“Decree 677-Regulation on the Administration of Pesticides” was a prelude to more far reaching regulatory/legislative/administrative reform in the Chinese pesticide sector. Comparing current regulations with pending regulations and the drafts of the 5 supporting rules, the impact on pesticide production is foreseeable. Clearer Division of Labor, Centralized Management and Fewer Certificates Under the new system enterprises wishing to engage in pesticide production should firstly notify the MIIT. Depending on the corresponding product quality standard, an enterprise should either apply to the AQSIQ for the production license or apply to the MIIT for the single product production approval. In the past multiple authorities were involved which lead to administrative overlap, redundancy and overall inefficiency. Pesticide Production Management under Chinese Current and New Regulations

China’s new pesticide regulation will take effect on on 1 June 2017 and 5 draft supporting rules have been released for departmental consultation, all of which support the pending new regulation. An analysis on the context, alternation and timeline of the new license requirements and regulations specified in the new pesticide regulation and supporting documents will provide important data to help minimize compliance failures. Pesticide Registration Existing Regulation(old) Data Requirement on Pesticide Registration (MoA order 10) New Regulation(draft) Administrative Measures for the Registration of Pesticide Alternation To be abolished with the effectiveness of new regulation Transitional Term Applications accepted prior to the new regulation will be reviewed under old regulation; Temporary registration issued prior to the new regulation will not be renewed; Note: Detail guidance on the administrative and technical requirements is still needed and MoA would release the supporting document separately Pesticide Production Existing Regulation(old) Rules for implementing the Production license on Pesticide (AQSIQ rules); Measures for the Administration on the Manufacturing of Pesticide-(order 23 of NDRC, being implemented by MIIT) New Regulation(draft) Administrative Measures for the Production of Pesticide; Transitional Term Enterprises that obtained the production license/manufacturing approval prior to the effectiveness of new regulation may continue to produce pesticide before the expiry; Enterprises that want to continue the production after the expiry of

Biopesticides are certain types of pesticides derived from such natural materials such as animals, plants, bacteria, and certain minerals. For example, canola oil and baking soda have pesticidal applications and are considered biopesticides. From the legislative/regulatory perspective, in China Biopesticide is considered as a type of pesticide category which belongs to biological pest control (kill or inhibit harmful organisms by biological measures). Different countries or regions have different definition and scope of biopesticides. Please refer to the table below for the scope of biopesticide in different countries or regions.

Risk assessment of pesticides has been given higher priority in recent years. Reform of Chinese pesticide regulations has seen increasing restrictions/prohibition place on many pesticides. In terms of the money an enterprise must spend during registration, registering a pesticide for use on vegetables offers no clear economic or market incentives to registrants when compared to registering a pesticide for use on grains. In addition there are no specific favorable policies afforded to pesticides registered for use on vegetables when compared to registering a pesticide for use on minor crops. An analysis of the registration status of pesticides designated for use on vegetables pesticides can help to predict which pesticides will be subject to revaluation and also help reflect the degree of competition in this niche market. Product analysis By then end of 2013, 7,473 formulations of 635 active ingredients/combinations had been registered on vegetable crops, of which 262 are single compound pesticides and 373 are multiple compound pesticides. Usage of these pesticides covers 94 crops and 123 pests/diseases. Insecticides accounted for 59% (4361) of registrations, followed by fungicides (2459), herbicides (469) and PGRs(148).

A double digit decrease in exportation figures and a muted performance from China’s domestic market have reduced the profits of Chinese agrochemical producers; The full chain agronomic services offered by multinationals and domestic distributors have forced the traditional middleman out of the supply chain equation; Rising costs of compliance with China’s EHS regulations has transmitted to the agrochemical industry; Domestic products saw reduced or flat prices while imported products achieved 10 to 20 percentage growth; In 2015, China produced 1.33 million tons of pesticide active ingredients, down from 1.49 tons in 2014. Exportation fell by more than 10% in both volume and value terms. Influenced by complex factors including weather, regulatory policies and changing distribution channels, the domestic usage was slightly lower than expectation at 0.3 million tons, causing Chinese producers to feel the pinch of higher fuel and labor costs. Production and International Trade The largest percentage reduction occurred in herbicide and insecticide categories, decreasing the total production by about 11.7% compared to 2014, representing a 4-year low. Table1- Chinese Pesticide Production in 2015 (a.i., 000 tons)

As a preliminary and essential step in registering a pesticide finished product in China, the applicant should obtain the field trial approval from the MoA. Efficacy and residue studies can be then performed in accordance with full registration requirements. The MoA Order 10 “Data Requirement on Pesticide Registration” was issued in 2008 to specify the requirement for each category of pesticide. The success rate of field trial application decreased from over 90% in 2007 to less than 70% in 2009. ICAMA has summarized the most common problem during field trail application and efficacy study to help applicants better understands data requirements. Field Trial Application General Requirement Applicants are required to fill the “Application form of Field Trial for Pesticide Registration” including the following details: Data Requirement for Field Trial Application   New Pesticide New Formulation Me-too Product Novelty containing on AI(active ingredient )which was not yet registered in China or the active ingredient was within the 6 years’ data protection period containing on AI which was already registered in China, but differ from previously registered product in formulation type, AI composition (AI of single compound formulation or the combination and ratio of the AIs in multiple compound formulation) or content level Formulation , AI combination/ratio and content level were identical to the product previously registered in China Product Chemistry Summary on the active ingredient, technical material and formulation; Summary on the active ingredient and formulation If the product contains active ingredient which was previously registered but under data protection in China, the applicant should provide the infor

Although Indonesia is one of the world’s major agricultural countries, in terms of its domestic capacities it lacks many of the basic agricultural inputs particularly in its indigenous pesticide industry. Indonesia’s pesticide industry is highly dependent on importation. In 2012 Indonesia’s pesticide market was valued at approximately 400 million USD. About 64% of Indonesia’s market was controlled by MNCs and the largest pesticide consumers by sector were rice cultivation (41%) and palm plantation crops (27%).  

Currently the most important regulation on non-agricultural pesticides in Taiwan is the Environmental Agents Control Act (Taiwan EACA), which was updated by Presidential Order on 27 January 2006. The EACA stipulates that chemical agents or microbial preparations used for environmental sanitation and pollution control are subject to this regulation. Classification and Registration Permit Generally, environmental agents can be classified into the following three types by their product features and application range: Insecticides, miticides, rodenticides, bactericides/fungicides used for environmental sanitation, and other chemical agents used against target organisms (Sanitation Environmental Agent); Synthetic chemical agents used for preventing air, water, or soil pollution, or treat waste, which should be officially announced by Taiwan EPA(pollution control agent); Natural or artificially-modified microbe organisms or their metabolites used for preventing air, water, or soil pollution, or treat waste all of which should be officially announced by Taiwan EPA (microbial environmental agent);   Depending on the role they play in the supply chain and the supervision they are subject to, environmental agents can be also distinguished as technical grade environmental agent, general use environmental agent and special environmental agent: Technical Grade EA: raw material containing the active ingredient and utilized for manufacturing or processing general use environmental agents or special environmental agents General Use EA: manufactured or processed from the Technical Grade EA and used in a similar manner. The concentration of active ingredient(s) should conform to the limits designated by Taiwan EPA; Special Environmental Agent: manufactured or processed from the Technical Grade EA or other chemical agents designated by the central competent authority, SEA shall be used following specific safety protection measures.

In the United States, the overarching regulation on pesticide management is the Federal Insecticide, Fungicide, and Rodenticide Act(FIFRA), which specifies the definition of a pesticide as: any substance or mixture of substances intended for preventing, destroying, repelling or mitigating any pest, or use as a plant regulator, defoliant, or desiccant, as well as any nitrogen stabilizer. On day two of the Chemical Regulatory Annual Conference, Mr. Robert Kiefer from Reach24H USA introduced the regulatory system of pesticide and antimicrobial products in the US. Overview of Requirements for US Pesticide Registration Laws and Regulations All pesticides (including imported pesticide) sold or distributed in the US are required to be registered with the Environmental Protection Agency (EPA).However, if the substance falls under the category of liquid chemical sterilizing agent, nitrogen stabilizer, human drug, animal drug, animal feeds (vitamin hormone products) or is intended to aid the growth of desirable plants, it is excluded from regulation by FIFRA. In addition, pesticides are regulated by the EPA under a series of supporting regulations. The name and EPA’s function under associated regulations are summarized as follow: Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA) – requires all pesticides sold or distributed in the U.S. (including imported pesticides) to be registered by EPA Federal Food, Drug and Cosmetic Act (FFDCA) – requires EPA to set pesticide residue tolerances for all pesticides used in or on food Food Quality Protection Act of 1996 (FQPA) – established safety criteria of “reasonable certainty of no harm”, and EPA must review pesticide registrations every 15 years Pesticide Registration Improvement Act of 2003 (PRIA) – established pesticide registration fees and defined Agency  timelines Regulations implementing the pesticide statutes a