What are the regulations on requirements for pesticide manufacturers in Vietnam? - Van Khuong (Binh Dinh, Vietnam)
Regulations on requirements for pesticide manufacturers in Vietnam (Internet image)
1. What are pesticides?
According to Clause 16, Article 3 of the Law on Plant Protection and Quarantine 2013, pesticide means the substance or any mixture of substances or the microbiological agent which is meant for preventing, inhibiting, repelling, seducing, destroying or mitigating the harmful impact of plant pests, pathogens and diseases; regulating or controlling the growth of plants or insects; serving the purpose of plant storage; increasing the safety and efficacy for the use of various plant protection products.
2. Regulations on requirements for pesticide manufacturers in Vietnam
2.1. General requirements for pesticide manufacturers in Vietnam
* Technical facility requirements
According to Clause 1, Article 61 of the Law on Plant Protection and Quarantine 2013, the technical facility requirements include:
- The factory and warehouse of the manufacturer must be built with sufficient space and safe distances in order to ensure the safety for people, animals and environment according to the regulations;
- Machines, equipment and technology process must be suitable for the manufacturing of pesticides;
- Waste treatment system must meet the national technical regulations and standards for the environment protection;
- The manufacturer should have equipment in order to inspect the quality of the pesticides to be produced.
If it does not have sufficient equipment, it must enter into a contract for the quality examination with an organization specializing in the pesticide quality examination for every product batch.
* Personnel requirements
The conditions for personnel are specified as follows:
- The production supervisor must achieve a bachelor degree in the plant protection, biology or chemistry or any other higher degrees;
- The employees who directly participate in the production must be well-trained.
(Clause 2, Article 61 of the Law on Plant Protection and Quarantine 2013)
2.2. Specific requirements for manufacturing of pesticides in vn
According to Article 3 of Decree 66/2016/ND-CP (amended in Clause 1, Article 1 of Decree 123/2018/ND-CP), pesticide formulating facilities shall meet conditions prescribed in Section 2.1 and the following specific conditions:
- The persons directly managing and operating pesticide plants must obtain at least bachelor degree in one of the following majors, e.g. chemistry, plant protection, biology or agronomy; workers directly participating in producing pesticides shall be provided with training in professional practice and knowledge of pesticides.
- Factories and warehouses designed for storage and preservation of pesticides must be located within industrial zones and ensure conformance to Vietnam National Standard TCVN 5507:2002: Hazardous chemicals – Code of Practice for Safety in Production, Commerce, Use, Handling and Transportation.
- All equipment and production lines for producing active ingredients, technical grade active ingredients, formulation of products from technical grade active ingredients and pesticide packaging must meet manufacturing process and technological standards and satisfy safety requirements defined in the Vietnam National Standard TCVN 5507:2002 Hazardous chemicals – Code of Practice for Safety in Production, Commerce, Use, Handling and Transportation.
- Solid waste, emission and wastewater treatment systems must comply with legislative regulations and National Technical Regulations, such as
+ Decree 38/2015/ND-CP on waste and scrap management;
+ The National Technical Regulation QCVN 19:2009/BTNMT on industrial emission, applicable to dust and inorganic substances and the National Technical Regulation QCVN 20:2009/BTNMT on industrial emission, applicable to certain inorganic substances;
+ The National Technical Regulation QCVN 07:2009/BTNMT on Hazardous Waste Thresholds and the National Technical Regulation QCVN 40:2011/BTNMT on industrial wastewater.
- Available product quality inspection laboratories must be registered and designated as per laws on conditions for eligibility to obtain the license to provide product conformity assessment and product quality assessment services.
In case there is none of laboratories, they must enter into product quality inspection contracts with laboratories which have already been registered or designated as per laws on conditions for eligibility to obtain the license to provide product conformity assessment and product quality assessment services with regard to each batch.
- Pesticide formulating facilities must design their product quality management systems that obtain the ISO 9001 or equivalent certification, issued by certification bodies that have been registered under legislative regulations on conditions for eligibility for license to provide conformity assessment services.
Thanh Rin