Interpretation of China’s Regulatory Requirements on Public Health Pesticides

Introduction

The continuous increase in people’s living standards in recent years has posed higher requirements on comfortableness and comfort and well-being of living environment, which led to continued increase in people’s demands of public health pesticide products. To strengthen pesticide supervision, the State Council of the People's Republic of China formulated and implemented new version of Regulation on Pesticide Administration in 2017, and then Ministry of Agriculture and Rural Affairs promulgated a series of supporting regulations successively for detailed provisions on pesticide registration, pesticide production, pesticide business operation, pesticide application, pesticide supervision and administration as well as legal liabilities, which caused certain impacts on pesticide industry and certain changes in public health pesticide supervision. Based on new version of Regulation on Pesticide Administration and supporting regulations, this article has explained in detail of China’s specific requirements on supervision, registration procedure, labeling and import of public health pesticides.

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Definition and Classification of Public Health Pesticides

Chapter 2 of new version of Data Requirements on Pesticide Registration has clarified definition of public health pesticides, which refer to pesticide used for prevention and control of mosquitoes, flies, cockroaches, ants and other pests in living environment of human beings as well as living environment of animals in breeding industry under agriculture and forestry industry.

Public health pesticides are divided into household health insecticides and environmental health insecticides by place and method of application. Among which, household health insecticides mainly refer to public health pesticides that can be directly used in room without dilution and other treatments, which include household products such as mosquito coils, liquid vaporizers (vaporizing mats), aerosol dispensers, anti-cockroach and anti-moth products as well as personal protection products such as repellent liquid, repellent milk, repellent floral water and repellent wipe. Environmental health insecticides mainly refer to public health pesticides used in indoor and outdoor environment after dilution and other treatments, such as outdoor mosquitocide, snail-killing agent and termite control agent.

Public health pesticides can be divided into chemical pesticides, biochemical pesticides, microbial pesticides and botanical pesticides by sources of active ingredients of products, see active ingredients of different categories of public health pesticides in Table 1, which functions cover insect disinfestations, sterilization, repellent and moth proofing.

Table 1 Active ingredients of different categories of public health pesticides

Category  of public health pesticide	Active  ingredient
Chemical pesticides	Organic:  pyrethroids, organic phosphor, methyl carbamate, BPUs, nicotinoids, amides and  others
	Inorganic:  silicon dioxide, boric acid, zinc borate, sodium tungstatr dihydrate, sodium  tungstatr dihydrate, copper sulfate and others
Biochemical pesticides	Muscalure  and S-methoprene
Microbial pesticides	Bacteria:  bacillus thuringiensis H-14 and bacillus sphaericus H5a5b
	Fungus:  metarhizium anisopliae
	Virus:  periplaneta fuliginosa densovirus (PfDNV)
Botanical pesticides	D-limonene, pyrethrins, D-camphor, camphor and eucalyptol

Regulatory System for Public Health Pesticides

China’s regulatory system along with laws and regulations on public health pesticide products are as follows:

Administrative supervision

Regulator	Main function
Ministry of Agriculture  and Rural Affairs	Nationwide pesticide supervision and  administration, administration of pesticide registrations throughout the  country, organization and establishment of pesticide registration review  committee, formulation of review rules on pesticide registration, pesticide  registration review, test for new pesticide registration and new pesticide  application.
Provincial agricultural departments	Filing of test for pesticide registration,  pesticide registration application, preliminary examination of registration,  specific pesticide registration works and production license application.
Agricultural departments  at county level and above	Pesticide supervision and administration within  local administrative area, pesticide application related guidance and  services, organization of free technical trainings provided by plant protection,  agricultural technology extension and other institutions to pesticide users, organization  and implementation of pesticide reduction program of local administrative  area, establishment of specialized pest control service organizations, regular  investigations and statistics of pesticide production, distribution and  application situations and timely report to related departments of the people’s  government of the same level.

Self-inspection by industry associations

Name	Main function
China Crop Protection  Industry Association	Self-regulatory organization mainly assist  related departments of the country in participation in administration of  pesticide industry as well as formulation of industrial policies, mid-to-long  term development plans, technical and economic regulations as well as product  quality standards.
China Association of  Pesticide Development and Application	Self-regulatory organization mainly responsible  for conversion and promotion of pesticide related scientific achievements,  exploration of international pesticide market, promotion of new types of  pesticides and new technologies as well as guidance on scientific and  reasonable application of pesticides.

Laws and regulations

Regulation name	Relea se authority	Implementation date
Regulation on Pesticide  Administration	State Council	June 1, 2017
Measures on  Administration of Pesticide Registration	Ministry of Agriculture	August 1, 2017
Data Requirements on  Pesticide Registration	Ministry of Agriculture	November 1, 2017
Measures on  Administration of Pesticide Registration Test	Ministry of Agriculture	August 1, 2017
Measures on Administration  of Pesticide Labels and Manuals	Ministry of Agriculture	August 1, 2017
Regulation on  Administration of QR Code of Pesticide Labels	Ministry of Agriculture	January 1, 2018
Inventory of Limited  Pesticides (2017)	Ministry of Agriculture	October 1, 2017
Measures on  Administration of Pesticide Business License	Ministry of Agriculture	August 1, 2017
Measures on  Administration of Pesticide Production License	Ministry of Agriculture	August 1, 2017

Regulatory Requirements on Public Health Pesticides

According to Measures on Administration of Pesticide Registration, pesticide registration shall be acquired for pesticides produced, operated and used in the territory of the people’s republic of China, and a pesticide for which a pesticide registration certificate’s not obtained pursuant to laws and regulations shall be deemed as a fake pesticide.

In case of pesticide products produced by pesticide manufacturers and enterprises export pesticides to China, in addition to necessary pesticide registrations, pesticide labels shall be in line with Order No.7/2017 of MOA of Measures on Administration of Pesticide Labels and Manuals.

Besides, public health pesticide products shall also meet production and operation requirements of related regulations.

Pesticide registration requirements

1) Applicants

There are three categories of applicants eligible for pesticide registration. The first category covers pesticide manufacturers, which refer to enterprises obtained pesticide production license in the territory of China. The second category covers enterprises export pesticides to China and those export pesticides manufactured in overseas countries to China. Compared with previous regulations, new regulations have no mandatory requirement on whether overseas enterprises are manufacturers. The third category covers new pesticide developers, which refer to Chinese citizens, legal persons or other organizations engaged in R&D of new pesticides in the territory of China. In case of new pesticides jointly developed by several entities, one of them shall be specified as applicant, and others are not allowed to make repeated applications. No other organization and individual are allowed to apply for pesticide registration except for aforesaid three categories of applicants.

2) Registration principles

Registration principles to be observed during pesticide registration are scientificity, fairness, equality, efficiency and convenience. In case of public health pesticides, their formulation products normally shall be controlled under low toxicity, applications for registration of highly toxic and extremely toxic public health pesticides will be rejected.

3) Formula and content requirements of formulations

Formula of formulation products shall be scientific, reasonable and easy to use. Formulation products include single active ingredient formulation products and mixture products. Content-grades of single active ingredient formulation products of the same active ingredient and formulation shall not exceed three. In case of ready mixture products, there shall be no more than two kinds of active ingredients and no more than three kinds of active ingredients in pheromone. As for mixtures of the same active ingredients and formulation, the ratio shall not exceed three, and the total content-grades of the same ratio shall not exceed three.

4) Adjuvant requirements

At present, China has implemented certain administrative measures on pesticide adjuvants, which mainly include:

• Limit the use of CFCs propellent of pest control aerosol dispenser;
• Prohibit the use of OCDPE (S2/S421);
• Implement the standard of Limit of Harmful Solvents of Emulsifiable Concentrate Pesticide (HG/T 4576－2013), limit the contents of benzene, toluene, naphthalene, ethyl benzene, N, N-dimethylformamide, methyl alcohol and xylene in EC products, and facilitate the development of water-based products;
• It’s no longer necessary to file scents of essences added into public health pesticides, and the provision of ‘three scents for a certificate’ has been removed. Essences belong to limited adjuvants, which shall be added properly and the amount added shall not exceed 1%. It’s not necessary to apply for changes in registration in case of changes in kinds of essences. In other words, it’s not necessary to submit composition information of essences if changes in scents of domestic sanitary pesticides wouldn’t lead to obvious changes in composition of formulations (change of ≤1%).

5) Registration data requirements

Registration data of public health pesticides include test data and general information, and all registration data shall meet risk assessment requirements.

Test data can be divided into: product related chemical test, toxicology test, efficacy test and environmental impact test (only limited to environmental sanitary insecticides, domestic sanitary insecticides and mosquito repellent products directly applied to human body can be exempted from the test);

General information include: application form, supporting documents of applicant, declaration of applicant, summary report, labels and manual, other registration related supporting materials, product safety data sheet and references.

6) Flow chart for application approval

Flow chart for approval of pesticide registration application is as follows (see Diagram 1).

Diagram 1 Flow chart for approval of pesticide registration application

Production

China has implemented pesticide production license system and established unified licensing criteria, which include requirements on technical personnel, workshop facilities, quality inspection, rules and regulations, industrial policies, work safety and environment protection as well as non-production-related aspects of overseas products.

Another production behavior worth mentioning’s entrusted processing. The new Regulation on Pesticide Administration loosened control over entrusted processing and repackaging among pesticide enterprises. According to its provision, in case of entrusted processing and repacking of pesticide, the entrusting party shall acquire corresponding pesticide registration certificate, while the entrusted party shall acquire pesticide production license. The entrusting party shall be held liable for the quality of pesticide processed or repackaged on entrustment. New pesticide developers and other pesticide manufacturers may entrust others for processing or repackaging of pesticides. Overseas enterprises may entrust domestic pesticide manufacturers for repackaging of pesticides instead of processing of pesticides. Only pesticide formulations can be entrusted for processing and repackaging, and technical materials (technical concentrates) are not allowed to be entrusted for processing.

Operation

The country implements pesticide business license system, but those specialized in public health pesticides are excluded. In other words, enterprises specialized in public health pesticides don’t need to apply for pesticide business licenses, but they have to establish procurement ledger. Besides, public health pesticides shall be sold in counters separated from other goods.

Labeling

Chinese labels shall be attached to pesticides distributed in China and exported to China. There are some new changes in pesticide labels after implementation of new regulations. Newly added label contents mainly cover the following two aspects: (1) traceable electronic information code, which shall be marked QR code and other means; (2) characters of ‘limited uses’ shall be marked on labels of limited pesticides, and special limits and requirements shall be identified. Public health pesticides mentioned in No. 2567 Inventory of Limited Pesticides (2017) announced by Ministry of Agriculture of the People’s Republic of China include: Fipronil, acephate, chlorpyrifos and fenvalerate.

It’s not necessary to mark safety interval on labels of public health pesticides. It’s not necessary to label public health pesticides for direct uses with featured color band and formulation name. Indoor sanitary pesticides shall be labeled with the words of ‘indoor only’ or ‘prohibited to be used outdoor’ as well as ‘prohibited to be used in silkworm rearing room and nearby areas’. Rodenticide products shall be labeled with prescribed rodenticide symbol. It’s not necessary to mark pesticide production license number of pesticides exported to China, but overseas place of production along with name and contacts of working bodies or agencies established in China shall be labeled. In case of labels of pesticides processed or repackaged on entrustment, pesticide production license number of entrusting party, name and contacts of entrusted party as well as processing and packaging date shall be identified.

In case of existing product labels or manuals nonconforming to Measures on Administration of Pesticide Labels and Manuals, labels and manuals in line provisions of these measures shall be used as of January 1, 2018.

How to Successfully Import Public Health Pesticides into China

In case of pesticide products produced in overseas countries, it doesn’t mean that they can be imported to China for distribution after receiving pesticide registration certificate in the territory of China. According to the provisions, an overseas enterprise can only successfully import products into China by presenting registration certificate, making the enterprise or unit with import and export qualifications in the territory of China who executed and implemented import and export trade contract with foreign party the applicant, and applying for clearance notice for administration of pesticide import registration with ICAMA. Once products have been imported to China after issuance of clearance notice, overseas enterprises are not allowed to directly involve in distribution in China pursuant to Regulation on Pesticide Administration, and they need to establish sales organization in China pursuant to laws and regulations or entrust qualified Chinese agencies for distribution of public health pesticide products.

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