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Since ancient Greece, humans have known how to use inorganic substances to kill harmful insects and protect crops. By the late 19th century, plant protection products began to develop more strongly, making a significant contribution to agricultural production and protection.

By the late 19th century, plant protection products began to develop more strongly, making a significant contribution to the production and protection of agricultural products.

I. Understanding Plant Protection Product Manufacturing Facilities

Today, many plant protection product manufacturing facilities have been established, annually supplying a large volume of plant protection products to the market. A plant protection product manufacturing facility can be understood as an establishment or unit that produces active ingredients, technical-grade products, finished products, and packages plant protection products.

Generally, plant protection products offer numerous benefits to the agricultural sector. However, they also have negative impacts on the environment and human health. Therefore, to operate, plant protection product manufacturing facilities must meet various conditions stipulated by law.

II. Legal Regulations on Plant Protection Product Manufacturing Facilities

1. Do plant protection product manufacturing facilities need business registration?

Clause 1, Article 65 of the Law on Plant Protection and Quarantine 2013 (Luật Bảo vệ kiểm dịch thực vật) stipulates the application dossier for a certificate of eligibility for plant protection product manufacturing as follows:

“1. The dossier requesting the issuance of a Certificate of Eligibility for Plant Protection Product Manufacturing and a Certificate of Eligibility for Plant Protection Product Trading includes:

...

b) A copy of the Business Registration Certificate;

...”.

To be eligible to manufacture plant protection products, a facility must be granted a certificate of eligibility for plant protection product manufacturing. The dossier for applying for this certificate is stipulated in Clause 1, Article 65 of the Law on Plant Protection and Quarantine 2013. Since a copy of the Business Registration Certificate is required as part of the dossier, plant protection product manufacturing facilities must complete business registration.

2. Conditions for Establishing a Plant Protection Product Manufacturing Facility

As previously stated, to be established and operate, a plant protection product manufacturing facility must meet various conditions stipulated by law. According to Article 61 of the Law on Plant Protection and Quarantine 2013, manufacturing facilities must satisfy the following conditions:

Firstly, conditions regarding physical and technical infrastructure:

  • Possess a location, workshop, and pesticide warehouse, ensuring sufficient area and safe distances for people, livestock, and the environment in accordance with regulations, suitable for the production scale;
  • Machinery, equipment, and technological processes suitable for the type of plant protection products to be manufactured;
  • Have a waste treatment system that ensures waste treatment meets national technical standards and regulations on the environment;
  • Have sufficient equipment to inspect the quality of the plant protection products it manufactures. If not, there must be a quality inspection contract with an organization designated to inspect the quality of plant protection products for each batch of products released from the factory.

Secondly, conditions regarding human resources:

  • The person directly managing and operating the production of the plant protection product manufacturing facility must possess a university degree or higher in chemistry, plant protection, or biology;
  • Direct laborers involved in plant protection product manufacturing must receive appropriate professional training and fostering.

3. Procedures and Dossier for Establishing a Plant Protection Product Manufacturing Facility

The prerequisite for establishing a plant protection product manufacturing facility is that the facility must possess a Certificate of Eligibility for Plant Protection Product Manufacturing. According to Article 65 of the Law on Plant Protection and Quarantine 2013, the dossier, order, and procedures for issuing a certificate of eligibility for plant protection product manufacturing are as follows:

Firstly, the dossier requesting the issuance of a certificate of eligibility for plant protection product manufacturing includes:

  • An application form for a certificate of eligibility for plant protection product manufacturing;
  • A copy of the business registration certificate;
  • A descriptive report on the physical and technical infrastructure, human resources, and professional qualifications ensuring the conditions for manufacturing and trading plant protection products as stipulated in Article 61 of the Law on Plant Protection and Quarantine 2013;
  • Certificates of professional qualifications, certificates of training and fostering knowledge about plant protection products for the facility owner and individuals directly involved in manufacturing and trading plant protection products as stipulated in Article 61 of the Law on Plant Protection and Quarantine 2013;
  • Health certificates for the facility owner and individuals directly involved in manufacturing plant protection products;
  • Documents proving sufficient conditions for fire prevention and fighting, and environmental protection as stipulated by law.

Secondly, the order and procedures for issuing a certificate of eligibility for plant protection product manufacturing:

Pursuant to Article 30 of Circular No. 21/2015/TT-BNNPTNT, the order and procedures for issuing a certificate of eligibility for plant protection product manufacturing are carried out as follows:

  • Step 1: Organizations or individuals (plant protection product manufacturing facilities) submit the dossier directly, online, or via postal service to the Plant Protection Department (Cục Bảo vệ thực vật). 
  • Step 2: Receive and check the validity of the dossier within 02 working days.
  • In cases where the dossier is invalid, it shall be returned with a request for supplementation and completion.
  • Step 3: Appraise the dossier and establish an on-site assessment team within 05 working days.

In cases where the dossier does not meet the regulations, the Plant Protection Department shall notify the organization or individual to supplement and complete the dossier.

  • Step 4: Conduct on-site assessment

The assessment team shall notify the facility in writing 07 working days before the assessment date. The on-site assessment period shall not exceed 01 working day.

  • Step 5: Issue the Certificate of Eligibility for Plant Protection Product Manufacturing (according to the mẫu quy định tại Phụ lục XIX ban hành kèm theo Thông tư số 21/2015/TT-BNNPTNT) within 15 working days.

In cases where the assessment results do not meet the requirements, the Plant Protection Department shall notify the facility in writing of the unsatisfied conditions and the deadline for rectification. Within 05 working days from the date of receiving the facility's rectification report or re-inspection results, the Plant Protection Department shall issue the Certificate of Eligibility for Plant Protection Product Manufacturing to the facility.

In cases where the Certificate of Eligibility for Plant Protection Product Manufacturing is not issued, the Plant Protection Department shall provide written notification, clearly stating the reasons.

III. Common Questions Regarding Plant Protection Product Manufacturing Facilities

1. Which authority is competent to license the establishment of plant protection product manufacturing facilities?

Point a, Clause 4, Article 65 of the Law on Plant Protection and Quarantine 2013 stipulates: “The central specialized agency for plant protection and quarantine shall issue and revoke Certificates of Eligibility for Plant Protection Product Manufacturing.”

Concurrently, Point d, Clause 3, Article 30 of Circular No. 21/2015/TT-BNNPTNT stipulates: “The Plant Protection Department shall review the dossier appraisal results and assessment results to issue the Certificate of Eligibility for Plant Protection Product Manufacturing...”.

Based on the above provisions, the competent authority to license the establishment of plant protection product manufacturing facilities is the Plant Protection Department (Cục Bảo vệ thực vật) – Ministry of Agriculture and Rural Development (Bộ Nông nghiệp và Phát triển nông thôn).

2. Do manufacturing facilities need to pay environmental protection fees for plant protection product manufacturing facilities?

Point i, Clause 2, Article 62 of the Law on Plant Protection and Quarantine 2013 stipulates the obligations of plant protection product manufacturing facilities as follows: “Comply with legal provisions on environmental protection tax and other relevant legal provisions.”

Based on the above provisions, plant protection product manufacturing facilities are required to pay environmental protection fees.

3. Do individuals have the right to establish a plant protection product manufacturing facility?

Currently, the law does not prohibit or disallow individuals from establishing plant protection product manufacturing facilities. However, the Law on Plant Protection and Quarantine 2013 stipulates conditions for plant protection product manufacturing facilities, such as:

  • Conditions regarding physical infrastructure: workshops, pesticide warehouses ensuring safety and suitability for the production scale; machinery and equipment suitable for the production scale; an adequate waste treatment system; complete quality inspection equipment;...
  • Conditions regarding human resources: conditions for direct managers and operators; conditions for laborers;...

Thus, if individuals meet the prescribed conditions, they are entirely entitled to establish plant protection product manufacturing facilities.

4. Is it mandatory for direct laborers in plant protection product manufacturing to have expertise in plant protection products?

According to Clause 2, Article 61 of the Law on Plant Protection and Quarantine 2013, individuals directly managing and operating the production of plant protection products at a facility must possess a university degree or higher in chemistry, plant protection, or biology. Direct laborers involved in plant protection product manufacturing must receive appropriate professional training and fostering.

Therefore, direct laborers involved in plant protection product manufacturing must have appropriate expertise in plant protection products.

5. Do plant protection product manufacturing facilities have the right to import plant protection products for manufacturing?

Clause 1, Article 62 of the Law on Plant Protection and Quarantine 2013 stipulates:

“1. Plant protection product manufacturing facilities have the following rights:

...

b) To import plant protection products for manufacturing or re-export under contracts signed with foreign countries;

...”.

Based on the above provisions, plant protection product manufacturing facilities have the right to import plant protection products for manufacturing or re-export under contracts signed with foreign countries.

6. Is it permissible to authorize another organization to register plant protection products?

According to Clause 3, Article 5 of Circular No. 21/2015/TT-BNNPTNT, organizations or individuals manufacturing active ingredients, technical-grade products, or finished products that do not directly register them may authorize a single qualified organization or individual as prescribed.

Thus, organizations or individuals manufacturing active ingredients, technical-grade products, or finished products are allowed to authorize a single qualified organization or individual, as stipulated in Clause 3, Article 50 of the Law on Plant Protection and Quarantine (Luật Bảo vệ và kiểm dịch thực vật) to register each type of their plant protection products. 

Furthermore, according to Clause 4, Article 5 of Circular No. 21/2015/TT-BNNPTNT each authorized organization or individual acting as the registrant may receive authorization from only one manufacturer of active ingredients, technical-grade products, or finished products for each type of active ingredient, technical-grade product, or finished product.

IV. Legal Consulting Services Related to Plant Protection Product Manufacturing Facilities

Above is all the detailed information that NPLaw provides to assist our clients with issues concerning plant protection product manufacturing facilities. Should clients have any further questions related to the aforementioned matters or other legal issues, please contact NPLaw immediately using the information below to receive direct consultation and guidance from our team.

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