China EC Pesticide Products: Current Status and Regulatory Overview

The first China pesticide approval council since the implementation of China’s first regulations on pesticide solvents HG/T 4576-2013 was held recently in Beijing. There was no new pesticide emulsifiable concentrates( EC) product application considered on the council agenda. However sources suggest that application for production approval of EC products has been reopened.
Production approval for new EC product was suspended by the MIIT in 2009. Since then there have been almost 400 EC product applications made by over 300 companies rejected. The reopening of application for new EC product has been eagerly anticipated by the industry
The obvious questions however still remain… why have EC products been the target of such stringent regulation? What are the consequences for EC products in china? What can we expect in the future?
 
Past
The Pesticide EC formulations are characterized by high active ingredient content, storage stability, convenient to use, simple formulation process, low technological requirements for formulation machinery and in comparison to other pesticide products reduced waste during formulated process. The production of EC products always exceeding 20% of the total output of pesticide formulated products in China.
According to ICAMA，total 9466 EC products have been registered with ICAMA by the end of 2013. The second highest number of registered formulated products is wettable powder at 6122. The culminative total number of other registered formulation is 9240. The registration number of EC products represents almost 40% of all the registered formulations registered in china.

Though Pesticide EC formulation has the advantages previously mentioned there are still some disadvantages caused by the large quantity of light aromatic solvents contained in the EC products, which are volatile, inflammable, and highly hazardous to humans and environment. These solvents include benzene, toluene, xylene etc. Some highly toxic or carcinogenic substances have also been used in EC products such as methanol and DMF.
To control the hazards caused by EC products, the competent authorities have taken some measures since 2006:
*In 2006, the former National Development and Reform Commission (now MIIT) announced in 4^th Announcement of 2006: No EC pesticide enterprise shall be granted production application approval after 1^st July, 2006.
*In 2009, MIIT announced in Announcement “GONGYUAN (2009)29^th) that new EC pesticide’s production approval will be suspended from 1^st August, 2009
MIIT has also considered stopping the production of EC products containing aromatic solvents such as benzene, toluene and xylene at a right time except the pesticides which can only be formulated as EC products.
The production of new EC products have been suspended for several years since the two announcements ( 4^th Announcement at 2006 and GONGYUAN (2009)29^th), the proportion of EC products registered has decreased from about 40% to about 20%.
It’s generally only the solvents in the EC products that contribute to the risk caused by EC products. The EC formulation is usually comparatively safe and considered as a good formulation. The best way to manage EC products is not to impose blanket bans on the industry but to control the chief causative agents associated with their poor safety profile. If the hazardous solvents in EC products are replaced by safer and more environmentally friendly products, it will greatly improve their poor reputation.
In 2010 MIIT outlined its agenda on prioritizing the use of safer solvents in EC products to decrease environmental impact. Solvents such as plant oil or straight-chain paraffin were referenced as ideal alternatives to hazardous compounds. In 2010 CCPIA also proposed to limit the content of those hazardous solvent in EC products which was accepted by MIIT in 2011.
Current status
The final content of the proposal was released in 2013 as Industry standard HG/T 4576-2013 by MIIT Announcement No. 52.  The content of five hazardous solvent and two common impurities have been limited as followed:

The work schedule of MIIT concerning on the standard is as followed:
From 1^st March 2014, companies who apply for the new production approval or renewal production approval shall submit test reports issued by recognized test units and tested according to the HG/T 4576-2013 for the contents of those solvents in their EC products. Testing should also be conducted in accordance to the enterprise product quality standard. Alternatively, the content of the hazardous solvents should be listed as items that must be checked in the enterprise product quality standard of EC products. These items must appeared in the test reports issued by governmentally sanctioned test units
Next, the enterprise product quality standard and the standard on the limit of hazardous solvents shall both be printed on the column of product implementation standard on the new product production approval certificate.
The other step is to recommend one list of safe and applicable organic solvents.
Now one list of acceptable solvents has been published by CCPIA, on which examples of acceptable heavy aromatic solvents, plant source solvents and substitute solvent all are listed. Plant based solvents and substitute solvent will generally be prohibitively priced to make them a viable option however heavy aromatic solvents are much cheaper.
As the management of pesticide in china is controlled by several departments, MIIT’s influence only extends to the product production approval. The pesticide registration and pesticide production license are run by ICAMA and AQSIQ. The ICAMA and AQSIQ have not released any rules special for EC products. That’s why there are still so many EC products registered and circulated in china pesticide market after the ban of pesticide production approval.
The ICAMA and AQSIQ have declared to support and coordinate the implementation of the HG/T 4576-2013, but there is no schedule at present.
At the beginning of 2013, china MIIT, MOST (Ministry of Science and Technology) and MEP (Ministry of Environmental Protection) jointly published the National Encouraged Substituted Category for Toxic and Harmful Raw Materials, which mentioned that organic light aromatic solvents (such as benzene, xylene)used in EC products shall be substituted by green solvents like resin-based solvents or white oil etc.
Industry feedback on the hazardous solvent substitution agenda
One industry representative pointed out that plant source solvents are only applicable for some oil liquid TC products. The solubility, reduced emusifiability and the poor stability at low temperature characteristic of plant based solvents are not good as aromatic solvents.
Concerning the cost, one business representative complained that the profitability of china’s EC products is based on a model that requires high production volume and low price. Any price inflation is likely to seriously damage the competiveness of the market. Solvent substation in EC products will certainly increase the cost substantially. An industry precedent can be seen in the past increase in methanol prices. The recommended solvents are even more expensive than methanol, so how will the industry respond?
Another major concern is how the new standards will effect exportation of EC products. In fact EC products manufactured only for export still legally require production approval or licence in china.
Future
The roadmap and timeline for regulatory reform of EC products have not been published by the relative competent authorities. CCPIA has proposed that the standard will be implemented over the next four years. EC products which are concentrated, commonly used and for which new solvents have been launched shall be the first batch of products to implement the standard. 44 products including abamectin and chlorpyrifos have been added in the list.
First products to be implemented HG4576-2013 proposed by CCPI

 
According to CCPIA plan, solvent substitutes for the first batch of EC products shall be finished before 30 September, 2014, and the review on the new formulations shall be conducted along with the application or renewal of pesticide production approval or pesticide production license. The solvents substitutions of the second batch EC products will be conducted from the 1st October 2014 to 30th September 2015. EC products for which there are no viable substitute solvents for both domestic and overseas EC products shall have production approval postponed, have restricted or limited use, require change of the formulation or be banned.
There is only 5 months left for the first EC products to substitute solvents. The implementation of HG 4576-2013 is has yet to have any practical application as there is no new EC product awaiting pesticide production approval. The competent authorities issued statements, but not officially published anything on the topic. Though HG/T4576-2013 is only a recommended standard competent authorities will use it as a reference when reviewing products for administrative licensing. The possibility of this recommendatory standard being upgraded to a compulsory standard is very high. Compliance now will ensure are ready in the future.
 
Taking Abamectin 1.8% EC as an example (which has been listed as top 10 products exported from china during recent years) we can outline what manufacturers should do to comply with HG/T4576-2013.
The execution product quality standard of Abamectin 1.8%EC is national standard GB 19337-2003. A registration certificate and pesticide production license must be obtained before it can be legally manufactured and marketed both in China and abroad. The commonly used solvents contained in Abamectin 1.8% EC are toluene and xylene The company should take the following steps to meet the requirement of HG/T4576-2013:

1. Substitute the old harmful solvents by new solvents and correspondingly amend chemical ingredients list

2. Provide test report issued by recognized test unit to confirm the compliance of the product with standard when applying for or renewing the pesticide product license

3. Provide test report issued by recognized test unit to confirm the compliance of the product with standard when applying for or renewing pesticide registration certificate

4. Apply to ICAMA for change of the pesticide registration after the new data requirement on pesticide registration is released.

5. Change certain ingredients to comply with registration regulations outside china.

A major consideration is cost benefit analysis of solvent substitutes. A feasibility study must be conducted to assess the costs of solvents versus the expected acceptance of the cost increase passed on to the consumer of the final product. The performance of new solvents will need time to be tested and verified etc. The implementation of HG/T 4576-2013 and the innovation of China EC pesticide product is going to take considerable time.
 
Abbreviation in the article:
ICAMA: Institute for the Control of Agrochemical, Ministry of Agriculture, P.R.China
MIIT: Ministry of Industry and Information Technology of the People’s Republic of China
AQSIQ: General Administration of Quality Supervision, Inspection and Quarantine of the people’s Republic of China
CCPIA: China Crop Protection Industry Association
EC: Emulsifiable Concentrates
 
Glossary
Pesticide production license:
 One of the two legal production certificates needed to manufacture pesticide in China. If the product quality standard of one product is a national standard (GB), or     industry standard (HG), the manufacturer must apply for pesticide production license for that product before it can be legally produced.
Pesticide production approval:
One of the two legal production certificates required to manufacture pesticide in China. If the execution product quality standard of one product is enterprise standard (Q/), the manufacturer shall apply for pesticide production approval for that product before the product can be legally produced.
Execution product quality standard:
One file containing the specification, test methods of the test items in specification, and other requirements including label, marks, package shipment, storage and shelf life of the pesticide product. There are three types of product quality standards in china including national standard, industry standard and enterprise standard. For more information on pesticide standards, please refer to Chemlinked agropedia…
Harmful solvents:
A solvent shall be considered a harmful solvent if any of the following conditions are met:

1. Significantly carcinogenic or teratogenic

2. Potential risk to the handler and user

3. Low flash point, inflammable and explosive

4. Volatile organic compound (VOC)

5. Easy water-soluble