Circular No. 15/2022/TT-BNNPTNT on the inspection and supervision of veterinary hygiene and food safety for honey

CIRCULAR

Article 24Prescribes regulations on veterinary hygiene inspection and food safety supervision for honey

và an toàn thực phẩm đối với mật ong ||| and food safety for honey

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

Pursuant to the Food Safety Law 2010;

Pursuant to the Animal Health Law 2015;

Based on Decree No. 78/2018/NĐ-CP dated May 16, 2018 of the Government amending and supplementing certain provisions of Decree No. 127/2007/NĐ-CP dated August 1, 2007 of the Government detailing implementation of certain provisions of the Law on Standards and Technical Regulations;

Pursuant to Decree No. 15/2018/NĐ-CP dated February 2, 2018, issued by the Government detailing the implementation of certain articles of the Food Safety Law;

1. The List of veterinary drugs permitted for circulation in Vietnam (Annex I).

The Minister of Agriculture and Rural Development issues this Circular prescribing regulations on veterinary hygiene inspection (hereinafter referred to as VSTY) and food safety supervision (hereinafter referred to as ATTP) for beekeeping, honey procurement, initial processing, and commercial processing of honey for domestic consumption and export.

PART I

GENERAL PROVISIONS

Article 1. Scope of Regulation

1. This Circular prescribes the inspection and supervision of veterinary hygiene (hereinafter referred to as VSTY) and food safety (hereinafter referred to as ATTP) for beekeeping, honey procurement, initial processing, and commercial processing of honey for domestic consumption and export purposes.

2. The inspection shall be carried out according to the commitments made by beekeeping facilities and honey procurement facilities in accordance with the provisions of Circular No. 17/2018/TT-BNNPTNT dated October 31, 2018, issued by the Minister of Agriculture and Rural Development, which stipulates the management methods for ensuring food safety conditions for agricultural, forestry, and aquatic product production and business establishments not subject to issuance of a Food Safety Assurance Facility Certificate under the jurisdiction of the Ministry of Agriculture and Rural Development (hereinafter referred to as Circular No. 17/2018/TT-BNNPTNT).

3. The assessment and certification of food safety assurance conditions for honey processing establishments shall be carried out in accordance with the provisions of Circular No. 38/2018/TT-BNNPTNT dated December 25, 2018, issued by the Minister of Agriculture and Rural Development, which stipulates the assessment and certification of food safety assurance conditions for agricultural, forestry, and aquatic product production and business establishments under the jurisdiction of the Ministry of Agriculture and Rural Development (hereinafter referred to as Circular No. 38/2018/TT-BNNPTNT).

Article 2. Applicability

This Circular applies to:

1. Organizations and individuals related to beekeeping activities, honey procurement, initial processing, and commercial processing of honey for domestic consumption and export purposes.

2. Agencies, organizations, and individuals related to the inspection and supervision of veterinary hygiene and food safety for honey.

Article 3. Explanation of Terms

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

1. Raw honey: is honey harvested from bee colonies without undergoing any initial processing steps.

2. Honey raw material: is raw honey that has undergone initial processing (coarse filtration to remove impurities) from one or more different batches of raw honey.

3. Finished honey: is honey that has undergone processing (filtration, blending, yeast reduction) to be ready for immediate use or as a food processing ingredient.

4. Beekeeping facility: is a facility engaged in beekeeping and raw honey harvesting activities.

5. Honey procurement facility: is a facility engaged in raw honey procurement and storage to supply to honey processing facilities.

6. Honey processing facility: is a facility engaged in processing raw honey and honey raw materials using manual or industrial methods to produce finished honey.

7. Residues of harmful substances (hereinafter referred to as residues): are the remaining amounts of veterinary drugs, growth and reproduction stimulants, plant protection chemicals, environmental pollutants, contaminants from feed, and their metabolites present in honey that may harm consumer health.

Article 4. Inspection and Supervision Authority

1. The Department of Animal Health organizes inspections and supervision of honey production facilities (including: beekeeping facilities, honey procurement facilities, honey processing facilities) for export; mixed-use facilities for both export and domestic consumption (hereinafter collectively referred to as export facilities).

2. The Department of Agriculture and Rural Development organizes inspections and supervision of honey production facilities not covered by Clause 1 of this Article.

3. The Department of Animal Health and the Department of Agriculture and Rural Development are collectively referred to as the Inspection and Supervision Authority.

Article 5. Principles for Building and Implementing the Monitoring Program

1. Basis for building the Monitoring Program: carried out in accordance with the provisions of Article 8 of this Circular.

2. Content of the Monitoring Program: carried out in accordance with the provisions of Article 9 of this Circular.

3. Funding for implementing the Monitoring Program

a) Operating costs for inspection and monitoring activities of the Inspection and Supervision Agency shall be implemented according to the current state budget classification. The preparation of budgets, management, and use of inspection and monitoring funds shall comply with the Law on State Budget and related guiding documents;

b) The Animal Health Department shall take the lead in preparing the budget, submit it for approval by the Ministry of Agriculture and Rural Development, and allocate funding for the annual implementation of the Monitoring Program for facilities specified in Clause 1 of Article 4 of this Circular;

c) The Department of Agriculture and Rural Development shall take the lead in preparing the budget, submit it for approval by the competent authority at the local level, and allocate funding to organize the annual implementation of the Monitoring Program for facilities specified in Clause 2 of Article 4 of this Circular.

Article 6. Requirements for Organizations and Individuals Participating in the Monitoring Program

1. Testing laboratories participating in the Monitoring Program

a) Testing laboratories under the Animal Health Department participating in the implementation of the honey export monitoring program must be recognized as compliant with ISO 17025 standards; testing methods must be approved according to regulations;

b) Testing laboratories not covered by point a of this clause must be recognized as compliant with ISO 17025 standards; they must have a Certificate of Registration for Testing Activities issued in accordance with Decree No. 107/2016/ND-CP dated July 1, 2016 of the Government on conditions for operating conformity assessment services, including testing fields relevant to the annual monitoring plan approved;

2. Team leaders, team members for inspection and supervision, and sample collectors

a) Team leader: must be a department-level leader or higher of the Inspection and Supervision Agency or a unit leader assigned by the Inspection and Supervision Agency to head the Monitoring Program;

b) Members: must include at least one member with a bachelor's degree or higher in one of the following fields: animal husbandry, veterinary science, food technology, biotechnology, agricultural product processing; having participated in specialized training courses suitable for the inspection and evaluation field and training courses organized by the Animal Health Department;

c) Sample collector: must have expertise in one of the following fields: animal husbandry, veterinary science, food technology, biotechnology, agricultural product processing; must hold a certificate of participation in sampling training organized by the Animal Health Department.

Chapter II

INSPECTION AND SUPERVISION OF HONEY

Article 7. Inspection and Supervision of VSTY and Food Safety for Honey Export Production Facilities

1. Beekeeping facilities, honey purchasing facilities: monitor compliance with commitments made in accordance with Circular No. 17/2018/TT-BNNPTNT and import country requirements.

2. Honey Processing Facilities

a) Inspection through certification of VSTY conditions (hereinafter referred to as VSTY Certificate);

b) Supervision of VSTY conditions shall be carried out in accordance with the provisions of Article 38 of Circular No. 09/2016/TT-BNNPTNT dated June 1, 2016 of the Minister of Agriculture and Rural Development on slaughter inspection and veterinary hygiene inspection (hereinafter referred to as Circular No. 09/2016/TT-BNNPTNT), amended and supplemented by Clause 11 of Circular No. 10/2022/TT-BNNPTNT dated September 14, 2022 of the Minister of Agriculture and Rural Development amending and supplementing some articles of Circular No. 09/2016/TT-BNNPTNT (hereinafter referred to as Circular No. 10/2022/TT-BNNPTNT);

c) Inspection and supervision of VSTY and food safety for facilities that have been granted certificates equivalent to the VSTY Certificate shall be carried out in accordance with the requirements of the importing party or exporting organizations and individuals;

Certificates equivalent to the VSTY Certificate include those types of certificates stipulated in Clause 3 of Article 36 of Circular No. 09/2016/TT-BNNPTNT, amended and supplemented by Clause 9 of Article 1 of Circular No. 10/2022/TT-BNNPTNT.

3. Supervision of VSTY and food safety for production facilities mentioned in Clauses 1 and 2 of this Article shall be conducted concurrently with food safety monitoring sampling activities for honey in the annual Monitoring Program and in accordance with import country requirements.

4. Handling of production facilities failing to meet VSTY and food safety monitoring criteria as prescribed

a) The Inspection and Supervision Agency shall handle in accordance with current laws if the facility does not implement corrective actions or report results and timeframes for corrections for non-compliance criteria recorded in the Inspection Report or Evaluation Report;

b) Recommend relevant conformity assessment organizations or authorities to revoke the Certificate in cases where non-compliance with the application of recognized quality management systems is discovered for facilities holding certificates equivalent to the VSTY Certificate.

Article 8. Basis for developing the Monitoring Program

1. List of honey production facilities that have been issued a Certificate of Veterinary Sanitary and Hygiene Safety (VSTY) or a Certificate with equivalent value to the VSTY Certificate, including related information about the facility (facility name, address, phone number, email), date of issuance, validity period of the Certificate, issuing authority.

2. Honey production volume of the year immediately preceding the year of the Monitoring Program development.

3. Results of honey and bee feed sample testing from the Monitoring Program implemented in the three years immediately preceding the year of the Monitoring Program development.

4. Warning and recommendation information from competent state agencies regarding food safety for honey to identify high-risk indicators causing food safety issues.

5. Requirements and regulations of Vietnam on the use of chemicals, antibiotics, prohibited veterinary drugs, and restricted use in veterinary practices; regulations of importing countries concerning the honey production export chain.

Article 9. Content of the Monitoring Program

1. Supervision of compliance with laws on veterinary and food safety at honey production facilities

a) For honey production facilities exporting honey: implement supervision according to Clause 1 and Clause 2, Article 7 of this Circular;

b) For honey production facilities not covered under point a of this clause: implement supervision according to Circular No. 17/2018/TT-BNNPTNT and Circular No. 38/2018/TT-BNNPTNT;

c) Handling of honey production facilities with non-compliant monitoring criteria: implement according to Clause 4, Article 7 of this Circular.

2. Establishing the sampling structure and announcing the implementation plan of the Monitoring Program, including:

a) Number of honey samples taken from beekeeping facilities, honey purchasing, and processing facilities for monitoring residue and pathogenic microorganisms;

b) Number of feed samples taken from beekeeping facilities for monitoring the use of veterinary drugs in beekeeping;

c) Announcing the implementation plan of the Monitoring Program to relevant authorities, units, and sampled facilities.

3. Organizing the implementation of sampling, adjusting the sampling plan (if necessary) and analyzing samples based on annually approved indices and methods: implement according to Article 10 of this Circular.

4. Handling cases where monitored samples do not meet veterinary sanitary and hygiene safety and food safety requirements according to Article 11 of this Circular.

5. Summarizing and reporting annual monitoring results according to management requirements and requirements of importing countries (for honey production facilities exporting honey).

Article 10. Sampling and Analyzing Samples

1. Based on the sampling structure of the annual Monitoring Program as stipulated in Point a and Point b, Clause 2, Article 9 of this Circular, the Inspection and Supervision Authority shall conduct random or targeted sampling for monitoring raw honey, raw material honey, finished honey, and bee feed.

2. The time for annual sampling is determined according to the honey harvesting and production seasons of the facilities.

3. Sampling locations

a) Raw honey samples from beekeeping facilities and honey purchasing facilities: based on the harvesting season, honey harvesting region, and places with honey purchasing facilities; In case sampling cannot be conducted at beekeeping facilities and honey purchasing facilities, raw honey samples can be taken from the processing facilities but before preliminary processing for monitoring;

b) Raw material honey and finished honey samples from honey processing facilities: based on the monitoring time and concentrated sampling in localities with honey processing facilities.

4. Sampling method

a) Honey sampling: carried out according to the guidance in Appendix I attached to this Circular;

b) Feed sampling: carried out according to TCVN 13052:2021. Livestock feed - Sampling.

5. Samples after collection must be sealed and marked with identification codes (encoded).

6. Sample analysis

a) The Inspection and Supervision Authority sends the monitoring samples to the laboratory for analysis of residues and pathogenic microorganisms according to the annually approved Monitoring Program by the competent authority;

b) Analysis results are stored in the laboratory;

c) Organizations and individuals have the right to request review of the first analysis results; they are permitted to take new samples from the containers previously sampled or use retained samples for re-analysis; all costs for re-analysis will be borne in such cases.

Article 11. Handling samples not meeting VSTY and ATTP standards during the implementation of the Monitoring Program

During the sample analysis process, if indicators of VSTY and ATTP are found to be non-compliant with Vietnamese regulations or those of the importing country, the Inspection and Supervision Authority shall implement the following:

1. Notify in writing the results of the monitoring sample analysis to relevant management agencies.

In case a non-compliant monitoring sample is discovered, immediately notify in writing the relevant management agency and the establishment with non-compliant monitoring samples of the following information:

a) Name of the establishment with non-compliant monitoring samples of VSTY and ATTP;

b) Batch number and quantity of products not meeting VSTY and ATTP requirements;

c) Date of sampling and test results;

d) Reason for the samples not meeting VSTY and ATTP requirements;

e) Require the establishment not to use honey in processing or temporarily suspend business activities for the batch of honey not meeting VSTY and ATTP requirements or cease using veterinary drugs in beekeeping;

f) Require the establishment to immediately carry out traceability according to Circular No. 17/2021/TT-BNNPTNT dated December 20, 2021 issued by the Minister of Agriculture and Rural Development on traceability, recall, and handling of food that does not meet safety standards under the jurisdiction of the Ministry of Agriculture and Rural Development (hereinafter referred to as Circular No. 17/2021/TT-BNNPTNT) and report the results to the Inspection and Supervision Authority.

2. The Inspection and Supervision Authorities organize verification of the implementation of traceability and corrective actions by the establishment; where necessary, organize full traceability of the honey production chain (if honey samples are found to be non-compliant) to recall and handle honey that does not meet ATTP requirements according to Articles 12, 13, and 14 of Circular No. 17/2021/TT-BNNPTNT.

3. Implement enhanced monitoring measures and targeted sampling from honey production establishments with non-compliant monitoring samples of VSTY and ATTP during the year of the Monitoring Program implementation and the following year. If the establishment continues to have non-compliant monitoring samples, the Inspection and Supervision Authority shall organize inspection and handling according to regulations.

4. Establishments with non-compliant monitoring samples of VSTY and ATTP must bear all costs for enhanced sampling and analysis and handling of the batch.

Chapter III

USE OF VETERINARY DRUGS AND FEED IN BEEKEEPING

Article 12. Use of veterinary drugs and feed in beekeeping

1. Only use veterinary drugs permitted for circulation in Vietnam to prevent and treat diseases in bees as prescribed.

2. The use of drugs to prevent and treat diseases in bees must follow the instructions of the manufacturer and prescriptions of veterinary practitioners. Prescription of veterinary drugs shall be carried out according to Circular No. 12/2020/TT-BNNPTNT dated November 9, 2020 issued by the Minister of Agriculture and Rural Development on the management of veterinary drugs containing narcotic substances and precursors; prescription and veterinary prescriptions; amendments and supplements to some articles of Circular No. 18/2018/TT-BNNPTNT; and Circular No. 13/2022/TT-BNNPTNT dated September 28, 2022 issued by the Minister of Agriculture and Rural Development amending and supplementing some articles of circulars on the management of veterinary drugs.

3. The use of feed in beekeeping must comply with legal provisions on animal feed.

Chapter IV

IMPLEMENTATION

Article 13. Responsibilities of the Animal Health Department

1. Implement the tasks specified in point b, Clause 3, Article 5 of this Circular.

2. Annually review, adjust, and supplement the Monitoring Program for indicators, analytical methods for samples; maximum residue levels allowed in honey; list of establishments to be monitored and notify relevant agencies, organizations, and individuals related to the Monitoring Program.

3. Establish and update files, codes of honey production establishments serving commercial purposes for export in the Monitoring Program; systematically retain all related information and data.

4. Conduct traceability checks and verify corrective actions taken by establishments with non-compliant samples in terms of veterinary health and food safety during monitoring as stipulated in Circular No. 17/2021/TT-BNNPTNT.

5. Conduct inspections to issue Certificates of Veterinary Health Conditions for honey processing establishments for export according to point a, Clause 1, Clauses 2, 3, 4, 5, and 6, Article 37 of Circular No. 09/2016/TT-BNNPTNT amended and supplemented by Clause 10, Article 1 of Circular No. 10/2022/TT-BNNPTNT.

6. Compile and report statistical data, explain issues related to the implementation of the Monitoring Program; submit regular annual and ad hoc reports as required by the Ministry of Agriculture and Rural Development on the results of implementation; compile information, analyze and evaluate activities appropriately to propose recommendations for necessary measures to correct or amend contents in the Monitoring Program.

7. Manage, utilize, and allocate funds approved for subordinate units of the Animal Health Department according to regulations.

8. Promote, disseminate, and guide honey production establishments to comply with the provisions of this Circular and regulations, standards, and technical specifications regarding residues in honey products, and the use of veterinary drugs in disease prevention and treatment for bees to ensure veterinary health and food safety in honey production.

9. Organize training and provide professional guidance to agencies, organizations, and individuals involved in implementing the Monitoring Program.

10. Chair meetings with inspection teams from importing authorities; report and provide information as requested by the importing authority.

Article 14. Responsibilities of the Department of Agriculture and Rural Development

1. Implement the tasks specified in point c, Clause 3, Article 5 of this Circular.

2. Update and notify honey production establishments under its jurisdiction about the list of establishments to be monitored annually in the Monitoring Program.

3. Establish and update files, codes of honey production establishments serving domestic consumption purposes within its jurisdiction in the Monitoring Program; systematically retain all related information and data.

4. Conduct traceability checks and verify corrective actions taken by establishments with non-compliant samples in terms of veterinary health and food safety during monitoring as stipulated in Circular No. 17/2021/TT-BNNPTNT.

5. Compile and submit regular annual and ad hoc reports as required by the People's Committee of the province and the Ministry of Agriculture and Rural Development on the Monitoring Program within its jurisdiction; compile information, evaluate activities appropriately to propose recommendations for necessary measures to correct or amend contents in the annual Monitoring Program.

6. Manage and utilize funds approved for subordinate units of the Department of Agriculture and Rural Development according to regulations.

7. Promote, disseminate, and guide regulations on bee feed production; the use of veterinary drugs in disease prevention and treatment for bees to ensure veterinary health and food safety for honey production establishments under its jurisdiction.

8. Coordinate with the Animal Health Department to implement the Monitoring Program for honey production establishments for export within its territory when required.

Article 15. Responsibilities of Testing Laboratories

1. Adhere to procedures correctly, ensuring accurate, objective, and truthful results; be responsible for the analysis results of samples under the Monitoring Program.

2. Maintain confidentiality of information and analysis results in accordance with regulations; only report analysis results to the Inspection and Supervision Authority.

3. Comply with the sample analysis timeframes within the Monitoring Program as required by the Inspection and Supervision Authority.

4. Properly retain relevant records and documents in accordance with regulations and provide them when requested by the Competent Authority.

Article 16. Responsibilities of the Vietnam Beekeeping Association

1. Coordinate with the Animal Health Department to work with relevant authorities of importing countries regarding honey exports; update information from the importing country's authorities about food safety requirements for exported honey.

2. Participate and cooperate in disseminating and guiding honey production facilities on regulations concerning hygiene and food safety for honey.

3. Compile difficulties and issues encountered in honey production and propose solutions to relevant authorities for consideration and resolution.

4. Propose and recommend to the Inspection and Supervision Authority, as stipulated in Article 4 of this Circular, regarding risks that may compromise hygiene and food safety for honey.

Article 17. Responsibilities of Beekeeping Facilities, Honey Purchasing and Processing Enterprises

1. Beekeeping Facility

a) Implement beekeeping procedures ensuring hygiene and food safety;

b) Only harvest honey for food use after adhering strictly to the drug withdrawal period as directed by the drug manufacturer;

c) Maintain a beekeeping logbook recording disease conditions, drug usage for disease prevention and treatment, feeding practices, and honey harvesting and supply to purchasing and processing enterprises as specified in Appendix III attached to this Circular;

d) Comply with inspection and supervision procedures as stipulated in this Circular and guidance from Inspection and Supervision Authorities to ensure hygiene and food safety for honey. Provide complete information, records, and documents related to beekeeping and honey harvesting upon request by the Inspection and Supervision Authority;

đ) Strictly comply with violation handling decisions made by Competent Authorities and bear all costs associated with traceability, sampling, and enhanced monitoring testing when honey samples fail to meet hygiene and food safety standards.

2. Honey Purchasing Enterprise

a) Organize and maintain hygienic conditions during honey procurement and trade in accordance with regulations;

b) Maintain a list of beekeeping facilities supplying raw honey as specified in Appendix II attached to this Circular;

c) Retain complete quality management and food safety records; raw honey trading records must be kept for a minimum of three years;

d) Comply with inspection and supervision procedures as stipulated in this Circular and guidance from Inspection and Supervision Authorities to ensure food safety during honey procurement;

đ) Strictly comply with violation handling decisions made by Competent Authorities and bear all costs associated with traceability, recall, disposal, sampling, and enhanced monitoring testing when honey samples fail to meet food safety standards.

3. Honey Processing Enterprise

a) Organize and maintain hygienic conditions during honey processing according to certified food safety management systems;

b) Establish and maintain a traceability system, retain information for traceability purposes, and set up procedures for recalling honey that fails to meet food safety standards as stipulated in Circular No. 17/2021/TT-BNNPTNT;

c) Maintain a list of beekeeping facilities and honey purchasing enterprises supplying raw honey as specified in Appendix II attached to this Circular;

d) Disseminate and guide beekeeping facilities and honey purchasing enterprises within their system on beekeeping, honey harvesting, and procurement procedures ensuring hygiene and food safety, and enhance beekeepers' knowledge on disease prevention and veterinary drug usage;

đ) Retain complete quality management and food safety records; records must be kept for a minimum of three years;

e) Comply with inspection and supervision procedures as stipulated in this Circular and guidance from Inspection and Supervision Authorities to ensure food safety for honey. Provide complete information, records, and documents related to production processes upon request by the Inspection and Supervision Authority and be responsible for the accuracy of provided information and documents;

g) Strictly comply with violation handling decisions made by Competent Authorities and bear all costs associated with traceability, recall, disposal, sampling, and enhanced monitoring testing when honey samples fail to meet food safety standards.

Chapter IV

IMPLEMENTING PROVISIONS

Article 18. Effective Date

1. This Circular takes effect from December 10, 2022.

2. This Circular replaces Circular No. 08/2015/TT-BNN dated March 2, 2015, issued by the Minister of Agriculture and Rural Development, which regulates inspection and supervision of animal health and food safety for honey production and export.

3. Programs and plans for honey inspection and supervision approved before the effective date of this Circular shall continue to be implemented until December 31, 2022.

4. Certificates for participation in specialized training programs on inspection, evaluation, and sampling issued prior to the effective date of this Circular shall continue to be valid.

5. The Director of the Animal Health Department, heads of units, organizations, and individuals involved are responsible for implementing this Circular. Any difficulties or issues encountered during implementation should be reported to the Ministry of Agriculture and Rural Development (through the Animal Health Department) for review and amendment. /