Circular No. 23/2015/TT-BNNPTNT on Management of Products for Environmental Treatment and Improvement Used in Livestock Raising and Aquaculture

CIRCULAR

Management of products for environmental treatment and improvement used in livestock breeding and aquaculture

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Pursuant to the Fisheries Law 2003;

Pursuant to the Law on Product Quality and Goods 2007;

Pursuant to the Chemicals Law 2007;

Pursuant to the Trade Law 2005;

Pursuant to the Investment Law 2014;

Pursuant to the Enterprise Law 2014;

Based on the Veterinary Ordinance 2004;

Pursuant to Decree No. 33/2005/NĐ-CP dated March 15, 2005 of the Government detailing implementation of certain provisions of the Animal Health Ordinance and Decree No. 119/2008/NĐ-CP dated November 28, 2008 of the Government amending and supplementing some articles of Decree No. 33/2005/NĐ-CP;

Pursuant to Decree No. 89/2006/NĐ-CP dated August 30, 2006 of the Government on product labeling;

Pursuant to Decree No. 132/2008/NĐ-CP dated December 31, 2008 of the Government guiding the Law on Product Quality and Goods;

Pursuant to Decree No. 199/2013/CP- dated October 20, 2015 of dated November 26, 2013 of the Government stipulating the functions, tasks, powers, and organizational structure of the Ministry of Agriculture and Rural Development;;

At the proposal of the Director of the General Department of Fisheries and the Director of the Livestock Production Department,

The Minister of Agriculture and Rural Development issues this Circular on management of products for environmental treatment and improvement used in livestock breeding and aquaculture.

PART I

GENERAL PROVISIONS

Article 1. Scope of Regulation and Applicability

Article 1. Scope of Regulation: This Circular regulates production, business; testing, trial, experimentation, and certification; registration for circulation; quality management of biological preparations, microorganisms, chemicals (excluding chemicals in the National Agricultural Reserve List), environmental treatment and improvement products used in livestock breeding and aquaculture (hereinafter referred to as environmental treatment products) and the responsibilities of related organizations and individuals.

Article 2. Applicability: This Circular applies to organizations and individuals related to the production, business, trials, experiments, testing, and certification of environmental treatment products within the territory of Vietnam.

Article 2. Interpretation of Terms

In this Circular, the following terms are understood as follows:

Point 1. New product is a product with a new formula containing new active ingredients, a new combination of active ingredients, a new formulation that changes the product's quality, a new function, or a new target user.

Point 2. Certificate of imported product quality is a quality analysis report issued by the competent authority of the exporting country or an independent laboratory in the exporting country.

Article 3. Fees, Stamp Duties, and Other Costs

Clause 1. Fees and stamp duties in the management of environmental treatment products shall be implemented according to current regulations of the Ministry of Finance.

Clause 2. Costs for trials, experiments, testing, and certification shall be carried out according to agreements between the trial, experiment, test, and certification facilities and the facilities requiring such services, in accordance with the law.

Chapter II

CONDITIONS FOR PRODUCTION AND BUSINESS FACILITIES OF ENVIRONMENTAL TREATMENT PRODUCTS

Article 4. Conditions for Production Facilities

Conditions for production facilities of environmental treatment products (including facilities engaged in processing, repackaging) shall be implemented according to Clauses 1, 2, 3, 5, 6, 7, and 8 of Article 38 of the Animal Health Ordinance and Clauses 2, 4, 5, 6, 7, and 8 of Article 52 of Decree No. 33/2005/NĐ-CP dated March 15, 2005 of the Government detailing implementation of certain provisions of the Animal Health Ordinance. Specifically, Clauses 1, 5, and 6 of Article 38 of the Animal Health Ordinance are detailed as follows:

Clause 1. Having a business registration certificate or investment registration certificate.

Clause 2. Direct producers must have a health certificate issued by a district-level health center or higher; direct managers of production and testers must have a professional qualification certificate for producing and testing environmental treatment products.

Article 5. Conditions for business establishments

The conditions for operating products for environmental treatment and improvement (including import and export establishments) shall be implemented in accordance with Article 39 of the Veterinary Law and Clause 1, Point 3 of Article 54 of Decree No. 33/2005/NĐ-CP dated March 15, 2005 of the Government detailing certain provisions of the Veterinary Law. Specifically, Clause 1 and Point 3 of Article 39 of the Veterinary Law are detailed as follows:

Clause 1. Having a business registration certificate or investment registration certificate.

2. Managers and persons directly selling goods must have a professional practice certificate for operating environmental treatment and improvement products; the owner or technical supervisor of import and export establishments must have a professional practice certificate for importing and exporting environmental treatment and improvement products.

Chapter III

TESTING, TRIALING, INSPECTION, AND CERTIFICATION OF ENVIRONMENTAL TREATMENT AND IMPROVEMENT PRODUCTS

Article 6. Conditions for testing and trial establishments

The conditions for testing and trial establishments of environmental treatment and improvement products shall be implemented in accordance with Point d of Clause 2 of Article 55 of Decree No. 33/2005/NĐ-CP dated March 15, 2005 of the Government detailing certain provisions of the Veterinary Law and Clause 5 of Article 52 of the Veterinary Law. Specifically, Point d of Clause 2 of Article 55 of Decree No. 33/2005/NĐ-CP dated March 15, 2005 of the Government detailing certain provisions of the Veterinary Law is detailed as follows: Having sufficient tools, means, and equipment necessary to meet the requirements for testing and trials. In cases where the establishment does not have sufficient analytical tools, means, and equipment for the required testing indicators, it must have a contract with a testing establishment designated by the Ministry of Agriculture and Rural Development.

Article 7. Documents and procedures for recognizing establishments meeting testing and trial conditions

1. The documents include:

a) A request for recognition of a testing and trial establishment (in Form KN-1 attached as Appendix I to this Circular);

b) A copy (certified by the establishment) of one of the following documents: Decision on establishment of a public service unit; Business Registration Certificate (or Business License); Investment Registration Certificate (or Investment Permit);

c) An original statement of the conditions of the testing and trial establishment (in Form KN-2a or KN-2b attached as Appendix I to this Circular);

d) A copy (certified by the establishment) of the professional practice certificate of the establishment owner or technical supervisor. For renewal applications, if the application file does not contain changes from the previous registration, only a certified copy needs to be submitted.

2. Procedures for recognizing establishments meeting testing and trial conditions:

a) Establishments wishing to apply for recognition as meeting testing and trial conditions shall prepare one set of documents and submit them directly or through postal services to the Fisheries General Department (for products used in aquaculture) or the Livestock Service (for products used in livestock farming);

b) Within two working days from the date of receipt of the application, the Fisheries General Department or the Livestock Service will issue a written request for additional documentation if the application is incomplete or invalid;

c) Within twelve working days from the date of receipt of complete and valid documents, the Fisheries General Department or the Livestock Service will review the documents and conduct inspections and evaluations of the establishment's conditions;

d) If the inspection results show that the establishment's conditions do not meet the requirements, the Fisheries General Department or the Livestock Service will notify the establishment in writing about the non-compliance and the time required for rectification reports. Within five working days from the date of receipt of the rectification report, the Fisheries General Department or the Livestock Service will assess the rectification report; if necessary, they will organize inspections of the rectified items.

đ) If the inspection results show that the establishment's testing and trial conditions meet the requirements, the Fisheries General Department or the Livestock Service will submit a proposal to the Ministry for approval of recognition within five working days.

e) Within two working days after receiving the Minister's approval, the Fisheries General Department or the Livestock Service will issue a Decision recognizing the establishment as meeting testing and trial conditions. If the Ministry does not approve, the Fisheries General Department or the Livestock Service will notify the establishment applying for recognition in writing and specify the reasons.

g) The Decision recognizing the establishment as meeting testing and trial conditions is valid for five years. Six months before the Decision recognizing the testing and trial establishment expires, the establishment wishing to renew its recognition shall prepare and submit a new application according to the provisions of Clause 1 of this Article.

Article 8. Cases requiring examination and testing and contents of examination and testing of products

1. Cases requiring examination and testing:

a) New domestically produced products before registration for circulation;

b) Imported products from abroad that have not been included in the list of environmental treatment and improvement products permitted for circulation in Vietnam.

2. Contents of examination and testing:

a) Checking product components and quality according to published standards;

b) Evaluating product characteristics and functions through assessing changes in physical, chemical, and biological indicators (for aquaculture, including total microbial indicators, plankton, bottom organisms, and pathogenic microorganisms for the subjects of examination and testing) in the livestock and aquaculture environment; evaluating other technical indicators specified in the product dossier.

c) Assessing safety for human health, rearing subjects, and the environment during use: Residual components of the product in the environment and in animals at harvest (applicable to products with chemical components or restricted components in livestock and aquaculture); heavy metal residues in the environment and in animals at harvest (applicable to natural mineral products); survival rate and growth rate of rearing subjects.

Article 9. Dossiers and procedures for conducting product examinations and tests

1. The documents include:

a) Product examination and testing registration form (KN-3 Model in Appendix I issued together with this Circular);

b) A copy (certified by the entity) of one of the following documents: Business Registration Certificate (or Enterprise Registration Certificate); Investment Registration Certificate (or Investment Certificate); Decision on Establishment of Public Service Units;

c) Technical information description of the product (KN-4 Model in Appendix I issued together with this Circular);

d) Original Quality Testing Report of the product;

đ) Original Examination and Testing Outline (KN-5a or KN-5b Model in Appendix I issued together with this Circular);

e) Original or certified copy of the Examination and Testing Contract;

g) Original or certified copy of the Free Sale Certificate issued by the competent authority of the exporting country (applicable to imported products).

"2. Implementation procedures:"

a) Entities wishing to conduct product examinations and tests for environmental treatment and improvement select examination and testing entities recognized by the Fisheries General Department or the Livestock Production Department, prepare one set of dossier in accordance with Clause 1 of this Article, and submit it directly or via postal service to the Fisheries General Department (for products used in aquaculture) or the Livestock Production Department (for products used in livestock production);

b) Within two working days from the date of receipt of the application, the Fisheries General Department or the Livestock Service will issue a written request for additional documentation if the application is incomplete or invalid;

c) Within 12 working days from receiving a valid dossier, the Fisheries General Department or the Livestock Production Department will review the examination and testing registration dossier according to Technical Regulations. In cases where there are no Technical Regulations, the Fisheries General Department or the Livestock Production Department will organize a scientific council to evaluate the examination outline;

d) If the review and evaluation results of the dossier and examination outline meet the requirements, the Fisheries General Department or the Livestock Production Department will submit to the Ministry for approval of the examination and testing of the product within 5 working days;

đ) Within 2 working days from the date of the Minister's approval, the Fisheries General Department Director or the Livestock Production Department Director will approve the examination outline and issue the examination and testing decision, assigning the supervising unit for the examination and testing;

e) If the review and evaluation results of the dossier and examination outline do not meet the requirements or are not approved by the Ministry, the Fisheries General Department or the Livestock Production Department will notify the registering entity in writing and specify the reasons;

g) The examination and testing entity will conduct the examination and testing according to the outline approved by the Fisheries General Department or the Livestock Production Department.

3. Inspection of examination and testing activities

a) Inspection method: The Fisheries General Department or the Livestock Production Department will inspect the examination and testing activities no more than twice during the examination and testing period of the product or conduct surprise inspections if deemed necessary.

b) Inspection content: Conducted according to the examination and testing outline approved by the Fisheries General Department or the Livestock Production Department.

4. Supervision of examination and testing activities

a) The supervisory agency for examination and testing activities is the livestock or fisheries management agency under the Department of Agriculture and Rural Development in the locality where the examination and testing is arranged.

b) Supervision content: Conducted according to the approved examination and testing outline.

c) Within 5 working days after the completion of the examination and testing process, the supervisory agency for examination and testing will report the supervision results according to KN-6 Model in Appendix I issued together with this Circular to the Fisheries General Department or the Livestock Production Department.

5. Handling and rectification after inspection and supervision

a) Based on the inspection team's report and the supervisory agency's recommendation, the Fisheries General Department Director or the Livestock Production Department Director decides on the correction of contents, remedial measures, and the time frame for rectification.

b) The examination and testing entity and the entity with the examined and tested product will implement the corrections and rectifications decided by the Fisheries General Department Director or the Livestock Production Department Director, and report the rectification results to the Fisheries General Department or the Livestock Production Department within the stipulated timeframe.

c) Re-inspect the implementation of the contents needing correction and rectification in the examination and testing as decided by the Fisheries General Department Director or the Livestock Production Department Director.

d) The records for inspection, supervision, examination, and testing of products for environmental treatment and improvement in animal husbandry shall be retained at the Animal Husbandry Department; the records for inspection, supervision, examination, and testing of products for environmental treatment and improvement in aquaculture shall be retained at the Fisheries General Department and included in the dossier when assessing the recognition of products that have been examined and tested to provide the relevant specialized scientific council with grounds for evaluation.

Article 10. Product Examination

1. Cases requiring examination: Products not listed in the Catalogue of Permitted Environmental Treatment and Improvement Products circulating in Vietnam when registering for circulation or importation for examination.

2. Content of examination: Full analysis of the main components (active components for environmental treatment and improvement) in the product according to the published standards or registration, and other components according to corresponding technical regulations (if applicable).

3. Examination facility: The examination facility designated in Circular No. 16/2011/TT-BNNPTNT dated April 1, 2011, issued by the Ministry of Agriculture and Rural Development on the assessment, designation, and management of agricultural and rural development laboratories.

Article 11. Product Certification

1. Product certification in the following cases:

a) When there are complaints or reports about quality.

b) Upon request of a competent state authority.

2. Content of certification: Re-evaluation of the quality of products that have been examined, tested, or are currently circulating in the market.

3. Implementation of certification: The Fisheries General Department or the Animal Husbandry Department shall cooperate with competent authorities and designated examination facilities recognized by the Ministry of Agriculture and Rural Development to form inspection teams, collect samples, re-evaluate product quality, and implement handling measures within their authority or transfer the certification results to competent authorities for processing according to current regulations.

4. Certification facility: The certification facility designated by the Ministry of Agriculture and Rural Development suitable for the certification content.

Chapter IV

PROCEDURE AND REGULATIONS FOR REGISTERING ENVIRONMENTAL TREATMENT AND IMPROVEMENT PRODUCTS FOR CIRCULATION

Article 12. Initial Registration for Circulation, Re-registration, Extension of Circulation Period, and Change of Information of Products Currently Circulating

1. Initial Registration for Product Circulation:

a) Products resulting from research projects recognized by the Ministry of Agriculture and Rural Development as technological advancements in biotechnology according to Circular No. 23/2010/TT-BNNPTNT dated April 7, 2010, issued by the Ministry of Agriculture and Rural Development regarding the recognition of technological advancements in biotechnology in agriculture and rural development;

b) Newly produced domestic products or first imported products into Vietnam that have been examined and tested in accordance with Article 9 of this Circular;

c) Products meeting the requirements set out in Appendix IIA or Appendix IIB attached to this Circular and corresponding national technical standards (if applicable).

2. Re-registration for Product Circulation: Products already recognized for circulation in Vietnam must be re-registered if there is a change in any of the following circumstances: Change in composition or formula; change in dosage form; change in target user; change in production method or process affecting product quality; re-evaluation of product quality, efficacy, and safety.

3. Application for Extension of Product Circulation Period: Six months before the expiration of the circulation period, when the entity has a need to continue circulation.

4. Application for Change of Information of Products Currently Circulating

Products permitted to circulate in Vietnam when there is any of the following changes:

a) Change in business type or company name;

b) Change in label presentation format;

c) Change or addition in packaging specifications;

d) Change in headquarters or production location;

đ) Change in product form or color but without change in product quality.

Article 13. Documents for initial registration, re-registration, extension of circulation, and change of information of products currently in circulation

1. Documents for initial registration of products:

a) Product Circulation Registration Form (according to Model DKLH-1 in Appendix I issued together with this Circular);

b) A copy (certified by the entity) of one of the following documents: Business Registration Certificate (or Enterprise Registration Certificate); Investment Registration Certificate (or Investment License); Decision on Establishment of Public Service Unit;

c) A copy (certified by the entity) of the certificate of practice for production or import of products used for livestock management or aquaculture environmental treatment;

d) Original Basic Standard (or a copy certified by the entity of the published standard applied);

đ) Product label certified by the entity (according to the guidance at Model DKLH-2 in Appendix I issued together with this Circular) (in color, two copies);

e) A copy (certified by the entity) of the results of inspection, evaluation, and classification of the entity's conditions as prescribed by the Ministry of Agriculture and Rural Development;

g) Original or a copy (certified by the entity) of the production process description (according to Model DKLH-3 in Appendix I issued together with this Circular) for domestically produced products;

h) Original or a copy (certified by the entity) of the report on research and testing results and the Decision recognizing technological progress in biotechnology of the Ministry of Agriculture and Rural Development applicable to products that are the result of research recognized by the Ministry of Agriculture and Rural Development as technological progress in biotechnology;

i) Original report on product trial and test results (according to Model KN-7 in Appendix I issued together with this Circular) applicable to products that have undergone trials and tests;

k) Original test results of the product applicable to products registered according to point a and c, Clause 1, Article 12 of this Circular;

l) Original or certified copy of the Free Sale Certificate (Certificate of Free Sale) issued by the competent authority of the producing country for imported products according to point c, Clause 1, Article 12 of this Circular;

2. Documents for re-registration:

a) Documents as prescribed in points a, b, c, d, đ, e, g, Clause 1 of this Article;

b) A copy (certified by the entity) of the Product Circulation Certificate or circulation certification document issued by the competent authority;

c) Original report on re-trial and re-testing results of the product (according to Model KN-7 in Appendix I issued together with this Circular);

3. Documents for extension of circulation of products:

a) Documents as prescribed in points a, b, c, d, đ, e, Clause 1 of this Article;

b) A copy (certified by the entity) of the Product Circulation Certificate or circulation certification document issued by the competent authority;

c) Original test results of the product, Report on production, business, and use of the product (according to Model DKLH-4 in Appendix I issued together with this Circular);

4. Change of information of products currently in circulation:

a) Documents as prescribed in points b, d, đ, e, Clause 1 of this Article;

b) A copy (certified by the entity) of the Product Circulation Certificate or circulation certification document issued by the competent authority;

c) Request for Change of Product Information (according to Model DKLH-5 in Appendix I issued together with this Circular). For cases where an entity registers multiple products in one registration, the documents prescribed in points b, c, and e, Clause 1 of this Article only need to be submitted once.

Article 14. Procedures for initial circulation certification, re-circulation, extension of circulation period, and change of information on products currently circulating

1. For entities wishing to register for initial circulation, re-circulation, extension of circulation period, or change of information on products currently circulating, they shall prepare one set of documents in accordance with Article 13 of this Circular and submit it directly or through postal service to the Fisheries General Department (for products used in aquaculture) or the Livestock Production Department (for products used in livestock production).

2. Within two working days from receipt of the application, the Fisheries General Department or the Livestock Production Department shall issue a document requesting additional information if the submitted application is incomplete or invalid.

3. In cases of registration for initial circulation or re-circulation.

a) Within twenty working days from receipt of valid documents, the Fisheries General Department or the Livestock Production Department shall be responsible for: Examining the application according to the form provided in Appendix III attached to this Circular; Organizing an evaluation council to assess the testing, trial, and research results of the product.

b) If the examination results and the evaluation council's assessment meet the requirements, the Fisheries General Department or the Livestock Production Department shall submit to the Minister for comments on recognizing the product for treatment and environmental improvement. The Ministry shall provide comments within five working days.

c) Within two working days from receipt of the Minister’s approval, the Director of the Fisheries General Department or the Director of the Livestock Production Department shall issue a Circulation Certificate for each registered product (according to the form provided in Appendix IV attached to this Circular).

d) In case of non-approval by the Ministry, the Fisheries General Department or the Livestock Production Department shall notify the entity in writing, stating the reasons and not returning the application.

4. In cases of extending the circulation period of a product. Within ten working days from receipt of valid documents, the Fisheries General Department or the Livestock Production Department shall be responsible for:

a) Organizing the examination of the application (according to the form provided in Appendix III attached to this Circular) and evaluating the testing results, production process reports, business operations, and usage of the product. If the examination and evaluation results meet the requirements, the Director of the Fisheries General Department shall issue a Circulation Certificate for each product for treatment and environmental improvement in aquaculture for the entity applying for extension, and the Director of the Livestock Production Department shall issue a Circulation Certificate for each product for treatment and environmental improvement in livestock production for the entity applying for extension (according to the form provided in Appendix IV attached to this Circular);

b) In case of non-issue of a Circulation Certificate, the Fisheries General Department or the Livestock Production Department shall notify the entity in writing, stating the reasons and not returning the application.

5. In cases of changing information on products currently circulating

Within eight working days from receipt of valid documents, the Fisheries General Department or the Livestock Production Department shall be responsible for:

a) Examining the application (according to the form provided in Appendix III attached to this Circular). If the examination results meet the requirements, the Fisheries General Department or the Livestock Production Department shall issue a Circulation Certificate for each product with changed information for the entity applying (according to the form provided in Appendix IV attached to this Circular);

b) Notifying the entity in writing, stating the reasons if a Circulation Certificate is not issued and not returning the application.

6. Validity of the Circulation Certificate for products

a) The validity of the Circulation Certificate for products registered for initial circulation and re-circulation is five years.

b) The validity of the Circulation Certificate for products registered for extension is three years.

c) The validity of the Circulation Certificate for products registered for change of information is equal to the remaining circulation period of the product before the information was changed.

7. List of products for treatment and environmental improvement permitted for circulation.

a) Monthly, the Fisheries General Department and the Livestock Production Department shall issue a supplementary list of products for treatment and environmental improvement permitted for circulation in Vietnam and publish it on their respective websites and the Ministry of Agriculture and Rural Development's website for relevant organizations and individuals to access and implement.

b) Annually in the first quarter, the Fisheries General Department and the Livestock Production Department shall review, compile, and issue a list of products for treatment and environmental improvement permitted for circulation in Vietnam and publish it on their respective websites and the Ministry of Agriculture and Rural Development's website for relevant organizations and individuals to access and implement.

Article 15. Removal from the List of Permitted Circulation

1. Products containing prohibited active ingredients as stipulated by current regulations of the Ministry of Agriculture and Rural Development;

2. Products causing harm to production, environment, food safety, and human health, as re-evaluated by the Scientific Council according to the provisions;

3. Products currently circulating but not compliant with international regulations to which Vietnam is a member;

4. Product certificates for circulation that have expired their validity period but the entity has not registered for extension;

5. Products registered for circulation but the production and business entities have ceased operations;

6. Products infringing industrial property rights of registered products;

7. Imported products withdrawn from circulation certification by the exporting country.

Based on any of the above cases, the Fisheries General Department or the Livestock Production Department shall submit to the Ministry for a decision to remove products from the list of permitted circulation and handle environmental remediation. Upon approval by the Ministry, the Fisheries General Department or the Livestock Production Department will announce the products removed from the list of permitted circulation and publish this information on the websites of the Fisheries General Department, the Livestock Production Department, and the Ministry of Agriculture and Rural Development so that relevant organizations and individuals can be informed and comply.

Chapter V

INSPECTION OF PRODUCTION AND BUSINESS FACILITIES AND QUALITY CONTROL OF PRODUCTS FOR REMEDIATION

Article 16. Inspection of Production and Business Facilities

1. Inspecting Authority:

a) The Fisheries General Department or the Livestock Production Department will inspect local authorities' inspections of production and business conditions of facilities and coordinate with local management agencies to conduct planned or spot inspections of production and business facilities;

b) Local state management agencies for livestock breeding and aquaculture will inspect the conditions of production and business facilities within their jurisdiction.

2. Procedures and contents of inspection shall be carried out in accordance with Circular No. 45/2014/TT-BNNPTNT dated December 3, 2014, issued by the Ministry of Agriculture and Rural Development, regarding the inspection of agricultural material production and business facilities and the inspection and certification of agricultural, forestry, and aquatic production and business facilities meeting food safety conditions.

Article 17. Quality Control of Products During Production

1. Inspecting Authority:

a) The Fisheries General Department or the Livestock Production Department will implement inspections of local authorities' management work on domestic product quality, and conduct spot checks on product quality at production facilities;

b) Provincial-level management agencies for livestock breeding and aquaculture will conduct quality inspections at production facilities under their management.

2. Basis for conducting inspections:

a) Information and warnings about exported products not conforming to the conditions specified in Article 32 of the Law on Product and Goods Quality;

b) Results of product quality inspections or surveys, or complaints about products circulating on the market not meeting published standards or national technical regulations, or registration requirements;

c) Annual inspection plans approved by competent authorities.

3. Inspection forms: Inspection teams established by the inspecting authority.

4. Inspection contents:

a) Inspection of compliance with requirements and regulations in relevant national technical standards concerning production conditions and state management measures for product quality during production; Inspection of other regulations of the Ministry of Agriculture and Rural Development on product quality management;

b) Inspection of implementation and results of conformity assessment, labeling, marking, and accompanying documentation of products; In necessary cases, the inspecting authority may use experts to perform assessments according to the requirements of corresponding technical standards. Experts must be independent, objective, and legally responsible for their assessment results;

c) During inspections at production facilities, if products showing signs of non-compliance with quality standards are found, samples should be taken for quality testing. Samples must be sent to designated testing institutions by the Ministry of Agriculture and Rural Development for quality testing. Testing results serve as legal grounds for the inspecting authority to proceed with further actions during the inspection process. The permissible error margin when conducting quality inspections shall follow the guidelines set forth in Appendix V attached to this Circular.

5. Procedures and formalities for inspections shall be implemented in accordance with Clause 3 of Article 29 of the Law on Product and Goods Quality.

6. Handling of inspection results for domestically produced products shall be carried out in accordance with Article 30 of the Law on Product and Goods Quality and Article 6 of Decree No. 132/2008/NĐ-CP dated December 31, 2008, guiding the Law on Product and Goods Quality.

Article 18. Quality Inspection of Imported Products

1. Inspection Authority: The General Department of Fisheries or the Livestock Production Department or other state management agencies authorized by the General Department of Fisheries or the Livestock Production Department.

2. Cases for Inspection:

a) Cases requiring quality inspection: Imported products must undergo quality inspection upon entry into Vietnam (except for products specified in point b, Clause 2 of this Article).

b) Cases not requiring quality inspection: samples, promotional goods at trade fairs; temporarily imported-reexported goods; transit goods; goods stored in bonded warehouses; goods processed by Vietnamese enterprises for foreign traders; imported products determined by the Ministry of Agriculture and Rural Development to be subject to inspection when necessary.

3. Basis for Inspection: technical standards, announced standards, labeling regulations, and other relevant laws.

4. Inspection contents:

a) Verify the conformity of the quality certificate content of the imported consignment with the requirements of technical standards, announced standards, and current regulations. Check the expiration date of the product (only allowing importation of products still within two-thirds of their shelf life).

b) Inspect the product label and conformity mark applied to products that have been declared compliant and verify their consistency with the import declaration: Inspect mandatory information on the label (including the supplementary label) including the product name, address of the responsible entity, origin of the product, and other required information for each type of product; conduct sensory inspections of the product.

c) Collect samples for quality testing in cases where there are complaints, reports, or suspicions about the assessment results; based on survey or market quality inspection results conducted by the inspection agency, if the product does not meet the announced standards or corresponding technical standards or registration for circulation. The permissible limit of error when conducting quality testing shall follow the guidelines set out in Appendix V issued together with this Circular.

5. Handling Inspection Results

Handling the results of quality inspection of imported products shall be carried out according to Article 36 of the Product Quality Law.

Article 19. Documents and Procedures for Quality Inspection of Imported Products

1. The documents include:

a) Application for Quality Inspection (Model KTCL-1 attached in Appendix I of this Circular) (two copies);

b) Photocopies (certified by the entity) of the following documents: Purchase Contract, Product List;

c) Certified copy of the Quality Certificate (C/A - Certificate of Analysis);

d) Other related documents: Photocopies (certified by the entity) of the Bill of Lading, Invoice, Import Declaration Form, Certificate of Origin (if available), product images or descriptions, imported product labels (with conformity marks if the product has been declared compliant), and supplementary labels (if the main label lacks required information).

"2. Implementation procedures:"

a) The entity applying for quality inspection of imported products prepares one set of documents and submits it directly or through postal service to the General Department of Fisheries (for products used in aquaculture) or the Livestock Production Department (for products used in livestock production);

b) Within two working days from receipt of the application, the General Department of Fisheries or the Livestock Production Department will issue a request for additional documentation if the application is incomplete or non-compliant;

c) Within three working days from receipt of complete and valid applications, the General Department of Fisheries or the Livestock Production Department will review the application according to points a and b, Clause 4 of Article 18 of this Circular. If the application meets the requirements, the General Department of Fisheries or the Livestock Production Department will notify the importer and customs authority of the satisfactory national quality inspection result of the imported product (Model KTCL-2 attached in Appendix I of this Circular) to facilitate clearance procedures for the consignment;

d) In cases where the application review does not meet the requirements as stipulated in points a and b, Clause 4 of Article 18 of this Circular, the General Department of Fisheries or the Livestock Production Department will notify the unsatisfactory quality inspection result of the imported product, specifying the non-conformities and the time frame for rectification by the importer (Model KTCL-3 attached in Appendix I of this Circular). The General Department of Fisheries or the Livestock Production Department will only issue a notification of compliance with quality requirements for the imported consignment once the importer provides evidence of successful rectification actions;

đ) In cases where the imported product falls under the provisions of point c, Clause 4 of Article 18 of this Circular, the General Department of Fisheries or the Livestock Production Department will confirm the Quality Inspection Application, notify the entity and customs authority to proceed with customs declaration. Upon confirmation of the Quality Inspection Application, the entity may transfer the goods to the location stated in the Application, maintaining the original condition of the goods without processing, trading, or using them before receiving the confirmed quality inspection result. Within ten working days, the General Department of Fisheries or the Livestock Production Department will collect samples for testing and analysis and notify the entity of the quality inspection result. If the imported product fails to meet quality standards, the General Department of Fisheries or the Livestock Production Department will handle the situation according to Article 36 of the Product Quality Law.

Article 20. Quality inspection of products circulating in the market

1. Inspecting Authority:

a) The Fisheries General Department or the Livestock Breeding Department shall implement inspections to assess the responsibility of local management agencies regarding product quality management work, and conduct surprise inspections of product quality at production and business establishments.

b) Local management agencies in the livestock breeding and aquaculture sectors shall carry out quality inspections at establishments under their jurisdiction.

2. The content, procedures, and formalities for conducting quality inspections of products for processing and environmental improvement in circulation on the market shall be carried out in accordance with Circular No. 26/2012/TT-BKHCN dated December 12, 2012, issued by the Ministry of Science and Technology, concerning state inspections of product quality in circulation on the market.

Article 21. Quality Inspection of Export Products

1. Inspection Authority: The General Department of Fisheries or the Livestock Production Department or other state management agencies authorized by the General Department of Fisheries or the Livestock Production Department.

2. Inspection Objectives:

a) Recalled or returned products. The procedures, formalities, and content of the inspection shall be carried out in accordance with Article 17 of this Circular.

b) Export products entering markets that require quality testing, confirmation, or certification by authorized agencies in Vietnam. Establishments with products requiring quality testing, confirmation, or certification shall register in accordance with Clauses 5 and 6 of this Article.

3. Basis for Inspection: Announced standards; import country regulations, contracts, or international treaties, mutual recognition agreements on conformity assessment results with relevant countries or territories.

4. Content of Inspection: In accordance with the requirements of the establishment or to verify compliance with import country regulations, contracts, or international treaties, mutual recognition agreements on conformity assessment results with relevant countries or territories.

5. Registration Documents for Quality Inspection of Export Products when requested by the exporting establishment include:

a) Quality Inspection Registration Form (Model KTCL-1 attached as Appendix I to this Circular);

b) Photocopies (certified by the establishment) of the following documents: Purchase and sale contracts, announced standards, product label samples, and other related documents;

c) Photocopies (certified by the establishment) of one of the following documents: Business Registration Certificate (Enterprise Registration Certificate), Investment Certificate, Decision on Establishment of Public Service Units;

d) Photocopies (certified by the establishment) of the results of inspections, evaluations, and classification of establishment conditions rated as Class A or B.

6. Procedures for Conducting Quality Inspections of Export Products when requested by the exporting establishment:

a) The exporting establishment submits one set of registration documents directly or through postal service to the Fisheries General Department or the Livestock Breeding Department.

b) Within two working days from receipt of the application, the General Department of Fisheries or the Livestock Production Department will issue a request for additional documentation if the application is incomplete or non-compliant;

c) Within ten working days from receipt of valid registration documents, the Fisheries General Department or the Livestock Breeding Department shall review the documents, notify the establishment of the sampling plan for inspection; organize sampling or authorize local management agencies in the livestock breeding or aquaculture sectors to conduct sampling inspections; transfer samples to testing laboratories for product quality testing.

d) Notify the results of the export product quality inspection immediately upon receipt of the quality test report from the testing laboratory according to Model KTCL-2 attached as Appendix I to this Circular if the inspection results meet quality standards, or according to Model KTCL-3 attached as Appendix I to this Circular if the inspection results do not meet quality standards.

Article 22. Inspection of production facilities for environmental treatment and improvement products in the exporting country

1. Based on international treaties or agreements, cooperation regarding animal husbandry or aquaculture with the management agencies of these fields in the exporting countries, the Ministry of Agriculture and Rural Development decides to establish inspection teams, plans, and contents for practical inspections of production facilities in the exporting country that supply products to Vietnam.

2. The budget for implementing inspections shall be allocated annually from the state budget according to current regulations.

Chapter VI

ISSUING PRACTICE LICENSES

Article 23. Conditions for issuing practice licenses

The conditions for issuing practice licenses for producing, trading, exporting, importing, testing, and trial of environmental treatment and improvement products shall be carried out in accordance with Article 64 of Decree No. 33/2005/NĐ-CP dated March 15, 2005, detailing certain provisions of the Veterinary Law, specifically as follows:

1. Professional qualification conditions for practicing in the production, trading, export, import, testing, and trial of environmental treatment and improvement products in animal husbandry.

a) The owner or technical manager of the facility practicing in the production and testing of environmental treatment and improvement products in animal husbandry must have at least a bachelor's degree in veterinary science, veterinary doctor, or pharmacist, and must have at least two years of experience in the registered field of practice.

b) The owner of a retail store dealing in environmental treatment and improvement products in animal husbandry must have at least a secondary vocational degree in veterinary science or veterinary medicine. The person directly selling the products must have a training certificate in the registered field of practice issued by the specialized state management agency.

c) The owner or technical manager of the facility conducting trials and tests of environmental treatment and improvement products in animal husbandry must have at least a bachelor's degree in veterinary science, veterinary doctor, and must have at least two years of experience in the registered field of practice.

d) The owner or technical manager of the facility exporting and importing environmental treatment and improvement products in animal husbandry must have at least a bachelor's degree in veterinary science or veterinary doctor.

2. Professional qualification conditions for practicing in the production, trading, export, import, testing, and trial of environmental treatment and improvement products in aquaculture.

a) The owner or technical manager of the facility practicing in the production and testing of environmental treatment and improvement products must have at least a bachelor's degree in chemistry or biology or a bachelor's degree in aquaculture engineering and must have at least two years of experience in the registered field of practice.

b) The owner of a retail store dealing in environmental treatment and improvement products must have at least a secondary vocational degree in biology or aquaculture. The person directly selling the products must have a training certificate in the registered field of practice issued by the specialized state management agency for aquaculture at the provincial level.

c) The owner or technical manager of the facility conducting trials must have at least a bachelor's degree in biology or biochemistry or a bachelor's degree in aquaculture engineering who has completed a training course in the registered field of practice and must have at least two years of experience in the registered field of practice.

d) The owner or technical manager of the facility exporting and importing must have at least a bachelor's degree in biology or biochemistry or a bachelor's degree in aquaculture engineering who has completed a training course in the registered field of practice issued by the specialized state management agency for aquaculture at the provincial level.

3. Health conditions The health conditions for veterinary practitioners shall be implemented in accordance with Clause 2 of Article 64 of Decree No. 33/2005/NĐ-CP.

4. Conditions for issuing practice licenses for foreign nationals shall be implemented in accordance with Clause 3 of Article 64 of Decree No. 33/2005/NĐ-CP.

Article 24. Issuing Authority for Practice Certificates

1. The General Fisheries Department shall issue practice certificates for the following fields: production and business operations; import operations; export operations; testing operations; product testing and environmental improvement operations used in aquaculture according to Model CCHN-3 in Appendix I attached hereto.

2. The Livestock Production Department shall issue practice certificates for the following fields: production and business operations; import operations; export operations; testing operations; product testing and environmental improvement operations used in livestock production. The practice certificate shall be issued according to Model CCHN-3 in Appendix I attached hereto.

3. The provincial fisheries management agency shall issue practice certificates for business operations involving products used for environmental improvement in aquaculture according to Model CCHN-4 in Appendix I attached hereto.

4. The provincial livestock production management agency shall issue practice certificates for business operations involving products used for environmental improvement in livestock production according to Model CCHN-4 in Appendix I attached hereto.

Article 25. Procedures and Formalities for Issuing Practice Certificates

1. Documents for initial issuance of practice certificates:

a) An application form for issuing a practice certificate (according to Model CCHN-1 in Appendix I attached hereto) accompanied by two color photographs measuring 4 x 6 cm;

b) Certified copies of diplomas and certificates of professional qualifications;

c) A curriculum vitae;

d) A health certificate confirming fitness to work issued by a healthcare facility at the district level or higher;

đ) A confirmation letter from the production, testing, or product testing and environmental improvement facility regarding the time spent practicing at the facility, applicable to cases specified in points a and c, Clause 1, Article 23 of this Circular;

e) A written consent from the head of the agency where the applicant works, applicable to cases where the applicant for a practice certificate is a civil servant or public official.

2. Documents for renewing practice certificates:

a) A registration form for renewing a practice certificate (according to Model CCHN-2 in Appendix I of this Circular) accompanied by two color photographs measuring 4 x 6 cm;

b) A certified copy of the previously issued practice certificate;

c) A health certificate confirming fitness to work issued by a healthcare facility at the district level or higher.

3. Procedure for issuing practice certificates

a) Individuals requiring a practice certificate shall prepare one set of documents as prescribed in Clause 1 of this Article and submit it directly or send it via postal service to the competent authority for issuing practice certificates as stipulated in Article 24 of this Circular.

b) Within two working days from the date of receipt of the documents, the competent authority for issuing practice certificates shall request additional documents if the submitted application is incomplete or invalid.

c) Within five working days from the date of receipt of complete and valid documents, the competent authority for issuing practice certificates shall review the documents and issue a practice certificate to the applicant if the documents meet the requirements. In cases where a practice certificate is not issued, the competent authority for issuing practice certificates shall notify the applicant in writing and specify the reasons.

d) The validity period of a practice certificate is five years. One month before the expiration of a practice certificate, the holder wishing to continue practicing must submit one set of documents as prescribed in Clause 2 of this Article to the competent authority for issuing practice certificates. The procedure for renewing a practice certificate is as stipulated in points b and c, Clause 3 of this Article.

Chapter VII

RESPONSIBILITIES OF THE PARTIES INVOLVED

Article 26. Fisheries General Department

1. State management over products for water treatment and environmental improvement in aquaculture throughout the country. Directing and providing professional guidance related to the management of products for water treatment and environmental improvement in aquaculture.

2. Inspecting the quality of imported and exported products for water treatment and environmental improvement in aquaculture, or delegating such inspection to local management agencies.

3. Reviewing applications and recognizing facilities meeting the conditions for testing and trial products for water treatment and environmental improvement used in aquaculture; reviewing applications, issuing Certificates of Circulation, compiling, and promulgating Lists of products for water treatment and environmental improvement permitted for circulation in Vietnam on the Fisheries General Department’s and the Ministry of Agriculture and Rural Development’s websites for relevant organizations and individuals to access and implement.

4. Issuing certificates for practicing production, testing, trial, import, and export of products for water treatment and environmental improvement used in aquaculture.

5. Submitting to the Ministry of Agriculture and Rural Development for removal of products from the List of products for water treatment and environmental improvement used in aquaculture permitted for circulation in Vietnam as prescribed.

6. Submitting to the Ministry of Agriculture and Rural Development for issuance of national technical standards related to products for water treatment and environmental improvement used in aquaculture.

7. Inspecting and auditing products for water treatment and environmental improvement nationwide; inspecting the responsibilities of local management agencies in managing products for water treatment and environmental improvement in aquaculture.

8. Organizing guidance and implementation of this Circular.

Article 27. Livestock Breeding Department

1. State management over products for water treatment and environmental improvement in livestock breeding throughout the country. Directing and providing professional guidance related to the management of products for water treatment and environmental improvement in livestock breeding.

2. Inspecting the quality of imported and exported products for water treatment and environmental improvement in livestock breeding, or delegating such inspection to local management agencies.

3. Reviewing applications and recognizing facilities meeting the conditions for testing and trial products for water treatment and environmental improvement used in livestock breeding; reviewing applications, issuing Certificates of Circulation, compiling, and promulgating Lists of products for water treatment and environmental improvement permitted for circulation in Vietnam and announcing them on the Livestock Breeding Department’s and the Ministry of Agriculture and Rural Development’s websites for relevant organizations and individuals to access and implement.

4. Issuing certificates for practicing production, testing, trial, import, and export of products for water treatment and environmental improvement used in livestock breeding.

5. Submitting to the Ministry of Agriculture and Rural Development for removal of products from the List of products for water treatment and environmental improvement used in livestock breeding permitted for circulation in Vietnam as prescribed.

6. Submitting to the Ministry of Agriculture and Rural Development for issuance of national technical standards related to products for water treatment and environmental improvement used in livestock breeding.

7. Inspecting and auditing products for water treatment and environmental improvement nationwide; inspecting the responsibilities of local management agencies in managing products for water treatment and environmental improvement in livestock breeding.

8. Organizing guidance and implementation of this Circular.

Article 28. Department of Agriculture and Rural Development

1. Manage state affairs regarding products for environmental treatment and improvement according to this Circular within its jurisdiction.

2. Direct, guide, inspect, and supervise subordinate agencies in their work managing products for environmental treatment and improvement within their jurisdiction.

3. Organize inspections, checks, handle violations within its authority, and report results on managing products for environmental treatment and improvement after conducting inspections and checks.

4. Assign and direct local agencies responsible for livestock and aquaculture management to perform the following contents:

a) The agency responsible for aquaculture manages products for environmental treatment and improvement in aquaculture. The agency responsible for livestock management manages products for environmental treatment and improvement used in livestock farming.

b) Organize statistics, inspections, evaluations, and classifications of production and business establishments of products for environmental treatment and improvement; inspect the quality of products for environmental treatment and improvement within their jurisdiction as prescribed.

c) Inspect the quality of imported and exported products for environmental treatment and improvement when authorized by the General Fisheries Department and the Livestock Production Department.

d) Issue certificates for operating businesses of products for environmental treatment and improvement.

đ) Take the lead and coordinate with related agencies to organize inspections and checks of production and business establishments of products for environmental treatment and improvement at the same time.

e) Organize training and dissemination of legal regulations concerning the production and business of products for environmental treatment and improvement.

g) Perform other tasks related to managing products for environmental treatment and improvement as authorized by the General Fisheries Department and the Livestock Production Department.

h) Summarize and report the situation of production, business, and product quality for environmental treatment and improvement in the province to the General Fisheries Department and the Livestock Production Department every six months according to the assigned management and annual or ad hoc comprehensive reports as required by the General Fisheries Department and the Livestock Production Department. Report the results of inspections and checks and handling of violations after conducting inspections and checks (if applicable).

Article 29. Testing and Trial Facilities

1. Develop and implement testing and trial programs strictly according to approved outlines.

2. Maintain confidentiality of data and information related to tested and trial products.

3. Be responsible for the results of testing and trials; retain records for a minimum of five years.

4. In case the results of testing and trials are inaccurate, causing damage to production, business, and livestock or aquaculture farmers, they must bear responsibility for compensating the costs of testing and trials for the establishment with tested and trial products and compensate for losses caused during production due to incorrect testing and trials.

5. Notify the General Fisheries Department and the Livestock Production Department in cases of dissolution or cessation of activities within the recognized scope.

Article 30. Establishments Producing and Trading Products for Environmental Treatment and Improvement

1. Strictly comply with the provisions of this Circular and other relevant regulations under the law.

2. Bear legal responsibility and liability to consumers for the quality of products produced, imported, recalled, returned, during circulation and distribution.

3. Be subject to inspection and investigation by competent state agencies. Provide technical documents, related files, product samples, and facilitate conditions for inspection agencies while performing their duties.

4. Only produce and trade products for environmental treatment and improvement that are permitted to circulate in Vietnam.

5. Store records during production and business operations as prescribed.

6. Production establishments must have written regulations and fully implement all regulations, including: raw material, semi-finished product, finished product quality control, recycling products; arrangement, storage, regular inspection schedules, and timely handling of incidents during production and storage; equipment operation, workshop hygiene, wastewater treatment, labor safety, and fire prevention.

7. Production establishments must test product quality according to published standards before releasing them from the factory and retain product samples for a minimum period equal to the product's shelf life plus six months.

8. Production and import establishments must provide certified copies of product circulation permits to trading and distribution establishments and upon request of competent inspection authorities when circulating products on the market.

9. Must declare prices and display prices according to legal regulations.

10. Report the situation of production and business of products for environmental treatment and improvement to management agencies when requested.

11. Pay fees and charges as stipulated in Article 3 of this Circular.

12. Notify the local livestock or aquaculture management agency of changes in production locations, dissolution, or cessation of production of registered products.

13. Notify the local livestock or aquaculture management agency of the content and location of implementing models applying products in actual production within the local management area.

Chapter VIII

IMPLEMENTATION

Article 31. Transitional Provisions

1. Testing and trial facilities for products for environmental treatment and improvement recognized by Decision No. 18/2002/QĐ-BTS dated June 3, 2002, promulgating the Regulation on Testing and Trials of Aquatic Species, Feed, Drugs, Chemicals, and Biological Preparations Used in Aquaculture, must re-register as testing and trial facilities according to this Circular within twelve months from the effective date of this Circular.

2. Products for environmental treatment and improvement used in livestock and aquaculture that were licensed for circulation before June 30, 2011, may continue to circulate until June 30, 2016. Products for environmental treatment and improvement used in livestock and aquaculture that were licensed for circulation from June 30, 2011, may continue to circulate until the end of their five-year circulation period. At least three months before the expiration of the transitional period, establishments wishing to continue circulating these products must register for circulation according to Clause 3, Article 13 and Clause 4, Article 14 of this Circular.

Article 32. Implementation Provisions

1. This Circular shall take effect from August 6, 2015.

2. This Circular replaces the relevant contents concerning aquatic environmental treatment and improvement products used in aquaculture as prescribed in Decision No. 03/2007/QĐ-BTS dated April 3, 2007 of the Minister of Fisheries on the issuance of the Regulation on Registration for Circulation of Aquatic Drugs; Aquatic Environmental Treatment and Improvement Products, and Decision No. 18/2002/QĐ-BTS dated June 3, 2002 on the issuance of the Regulation on Testing of Aquatic Breeding Stocks, Feed, Drugs, Chemicals, and Biological Preparations Used in Aquaculture.

3. Any referenced documents that are amended, supplemented, or replaced shall be applied according to the amended, supplemented, or replacing document.

Article 33. Implementation Organization

During implementation, if there are difficulties, obstacles, or new issues arising, they should be promptly reported to the Fisheries General Department or the Livestock Production Department for timely submission to the Minister of Agriculture and Rural Development for amendment or supplementation./.