China's MEE Order 12 Draft: Key Changes for Pesticide Exporters to China

I. Key Regulatory Changes

According to the draft amendment, two major revisions will directly affect pesticide exporters to China:

• Redefinition of the Pesticide Exemption Scope: The current MEE Order 12 provides an exemption for pesticides and other products already governed by dedicated regulatory frameworks. The draft amendment redefines the scope of this product-category exemption, meaning that certain chemical substances in pesticide products — including active ingredients in pesticide technical materials and formulation adjuvants — that are not listed in the Inventory of Existing Chemical Substances in China (IECSC) may become subject to dual regulation by both the Ministry of Agriculture and Rural Affairs (MARA) and the MEE.

• Cancellation of the Local Representative System: The draft amendment specifies that the applicant must be a legally registered enterprise in China capable of independently assuming legal liabilities. Foreign companies will no longer be allowed to apply for registration directly through a local representative.

II. Major Impacts on Companies Exporting to China

These two adjustments will have a direct impact on companies relying on pesticide exports to the Chinese market:

• Shift of Registration Obligations: The registration obligations for new chemical substances will transition to domestic importers in China.

• Confidential Business Information (CBI) Protection: Since companies outside China cannot apply directly, if a new chemical registration is required, foreign suppliers and domestic importers/partners must redefine the boundaries and transmission pathways for CBI (such as formulation details and impurity profiles).

• Restructuring of Commercial Agreements: These companies will need to renegotiate with their Chinese partners regarding the cost-sharing of testing and the provision of data required for registration.

III. Compliance Recommendations

In light of these regulatory updates, companies exporting pesticides to China are advised to take the following measures:

• Conduct Substance Inventory and IECSC Search: Promptly review the chemical components of products exported to China (both active ingredients and formulation adjuvants) and search their status in the IECSC.

• Re-evaluate Compliance Entities and Data Transmission: Assess the feasibility of coordinating registration through a local subsidiary in China to retain registration ownership. If registering through a Chinese partner/importer, plan ahead for formula information isolation and safe transmission pathways.

• Adjust Supply Chain Contracts: In upcoming commercial agreements, clearly define the cost-sharing of registration, the methods of data support from the foreign supplier, and strict confidentiality clauses for CBI.

Meanwhile, enterprises are advised to closely monitor the latest progress of this revision. The final compliance plan should be subject to the officially released regulatory texts and supporting technical guidelines, and compliance strategies should be adjusted in a timely manner accordingly.