THE MINISTRY OF AGRICULTURE AND RURAL DEVELOPMENT --------------- No. 28/2019/TT-BNNPTNT | THE SOCIALIST REPUBLIC OF VIETNAM Independence – Freedom – Happiness -------------- Hanoi, December 31, 2019 |
CIRCULAR
On technical requirements for testing banned chemicals and antibiotics in aqua feed
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Pursuant to the Government s Decree No. 15/2017/ND-CP of February 17, 2017 defining the functions, tasks, powers and organizational structure of the Ministry of Agriculture and Rural Development;
Pursuant to the Law on Food Safety June 17, 2010;
Pursuant to the Government s Decree No. 15/2018/ND-CP dated February 2, 2018, detailing a number of articles of the Law on Food Safety;
At the proposal of the Director of Agro-Forestry-Fisheries Quality Assurance Department,
The Minister of Agriculture and Rural Development promulgates the Circular providing technical requirements for testing banned chemicals and antibiotics in aqua feed.
Chapter I
GENERAL PROVISIONS
Article 1. Scope of regulation
1. This Circular provides technical requirements for testing for some indicators of chemicals and antibiotics that are banned from being used in aqua feed with prescribed minimum required performance levels (MRPL) under the management of the Ministry of Agriculture and Rural Development.
2. Exported aqua feed shall conform to domestic regulations of importing countries and not be governed by this Circular.
Article 2. Subjects of application
1. Food testing laboratories in service of the state management, which are designated by Ministry of Agriculture and Rural Development and qualified to test for chemical and antibiotic indicators in aqua feed according to the Joint Circular No. 20/2013/TTLT-BYT-BCT-BNNPTNT dated August 01, 2013, defining requirements, order and procedures for appointing food testing laboratories in service of the state management (hereinafter referred to as “testing laboratories”). Regulatory authorities, organizations and individuals involved in the testing for aqua feed, and regulatory authorities in charge of aqua feed safety.
2. Organizations and individuals producing and/or trading aqua feed.
Article 3. Interpretation of terms
In this Circular, the terms below are construed as follows:
1.β errormeans the probability that the tested sample is truly non-compliant even though a compliant measurement has been obtained.
2.Detection capability (CCβ)means the smallest content of the substance that may be detected, identified and/or quantified in a sample with a β error. In the case of substances with no permitted limit, the detection capability is the lowest concentration at which a method is able to detect truly contaminated samples with a statistical certainty of 1 – β.
3.Minimum required performance limit (MRPL)means the minimum content of a substance, which need to be determined and confirmed in the test sample. It is intended to harmonize the analytical performance of methods for substances for which no permitted limit has been established.
Chapter II
TECHNICAL REQUIREMENTS FOR TESTING
BANNED CHEMICALS AND ANTIBIOTICS IN AQUA FEED
Article 4. MRPL levels and CCβ values for some banned chemicals and antibiotics in aqua feed
1. The MRPL levels for some banned chemicals and antibiotics in aqua feed are specified in the Appendix issued together with this Circular.
2. The CCβ value for a banned chemical and antibiotic in aqua feed must be less than or equal to (<) the corresponding MRPL value as specified in the Appendix issued together with this Circular.
Article 5. Requirements for testing laboratories
1. Satisfying the requirements for testing laboratories defined in Articles 4 and 5 of the Joint Circular No. 20/2013/TTLT-BYT-BCT-BNNPTNT dated August 01, 2013, providing requirements, order and procedures for appointing food testing laboratories in service of the state management.
2. Determining CCβ values of testing methods according to Section 3.1.2.6 of the Appendix issued together with the Decision No. 2002/657/EC dated August 17, 2002 of the European Commission and the announcement of CCβ values for banned chemicals and antibiotics in corresponding test reports.
3. Being assessed and designated by a competent authority to perform testing for some banned chemicals and antibiotics in aqua feed with established permitted MRPLs in order to serve the performance of food safety management tasks by the Ministry of Agriculture and Rural Development as prescribed in this Circular.
Article 6. Announcement of test results and measures to handling aqua feed
Testing laboratories shall announce test results by using the form of test report provided in Appendix 3 of the Joint Circular No. 20/2013/TTLT-BYT-BCT-BNNPTNT dated August 1, 2013 and take measures to handle aqua feed according to 3 circumstances as follows:
1. In case the test value for banned chemicals and antibiotics for a consignment is lower than (<) the CCβ value, the testing laboratory shall announce the result of “no detection”, and organizations and individuals producing and/or trading aqua feed shall be allowed to sell the consignment on the market.
2. In case the test value for banned chemicals and antibiotics for a consignment is higher than or equal to (≥) the CCβ value but smaller than (<) the MRP, the testing laboratory shall announce the result of “higher than or equal to the CCβ value but smaller than the MRPL”, and organizations and individuals producing and/or trading aqua feed shall be allowed to sell the consignment on the market and must keep all documents about the consignment.
If an organization or individual having 04 consignments that have the result of “higher than or equal to the CCβ value but smaller than the MRPL” within a period of 06 consecutive months for the same type of aqua feed product and testing indicator, such organization or individual must conduct a thorough review of the entire food safety control system to find out appropriate remedial measures against non-compliant contents (if any).
3. In case the test value for banned chemicals and antibiotics for a consignment is higher than or equal (≥) the MRPL, the testing laboratory shall announce the result of “exceeding the MRPL”, organizations and individuals producing and trading the consignment must trace the origin of feed, and recall as well as handle any unqualified aqua feed consignments as prescribed in Articles 54 and 55 of the Law on Food Safety.
Chapter III
RESPONSIBILITIES OF RELEVANT PARTIES
Article 7. Responsibilities of testing laboratories
1. Ensuring the satisfaction of technical requirements for testing as prescribed in Article 5 of this Circular.
2. Ensuring the reliability and precision of test results and providing test results in accordance with Article 6 of this Circular.
3. Complying with regulations on periodical and ad-hoc reports and bearing the inspection of testing activities by regulatory authorities in charge of assessing and designating testing laboratories to serve state management tasks.
Article 8. Responsibilities of organizations and individuals producing and/or trading aqua feed
1. Taking measures to handle aqua feed in accordance with Article 6 of this Circular.
2. Keeping all documents about tested consignments of aqua feed, taking measures to handle aqua feed and submit reports thereof to food safety authorities as requested. Retention period of documents must be conformable with the expiry date of each type of aqua feed as prescribed in the national technical regulation QCVN 02-02:2009/BNNPTNT on Aqua Feed Business Operators and HACCP-based Program for Quality and Safety Assurance.
Article 9. Responsibilities of regulatory authorities in charge of assessing and designating testing laboratories
1. Providing professional training and drilling courses for testing laboratories.
2. Updating regulations on MRPLs for banned chemicals and antibiotics in aqua feed according to this Circular.
3. Assessing and designating testing laboratories to perform testing for banned chemicals and antibiotics in aqua feed with permitted MRPLs.
Article 10. Responsibilities of food safety authorities
Regulatory authorities shall examine the compliance by organizations and individuals producing and/or trading aqua feed with provisions in Article 6 of this Circular when carrying out inspections, and the satisfaction of food safety conditions as prescribed.
Chapter IV
IMPLEMENTATION PROVISIONS
Article 11. Effect
1. This Circular takes effect on February 13, 2020.
2. Difficulties that arise during the implementation of this Circular should be reported to the Ministry of Agriculture and Rural Development for consideration./.
For The Minister
The Deputy Minister
Phung Duc Tien