China Pesticide Registration: Assessment of Risk to Aquatic Ecosystems
Pesticides are wildly used in agricultural production in China. The use of pesticides affects the environment significantly. Pesticides are introduced to the aquatic ecosystem in a variety of ways such as, leaching, evaporation and precipitation cycles, surface runoff etc. Chinese manufacturers produce a large amount of pesticides every year. Technical material production accounts for about 60% of global production capacity. This article will briefly introduce assessment of risk to aquatic ecosystems in China. Pesticide registration in China is based on tiered assessment whereby increased production volume incurs increased regulatory compliance requirements including the evaluation of pesticide impact to aquatic ecosystems. If primary evaluation is unacceptable, senior assessment is necessary. Environmental risk assessment consists of:
Exposure assessment (predicted environmental concentration, PEC)
Effect assessment (predicted no effect concentration, PNEC)
Risk characterization (risk quotient, RQ).
Exposure Assessment
Exposure assessment is made up of primary exposure assessment and senior exposure assessment. For primary exposure assessment, a model is used to predict the surface water exposure level in which worst case scenarios are chosen for model parameters. Generally, the PEC is the maximal predicted environmental concentration, or the weighted predicted environmental concentration.
For senior exposure assessment, modified parameters or field test data are often used in the exposure model, to find parameters similar to the actual situation. Actual monitoring data of common pesticides is also used as the exposure level. When using a model to analyze the exposure concentration, the areas of use, sites of application and methods of application should be considered to obtain the final PEC. During the exposure analysis, we need to find the appropriate endpoint, including soil adsorption coefficient, hydrolysis half-life, photolysis hal
Overview of Chinese Pesticide Market in 2015
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)
Biostimulants under China’s Fertilizer Regulations
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
China Pesticide Registration Hampered by Major Deficiency in Field Trial Application and Efficacy Study
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
Chinese Pesticide GLP Compliance
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
China's Top 100 Pesticide Companies in 2013
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
Natural Selection By Regulation: Survival of China’s Fittest Glyphosate Producers
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
The Impact of China’s Environmental Inspection on the Glyphosate Industry
The effect of environmental protection inspection on China Glyphosate industry, EPI progress, the next work plan of CCPIA on Glyphosate manufacturers and how EPI effect on the price of Glyphosate etc. are all discussed in this article. The author is came from CCPIA, one half government organization organized and directing the Glyphosate EPI.
Chinese Disinfectant Product Regulations
The last change and development of China disinfectants management are frequent and significant. what has happened and what's the new requirements of regulatory compliance in China? what's the most relevant issues?
China Pesticide Import/Export Management
This article details the regulatory requirements and mandatory procedures for import and export of pesticides in China and the management of the two special pesticide types a) pesticide for export only and b) substances falling outside the regulatory definition of pesticides but used in pesticide applications commonly known as “non-pesticide use pesticide (NPUP)”
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