A summary of 14 issues that manufacturers are most concerned about in the new regulations

In the "Regulations on Pesticide Management", there are new provisions on "pesticide registration", "pesticide production", "pesticide management" and other content
.
Today we will sort out the 14 hot issues that companies are most concerned about in the new regulations
.
1?? When will the pesticide production license be declared? Is the proportion of on-site inspections large? Or does the original drug need to be checked? Answer: The "Measures for the Administration of Pesticide Production Licenses" came into effect on August 1.
It stands to reason that the provincial agricultural administrative department can accept applications for pesticide production licenses on August 1
.
However, because the Ministry of Agriculture is still seeking comments on the "Detailed Rules for the Review of Pesticide Production License", it has not been promulgated and implemented.
In addition to the fact that pesticides were managed by multiple departments, it is now managed by the agricultural department.
There is also a process of division of responsibilities, definition of responsibilities, and work handover.
The agricultural sector also needs to set up a corresponding pesticide administrative license management agency, increase its staff, and staff, so it will take a while to start accepting pesticide production license applications
.
All pesticide manufacturers are waiting for notification from the provincial agricultural authority
.
According to the "Administrative Measures for Pesticide Production Licensing", where a pesticide production licensing application has one of the following circumstances, the provincial agricultural authority shall promptly organize a written review, technical review and on-site verification: (1) The first application for a pesticide production license; ( 2) The production company that has obtained the pesticide production license expands the scope of pesticide production or changes the production address; (3) The production company that has obtained the pesticide production license adds the scope of chemical pesticide production; (4) The technical review believes that on-site verification is required Of
.
Therefore, the on-site verification does not determine the proportion, but the technical requirements for the production equipment of the original drug (parent drug) are high, the technology is complex, and the responsibility for safe production is heavy, and it should be verified
.
It is hoped that all enterprises will make relevant preparations for the application materials
.
This is difficult for companies that have the original drug registration certificate but no production equipment at all, that is, it is difficult to obtain the original drug production license for the company that obtains benefits by issuing the original drug certificate.

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2? When the operator sells pesticides nationwide (excluding the restricted use of pesticides), do they need to apply for operating licenses in each province or do they only need to apply for operating licenses at the location of the company to sell? Answer: Pesticide production companies can directly sell their own pesticides to the whole country in the factory, and do not need to apply for a business license
.
However, the restricted use of pesticides in production can only be sold to units that have restricted use of pesticides in designated operations
.
Operators who apply for a pesticide business license locally can sell pesticides across the country, because they can distribute pesticides to other provinces through the Internet
.
However, even if there are operating permits for restricted use of pesticides in this province, it is not possible to sell restricted use of pesticides in other provinces
.
This is because the restrictions on the use of pesticides are planned by the provincial agricultural department, issuing permits, and operating at designated locations
.
If you set up a business unit in another province, you should go to the province where the business unit is located to apply for a pesticide business license
.
3?? The implementation time and location of the two-dimensional code of pesticide labels; is the two-dimensional code one certificate and one code; is the two-dimensional code issued uniformly or is it designed by the enterprise? Answer: According to the "Administrative Measures for Pesticide Labels and Instructions", "If the existing product labels or instructions do not conform to these Measures, the labels and instructions that comply with these Measures shall be used from January 1, 2018.

" Therefore, label two The implementation time of Dimension Code should be January 1, 2018
.
In other words, if there is no QR code on the label of the pesticide product, the production date of the pesticide product must be before December 31, 2017
.
Therefore, pesticide manufacturers must produce in advance and use up old labels
.
The Ministry of Agriculture is about to issue the "Regulations on the Management of Pesticide Label QR Codes", which will make detailed specifications
.
The position and size of the QR code should be guaranteed not to be easily deformed, easy to scan, operate and read, and be used normally in all links of production and circulation
.
The size of the two-dimensional code picture can be determined according to the size of the package, and should not be less than 2 square centimeters
.
Therefore, there is no clear requirement for the location of the QR code
.
Two-dimensional code implements a two-dimensional code corresponding to only one sales and packaging unit, which can be understood as "one bottle, one code"
.
The unit identification code is composed of 32 Arabic numerals
.
The first to sixth digits are the last six digits of the pesticide registration certificate number of the product, which can be queried from the China Pesticide Information Network
.
The 7th to 12th digits are the generation time code, and the year, month and day are two digits respectively; the 13th digit is the packaging classification code, which supports multi-level packaging, "1" represents the smallest packaging, "2" represents the upper level packaging, and so on ; The 14th digit is the type of production, "1" represents production by the pesticide registration certificate holder, "2" represents commissioned processing, and "3" represents commissioned packaging; the 15th to 32nd digits are random codes, which should be designed by the company
.
Pesticide production companies and overseas companies exporting pesticides to China can establish their own or entrust a third party to establish a QR code traceability information system website, independently produce, label and manage pesticide label QR codes, and ensure that pesticides can be traced to the traceability information system website.
Product production batch, quality inspection, logistics and sales information
.
The web page should have strong compatibility, and can be browsed on the PC and mobile phones
.
In order to reduce the burden on pesticide companies, relevant agencies of the Ministry of Agriculture have established a national pesticide traceability information system platform (website).
Pesticide manufacturers and overseas companies exporting pesticides to China can use this platform to apply for and download QR codes for free, and make and mark them on the platform.
Pesticide labels, and timely upload product warehousing traceability information to the national pesticide traceability information system platform
.
4? The label is registered as "Brassica oleracea" and "Beet Armyworm".
Can the graphic be printed on the label? Answer: According to the "Administrative Measures for Pesticide Labels and Instructions", "Pesticide labels should be marked with the following contents: (1) pesticide name, formulation, active ingredient and content; (2) pesticide registration number, product quality standard number, and pesticide production license Certificate number; (3) Pesticide category and color band, product performance, toxicity and identification; (4) Use range, use method, dosage, technical requirements and precautions for use; (5) First aid measures for poisoning; (6) Storage and transportation methods; (7) production date, product batch number, quality assurance period, net content; (8) pesticide registration certificate holder name and contact information; (9) traceable electronic information code; (10) pictogram ; (11) Other content required by the Ministry of Agriculture
.
The other content is set by yourself, so the graphics of "cabbage" and "beet armyworm" can be marked
.
5? When can the registration test record be carried out? Answer: According to the "Administrative Measures for Pesticide Registration Tests", "before conducting pesticide registration tests, applicants should file with the provincial agricultural department where the test is registered
.
The record information includes the filer , product overview, test items, test locations, test units, and test sites.
Time, safety precautions, etc.

" "The measures will be implemented on August 1, 2017.

" Therefore, all enterprises should file with the provincial agricultural department in a timely manner.
Generally speaking, the filing unit is the Provincial Pesticide Inspection Institute (station)
.
6? Article 18 of the "Administrative Measures for Pesticide Labels and Instructions" stipulates that "the use of pesticides shall be restricted, and warning signs shall be set up after application of pesticides on the label, and the interval between humans and animals allowed to enter
.
" How is the interval determined and what is there? Can the standard be checked? Answer: The interval time should be determined according to the results of pesticide residue test.
The same product can be determined by referring to the registered products of the same kind
.
7? Can the original production license be used normally as long as it is within the validity period? Since June 1st, due to the alternation of the old and new policies, and the validity period of the original production license is less than 3 months, should the assessment be conducted in accordance with the new license requirements? Where do pesticide companies go to apply for pesticide production licenses now? Answer: According to the "Management Measures for Production Licensing", "Pesticide manufacturers that have obtained a pesticide production approval certificate or a pesticide production license before the implementation of these Measures may continue to produce the corresponding pesticide products within the
validity period.
After the validity period expires, they need to continue to produce pesticides The pesticide production enterprise shall, in accordance with the provisions of these Measures, apply for a pesticide production license to the provincial agricultural department 90 days before the expiration of the validity period
.
” That is to say, the pesticide enterprise shall issue the approval certificate by the Ministry of Industry and Information Technology, and the production license shall be within the validity period.
Can continue to produce pesticides
.
After June 1st, the Ministry of Industry and Information Technology will not accept the renewal of approval certificates and production licenses, and the provincial agricultural departments have not started accepting applications for production licenses.

.
There is a gap here.
During this period, some of the approval certificates and production licenses issued by the Ministry of Industry and Information Technology expire and cannot be renewed in time.
This is a problem that the Ministry of Agriculture needs to study and solve, and clarify the policy, because this is not a pesticide production enterprise.
Fault
.
If the Ministry of Industry and Information Technology issues an approval certificate and a production license expires and needs to continue to produce pesticides, the pesticide production enterprise shall apply to the provincial agricultural department for a pesticide production license in accordance with the provisions of these Measures 90 days before the expiration of the validity period
.
Pesticide production licenses are managed by one enterprise, one license, and only one pesticide production license is issued by a pesticide production enterprise
.
The original drug is applied according to the variety, and the preparation is applied according to the dosage form
.
It should be the first time to apply for a pesticide production license to the agricultural department, that is, if the scope of application for pesticide production is the original drug (the mother drug), the corresponding application materials for the original drug (the mother drug) should be provided
.
If the scope of application for pesticide production is a parent drug, the main reason for the production of the parent drug shall also be explained, and relevant certification that the parent drug of the pesticide variety has obtained pesticide registration shall be provided
.
If the scope of application for pesticide production is a formulation dosage form, a representative pesticide product of the dosage form shall be selected and corresponding application materials shall be provided, and materials of other products shall not be borrowed
.
Therefore, since it is the first time that a pesticide company has applied for a pesticide production license, it should be handled in accordance with the new license requirements
.
That is, the agricultural department at the provincial level shall review the application materials in writing and technical review, conduct on-site inspections when necessary, and make a decision on whether to issue a production license within 20 working days from the date of acceptance of the application (the competent agricultural department at the provincial level shall Starting from the date of acceptance of the pesticide production license application, for those who apply for the pesticide production license for the first time and apply for the expansion of the pesticide production license or change the production address, the organization will complete the pesticide production license technical review within 90 days, and the pesticide production license shall be renewed.
Organize and complete the pesticide production license technical review within 60 days
.
) If the requirements are met, the pesticide production license will be issued; if the requirements are not met, the applicant will be notified in writing and the reasons will be explained.

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If a pesticide manufacturer has obtained a pesticide production approval certificate or a pesticide production license for multiple pesticide varieties or formulations, it shall apply for all required production at one time in accordance with the conditions of the "Pesticide Production License Management Measures" 90 days before the expiration of the first period of validity.
Variety or dosage form license
.
What everyone should pay attention to here is that even if the dosage form has a license, that is, the company has a pesticide production approval certificate or a pesticide production license for 5 dosage forms, and 80 products, but the company has 5 dosage forms on the production license.

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8? How to interpret the entrusted processing; how to handle the entrusted processing after the original import sub-package registration certificate is cancelled? Answer: Enterprises with pesticide production licenses can accept the commission of new pesticide developers and other pesticide manufacturers to process or sub-package pesticides; they can also accept the commissions of companies exporting pesticides to China to sub-package pesticides
.
However, it should be noted that the client should obtain a pesticide registration certificate (for new pesticide developers and other pesticide manufacturers), and domestic pesticide manufacturers should have a production license (certify your pesticide manufacturer).
Responsible for the quality of pesticides; the trustee should obtain a pesticide production license (should be a production license for the corresponding formulation); entrust processing and sub-packaging of fake pesticides and inferior pesticides, and both parties will be punished according to the production of fake pesticides and inferior pesticides.
In addition to other penalties, entrust The pesticide registration certificate shall be revoked, and the pesticide production license shall be revoked on commission
.
Entrusted processing and sub-packaging can only be pesticide preparations, because processing and sub-packaging are physical processes; technical materials (parent drugs) cannot be entrusted, because technical materials refer to products composed of active ingredients and related impurities obtained during the production process If necessary, a small amount of additives can be added; the mother drug refers to a product composed of active ingredients and related impurities obtained in the production process, and can contain a small amount of necessary additives and appropriate diluents
.
The original drug (parent drug) is a production process of chemical synthesis, that is to say, the original drug (parent drug) cannot be commissioned for processing and packaging
.
Labels for entrusted processing and packaging of pesticides
.
The pesticide registration certificate number of the consignor should be indicated, the pesticide production license number of the consignee, the name of the consignor and the consignee and their contact information and the date of processing and repackaging should be indicated
.
Pesticides exported to China need not be marked with the pesticide production license number, but the place of production abroad, and the name and contact information of the office or agency established in China should be marked
.
In this way, the marked unit also assumes corresponding responsibilities
.
Enterprises that export pesticides to China may entrust domestic pesticide manufacturers to repackage the pesticides, but they shall not entrust the processing of pesticides
.
9? How to do the risk assessment report; are there relevant specific requirements; do all products need to be done? Answer: According to the requirements of the "Measures for the Administration of Pesticide Registration", "The relevant data or materials provided by the applicant should be able to meet the needs of risk assessment, and the product and the registered product are equivalent to or have obvious advantages in terms of safety and effectiveness
.
For application for registration When reviewing products, it is necessary to refer to the risk assessment results of registered products and follow the principle of maximum risk
.
" "Pesticide registration certificate holders should collect and analyze the safety and effectiveness of pesticide products, product recalls, accidents during production and use, etc.
Situation
.
” This requires applicants to provide registration application data and materials that can meet the needs of risk assessment, and does not require a risk assessment report
.
In accordance with the "Regulations on Pesticide Management", the competent agricultural department of the State Council and the competent agricultural department of the people's government of the province, autonomous region, and municipality shall organize the agencies responsible for pesticide verification and plant protection agencies to monitor the safety and effectiveness of registered pesticides
.
It is found that the registered pesticides have been registered.
Where pesticides cause serious harm or greater risks to agriculture, forestry, human and livestock safety, agricultural product quality and safety, ecological environment, etc.
, the competent agricultural department of the State Council shall organize the pesticide registration review committee to conduct review, and revoke or change the corresponding pesticide registration certificate based on the review results.
When necessary, it should be decided to ban or restrict the use and make an announcement
.
” Therefore, it should be the pesticide verification agency and the plant protection agency that make the risk assessment report.
The Ministry of Agriculture organizes the pesticide registration review committee to review
.
10?? The specific implementation time of the new pesticide registration regulations; the registration process of the new "Regulations"; whether the product efficacy tests and other registration materials completed before the introduction of the "Pesticide Registration Management Measures" are valid; whether there are new and old materials that require a transition period and transition How long is the period? Answer: In accordance with the "Measures for the Administration of Pesticide Registration", these measures will come into force on August 1,
2017.
Before June 1, 2017, the temporary pesticide registration certificate that has been obtained will not be renewed; it has been accepted and has not yet been approved.
The pesticide registration application for pesticides shall be handled in accordance with the relevant provisions of the "Pesticide Management Regulations
.
" Therefore, the new pesticide registration regulations should be implemented from August 1
.
However, since the Ministry of Agriculture is soliciting amendments to the "Pesticide Registration Information Requirements", it has not been formally issued, and the formal implementation time needs to be pushed back
.
This requires waiting for a period of time
.
There is a link between the old and new policies of pesticide registration
.
As the newly revised "Measures for the Administration of Pesticide Registration" adopts more stringent requirements for pesticide registration, the threshold for registration has been raised, and the registration control of the same product is especially stricter, which increases the difficulty of registration application approval
.
Therefore, after the new "Requirements for Pesticide Registration Information" is promulgated, it is necessary to specify the specific time for implementation
.
Whether there is a transition period and how long the transition period is, the Ministry of Agriculture needs to determine
.
Whether to consider the transition period of about half a year, because the company conducted experiments in accordance with the old method a few years ago
.
The experiment report that has been done should be effective, but if the content of the new requirement experiment changes, the company needs to implement it in accordance with the new requirement and add or reduce the relevant information
.
Once the implementation time is clarified, the previous one should be implemented in accordance with the "Pesticide Registration Information Regulations" of the Ministry of Agriculture Order No.
10 on December 8, 2007, and those that can pass the data review will be passed
.
If from the date of implementation of the new "Requirements for Pesticide Registration Information" of the Ministry of Agriculture, the new pesticide registration requirements must be reviewed and strictly required
.
Therefore, enterprises should provide relevant information as soon as possible to ensure the quality of the information, and it is best to pass the review at one time
.
11? Obtained pesticide registration, the formulation of the product has not obtained the production license, and the processing is entrusted to other enterprises.
Can it be renewed after the registration expires? Answer: (1) If you are not a pesticide manufacturer, the registration certificate cannot be renewed, and you can only apply for a new pesticide registration as a new pesticide developer
.
According to the "Administrative Measures for Pesticide Production Licensing", "If you have obtained a pesticide registration certificate but have not obtained a pesticide production approval certificate or a pesticide production license before the implementation of this method, and need to continue to produce pesticides, you should obtain the pesticide within two years from the date of implementation of this method.
Production license
.
" If the holder of the pesticide registration certificate does not have the qualifications of the pesticide registration applicant, the Ministry of Agriculture shall cancel the pesticide registration certificate and announce it
.
Therefore, if you do not apply for a pesticide production license, and then entrust a legal enterprise with a pesticide production license to process products, it is possible in the near future, but the registration certificate cannot be renewed.
It is better to apply for a pesticide production license to the provincial agricultural authority in time
.
(2) If you are a pesticide manufacturer and have a pesticide production license, you lack the product formulation license.
It should be said that it can be renewed, but you still need to wait for the relevant provisions of the specific implementation rules
.
Therefore, to keep the pesticide production license is a prerequisite for being a pesticide production enterprise
.
12?? The difference between pesticide registration data authorization and registration data transfer; what are the specific changes in residue authorization? Answer: (1) Authorization of pesticide registration data
.
Refers to a form of data sharing for products that have met the requirements of China's pesticide registration policies, regulations and normative documents, and have obtained the official pesticide registration certificate, and authorized their product information to be used by other companies
.
(1) Conditions for authorization: ① The product authorized to the outside must be a product that has been officially registered; ② The authorized product must be equal to or better than the original company's product to a certain extent, that is, it must be recognized as the same product with no significant difference in quality (The crops, or ingredients, or formulations are the same); ③ Authorize other companies to provide copies of power of attorney and related materials
.
(2) Residue authorization regulations: ① Single-preparation products with the same active ingredient and same dosage form can be authorized to products whose active ingredients do not exceed 1.
5 times the original enterprise product dose; ② Single-preparation products with the same active ingredient and same dosage form can be authorized For mixed preparation products of the same dosage form, but the amount of effective ingredients of the authorized product shall not exceed 1.
5 times that of the original enterprise
.
Authorize residual data
.
(3) Environmental authorization regulations: Environmental data can only be authorized to the same products that can be identified as having no significant difference in quality
.
Authorize a full set of information
.
(4) Toxicological authorization regulations: Acute toxicity test data cannot be authorized for use by other companies
.
Authorize a full set of information
.
(5) Special provisions: Materials jointly owned by multiple enterprises generally require the mutual consent of the owners of the ownership before they can be authorized externally
.
(6) In accordance with the notice issued by the General Office of the Ministry of Agriculture on the “Minutes of the Fifth Plenary Meeting of the Eighth National Pesticide Registration Review Committee”, “Testing and registration issues during technology transfer of domestic self-created products
.
In order to encourage domestic enterprises to independently develop and develop pesticides For new products, the meeting agrees that after the first registration of domestically created products, the first registrant can authorize its registration data as a whole, and the authorized unit is limited to one
.
When the authorized unit applies for registration, it can no longer conduct drug efficacy, residue, environmental protection Toxicology and other related tests
.
After the authorized unit obtains the registration of the authorized product, the first registration certificate of the created product is automatically revoked
.
" (7) According to the "Regulations", "the composition, scope and method of use of pesticides that have obtained pesticide registration in China are the same The pesticides that have been registered in China are exempted from residue and environmental testing, but the pesticides that have obtained the pesticide registration in China shall be in accordance with Article 15 of the Regulations (the country has obtained and did not disclose the information submitted by the applicant for the first-registered pesticides containing new compounds) The test data and other data
shall be protected .
) If the registration data protection period is specified, the pesticide registration certificate holder shall be authorized to agree.

.
"According to the "Measures for the Administration of Pesticide Registration", "Pesticide Registration Certificate holders independently possess complete registration materials that meet the registration requirements and can authorize other applicants to use them
.
" Therefore, the authorization can also retain the registration certificate of the authorized person
.
General information transfer is used for the registration of new products, new crops, and new formulations
.
I have not seen any specific changes to the residual authorization
.
(2) Transfer of pesticide registration data
.
According to the "Regulations", "new pesticide developers can transfer the registration materials of new pesticides that they have obtained registration; pesticide production enterprises can transfer the registration materials of their registered pesticides to pesticide production enterprises with corresponding production capacity
.
" According to the "Pesticides" "Registration Management Measures" "For the transfer of pesticide registration materials, the transferee shall apply for pesticide registration on the basis of the transfer contract of both parties and the registration materials that meet the requirements of the registration materials
.
" If the pesticide registration materials have been transferred in accordance with the law, the Ministry of Agriculture shall cancel the original pesticide registration certificate
.
After obtaining the transferred materials, registration is required, and all materials should be prepared in accordance with the new registration regulations
.
The transfer of registration data is mainly used for corporate mergers and reorganizations
.
13? Do I need to apply for a business license for trading in technical materials (purchasing from technical manufacturers and selling to preparation manufacturers or foreign trade companies)? If it is done, this kind of operation does not require counters and warehouses, and it does not meet the requirements of the permit.
Can the requirements of counters and warehouses that do not meet the actual conditions be exempted? Answer: According to the "Administrative Measures for Pesticide Business License", "Pesticide business licenses shall be obtained if pesticides are sold within the territory of the People's Republic of China
.
"Pesticide operators should meet the following requirements: (1) Have a technical secondary school education or above in agronomy, plant protection, pesticides and other related majors or have more than 56 hours of study experience in a professional education and training institution, be familiar with pesticide management regulations, and master professional knowledge of pesticides and pest control.
Operators who can guide the safe and reasonable use of pesticides; (2) Have a business place of no less than 30 square meters and a storage place of no less than 50 square meters, and be effectively isolated from other commodities, living areas, and drinking water sources; For other agricultural inputs, there should be a relatively independent pesticide business area; (3) Business sites and storage sites should be equipped with facilities such as ventilation, fire fighting, and poisoning prevention, and display shelves and counters suitable for the types and types of pesticides handled , Display facilities and equipment; (4) have traceable electronic information code scanning and identification equipment and a computer management system used to record the electronic ledger of pesticide purchase, storage, sales, etc.
; (5) have purchase inspection, ledger records, and safety Management, safety protection, emergency disposal, warehousing management, pesticide waste recycling and disposal, use guidance and other management systems and post operating procedures
.
"So, as long as you are engaged in pesticide distribution, you are not selling your own products within the pesticide production enterprise.
, You should apply for a business license
.
To apply for a business license, you should have the prerequisites for the declaration of a business license, and a counter warehouse is indispensable
.
14? How to stipulate the three contents of the product; is it according to the first approval or the first approval? Answer: According to the "Measures for the Administration of Pesticide Registration", "The effective ingredients, content, and formulation 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 product should be scientific, reasonable, and convenient to use
.
The same is effective.
For single-preparation products of ingredients and dosage forms, the content gradient does not exceed 3.

The effective ingredients of the mixed formulations do not exceed 2, and the effective ingredients such as herbicides, seed treatment agents, and pheromones do not exceed 3.

The mixtures with the same effective ingredients and dosage forms For formulations, the formulation ratio shall not exceed 3, and the total content gradient of the same formulation shall not exceed 3.
The
pesticides with low active ingredient content that are used directly without dilution or dispersion are classified separately
.
The specific requirements shall be separately formulated by the Ministry of Agriculture
.
"Previously stipulated "For pesticide products with the same active ingredient and dosage form (including mixed formulation products with the same ratio), the gradient of the effective ingredient content shall not exceed 5
.
"It should be said that the number of products that have already reached 5 in the past can only be gradually reduced during the registration process
.
After the implementation of the "Pesticide Registration Management Measures" and the "Requirements for Pesticide Registration Information", three gradients of approval must be strictly followed.
One product is naturally enough.
After 3 gradients, there will be no increase or approval
.