Ministry of Agriculture Order No. 4，2017
Measures on the Management of the Pesticide Production License
第一章 总 则
Chapter I General
Article 1 To regulate pesticide production practices, strengthen pesticide production management and ensure the quality of pesticides, the Measures on the Management of the Pesticide Production License (the Measures) is hereby developed in accordance with the Regulations on the Management of Pesticides.
Article 2 The pesticide production referred to in the Measures includes the production of the TC (TK), formulation processing or repackaging.
Article 3 The Measures shall apply to the application, review, issuance, supervision and management of a pesticide production license.
Article 4 The Ministry of Agriculture shall be responsible for the nationwide supervision and guidance regarding the management of a pesticide production license and establishment of production condition requirements and review rules.
The agricultural authorities under the provincial people’s government (hereinafter referred to as the agricultural authorities at the provincial level) shall be responsible for accepting, reviewing applications and issuing a pesticide production license.
Local agricultural authorities above the county level shall strengthen the supervision and management of a pesticide production license within their respective administrative areas.
Article 5 The pesticide production license shall be managed on the principle of one license for one enterprise, and a pesticide producer will be granted only one pesticide production license.
Article 6 Pesticide production shall comply with national industrial policies, and pesticide producers shall not produce products considered obsolete by the state, or use any technology, equipment or raw materials considered obsolete by the state during pesticide production, and shall not add the production of products restricted by the state, or add any technology, equipment or raw materials restricted by the state for the purpose of pesticide production.
Article 7 Agricultural authorities at all levels shall strengthen information-based management of a pesticide production license. The Ministry of Agriculture shall accelerate the creation of a uniform national pesticide management information platform, and gradually realize the uniform handling of pesticide production license applications, acceptances, reviews, issuances and printing through the pesticide management information platform. Local agricultural authorities shall timely upload and update pesticide production licenses, and details pertaining to supervision and management and other information in a timely manner.
Chapter II Application and Review
Article 8 Enterprises engaged in pesticide production shall meet the following requirements:
(I) comply with national industrial policies;
(II) have in place management, technology, operations, inspection and special post personnel, etc. meeting the requirements of the production process;
(III) have in place a permanent production site;
(IV) have in place reasonably arranged plants, and where a newly established chemical pesticide producer or non-chemical pesticide producer expands the production scope of chemical pesticide, it shall establish factories in a chemical industry park above the provincial level; where a newly established non-chemical pesticide producer, household hygienic insecticide producer or chemical pesticide producer increases the production scope of the TC (TK), they shall be located in a chemical industry park or industry park above the municipal level;
(V) have in place automation production equipment and facilities suitable for the pesticide it produces, as well as the facilities used in production and sales with traceable product electronic information codes;
(VI) have in place a specialized quality testing organization, complete testing instruments and equipment, and integrated quality assurance system and technical standards;
(VII) have in place a complete management system, including raw material procurement, processing equipment, quality control, product sales, product recall, product storage and transportation, production safety, occupational health, environmental protection, pesticide waste collection and disposal, staff training, documenting and recording, and other management systems.
(VIII) other conditions specified by the Ministry of Agriculture.
Where there are other requirements on the production conditions of enterprises regarding work safety and environmental protection laws and regulations, the pesticide producers shall comply with the requirements and consciously accept the supervision of relevant management authorities.
Article 9 The following materials shall be submitted to the local agricultural authority at the provincial level in the application for a pesticide production license:
(I) an application form for a pesticide production license;
(II) a copy of the enterprise’s business license;
(III) identity certificates and basic information of the legal representative (person in charge);
(IV) copies of resumes and qualification certificates of main management personnel, technical personnel and inspection personnel, as well as basic information of relevant personnel engaged in pesticide production;
(V) floor plan layout, land use or lease certificate of the production site;
(VI) process charts for production devices of the TC (TK) or formulation types of the pesticides to be produced in the application, floor layout of production devices, process chart and process specification, as well as the name, quantity and pictures of the corresponding main plant, equipment and facilities and ancillary facilities ensuring normal operation;
(VII) product quality standards and the list of main test instruments and equipment for the TC (TK) or formulation types to be produced in the application;
(VIII) product quality assurance files and files pertaining to the management system;
(IX) primary records of three batches of pesticides manufactured in a trial production and for which the application is made, in accordance with the requirements found in the product quality assurance documents and the management system;
(X) authenticity and legitimacy statements for application data;
(XI) other data specified by the Ministry of Agriculture.
The application data shall be submitted in both paper and electronic forms.
Article 10 For the application data submitted by the applicant, the agricultural authorities at the provincial level shall treat them respectively based on the following circumstances:
(I) where no pesticide production license is required, the applicant shall be timely informed that the application is not accepted;
(II) where any error is found in the application data, the applicant shall be allowed to correct it on site;
(III) Where the application data is not complete or consistent with legal forms, the applicant shall be informed of all the contents that should be corrected or supplemented once and for all on site or within five working days; if the applicant is not informed within the aforesaid period, the application shall be deemed as accepted upon receipt of the application data;
(IV) where the application data is complete, consistent with legal forms, or the applicant submits all supplemental or corrected data as required, the application shall be accepted.
Article 11 The agricultural authorities at the provincial level shall review in writing and conduct a technical assessment of the application data, and if necessary, carry out an on-the-spot investigation. The agricultural authorities shall make a decision on whether the production license should be issued within twenty working days upon acceptance. If the conditions are met, the pesticide production license shall be issued; if not, written notice indicating the reasons to the applicant shall be given.
The technical assessment may be conducted by professionals in the fields of pesticide management, production, quality control, etc., and the time needed is not included in the license term and shall not exceed ninety days.
Article 12 The pesticide production license pattern and the format of the forms will be uniformly determined by the Ministry of Agriculture.
The pesticide production license shall clearly indicate the license number, name of the producer, uniform social credit code, domicile, legal representative (person in charge), scope of production, production address, validity period, etc.
The numbering format of the pesticide production license: pesticide production license + abbreviation of province + serial number (four numerals).
The production scope of the pesticide production license shall be marked according to the following regulations:
(I) category of the TC (TK);
(II) formulation type, with the chemical pesticides and non-chemical pesticides distinguished.
Chapter III Alteration and Renewal
Article 13 The pesticide production license is valid for five years. In case of any change of name, domicile, legal representative (person in charge) of a pesticide producer or narrowing of production scope, an application for change shall be filed to the agricultural authority at the provincial level within thirty days from the date of change and related proof of materials shall also be submitted.
The agricultural authority at the provincial level shall approve or disapprove an application for change upon acceptance within twenty working days. If the application is qualified, the change will be approved; if not, a written notice indicating the reasons will be given to the applicant.
Article 14 In case a pesticide producer expands the production scope or changes the production site, he or she shall apply for a new pesticide production license according to the Measures. In case of relocation, chemical pesticide producers shall be relocated into a chemical industry park or industrial park above the municipal level.
For a newly increased production site, it shall be subject to the requirements on newly established pesticide producers.
Article 15 If the production of a pesticide needs to continue upon expiration of the period of validity, the pesticide producer shall apply to the agricultural authority at the provincial level for renewal ninety days before the expiration.
Article 16 For the application of a pesticide production license renewal, the producer shall submit the application form, production report and other materials. The agricultural authorities shall review the application data. Where the application is not filed within the specified time limit, or the conditions are not met, the renewal will not be approved.
Article 17 In case of loss or damage of the pesticide production license, the pesticide producer shall state the reasons and provide relevant supporting documents, as well as apply to a local agricultural authority at the provincial level for re-issuance.
Chapter IV Supervision and Inspection
Article 18 Pesticide producers shall organize production in accordance with the product quality standards and provisions of the production license, ensue the pesticide products are consistent with those registered, and be responsible for the quality of pesticides they produce.
Within the pesticide production license scope, pesticide producers may accept the entrustment of new pesticide developers and other pesticide producers to toll or repack pesticides, as well as the entrustment of enterprises exporting pesticide to China to repack pesticides according to Article 19 of the Regulations on the Management of Pesticides.
Article 19 Pesticide producers shall upload production and sales data of the last quarter within fifteen days upon the end of each quarter to the pesticide management information platform specified by the Ministry of Agriculture. In case of tolling or subpacking of pesticides, the entrusting party shall be responsible for such reporting.
Article 20 The local agricultural authority above the county level shall strengthen the supervision and inspection of pesticide producers, conduct regular surveys and statistics on pesticide production, and establish pesticide production credit files and publish them.
Article 21 Agricultural authorities at the provincial level shall withdraw a pesticide production license according to law, in the event of any of the following circumstances:
(I) a fake pesticide is produced;
(II) a sub-standard pesticide is produced (considered a severe circumstance);
(III) the continued production of pesticides when no longer meeting the requirements of a pesticide production license, and refusal to rectify or still fail to satisfy the requirements after rectification;
(IV) a violation of regulations specified in Article 53 and Article 54 of the Regulations on the Management of Pesticides;
(V) due to a transfer, lease or loan of the pesticide production license;
(VI) due to the employment of any personnel specified in Paragraph I, Article 63 of the Regulations on the Management of Pesticides for pesticide production activities;
(VII) other circumstances where the pesticide production license shall be revoked according to law.
Article 22 Agricultural authorities at the provincial level shall revoke a pesticide production license according to law, in the event of any of the following circumstances:
(I) the decision of granting the pesticide production license is made by the personnel of the issuing authority through an abuse of powers or a neglect of their duties;
(II) the decision for granting the pesticide production license is made by the issuing authority against legal procedures;
(III) the pesticide production license is granted by the issuing authority to an applicant who is unqualified or does not conform to the statutory requirements;
(IV) the applicant obtained the pesticide production license by fraud, bribery and other improper means;
(V) other circumstances where the pesticide production license shall be revoked according to law.
Article 23 In the event of any of the following circumstances, the original issuing authority shall cancel its pesticide production license according to law:
(I) if the enterprise applies for cancellation;
(II) if the qualifications of the subject are terminated according to law;
(III) if the application for renewal is not filed upon expiration of the term of validity of the pesticide production license;
(IV) if the pesticide production license is withdrawn, canceled or revoked according to law;
(V) based on other circumstances where the license shall be canceled according to law.
Article 24 Any pesticide producer shall be deemed as not validly holding a pesticide production license under any of the following circumstances:
(I) if the continued production of pesticides is beyond the term of validity of the pesticide production license;
(II) if the production of pesticides is beyond the scope of the pesticide production license;
(III) if the production of pesticides in other places is carried out without approval;
(IV) if an enterprise which has obtained the pesticide production license is entrusted to process or sub-package pesticides beyond the scope of the license;
(V) other circumstances where the pesticide production license is deemed not obtained.
Article 25 The Ministry of Agriculture shall strengthen supervision and inspection of pesticide business licensing management by agricultural authorities at the provincial level, and if any personnel is found violating rules, the personnel shall be ordered to correct such a violation, and if punishment shall be imposed according to the law, suggestions for punishment shall be made to the personnel’s appointment and removal agency or supervision agency.
Article 26 Agricultural authorities above the county level and their personnel shall be ordered to remedy any of the following actions below. Those who bare such direct responsibility for any such actions shall be investigated. Punishment shall be meted out according to the law, and if the actions constitute a crime, they shall be held criminally liable. The actions include:
(I) a failure to perform pesticide production supervision and management duties, and if illegal pesticide production activities in their administrative region caused material loss or adverse social influence;
(II) granting a production license to any unqualified applicant, or withholding a production license to any qualified applicant;
(III) being engaged in pesticide production and operation activities;
(IV) playing favoritism and committing irregularities, abusing powers and neglecting duties.
Article 27 If any unit or individual finds any one is engaged in pesticide production activities in violation of the law, it has the right to report the violation to the agricultural authority, and the agricultural authority shall verify such reporting, deal with the issue in a timely manner, and keep confidential the information of the informer. If the case is verified to be true and plays an active role in production safety or saves great loss, a reward or award shall be given according to relevant national regulations.
Article 28 If a pesticide producer is engaged in illegal pesticide production activities, it shall be punished according to the stipulations in the Regulations on the Management of Pesticides; if the aforesaid activities constitute a crime, the pesticide producer shall he held criminally liable according to law.
Chapter V Supplementary Provisions
Article 29 Chemical pesticides mentioned in the Measures refer to pesticides artificially synthesized with chemical substances.
Article 30 The Measures will come into force from August 1, 2017.
If any pesticide producer has obtained a production approval certificate or license before the Measures come into effect, it is allowed to continue such production of corresponding pesticides within the validity term. Where the production of pesticides needs to continue upon expiration of the term of validity, the pesticide producer shall apply for a new pesticide production license at the agricultural authority of the provincial level ninety days before expiration of the term of validity in accordance with the Measures.
If any pesticide producer which has obtained a pesticide registration certificate, but not the approval certificate for pesticide production or a pesticide production license before the implementation of the Measures and needs to continue the production of pesticides, it shall obtain a pesticide production license within two years after the implementation of the Measures.
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