Photo taken by ChemLinked reporter Fang Lin on 14 September 2014, Shenzhen
Export only registration was offered to facilitate and expedite export of China’s domestically produced pesticides;
Subject to reduced registration data requirements relating to safety and efficacy, production of pesticide for export only poses significant environmental and health and safety risks;
The article relating to export only registration has been removed from the revised draft of China’s new pesticide regulation;
In the short term ICAMA will continue issuing custom notifications for these products to ensure continued exportation;
Communication and interaction with competent authorities managing pesticide manufacturing is crucial at this stage to stay abreast of regulatory obligations;
China has a mandatory registration system for importation and production of all pesticide products. Holding a registration certificate is a precondition of manufacturing approval (MIIT’s approval certificate or AQSIQ’s Production License) for domestic producers. Furthermore, customs will also verify the registration status before each release of imported/exported pesticides.
However, some pesticides banned in China are very profitable in overseas market and some novel pesticides not yet released in China lack requisite efficacy and residue data required during pesticide registration. Under such circumstance, these pesticides are unable to obtain a registration certificate under normal approval procedures. To ensure the competitiveness of China’s pesticide industry on a global stage, ICAMA established the export-only registration category which is applicable to the production and exportation of pesticide banned or not yet commercialized in China.
This registration category requires has significantly reduced data requirements with the stipulation that pesticides registered for export only purposes are not allowed to be sold and used in China. This registration practice was strongly welcomed by both ingenious producers and MNCs. Domestic producers can profit from demand in overseas market and MNCs can quickly produce large amounts of novel pesticide either through their Chinese based companies or by OEM and then export it to target markets without having undertaken more costly and time consuming full pesticide registration requirements for ICAMA registration. According to statistics from ICAMA, over half of the pesticides produced in China are exported and 17% of exported pesticides are registered as export only.
However, the legitimacy of this registration category was questioned by other ministries and departments and a proposal to change this rule was made during the 8th National Expert Committee for Pesticide Registration, which was concluded on 30 Dec 2013. The committee judged that this registration category was only beneficial for industry and did little to ensure environmental and social safety. The committee announced that export only registration should be terminated(see ChemLinked News Release on 24 Jan 2014). In response to the proposal, ICAMA suspended the acceptance of new applications on the 21 Jan 2014 (new applications filed before 21 Jan are still reviewed and approved under the approval procedure) and suspended extension of approval from 9 Apr 2014. As a consequence, all existing export only registrations will expire within one year.
This pending change has caused extensive concern among industry that stand to take a significant financial blow when registration for export only stops. Mr. Zhang Wenjun Division Director of International Exchange and Service from ICAMA delivered some updates about exportation relevant articles that will be included in China’s new pesticide regulation in addition to some of the measures to be adopted in the future.
The controversy surrounding export only pesticides revolves around the fact that existing pesticide regulations provide no legal basis for this registration category. The “Regulation on Pesticide Administration” provides no specific mention of registration of pesticides for export only, nor are there any supporting departmental rules that outline this clause. To solve this dilemma, MoA attempted to append an article into the “Revised Draft of Regulation on Pesticide Administration (2011)”, which was released for public consultation on 20 Jul 2011. The article stated that export only pesticides and minor-crop pesticides had specific data exemptions during registration approval.
However, this article was strongly opposed by other ministries and removed from the draft and the final version of the regulation. Mr. Zhang suggested that companies involved in production of export only pesticides should undertake necessary efficacy and safety studies of their pesticides and apply for full registration. If full registration is still unfeasible in the short term ICAMA will continue issuing the custom notification for these products. However in future production of these pesticides will be illegal. Without a registration certificate manufacturing approval will become invalid. Mr. Zhang revealed that the competent authority of manufacturing management is to issue a special document for the production of pesticides for export only. With the uncertainty surrounding the current and future management of pesticide for export only it is recommended that affected companies communicate and interact with competent authorities at this crucial stage.
