Biostimulant includes diverse substances and microorganisms that are utilized for plant enhancement or stimulate natural processes to benefit nutrient uptake, nutrient efficiency, tolerance to abiotic stress, and/or crop quality apart from its “nutrient content”. Although the term “biostimulant” has not yet been defined under any specific regulation in China, these types of products are most frequently marketed as two types of novel fertilizer: microbial fertilizers and water soluble fertilizers. As stipulated under the MoA Order 32 “Measures for the Registration Management on Fertilizer”, products fall into both categories have to be registered with the MoA prior to placement on the market.   Product under Fertilizer Registration Depending on the nature, nutrient element, origin, production process, mechanism, function and availability of official product specification, analytical method of nutrient/functional ingredient, criterion for efficacy evaluation and other considerations, products subject to fertilizer registration should be registered, labeled and marketed under 29 mandatorily generic names(AgroPedia:China Fertlizer Registration Overview): Types Mandatorily Generic Name Macronutrient Water-soluble fertilizer containing nitrogen, phosphorus and potassium* Urea ammonium nitrate solution* Potassium nitrate for agricultural use Modified ammonium nitrate for agriculture* Calcium ammonium nitrate for agriculture use* Magnesium-potassium sulfate for agriculture use Magnesium-potassium chloride for agriculture use Slow-release fertilizer* Synergized nitrogen fertilizer Secondary Element Water-soluble fertilizer containing calcium and magnesium* Fertilizer containing calcium and magnesium Calcium nitrate for agricultural use Magnesium sulfate for agricultural

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

It has been more than 2 years since Biocidal Products Regulation (BPR, Regulation (EU) 528/2012) applied on 1st September 2013. In 2016, legal deadlines of several articles are approaching, including the notification of 'in situ generated' biocidal active substances, treated article and Union Authorization.

The US is the world’s agricultural superpower and therefore takes the safe use of pesticides and supervision & administration of pesticides registration very seriously. It set up EPA (United States Environmental Protection Agency) in 1970 to safeguard the environment and human health. EPA is responsible for evaluation, suspension and withdrawal of pesticide registration and market approval. 

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%).  

The GLP principle was initially proposed by the US FDA, to ensure the accuracy, reliability and the traceability of test data. The US EPA subsequently implemented the GLP rules within its registration management of pesticide and chemicals. In 1978, the Organization for Economic Co-operation and Development (OECD) issued the “Principles of Good Laboratory Practice” and pushed forward implementation within its member states. Meanwhile, OECD also accepted other non-OECD countries to join its MAD (Mutual Acceptance of Data) system. Currently South Africa, Israel and India have joined OECD’s MAD. However GLP development in China is far behind that of its OECD counterparts despite its dominating position in agrochemical production and exportation. China has not yet joined the MAD system and only a small percentage of its domestic labs are recognized as GLP-compliant by the monitoring authority from OECD members. Much of the safety assessment data obtained by Chinese laboratories is not accepted for pesticide registration by OECD member countries. Chinese companies that wish to export to OECD states must conduct their testing in OECD GLP accredited laboratories which can often mean duplication of testing and heavy financial input. The Chinese authority therefore established its own GLP management system and seek data acceptance by intergovernmental cooperation with other countries. In August 2013, China ICAMA signed an LOI with the Office of EPA on the mutual acceptance of GLP data. The US EPA has just visited China to conduct the compatibility assessment on China’s GLP management system, which could be a milestone in China’s accession to the OECD/GLP/MAD system. It is also expected that a final MOU on GLP MAD would be reached in the near future. Then the data generated by a MoA-accredited GLP laboratory will be accepted by US authorities. The US EPA’s evaluation on Chinese GLP was mainly conducted by Ms. Francisca E. Liem. She also com

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

In 2013 China produced 3.19 million tons of pesticide, continuing the impressive growth the industry has witnessed over the last five years. Import volumes have also grown over the past 5 years, which have diluted profit margins for domestic interests and greatly increased competition. (See ChemLinked News Release on 13 May 2014. Domestic interests can take some solace in the fact that the increase in exportation has heavily outweighed importation. In the early 21th century, China mainly exported glyphosate and paraquat to the overseas market, but China become the major exporter of new generics and out of some profitable generic active ingredient, which includes azoxystrobin, kresoxim-methyl, mesotrione and glufosinate, etc. Driven by favorable exportation importation ratios, the industry has seen growth and significant increase in both revenue and investment. Major Economic indicator of Chinese Pesticide Industry in FY2013 Category Assets(billion CNY) Change (%) Income(billion CNY) Change (%) Profit(billion CNY) Change (%) Chemical Pesticide 176.22 17.3 252.24 18.7 20.74 32.8 Biopesticide 15.22 12.6 28.72 22.3 20.74 13.7 Total 191.44 16.9 281.26 19.1 22.92 30.8 Fixed Asset Investment in FY2013 Category Planned (billion CNY) Change (%) Achieved (billion CNY) Change (%) Number of Projects Change (%) Chemical Pesticide

In June 2014 the price of Chinese produced glyphosate was CNY 30,000 per ton which represented a significant decrease from April’s values which were on average 36,000 and was a mere shadow of the heights witnessed during 2013’s glyphosate rush. It would be reasonable to point the finger at poor overseas sales performances. However upon closer scrutiny China MEP’s failure to stabilize production volume is probably the telling factor and requires both China’s government and domestic industry to profoundly rethink China’s domestic development strategy. China’s government has been almost powerless in reigning in the massive fluctuations in the value of Chinese produced glyphosate and has laid the foundations for massive regulatory reform with the hope of changing this situation.    Global Demand and Policy Failures: The relationship between South American demand and Chinese glyphosate prices was highlighted by a sharp decline in consumption and the inevitable negative impact on glyphosate prices. In response to declining sales, China’s knee jerk reaction has been to attempt to decrease overall supply in the hope of stabilizing price. The Chinese glyphosate industry and the price of Chinese glyphosate exports have been victims of China’s high volume/low quality production paradigm. A dispersed production base divided into the hands of hundreds of small production operations has made price fixing almost impossible. Stabilizing Value Means Controlling the Supply The government’s solution to this problem is to centralize production and ultimately control supply variables, a natural selection by regulation designed to thin China’s glyphosate production herd allowing only the fittest producers to survive. The supposition is that increased regulatory standards and greater regulation of production certification will force substandard glyphosate exporters out of business and thereby consolidat