Decree No. 39/2017/ND-CP dated April 4, 2017 of the Government on providing the regulatory framework for animal feeds and aqua feeds

THE GOVERNMENT

Decree No. 39/2017/ND-CP dated April 4, 2017 of the Government on providing the regulatory framework for animal feeds and aqua feeds

Pursuant to the Law on Government Organization dated June 19, 2015;

Pursuant to the Law on Fishery dated November 26, 2003;

Pursuant to the Law on Technical Standards and Regulations dated June 29, 2006;

Pursuant to the Law on Quality of Products and Commodities dated November 21, 2007;

Pursuant to the Law on Investment dated November 26, 2014;

Pursuant to the Law on Enterprises dated November 26, 2014;

Pursuant to the Law on Animal Health dated June 19, 2015;

Pursuant to the Ordinance on Animal Breeds dated March 24, 2004;

At the request of the Minister of Agriculture and Rural Development;

The Government hereby adopts the Decree that provides the regulatory framework for animal feeds and aqua feeds.

Chapter I

GENERAL PROVISIONS

Article 1. Scope of adjustment

This Decree prescribes statutory requirements for commercial animal feed and aqua feed trading, utilization, experiment, certification, testing and regulatory management.

Article 2. Subjects of application

This Decree shall apply to domestic and foreign organizations or individuals engaged in the animal and aqua feed industry within the territory of Vietnam.

Article 3. Definition

For the purpose of this Decree, terms used herein shall be construed as follows:

1. Animal feed and/or aqua feed refers to a range of products, whether fresh, live, processed or preserved, that are orally fed to food-producing animals (for the purpose of defining ‘aqua feed individually, a range of products that are added to the culture environment), including animal nutrition and functional feeds in the form of a feed ingredient or individual feed; complete feeds; concentrated feeds, supplementary feeds, feed additives and products that are added to the culture environment (aqua feeds) in order to create natural food, stabilize the culture environment and increase effectiveness in use of animal feed products (hereinafter collectively referred to as animal and aqua feed, or feed product)

a) Commercial animal and aqua feed refers to any animal and aqua feed products manufactured for the purpose of being bartered or traded in the market.

b) Commercial animal and aqua feed produced for internal consumption purposes refers to any animal and aqua feed products mixed or compounded by farming facilities to meet their internal consumption demands which are not bartered or traded in the market.

c) Animal and aqua feed used according to the conventional practices refers to any agricultural, fishery products and those of the processing industry which have been used by farmers for a long time, including whole or unprocessed rice and; rice or cereal bran; corn or maize, sweet potatoes, cassava; distiller’s grains, brewer’s grains; cassava and pineapple waste; molasses; straw, stove, silage, hay or green crops; shrimps, crabs, fish and others.

d) New animal and aqua feed refers to a feed imported into or manufactured in Vietnam for the first time which contains new active ingredients that have not undergone any experiment in Vietnam.

dd) Complete feed refers to a mixture of multiple feed ingredients compounded by a specific formula to create a nutritionally adequate feed capable of maintaining life and promoting production of a food-producing animal over maturity or development stages or production cycles.

e) Concentrated feed refers to a combination or mixture of animal and aqua feed ingredients of which nutritional content is higher than the nutritional need of a food-producing animal and that is intended to be diluted or mixed with other feed materials to produce a complete feed (hereinafter referred to as concentrate)

g) Supplementary feed refers to an individual feed or a mixture of multiple feed ingredients added to the feeding ration or the culture environment (in terms of aqua feeds) to provide balanced required nutrients for the animal.

h) Animal and aqua feed ingredient or individual feed refer to a feed used for providing single or multiple nutrients in the feeding ration for the animal.

i) Animal and aqua feed additive refer to a substance, whether or not it has nutritional value, which is added to an animal and aqua feed during processing or treatment, or added to the environment during culture (in terms of aqua feeds) in order to enhance utilization, maintain or improve a characteristic of the animal and aqua feed.

k) Carrier is an edible material used for mixing with active ingredients in premixes without affecting the animal s health.

l) Antibiotic premix refers to a mixture of no more than 02 types of antibiotics permitted to be used in livestock and poultry feeds as growth promoters with less than 20% of total antibiotic content.

2. Main ingredient used in an animal and aqua feed refers to a determinant of useful effects and attributes of products which is defined by the Ministry of Agriculture and Rural Development to be appropriate for specific products.

3. Animal and aqua feed safety standard refers to standards affecting food safety for animal and aqua feeds which are prescribed by relevant technical regulations and other equivalents released by the Minister of Agriculture and Rural Development.

4. Animal/food-producing animal/domesticated or domestic animal used in a broad sense in this Decree covers livestock, poultry, bees, silkworms and aquatic animals which are raised, farmed or kept in captivity by human beings.

5. Young/immature livestock and poultry include the following species:

a) Pigs: From 01 to 60 days of age or from the neonatal period to the period when the body weight is 25 kg.

b) Fowls, ducks, geese, quails or rabbits: From 01 to 21 days of age.

c) Bull calves, buffalo calves, goats or sheep: Below 06 months of age.

6. Food safety for animal and aqua feeds refers to conditions and approaches which are necessary to ensure that animal and aqua feeds do not harm health of animals and humans due to their uses of animal products as well as environment.

7. Animal and aqua feed business includes manufacturing, processing, sale, purchase, exportation and importation of animal and aqua feeds.

a) Manufacturing of animal and aqua feeds refers to partial or full implementation of the procedure involving the following activities, such as production, processing, segregation, packaging, storage and transportation of animal and aqua feeds.

b) Processing of animal and aqua feeds refers to partial or full implementation of the processes for production of animal and aqua feeds in order to create products at the request of the order-placing party.

8. Trade name of an animal and aqua feed refer to the commercial name of an animal and aqua feed product that is used for making a distinction between animal and aqua feeds on the market.

Article 4. Contents of the regulatory management of animal and aqua feeds

1. Draw up the plan for development of production and usage of animal and aqua feeds.

2. Issue and take charge of implementation of legislative documents on administration, manufacturing process of, and standards, regulations, incentive mechanisms and policies for, animal and aqua feeds.

3. Manage experiments with and recognize new animal and aqua feeds.

4. Collect and manage information or data on animal and aqua feeds.

5. Conduct researches on and apply scientific and technological advances which are used in the animal and aqua feed industry.

6. Invest in and develop experimentation and testing systems to meet production, trading and regulatory management requirements concerning quality of animal and aqua feed products.

7. Provide training, coaching and certification for personnel tasked with exercising regulatory authority over animal and aqua feeds.

8. Raise public awareness of and disseminate knowledge and experience regarding production, management and use of animal and aqua feeds.

9. Check and inspect compliance with state regulatory requirements concerning animal and aqua feeds.

10. Promote international cooperation in the animal and aqua feed industry.

Article 5. Regulatory policies of animal and aqua feeds

1. Provide incentive policies to encourage all socio-economic sectoral involvements in research, training, agricultural and industrial extension and transfer of scientific and technological advances in the nutrition, animal and aqua feed processing industry.

2. Prioritize investment in and encourage various economic sectors to get involved in investment in development, production, exploitation and effective utilization of animal and aqua feed ingredients or materials and offer other policies which include allocation of more land and extension of concessional credits for cultivation, harvest, storage, production, preparation and processing domestic animal and aqua feed ingredients or materials.

3. Make investment in and encourage private sector s involvement in improvement of the capacity for testing and certification of conformity as the basis for inspection, audit and control of quality of animal and aqua feeds. Intensify the private sector’s involvement in public services for development of the animal and aqua feed industry.

Article 6. Principles of the regulatory management of animal and aqua feeds containing antibiotics

1. Prohibit using antibiotics in aqua feeds.

2. Ensure that antibiotics used in animal feeds for promoting growth of livestock and poultry must be emplaced in the classification list of antibiotics allowed for use in animal feeds.

3. Assure that antibiotics used in animal feeds for the purpose of curing livestock and poultry diseases and preventing immature livestock and poultry diseases must be those approved for sale in Vietnam and must be administered by prescription given by veterinary physicians who are granted practicing certificates in animal disease prevention and treatment in accordance with applicable laws and regulations on animal health.

4. Manufacture and use animal feeds containing antibiotics that are suitable for specific animals, purposes and within their permitted useful life to ensure that residues of antibiotics contained in animal feed products neither exceed the allowed limits nor cause any effect on resistance against antibiotics in the process of treatment of human and animal diseases.

5. Allow a maximum of 02 types of antibiotics used in an animal and aqua feed product.

6. Ensure that facilities manufacturing animal feeds used for livestock and poultry disease prevention and treatment purposes must be staffed by veterinary physicians holding practicing certificates in animal disease prevention and treatment in accordance with applicable laws and regulations on animal health.

7. Clearly specify names, antibiotic contents, user’s manuals and administration duration on packages or attached documents of animal feeds.

Chapter II

ELIGIBILITY REQUIREMENTS FOR TRADE IN ANIMAL AND AQUA FEEDS

Article 7. Eligibility requirements applied to facilities manufacturing and processing animal and aqua feeds

Organizations or individuals engaged in the manufacturing and processing of animal and aqua feeds must meet the following requirements:

1. Animal and aqua feed manufacturing and processing sites must be placed in the vicinity of areas which are not affected by polluting factors such as hazardous wastes, chemicals, livestock and aquatic animal farms.

2. Production sites must be enclosed by walls or fences.

3. Environmental impact assessment report or environmental protection plan must be prepared in accordance with applicable laws and regulations on environment.

4. Requirements concerning a production plant and equipment:

a) A production site is designed and furnished with equipment items according to the single-direction rules in which raw material areas and product areas are kept separate in order to prevent cross-contamination.

b) The technological production line is appropriate for manufacturing of particular types of animal and aqua feed products; feed materials, ingredients and finished feed products are palletized (except when warehouse and entire plant grounds are well-ventilated and moisture-resistant).

c) Its warehouse or storage facility must be designed to store animal and aqua feed ingredients that require a particular storage mechanism in uniformity with specific feed manufacturer’s instructions.

d) With respect to a facility manufacturing and processing animal feeds containing antibiotics, it must set up a separate area for mixing, preparation and formulation of these products in order to ensure cross-contamination that may occur is contained so that it cannot affect the ambient environment.

dd) Measurement devices or instruments must be in place in order to control quality of animal and aqua feed products and ensure accuracy in accordance with applicable laws and regulations on measurement.

e) Technical solutions to controlling foreign matters (e.g. sand, dust or metals) that may affect quality of feed ingredients must be offered by using equipment and devices (fans, sieves, magnets, etc.).

g) Solutions to preventing and controlling fire, avoiding rodent, bird and other harmful animal infestation must be available.

h) Relevant dust collection equipment and waste treatment systems must be in place to avoid contaminating feed products and assure that environmental standards conform to relevant regulations.

5. Technicians working for these facilities must obtain at least university degrees in one of the following majors, including animal science, animal science - animal health, animal health, food technology or biotechnology (in terms of animal feeds) or in the aquaculture science, biology or food technology (in terms of aqua feeds).

6. They must have or rent testing laboratories used for analyzing quality of animal and aqua feeds in the course of production and processing.

The Ministry of Agriculture and Rural Development shall issue specific technical regulations on technical requirements concerning those referred to in this Article.

Article 8. Eligibility requirements applied to facilities trading animal and aqua feeds

Organizations or individuals trading animal and aqua feeds must meet the following requirements:

1. Animal and aqua feeds displayed for sale at stores or kept in warehouses must be separate from pesticides, fertilizers and other hazardous chemicals.

2. These facilities must have equipment and instruments to preserve animal and aqua feeds under the instructions of manufacturers or distributors.

3. They must propose solutions to avoiding rodent, bird and other harmful animal infestation.

Article 9. Eligibility requirements applied to facilities importing animal and aqua feeds

Organizations or individuals importing animal and aqua feeds must have or rent storage facilities for preservation of animal and aqua feed products which conform to storage requirements in order to ensure that these products meet requirements concerning quality standards, environmental protection and conform to recommendations given by manufacturers.

Chapter III

EXPERIMENTS WITH NEW ANIMAL AND AQUA FEEDS

Article 10. Eligibility requirements and contents of experiments with animal and aqua feeds

1. Contents of experiments with new animal and aqua feeds

a) Animal and aqua feeds that require experiments shall be new animal and aqua feeds.

b) An animal and aqua feed shall not require experiments if it is the result of a research project or scheme recognized by the Ministry of Agriculture and Rural Development as a technological advance or if it passes experiments and is approved for sale in countries with which Vietnam has made mutual recognition agreements on the procedures for experiment with and recognition of new animal and aqua feeds.

c) The Ministry of Agriculture and Rural Development shall be assigned to provide instructions for experiments with new animal and aqua feeds and mutual recognition for the procedures for experiments with and recognition of animal and aqua feeds that has been agreed on with countries with which Vietnam is trading animal and aqua feeds.

2. Eligibility requirements for facilities experimenting with animal and aqua feeds

Facilities experimenting with animal and aqua feeds must fully meet the following requirements:

a) Have or rent locations, infrastructure or dedicated equipment necessary to meet requirements concerning experiments with specific feeds on animals, including enclosures, cages, ponds, pens, rafts and pools appropriate for experimental purposes.

Facilities experimenting with aqua feeds must have enough water sources meeting the quality requirements; have a separate water supply and drainage system and a wastewater pond to facilitate inspection of environmental indicators and aquatic disease indicators.

b) Technicians working for these facilities must obtain at least university degrees in one of the following majors, including animal science, animal science - animal health or biotechnology (in terms of animal feeds) or in the aquaculture science or biology (in terms of aqua feeds).

Article 11. Processes and procedures for application for experiment with and recognition of animal and aqua feeds

1. Organizations or individuals applying for experiment with new animal and aqua feeds must prepare a set of documents for submission to the Ministry of Agriculture and Rural Development.

2. That set of documents submitted to apply for experiments with new animal and aqua feeds shall include:

a) Application form for experiment with animal and aqua feed by using the Form No. 01 given in the Appendix hereto attached.

b) Outline of the experiment.

c) Demonstration of eligibility requirements for facilities experimenting with animal and aqua feeds referred to in Clause 2 Article 10 hereof.

3. Within the duration of no more than 05 business days of receipt of the application documents, the Ministry of Agriculture and Rural Development shall be responsible for checking submitted documents and notifying organizations or individuals in writing of documents which are not acceptable and need to be improved or supplemented.

Within the maximum duration of 30 business days of receipt of the valid submissions, the Ministry of Agriculture and Rural Development shall be responsible for establishing a council or reviewing and approving contents of the outline of experiment (according to the Form No. 02). In case of refusing to grant a decision on approval of the outline of experiment, the Ministry of Agriculture and Rural Development must give a written response which clearly states reasons.

4. Upon completion of an experiment, organizations or individuals whose animal and aqua feeds have undergone such experiment shall be responsible for preparing an assessment report on such experiment for submission to the Ministry of Agriculture and Rural Development.

Within the maximum duration of 15 business days of receipt of the assessment report on experiment, the Ministry of Agriculture and Rural Development shall establish a scientific council to evaluate the experimental result and issue a decision to recognize new animal and aqua feeds (according to the Form No. 03). In case of refusing to grant a decision on approval of a new animal and aqua feed, the Ministry of Agriculture and Rural Development must give a written response which clearly states reasons.

5. Inspection of experimental activities

a) Inspection method and degree: The Ministry of Agriculture and Rural Development must establish a working group composed of relevant regulators and scientists to carry out field inspection at least once during the procedures for experiment with a new animal and aqua feed.

b) Inspection contents: Eligibility requirements for experimenting facilities; contents of experiment specified in the approved outline of experiment.

Chapter IV

ANIMAL AND AQUA FEEDS APPROVED FOR SALE IN VIETNAM

Article 12. Animal and aqua feeds approved for sale in Vietnam

1. Animal and aqua feeds approved for sale in Vietnam shall be those certified by the Ministry of Agriculture and Rural Development conformable to the applicable standards and relevant technical regulations (if any) and published on the website of the Ministry.

The duration of approval for sale of animal and aqua feeds in Vietnam is 05 years from the date of certification. Within a period of 06 months before the expiry date of approval for sale, where necessary, organizations or individuals may re-submit their application for approval for sale to the Ministry of Agriculture and Rural Development.

2. Animal and aqua feeds approved for sale in Vietnam shall be obliged to meet the following requirements:

a) Release applicable standards in accordance with laws and regulations on construction, apply relevant standards and have appropriate quality relative to standards which have been announced for application. Make a declaration of conformity as prescribed by relevant national technical regulations (if any).

b) Each animal and aqua feed product for which only one quality standard is announced for application shall bear only 01 corresponding trade name.

c) New animal and aqua feed: Upon receipt of the decision to recognize a new animal and aqua feed granted by the Ministry of Agriculture and Rural Development, if an organization or individual needs to have its new animal and aqua feed approved for sale in Vietnam, such organization or individual must comply with regulations set forth in Point a Clause 2 of this Article and shall be allowed to use experimental results included in the documentation submitted to apply for recognition of that new animal and aqua feed for declaration of applied standards or declaration of conformity.

3. Animal and aqua feeds manufactured for internal consumption or for consumption according to the conventional practices shall not require application for approval for sale in Vietnam but must meet regulations set out in relative technical regulations.

The Ministry of Agriculture and Rural Development shall make a public statement about animal and aqua feeds used according to conventional practices which are approved for sale in Vietnam, including provisions on minimum quality levels and provisions set forth in relevant national technical regulations (if any) in order to be applied to the production process.

4. Documentation submitted to apply for approval for sale of animal and aqua feeds in Vietnam shall comprise:

a) With respect to domestically-manufactured animal and aqua feeds

Application form for approval for sale of animal and aqua feeds in Vietnam (according to the Form No. 04);

Duplicate copy of the acknowledgement of receipt of declaration of conformity with eligibility requirements for facilities manufacturing and processing animal and aqua feeds;

Original or certified duplicate copy of the contract for processing of animal and aqua feeds (if organizations or individuals apply for registration of animal and aqua feeds processed at the facilities that have declared conformity with stipulated requirements for production and processing of animal and aqua feeds);

Original or duplicate copy of the following documents: applied standards, acknowledgement of receipt of declaration of conformity, decision on recognition of animal and aqua feeds (where available);

Original or duplicate copy of the test report showing product quality and safety indicators specified in relevant applied standards and national technical regulations, which is issued by test laboratories designated or recognized by the Ministry of Agriculture and Rural Development. In case where product quality or safety indicators are not tested by designated or recognized laboratories, the Minister of Agriculture and Rural Development shall temporarily appoint an appropriate testing facility;

Product label samples (with certifying stamps of product manufacturers).

b) With respect to imported animal and aqua feeds:

Application form for approval for importation of animal and aqua feeds into Vietnam (according to the Form No. 05);

Certificate of free sale or other equivalent proving imported animal and aqua feeds, which is issued by competent authorities of the countries of origin in accordance with applicable laws and regulations;

Duplicate copy of one of the following documents such as ISO, GMP and HACCP or equivalents held by manufacturing facilities;

Product specification datasheet issued by manufacturers, including names of feed ingredients, quality, safety indicators, effects and user’s instructions;

Copy of written standards applied to organizations or individuals applying for approval for sale of animal and aqua feeds in Vietnam; secondary labels written in the Vietnamese language as required by laws or regulations;

Test reports showing product quality and safety indicators, which are issued by test laboratories designated by competent authorities of the origin countries or recognized by international or regional accreditation organizations, or designated or recognized by the Ministry of Agriculture and Rural Development;

Product label samples (with certifying stamps of manufacturers or importers);

Submitted application documentation must be original or duplicate and enclose Vietnamese translations certified by importing organizations or individuals. If the original copy is not written in English, the Vietnamese translation with attestation affixed is required.

For new animal and aqua feeds that require experiments, the provisions laid down in Article 11 hereof shall apply.

5. Documentation submitted to apply for re-registration of free sale of animal and aqua feeds in Vietnam shall include:

a) Re-registration form for approval for free sale of animal and aqua feeds in Vietnam (according to the Form No. 06);

b) Copy of applied standards, acknowledgement of receipt of declaration of conformity (where available), all of which must be either original or photocopy with certification granted by the manufacturer.

c) Product label samples (with certifying stamps of manufacturers, suppliers or importers).

6. Processing an application for free sale of animal and aqua feeds in Vietnam (including re-registration of free sale thereof in Vietnam) shall be carried out according to the following steps:

a) Organizations or individuals applying for free sale of animal and aqua feeds in Vietnam must prepare a set of documents for submission to the Ministry of Agriculture and Rural Development.

Within the duration of no more than 05 business days of receipt of the application documents, the Ministry of Agriculture and Rural Development shall be responsible for checking submitted documents and notifying organizations or individuals in writing of documents which are not acceptable and need to be improved or supplemented.

c) Within the maximum duration of 20 (in terms of initial registration) or 10 (in terms of re-registration) business days of receipt of the valid submissions, the Ministry of Agriculture and Rural Development shall be responsible for verifying such documentation and issuing the written confirmation of permission for free sale of animal and aqua feed in Vietnam (according to the Form No. 07)  and publishing such permission on the website of the Ministry of Agriculture and Rural Development. In case of refusing to issue such written confirmation, the Ministry of Agriculture and Rural Development must give a written response which clearly states reasons.

7. Change of information about animal and aqua feeds approved for free sale in Vietnam:

Organizations or individuals may change information about animal and aqua feeds approved for free sale in Vietnam only if there is any change made to quality thereof, including:

a) Information about animal and aqua feed products approved for sale in Vietnam that may be changed by organizations or individuals by themselves shall include address, telephone number, fax number of organizations or individuals applying for registration of sale thereof; name of the importer; color, size and classification of these products; packaging.

Upon making these changes, organizations or individuals must send or email (where available) the Ministry of Agriculture and Rural Development a written notification so that the Ministry update and publish these changes on its website.

b) Changes to information about animal and aqua feed products approved for sale in Vietnam that may be allowed by the Ministry of Agriculture and Rural Development shall include changes to the manufacturer’s name and address; name and number of the applied standard, product code (trade name).

Organizations or individuals applying for confirmation of changes to information about animal and aqua feeds must prepare a set of documents for submission to the Ministry of Agriculture and Rural Development, including the followings:

a) Application form for confirmation of changes to information about animal and aqua feeds (according to the Form No. 08).

Photocopy of the applied standard and acknowledgement of receipt of declaration of conformity (if any); product label samples certified by manufacturers or importers.

Original or authenticated duplicate copy of the written confirmation of changed contents of manufacturers (in terms of imported animal and aqua feeds).

Authenticated copy of enterprise registration certificate or written confirmation by competent authorities (in case of changes to name of the manufacturing facility, trade name of imported animal feed).

Within the duration of no more than 05 business days of receipt of the documentation submitted to apply for confirmation of changes to information about animal and aqua feeds, the Ministry of Agriculture and Rural Development shall be responsible for checking submitted documents and notifying organizations or individuals in writing of documents which are not acceptable and need to be improved or supplemented.

Within the maximum duration of 15 business days of receipt of the valid submissions, the Ministry of Agriculture and Rural Development shall be responsible for issuing the written confirmation of changes to information about animal and aqua feeds approved for sale in Vietnam (according to the Form No. 09) and publishing such changes on the website of the Ministry of Agriculture and Rural Development. In case of refusing to issue such written confirmation, the Ministry of Agriculture and Rural Development must give a written response which clearly states reasons.

c) Changes to information about animal and aqua feeds used according to conventional practices shall be made by the Ministry of Agriculture and Rural Development based on national standards and national technical regulations and market requirements.

8. Animal and aqua feeds commonly used for rearing fish, livestock or poultry:

a) Organizations or individuals applying for free sale of animal and aqua feeds in Vietnam or changes to information concerning animal and aqua feeds must submit their application package to the Ministry of Agriculture and Rural Development.

b) Processes, procedures for and contents of application for free sale of animal and aqua feeds commonly used in the aquaculture, livestock and poultry farming industry in Vietnam shall apply the same regulations as applied to other animal and aqua feeds set out in this Decree.

9. Sale of commercial animal and aqua feed products shall be suspended in the following circumstances:

a) These products contain substances prohibited for use in the animal farming and aquaculture.

b) After 03 times of inspection of a quality indicator or after 02 times of inspection of a safety indicator, these products have displayed successive violations.

c) The entity granting registration for free sale of animal and aqua feeds issues any notice of suspension of free sale of

The Ministry of Agriculture and Rural Development shall make a written notification of, or publicly post on its website, suspended animal and aqua feed products.

If a facility wishes to apply for re-registration for sale of animal and aqua feed products subject to sale suspension as referred to in Point a, b Clause 9 of this Article, it must go through the procedures the same as applied to initial registration.

If a facility wishes to apply for re-registration for sale of animal and aqua feed products subject to sale suspension even though its approval for sale has not expired yet, as referred to in Point c Clause 9 of this Article, it must send a written notification to the Ministry of Agriculture and Rural Development to request the Ministry to make another public notice and re-posting of its approval for sale on its website.

Article 13. Import of animal and aqua feeds which have not yet been approved for free sale in Vietnam

1. In order to import animal and aqua feed products to be used in exhibitions, trade fairs, researches or as samples at testing laboratories,

a) Organizations or individuals that wish to import animal and aqua feeds to be used in exhibitions, trade fairs, researches or as samples at testing laboratories must prepare a set of documents for submission to the Ministry of Agriculture and Rural Development.

b) Documentation required to apply for import of animal and aqua feeds for use in exhibitions or trade fairs shall include:

Application form for import of animal and aqua feeds for use in exhibitions or trade fairs (according to the Form No. 10);

Written confirmation evidencing organization of or participation in an exhibition or trade fair in Vietnam.

c) Documentation required to apply for import of animal and aqua feeds to be used as samples in testing laboratories shall include:

Application form for import of animal and aqua feeds for use as samples in testing laboratories (according to the Form No. 11);

The written agreement on use of the analysis service between a testing laboratory or a domestic enterprise on the one side, and a testing laboratory or enterprise or entity vested with regulatory authority over animal and aqua feeds of a country of origin on the other side, under which both parties agree that imported animal and aqua feeds are used for non-commercial purposes.

d) Documentation required to apply for import of animal and aqua feeds for research purposes:

Application form for import of animal and aqua feeds for research purposes (according to the Form No. 11);

Attached research outline.

dd) Within the maximum duration of 15 business days of receipt of the valid submissions, the Ministry of Agriculture and Rural Development shall decide whether import of these feed products is approved (according to the Form No. 12). In case of refusing to approve such import, the Ministry of Agriculture and Rural Development must give a written response which clearly states reasons for such refusal.

2. In order to import animal and aqua feeds used for manufacturing and processing of exported products:

Organizations or individuals importing animal and aqua feed products to be used for manufacturing and processing of feed products for export purposes under current contracts with foreign partners must prepare a set of documents for submission to the Ministry of Agriculture and Rural Development, including the followings:

Application form for import of animal and aqua feeds to be used for manufacturing and processing of exported feed products (according to the Form No. 13);

Contract for manufacturing and processing of animal and aqua feeds for export purposes as conformable to Vietnam’s laws and regulations on import of goods to be used for manufacturing and processing of exported feed products;

Within the maximum duration of 15 business days of receipt of the documentation submitted to apply for import of animal and aqua feed products to be used for manufacturing and processing of feed products for export purposes under current contracts with foreign partners, the Ministry of Agriculture and Rural Development must send a written response which states whether or not such import is allowed. In case of refusal, clear reasons must be stated.

Article 14. Export of animal and aqua feeds

1. Animal and aqua feeds used for both export and domestic consumption purposes must meet quality requirements as applied to other feed products approved for free sale in Vietnam and requirements set out by importing countries or importers.

2. Animal and aqua feeds solely used for export purposes must meet quality requirements set out by importing countries, except for animal and aqua feed production and business activities which are prohibited in Vietnam.

Chapter V

INSPECTION OF QUALITY OF ANIMAL AND AQUA FEEDS

Article 15. Inspection of domestic animal and aqua feeds

1. Subject matters of inspection

a) Commercial animal and aqua feeds:

Compliance with regulations on eligibility requirements applied to facilities manufacturing, processing and trading animal and aqua feeds;

Declaration of the applied standards and declaration of conformity (where appropriate);

Implementation of methods for managing quality of animal and aqua feeds;

Compliance with regulations on product and commodity labeling;

Sampling of animal and aqua feeds for examination of conformity with the relevant applied standard and technical regulations. Particular attention shall be paid to evaluation of safety indicators and other major quality indicators of feed products.

b) Self-formulated animal and aqua feeds, and animal and aqua feeds used according to conventional practices:

Check and inspect product safety indicators in accordance with applicable laws and regulations on food safety.

2. Inspecting entity: the Ministry of Agriculture and Rural Development, the Department of Agriculture and Rural Development of a centrally-affiliated city or province.

3. Inspection mechanism: State authorities shall send a prior written notice of their regular inspection which is limited to once a year at the maximum, except for unscheduled inspection carried out in case of any violation which has been detected. Unscheduled inspection of quality of animal and aqua feeds at the workplace of a facility manufacturing and processing feed products, facility using feed products shall be carried out when the head of a competent authority makes his/her decision on such inspection, and in such case, be carried out without any prior notice.

Article 16. Inspection of exported or imported animal and aqua feeds

Registration for inspection or confirmation of quality of animal and aqua feeds which are imported, recalled or returned shall be compulsory. With respect to exported animal and aqua feeds, inspection thereof shall be carried out as requested by the importing countries.

1. Subject matters of inspection

a) With respect to imported animal and aqua feeds

Inspect import dossiers as prescribed by Clause 1 Article 19 hereof;

Carry out physical inspection of quantity, weight, packaging, labeling, expiry date, origin and other organoleptic indicators of a feed product;

Conduct a sampling of a feed product for evaluation of conformity in terms of quality and food safety aspects.

b) With respect to recalled or returned animal and aqua feeds

Determine causes for such recall or return;

Check packaging, labeling, expiry date and organoleptic issues;

Get a sample of a recalled or returned feed product for product quality inspection.

c) With respect to exported animal and aqua feeds

Review the dossier of declaration of quality and declaration of conformity (where appropriate);

Check packaging, labeling, expiry date and organoleptic issues;

Make a quality analysis at the request of the importing enterprise or country and other request (if any).

2. Inspecting entity

The inspecting entity is a competent state authority or an organization appointed by the Ministry of Agriculture and Rural Development as an entity vested with authority to grant certification of conformity with quality standards for animal and aqua feeds used for export and import purposes (hereinafter referred to as appointed organization) in order to perform certain inspection activities in the entire inspection process which are specified by the appointment decision. Appointment requirements, processes and procedures shall conform to provisions laid down in Article 17 hereof.

Bases for assessment of competence of appointed organizations shall be subject to regulations on organizations granting certificates of conformity which are issued or recognized to be in effect by competent authorities. The Ministry of Agriculture and Rural Development shall release the procedures for assessment, publicly provide written guidance on assessment procedures and publish them on its website.

3. Inspection mechanism shall be subject to provisions laid down in Article 20 hereof.

Article 17. Appointment requirements, processes and procedures

1. Appointed organization must meet the following requirements:

a) Be appointed by the Ministry of Agriculture and Rural Development to be an organization granting certificate of conformity in the animal and aqua feed industry.

b) Have procedures for inspection and confirmation of conformity in terms of quality of imported and exported animal and aqua feeds relative to specific feed products which are assessed by the Ministry of Agriculture and Rural Development.

2. Appointment processes and procedures

The organization granting certification of conformity in the animal and aqua feed industry that has the demand for participation in inspection and accreditation of quality of imported and exported animal and aqua feeds shall submit a set of documents to the Ministry of Agriculture and Rural Development, including the followings:

a) Application form for participation in inspection and accreditation of quality of animal and aqua feeds (according to the Form No. 14).

b) Certified duplicate copy of the appointment decision wherein the organization is appointed to become the organization granting certification of conformity in the animal and aqua feed industry.

c) Procedures for inspection and accreditation of quality of imported and exported animal and aqua feeds relative to specific feed products which are released by the organization applying for permission to participate in inspection and accreditation of imported and exported animal and aqua feeds.

Within the maximum duration of 15 business days of receipt of the valid submissions, the Ministry of Agriculture and Rural Development shall assess the submitted documentation and carry out field audit of actual competence at the inspected entity ‘s workplace (where necessary) and issue the appointment decision (according to the Form No. 15). In case of refusing appointment, the Ministry of Agriculture and Rural Development must give a written response which clearly states reasons for such refusal.

3. Effect of the appointment decision

a) The term of the appointment decision is 03 years.

b) Within the duration of 03 months before the expiry date of this decision, when necessary, the appointed organization shall submit application for re-appointment to the Ministry of Agriculture and Rural Development, including the followings:

Application form for participation in inspection and accreditation of quality of animal and aqua feeds (according to the Form No. 14);

The appointed organization’s report on the result of inspection and accreditation of quality of imported and exported animal and aqua feeds made in the previous time (according to the Form No. 16).

Within the maximum duration of 07 business days of receipt of the valid submissions, the Ministry of Agriculture and Rural Development shall assess the submitted documentation and carry out field audit of its actual competence at the inspected entity ‘s workplace (where necessary) and issue another appointment decision (according to the Form No. 15). In case of refusing re-appointment, the Ministry of Agriculture and Rural Development must give a written response which clearly states reasons for such refusal.

Article 18. Sampling of an experiment with animal and aqua feeds

1. Getting a sample of an animal and aqua feed product shall be subject to provisions laid down in national standards (Vietnamese abbreviation: TCVN) or those adopted by the Ministry of Agriculture and Rural Development. Persons who get a sample of an animal and aqua feed must be trained by and obtain certificates in sampling of animal and aqua feed products from the Ministry of Agriculture and Rural Development.

2. Testing of quality of animal and aqua feeds used as the basis for regulatory management of these feed products shall be recognized only if such testing is carried out by employing testing methods at testing laboratories appointed by the Ministry of Agriculture and Rural Development. Where testing methods have not yet been designated or approved, the Ministry of Agriculture and Rural Development shall make a decision on the applied testing method.

The Ministry of Agriculture and Rural Development shall publish the procedures for appointment of a testing laboratory engaged in the animal and aqua feed industry; publicly provide written guidance on and update its website with a post regarding such procedures.

3. Testing bases shall be indicators showing quality and safety of animal and aqua feeds as referred to in relevant technical regulations issued by the Government and included as part of the applied product standards published by manufacturers or distributors, or specific written requirements set out by competent authorities.

Article 19. Processes and procedures for inspection and certification of quality of exported or imported animal and aqua feeds

1. Application for inspection and certification of quality of exported or imported animal and aqua feeds shall include:

a) Application form for inspection and certification of quality of animal and aqua feeds by adopting the Form No. 17 given in the Appendix hereto attached.

b) Certified photocopy of the following documents, held by the importing organization or individual: Sale and purchase agreement, packing list, invoice, certificate of analysis and manufacturer’s product label; copy of the applied standard of the importing entity.

c) Review report on import and consumption of lots of animal feeds containing antibiotics imported earlier and plan for consumption of animal feeds containing antibiotics that await import customs clearance according to the Form No. 18 given in the Appendix hereto attached.

2. Application for inspection and certification of quality of exported animal and aqua feeds shall include:

a) Application form for inspection and certification of quality of exported animal and aqua feeds (03 copies) by adopting the Form No. 17 given in the Appendix hereto attached; request for quality indicators subject to inspection and accreditation.

b) Authenticated duplicate of sale and purchase agreement and quality declaration documentation.

3. Application for inspection and certification of quality of recalled or returned animal and aqua feeds shall include:

a) Application form for inspection and certification of quality (03 copies) by adopting the Form No. 17.

b) Certified duplicate copy of sale and purchase agreement, certificate of quality of lots of animal and aqua feeds prior to export (where available), product recall letter or return notice wherein reasons for such recall or return should be clearly stated.

4. Processes for application for inspection and certification of quality of exported and imported animal and aqua feeds shall include:

a) Enterprise makes a set of documents submitted to apply for inspection and send it to the inspecting entity.

b) Upon receipt of application for inspection, within the maximum duration of 03 business days, the inspecting entity reviews and provides guidance on supplementation of documents or correction of those in breach of applicable laws and regulations;

Upon receipt of all required documents, within the duration of 03 business days, the inspecting entity will write its confirmation into the application form which specifies inspection contents, inspection time, date and venue.

Article 20. Policies on inspection of quality of imported animal and aqua feeds

1. The followings shall be exempted from inspection of quality of imported animal and aqua feeds:

a) Temporarily imported and re-exported animal and aqua feeds.

b) Animal and aqua feeds in transit or merchanting trade.

c) Animal and aqua feeds stored in the bonded warehouse.

d) Animal and aqua feeds used as sample products at exhibition or trade fair events.

dd) Animal and aqua feeds used as samples at testing laboratories.

e) Animal and aqua feeds used as samples for experiment and testing.

2. Policy on fixed-term exemption from quality inspection (not applied to animal and aqua feeds containing antibiotics)

a) For the purpose of this policy, it is required that inspection of related documents is performed, and organoleptic inspection and getting a sample for assessment of conformity are not performed within the permitted duration of 06 months.

b) This inspection system shall be applied to shipments of imported feed products meeting the following requirements: these products must be imported animal and aqua feeds of the same kind that are produced by the same manufacturer or imported by the same importer and of which certificates of quality are presented (according to the Form No. 19 given in the Appendix hereto attached) upon entry of 05 consecutive shipments thereof which are subject to the normal inspection or of 03 consecutive shipments thereof which are subject to the reduced inspection carried out within the definite term of fewer than 12 months before.

c) During the period of fixed-term exemption from quality inspection, the state inspecting entity or appointed organization tasked with monitoring goods under the policy for fixed-term quality inspection exemption may carry out random inspection of imported goods by employing the normal or ad-hoc inspection when there is any sign of violation against stipulated product quality standards. If there is sufficient grounds that these products fail to meet stipulated quality standards, actions must be taken in the same manner as applied to shipments of products in breach of quality standards and regulatory authorities having appropriate jurisdiction shall be advised to promptly cancel fixed-term exemption from quality inspection at the time when such violation has been detected, and switch to the tightened inspection system.

d) Importing organizations or individuals whose animal and aqua feeds conform to requirements above shall send their application package to the Ministry of Agriculture and Rural Development, including the following documents:

Application form for fixed-term exemption from inspection of quality of animal and aqua feeds (according to the Form No. 20);

Certificate of quality of 05 consecutive shipments meeting requirements of the normal inspection system or certificate of quality of 03 consecutive shipments meeting requirements of the fixed-term reduced inspection system (a photocopy certified by the importing entity).

Within the stipulated duration of 10 business days of receipt of the valid submissions, the Ministry of Agriculture and Rural Development shall send importing organizations or individuals written notification of fixed-term exemption for quality inspection (according to the Form No.21) and make a post on the Ministry’s website; in case of refusing to give permission to apply the fixed-term exemption from quality inspection, the Ministry of Agriculture and Rural Development must send a written response in which reasons for such refusal should be clearly stated.

Importing organizations or individuals shall be responsible for sending authenticated copies of documents about permission to apply the policy on fixed-term exemption from quality inspection to appointed organizations to write confirmation of such exemption in registration forms submitted to apply for inspection and accreditation of quality of specific imported shipments (according to the Form No. 17) as the basis for customs clearance.

3. Fixed-term reduced inspection (not applied to animal and aqua feeds containing antibiotics)

a) Inspection manner: Documentation and organoleptic inspection shall serve the purpose of assessing conformity of a product in terms of information included in the documentation with information on the label or attached technical documentation; checking integrity, type and color of the product. The reduced inspection system shall last for a period of 12 months. This inspection system requires sampling of a feed product only if it is discovered that such product is not consistent with submitted documentation, displays any sign of threat to, and failure to meet, quality standards such as fusty, musty, intact package, and modified appearance and color which could cause adverse effects on quality and safety of the product, or requires the random sampling according to requirements of the process for monitoring and controlling product quality. If there is sufficient grounds that the product fails to meet stipulated quality standards, actions must be taken in the same manner as applied to shipments of products in breach of stipulated quality standards and regulatory authorities having appropriate jurisdiction shall be advised to immediately end the fixed-term reduced inspection at the time when such violation is found and switch to the tightened inspection.

b) This inspection system shall apply to shipments of imported feed products that meet one of the following requirements:

the product subject to this inspection system must be imported animal and aqua feeds of the same kind that are produced by the same manufacturer or imported by the same importer and of which certificates of quality are presented (according to the Form No. 19) upon entry of 03 consecutive shipments thereof which are subject to the normal inspection within the definite term of fewer than 12 months before;

This product has been accredited as meeting stipulated quality and safety requirements by an organization having appropriate competency of the country with which Vietnam has entered into a mutual recognition arrangement during the process of inspection of animal and aqua feed quality; or by a testing laboratory assessed and recognized by the Ministry of Agriculture and Rural Development.

c) Importing organizations or individuals whose animal and aqua feeds conform to requirements of the fixed-term reduced inspection shall send their application package to the Ministry of Agriculture and Rural Development, including the following documents:

Application form for application of the fixed-term reduced inspection system (according to the Form No. 20);

Certificate of quality stating that 03 consecutive shipments have met stipulated quality standards according to the normal inspection system (a photocopy certified by an importing organization or individual) or certificate of fulfillment of quality and safety requirements by an organization having appropriate competency of the country with which Vietnam has entered into a mutual recognition arrangement during the process of inspection of animal and aqua feed quality, or by a testing laboratory recognized by the Ministry of Agriculture and Rural Development (an original or certified duplicate copy);

Within the stipulated duration of 10 business days of receipt of the valid submissions, the Ministry of Agriculture and Rural Development shall send importing organizations or individuals written notifications of whether they are permitted to apply the fixed-term reduced inspection (according to the Form No.21) and make a post on the Ministry’s website; in case of refusing to give permission to apply the fixed-term reduced inspection, the Ministry of Agriculture and Rural Development must send a written response in which reasons for such refusal should be clearly stated.

Importing organizations or individuals shall be responsible for sending authenticated copies of documents about permission to apply the fixed-term reduced inspection to appointed organizations that carry out inspections under the provisions of Point a Clause 4 of this Article.

4. Normal inspection

a) Inspection manner: Documentation, organoleptic inspection and collection of representative samples for analysis of at least 01 safety indicator and 01 quality indicator included in the applied standards or relevant national technical regulations, which ensure that level of safety and quality of the inspected product is duly measured. With respect to animal feeds containing antibiotics, it is compulsory for all types of antibiotics contained in these feed products to be inspected.

The inspecting entity or appointed organization shall determine specific indicators and bear responsibility for inspection results and evaluation of quality and safety of animal and aqua feeds.

b) This inspection system shall be applied to shipments of imported feed products which are not covered by provisions set forth in Clauses 1, 2, 3 and 5 of this Article.

5. Tightened inspection

a) Inspection manner: Documentation, organoleptic inspection and sampling of all production batches for analysis of at least 50% of safety indicators prescribed in the relevant national technical regulations and at least 50% of quality indicators prescribed in the applied standards, and other indicators (if any) as requested in writing by the Ministry of Agriculture and Rural Development. The tightened system shall be applied to 03 consecutive shipments on arrival.

b) This inspection system shall be applied to imported shipments if:

Previously imported products fail to meet quality and safety requirements as prescribed;

Imported goods are included in the list of animal and aqua feeds exposed to high food safety risks which is issued by the Ministry of Agriculture and Rural Development or originate from areas posing high risks of human, animal and environmental safety which are warned of by the Ministry of Agriculture and Rural Development;

The Ministry of Agriculture and Rural Development has issued a written request for application of the tightened inspection system when it is determined that quality of products sold in the market does not meet required quality standards or issued a written document that gives a warning of factors threatening human, animal and environmental safety of domestic or foreign organizations or individuals concerned.

Article 21. Recall and treatment of animal and aqua feeds in violation of stipulated quality standards

1. Upon receipt of the decision from a competent authority on mandatory recall of animal and aqua feed products, traders whose animal and aqua feeds need to be recalled shall promptly notify their customers to halt trading and use of these feed products and take actions to recall all of these products for their treatment sites at the request of the regulators. Defaulting traders must explain reasons for failure to recall the remaining quantity of animal and aqua feed products to which the regulator’s consent must be obtained, and assume responsibility for providing any necessary remedy.

2. Competent authorities must set up a Council tasked with overseeing the process of recalling and treating animal and aqua feeds in breach of stated quality standards to ensure compliance with applicable laws and regulations on product and commodity quality and environment; make an immediate post on the website of the Ministry of Agriculture and Rural Development that is charged with imposing penalties for offences arising from animal and aqua feeds in breach of stipulated quality standards that are subject to compulsory recalls.

Article 22. Sources of finances for regulatory management of animal and aqua feeds

1. Fund for regulatory management of animal and aqua feeds shall be derived from the state budget’s annual current allocations or appropriations to entities or authorities exercising regulatory authority over animal and aqua feeds under applicable laws and regulations on delegation of authority over the state budget.

2. Fund for regulatory management of animal and aqua feeds shall be mobilized from participation or contribution by domestic or overseas entities or individuals and other legitimate receipts.

Drawing up the budget plan, managing and utilizing the fund for regulatory management of animal and aqua feeds shall be subject to regulations enshrined in the Law on State Budget.

Chapter VI

RESPONSIBILITIES OF ENTITIES, ORGANIZATIONS OR INDIVIDUALS ENGAGED IN THE ANIMAL AND AQUA FEED INDUSTRY

Article 23. Responsibilities for regulatory management of animal and aqua feeds

1. The Government shall exercise the central regulatory authority over animal and aqua feeds.

2. The Ministry of Agriculture and Rural Development shall assume the following responsibilities:

a) Take charge of and cooperate with relevant ministries or sectoral departments in establishment of strategic plans, aims and objectives, policies for development and utilization of animal and aqua feeds across the nation.

b) Draft, issue, or submit to competent authorities to request them to issue or implement, legislative documents on animal and aqua feeds.

c) Prepare national standards and national technical regulations on animal and aqua feeds.

d) Set a limit on the minimum number of indicators that must be included in the applied standards.

dd) Manage experiments with and recognize new animal and aqua feeds.

e) Collect and manage information or data on animal and aqua feeds.

g) Issue the negative list of substances prohibited for use in animal and aqua feeds and publicize animal and aqua feed products approved for free sale in Vietnam.

h) Issue the positive list of antibiotics allowed for use in animal feeds for promotion of growth of livestock and poultry. Provide instructions for production and utilization of animal feeds containing antibiotics for the purpose of livestock and poultry disease prevention and treatment.

i) Provide guidance on, direct and carry out inspection, audit of compliance with, and imposition of sanctions for any violations against, regulations on production, trading and usage of animal and aqua feeds.

k) Raise public awareness of and disseminate legislative documents on animal and aqua feeds.

l) Promote international cooperation in the animal and aqua feed industry.

m) Carry out regulatory management of quality of animal and aqua feeds as prescribed.

n) Conduct researches on and apply scientific and technological advances which are used in the animal and aqua feed industry.

o) Provide training, coaching and certification for personnel working in the animal and aqua feed industry.

3. Ministries and Ministry-level bodies shall, within their duties and jurisdiction, take responsibility for collaborating with the Ministry of Agriculture and Rural Development in exercising regulatory authority over animal and aqua feeds.

4. People’s Committees of centrally-affiliated cities and provinces shall assume the following responsibilities:

a) Draw up the plan for development and use of animal and aqua feeds within their jurisdictions.

b) Direct guidance on effective and environment-friendly utilization of animal and aqua feeds.

c) Adopt incentive policies for and command competent authorities within their jurisdictions to provide facilitation for enterprises located within their jurisdictions to improve animal and aqua feed quality and safety.

d) Raise public awareness of, disseminate, and provide organizations or individuals manufacturing, trading and using animal and aqua feeds with instructions on laws and regulations and information on quality of animal and aqua feeds.

dd) Plan and carry out inspection, audit of compliance with, and imposition of sanctions for any violations against, regulations in the animal and aqua feed industry within their jurisdictions.

Article 24. Responsibilities of entities or individuals engaged in production of animal and aqua feeds

1. Declare conformity with eligibility requirements for facilities manufacturing and processing animal and aqua feeds, and deposit 01 set of documents at their offices.

2. Declare the applied standards and make declaration of conformity (if any) with quality standards of animal and aqua feeds as prescribed and deposit 01 set of documents at their offices.

3. Adopt the due process for manufacturing and control of quality of products. Write and keep a logbook of the production process for at least 02 years after the product’s expiry date.

4. Carry out testing and file results of testing of raw materials and finished feed products as a manner to satisfy requirements for in-process quality control and needs for access to these results for imposition of sanctions for any future violation. Store the test results for the duration of 02 years and deposit and preserve test samples for a period of 30 days after the expiry date.

5. Display quality information on the product label or package or attached documents in which main ingredients or antibiotics (if any) must be specified in accordance with regulations adopted by the Ministry of Agriculture and Rural Development.

6. Comply with requests for audit or inspection of conformity and quality requirements for animal and aqua feeds in accordance with applicable laws and regulations.

7. Commence their production only after having made declaration of conformity with eligibility requirements for facilities manufacturing and processing animal and aqua feeds.

8. Produce animal and aqua feeds for Vietnamese markets only in accordance with Chapter IV hereof.

9. Take legal responsibility for quality of animal and aqua feeds manufactured under their management; treat, recall or eliminate animal and aqua feed products that fail to meet stipulated quality and safety standards, and pay any required compensation to livestock farmers.

10. On a periodical basis on the 25^thday of every month, prepare a review report on manufacturing of animal and aqua feeds for submission to the Ministry of Agriculture and Rural Development and an ad-hoc report upon the request of competent authorities having regulatory authority over activities relating to animal and aqua feeds.

Article 25. Responsibilities of entities or individuals engaged in purchase, sale and import of animal and aqua feeds

1. Purchase, sell and import animal and aqua feeds for Vietnamese markets only in accordance with Chapter IV hereof.

2. Check product origin, expiry date and intactness of animal and aqua feed products; pay attention to marks showing conformity with standards or regulations (if any).

3. Apply methods for preserving quality of animal and aqua feeds under manufacturer’s recommendations in order to maintain acceptable quality of animal and aqua feed products.

4. Comply with requests for audit of prices of animal and aqua feeds in accordance with applicable laws and regulations.

5. Comply with requests for audit or inspection of eligibility requirements for trading of and quality of animal and aqua feeds in accordance with applicable laws and regulations. Treat, recall or eliminate animal and aqua feed products that fail to meet stipulated quality and safety standards in accordance with applicable laws and regulations, and pay any necessary compensation to livestock farmers.

6. Organizations or individuals importing antibiotic premix products must prepare a review report on import and consumption of feed products for submission to the sectoral regulators affiliated to the Ministry of Agriculture and Rural Development for its supervision of trading and use of feed products to serve the right purposes and according to the appropriate procedures.

Article 26. Responsibilities of entities or individuals using animal and aqua feeds

1. Comply with the Government s regulations and instructions given by animal and aqua feed suppliers for transportation, storage, conservation and usage of animal and aqua feeds. Avoid using prohibited substances in farm animal production activities.

2. Comply with requests for audit or inspection of quality of animal and aqua feeds made by regulators.

3. Cooperate in treatment and elimination of animal and aqua feed products and livestock products in breach of stipulated quality and safety standards.

4. Keep a logbook that records usage of animal feeds containing antibiotics for the purpose of animal disease prevention and treatment.

Article 27. Responsibilities of organizations granting certification of conformity in the animal and aqua feed industry

1. Assume liability and accountability to the appointed entity for the result of certification of conformity in the animal and aqua feed industry.

2. Submit the evaluation report on the result of certification of conformity in the animal and aqua feed industry to the appointed entity on a monthly basis or upon request.

3. Provide organizations or individuals with services such as storing and preserving samples for a period of at least 90 days from the date of notification of the result of certification of conformity in the animal and aqua feed industry.

4. Deposit the dossiers of certification of conformity in the animal and aqua feed industry for a period of at least 05 years.

5. Comply with requests for audit or inspection of certification of conformity in the animal and aqua feed industry made by regulators.

Article 28. Responsibilities of organizations performing experiments with animal and aqua feeds

1. Assume liability for the results of experiments with animal and aqua feeds.

2. Deposit the documentation on experiments with animal and aqua feed products for a period of at least 03 years.

3. Comply with requests for audit or inspection of experiments with animal and aqua feed products made by regulators.

Chapter VII

IMPLEMENTATION PROVISIONS

Article 29. Transitional provisions

1. Within the duration of 18 months from the date of entry into force of this Decree, facilities manufacturing and processing commercial animal and aqua feeds shall be responsible for making declaration of conformity with eligibility requirements for facilities manufacturing and processing animal and aqua feeds in accordance with this Decree.

2. Animal feeds containing antibiotics for promotion of growth of livestock and poultry shall be approved for free sale till end of December 31, 2017. Animal feeds containing antibiotics for young livestock and poultry disease prevention and treatment purposes shall be approved for free sale till end of the 31^stday of December of 2020.

3. Application for approval for free sale of animal and aqua feeds in Vietnam, application for re-grant of approval for free sale and application for confirmation of changes to information about animal and aqua feeds approved for free sale in Vietnam, all of which are received by the Ministry of Agriculture and Rural Development prior to the entry into force of this Decree, shall be subject to the Decree No. 08/2010/ND-CP dated February 05, 2010 on management of animal feeds. Notwithstanding, regulations on trade names of animal and aqua feed products shall be immediately applied to all of the products of which approval for sale is granted or re-granted from the date of entry into force of this Decree.

4. Within the duration of 18 months from the date of entry into force of this Decree, facilities manufacturing and trading commercial animal and aqua feeds shall be responsible for re-declaration of trade names of animal and aqua feed products in breach of regulations laid down in Point b Clause 2 Article 12 hereof.

5. Animal and aqua feed products which were approved for sale in Vietnam by the Ministry of Agriculture and Rural Development before the date of entry into force of this Decree shall be approved for free sale within a period of 05 years from the recognition date.

6. The validity term of the decision on appointment of an organization granting certification of conformity with stipulated quality standards of exported or imported animal and aqua feeds which was made by the Ministry of Agriculture and Rural Development before the date of entry into force of this Decree shall be kept unchanged.

Article 30. Effect

1. This Decree takes effect on May 20, 2017.

2. This Decree replaces the Government s Decree No. 08/2010/ND-CP dated February 05, 2010 on management of animal feeds.

3. To annul Article 12, 13, 14 of the Government’s Decree No. 66/2016/ND-CP dated July 1, 2016 defining investment and trading requirements concerning the plant protection and quarantine, plant varieties, normal forest animal farming, animal husbandry, aquaculture, fishery and food industry.

Article 31. Implementation responsibilities

1. The Ministry of Agriculture and Rural Development shall be responsible for providing guidance on implementation of this Decree.

2. Ministers, Heads of Ministry-level bodies, Heads of Governmental agencies, and Presidents of the People’s Committees of centrally-affiliated cities or provinces, shall be responsible for enforcement of this Decree./.

For the Government

The Prime Minister

Nguyen Xuan Phuc

* All Appendices are not translated herein.