Are the identification, production, and procurement of pesticide intermediates in compliance with applicable regulations?

China is a major producer and exporter of pesticides and has gradually established a complete industrial chain encompassing research and development, intermediate production, active ingredient manufacturing, and formulation. The synthesis of pesticide intermediates constitutes one of the critical steps in pesticide production.

What is a pesticide intermediate?

Pesticide intermediates are chemical substances produced during the synthesis of pesticides, derived from petrochemical feedstocks through a series of chemical reactions. These intermediates can subsequently undergo further chemical transformations to yield active ingredients with insecticidal, herbicidal, or fungicidal properties. As intermediate materials in pesticide production, they can be categorized into fluorine‑containing, cyano‑containing, and heterocyclic‑containing types, among others. From a supply-chain perspective, pesticide intermediates occupy the midstream segment; upstream inputs include inorganic raw materials such as yellow phosphorus and liquid chlorine, as well as basic organic feedstocks like methanol and benzene. The resulting technical-grade pesticides are then formulated into specific pesticide formulations for use in agriculture, forestry, animal husbandry, and public health applications. A typical supply-chain diagram is shown below:

Figure 1: Pesticide Industry Chain

What regulatory requirements apply to pesticide intermediates if they are classified as new substances?

In April 2020, China’s Ministry of Ecology and Environment issued Ministerial Order No. 12, the Measures for the Environmental Management Registration of New Chemical Substances (hereinafter referred to as the “Measures”), which entered into force on January 1, 2021. The Measures contribute to strengthening the administrative oversight and market regulation of intermediates in China. The competent authority for the Measures is the State Council’s department responsible for ecological and environmental protection.

Under Order No. 12, the scope of intermediates encompasses not only those used in the chemical and pharmaceutical industries but also intermediates employed in other sectors. Specifically, intermediates for pharmaceuticals (including active pharmaceutical ingredients), agrochemicals (including technical-grade active ingredients), veterinary medicines (including active pharmaceutical ingredients), cosmetics, food, food additives, animal feed, feed additives, fertilizers, and related products all fall within its regulatory purview.

The “Guidance on Environmental Management Registration of New Chemical Substances” (hereinafter referred to as the “Guidance”), issued in conjunction with Order No. 12, clearly defines both intermediates and non‑isolated intermediates. Non‑isolated intermediates are classified as exempted substances, while all other intermediates fall under the scope of the Measures.

❖ Intermediate:

It refers to a chemical substance produced in one step of a chemical reaction that is consumed in the subsequent step, serving as a reactant to synthesize other chemicals or products. Intermediates should not be present in the final chemical substance or product unless they occur as impurities.

❖ Non-isolated intermediate:

It refers to intermediates that remain within the reaction vessel or reactor, and also includes cases where such intermediates are transferred to a container for temporary storage and subsequently used in a subsequent chemical reaction within the same plant.

According to the Measures, pesticides (including technical-grade active ingredients) are classified as exempted substances under pesticide regulations; however, special attention must be paid to pesticide intermediates. If such intermediates are new chemical substances and do not meet the criteria for non‑isolated intermediates, they must be filed or registered prior to production or import. Furthermore, downstream processors may not manufacture or use pesticide intermediates that have not obtained a registration certificate or been duly filed.

Next, let’s take a look at the relevant requirements for environmental compliance regarding new chemical substances:

What is a new chemical substance?

Pursuant to Article 3 of Chapter I of the Measures, a new chemical substance refers to a chemical substance that is not listed in the Inventory of Existing Chemical Substances in China (IECSC).

Figure 2: Inventory of Existing Chemical Substances in China

How can you determine whether a substance is a new chemical substance?

Whether a substance is listed in the IECSC is the sole criterion for determining whether it qualifies as a new chemical substance. The current edition of the IECSC was issued by the former Ministry of Environmental Protection in 2013 and has, to date, been supplemented through 26 additional announcements.

❖ Query method:

1. Directory Inquiry: When conducting a directory inquiry, enterprises should consult both the 2013 edition of the directory and all previous supplementary announcements. This approach is rather cumbersome and prone to oversight.

2. Official system inquiry: At present, the Ministry of Ecology and Environment has also established an online inquiry service on its government service portal. Enterprises are required to register an account on the portal and log in using a verification code before conducting their inquiries, which can be somewhat inconvenient.

3. “RuiChacha” Search: To enable businesses to conduct quick and convenient searches, RIO Technology has developed an online global chemical inventory search system—RuiChacha. Users can access it free of charge without registration, and RuiChacha supports queries by CAS registry number or chemical name.

If, after searching by CAS registry number or chemical name, the substance is found in the IECSC, it indicates that the substance is a existing chemical; however, the reverse is not necessarily true.

The IECSC consists of two parts: public substances and confidential substances. Public substances can be retrieved by their CAS registry number or chemical name, while confidential substances are listed under generic names, with their specific chemical names, CAS registry numbers, and other details concealed.

Therefore, if the query reveals that the substance is not part of the IECSC’s publicly available section, a formal novelty search may be submitted to the authorities to determine whether the substance is classified as belonging to the IECSC’s confidential section.

❖ Query example:

The following are two cases involving the use of the REACH regulation to determine whether a substance qualifies as a new chemical substance.

Case 1: Non- new chemical substance

2-Chloro-5-chloromethylpyridine (CAS No. 70258-18-3) is an organic compound belonging to the pyridylmethylamine class and serves as an important intermediate in the synthesis of herbicides, pharmaceuticals, and insecticides.

IECSC query result: This substance is already listed in the IECSC; no new environmental management registration for new chemical substances is required.

Case 2: Non-Public Chemical Substance

2-Amino-5-chloro-N,3-dimethyl-benzamide (CAS No. 890707-28-5) is an important intermediate in the synthesis of chlorantraniliprole, a member of the ortho‑formamidobenzamide class of insecticides.

IECSC query result: This substance is not listed in the IECSC public inventory. RuiChacha advises submitting a formal novelty search to the competent authorities to determine whether it qualifies as a new chemical substance. If it is confirmed that the substance is not included in the IECSC, the enterprise shall, in accordance with the provisions of the Measures, carry out environmental management registration for new chemical substances.

Special reminder: When pesticide manufacturers plan to procure pesticide intermediates, if they find that the substance is not listed in the IECSC, they should also verify whether environmental registration for the new chemical substance has been completed. It is recommended to source products that have already undergone filing or registration.

Who is eligible to apply for new chemical substance registration?

According to the Guidelines, applicants seeking environmental registration for new chemical substances must be domestic manufacturers or importers, as well as foreign manufacturers or trading enterprises intending to export new chemical substances into China (who are required to designate a qualified domestic enterprise or institution as their agent).

Taking into account different supply-chain dynamics, selecting the most appropriate party as the applicant can often lead to significant cost savings.

Next, we will outline several typical types of commercial flows to determine which party is more appropriate as the applicant for registration.

Case 1: The production of pesticide intermediate S, which is classified as a new chemical substance, takes place within the territory of China. In this scenario, the applicant must be pesticide intermediate manufacturer A, and prior to commencing production of the substance, it must carry out environmental management registration for the new chemical substance and obtain a registration certificate.

Case 2: The new chemical substance S is manufactured outside China and imported into China as an agrochemical intermediate. In this scenario, the applicant has two options:

Type 1: The foreign trading company B, as the applicant, must also designate a qualified domestic enterprise (such as Rui’ou) as its domestic agent and complete environmental management registration for new chemical substances prior to import. Upon successful registration, the foreign company B may legally export to multiple domestic enterprises within the scope of the registered tonnage and intended uses.

Type 2: Pesticide manufacturer C, which holds trade qualifications, acts as the applicant and initiates environmental management registration for the intermediate substance prior to its import. Upon completion of the registration, manufacturer C may procure and import the substance from multiple overseas trading companies, within the scope of the registered quantity and intended uses (this discussion focuses solely on regulatory feasibility and does not address actual commercial circumstances).

It is particularly important to note that, under different supply-chain scenarios, companies can select the most advantageous approach to minimize compliance-related costs and time expenditures, thereby maintaining control over their trade operations.

In summary, manufacturers and traders of pesticide intermediates, as well as pesticide producers, must determine, in accordance with the Measures for Environmental Management Registration of New Chemical Substances, whether environmental management registration is required before producing such intermediates within China or intending to import them into the country. Pesticide manufacturers, when procuring new chemical‑substance intermediates, should likewise verify the status of environmental management registration and are advised to source products that have already completed filing or registration.

Source: Rui'ou Technology