eliminate releases of unintentionally produced POPs
  • Reduce or eliminate releases originating from POPs stockpiles and wastes
  • Manage POPs contaminated sites
• After 2015 (long-term aims)
  • Complete the identification of currently used equipment containing PCBs and eliminate uses of PCBs by 2025
  • Promote the Best Available Techniques and Best Environmental Practices in all relevant areas for maximum reduction of Dioxin releases
  • Improve the inventories of POPs wastes and contaminated sites, pursuing their gradual recovery

The overall steps for the National Implementation Plan for POPs are depicted below:

Currently, China’s legislation addresses phasing-out, reduction, control, and disposal of POPs or contaminated articles with POPs, specifically with alpha hexachlorocyclohexan, beta hexachlorocyclohexane, chlordecone, hexabromobiphenyl, hexabromodiphenyl ether, heptabromodiphenyl ether, lindane, pentachlorobenzene, perfluorooctane sulfonic acid, tetrabromodiphenyl ether, pentabromodiphenyl ether, endosulfan, and hexabromocyclododecane.

The China Food & Drug Administration (CFDA), now called the National Medical Products Administration (NMPA), is responsible for medical devices, drugs, and healthcare services. The organization is headquartered in Beijing, with offices in each province. The Centre for Medical Device Evaluation (CMDE) is responsible for conducting the dossier review during the medical device registration process. The General Administration of Quality Supervision, Inspection, and Quarantine (AQSIQ) conducts mandatory safety registration, certification, and inspection for certain devices. 

China has National Standard for medical devices. Any medical device must follow the Chinese National Standard Specifications. More than 35% of all the IEC and ISO standards have now been adopted by China, but many are not direct transpositions and contain China specific requirements. 

           Primary medical device related international standards and their Chinese equivalents.

• The first step in registering your medical device in China is to classify your product in China. China classifications range from Classes 1-3. 

*Note: If the medical product is registered as a Class 2 product in the US or EU, it does not mean it will be a Class 2 product in China. 

• The second step in registering the medical device in China is local type testing. This requires the device manufacturer to send a sample(s) of the product to China, where one of the NMPA testing centres in China will perform local type testing. 

• The third step for Class 2 and Class 3 products is to determine whether a clinical evaluation report (CER) or a local clinical study will be needed for China device approval. Hopefully a CER will suffice, but if not, a local clinical trial may be needed. Local clinical trials in China can be expensive and normally take 1-1.5 years.

• In June 2021, the NMPA issued a new set of regulations that will make it easier for innovative medical devices for the treatment of urgent public health emergencies and rare diseases to obtain approval in China.  

• Certain products will be exempt from clinical trials in China if their manufacturers can demonstrate their safety and efficacy in other markets. All medical devices require CFDA registration prior to being sold in China.

• The Chinese State Council released the new Regulations for the Supervision and Administration of Medical Devices in 2014. Compared with the old regulations (48 articles), the new ones have 80 articles and many changes on device registration; clinical trials; adverse events; recalls, etc.  

• The new regulations are consistent with the goal of the “National 12th five-Year Plan” to foster innovation and encourage domestic companies’ research and development while enhancing the protection of public health.

1. Product Risk Analysis Document 
2. Product Technical Specification 
3. Product Testing Report (company’s self-testing report or 3rd party report) 
4. Clinical Evaluation Report 
5. Key Manufacturing Information (process, flowchart, material, etc.) 
6. Design/artwork of IFU and product label for the minimum selling unit 
7. Legal Documents 

• Legal qualification of the foreign manufacturer (i.e. ISO 13485) 
• Market authorization approval at the country of origin (i.e. CFG+510k or CE) 
• Authorization letter to the agent in China.