Circular No. 28/2019/TT-BNNPTNT stipulates technical requirements for testing prohibited chemicals and antibiotics in aquatic food products. This Circular applies to testing facilities, organizations and individuals producing and trading in aquatic food products, and state management agencies. The MRPL level is specifically defined for each type of chemical and antibiotic.
Đối tượng áp dụng
Aquatic food product testing facilities, organizations and individuals producing and trading in aquatic food products, state management agencies on food safety.
Các điểm cốt lõi
- Testing facilities must meet the requirements regarding conditions and determine the CCβ value for prohibited chemicals and antibiotics in aquatic food products.
- If the test result is lower than the CCβ value, the testing facility shall notify "not detected" and the organization or individual may circulate and consume the batch.
- If the test result is equal to or greater than the CCβ value but less than the MRPL, the testing facility shall notify "equal to or greater than the CCβ value and less than the MRPL value," and the organization or individual may circulate and consume the batch but must retain records.
- If the test result is equal to or greater than the MRPL, the testing facility shall notify "exceeding the MRPL threshold" and the organization or individual must trace the origin, recall, and handle non-compliant aquatic food products according to Articles 54 and 55 of the Food Safety Law.
- The MRPL level is specifically defined for each type of prohibited chemical and antibiotic: Chloramphenicol (0.3 µg/kg), Nitrofuran metabolites (1 µg/kg for each substance), total Malachite Green and Leuco-Malachite Green (2 µg/kg).
🌐 Tác động xã hội từ văn bản này
- Positive impact: Ensures the safety of aquatic food products, prevents the use of prohibited chemicals and antibiotics.
- Negative impact: Increases costs for testing facilities and organizations and individuals producing and trading in aquatic food products.
❓ Câu hỏi thường gặp
What requirements must testing facilities meet?
Testing facilities must meet the requirements regarding conditions as stipulated in Article 5 of Joint Circular No. 20/2013/TTLT-BYT-BCT-BNNPTNT and determine the CCβ value for prohibited chemicals and antibiotics in aquatic food products.
If the test results of prohibited chemicals and antibiotics in a batch are equal to or greater than the MRPL, what actions must organizations and individuals take?
The testing facility shall notify "exceeding the MRPL threshold" and organizations and individuals producing and trading in aquatic food products must trace the origin, recall, and handle non-compliant batches according to Articles 54 and 55 of the Food Safety Law.
For which chemicals is the MRPL level specifically defined?
The MRPL level is specifically defined for Chloramphenicol (0.3 µg/kg), Nitrofuran metabolites (1 µg/kg for each substance), and total Malachite Green and Leuco-Malachite Green (2 µg/kg).
How long must testing facilities retain records of test results?
The retention period for records is consistent with the shelf life of each type of product as specified in National Technical Regulation QCVN 02 - 02: 2009/BNNPTNT for Aquatic Food Product Production and Trading Enterprises - Quality Assurance and Food Safety Program based on HACCP principles.
When does this Circular take effect?
This Circular takes effect from February 13, 2020.
Toàn văn
|
MINISTRY OF AGRICULTURE AND RURAL DEVELOPMENT |
SOCIALIST REPUBLIC OF VIET NAM |
|
Number: 28/2019/TT-BNNPTNT |
Hanoi, December 31, 2019 |
CIRCULAR
REGULATIONS ON TECHNICAL REQUIREMENTS FOR TESTING PROHIBITED CHEMICALS AND ANTIBIOTICS IN AQUATIC FOOD PRODUCTS
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 dated June 17, 2010;
Pursuant to Decree No. 15/2018/NĐ-CP dated February 2, 2018 of the Government detailing implementation of certain provisions of the Food 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 to regulate technical requirements for testing prohibited chemicals and antibiotics in aquatic food products under the management of the Ministry of Agriculture and Rural Development.
PART I
GENERAL PROVISIONS
Article 1. Scope of Regulation
1. This Circular stipulates technical requirements for testing certain chemical and antibiotic indices prohibited in aquatic food products with specified Minimum Required Performance Limit (MRPL) under the management of the Ministry of Agriculture and Rural Development.
2. Exported aquatic food products shall comply with the regulations of the importing country and are not subject to the provisions of this Circular.
Article 2. Applicability
1. Testing facilities serving state management that are designated by the Ministry of Agriculture and Rural Development to have the capability to test certain chemical and antibiotic indices prohibited in aquatic food products in accordance with Circular Jointly Issued No. 20/2013/TTLT-BYT-BCT-BNNPTNT dated August 1, 2013 on conditions and procedures for designating testing facilities for state management (hereinafter referred to as testing facilities).
2. State management agencies, organizations, and individuals related to aquatic food product testing activities and state management agencies for aquatic food safety.
3. Organizations and individuals producing and trading in aquatic food products.
Article 3. Explanation of Terms
In this Circular, the following terms are understood as follows:
1. Beta error (β): is the probability that a sample actually does not meet the standard, even though the test result shows it meets the standard.
2. Detection Capability (CCβ): is the lowest concentration that can be detected, confirmed, and/or quantified of the substance to be determined in the sample with beta error. For substances without maximum permitted levels, detection capability is the lowest concentration that the method can reliably detect in contaminated samples with a confidence level of 1 - β.
3. Minimum Required Performance Limit (MRPL): is the lowest concentration that can be detected and confirmed of a substance to be determined in the sample. This parameter is set to harmonize the performance of testing methods for certain substances without specified maximum permitted levels.
Chapter II
TECHNICAL REQUIREMENTS FOR TESTING PROHIBITED CHEMICALS AND ANTIBIOTICS IN AQUATIC FOOD PRODUCTS
Article 4. MRPL Levels and CCβ Values for Certain Prohibited Chemicals and Antibiotics in Aquatic Food Products
1. MRPL levels for certain prohibited chemicals and antibiotics in aquatic food products are specified in the Appendix attached to this Circular.
2. The CCβ value for each prohibited chemical and antibiotic index in aquatic food products must be less than or equal to (≤) the corresponding MRPL value specified in the Appendix attached to this Circular.
Article 5. Requirements for Testing Facilities
1. Meet the requirements for testing facility conditions stipulated in Articles 4 and 5 of Circular Jointly Issued No. 20/2013/TTLT-BYT-BCT-BNNPTNT dated August 1, 2013 on conditions and procedures for designating testing facilities for state management.
2. Determine the CCβ value of the testing method according to Section 3.1.2.6 of the Appendix issued with Decision No. 2002/657/EC dated August 17, 2002 of the European Commission and publish the CCβ value for the prohibited chemical and antibiotic index in the corresponding test result report.
3. Be evaluated and designated by competent state authorities as a testing facility for certain prohibited chemical and antibiotic indices in aquatic food products with specified MRPL for state management of food safety by the Ministry of Agriculture and Rural Development in accordance with this Circular.
Article 6. Notification of Testing Results and Measures for Handling Aquatic Food Products
The testing facility shall notify the testing results in accordance with the Sample Testing Report form prescribed in Appendix 3 of Circular Joint Circular No. 20/2013/TTLT-BYT-BCT-BNNPTNT dated August 1, 2013, and corresponding measures based on the following three possibilities:
1. In case the testing results of prohibited chemicals and antibiotics in the batch are lower than (<) the CCβ value: the testing facility shall notify the result as "not detected"; organizations and individuals producing and trading aquatic food products are permitted to circulate and sell that batch in the market.
2. In case the testing results of prohibited chemicals and antibiotics in the batch are equal to or higher than (≥) the CCβ value but lower than (<) the MRPL value: the testing facility shall notify the result as "equal to or higher than the CCβ value and lower than the MRPL value"; organizations and individuals producing and trading aquatic food products are permitted to circulate and sell that batch in the market and must retain complete records of cases where the notification result is "equal to or higher than the CCβ value and lower than the MRPL value".
If an organization or individual has four batches of production notified with the result "equal to or higher than the CCβ value and lower than the MRPL value" within six consecutive months for the same type of aquatic product and testing criteria, such organization or individual must conduct a comprehensive review of their entire food safety management system to promptly take corrective actions and address any non-compliant contents (if any).
3. In case the testing results of prohibited chemicals and antibiotics in the batch are equal to or higher than (≥) the MRPL value: the testing facility shall notify the result as "exceeding the MRPL threshold"; organizations and individuals producing and trading the batch must trace the origin of the food and recall and handle batches that do not meet safety requirements according to Articles 54 and 55 of the Food Safety Law.
Chapter III
RESPONSIBILITIES OF THE RELATED PARTIES
Article 7. Responsibilities of Testing Facilities
1. Ensure technical testing requirements as stipulated in Article 5 of this Circular.
2. Ensure reliability and accuracy of testing results and notification of testing results as stipulated in Article 6 of this Circular.
3. Adhere to regular and ad hoc reporting systems and inspection and supervision mechanisms regarding testing activities of state management agencies responsible for evaluating and designating food testing facilities.
Article 8. Responsibilities of Organizations and Individuals Producing and Trading Aquatic Food Products
1. Implement handling measures for aquatic food products as prescribed in Article 6 of this Circular.
2. Retain complete records of cases where the testing facility has notified testing results and handling measures for aquatic food products, and report to the competent state agency for food safety when requested. The record retention period must comply with the shelf life of each type of product as specified in National Technical Regulation QCVN 02 - 02: 2009/BNNPTNT for Aquatic Food Production and Trading Enterprises - Quality Assurance and Food Safety Program according to HACCP principles.
Article 9. Responsibilities of State Management Agencies for Evaluation and Designation of Testing Facilities
1. Organize professional training for testing facilities.
2. Update the MRPL levels for prohibited chemicals and antibiotics in aquatic food products as prescribed in this Circular.
3. Evaluate and designate testing facilities for chemical and antibiotic criteria in aquatic food products that have been assigned MRPL values.
Article 10. Responsibilities of State Management Agencies for Food Safety
State agencies shall be responsible for reviewing the implementation by organizations and individuals engaged in the production and business of aquatic food products as stipulated in Article 6 of this Circular during inspection, examination, and assessment of conditions to ensure food safety in accordance with current regulations.
Chapter IV
IMPLEMENTING PROVISIONS
Article 11. Effective Date
1. This Circular shall take effect from February 13, 2020.
2. During the implementation of this Circular, if there are difficulties or obstacles, agencies, organizations, and individuals shall report to the Ministry of Agriculture and Rural Development for consolidation and consideration of amendments and supplements./.
|
Place of Receipt: |
DEPUTY MINISTER |
ANNEX
MAXIMUM RESIDUE LIMITS FOR CERTAIN CHEMICALS AND ANTIBIOTICS PROHIBITED IN AQUATIC FOOD PRODUCTS
(issued together with Circular No. 28/2019/TT-BNNPTNT dated December 31, 2019 of the Minister of Agriculture and Rural Development)
|
No. |
Name of Chemicals, Antibiotics |
Maximum Residue Limit (MRPL) |
|
1 |
Chloramphenicol |
0.3 µg/kg |
|
2 |
Metabolites of Nitrofuran (including: Nitrofurazon, Nitrofurantoin, Furazolidone, Furaltadon) |
1 µg/kg for each substance |
|
3 |
Total Malachite Green, Leuco-Malachite Green |
2 µg/kg |
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