The main legislations governing the chemical market in China is Order No. 12 of the Ministry of Ecology and Environment (MEE), Measures for the Environmental Management Registration of New Chemical Substances, also known as MEE Order No.12. This regulation came into force on 1 January 2021 and the previous regulation (MEP Order No.7) was simultaneously repealed.
In 2003 the former State Environmental Protection Administration (SEPA) published the first national-level regulation dedicated to new chemical management, SEPA Order No. 17, Measures on Environmental Management of New Chemical Substances. In 2010, this regulation was revised for the first time by the the former Ministry of Environmental Protection (MEP) that published it as MEP Order No. 7. The Inventory (IECSC) was first introduced under MEP Order No.7. Finally, in 2020 MEP Order No.7 was amended again by the Chinese Ministry of Ecology and Environment (MEE) and MEE Order No.12 came into force.
MEE Order No.12 imposes registration obligations on new chemical substances which are not listed in the Inventory of Existing Chemical Substances in China (IECSC) and chemicals subject to new usage environmental management. Chemicals already under the management of other existing laws are exempted under MEE Order No.12. They include:
Also exempted are substances existing in nature such as natural polymers and biomacromolecules as well as substances of non-commercial purpose and unintentionally produced substances.
The pesticide regulation in China is called Measures for the Administration of Pesticide Registration. The Measures came into force from the promulgation of the decree of the Ministry of Agriculture and Rural Affairs (MARA) on Aug. 1, 2017. The temporary pesticide registration permit that had been obtained prior to Jun. 1, 2017, would not be renewed; the application for pesticide registration that had not yet been approved would be processed in accordance with the relevant provisions of the Pesticide Management Regulations (PMR).
The PMR aims to better standardize pesticide registration behavior, it is to strengthen pesticide registration management to ensure the safety and effectiveness of pesticides.
New pesticides: refer to pesticides whose active ingredients have not been approved and registered in China, including new pesticide technical (parent drug) and new pesticide formulations.
Technical medicine: refers to the product obtained in the production process, which is composed of active ingredients and related impurities, and a small amount of additives can be added if necessary.
Parent drug: refers to the product obtained during the production process, which is composed of active ingredients and related impurities, and may contain a small amount of necessary additives and appropriate diluents.
Preparation: refers to the pesticide product in a stable state which is processed from the original pesticide (parent drug) and suitable auxiliary agents, or processed by biological fermentation, plant extraction and other methods.
Auxiliary: refers to any single component or multiple components added to pesticide products, other than active ingredients, that do not have pesticide activity and active ingredient functions, but can or help to improve or improve the physical and chemical properties of pesticide products substance.
The name of the pesticide should use the Chinese generic name of the pesticide or the simplified Chinese generic name, and the name of the botanical pesticide can be represented by the plant name plus the extract. The name of the directly used sanitary pesticide is expressed by the functional description word plus the dosage form.
The content of active ingredients and formulations of pesticides should be set in accordance with the principles of improving quality, protecting the environment, and promoting sustainable agricultural development.
The formulation of the preparation product shall be scientific, reasonable and convenient to use. Single preparation products of the same active ingredient and dosage form, with no more than three content gradients. The active ingredients of the mixed preparation shall not exceed two, and the active ingredients such as herbicides, seed treatment agents and pheromones shall not exceed three. For mixed preparations with the same active ingredients and dosage forms, the proportions shall not exceed three, and the total content gradients of the same proportions shall not exceed three. Pesticides with low active ingredient content for direct use without dilution or dispersion are classified separately.
If the specified adjuvant needs to be added during use, the corresponding test data should be submitted when applying for pesticide registration.
The dilution ratio or concentration of pesticide products should be matched with the application technology.
The specific requirements shall be formulated separately by MARA, and according to the toxicity and hazard of pesticide adjuvants, the list, and limit of prohibited and restricted adjuvants shall be announced and adjusted in a timely manner.
Pesticide manufacturers, companies exporting pesticides to China, or developers of new pesticides will need to apply for pesticide registration in China, depending on their roles there are different requirements apply.
Domestic applicants apply for pesticide registration to the local provincial agricultural and rural departments. Overseas enterprises submit pesticide registration applications to the Ministry of Agriculture and Rural Affairs.
Pesticide production enterprises: refers to domestic enterprises that have obtained pesticide production licenses.
Enterprises exporting pesticides to China (hereinafter referred to as overseas enterprises): refers to enterprises that export pesticides produced overseas to China.
New pesticide developers: refers to Chinese citizens, legal persons or other organizations that develop new pesticides within the territory of China.
For new pesticides jointly developed by multiple entities, one entity should be identified as the applicant, and other cooperative research institutions and relevant test samples should be specified; other subjects may not apply repeatedly.
The applicant shall submit the product chemistry, toxicology, efficacy, residues, environmental impact and other test reports, risk assessment reports, labels or instruction sheets, product safety data sheets, relevant documents, application forms, applicant qualification certificates, and materials Authenticity statement and other true, standardized, complete and valid application materials.
The registration test report should be issued by a registration test unit recognized by the MARA, or by a relevant overseas laboratory that has signed a mutual recognition agreement with relevant departments of the Chinese government; experiments and registration experiments of endemic biological species in China should be completed within the territory of China.
When applying for new pesticide registration, the registration application for new pesticide technical and new pesticide formulation shall be submitted at the same time, and pesticide standard products shall be provided.
Within 6 years from the date of new pesticide registration, if other applicants submit the data obtained by themselves or with the authorization and consent of the holder of the new pesticide registration permit to apply for registration, the application for new pesticide registration shall be applied.
MARA or the provincial agricultural and rural department shall deal with the application materials submitted by the applicant according to the respective following circumstances:
Review and decision will take at least 11 months.
The provincial agriculture and rural departments shall, within 20 working days from the date of accepting the application, conduct a preliminary examination of the materials submitted by the applicant, put forward preliminary examination opinions, and submit them to MARA. If the applicant fails to pass the preliminary examination, the applicant may be notified in writing and explain the reasons as per the applicant's wishes.
After the MARA accepts the application or receives the application materials and preliminary review opinions submitted by the provincial agricultural and rural department, it shall complete the product chemistry, toxicology, efficacy, residue, environmental impact, label proofs, etc. within 9 months and submit the review comments to the Pesticide Registration Review Committee for review.
After receiving the technical review comments, the Pesticide Registration Review Committee will issue review comments in accordance with the pesticide registration review rules. After the application is accepted, the applicant may withdraw the registration application and re-apply after supplementing and improving the relevant information. At the same time, the MARA may also request the applicant to supplement the information according to the opinions of the Pesticide Registration Review Committee.
During the registration review and review period, the types of registration applications submitted by the applicant, as well as the technical requirements and approval procedures they follow, shall not be changed because other applicants have obtained pesticide registration permits during this period. If the new pesticide is approved, the new pesticide registration applications of other applicants that have been accepted can continue to be reviewed and reviewed in accordance with the new pesticide registration approval procedures, or the application can be withdrawn and a new registration application can be submitted.
MARA will make an approval decision within 20 working days from the date of receipt of the review comments. If the requirements are met, the pesticide registration permit will be issued; if the requirements are not met, the applicant will be notified and explain in writing.
The pesticide registration permit is uniformly printed by MARA and the pesticide registration permit is valid for 5 years. If the applicant wish to change the holder of the pesticide registration permit within the validity period of the pesticide registration permit, relevant certification materials should be submitted and application sent to MARA for a replacement of the pesticide registration permit; under any of the following circumstances, the holder of the pesticide registration permit should report Ministry application changes:
The extension of license will take at least 10 month.
If it is still necessary to continue to produce pesticides or export pesticides to China after the expiration of the validity period, an application for renewal shall be made 90 days before the expiration of the validity period. If the applicant fails to apply for renewal within the time limit, registration must be re-applied. MARA will review the application materials for registration renewal and make a decision on whether to extend the registration before the expiration of the validity period. If there are hidden dangers or risks in safety and effectiveness during the review, it will be submitted to the Pesticide Registration Review Committee for review.
Application for registration change or renewal must be submitted by the holder of the pesticide registration permit to the MARA, with the application form filled in and relevant information submitted. MARA shall complete the review of registration changes within 6 months, form review opinions, submit them to the Pesticide Registration Review Committee for review, and make an approval decision within 20 working days from the date of receipt of the review opinions. If the requirements are met, the registration change will be allowed, and the registration permit number and validity period will remain unchanged; if the requirements are not met, the applicant will be notified in writing and the reasons will be explained.
Provincial agricultural and rural departments should report monitoring and evaluation results to MARA in a timely manner.
The authenticity, integrity or normativeness of the application materials does not meet the requirements;
For those who submit false information and test samples, MARA will list the applicant's illegal information in the integrity file and publish it. In any of the following situations, MARA will cancel the pesticide registration permit and announce it: