Circular No. 03/2013/TT-BNNPTNT On Plant Protection Chemical Management

CIRCULAR

On the management of plant protection products

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Pursuant to Decree No. 01/2008/ND-CP dated January 3, 2008 of the Government stipulating the functions, tasks, powers, and organizational structure of the Ministry of Agriculture and Rural Development and Decree No. 75/2009/ND-CP dated September 10, 2009 of the Government amending Article 3 of Decree No. 01/2008/ND-CP dated January 3, 2008 of the Government stipulating the functions, tasks, powers, and organizational structure of the Ministry of Agriculture and Rural Development;

Pursuant to Decree No. 33/2005/NĐ-CP of the Government dated March 15, 2005 detailing and guiding the implementation of certain provisions of the Veterinary Law, and Decree No. 119/2008/NĐ-CP dated November 28, 2008 amending and supplementing certain provisions of Decree No. 33/2005/NĐ-CP;

Pursuant to Decree No. 58/2002/ND-CP dated June 3, 2002 of the Government promulgating the Plant Protection Regulations, the Plant Quarantine Regulations, and the Plant Protection Product Management Regulations;

Pursuant to Decree No. 104/2009/ND-CP dated November 9, 2009 of the Government stipulating the list of dangerous goods and the transportation of dangerous goods by road transport vehicles;

At the proposal of the Director of the Plant Protection Department;

Article 1. Amending and supplementing some articles of Circular No. 21/2023/TT-BTTTT dated December 31, 2023 of the Ministry of Information and Communications on functions and technical features of the Administrative Procedure Handling Information System at the ministerial and provincial levels (hereinafter referred to as Circular No. 21/2023/TT-BTTTT) as follows: The Ministry of Agriculture and Rural Development issues this Circular on the management of plant protection products.

PART I

GENERAL PROVISIONS

Article 1. Scope of Regulation

This Circular provides for the management of plant protection products including: registration; production, processing, bottling, packaging; export, import; trading; storage, transportation; use; destruction; labeling; packaging; seminars, advertising; trials, quality testing, residue testing; certification of conformity and declaration of conformity of plant protection products in Vietnam.

Article 2. Applicability

This Circular applies to organizations and individuals both within and outside Vietnam that engage in activities related to plant protection products in Vietnam.

Article 3. Fees and charges

Organizations and individuals engaging in activities related to plant protection products must pay fees and charges as prescribed by laws on fees and charges.

Chapter II

REGISTRATION OF PLANT PROTECTION PRODUCTS

Article 4General principles

1. All plant protection products used for pest control or growth regulation of crops; disinfection of warehouses, wharfs; preservation of agricultural and forestry products not intended for food or medicinal use; termite control in construction works, dykes; seed treatment shall be registered in Vietnam.

2. Domestic or foreign organizations and individuals (having representative offices, companies, branches of companies engaged in the business of plant protection products permitted to operate in Vietnam) who produce active substances or technical products shall directly register one trade name for one active substance or technical product produced by themselves.

3. Organizations and individuals producing active substances or technical products who do not directly register may authorize once a domestic or foreign organization or individual (having representative offices, companies, branches of companies engaged in the business of plant protection products permitted to operate in Vietnam) to register one trade name for one active substance or technical product produced by themselves.

4. Each authorized organization or individual registering a trade name can only receive authorization from one producer for one active substance (cannot receive additional authorization from another producer for the already authorized active substance) to register one trade name.

5. Each organization or individual producing active substances or technical products is only allowed to register or authorize registration of one trade name for one active substance or technical product for pest control or growth regulation of crops. If these active substances or technical products are used for warehouse and wharf disinfection; preservation of agricultural and forestry products not intended for food or medicinal use, post-harvest treatment of agricultural products; termite control in construction works, dykes; seed treatment, then an additional trade name must be registered.

6. Organizations and individuals registering a trade name can change the producer, transfer the trade name, and change the trade name.

Organizations and individuals are only permitted to accept the transfer of trade names of plant protection products containing active substances that have not been registered under their own names.

After the transfer, the registering entity and the entity receiving the right to register the trade name cannot use the same type of active substance to register another trade name.

A plant protection product can only change its trade name if there is a written conclusion by a competent state agency regarding intellectual property rights or by a court regarding trademark infringement. The old trade name will be canceled and cannot be reused.

Changing the producer, transferring the trade name, and changing the trade name of plant protection products must comply with the relevant legal procedures stipulated in Articles 11, 12, and 13 of this Circular.

7. Organizations and individuals can only submit supplementary registration applications for trade names of ‎plant protection products containing new active substances that have been officially registered by other organizations and individuals (who first registered the new active substance in Vietnam) within five years from the date of issuance of the Plant Protection Product Registration Certificate.

Article 5Types of plant protection products permitted to be registered in Vietnam

1. Plant protection products containing active substances not listed in the List of Plant Protection Products Permitted for Use in Vietnam.

2. Plant protection products containing active substances listed in the List of Plant Protection Products Permitted for Use in Vietnam but with different trade names.

3. Plant protection products listed in the List of Plant Protection Products Permitted for Use in Vietnam but with expanded scope of use, dosage, application method, formulation, or active substance content, or mixed together to form new products.

4. Plant protection products containing active substances listed in the List of Restricted Plant Protection Products in Vietnam for warehouse and wharf disinfection; preservation of forestry products not intended for food or medicinal use; termite control in construction works, dykes.

Article 6 Types of plant protection products not permitted to be registered in Vietnam

1. Plant protection products listed in the List of Prohibited Plant Protection Products in Vietnam; plant protection products listed in the List of Restricted Plant Protection Products in Vietnam for pest control in fields.

2. Plant protection products containing single substances or mixtures of patented substances abroad but not yet registered for use abroad.

3. Plant protection products with trade names identical to those of active substances or existing registered products.

4. Plant protection products containing active substances that are a mixture of active substances from the same organization or individual when registering to change the proportion of active substance components without altering the total amount of active substance compared to the product already registered.

5. Finished plant protection products with acute toxicity group I or finished products with acute toxicity group II but containing active substances belonging to toxicity group I, according to the classification of the World Health Organization (WHO); except for products specifically used for warehouse and storage disinfection, wharf disinfection; wood preservation products not intended for food or medicinal purposes; termite control products for construction works and dyke structures; rodenticides.

6. Active substances or finished plant protection products listed in Appendix III of the Rotterdam Convention; active substances or finished plant protection products warned against by the Food and Agriculture Organization of the United Nations (FAO), the United Nations Environment Programme (UNEP), or the Scientific Council of the Ministry of Agriculture and Rural Development recommending prohibition of their use in Vietnam.

7. Chemical plant protection products with active substances classified as acute toxicity groups I or II according to the WHO classification; containing organic chlorine active substances; having a pre-harvest interval in Vietnam exceeding 07 (seven) days shall not be registered for pest control, growth regulation of fruit trees, tea plants, and vegetables, or for post-harvest crop preservation.

8. Products containing methyl bromide.

Article 7. Registration of plant protection products

1. Registration for issuance of experimental permit for plant protection products

a) All types of plant protection products registered for use in Vietnam must apply for issuance of an experimental permit for plant protection products in Vietnam.

b) Chemical plant protection products officially registered under trade names must undergo efficacy testing on a limited and wide scale.

c) Biological plant protection products officially registered under trade names; plant protection products registered for additional scope of use, dosage, application method, formulation, and active substance content must undergo wide-scale efficacy testing.

d) Chemical plant protection products being registered for the first time for use on fruit trees, tea plants, and vegetables must conduct testing to determine the pre-harvest interval in Vietnam (except herbicides for fruit trees).

2. Official registration

Types of plant protection products officially registered in the List of Permitted and Restricted Plant Protection Products for use in Vietnam include:

a) Plant protection products containing active substances registered for the first time in Vietnam or mixtures of active substances already in the List forming new products developed by organizations or individuals abroad and already registered for use abroad;

b) Plant protection products containing active substances registered for the first time in Vietnam or mixtures of active substances already in the List forming new products developed by organizations or individuals domestically and recognized by the Plant Protection Department as a type of plant protection product.

3. Supplementary registration

Types of plant protection products registered for supplementary inclusion in the List of Permitted and Restricted Plant Protection Products for use in Vietnam include:

a) Trade names different from those of plant protection products with the same active substance in the List;

b) Supplementing the scope of use, dosage, application method, formulation, and active substance content of plant protection products already in the List.

4. Extension of the Registration Certificate for plant protection products.

a) Extension applies to plant protection products in the List of Permitted and Restricted Plant Protection Products for use in Vietnam (for warehouse and wharf disinfectants; preservation of agricultural and forestry products not intended for food or medicinal purposes; termite control for construction works and dykes) when the Registration Certificate expires.

b) Application for extension must be submitted three (3) months before the expiration date of the Registration Certificate.

c) Plant protection products not following the extension procedures will be removed from the List of Permitted and Restricted Plant Protection Products for use in Vietnam.

Article 8. Procedure and formalities for registration for issuance of experimental permit for plant protection products

1. Submitting application

a) Organizations or individuals submit applications directly or via postal service to the Plant Protection Department.

b) Number of applications: two (2) copies including one (1) hard copy (paper application) and one (1) soft copy in PDF format.

c) Check the completeness of the application within three (3) working days. If complete, accept the application; if incomplete, return it to the organization or individual and request supplementation and completion.

2. Documents

a) For official registration and supplementary registration of trade names.

A registration application for issuance of an experimental permit for plant protection products as prescribed in Appendix I attached to this Circular;

Original power of attorney from the active substance manufacturer or technical product manufacturer applying for registration (in cases where the manufacturer authorizes another organization or individual);

Original or certified true copy of the certificate confirming the status as an active substance or technical product manufacturer issued by the competent authority of the country of origin;

Original or certified true copy of the registration certificate for use of the product abroad for products officially registered and developed abroad or Decision of the Plant Protection Department recognizing the product as a type of plant protection product for products officially registered and developed domestically;

Detailed technical documentation in Vietnamese or English, copied and translated from the original, with confirmation stamp from the active substance or technical product manufacturer as prescribed in Appendix IV attached to this Circular;

Label sample of the product as prescribed in Chapter IX of this Circular;

Certified true copy of industrial property rights certificates issued by the National Office of Intellectual Property of Vietnam or authorization and transfer agreements for the use of such certificates for products in Vietnam held by the owners of such products (if any).

b) For supplementary registration of scope of use, dosage, and application method.

A registration application for issuance of an experimental permit for plant protection products as prescribed in Appendix I attached to this Circular;

Copy of the Registration Certificate for plant protection products already issued;

Label sample of the product as prescribed in Chapter IX of this Circular.

c) For supplementary registration of formulation and active substance content.

A registration application for issuance of an experimental permit for plant protection products as prescribed in Appendix I attached to this Circular;

Copy of the Registration Certificate for plant protection products already issued;

Label sample of the product as prescribed in Chapter IX of this Circular;

Detailed finished technical documentation in Vietnamese or English, photocopied or translated from the original, bearing the manufacturer's confirmation stamp for the active ingredient or technical pesticide as specified in Section II, Appendix IV issued together with this Circular.

d) Trial registration (for new active ingredients not listed in the Catalogue of Permitted and Restricted Pesticides in Vietnam)

A registration application for issuance of an experimental permit for plant protection products as prescribed in Appendix I attached to this Circular;

Safety Data Sheet (SDS).

3. Reviewing the application and issuing the Pesticide Field Testing Permit

The Plant Protection Department shall review the application within fifteen working days from the date of receipt of a complete application as prescribed (For cases specified in Point d, Clause 2, this Article, the review shall be completed within five working days):

a) If the application is valid and meets the technical requirements stipulated in Appendix IV issued together with this Circular, issue the Pesticide Field Testing Permit according to the form prescribed in Appendix XIII issued together with this Circular.

b) If the application is invalid or does not meet the technical requirements stipulated in Appendix IV issued together with this Circular, notify the organization or individual of the contents that need to be supplemented or completed in accordance with the regulations.

In case the Pesticide Field Testing Permit is not issued, the Plant Protection Department shall notify the organization or individual in writing and specify the reasons.

Article 9Procedure and formalities for registering pesticides officially and supplementarily

1. Submitting application

a) Follow the provisions at Point a, c, Clause 1, Article 8 of this Circular.

b) Number of applications: one hard copy (paper application), one electronic copy in Word or Excel format for the label template.

2. Documents

a) Application for pesticide registration according to the form prescribed in Appendix II issued together with this Circular;

b) Photocopy of the Pesticide Field Testing Permit issued by the Plant Protection Department;

c) Label sample of the pesticide as prescribed in Chapter IX of this Circular;

d) Original results of biological efficacy testing and isolation period determination testing according to the forms prescribed in Appendices XVII and XVIII issued together with this Circular.

3. Reviewing the application and issuing the Pesticide Registration Certificate

a) The Plant Protection Department shall review the application within five working days from the date of receipt of a complete application as prescribed.

If the application is valid and meets the requirements stipulated in Chapters IX, XII and other provisions of this Circular, proceed with the procedures as prescribed in Points b, c, d, đ, Clause 3, this Article.

If the application is invalid or does not meet the requirements stipulated in Chapters IX, XII and other provisions of this Circular, notify the organization or individual of the contents that need to be supplemented or completed in accordance with the regulations.

b) The Plant Protection Department shall convene the Pesticide Advisory Council to evaluate and approve officially registered and supplementary registered pesticides three times a year.

c) Immediately upon receiving the Council's evaluation results, the Plant Protection Department shall notify the organization or individual in writing of the Council's conclusions on:

The pesticide registration application is accepted and the Pesticide Registration Certificate will be issued according to the form prescribed in Appendix XIV issued together with this Circular, and the pesticide is permitted for circulation.

The pesticide registration application is accepted but requires supplementation or completion of the application.

The pesticide registration application is rejected and the reasons are specified.

d) The Plant Protection Department shall prepare files of all pesticides reviewed by the Advisory Council and propose recognition to the Ministry of Agriculture and Rural Development.

đ) Within a maximum of fifteen working days from the date of submission by the registration authority, the Minister of Agriculture and Rural Development shall issue the Circular on the Catalogue of Permitted, Restricted, and Prohibited Pesticides in Vietnam.

Article 10. Procedure and formalities for extending the Plant Protection Product Registration Certificate

1. Submitting application

a) Follow the provisions at Point a, c, Clause 1, Article 8 of this Circular.

b) Number of applications: one hard copy (paper application), one electronic copy in Word or Excel format for the label template.

2. Documents

a) A request for extension of the Plant Protection Product Registration Certificate according to the form prescribed in Appendix II issued together with this Circular;

b) The original Plant Protection Product Registration Certificate that has been issued;

c) The label of the plant protection product in circulation or a sample label if there are changes to the contents prescribed in Chapter IX of this Circular.

3. Reviewing the application and issuing the Pesticide Registration Certificate

The Plant Protection Department shall examine the dossier within five working days from the date of receipt of a complete dossier in accordance with regulations:

a) If the dossier is valid and meets the requirements stipulated in Chapter IX and other provisions of this Circular, issue the Plant Protection Product Registration Certificate according to the form prescribed in Appendix XIV issued together with this Circular.

b) If the dossier is not valid and does not meet the requirements stipulated in Chapter IX and other provisions of this Circular, notify the organization or individual of the necessary supplementary and completion of the dossier in accordance with regulations.

c) In case the Plant Protection Product Registration Certificate is not issued, the Plant Protection Department shall notify the organization or individual in writing and specify the reasons.

Article 11Procedure and formalities for changing the manufacturer of plant protection products

1. Submitting application

Implement in accordance with Clause 1, Article 8 of this Circular.

2. Documents

a) A request for change of manufacturer according to the form prescribed in Appendix III issued together with this Circular;

b) The original power of attorney from the active ingredient or technical product manufacturer (for cases where the manufacturer authorizes another organization or individual);

c) The original or certified copy of the certificate confirming the status as the active ingredient or technical product manufacturer issued by the competent authority of the home country;

d) Detailed technical documentation in Vietnamese or English, copied and translated from the original, with confirmation stamp of the active ingredient or technical product manufacturer as prescribed in Appendix IV issued together with this Circular;

đ) The original Plant Protection Product Testing Permit, Plant Protection Product Registration Certificate that have been issued;

e) The label of the plant protection product as prescribed in Chapter IX of this Circular.

3. Examination of the dossier and issuance of the Plant Protection Product Testing Permit, Plant Protection Product Registration Certificate

The Plant Protection Department shall examine the dossier within fifteen working days from the date of receipt of a complete dossier in accordance with regulations.

a) If the dossier is valid and meets the technical requirements stipulated in Appendix IV issued together with this Circular, issue the Plant Protection Product Testing Permit, Plant Protection Product Registration Certificate according to the form prescribed in Appendices XIII and XIV issued together with this Circular. The validity period of the new Plant Protection Product Testing Permit, Plant Protection Product Registration Certificate shall remain the same as the previous certificates.

b) If the application is invalid or does not meet the technical requirements stipulated in Appendix IV issued together with this Circular, notify the organization or individual of the contents that need to be supplemented or completed in accordance with the regulations.

c) In case the Plant Protection Product Testing Permit, Plant Protection Product Registration Certificate is not issued, the Plant Protection Department shall notify the organization or individual in writing and specify the reasons.

Article 12Procedure and formalities for transferring the trade name of plant protection products.

1. Submitting application

a) Follow the provisions at Point a, c, Clause 1, Article 8 of this Circular.

b) Number of applications: one hard copy (paper application), one electronic copy in Word or Excel format for the label template.

2. Documents

a) A request for transfer of trade name according to the form prescribed in Appendix III issued together with this Circular;

b) The original or certified copy of the transfer contract or agreement;

c) The original Plant Protection Product Testing Permit, Plant Protection Product Registration Certificate that have been issued;

d) The original power of attorney from the active ingredient or technical product manufacturer to the organization or individual receiving the transfer;

đ) The label of the plant protection product as prescribed in Chapter IX of this Circular.

3. Examination and issuance of the Plant Protection Product Testing Permit, Plant Protection Product Registration Certificate:

a) The Plant Protection Department shall review the application within five working days from the date of receipt of a complete application as prescribed.

If the dossier is valid and meets the provisions of this Circular, issue the Plant Protection Product Testing Permit according to the form prescribed in Appendix XIII issued together with this Circular.

If the dossier is not valid, notify the organization or individual of the necessary supplementary and completion of the dossier in accordance with regulations.

In case the Plant Protection Product Testing Permit, Plant Protection Product Registration Certificate is not issued, the Plant Protection Department shall notify the organization or individual in writing and specify the reasons.

b) For trade names of plant protection products already included in the List of Permitted, Restricted, and Prohibited Plant Protection Products in Vietnam: if the dossier is valid and meets the provisions of this Circular, the Plant Protection Department shall submit to the Ministry of Agriculture and Rural Development. Within no more than fifteen working days from the date of submission by the registration agency, the Minister of Agriculture and Rural Development shall issue the List of Plant Protection Products or amend and supplement the List of Permitted, Restricted, and Prohibited Plant Protection Products in Vietnam.

Within ten working days from the date of issuance of the Circular, the Plant Protection Department shall issue the Plant Protection Product Registration Certificate according to the form prescribed in Appendix XIV issued together with this Circular.

c) The validity period of the new Plant Protection Product Testing Permit, Plant Protection Product Registration Certificate shall remain the same as the previous certificates.

Article 13Procedure and formalities for changing the trade name of plant protection products.

1. Submitting application

a) Follow the provisions at Point a, c, Clause 1, Article 8 of this Circular.

b) Number of applications: one hard copy (paper application), one electronic copy in Word or Excel format for the label template.

2. Dossier

a) A request for change of trade name according to the form prescribed in Appendix III issued together with this Circular;

b) The original Plant Protection Product Testing Permit, Plant Protection Product Registration Certificate that have been issued;

c) Label sample of the pesticide as prescribed in Chapter IX of this Circular;

d) The original or certified copy of the document from the competent state authority on intellectual property or court regarding the violation of the trademark of the plant protection product that has been issued the Plant Protection Product Registration Certificate.

3. Examination of the dossier and issuance of the Plant Protection Product Testing Permit, Plant Protection Product Registration Certificate

Implement in accordance with Clause 3, Article 12 of this Circular.

Article 14Procedure and formalities for reissuing the Plant Protection Product Testing Permit, Plant Protection Product Registration Certificate

1. Cases for reissuance

a) The original Plant Protection Product Testing Permit, Plant Protection Product Registration Certificate is still valid but lost or missing;

b) The original Plant Protection Product Testing Permit, Plant Protection Product Registration Certificate is still valid but damaged and cannot be used further;

c) When errors are discovered or changes are made to the information on the Plant Protection Product Testing Permit or the Plant Protection Product Registration Certificate;

d) Changing the name of the registering organization or individual;

đ) Converting the Chemical Plant Protection Product Testing Permit already listed in the Catalogue to register additional usage scope, dosage, application method, formulation, and active ingredient content;

e) Consolidating the Registration Certificate according to the request of the registering organization or individual.

2. Submission of documents

a) Follow the provisions at Point a, c, Clause 1, Article 8 of this Circular.

b) Number of files: 01 (one) hard copy (paper file).

3. Documentation

a) A request form for reissue according to the model prescribed in Appendix III attached to this Circular;

b) Original Plant Protection Product Testing Permit, Plant Protection Product Registration Certificate (for cases specified in Points b, c, d, đ, e, Clause 1, Article this);

c) Certified true copy of the new Business Registration Certificate (for cases specified in Point d, Clause 1, Article this);

d) Label sample of the drug as prescribed in Chapter IX of this Circular (for cases specified in Points c, d, Clause 1, Article this).

3. Reviewing the file and reissuing

a) The Plant Protection Department reviews the file within 05 (five) working days from the date of receipt of the complete file as stipulated:

If the file is valid, issue the Plant Protection Product Testing Permit, Plant Protection Product Registration Certificate according to the model prescribed in Appendices XIII, XIV issued together with this Circular.

If the dossier is not valid, notify the organization or individual of the necessary supplementary and completion of the dossier in accordance with regulations.

In case the Plant Protection Product Testing Permit, Plant Protection Product Registration Certificate is not issued, the Plant Protection Department shall notify the organization or individual in writing and specify the reasons.

b) For cases specified in Point d, Clause 1, Article this, implement as prescribed in Point b, Clause 3, Article 12.

c) The validity period of the reissued Plant Protection Product Testing Permit, Plant Protection Product Registration Certificate remains the same as the original permits. For cases specified in Point e, Clause 1, Article this, the validity period of the reissued Plant Protection Product Registration Certificate is the shortest validity period of the Plant Protection Product Registration Certificates that have been issued.

Article 15. Revoking the Plant Protection Product Testing Permit, Reissued Plant Protection Product Registration Certificate

Cases requiring revocation:

1. The Plant Protection Product Testing Permit, Plant Protection Product Registration Certificate has been erased or altered;

2. Using false documents or providing inaccurate information in the registration file;

3. Other violations as prescribed by law that require revocation.

Article 16. Reference Standards

1. Organizations or individuals with registered chemical plant protection products (officially registered, trade named) must submit 02 (two) grams (g) of reference standard for each active ingredient of the registered product to the registration authority upon receiving the Plant Protection Product Testing Permit.

2. The reference standards must be accompanied by an analysis certificate from a laboratory meeting ISO standards or equivalent, and have a shelf life of at least 02 (two) years.

Article 17. Registration Authority and Responsibilities of the Registration Authority

1. The Plant Protection Department is the registration authority for plant protection products in Vietnam.

2. Responsibilities of the registration authority:

a) Accepting registration files and reference standards;

b) Reviewing, retaining, and securing files;

c) Responding to review results, issuing and revoking Plant Protection Product Registration Certificates, Plant Protection Product Testing Permits;

d) Organizing advisory council meetings to review officially registered products, soliciting opinions from advisory council members on supplementary registered products, and preparing files for submission to the Minister of Agriculture and Rural Development to issue the Circular Catalogue of plant protection products permitted, restricted, or prohibited for use in Vietnam following the advisory council's examination and recommendation;

e) Collecting fees and charges for issuing and reissuing Plant Protection Product Testing Permits; Plant Protection Product Registration Certificates; extending the validity period of Plant Protection Product Registration Certificates according to current regulations.

Article 18. Validity Period of Certificates and Licenses

1. The Registration Certificate for Plant Protection Chemicals is valid for a period of five (5) years.

Three (3) months before the Registration Certificate for Plant Protection Chemicals expires, organizations and individuals must submit an application to extend the Registration Certificate to the Plant Protection Department if they wish to renew it. The procedures and requirements for extending the Registration Certificate for Plant Protection Chemicals are carried out according to Article 10 of this Circular.

2. The Field Trial Permit for Plant Protection Chemicals is valid for a period of five (5) years.

The Field Trial Permit for Plant Protection Chemicals cannot be extended. In cases where organizations and individuals have not conducted field trials and the permit has expired, they must apply for a new Field Trial Permit for Plant Protection Chemicals in accordance with Article 8 of this Circular.

Article 19Time for retaining records

1. Retention time for records: five (5) years for hard copies, ten (10) years for electronic copies.

2. When the retention period ends, the records shall be destroyed in accordance with current regulations.

Chapter III

PRODUCTION, MANUFACTURING, REPACKAGING, AND PACKAGING OF PLANT PROTECTION CHEMICALS

Article 20. General Principles

1. Only plant protection chemicals listed in the Catalogue of Permitted and Restricted Plant Protection Chemicals in Vietnam and those already permitted for import for manufacturing, repackaging, and packaging for re-export under contracts signed with foreign countries may be produced, manufactured, repackaged, and packaged.

2. Organizations and individuals producing, manufacturing, repackaging, and packaging plant protection chemicals must meet all conditions stipulated in Article 7 of the Regulation on Management of Plant Protection Chemicals issued together with Decree No. 58/2002/ND-CP dated June 3, 2002, and Decree No. 59/2006/ND-CP dated June 12, 2006 of the Government detailing the implementation of the Law on Trade regarding prohibited goods and services, restricted goods and services, and goods and services subject to conditions, and Article 12 of Decree No. 108/2008/ND-CP dated October 7, 2008 of the Government detailing and guiding the implementation of certain provisions of the Law on Chemicals.

3. Individuals directly managing and operating production, manufacturing, repackaging, and packaging of plant protection chemicals must hold a professional practice certificate issued by the Provincial Plant Protection Service.

Article 21. Registration for Production, Manufacturing, Repackaging, and Packaging of Plant Protection Chemicals

1. The competent state agency will only issue business registration for activities related to production, manufacturing, repackaging, and packaging of plant protection chemicals when the person directly managing and operating these activities holds a professional practice certificate issued by the local plant protection management authority.

2. Individuals applying for a professional practice certificate for production, manufacturing, repackaging, and packaging of plant protection chemicals must meet the conditions stipulated in Article 8 of the Regulation on Management of Plant Protection Chemicals issued together with Decree No. 58/2002/ND-CP dated June 3, 2002.

Procedures for issuing a professional practice certificate for production, manufacturing, repackaging, and packaging of plant protection chemicals are carried out according to the regulations of the Minister of Agriculture and Rural Development.

A production, manufacturing, repackaging, and packaging facility for plant protection chemicals can only operate from the date it receives a Certificate of Compliance with Conditions for Production, Manufacturing, Repackaging, and Packaging of Plant Protection Chemicals in accordance with Decree No. 59/2006/ND-CP dated June 12, 2006 of the Government detailing the implementation of the Law on Trade regarding prohibited goods and services, restricted goods and services, and goods and services subject to conditions.

The procedures for issuing a Certificate of Compliance with Conditions for Production, Manufacturing, Repackaging, and Packaging of Plant Protection Chemicals are carried out according to the regulations of the Minister of Agriculture and Rural Development.

Article 22. Responsibilities of organizations and individuals producing, processing, repackaging, and packaging plant protection chemicals

1. Production, processing, repackaging, and packaging of plant protection chemicals must comply with registered production procedures, technical regulations, and quality standards.

2. Shall be liable under the law if their activities in producing, processing, repackaging, and packaging plant protection chemicals adversely affect people, livestock, and the environment.

3. Shall be responsible for the quality and other legal provisions applicable to types of chemicals produced by the facility within the shelf life period circulating on the market.

4. Shall submit periodic reports in writing to the Plant Protection Department and the Plant Protection Sub-department in their locality regarding the situation of producing, processing, repackaging, and packaging plant protection chemicals annually in the fourth quarter.

5. Shall notify in writing the Plant Protection Department when changing the factory or workshop location; production capacity, form of operation, types of chemicals produced, processed, repackaged, and packaged; discontinuation of production, processing, repackaging, and packaging.

Article 23. Responsibilities of the Plant Protection Department

1. To receive reports on production, processing, repackaging, and packaging activities; notifications on discontinuing production, processing, repackaging, and packaging of plant protection chemicals from organizations and individuals and compile reports to the Ministry of Agriculture and Rural Development.

2. To organize regular annual inspections; and spot inspections of production, processing, repackaging, and packaging facilities for plant protection chemicals upon request.

Chapter IV

EXPORT AND IMPORT OF PLANT PROTECTION CHEMICALS

Article 24. General Principles

1. Organizations and individuals holding a business registration certificate for the plant protection chemical industry or agricultural supplies are permitted to export and import plant protection chemicals.

2. Only allowed to import plant protection chemicals and raw materials listed in the Catalogue of Plant Protection Chemicals Permitted for Use in Vietnam issued by the Minister of Agriculture and Rural Development, without requiring permission, only customs clearance procedures at the customs office.

3. For those types of plant protection chemicals authorized for export and import, the authorized entity for export and import must present the authorization letter (authorization from the manufacturer to the exporter; authorization from the registrant to the importer) at the customs office.

4. Importation of plant protection chemicals and raw materials in the following cases must be approved by the Plant Protection Department::

a) Plant protection chemicals and raw materials listed in the Catalogue of Restricted Plant Protection Chemicals in Vietnam;

b) Plant protection chemicals and raw materials not listed in the Catalogue of Plant Protection Chemicals Permitted for Use in Vietnam: chemicals for scientific research, trials; used in foreign projects in Vietnam; for processing, repackaging, and re-export according to contracts signed with foreign countries; samples, chemicals for exhibitions, fairs, and special cases;

c) Reference substances for plant protection chemicals not listed in the Catalogue of Plant Protection Chemicals Permitted for Use in Vietnam for testing and research purposes.

5. Plant protection chemicals in the Catalogue of Plant Protection Chemicals Permitted for Use or Restricted Use in Vietnam must meet the following requirements upon importation:

a) Finished plant protection chemicals must have the active ingredient content, formulation, and manufacturer consistent with the Plant Protection Chemical Registration Certificate in Vietnam.

b) Raw materials or technical chemicals must have an active ingredient content equal to or higher than that of the raw materials or technical chemicals in the Catalogue of Plant Protection Chemicals Permitted for Use, Restricted Use in Vietnam, and must be imported from manufacturers with clear origin and source.

6. Prohibited from importing active ingredients or finished plant protection chemicals listed in Appendix III of the Rotterdam Convention.

7. The model of the Import Permit for Plant Protection Chemicals and Raw Materials is specified in Appendix VII attached to this Circular.

Article 25. Issuance of Import Permit for Plant Protection Chemicals and Raw Materials

The procedures for issuing the Import Permit for Plant Protection Chemicals and Raw Materials shall be carried out in accordance with the provisions of Circular No. 88/2011/TT-BNNPTNT dated November 28, 2011, issued by the Minister of Agriculture and Rural Development guiding the implementation of Decree No. 12/2006/NĐ-CP detailing the implementation of the Law on Trade regarding agency activities, purchase, sale, processing, and transshipment of goods with foreign countries in the fields of agriculture, forestry, and fisheries.

Article 26. Reporting System

At the end of each year's fourth quarter, organizations and individuals exporting or importing plant protection chemicals must submit a written statistical report on their export and import activities of plant protection chemicals to the Plant Protection Department.

Article 27Exporting and Importing Plant Protection Chemicals Containing Methyl Bromide

1. Conditions for Exporting and Importing Methyl Bromide.

a) Imports and exports of plant protection chemicals containing methyl bromide can only be conducted with countries participating in the Montreal Protocol.

b) Register with the Plant Protection Department the quantity of methyl bromide to be imported for different purposes: plant quarantine; export disinfection (QPS) and other purposes (non-QPS) for the following year before December 15 of the current year.

c) The Plant Protection Department will allocate the quantity of methyl bromide to be imported in the previous year before January 30 of the following year based on registration, scale of operation of fumigation and disinfection service organizations, and the phased-out schedule of methyl bromide that Vietnam has committed to internationally.

d) The Import Permit for methyl bromide specified in Appendix VIII attached to this Circular shall have a validity period until December 31 of the year it was issued and shall not be extendable under any circumstances.

đ) Possess a Business Registration Certificate for the trade in plant protection chemicals or agricultural supplies, allowing the import and export of plant protection chemicals.

2. Procedures for Issuing the Import Permit for Methyl Bromide shall be carried out in accordance with the provisions of Circular No. 88/2011/TT-BNNPTNT dated November 28, 2011, issued by the Minister of Agriculture and Rural Development guiding the implementation of Decree No. 12/2006/NĐ-CP detailing the implementation of the Law on Trade regarding agency activities, purchase, sale, processing, and transshipment of goods with foreign countries in the fields of agriculture, forestry, and fisheries.

3. Responsibilities of Organizations Exporting and Importing Plant Protection Chemicals Containing Methyl Bromide

a) Only permitted to use methyl bromide according to the registration with the Plant Protection Department and must comply with inspections and checks by state management agencies regarding the use of methyl bromide;

b) Only allowed to sell plant protection chemicals containing methyl bromide to organizations that meet the conditions for fumigation and disinfection services as stipulated by law;

c) Must annually report to the Plant Protection Department on fumigation and disinfection activities according to the model prescribed in Appendix 7 of the State Management Regulations on Fumigation and Disinfection Services for Quarantine Objects issued by Decision No. 89/2007/QĐ-BNN dated November 1, 2007, of the Minister of Agriculture and Rural Development, and the trading of methyl bromide according to the model prescribed in Appendix IX attached to this Circular. Reports for the first six months of the year must be submitted before July 15, and annual reports must be submitted before January 15 of the following year.

4. Organizations are not allowed to import methyl bromide if they violate any of the following cases:

a) Failure to comply with the reporting system as prescribed or providing false reports on the situation of importing, using, and trading methyl bromide.

b) Using methyl bromide for purposes other than those registered or changing the purpose of export disinfection in plant quarantine (QPS) to other purposes (non-QPS).

c) Importing additional quantities for activities outside the scope of quarantine and export disinfection (non-QPS).

Chapter V

TRADE IN PLANT PROTECTION CHEMICALS

Article 28. General Principles

1. Organizations and individuals engaged in the sale of plant protection products must meet the conditions stipulated in Article 16 of the Regulation on Management of Plant Protection Products issued together with Decree No. 58/2002/NĐ-CP dated June 3, 2002 of the Government and Article 7 of Decree No. 59/2006/NĐ-CP dated June 12, 2006 of the Government detailing the implementation of the Law on Trade regarding goods and services prohibited from trade, restricted trade, and conditional trade.

2. Only plant protection products listed in the Catalogue of Permitted and Restricted Plant Protection Products for Use in Vietnam, issued by the Minister of Agriculture and Rural Development, may be sold.

3. Only finished plant protection products within their shelf life, with clear origin and source, and bearing labels complying with Chapter IX of this Circular and other relevant laws on labeling may be sold.

4. Individuals directly selling plant protection products and managers of plant protection product trading establishments must hold a practice certificate issued by the Provincial Plant Protection Sub-department.

5. Domestic or foreign organizations and individuals registering and distributing plant protection products in Vietnam shall be responsible for the quality of such products circulating in the market.

Article 29. Registration for Sale of Plant Protection Products

1. The competent state agency shall only issue business registration certificates for the sale of plant protection products if the seller holds a practice certificate issued by the Provincial Plant Protection Sub-department.

2. Applicants for a practice certificate for the sale of plant protection products must meet the conditions stipulated in Article 17 of the Regulation on Management of Plant Protection Products issued together with Decree No. 58/2002/NĐ-CP dated June 3, 2002 of the Government and Article 3 of Decree No. 98/2011/NĐ-CP dated October 26, 2011 of the Government amending and supplementing certain articles of decrees on agriculture.

3. Organizations and individuals selling plant protection products may only commence operations from the date they obtain a Certificate of Compliance with Conditions for Business in Plant Protection Products in accordance with Decree No. 59/2006/NĐ-CP dated June 12, 2006 of the Government detailing the implementation of the Law on Trade regarding goods and services prohibited from trade, restricted trade, and conditional trade.

4. The procedures for issuing a Practice Certificate for the Sale of Plant Protection Products and a Certificate of Compliance with Conditions for Business in Plant Protection Products shall be carried out in accordance with the regulations of the Minister of Agriculture and Rural Development.

Article 30. Locations for Selling Plant Protection Products

The location for selling plant protection products must be approved by the commune authorities; it must be far from schools, hospitals, markets, and water sources; it must ensure safety for people, animals, and the environment; it must not be subject to flooding under any circumstances; it must have adequate fire prevention and extinguishing equipment and comply with the requirements set forth in Clause 2, Article 19 of the Regulation on Management of Plant Protection Products issued together with Decree No. 58/2002/NĐ-CP dated June 3, 2002 of the Government.

Chapter VI

TRANSPORTATION AND STORAGE OF DRUGS, RAW MATERIALS OF PLANT PROTECTION CHEMICALS

Article 31. General Principles

1. The transportation of plant protection chemicals and raw materials for such chemicals must comply with the provisions of Decree No. 104/2009/NĐ-CP dated November 9, 2009 of the Government on the list of dangerous goods and the transportation of dangerous goods by motor vehicles, road traffic laws, railway traffic laws, inland waterway traffic laws, and other relevant legal regulations.

Plant protection chemicals specified in Appendix I issued together with Decree No. 104/2009/NĐ-CP dated January 9, 2009 of the Government must be granted permission to transport.

2. The transportation of plant protection chemicals and raw materials for such chemicals must follow the schedule recorded in the contract or other relevant transportation documents between the vehicle owner and the cargo owner.

3. The transportation of plant protection chemicals and raw materials for such chemicals must ensure safety for people and the environment. Vehicles shall not stop in crowded areas, near schools, hospitals, markets, or sources of drinking water.

4. Plant protection chemicals and raw materials for such chemicals may only be transported if they have been properly packaged, labeled, and granted a Transportation Permit for Plant Protection Chemicals and Raw Materials for Such Chemicals by the competent authority as stipulated in Article 33 of this Circular.

5. Plant protection chemicals that can react with each other shall not be transported on the same vehicle.

6. Plant protection chemicals and raw materials for such chemicals shall not be transported on the same vehicle as passengers, animals, foodstuffs, flammable and explosive substances, and other goods, except fertilizers.

Article 32. Transportation of Plant Protection Chemicals and Raw Materials for Such Chemicals

1. Transporters of plant protection chemicals and raw materials for such chemicals

a) Vehicle drivers and escorts must understand the hazardous nature of plant protection chemicals and raw materials for such chemicals, including their toxicity, flammability, explosiveness, corrosiveness, and must know how to handle initial incidents during transportation and comply with legal regulations on the transportation of dangerous goods.

b) Drivers transporting plant protection chemicals and raw materials for such chemicals, in addition to current national certificates for operating vehicles, must also hold a Certificate of Training on Occupational Safety in the Transportation and Storage of Plant Protection Chemicals and Raw Materials for Such Chemicals.

c) Escorts of plant protection chemicals and raw materials for such chemicals must be trained on occupational safety in the transportation and storage of these chemicals.

2. Packaging, containers, or carriers containing plant protection chemicals and raw materials for such chemicals during transportation

a) Must be made from durable, waterproof materials;

b) Must bear a hazard label with a black skull and crossbones symbol on a white background in a square placed diagonally. The size of the hazard label affixed to each container of plant protection chemicals and raw materials for such chemicals is 100 millimeters (mm) x 100 millimeters (mm), and for carriers it is 250 millimeters (mm) x 250 millimeters (mm) according to the model prescribed in Appendix VI issued together with this Circular;

c) Must have a rectangular warning sign in orange-yellow color, with the United Nations Number (UN) in the center, the size of the warning sign is 300 millimeters (mm) x 500 millimeters (mm) according to the model prescribed in Appendix VI issued together with this Circular, located below the hazard label. For packaging and containers of plant protection chemicals, the warning sign should be smaller but still clearly visible.

3. Vehicles transporting plant protection chemicals and raw materials for such chemicals

a) Common transport vehicles permitted by competent authorities to operate for cargo transportation may carry plant protection chemicals and raw materials for such chemicals.

b) Vehicles transporting plant protection chemicals and raw materials for such chemicals must meet the following technical conditions:

Equip with appropriate fire-fighting tools and equipment suitable for plant protection chemicals and raw materials for such chemicals during transportation;

Have a roof or tarpaulin securely covering the entire cargo compartment to prevent water infiltration during transportation;

Shall not use flatbed trucks to transport plant protection chemicals.

c) Vehicles transporting plant protection chemicals and raw materials for such chemicals must be positioned last in each ferry trip if the ferry terminal does not have a dedicated ferry for dangerous goods.

d) Vehicles transporting containers of plant protection chemicals and raw materials for such chemicals must bear the hazard label corresponding to the type of goods being transported. The size of the hazard label affixed to the vehicle is 500 millimeters (mm) x 500 millimeters (mm). The hazard label must be affixed on both sides and at the rear of the vehicle.

4. Handling Incidents

In case of accidents such as spills or traffic accidents during the transportation of plant protection chemicals and raw materials for such chemicals, the driver, escort, or cargo owner must handle the incident and immediately report to the local authorities or the nearest state agency to take timely measures to prevent and mitigate the consequences caused by leakage of chemicals. The violator shall bear all costs of remediation.

Article 33. Permit for Transporting Pesticides and Raw Materials for Pesticides.

1. Organizations and individuals transporting pesticides and raw materials for pesticides with a volume of 1,000 kg per vehicle or more must have a permit for transporting pesticides and raw materials for pesticides issued by the Plant Protection Sub-department under the provincial department.

2. The permit for transporting pesticides and raw materials for pesticides shall be valid throughout the country.

3. The validity period of the permit for transporting pesticides and raw materials for pesticides shall be granted for each trip or period but not exceeding twelve months from the date of issuance.

4. The form of the permit for transporting pesticides and raw materials for pesticides is specified in Appendix XI attached to this Circular.

Article 34. Procedures and Formalities for Issuing Permits for Transporting Pesticides and Raw Materials for Pesticides.

1. Submitting application

Organizations and individuals requesting the issuance of permits for transporting pesticides and raw materials for pesticides shall submit directly or send by post one (01) set of documents to the competent authority as prescribed in Clause 1 of Article 33 of this Circular.

2. Documents

a) A request for issuing a permit for transporting pesticides and raw materials for pesticides according to the model specified in Appendix X attached to this Circular;

b) A copy of the certificate of training on occupational safety in the transportation and storage of pesticides and raw materials for pesticides of the driver or escort (when submitting, bring the original for verification);

c) One of the following documents (certified copy):

Supply contract;

Transportation contract for pesticides and raw materials for pesticides;

Financial invoice for exporting and importing pesticide goods;

Goods transportation declaration of the company (with confirmation and stamp of the company);

d) Transportation schedule, address and phone number of the consignor (with confirmation and stamp of the company).

3. Examination of Documents and Issuance of Permits for Transporting Pesticides and Raw Materials for Pesticides.

Within three (3) working days from the date of receipt of complete documents in accordance with regulations, the competent authority shall examine the documents, and if the documents are in order, issue the permit for transporting pesticides and raw materials for pesticides.

In case the documents are not in order, within one (1) working day from the date of receipt of complete documents, the competent authority shall notify the organization or individual of the contents that need to be supplemented and completed in accordance with regulations.

In case the permit for transporting pesticides and raw materials for pesticides is not issued, within one (1) working day, the competent authority shall notify the organization or individual in writing and specify the reasons.

Article 35. Contents of Occupational Safety Training in the Transportation and Storage of Pesticides and Raw Materials for Pesticides.

Drivers, escorts, and warehouse keepers shall be trained and instructed on the following contents:

1. Contents of occupational safety training as prescribed in Circular No. 37/2005/TT-BLDTBXH dated December 29, 2005 of the Ministry of Labor, Invalids and Social Affairs on guiding occupational safety training and labor hygiene work;

2. Relevant documents related to the transportation and storage of dangerous chemicals;

3. Characteristics of pesticides;

4. Hazard signs and symbols of goods;

5. Measures to ensure safety when transporting pesticides and raw materials for pesticides (rescue, safety on the road, basic knowledge about using protective equipment);

6. Preventive and response measures for each type of pesticide incident.

Article 36. Responsibility for organizing training and issuing Training Certificates

1. The Plant Protection Department under the Ministry of Agriculture and Rural Development shall be responsible for developing the content and training program for warehouse keepers, cargo escorts, and vehicle operators handling plant protection chemicals.

2. Provincial Plant Protection Agencies shall cooperate with educational institutions, vocational training centers, and enterprises to conduct training in accordance with the content and program specified in Article 35 of this Circular and issue Training Certificates according to the model prescribed in Appendix XII attached to this Circular.

3. Organizations and individuals involved in transporting plant protection chemicals and raw materials thereof must ensure that vehicle operators, cargo escorts, and warehouse keepers handling plant protection chemicals have been trained in accordance with the contents stipulated in Article 35 of this Circular.

Article 37. Chemical Storage Facilities     

1. The location of chemical storage facilities outside industrial zones must obtain the approval of the commune authorities.

2. The storage facility must be constructed solidly from non-flammable materials, not prone to flooding, ensuring good ventilation, and facilitating the operation of firefighting equipment; it must meet the requirements of TCVN 5507:2002 on safety regulations for hazardous chemicals in production, business, use, storage, and transportation.

3. The storage facility must have firefighting tools, protective gear against poisoning, first aid supplies, and hazard warning signs displaying a black skull and crossbones symbol on a white background within a square placed diagonally, with dimensions matching the hazard symbols of vehicles or containers as prescribed in Appendix VI attached to this Circular.

4. The storage facility must comply with legal provisions on environmental protection.

Article 38. Storage of Plant Protection Chemicals

1. The storage of plant protection chemicals must ensure safety for people, livestock, and the surrounding environment.

2. Warehouse keepers must be trained in occupational safety in the storage of plant protection chemicals.

3. In cases where leaks or dispersion of chemicals cause harm to the environment, the owner of the chemicals must take responsibility for remedying the consequences under the guidance or supervision of plant protection agencies, environmental management agencies, commune authorities, and bear all costs associated with remediation.

Chapter VII

USE OF PLANT PROTECTION CHEMICALS

Article 39. General Principles

1. Plant protection chemicals may only be used if they are listed in the Catalogue of Permitted Plant Protection Chemicals or the Restricted Use Catalogue in Vietnam issued by the Minister of Agriculture and Rural Development.

2. Plant protection chemicals must be used in accordance with the instructions provided on the label.

3. The use of plant protection chemicals must adhere to the four correct principles: correct chemical, correct timing, correct dosage and concentration, and correct method; compliance with the isolation period indicated on the label must also be observed.

4. It is strictly prohibited to use plant protection chemicals listed in the Catalogue of Prohibited Plant Protection Chemicals in Vietnam; chemicals not included in the permitted catalogue or restricted use catalogue; chemicals of unknown origin or source; and chemicals without labels or with labels only in foreign languages.

Article 40. Responsibilities of Plant Protection Chemical Users

1. Use plant protection chemicals for their intended purposes and ensure safety for oneself, the community, and the environment.

2. Persons using plant protection chemicals shall be liable under the law for the following acts:

a) Using chemicals arbitrarily, not in accordance with recommended techniques, without ensuring isolation periods;

b) Using prohibited chemicals, using chemicals outside the List of Permitted Plant Protection Chemicals, the Restricted Use List in Vietnam, or using chemicals of unknown origin or source;

c) Discarding packaging that previously contained chemicals, disposing of chemical solutions improperly, causing adverse effects on human and animal health and the environment.

3. If the use of plant protection chemicals causes material damage to others, compensation must be provided; if it causes harm to health or life, in addition to compensation, legal sanctions shall also be imposed according to the law.

Article 41. Responsibilities of Management Agencies and Units Engaged in Plant Protection Chemical Trade

1. Provincial or centrally-administered city state management agencies for plant protection and quarantine shall cooperate with relevant departments to inspect the use of plant protection chemicals in production areas, particularly in specialized vegetable, tea, and fruit production zones; identify and handle cases of intentional violations of general principles for plant protection chemical use as stipulated in Article 39 of this Circular. Guide the collection and disposal of empty chemical packaging after use in accordance with regulations.

2. The People's Committee at the commune level is responsible for managing the sale and use of plant protection chemicals locally; coordinate with specialized agencies on plant protection and quarantine to organize effective promotion and guidance on the use of plant protection chemicals, specify collection points for post-use packaging, and address violations.

3. Organizations and individuals engaged in the trade and sale of plant protection chemicals must provide clear and specific guidance to buyers, and bear legal responsibility and compensate for economic losses resulting from inadequate, incorrect, or inaccurate promotional, advertising, and usage guidance, which may lead to confusion among buyers and users, harming human and animal health, the environment, and production.

Chapter VIII

DISPOSAL OF PLANT PROTECTION CHEMICALS AND PACKAGING

Article 42. General Principles

Disposal of plant protection chemicals and packaging must comply with requirements set forth in Article 22 of the Plant Protection Chemical Management Regulations issued together with Decree No. 58/2002/NĐ-CP dated June 3, 2002, of the Government, and laws regarding hazardous waste disposal.

Article 43. Disposal Process

1. During the collection and disposal of plant protection chemicals and packaging, there must be no spillage, dispersion, or increase in hazardous waste released into the environment; safety for humans, animals, and the environment must be ensured.

2. The disposal of plant protection chemicals and packaging must comply with environmental protection laws.

3. Organizations and individuals possessing plant protection chemicals and packaging required for disposal must cover all costs associated with such disposal. If plant protection chemicals and packaging required for disposal have no local owner, the provincial People's Committee shall allocate funds from the budget to properly dispose of them in accordance with regulations.

Chapter IX

LABELING OF PLANT PROTECTION CHEMICALS

Article 44. General Principles

1. All types of plant protection products when sold and used must have labels in Vietnamese, the label content must be consistent with the content recorded in the approved label model by the Plant Protection Department during the registration review process, in accordance with the provisions of Government Decree No. 89/2006/NĐ-CP dated August 30, 2006 on product labeling and the guidelines of the Global Harmonization System for the Classification and Labeling of Chemicals..

2. The main label and auxiliary labels shall be printed in standard font size, at least 8 (Times New Roman or equivalent), clearly visible, easy to read, not faded or easily torn during circulation, storage, transportation, and use.

If the main label does not contain all required information, an auxiliary label must be attached to each package of the product.

The contents: trade name; name of the organization or individual responsible for the product; origin of goods; quantity; production date; expiration date of the product must be recorded on the main label.

3. The label must be firmly affixed or printed on the packaging of the product.

4. The background of the label shall not use colors that match the toxicity level color code of the plant protection product.

5. The active ingredient or raw material (technical product) name may only be recorded on the label under the section "ingredients."

6. Any changes to the label content compared to the approved label model during the registration review process must be approved by the Plant Protection Department.

7. Restricted-use plant protection products must indicate "restricted-use product" on the label (for example: restricted-use warehouse disinfectant Alumifos 56% TB).

8. For certain products, if there is a requirement from the plant protection product management authority to warn users, the label of such products must correctly record the warning according to the requirement (for example: do not use the product on rice after flowering; do not use the product in aquaculture areas).

Article 45. Content Recorded on the Label of Plant Protection Products

1. Finished Products

a) Product Information

Trade name;

Finished product form symbolized according to the international coding system for raw materials and finished plant protection products of the Croplife Organization (Croplife International Codes for Technical and Formulated Pesticides) as stipulated in Appendix XX issued together with this Circular;

Name, ingredients, active substance content: clearly state the unit of measurement in g/kg (for solid, viscous liquid, aerosol, or volatile liquid plant protection products); unit of measurement in g/l (for other liquid forms) or percentage by weight (% w/w);

Solvent (if it alters the toxicity of the product): name and content of the solvent. Unit and recording method are the same as for the active substance;

Actual volume, unit is liters (l) or milliliters (ml) (for liquid products); net weight, unit is kilograms (kg) or grams (g) (for powder or granular products); number of tablets, net weight unit is kilograms (kg) or grams (g) (for tablet products).

b) Safety Information

Toxicity information consistent with the provisions of Section 1 and Section 7 of Appendix V issued together with this Circular;

Symbolic images, colored stripes indicating toxicity levels and toxicity groups consistent with the provisions of Appendix VI issued together with this Circular;

Safety measures during and after use, and first aid measures in case of poisoning consistent with the provisions of Section 5 and Section 6 of Appendix V issued together with this Circular.

c) Usage Information

Usage instructions consistent with the registered content;

Symbolic images guiding storage, mixing, and usage methods (if applicable);

Pre-harvest interval (days);

Compatibility with other types of products (if applicable).

d) Other Information

Registration number‎ Plant protection product;

Name, address of the organization or individual registering the product;‎d. Reporting to the decision-making authority about the inspection results and bearing responsibility for the accuracy and truthfulness of the report.

Name, address of the entity ultimately responsible for the product in Vietnam;

Origin of goods;

Date of processing or bottling, packaging; shelf life (recorded in the same position, can be abbreviated).

Storage conditions.

2. Technical substances

a) Active ingredient name;

b) Name, components, active ingredient concentration: clearly state the unit of measurement in g/kg, g/l or mass percentage (% w/w);

c) Actual volume, net weight;

d) Importer's name, address;

đ) Manufacturer's name, production location address;

e) Production date; expiry date (recorded at the same position, may be abbreviated).

Chapter X

PACKAGING AND CONTAINERS FOR PLANT PROTECTION PRODUCTS

Article 46. General principles

Packaging of plant protection products must comply with the requirements of TCVN 5507:2002 Hazardous chemicals - Safety regulations for production, business, use, storage, and transportation, and the following requirements:

1. Plant protection products must be packaged in high-quality containers; this applies to all types of plant protection product packaging, including recycled or reused packaging. The packaging must ensure:

a) High quality capable of withstanding normal impacts and vibrations during transportation, transfer between means of transport, and manual or mechanical loading and unloading;

b) Must be sealed to prevent chemical loss during preparation for transportation or during transportation under influences such as shaking, increased temperature, humidity, and pressure;

c) The outer surface of the packaging must be clean and free from any hazardous chemicals.

2. Parts of the packaging that come into contact with plant protection products must ensure:

a) Not affected or deteriorate in quality due to the impact of the packaged chemicals inside;

b) No dangerous reactions, catalytic effects, or reactions with the plant protection products inside the packaging;

c) An appropriate inert liner layer must be used to protect and isolate the packaging from the packaged plant protection products.

3. When packaging liquid plant protection products, sufficient empty space must be left to ensure that the packaging does not leak or deform due to the increase in volume of the packaged liquids when temperatures rise during transportation.

4. Inner layers of packaging when plant protection products are double-layered must ensure that under normal transportation conditions, they cannot break, puncture, or leak the packaged contents to the outer layer of packaging.

5. Inner packaging types that are prone to breaking or puncturing, such as glass, ceramic, or certain types of plastic, must be securely fixed to the outer packaging layer using suitable cushioning materials to reduce vibration.

6. Plant protection products must not be packaged together in the same outer layer or large transport compartment if these chemicals can react with each other and cause:

a) Ignition or significant heat release;

b) Heat release or ignition producing suffocating, oxidizing, or toxic gases;

c) Formation of highly corrosive substances;

d) Formation of unstable substances.

7. The seal of packaging for volatile substances must be tight enough to ensure that during transportation, the liquid level does not fall below the limit.

8. Liquids must be packaged in containers suitable for internal pressure generated during transportation.

9. Plant protection product packaging produced or recycled, reused must meet technical requirements as specified.

10. Empty containers, packaging that have contained plant protection products must be managed as if they still contain plant protection products.

11. All packaging used to contain liquid plant protection products must be tested for leaks before use.

12. Packaging for granular or powdered plant protection products must be sufficiently sealed to prevent spillage or must have sealed cushioning layers.

Chapter XI

INFORMATION, DISCUSSIONS, ADVERTISING OF PLANT PROTECTION PRODUCTS

Article 47. General Principles

1. Information, seminars, and advertising of plant protection products listed in the Catalogue of Plant Protection Products Permitted for Use in Vietnam shall only be conducted.

For plant protection products listed in the Catalogue of Restricted Plant Protection Products in Vietnam, seminars may only be held to provide safety usage recommendations.

2. The content of seminars and advertisements for plant protection products must correspond with the information recorded on the Registration Certificate for Plant Protection Products of such products.

3. All commercial seminars on plant protection products organized by businesses and individuals engaged in trade must include a program introducing "Safe Use of Plant Protection Products." The content of the program follows Decision No. 779/QĐ-BVTV dated May 22, 2011, issued by the Plant Protection Department, establishing the standard TCCS 20:2010/BVTV Guidelines for Safe and Effective Use of Plant Protection Products.

4. It is prohibited to provide information, hold seminars, advertise, or recommend the use of plant protection products that do not comply with the provisions of Article 48, or that do not align with the intended purpose of the registered product; recommendations for use must not contradict the technical procedures established by competent authorities.

Article 48. Information, Seminars, and Advertising of Plant Protection Products

1. Information on plant protection products must ensure:

a) Truthfulness, clarity, and objectivity regarding the characteristics, effects, identification features, and usage methods of the product, as well as its adverse impacts on humans, living organisms, and the environment;

b) Comprehensive, easy-to-understand instructions for use that do not cause misunderstanding, misinterpretation, or confusion about the product; they must correspond with the registration content, ensuring rational, safe, and effective use of the product.

2. Seminars and advertising of plant protection products:

a) Advertising of plant protection products must comply with legal regulations on advertising;

b) Advertising of plant protection products must include warnings about their hazardous and toxic properties and preventive measures against their harmful effects.

3. Information on seminars, conferences, event organization, exhibitions, product advertisement carriers, advertising objects, and other advertising media that introduce marketed plant protection products, scientific education programs sponsored by plant protection product companies on local media must obtain written approval from the Provincial Plant Protection Sub-department regarding the content.

4. Procedures, methods of implementation, and filing requirements for advertising registration follow the laws on advertising.

Chapter XII

TESTING OF PLANT PROTECTION PRODUCTS

Article 49. General Principles

1. Field testing of plant protection products in Vietnam can only be conducted with a valid field testing permit in Vietnam. For testing purposes aimed at registration, the testing must be carried out by organizations meeting the required conditions.

Organizations and individuals directly conducting field tests of plant protection products must not know the name of the tested product to ensure impartiality.

2. Biological efficacy testing is conducted to determine the effectiveness of pest control or growth regulation for crops (including crop safety) under cultivation conditions in major production regions within Vietnam.

3. Testing to determine the pre-harvest interval is conducted to establish the time from the last application of a plant protection product until harvest under cultivation conditions in major production regions within Vietnam.

4. Field testing of plant protection products aimed at registration in the Catalogue of Plant Protection Products Permitted for Use in Vietnam includes:

a) Biological efficacy testing;

b) Testing to determine the pre-harvest interval;

c) For plant growth regulators, in addition to biological efficacy testing and pre-harvest interval determination, the impact of the product on certain quality indicators corresponding to each type of crop must also be evaluated.

Article 50. Forms and scale of trials for registration purposes The forms and scales of trials for a crop object and a pest type:

Forms, scales of trials for one crop variety and one pest type:

1. Biological efficacy trials

a) Narrow-scale trials are conducted on a small scale. The trial area ranges from 25 to 50 square meters (m²)/plot, repeated 3-4 times; must be carried out in at least two production regions (North and South), each region at two different locations, and must be conducted during two different production seasons. For crops or pests present only in one production region, trials should be conducted at three different locations within two seasons of that region.²)/repetition, three to four times; must be conducted at least in two (two) production regions (North and South), each region with two (two) trial sites and must be carried out in two (two) different production seasons. For crops or pests present only in one (one) production region, trials must be conducted at three (three) different sites within two (two) seasons of that region.

b) Wide-scale trials are conducted on a large scale, with an area ranging from 300 to 500 square meters (m²); must be carried out in two production regions (North and South), each region at one location, and conducted during one production season. For crops or pests present only in one production region, trials should be conducted at two different locations within that region.²); must be conducted in two (two) production regions (North and South), each region at one (one) site and carried out during one (one) production season. For crops or pests present only in one (one) production region, trials must be conducted at two (two) different sites within that region.

c) For perennial crops and special trial objects (pests in storage, post-harvest treatment, forest pests, rodent damage to crops, rodents in storage and colonies, termite damage to structures), the size of the trial plot must follow the specialized trial procedures.

2. Isolation period determination trials

a) Trials to determine the isolation period of plant protection products for crops are conducted on a large scale, with an area ranging from 300 to 500 square meters (m²), not repeated, in two production regions (North and South) over two production seasons.²), without repetition, in two (two) production regions (North and South) over two (two) production seasons.

b) For crops with only one season/year, trials are conducted at two different locations during that one production season.

c) For crops present only in one (one) production region, isolation time determination must be conducted at two (two) sites over two (two) seasons of that region. For crops present only in one (one) production region and having one season/year, trials must be conducted at four (four) different sites within that region.

c) For crops present only in one production region, the isolation period determination trials are conducted at two locations during two production seasons of that region. For crops present only in one production region and have only one season/year, trials are conducted at four different locations within that production region.

Article 51. Conditions for organizations conducting plant protection product trials

1. The head of the organization must have a university degree or higher in plant protection, agronomy, biology, or chemistry, and hold a training certificate for plant protection product trials.

2. Have a team of staff engaged in plant protection work who have been trained in plant protection product trials.

3. Possess technical facilities meeting the requirements for plant protection product trials.

4. Shall not directly conduct trials on plant protection products registered under the name of the trial organization or authorized to register such products in Vietnam. organization Article 52. Responsibilities of organizations conducting plant protection product trials

1. Register to join the network of plant protection product trials with the Plant Protection Department.

2. Strictly implement the trial procedures and requirements.

3. Shall not organize or guide field visits to plant protection product trial fields without the consent of the Plant Protection Department.

4. Shall be responsible under the law for the accuracy of the trial results.

5. Report the trial results according to the templates specified in Appendix XVII and Appendix XVIII issued together with this Circular.

6. Retain all raw data of the trials for a minimum of five years from the date the trials end.

Article 53. Responsibilities of Organizations and Individuals with Plant Protection Products Subject to Testing

1. Organizations and individuals with plant protection products subject to testing shall directly submit or send via postal service one set of application files to the organization conducting the plant protection product testing, including:

- A certified copy of the Plant Protection Product Testing Permit issued by the Plant Protection Department;

- Sample products.

2. Submitting sample products for testing must comply with the following requirements:

a) The correct type and quality as required for testing and recorded in the Plant Protection Product Testing Permit;

b) Sufficient quantity;

c) Carefully packaged in sealed containers or still in the original packaging provided by the manufacturer.

3. Provide the Plant Protection Department with complete information about the products subject to testing as stipulated in Articles 8 and 16 of this Circular and propose dosage and concentration levels for testing. They are responsible for the accuracy of such information. In case the tested products cause harm to people, crops, animals, and the environment, the organizations and individuals with such products shall bear responsibility for compensation according to Vietnamese law.

Article 54. Responsibilities of the Plant Protection Department

1. Manage and organize activities related to plant protection product testing to ensure objectivity and accuracy.

2. Designate organizations to conduct plant protection product testing.

3. Train staff involved in plant protection product testing work.

4. Organize inspections and evaluations of plant protection product testing results.

5. Utilize testing results to organize assessments serving registration and usage guidance when the products have been permitted for use in Vietnam.

Chapter XIII

QUALITY TESTING, RESIDUE TESTING, CERTIFICATION AND ANNOUNCEMENT OF COMPLIANCE WITH STANDARDS FOR PLANT PROTECTION PRODUCTS

1. Quality testing of plant protection products involves determining the active ingredient content, formulation, content of impurities that may be harmful to plants, humans, or the environment (if applicable), content of additives that enhance product safety for humans and crops (if applicable); chemical and physical properties related to biological activity and safety of the product during storage and use.

Article 551. Organizations operating in the field of information technology (including banks providing electronic transaction services in banking activities, organizations providing electronic tax declaration services) with IT infrastructure and electronic invoice software meeting all provisions of this Decree may provide electronic invoice services.

2. Residue testing of plant protection products in agricultural and forestry products, food, and the environment (referred to as items) involves determining the amount of active ingredients and metabolites of plant protection products remaining in the items.

3. Plant protection products subject to quality testing include technical products and finished plant protection products imported; finished plant protection products stored at production facilities, processing plants, bottling plants, packaging plants, and trading establishments.

4. Imported plant protection products and raw materials must be sampled and tested for quality before importation, in accordance with Circular No. 77/2009/TT-BNN PTNT dated December 10, 2009, issued by the Minister of Agriculture and Rural Development on State Inspection of Quality of Imported Plant Protection Products.

5. State inspection of residue levels of plant protection products in imported agricultural products of plant origin shall be carried out in accordance with Circular No. 13/2011/TT-BNNPTNT dated March 16, 2011, issued by the Minister of Agriculture and Rural Development on guiding the inspection of food safety of imported goods of plant origin and current laws.

6. State inspection of the quality of plant protection products and residue levels of plant protection products in agricultural products of plant origin circulating in the market shall be conducted in accordance with the Law on Product and Goods Quality and Circular No. 16/2009/TT-BKHCN dated June 2, 2009, issued by the Minister of Science and Technology on guiding state inspection of the quality of goods circulating in the market.

7. The state management agency for plant protection and quarantine shall take samples to test the quality of finished plant protection products at production facilities, processing plants, bottling plants, and packaging plants annually once for facilities holding GMP (Good Manufacturing Practices), ISO (International Standards Organization) or equivalent quality management system certificates; not more than twice a year for other facilities if no violations are found. When violations are detected, the frequency of inspections may increase.

8. State inspection of the quality of plant protection products and residue levels of plant protection products in agricultural products of plant origin shall be conducted at organizations meeting the conditions designated by the Ministry of Agriculture and Rural Development or agencies authorized by the Ministry of Agriculture and Rural Development.

The designation of testing organizations is carried out in accordance with Circular No. 16/2011/TT-BNNPTNT dated April 1, 2011, issued by the Minister of Agriculture and Rural Development on Evaluation, Designation, and Management of Agricultural and Rural Development Testing Laboratories and Circular No. 52/2012/TT-BNNPTNT dated October 22, 2012, amending and supplementing certain provisions of Circular No. 16/2011/TT-BNNPTNT dated April 1, 2011, and Circular No. 54/2011/TT-BNNPTNT dated August 3, 2011.

9. Certification and announcement of compliance with standards are mandatory activities for organizations and individuals producing and trading in plant protection products.

Based on quality testing, residue testing, certification, and announcement of compliance with standards.

Article 56Based on quality inspection, pesticide residue testing, conformity certification, and conformity announcement.

1. Sampling for quality testing and pesticide residue must be conducted according to National Standard TCVN 8143:2009: Pesticides - Determination of cypermethrin active ingredient content, Appendix A, sampling method; TCVN 5139:2008: Recommended sampling method for determining pesticide residues suitable for maximum residue limits (MRLs).

The sampling record for quality testing and pesticide residue shall be carried out according to the form prescribed in Appendices XV and XVI issued together with this Circular.

2. Quality testing and pesticide residue determination must be conducted according to National Technical Regulations (QCVN), National Standards (TCVN); Basic standards (TC) of the Plant Protection Department (if there are no national technical regulations or national standards). In cases where there are no such bases, international, regional standards, and manufacturer guidelines shall be applied.

3. The basis for certification and announcement of conformity regarding pesticides is stipulated in National Technical Regulations (QCVN), National Standards (TCVN); Basic standards (TC) of the Plant Protection Department announced annually by the Plant Protection Department.

4. Samples for quality testing and pesticide residue determination must be preserved for a period of three (3) months from the date of receipt.

5. Results of quality testing and pesticide residue determination must be stored for a period of three (3) years from the date of issuance of results.

Article 57Procedure and manner of implementation

1. Quality Testing and Pesticide Residue Determination

a) Sample Submission

Organizations and individuals having pesticides that need quality testing or agricultural products requiring pesticide residue testing (collectively referred to as samples) submit a quantity of samples according to the sampling standard for testing, the test request form prescribed by testing organizations, and the sampling record (if available), either directly or through postal service.

Upon receiving the sample, the recipient reviews the test request form, examines the condition of the sample, and schedules the time for result delivery as prescribed.

b) Testing and Issuance of Test Results

Within fifteen (15) working days from the date of receipt of the sample, testing organizations notify the test results.

2. Certification and Announcement of Conformity for Pesticides are implemented according to Circular No. 55/2012/TT-BNNPTNT dated October 31, 2012, issued by the Minister of Agriculture and Rural Development guiding procedures for designating organizations to certify conformity and announce conformity within the scope of management under the Ministry of Agriculture and Rural Development.

Article 58Responsibilities of the Plant Protection Department

1. Managing activities related to quality testing and pesticide residue determination;

2. Training staff involved in quality testing and pesticide residue determination work;

3. Designating organizations for conformity certification, pesticide testing laboratories according to Circular No. 55/2012/TT-BNNPTNT, Circular No. 16/2011/TT-BNNPTNT, and Circular No. 52/2012/TT-BNNPTNT. Lists of conformity certification organizations, testing laboratories, National Technical Regulations (QCVN), National Standards (TCVN), and Basic Standards (TC) are publicly announced on the website of the Plant Protection Department.

Chapter XIV

IMPLEMENTING PROVISIONS

Article 59. Transitional provisions

1. Plant protection products specified in Clause 7, Article 6 of this Circular shall only be permitted to import, produce, trade, and use for a maximum period of two (2) years from the date this Circular takes effect; if the registration certificate for plant protection products expires, it may only be extended for up to two (2) years from the date this Circular takes effect.

2. Plant protection products specified in Clause 5, Article 6 of this Circular shall only be allowed to trade and use for a maximum period of six (6) months from the date this Circular takes effect.

In case new plant protection products are added to Appendix III of the Rotterdam Convention, or are warned by the Food and Agriculture Organization of the United Nations (FAO), the United Nations Environment Programme (UNEP), or the Scientific Council of the Ministry of Agriculture and Rural Development to prohibit their use in Vietnam, such products shall be removed from the list of permitted plant protection products, restricted use, and shall only be allowed to import, produce, trade, and use for a maximum period of two (2) years from the date the competent authority's decision takes effect.

3. Chemical plant protection products registered on vegetables, fruit trees, and tea plants that have been granted trial permits without pre-isolation testing before the date this Circular takes effect must undergo pre-isolation testing.

4. Labels of plant protection products with contents as prescribed in Circular No. 38/2010/TT-BNNPTNT dated June 28, 2010, of the Minister of Agriculture and Rural Development on the management of plant protection products shall continue to be used for a maximum period of two (2) years from the date this Circular takes effect.

5. Foreign organizations and individuals directly named as registrants who have not met the requirements stipulated in Clause 2 and Clause 3, Article 4 of this Circular must comply with the regulations within one (1) year from the date this Circular takes effect.

Article 60. Effective date

This Circular takes effect from February 25, 2013.

This Circular replaces Circular No. 38/2010/TT-BNNPTNT dated June 28, 2010, of the Minister of Agriculture and Rural Development on the management of plant protection products and Article 1 of Circular No. 18/2011/TT-BNNPTNT dated April 6, 2011, of the Minister of Agriculture and Rural Development on amending, supplementing, and abolishing certain administrative procedures in the field of plant protection and quarantine according to Resolution No. 57/NQ-CP dated December 15, 2010.

Article 61Responsibility for Implementation

Units under the Ministry of Agriculture and Rural Development, Departments of Agriculture and Rural Development of provinces and centrally-administered cities, and related organizations and individuals are responsible for implementing this Circular;

During implementation, if there are difficulties or obstacles, organizations and individuals should report them to the Ministry of Agriculture and Rural Development (Plant Protection Department) for prompt resolution./.