Changes and Development Status of China’s Public Health Pesticide Registration in Recent Years

Public health pesticides refer to pesticides 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. The new version of Regulations on Pesticide Administration was promulgated for implementation in 2017, and then Measures on Administration of Pesticide Administration and 4 other supporting regulations along with Data Requirements on Pesticide Registration and 5 other regulatory documents were released successively, which have positive and profound impacts on the standardized development of public health pesticide industry. Pesticide registration is a critical factor for pesticide products’ entrance into the market, hence changes in pesticide registration can reflect the current status and future trend of development of pesticide industry to a certain extent. CIRS has specified changes in public health pesticide registration policies under new regulations, summarized and analyzed public health pesticide registration situations and characteristics in 2018 as well as recent years for the reference of R&D and registration of public health pesticide products.

1 Changes in administration of public health pesticide

1.1 Specify public health pesticides' classification

The new Data Requirements on Pesticide Registration divided public health pesticides into the two classes of household health insecticides and environmental health insecticides for the first time. Household health insecticides mainly refer to public health pesticides that can be directly used in room without dilution and other treatments, while environmental health insecticides refer to public health pesticides used in indoor and outdoor environment after dilution and other treatments. Those two classes are not only different in method of application, but also vary in efficacy and safety assessment as well as registration data requirements. This classification could benefit regulators’ scientific assessment of products and users’ proper use of products.

1.2 Increase requirements on registration of public health pesticide products

• The new Data Requirements on Pesticide Registration has divided public health pesticide registration data into general data, product chemical test data, toxicology test data, efficacy test data and environmental impact test data. New changes have been made in pesticide registration:
• Firstly, registration barriers of public health pesticides have been increased, content-grades of single active ingredient formulation products of the same active ingredient and formulation shall not exceed three, and limits on ratios and content-grades of mixtures have been imposed to reduce product similarity, which also limited the number of public health pesticides to a certain extent.
• Secondly, registration of technical materials of public health pesticides have been made basically the same to that of registration of active ingredients of field pesticides, registration standards have been unified, and the number of registration certificates all started with PD instead of WP.
• Thirdly, risk assessment requirements have been raised, report on resident health risk assessment shall be submitted for household health insecticides, while report on pesticide user’ health risk assessment along with report on environmental risk assessment shall be submitted for environmental health insecticides.
• Fourthly, analysis reports on substitutability and benefits have been added to prove the product which is to be registered has obvious advantage or equal efficacy when compared with the registered products.
• Fifthly, provision of ‘three scents for a certificate’ has been removed, it’s no longer necessary to file scents of public health pesticides with ICAMA, and alteration registration is not required in case of changes in contents of essence ingredients within 1%.

1.3 New labeling requirements

According to provisions of Measures on Administration of Pesticide Labels and Manuals, it’s not necessary to label public health pesticides for direct uses with featured color bands. In addition, following new label contents have been added to labels: firstly, traceable electronic information code shall be added; Secondly, characters of ‘limited uses’ shall be marked on labels of limited pesticides, which shouldn’t be smaller than pesticide name.

2 Analysis on general situation of public health pesticide registration

2.1 Number of registrations

New version of Regulation on Pesticide Administration (RPA) has cancelled temporary registration, and pesticides registered in China at the current stage are all formal registrations. By December 31, 2018, active ingredients and products of public health pesticides under valid registration status reached 95 and 2,594 respectively. Number of public health pesticide registrations had been dropping in the three years from 2014 to 2016 at an annual average speed of around 36.3%, while the number of public health pesticide registrations had been growing in the three years from 2016 to 2018 at an annual average speed of around 33.8%. See details in Diagram 1.

2.2 Registration characteristics

2.2.1 Continued increase in micro toxicity/low toxicity pesticides

The annual proportion of registrations of micro toxicity and low toxicity public health pesticides in annual number of registrations has been maintained at above 90% for 5 years in a row (annual average of 95%). Since public health pesticides are normally used in room, great attention has been paid to their safety. Accompanied with implementation of the new version of RPA and supporting regulations, registration of safe, economic and effective public health pesticides will be further encouraged to eliminate high-risk products and ensure safety of pesticides.

2.2.2 Environmentally friendly formulations increase

By the end of 2018, there have been over 50 registered formulations for public health pesticides, and the formulations were still dominated by six major formulations of aerosol dispensers, mosquito coils, liquid vaporizers, vaporizing mats, suspension concentrates and baits. The environmentally friendly formulations of suspension concentrates had shown a decrease in proportion from 2014 to 2016 with an annual average decrease rate of 32.6%, in contrast it had shown continued increase in proportion from 2016 to 2018 with an annual growth rate of 45.8%, and suspension concentrates still showed an increasing tendency as a whole. It’s worth mentioning that baits had experienced rapid development in recent 5 years in both type and number with an annual average growth rate of 27.1%. Since aerosol dispensers, mosquito coils, liquid vaporizers and vaporizing mats could generate VOCs and PM2.5 that affect people’s health and safety during their uses, proportions of those four formulations all showed decrease tendency in the recent 5 years with annual average decrease rate of 16.1%, 11.3%, 7.3% and 14.3% respectively.

Besides, types of environmentally friendly formulations in newly added pesticide registrations have been increasing on a yearly basis. In addition to conventional suspension concentrates and baits, there are also water dispersible granules, repellent liquid, repellent milk, dispensors and long-lasting insecticidal nets.

Notes: AE - aerosol dispenser, MC – mosquito coil, LV - liquid vaporizer, MV - vaporizing mat, SC - suspension concentrate and RB – bait.

2.2.3 Active ingredients were still dominated by pyrethroids

According to statistics, active ingredients and products with valid public health pesticide registrations in China reached over 70 and over 900 respectively by the end of 2018. From the perspective of registration data between 2014 and 2018, top ten active ingredients were as indicated in Table 1. Among which, meperfluthrin, prallethrin and permethrin had relatively large registration numbers, which were 213, 82 and 77 respectively. Besides, types of registered active ingredients had been slowly increased as well. In addition to conventional pyrethroids components, number of registrations of pyriproxyfen, dinotefuran, indoxacarb, icaridin and other active ingredients had been increased significantly in recent years, and there were also certain number of registrations of eucalyptol, S-methoprene and other new active ingredients of public health pesticides.

Table 1 Top 10 registered active ingredients between 2014 and 2018

3 Summary and perspective

Generally speaking, accompanied with promulgation and implementation of new regulations, China’s public health pesticides have been moving towards a safe, efficient and economic direction, and the elimination of high-risk products have been accelerated. Supporting document of Data Requirements on Pesticide Registration of the newly revised Regulation on Pesticide Administration has been implemented as of November 1, 2017, accompanied with gradual implementation and functioning of different new regulations, number of registered products will gradually level off due to increased requirements on registration data and limits on content-grades on one hand, and deregistration in case of major risks found on the other hand.

Regulation on Pesticide Administration has increased barriers for safety management of public health pesticides. In terms of formulation R&D, given the increase in both experimentation cost and risk assessment requirements, businesses shall carefully screen formulas and select adjuvants to develop low risk and environmental friendly products for successful acquirement of registrations.

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Interpretation of China's Regulatory Requirements on Public Health Pesticides