The current inflationary trend in glyphosate prices is reminiscent of 2008 when the price surged to over 100,000 Yuan per ton. This previous “glyphosate bubble” hallmarked by a huge price increase and subsequent crash is tempering investors and speculators enthusiasm with understandable caution. After bottoming out at a low of 19,000 Yuan per ton, glyphosate’s value has seen steady and dependable appreciation. At first glance this inflation can be attributed to simple fluctuations in the cost of raw materials and newly enacted government regulations in China. However upon closer scrutiny and detailed analysis we see that the recent price rise has been preceded by fierce political maneuverings, trade disputes and to a large extent the calculated business savvy demonstrated by Monsanto. Glyphosate production is an integral cog in the economic engine of China’s crop protection manufacturing base. The amount of associated industry upstream and downstream both foreign and international involved in its productions, distribution transport etc. cannot be understated and for this reason the Chinese government is understandably protective of its interest. Treading a dangerous line between outright anticompetitive behaviors and protecting its indigenous markets, the Chinese government has adjusted the export tax rebate on N-Phosphonomethyl Aminodiacetic Acid (PMIDA) (an important precursor chemical of glyphosate). The removal of the 13% rebate was pitched as an environmental initiative to protect China’s phosphorus resources. However an ulterior motive for this move which has a hugely significant (and surely intended) knock-on effect is the promotion of the indigenous Chinese glyphosate industry. Foreign manufacturers sourcing PMIDA from China are now at a sizeable disadvantage in comparison to their Chinese counterparts. The move has been welcomed by the Chinese glyphosate industry and seems to have had the desired effect with indigenous enterpr

REACH24H as member of the Regulatory Toxicology and Risk Assessment Committee attended the Member Congress hosted by Chinese Society of Toxicology at 29 May, in Suzhou China. At this congress, Mr. Tao Chuanjiang from ICAMA (Institute for the Control of Agrochemicals, Ministry of Agriculture) disclosed the recent progress and achievements in pesticide risk assessment in China through his presentation of “Development of Pesticide Environmental Risk assessment Approach in China”. In this article, I would like to outline the most significant issues addressed during this presentation. Pesticide regulations addressing safety considers from a dual perspective, attempting to manage and control both their inherent agricultural impact and the negative impact on public health associated with their use. The Chinese regulatory system bears some similarities to the US system but lacks the overall regulatory scope of its US counterpart. The legislative foundation which the risk assessment criteria are built upon is the “Regulation on the Administration of Pesticide” which is the primary law for management of pesticide in China, and which also specifies the registration requirements of pesticide.

The GB 2763-2012, which was issued under the joint Announcement 22 of MOA and MOH, has come into force on Mar 1 2013. As the latest compulsory standard, it contains 2293 limits for 322 active ingredients on 10 categories of food commodities, and can also be considered as a replacement of some previous national standards and industrial standards of pesticide MRLs. Overview of the 2293 MRLs The GB 2763-2012 set 2253 MRLs for plant-derived food and 40 for animal-derived food, constituting around 98.2% and 1.87% respectively. Vegetables will be subject to the most MRLs, followed by fruits, cereals and cereal products, oil plants and oil products, sugar crops, beverages and edible fungus (see Table 1). Table 1: Distribution of MRLs in different food categories GB 2763-2012 vs GB 2763-2005 Compared with the 2005 version, GB2763-2012 has a number of improvements: 1.More explicit in scope, terms and definitions. The 2005 version provided a precondition that “when producing food or protecting food commodities from pests, the pesticide should be utilized according to the rules of Good Agricultural Practices (GAP)”, which left the loopholes of MRL violations on some food commodities as the poor enforcement of GAP in China. The removal of this precondition has broadened the range of acceptable MRLs. Furthermore, other definitions in 2005 versions which included the “acute reference dose”, “provisional-acceptable daily intake”, and “provisional tolerable daily intake” have been removed as well. An important revision is that the English name/definition of the residue, the “pesticide residue” has been amended as is now reffered to as the “residue definition” (hereafter refer to the “pesticide residue” as “residue definition”). To better explain the MRLs applicable in different crops and food commodities, GB 2763-2012 specified the crop/food ranges in its Informative Annex

Pesticide residue problems and food safety scandals have proved fertile ground for the growth of the biopesticide sector in China's crop protection industry. Addiontally favourable legislation and regulations are designed to prioritize innovation in this sector. Buzz words surrounding the biopeticide industry in China such as, “data exemption” and “faster approval process” have been frequently mentioned by industry experts and ICAMA officials. Yet statistically, of  the 14 applications denied  full new pesticide registration in the second half year of 2012, 8 were submitted as bio-pesticide products. A key failing of these applications was the data submitted in the registration dossier. Insufficient communication between regulators and industry is a key factor in the poor performance of the biopesticide sector. Data Requirement for Biopesticide The supporting document, “Data Requirements on Pesticide Registration” which came into force on 8 Jan, 2008, has explicitly detailed the data requirements of different types of application. As for new bio-pesticides, the requirement falls under the Chapter IV, “Registration for New Special Pesticides”. Generally, biochemical pesticides, microbial pesticide, botanical pesticide, GMO and predator species are classified as bio-pesticide. As the above types of bio-pesticide are distinct in nature and properties, their differences or similarities during registration are demonstrated in Table 1 and table 2 Excerpt of Table 1 For full content of Table 1, click here to Download.   Excerpt of Table 2 For full content of Table 2, click here to Download. Regulatory Amendment on the Way To foster the development of the biopesticide industry, the Ministry of Agriculture issued a revised draft for data requirement on pesticide regulation in April 2011: The antibiotics for farm use will be regarded as biopestici

China is one of the largest pesticide exporters in the world with  exports of 1,440,000 tons in 2011. Chinese pesticides are however criticized by the international stakeholders for being inferior and of poor quality. To combat the dismal reputation of Chinese products, the government is developing new regulations. Although the final legal text of new pesticide regulation has not been published, inferences on its content and scope can be made based on statments made by officials from the ICAMA (the Institute for the Control of Agrochemicals, Ministry of Agriculture). Boosted R&D Oriented and Environmental-friendly Players The Chinese industry is saturated by small and medium sized companies producing a limited number of pesticides. Therefore, fierce competition and underselling of these pesticides to the overseas market is a common phenomenon. R&D activities are almost completely isolated to a number of the larger Chinese companies and of course multinational corportations.In China, pesticide companies are required to obtain both the ICAMA registration and the manufacturing permit issued by industrial authorities: the Ministry of Industry and Information Technology (MIIT) or the General Administration for Quality Supervision, Inspection and Quarantine (AQSIQ). Only manufacturing companies can be granted the ICAMA registration therefore there is little incentive for R&D. This dilemma will only be solved when registration for new pesticides can be applied for by  non-manufacturing companies and the registration certification can be subsequently transferred to other manufacturers. Furthermore, the “one registration certificate, one manufacturing permit” policy required by manufacturers is also likely to be relaxed. Under this potential ammendment if a pesticide company has been granted a manufacturing permit but not yet granted ICAMA registration, it can be commissioned by other ICAMA registration holders to manufacture the produ

There are four correlated regulations are available for the agrochemical companies to maintain their intellectual properties in China. However due to China’s backward IP protection system and different interpretations by different competent authorities, patent protection is increasingly favored by  MNCs and Chinese companies. 

Biocidal products in China are classified and administrated as different kinds of commercial products in terms of their various application targets and application areas, the 23 types of products in the EU BPR are regulated as pesticides, veterinary drugs, medicines, food or feed additives, disinfectants, drinking water-relevant products, etc. in China.

This Regulation is promulgated by the State Council of P.R. China to supervise and control manufacturing, marketing and use of pesticides/agrochemicals in China. It entered into force on May 8, 1997, and was revised on 29th November 2001 according to the decision of China State Council. Two subordinate regulations were issued by China Ministry of Agriculture to provide guidance on implementation of this Regulation.