Circular No. 38/2018/TT-BNNPTNT on the examination and certification of food production and business establishments in the agriculture, forestry, and fisheries sectors to meet food safety conditions under the management of the Ministry of Agriculture and Rural Development.

CIRCULAR

Regulations on the assessment and certification of food production and business establishments to meet food safety conditions under the management of the Ministry of Agriculture and Rural Development

food from agriculture, forestry, and fisheries that meets food safety conditions

under the management of the Ministry of Agriculture and Rural Development

Pursuant to Decree No.15/2017/NĐ-CPdated February 17, 2017 of the Government stipulating the functions, tasks, powers, and organizational structure of the Ministry of Agriculture and Rural Development;

Pursuant toFood Safety Law 2010 and Decree No. 15/2018/NĐ-CPdated February 22, 2018, of the Government detailing the implementation of certain provisions of the Food Safety LawFood Safety Law;

At the proposal of the Director of the Directorate for Quality Assurance of Agricultural Products, Forestry Products and Aquatic Products,

The Minister of Agriculture and Rural Development issues this Circular regulating the assessment and certification of food production and business establishments to meet food safety conditions under the management of the Ministry of Agriculture and Rural Development; responsibilities and authorities of relevant parties.

PART I

GENERAL PROVISIONS

This Circular regulates the assessment and certification of food production and business establishments to meet food safety conditions under the management of the Ministry of Agriculture and Rural Development; responsibilities and authorities of relevant parties.

1. Food production and business establishments under the management of the Ministry of Agriculture and Rural Development, except for the following:

a) Small-scale primary production;

b) Production and business of food without fixed locations, fishing boats less than 15 meters in length;

c) Small-scale processing;

d) Small-scale food business;

đ) Business of pre-packaged food;

e) Establishments that have been issued one of the following Certificates: Good Manufacturing Practices (GMP), Hazard Analysis and Critical Control Points System (HACCP), Food Safety Management System ISO 22000, International Food Standard (IFS), Global Food Safety Standard (BRC), Food Safety System Certification (FSSC 22000) or equivalent certificates still in effect.

g) Agricultural, forestry, and aquatic product production and business establishments exporting to countries or regions requiring health certification (health certificates, food safety certificates) by authorized agencies of the Ministry of Agriculture and Rural Development as prescribed by the Ministry of Agriculture and Rural Development.

(hereinafter referred to as the establishment).

2. Agencies, organizations, and individuals engaged in activities related to agricultural, forestry, and aquatic food production and business of the establishments specified in Clause 1 of this Article.

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

1. Serious defect: deviation from technical standards or national standards or regulations affecting food safety.

2. Major defect: deviation from technical standards or national standards or regulations, which if prolonged will affect food safety but not yet at a serious level.

3. Minor defect: deviation from technical standards or national standards or regulations, which may affect food safety or hinder food safety control.

4. Agricultural, forestry, and aquatic food business establishment: a place conducting one, several, or all activities of introducing, storage services, transportation services, or selling agricultural, forestry, and aquatic food, salt.

5. Primary agricultural, forestry, and aquatic food production establishment: a place conducting one, several, or all activities of cultivation, animal husbandry, aquaculture, harvesting, fishing, extraction of agricultural, forestry, and aquatic products, salt production.

6. Traceability: the process of tracing the formation and circulation of products.

7. Assessment: the activity of examining and verifying the validity of the file and actual conditions ensuring food safety of agricultural, forestry, and aquatic food production and business establishments.

Article 4. Basis for assessing food safety assurance conditions

1. National technical standards and national standards.

2. Legal regulatory documents and related provisions concerning food safety for agricultural, forestry, and aquatic products.

1. Central-level assessment authorities: These are the General Departments and specialized management Departments under the Ministry of Agriculture and Rural Development, as assigned by the Ministry of Agriculture and Rural Development.

2. Local-level assessment authorities: Determined by the People's Committee of the province based on the decentralization of the Ministry of Agriculture and Rural Development, local practical circumstances, and proposals from the Department of Agriculture and Rural Development.

1. Assessment for classification: This form involves prior notification and aims to comprehensively assess all aspects of food safety assurance conditions stipulated in Clause 1, Article 7 of this Circular for the establishment; applicable to:

a) Establishments undergoing initial assessment;

b) Establishments previously assessed as meeting requirements but have since made repairs or expanded production;

c) Establishments previously assessed as not meeting requirements but have since corrected all deficiencies;

d) Establishments previously assessed as meeting requirements but have had their periodic assessment deferred for more than six months;

e) Establishments that have been issued a certificate of compliance with food safety assurance conditions but have had it revoked or changed ownership, with changes to the original food safety assurance conditions.

2. Periodic assessment: This form involves unannounced assessments applied to establishments classified as meeting requirements to monitor the maintenance of food safety assurance conditions.

Article 7. Content and Methods of Assessment

1. Assessment Content

a) Physical facilities and equipment;

b) Human resources involved in production, business operations, and food safety management;

c) Implementation of national regulations, standards, and technical standards regarding food safety management programs and product labeling;

1. Classification forms include

a) Class A (excellent): Applied to establishments fully meeting food safety assurance condition requirements.

b) Class B (satisfactory): Applied to establishments basically meeting food safety assurance condition requirements; still having some minor errors that do not significantly impact food safety.

c) Class C (unsatisfactory): Applied to establishments failing to meet food safety assurance condition requirements.

2. Specific classification criteria for each type of establishment are detailed in the guidance document for assessment, classification, and completion of the assessment record as specified in Appendix II and Appendix III attached to this Circular.

The frequency of periodic inspection for food production and business establishments of agricultural, forestry, and aquatic products shall be as follows:

1. Class A establishments: once every 18 months;

2. Class B establishments: once every 12 months;

3. Class C establishments: The re-inspection time depends on the degree of errors of the establishment being inspected and is decided by the Inspection Authority, but not exceeding 3 months from the date of the Class C classification. If the re-inspection date coincides with the end of the season, the re-inspection will be conducted at the start of the next season.

Article 10. Requirements for the Head of the Inspection Team, Members of the Inspection Team, and Sample Collectors

a) Possessing relevant expertise in the field of inspection;

b) Having participated in specialized training courses suitable for the field of inspection and inspection officer training courses;

c) Having participated in at least five inspection rounds in the field of inspection.

a) Possessing relevant expertise in the field of inspection;

b) Having participated in specialized training courses suitable for the field of inspection and inspection training courses.

3. Requirements for Sample Collectors

a) Possessing relevant expertise;

b) Holding a certificate or certification regarding sample collection or having attended training or workshops that include sample collection content.

The collection of fees for issuing food safety certificates, periodic inspection fees for food safety conditions, and fees for confirming food safety knowledge shall be carried out according to the laws on fees and charges.

Chapter II

INSPECTION AND CERTIFICATION OF FOOD PRODUCTION AND BUSINESS ESTABLISHMENTS OF AGRICULTURAL, FORESTRY, AND AQUATIC PRODUCTS TO ENSURE FOOD SAFETY

Section 1

INSPECTION OF FOOD PRODUCTION AND BUSINESS ESTABLISHMENTS OF AGRICULTURAL, FORESTRY, AND AQUATIC PRODUCTS

Annually, the Inspection Authority shall compile and update the list of establishments under its jurisdiction according to the division of responsibilities set forth in Article 5 of this Circular, using the form provided in Appendix I attached hereto. This list serves as the basis for the Inspection Authority to conduct inspections, classify conditions ensuring food safety, and conduct surprise inspections when there are food safety incidents.

Article 13. Formation of Inspection Teams

a) Basis for inspection;

b) Scope, content, and form of inspection;

c) Name and address of the establishment to be inspected;

d) Names and positions of the head of the team and other members;

đ) Responsibilities of the establishment and the inspection team.

2. In cases where an establishment produces and trades multiple categories of agricultural, forestry, and aquatic food products, the head of the authority assigned the main responsibility shall notify related authorities to request personnel to join the inspection team.

1. The Inspection Authority shall notify the establishment of the planned inspection date for classification five working days in advance.

2. The inspection team shall announce the decision to establish the team, clearly stating the purpose and content of the inspection.

3. Conducting actual inspection: reviewing and evaluating documents and materials, assessing the physical conditions, equipment, and human resources involved in production and trade; conducting interviews and collecting samples for testing if necessary, as stipulated in Clause 1, Article 7 of this Circular.

4. Preparing the inspection record and announcing the inspection results.

5. In cases where violations are discovered, the inspection team shall prepare an administrative violation record and submit it to the competent authority for issuance of an administrative penalty decision in accordance with the law.

Article 15. Inspection Report

1. The inspection report shall be prepared according to the model set out in Appendix II and Appendix III issued together with this Circular.

2. Requirements for the inspection report:

a) It must be established by the inspection team at the facility immediately after the completion of the inspection.

b) It must fully and accurately reflect the results of the inspection.

c) It must clearly record the items that do not ensure food safety and the deadline for the facility to rectify the violations.

đ) It must include the opinion of the authorized representative of the facility regarding the inspection results and commitment to rectify the violations (if applicable).

e) It must bear the signature of the head of the inspection team, the signature of the authorized representative of the facility, and the stamp of the facility (if available) on the inspection report or signed page by page in case the facility does not have a seal.

g) In case the authorized representative of the facility disagrees to sign the inspection report, the inspection team must note: "The authorized representative of the inspected facility did not sign the report" and specify the reason why the representative did not sign. This report still has legal validity if it bears the signatures of all members of the inspection team.

h) It must be prepared in two copies: one copy retained by the inspecting authority, one copy retained by the facility; additional copies may be prepared if necessary.

Article 16. Handling Inspection Results

After reviewing the inspection report of the inspection team (on-site review may be conducted at the facility if necessary), within seven working days from the date of completion of the inspection, the inspecting authority shall proceed as follows:

1. In cases where the inspection is for classification purposes

a) Recognize and notify the inspection results to facilities classified as A or B. For facilities with multiple product categories, the frequency of periodic inspections will be determined based on the lowest classification level among the product categories.

b) Notify the facility classified as C about the handling of food safety violations according to the law, along with requirements to rectify the violations, deadlines for rectification, and re-inspection.

2. In cases where the inspection is for periodic evaluation

a) For facilities downgraded to B: Notify the facility about the downgrade and the inspection frequency to be applied in the future.

b) For facilities downgraded to C: Notify the facility about the handling of food safety violations according to the law, along with requirements to rectify the violations, deadlines for rectification, and re-inspection.

3. Issue a Certificate of Food Safety Conditions for facilities engaged in the production and business of agricultural, forestry, and aquatic products classified as A or B according to Article 17 of this Circular.

4. If the test results show that the product violates food safety regulations, the inspecting authority shall recommend the competent authority to handle the matter according to the law.

5. The inspecting authority shall not recognize a facility classified as A or B if the test results indicate a violation of food safety regulations. Recognition of the classification A or B shall be reconsidered after the facility investigates the cause and takes corrective measures, which are verified by the inspecting authority to meet the requirements.

6. The inspecting authority shall publicly announce through mass media the facilities that meet and those that do not meet the conditions for ensuring food safety.

Section 2

CERTIFICATE OF FOOD SAFETY CONDITIONS FOR FACILITIES ENGAGED IN THE PRODUCTION AND BUSINESS OF AGRICULTURAL, FORESTRY, AND AQUATIC PRODUCTS

1. Authority to issue the Food Safety Certificate: It is the agencies specified in Article 5 of this Circular that assess according to the principle that the agency which assesses the food safety assurance conditions of food production and business establishments shall issue the Food Safety Certificate.

2. The Food Safety Certificate is valid for a period of three years. The model of the Food Safety Certificate is prescribed in Appendix IV attached to this Circular.

3. Documents for requesting issuance of the Food Safety Certificate include:

a) Application form for issuance of the Food Safety Certificate as prescribed in Appendix V attached to this Circular;

b) Description of food safety assurance conditions of the establishment as prescribed in Appendix VI attached to this Circular.

4. Procedures and formalities for issuing the Food Safety Certificate

a) The establishment submits one set of documents for requesting issuance of the Food Safety Certificate to the authority issuing the Food Safety Certificate as prescribed in Clause 1 of Article 17 of this Circular. The documents can be submitted in one of the following forms: directly, via fax, email, electronic network (followed by submission of original documents); via postal service;

b) Within three working days from the date of receipt of the documents for requesting issuance of the Food Safety Certificate, the authority issuing the Food Safety Certificate must examine the completeness of the documents and notify the establishment in writing if the documents are incomplete;

c) From the date of receiving complete documents, the authority issuing the Food Safety Certificate conducts a review of the assessment file, classifies the establishment, and issues the Food Safety Certificate within seven working days (if the establishment has been assessed and classified as A or B); or organizes on-site assessment of food safety assurance conditions at the establishment and issues the Food Safety Certificate if it meets the conditions within fifteen working days (in cases where the establishment has not been assessed or classified). If the Food Safety Certificate is not issued, the authority must respond in writing and specify the reasons.

5. Reissuing the Food Safety Certificate

a) Six months before the expiration date of the Food Safety Certificate, the establishment submits documents for requesting reissuance of the Food Safety Certificate in cases of continued production and business operations. The reissuance of the Food Safety Certificate is carried out according to the provisions of Clauses 1, 2, 3, and 4 of this Article;

b) In cases where the Food Safety Certificate still has validity but is lost, damaged, misplaced, or there are changes or additions to information on the Food Safety Certificate, the establishment must submit a written request for reissuance of the Food Safety Certificate as prescribed in Appendix V attached to this Circular to the authority issuing the certificate for consideration and reissuance.

Within five working days from the date of receipt of the establishment's request for reissuance of the Food Safety Certificate, the authority issuing the Food Safety Certificate conducts a review of the documents and considers and reissues the Food Safety Certificate to the establishment. The validity period of the reissued Food Safety Certificate coincides with the expiration date of the previously issued Food Safety Certificate. If reissuance is not granted, the authority issuing the Food Safety Certificate must provide a written notification specifying the reasons.

6. Revocation of the Food Safety Certificate

a) Agricultural, forestry, and aquatic food production and business establishments will have their Food Safety Assurance Certificate revoked when they do not meet the conditions stipulated in Clause 1 of Article 34 of the Food Safety Law;

b) Authority to revoke the Food Safety Certificate

The agency that has the authority to issue the Food Safety Certificate also has the authority to revoke the Food Safety Certificate.

7. In cases where there are specific regulations regarding procedures and formalities for issuing, revoking, and reissuing the Food Safety Certificate for agricultural, forestry, and aquatic food production and business establishments with special characteristics, such specific regulations shall apply.

Clause 1. The authority issuing the Food Safety Knowledge Confirmation Certificate is the competent authority specified in Article 5 of this Circular, following the principle that the authority which issues the certificate confirming the establishment's compliance with food safety conditions shall have the authority to issue the Food Safety Knowledge Confirmation Certificate. The authority issuing the Food Safety Knowledge Confirmation Certificate may delegate or authorize subordinate units to issue such certificates in accordance with the provisions of the law.

Clause 2. Subjects eligible for issuance of the Food Safety Knowledge Confirmation Certificate

a) Owners of production and trading establishments: The owner of the establishment or the person hired or authorized by the owner to directly manage the production and trading activities of agricultural, forestry, and aquatic food products at the establishment;

b) Persons directly involved in production and trading: Individuals participating directly in the production and trading processes of agricultural, forestry, and aquatic food products at the establishments.

Clause 3. Subjects exempted from issuance of the Food Safety Knowledge Confirmation Certificate: The owner of the establishment or persons directly involved in the production and trading of agricultural, forestry, and aquatic food products who hold a relevant professional qualification at the intermediate level or higher, wherein the training program includes content on food safety. The production and trading establishments must retain certified true copies of the professional qualifications and photocopies of the training programs of these subjects.

Clause 4. The application dossier for the issuance of the Food Safety Knowledge Confirmation Certificate, the process of confirming knowledge about food safety, and the management of the Food Safety Knowledge Confirmation Certificate are stipulated in Articles 10, 11, and 12 of Joint Circular No. 13/2014/TTLT-BYT-BNNPTNT-BCT dated April 9, 2014, issued by the Ministry of Health, the Ministry of Agriculture and Rural Development, and the Ministry of Industry and Trade guiding the division of responsibilities and coordination in state management of food safety.

Clause 5. The assessment and evaluation of food safety knowledge shall be conducted through a multiple-choice test consisting of 30 questions, including 20 questions on general knowledge content and 10 questions on specialized knowledge content, with a time limit of 45 minutes for completing the test.

Clause 6. Materials on food safety knowledge content and the test questions evaluating food safety knowledge shall be developed and promulgated, or submitted for approval by the Ministry of Agriculture and Rural Development, under the main responsibility of the Directorate of Quality Assurance of Agricultural, Forestry, and Aquatic Products, in collaboration with related sectoral General Departments and Bureaus.

Chapter III

IMPLEMENTATION

Clause 2. Direct the Department of Finance to review and submit for approval the annual budget funds allocated to the inspection authorities as prescribed.

Clause 2. Guide and direct the implementation of this Circular within their assigned scope in the province.

Clause 3. Report the results of implementing this Circular to the Ministry of Agriculture and Rural Development (through the Directorate of Quality Assurance of Agricultural, Forestry, and Aquatic Products) according to the current reporting system.

1. Guide appraisal work throughout the system from central to local levels within the assigned management sector.

2. Guide the uniform application of materials, forms, and appraisal methods for the managed facilities. In necessary cases, propose, develop, and submit to the Ministry of Agriculture and Rural Development for issuance detailed inspection record models suitable for the specific characteristics of the facilities.

3. Organize training, instruction, and professional guidance for members of the appraisal team.

8. Report on the implementation results of this Circular to the Ministry of Agriculture and Rural Development (through the Quality Management Department of Agricultural, Forestry, and Fishery Products) according to the current reporting system.

1. Conduct appraisals and classify production and business establishments according to the delegation of the Ministry of Agriculture and Rural Development and the assignment of the Provincial People's Committee.

2. Organize training, instruction, and professional guidance for staff assigned with appraisal tasks.

3. Publicly announce on mass media the list of facilities meeting and not meeting food safety assurance conditions within the assigned scope in the province or city.

4. Systematically archive all related files concerning statistical, appraisal, and classification activities of agricultural, forestry, and fishery product production and business establishments within the scope of management according to the assigned and delegated levels.

5. Implement reports on the implementation results of this Circular to the Provincial Department of Agriculture and Rural Development (through the Quality Management Division of Agricultural, Forestry, and Fishery Products or units delegated by the Provincial Department of Agriculture and Rural Development) according to the current reporting system.

Article 23. Head and Members of the Appraisal Team

1. Head

a) Direct and guide members of the appraisal team to implement the contents recorded in the appraisal decision accurately.

b) Ensure objectivity, accuracy, and honesty during the appraisal process.

c) Sign the appraisal record, report on the appraisal results, and bear responsibility before the head of the appraisal authority and the law regarding the appraisal results conducted by the appraisal team.

d) Make the final conclusion of the appraisal team on the appraisal results.

đ) Protect confidential information related to the production and business operations of the appraised facility and protect the appraisal results until they are officially recognized and announced by the appraisal authority.

2. Members of the Appraisal Team

a) Appraise and evaluate the compliance of the food safety conditions of the facility with relevant regulations and technical standards.

b) Perform assigned tasks according to the division of labor by the head of the appraisal team.

c) Adhere strictly to the procedures, formalities, and methods of appraisal and sampling; ensure objectivity, accuracy, and honesty when conducting appraisals and sampling.

d) Bear responsibility and report on the results of assigned tasks to the head of the team.

đ) Protect confidential information related to the production and business operations of the appraised facility and protect the appraisal results until they are officially recognized and announced by the appraisal authority.

Article 24. Agricultural, forestry, and aquatic food production and business establishments

1. Arrange for a person with sufficient authority to represent the establishment to work with the inspection team.

2. Create conditions for the inspection team to conduct inspections and take samples on-site; provide complete information, specimens, files, and documents related to the requirements of the inspection team.

3. Fully rectify all errors noted in the inspection report and submit a written report to the inspection agency within the time limit specified in the inspection report.

4. Publicly post the inspection report at the establishment.

5. Pay the fee for issuing a food safety certificate, the periodic inspection fee for food safety conditions, and the fee for confirming food safety knowledge in accordance with current regulations.

6. Recall and handle products that do not meet food safety standards in accordance with the regulations.

7. Have the right to appeal to the inspection agency in cases where there is disagreement with the inspection results of the inspection team.

8. Notify the inspection agency in cases of cessation of production and business operations, dissolution, change of production location, change of production conditions, or change of ownership.

Chapter IV

IMPLEMENTING PROVISIONS

Article 25. Effective Date

1. This Circular takes effect from February 7, 2019.

2. This Circular replaces Circular No. 45/2014/TT-BNNPTNT dated December 3, 2014 of the Minister of Agriculture and Rural Development regarding the inspection of agricultural input production and business establishments and the inspection and certification of agricultural, forestry, and aquatic product production and business establishments meeting food safety conditions.

Article 26. Amendments and Supplements

During the implementation of this Circular, if there are difficulties or obstacles, organizations and individuals shall inform the Ministry of Agriculture and Rural Development for consideration of amendments and supplements./.