Decision No. 165/1999/QĐ-BNN-BVTV Regarding: Issuing Regulations on Procedures for Approval of Production, Processing, Registration, Export, Import; Trade, Storage, Destruction, Labeling, Packaging, Conferences, Advertising, and Use of Plant Protection Products

Pursuant to …; 
Regarding: Issuing regulations on procedures for production, processing, registration, export, import; trading, storage, destruction, labeling, packaging, seminars, advertising, and use of plant protection chemicals.
- Based on the Plant Protection and Quarantine Ordinance issued on February 15, 1993, and the Regulation on Management of Plant Protection Chemicals promulgated together with Decree No. 92/CP dated November 27, 1993 of the Government guiding the implementation of the Plant Protection and Quarantine Ordinance;
- Based on Decree No. 73/CP dated November 1, 1995 of the Government stipulating functions, tasks, powers, and organizational structure of the Ministry of Agriculture and Rural Development;

THE MINISTER OF AGRICULTURE AND RURAL DEVELOPMENT

- In accordance with the proposal of the Director of the Plant Protection Department, the Head of the Science, Technology, and Product Quality Department.

Now, we issue regulations on procedures for production, processing, registration, export, import; trading, storage, destruction, labeling, packaging, seminars, advertising, and use of plant protection chemicals.

These regulations apply to organizations and individuals both within and outside Vietnam involved in the above activities in Vietnam.

Pursuant to …;

Article 1. This Decision replaces Decision No. 100/NN-BVTV/QD dated February 23, 1995 of the Minister of Agriculture and Food Technology;

Previous regulations that conflict with this decision are hereby abolished;

Article 2. The Chairman of the Ministry's Office, the Director of the Plant Protection Department, the Heads of the Science, Technology, and Product Quality Department, the heads of units under the Ministry of Agriculture and Rural Development, the Directors of Provincial Departments of Agriculture and Rural Development, and related organizations and individuals are responsible for implementing this Decision.

On procedures for production, processing, registration, export, import; trading, storage, destruction, labeling, packaging, seminars, advertising, and use of plant protection chemicals.

This Decision shall take effect fifteen days from the date of issuance.

Article 3. (Issued together with Decision No. 165/1999/QD/BNN-BVTV dated December 13, 1999 of the Minister of Agriculture and Rural Development)

REGULATIONS

I. Procedures for production and processing of plant protection chemicals:

Article 1. Competent authority:

The conditions for organizations and individuals to be allowed to produce and process plant protection chemicals shall be determined according to Article 8 of the Regulation on Management of Plant Protection Chemicals promulgated together with Decree No. 92/CP dated November 27, 1993 of the Government, implemented by relevant state management agencies.

The Ministry of Agriculture and Rural Development or the agency authorized by the Ministry of Agriculture and Rural Development (hereinafter referred to as the Ministry of Agriculture and Rural Development) shall review the standards, types, forms of products, and efficacy of the chemicals.

Article 2. Review procedures:

1. Application for review submitted to the Ministry of Agriculture and Rural Development:

a. Request for review;

b. List of chemical types proposed for production and processing and documentation regarding their standards, types, forms, and efficacy.

2. The Ministry of Agriculture and Rural Development shall provide written comments on the results of the review within 45 days from the date of receipt of a complete application.

3. Organizations and individuals wishing to produce and process plant protection chemicals must pay the review fee as prescribed.

II. Registration procedures for plant protection chemicals

3. Organizations and individuals wishing to produce or process plant protection chemicals must pay the examination fee in accordance with current regulations.

II. Plant Protection Chemical Registration Procedures

Article 3. General Principles:

Organizations and individuals, both within and outside the country, that produce active ingredients or raw materials for plant protection products (technical products) may apply to register themselves or authorize another organization or individual to submit an application for registration of their product in Vietnam.

Each organization or individual, both within and outside the country, that produces active ingredients or raw materials for plant protection products may directly register only one trade name or authorize another organization or individual to register once for a trade name for one active ingredient or raw material produced by themselves. In cases where the purpose of use changes, a different trade name can be registered for each new purpose of use.

For registrations that require biological efficacy trials as stipulated in Article 6 below, such trials must be conducted according to the provisions set out in Part III on New Plant Protection Product Trials issued together with Decision No. 193 dated December 2, 1998 of the Minister of Agriculture and Rural Development.

Article 4. Types of Plant Protection Products Required to Be Registered for Use in Vietnam:

1. Products not listed in the directory of plant protection products permitted for use in Vietnam;

2. Products listed in the directory of plant protection products permitted for use but bearing a different trade name, changing the scope of use, form of the product, active ingredient concentration, solvent, additives, or mixed together to form a new product.

Article 5. Types of Plant Protection Products Not Permitted to Be Registered:

1. Products listed in the directory of restricted-use plant protection products in Vietnam (except those specifically used for warehouse disinfection, pest control at storage areas, wood treatment...);

2. Products without a registered trade name for use abroad;

3. Products with a trade name identical to the common name (generic name);

4. Finished products classified under Group I for acute toxicity according to the World Health Organization's classification, except those specifically used for warehouse disinfection, pest control at storage areas, wood treatment... and other products not in Group I but slow to decompose, causing environmental pollution, and currently under review by FAO/WHO.

Article 6. Forms of Registration:

1. Official Registration:

1.1. Official registration applies to the following types of products:

- Newly invented domestically and recognized by a competent scientific council at the sectoral level or higher as a type of plant protection product

- Already commercialized abroad but being introduced for the first time for use in Vietnam

1.2. Official registration involves conducting biological efficacy trials (referred to as trials) in two phases: narrow-scale trials and wide-scale trials. Wide-scale trials can only be conducted after the results of narrow-scale trials have been recognized.

2. Supplementary Registration:

2.1. Supplementary registration applies to the following types of products:

a. Changing the scope of use, form of the product, active ingredient concentration, solvent, additives;

b. Using a different trade name;

c. Mixing two or more active ingredients already listed in the directory of plant protection products permitted for use in Vietnam to create a new product;

d. Changing the purpose of use.

2.2. All cases mentioned above must conduct both narrow-scale and wide-scale trials, except when organizations or individuals who have already officially registered or supplementary registered now wish to apply for supplementary registration for their products as specified in points a and b above, they only need to conduct wide-scale trials.

3. Re-registration:

Re-registration applies to all types of products listed in the directory of plant protection products permitted for use in Vietnam, but whose registration certificates have expired. The application for re-registration must be submitted six months before the expiration date of the registration certificate. Plant protection products that do not go through the re-registration process will be removed from the directory of plant protection products permitted for use in Vietnam.

Article 7. Documents for registering plant protection products:

The organization or individual named on the registration must submit the following documents and samples to the Plant Protection Department:

1. Application form (in accordance with the model prescribed in Appendix 1 of this regulation).

2. Copy of industrial property right certificate (certified copy) issued by the National Office of Intellectual Property of Vietnam or certified copy of power of attorney or assignment agreement for the use of such certificates of the product owners in Vietnam (if applicable). In case there is no such certificate or document, the product owner shall not have the right to lodge complaints when other organizations or individuals apply for registration of similar products.

3. Sample product (as required in Appendix 2 of this regulation).

4. Documentation in Vietnamese or English, which must be detailed and copied from the original documents of the manufacturers of the active ingredients or raw materials of the registered product (as required in Appendix 2 of this regulation).

Article 8. Registration Fees:

Organizations and individuals applying for registration must pay the registration fee as prescribed by current regulations.

Article 9. Responsibilities of the registration issuing authority:

1. Receiving the application documents and sample products.

2. Examining the application documents and storing the sample products.

3. Responding to the examination results to allow the registration procedures within thirty days from the date of receiving complete valid application documents (except for the biological efficacy test results in Vietnam).

4. Issuing test permits and collecting examination fees.

5. Organizing and managing state administration over testing.

6. Organizing the evaluation of test results and preparing files to submit to the Ministry of Agriculture and Rural Development for registration decision (if conditions are met).

7. Issuing registration certificates and collecting registration fees.

Article 10. Validity Periods of Permits:

The validity period of the test permit is three years, while that of the formal registration certificate, supplementary registration certificate, and re-registration certificate is five years.

III. Export and Import Inspection Procedures for Plant Protection Products

Article 11. General Principles:

1. Only organizations and individuals possessing all types of documents such as business establishment license, export-import enterprise code registration certificate, business license, or certification of eligibility for plant protection product business may engage in export and import activities of plant protection products.

2. Only finished products of plant protection products with active ingredient content matching the registered plant protection product's active ingredient content can be imported; raw materials (technical products) of plant protection products with active ingredient content equal to or higher than the registered raw material's active ingredient content when used in Vietnam can be imported.

3. Only import orders for plant protection products with contents according to the prescribed model (with attached appendices) will be inspected.

Article 12. Documents and Procedures for Export and Import Inspection of Plant Protection Products:

1. Organizations and individuals wishing to export or import plant protection products (finished products or raw materials) must submit the following documents to the Plant Protection Department:

- Export and import order: The order must clearly specify the type, quantity, time, and location of export and import. For imported products, the origin and brand name intended for sale and use must match the registered brand name and must be approved in writing by the person who registered the brand name in Vietnam.

- Certified copy of the business license issued by the Ministry of Agriculture and Rural Development or certification of eligibility for business issued by the Department of Agriculture and Rural Development, enterprise establishment registration certificate issued by the provincial or centrally-administered city Department of Planning and Investment, and export-import enterprise code registration certificate issued by the customs authority.

2. The quantity and type inspection of restricted-use plant protection products will be proposed by the Plant Protection Department and submitted to the leadership of the Ministry of Agriculture and Rural Development for approval based on the import quotas allocated to enterprises by the Ministry of Agriculture and Rural Development. The response time for the result shall not exceed ten days from the date of receipt of complete valid documents.

The quantity and type inspection of permitted-use plant protection products will be conducted by the Plant Protection Department, approved, and the result responded to within seven days from the date of receipt of complete valid documents.

The inspection opinion of the Ministry of Agriculture and Rural Development or the Plant Protection Department has the value of allowing one or more imports or exports within the total amount of products inspected and throughout the allowed period.

IV. Trade in Plant Protection Products:

Article 13. General Principles:

The sale of plant protection chemicals shall be carried out in accordance with the provisions set forth in Articles 16 and 17 of the Regulations on Management of Plant Protection Chemicals issued together with Decree 92/CP dated November 27, 1993, and Articles 4 and 6 of Decree 11/1999/NĐ-CP dated March 3, 1999 of the Government. Individuals directly involved in selling plant protection chemicals must hold at least a diploma in agriculture or plant protection.

V. Transport of Plant Protection Chemicals and Raw Materials:

Article 14. General Principles:

- The transportation of plant protection chemicals and raw materials must comply with the regulations stipulated in Decree 36/CP dated May 29, 1995 on Ensuring Urban Traffic Order and Safety, Decree 39/CP dated July 15, 1996 on Ensuring Railway Traffic Order and Safety, and Decree 46/CP dated July 5, 1996 on Ensuring Inland Waterway Traffic Order and Safety of the Government.

- Strictly prohibited from transporting plant protection chemicals and raw materials on passenger-carrying vehicles, on vehicles carrying livestock, foodstuffs, flammable or explosive substances, and other goods.

Article 15. Transportation Process of Plant Protection Chemicals:

The transportation of plant protection chemicals and raw materials must follow the route specified on the cargo transport permit issued by the competent authority and must not stop or park in crowded areas, near schools, hospitals, or water sources for drinking.

VI. Storage of Plant Protection Chemicals:

Article 16. Warehouses for Plant Protection Chemicals:

Organizations and individuals engaged in the business of plant protection chemicals must have storage facilities that meet the following requirements:

1. The location of the warehouse for plant protection chemicals must be approved in writing by relevant authorities on Environment, Health, Public Security, and local government.

2. The warehouse must be constructed solidly with non-flammable materials, not prone to flooding, well-ventilated, surrounded by protective fencing, and maintain a minimum distance of 10 meters between warehouses to allow fire trucks easy access.

3. Firefighting equipment, anti-toxic measures, and emergency medical supplies must be available.

VII. Use of Plant Protection Chemicals:

Article 17. General Principles:

The use of plant protection chemicals must be conducted in accordance with the provisions set forth in Articles 19 and 20 of the Regulations on Management of Plant Protection Chemicals issued together with Decree 92/CP dated November 27, 1993 of the Government.

Article 18. Rights of Purchasers and Users of Plant Protection Chemicals:

Domestic and foreign organizations or individuals requiring the use of plant protection chemicals have the right to purchase and use types of plant protection chemicals listed in the permitted or restricted use catalogues aimed at preventing crop pests, forest products pests, eradicating vectors or animals transmitting diseases to humans or livestock, or purchasing and using growth-regulating products registered for use in Vietnam.

Article 19. Responsibilities of Users of Plant Protection Chemicals:

Users of plant protection chemicals are responsible for strictly adhering to technical procedures and usage and storage regulations for each type of chemical.

Users of plant protection chemicals bear legal responsibility for all consequences resulting from improper technical use or misuse of the chemicals.

VIII. Disposal of Plant Protection Chemicals and Packaging:

Article 20. General Principles:

The destruction of pesticides and their packaging must meet the following requirements:

1. The maximum allowable residue levels in soil, water, and air shall not exceed the limits prescribed by Vietnam or the World Health Organization (WHO) in cases where Vietnam has not established such limits.

2. Persons carrying out the destruction must be fully equipped with anti-toxic equipment and labor protection gear.

Article 21. Destruction:

The destruction of pesticides and their packaging shall be carried out in accordance with the regulations set forth in the Hazardous Waste Management Regulations issued together with Decision No. 155/1999/QĐ-TTg dated July 16, 1999 of the Prime Minister, and must comply with Section 5, Part II of Directive No. 29/1998/CT-TTg dated August 25, 1998 of the Prime Minister.

Article 22. Implementation and Supervision of Destruction:

The organization responsible for implementing the destruction shall be chaired by the provincial or centrally-administered city Plant Protection and Quarantine Agency, coordinating with local environmental protection agencies and relevant agencies to supervise the destruction.

Article 23. Costs of Destruction:

All costs associated with destruction shall be borne by the owner of the items to be destroyed.

IX/ Labels for Pesticides:

Article 24. General Principles:

1. All types of pesticides sold and used must have labels in Vietnamese, which may also include foreign languages, the content of which must correspond to the approved label during registration review and can only be changed upon approval by the agency handling the registration of that pesticide in Vietnam.

2. The labels must be clear, legible, not fade or easily tear during circulation, storage, and use;

3. The labels must be securely affixed or printed on the pesticide packaging;

4. Red color and colors identical to those indicating the toxicity level of pesticides generally shall not be used as background for the labels;

5. The common name (generic name) of the active ingredient shall not be used as the trade name on the label. The common name (generic name) may only be listed under the "ingredients" section of the label.

Article 25. Content on the Label Includes:

1. Information on toxicity;

2. Trade name, ingredients, active ingredient concentration, form, and function of the pesticide;

3. Usage instructions.

4. Safety measures during use, post-use, and first aid procedures in case of poisoning;

5. Compatibility with other types of pesticides (if applicable), storage methods;

6. Registration number; net volume or weight;

7. Name and address of the manufacturer, name and address of the processing facility, supplier;

8. Date of processing or packaging, shelf life.

9. Illustrations showing how to store, mix, and use the product (if applicable);

10. Isolation period, illustrations, colored stripes indicating toxicity level, toxicity group, and physical properties of the pesticide;

11. Quality inspection mark of the processing facility.

Article 26. Types of Pesticide Labels:

Single-column label, double-column label, triple-column label, and butterfly-shaped label (the layout and content of each type are detailed in the attached annex).

X/ Packaging of Pesticides:

Article 27. General Principles:

1. Pesticides must be packaged in separate containers;

2. It is prohibited to use packaging designed for food or beverages to package pesticides;

3. Pesticides shall not be packaged in containers that pose a danger to users, nor shall they be packaged in glass syringes;

4. Pesticide packaging must meet the following requirements:

a. Durability during storage, transportation, and use;

b. Prevention of changes to the composition, characteristics, and efficacy of the pesticide;

c. Resistance to environmental factors that could affect the quality of the pesticide;

d. Sufficient surface area to display all necessary information for one type of pesticide.

Article 28. Packaging:

The quantity and volume of plant protection products in packaging must match the quantity and volume (with tolerance) indicated on the label of the registered product.

XI. Seminars, advertising of plant protection products:

Article 29. General principles:

1. Only seminars and advertisements promoting the use of plant protection products listed in the permitted plant protection product catalog in Vietnam may be organized;

2. Terms asserting the safety and toxicity of the products such as "non-hazardous," "non-toxic," "harmless" shall not be used in any advertising;

3. Advertising must comply with Decree No. 194/CP dated December 21, 1994 of the Government on advertising activities within the territory of Vietnam.

4. The advertisement information for plant protection products must be approved by the provincial or centrally-administered city state management agency for Plant Protection and Quarantine.