Thông tư 08/2016/TT-BNNPTNT

CIRCULAR

ON FOOD SAFETY SUPERVISION OF AGRO-AQUA-FORESTRY PRODUCTS

Pursuant to the Government’s Decree No.199/2013/ND-CP defining functions, tasks, entitlements and organizational structure of the Ministry of Agriculture and Rural Development dated November 26, 2013;

Pursuant to the Law of Food safety ratified by the National Assembly of Vietnam on June 17, 2010 and the Government’s Decree No.38/2012/ND-CP detailing a numbers of articles of the Law on Food Safety dated April 25, 2012;

At request of the Director of the National Agro-aqua-forestry Quality Assurance Department, the Minister of Agriculture and Rural Development hereby introduces this Circular promulgating regulation on agro-aqua-forestry food safety supervision.

Chapter I

GENERAL PROVISIONS

Article 1. Scope

This Circular provides regulations on food safety supervision imposed on agro-aqua-forestry products (hereinafter referred to as “food safety supervision”) sold on the Vietnam's market within the administration of the Ministry of Agriculture and Rural Development; and responsibilities of relevant entities for the food safety supervision prior to distribution to consumers.

Article 2. Regulated entities

1. This Circular applies to cereals, meat, products made of meat; fisheries and fishery products, vegetables, fruits and their products; eggs and egg products; honey and products made from honey; salt; spices; sugar, tea, coffee, Cacao, pepper; cashew nuts and other agro products sold at:

a) Wholesale markets, agro-aqua-forestry markets (hereinafter referred to as “market”)

b) Bulk purchasing and distributing facilities and other facilities trading agro-qua-forestry products within the administration of the Ministry of Agriculture and Rural Development (hereinafter referred to as “business facility”)

2. This Circular shall not apply to agro-aqua-forestry products under the supervision by importing countries.

Article 3. Basis for food safety supervision

National technical regulations and standards related to food safety issued by the Ministry of Agriculture and Rural Development and Ministry of Health.

Article 4. Food safety authorities

Sub-Departments of Agro-Aqua-Forestry Quality Assurance or specialty authorities designated by Departments of Agriculture and Rural development of provinces where the Sub-Department of Agro-Aqua-Forestry Quality Assurance has not established (hereinafter referred to as “supervising authority”) shall be responsible for the safety of agro-aqua-forestry products sold on Vietnam’s market. 

Article 5.Food testing laboratories

Food testing laboratories specialized in testing and analyzing food samples are those certified by the Ministry of Agriculture and Rural Development (hereinafter referred to as “laboratory”).

Article 6. Requirements for sample collectors

Every sample collector shall:

1. Be qualified and specialized in related fields;

2. Obtain certificates of sampling or certificates of completion of training courses in agro-aqua-forestry product sampling for food safety testing.

Article 7. Scope and methods of supervision

The sample shall be randomly taken and assessed the conformity with national technical standards and regulations according to respective sets of criteria within a certain period of time.

Article 8. Funding for food safety supervision

Food safety supervision shall be funded according to the current State budget allocation. Estimates for food safety supervision shall be made in accordance with the Law on State budgets and guidance documents.

Chapter II

PROCEDURES FOR FOOD SAFETY SUPERVISION

Article 9. Preparation for sampling plans

The sampling plan includes:

1. Agro-aqua-forestry products undergoing the supervision;

2. Location of sampling;

3. Quantity of samples and analysis requirements;

4. Expected time for sampling;

5. Estimates for food safety supervision including costs of sampling, sample purchasing and analyzing.

Article 10. Criteria for identification of products needing undergoing food safety supervision

Any product shall undergo food safety supervision if:

1. It is warned by consumers, food safety authorities or competent authorities of importing countries;

2. It is found failing to meet requirements for food safety by previous food safety inspection or supervision;

3. It is a cause of mass food poisoning;

4. It is requested by the Ministry of Agriculture and Rural Development and Departments of Agriculture and Rural Development.

Article 11. Criteria for determination of sampling location

Sampling locations shall be:

1. Markets, local business facilities trading supervised products specified in Article 10 hereof; or

2. Places where the sample can be representative of the whole population and reveal the origin of products.

Article 12. Criteria for determination of sample quantity

The quantity of samples for foods safety supervision shall be determined according to:

1. Warnings by domestic State competent authorities or importing country’s competent authorities

2. Sampling methods prescribed in CODEX No.CAC/GL 33-1999;

3. At requested of the Ministry of Agriculture and Rural Development and Departments of Agriculture and Rural development.

Article 14. Date of sampling

Date of sampling may be a specific period of time in the year or may be determined at requests by the Ministry of Agriculture and Rural Development and Departments of Agriculture and Rural development.

Article 15. Approval for sampling plans

1. Every supervising authority shall submit their sampling plan to Departments of Agriculture and Rural development of the province in October of every year.

2. Departments of Agriculture and Rural Development shall assess and approve sampling plans not later than December of every year and notify supervising authorities and relevant agencies to execute their plan.

Article 16. Adjustments to sampling plans

According to the reality, supervising authorities may submit proposals for sampling plan adjustments (where necessary) to the Department of Agriculture and Rural Development of the province.

Article 17. Sampling

1. The supervising authority shall collect samples according to the sampling plan approved by the Department of Agriculture and Rural development of the province.

2. Food samples shall be stored and shall be tested according to specific requirements; the sample shall be taken for the initial testing and confirmation testing. The sampling shall be recorded in writing that is signed by sample collectors and representatives of the business facility.

3. The sample shall be sealed and encoded. The supervising authority shall have laboratories test such samples according to analysis requirements and categories.

4. Procedures for sampling, retention and transfer shall conform to the Annex to this Circular.

Article 18. Sample transfer

1. Representatives of supervising authorities and laboratories shall test and examine sample quantities, categories and testing criteria, transfer samples and make sample transfer records using the Annex hereof.

2. The laboratory has the right to refuse to receive samples which are attached with wrong identification tag or in pack or fail to satisfy storage requirements that may affect the analysis results. In this case, the supervising authority shall recall their samples.

Article 19. Testing and announcement of testing results

1. Every testing shall be carried out at laboratories specified Article 5 hereof.

2. Date of notification of testing results shall be negotiated by the laboratory and supervising authority that submits the sample.

3. The supervising authority shall submit the aggregate testing results to the Department of Agriculture and Rural Development of the province periodically or at request. In case of failure to pass the test, the business facility shall be dealt with in accordance with Article 19 hereof.

4. Departments of Agriculture and Rural Development shall publish testing results on their website.

Article 20. Handling of violations after testing

After the testing result is announced, every supervising authority shall:

1. Send a written notice of testing results and request the business facility having unsafe products to trace such unsafe product origin and recall all unsafe products, investigate causes of failure of safety and apply remedial measures for mitigating consequences and report them to the supervising authority. The tracing of unsafe product recall shall conform to the Circular No.03/2011/TT-BNNPTNT on unsafe aquatic product tracing dated January 21, 2011 by the Ministry of Agriculture and Rural Development and Circular No.74/2011/TT-BNNPTNT on tracing, recall and handling of unsafe food dated October 31, 2011 by the Ministry of Agriculture and Rural Development.

2. Submit written notification of testing results to local competent authorities assigned to take charge of food safety supervision.

3. Submit a written request for handling of violations against the Law on Inspection to specialized inspecting authorities in case the business facility delays to submit their report on investigation and mitigation of unsafe product consequences.

4. Report the Department of Agriculture and Rural development of provinces in case the unsafe sample is imported.

Chapter III

RESPONSIBILITIES OF RELEVANT ENTITIES

Article 21. Responsibilities of National Agro – Aqua-Forestry Quality Assurance Department

1. Submit reports on food safety supervision to the Ministry of Agriculture and Rural Development annually, periodically or irregularly at request of the Ministry of Agriculture and Rural Development ; take charge of and submit proposals for amendments to this Circular.

2. Cooperate with specialty authorities to provide training courses in food safety supervision for supervising authorities.

3. Introduce procedures for sampling, storage and transfer of samples.

4. Annually or irregularly inspect the compliance with this Circular by supervising authorities.

Article 21. Responsibilities of the Directorate of Fisheries, Plant Protection Department, Department of Livestock Production and Department of Animal Health
The Directorate of Fisheries, Plant Protection Department, Department of Livestock Production and Department of Animal Health shall:

1. Direct affiliated authorities of provinces to cooperate with supervising authorities to process the sample testing results.

2. Cooperate with the National Agro-Aqua-Forestry Quality Assurance Department to provide instructions for entities within their administration.

Article 22. Responsibilities of Departments of Agriculture and Rural Development
Every Department of Agriculture and Rural Development shall:

1. Inspect and provide instructions on the implementation of this Circular within their province.

2. Aggregate and approve the annual sampling plans of supervising authorities.

3. Direct affiliates to execute quality control measures, inspect and tackle violations against food safety in accordance with regulation of laws.

4. Cooperate with relevant authorities to instruct propagate and provide training courses in food safety for entities within their administration.

5. Periodically submit report on food safety supervision in December of very year or irregularly submit such reports at request of the Ministry of Agriculture and Rural Development (National Agro – Aqua - Forestry Quality Assurance Department).

Article 23. Responsibilities of supervising authorities

Every supervising authority shall:

1. Take charge of preparing sampling plans and submitting them to the Department of Agriculture of Rural Development and execute the approved sampling plan under provisions hereof.

2. Provide instruction on application of this Circular or facilities producing and trading agro-aqua-forestry products and Boards of Market Control.

3. Keep all documents and data related to food safety supervision and ensure the accountability for issues in connection with food safety supervision at request of Departments of Agriculture and Rural development or the National Agro – Aqua - Forestry Quality Assurance Department.

4. Pay for samples and testing

5. Monthly and annually submit reports on food safety supervision to the National Agro – Aqua-Forestry Quality Assurance Department and Department of Agriculture and Rural development of the province; propose amendments to sampling plans, where necessary.

6. Cooperate with National Agro – Aqua-Forestry Quality Assurance Department to provide training courses in food safety inspection.

Article 24. Responsibilities of laboratories

Every laboratory shall:

1. Take responsibilities for and ensure the accuracy and objectivity of testing results

2. Notify testing results to supervising authorities within the period agreed by both parties.

Article 25. Responsibilities of business facilities and Boards of Market Control

Every business facility and Board of Market Control shall:

1. Facilitate the sampling and provide all required information at requests by supervising authorities.

2. Comply with food safety supervision regulations, trace unsafe product origins and identify causes of unsafe products; apply remedial measures, recall all unsafe product and report remedial results to the supervising authority

3. Introduce internal regulations which define responsibilities of peoples in markets in general and responsibilities of traders for the compliance with food safety regulations.

Chapter IV

IMPLEMENTATION

Article 26. Entry into force

1. This Circular enters into force from July 15, 2016.

2. This Circular replaces the Circular No.05/2010/TT-BNNPTNT on guidance on the supervision and inspection of agro products before being sold on the market dated January 22, 2010 by the Minister of Agriculture and Rural Development and Circular No.61/2012/TT-BNNPTNT on aqua product safety supervision dated November 13, 2012 by the Minister of Agriculture and Rural Development.

Article 27. Amendments

The National Agro - Forestry - Fisheries Quality Assurance Department shall report difficulties and issues arising in connection with the application of this Circular to the Ministry of Agriculture and Rural Development.

ATTACHMENT

PROCEDURES FOR SAMPLING, STORAGE AND TRANSFER OF AGRO-AQUA-FORESTRY SAMPLES FOR FOOD SAFETY SUPERVISION
(Issued together with the Circular No.08/TT-BNNPTNT dated June 01, 2016 by the Minister of Agriculture and Rural Development)

1. Interpretation

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

Sampling is a technique for collection of food samples for food safety supervision.

1.2 Shipment means a certain quantity of goods provided by the same supplier at the same time.

1.3. Sample unit means the smallest separate part of a shipment forming part or whole of an initial sample.

1.4. Innitial sample means one or more sample units from the same position or pack of a shipment.

1.5. Bulk sample means a sample that is created by gathering all initial samples.

1.6. Laboratory sample means part of combined sample tested by the laboratory.

2. Rules for sampling:

Sampling shall conform to the following rules:

2.1. The purpose, scope and objects to be sampled shall be determined prior to sampling.

2.2. All samples shall be randomly taken and shall be representative of its population.

2.3. Sample shall be pure and clean.

2.4. Samples shall satisfy all analysis requirements

2.5. Samples shall be sealed, stored and transported in proper conditions.

2.6. Information on samples shall be fully recorded.

2.7. For small-packed products with the weight of not exceeding that of laboratory samples, the whole pack shall be sampled and considered as a sample unit.

2.8. For packed products, the sample shall be within its shelf-life.

3. Sampling requirements

3.1 Requirements for sampling devices and sample containers:
Every sampling device and sample container shall:

3.1.1. Have proper specifications and have been properly calibrated;

3.1.2. Do not affect samples

3.1.3. Be clean, dry and be made of proper materials. In case of microbiological analysis, such tools shall be sterilized.

3.1.4. Be dry, clean, closed and suitable with the sample weight, characteristics and storage conditions.

3.1.5. Be carefully prepared to ensure that 01 tool kits shall be used for only 01 sample.

3.2 Other sampling requirements

3.2.1. Wear sterile clothes to limit risks of infection

3.2.2. Wear sterile gloves prior to sampling. Change different gloves for different samples that may contain risk of cross-contamination.

3.2.3. Prevent risks of cross-infection In case of sampling for microbiological analysis: It is noticeable that sterile devices and gloves must not be in direct contact with objects other than sampled products. One tool kit shall be used for sampling only one different sample. Plastic bags for containing samples shall be sealed to prevent samples from falling out from the bags or being infected during the transport.

3.2.4. Be ready for sampling

3.2.5. Limit impact on sampled shipment quality

3.2.6. Pack all samples at places where the sample is collected.

3.2.7. Have samples labeled, sealed and recorded at places where such sample is collected.

3.2.8. Follow technical processes for sampling

4. Preparation for on-site-sampling plans
4.1. Identify business facilities for sampling:

4.1.1. Prepare lists of business facilities, sampled products and suppliers (including name of sampled products, amount of food monthly supplied, and origin)

4.1.2. Select business facilities on the list of business facilities for sampling according to the following aspects:

a) Whether the product is truly representative of its geographical indication, production scale, product suppliers/distributors

b) The weight of products

4.1.3. Randomly select one or more business facilities on the list for sampling or sampling in rotation for following supervisions in case such business facilities trading the same -origin product in the same weight.

4.1.4. Collect one laboratory sample from only one business facility to ensure the uniformity of samples. The number of selected business facilities shall not exceed the quantity of required samples.

4.2. Estimate the quantity of required samples taken from each selected business facilities.

The quantity of required samples taken from each selected business facilities shall be determined according the approved sampling plan and number of selected business facilities specified in item 4.1.

4.3. Determine time for sampling

4.3.1. Date of sampling:
The date of sampling shall be great-demand days (such as holidays, Tet holidays, etc. according to the local custom).

4.3.2. Time for sampling

a) In case of sampling for microbiological analysis, samples shall be taken at trading [peak hours of markets.

b) In case of sampling for chemical analysis (analyzing pesticide/growth stimulant/antibiotics residues): Samples shall be taken at the time of input to ensure the accuracy of sample origin.

5. Sampling procedures

5.1. Preparation for sampling

5.2. Sampling:

5.2.1. Fresh vegetable sampling for pesticide residue analysis

5.2.1.1. Step 1: Preparing for sampling

5.2.1.2. Step 2: Positioning sample units

According to the approved sampling plan, the sample collector shall position sample units as follows:

a) Determine shipments for sampling: The sample collector shall request the business facility to provide information necessary for identifying shipment origin and size.

b) Sample units may be taken from the top, bottom or middle of the shipment.

5.2.1.3. Step 3. Collecting sample units, initial samples, bulk samples and laboratory samples.

a) Prior to sampling, the sample collector shall fill the sample identification tag and stick it to PE plastic bag, and wear their sterile disposable gloves.

b) Sample units and initial samples shall be taken as follows:

b1) In case of stacked fresh vegetables: take at least 03 sample units from each stack to create initial samples and bulk samples. The bulk sample weight shall double that of laboratory sample.

b1) In case of vegetables and fruit packed with PE plastic bags: randomly taken according to the below table:

c) Create laboratory samples:

After getting bulk samples, the sample collector shall mix all products and portion the mixture out to be laboratory samples. A laboratory sample of ipomoea aquatic and cabbage shall be 01kg and 02 kg in weight, respectively.

5.2.2. Rice sampling for pesticide residue analysis

5.2.2.1. Step 1: Preparing for sampling

5.2.2.2. Step 2: Positioning sample units

According to the approved sampling plan, the sample collector shall position sample units as follows:

a) Determine shipments for sampling: The sample collector shall request the business facility to provide information necessary for identifying shipment origin and size, select rice bags for sample units.

b) Sample units may be taken from the top, bottom or middle of the rice bag.

5.2.2.3. Step 3. Taking sample units, initial samples, bulk samples and laboratory samples.

a) Prior to sampling, the sample collector shall fill the sample identification tag and stick it to PE plastic bag, and wear their sterile disposable gloves.

b) The sample collector shall take rice sample units from different parts of a rice bag at a certain quantity with sampling stick:

c) Create laboratory samples:

All initial samples shall be mixed and divided into four equal portions as follows:

-Put rice into cone-shaped devices

-Level the rice heap

-Divide the rice heap into 04 equal portions

-Mix 02 portions with each other, and keep doing this until we get the required amount of sample. The laboratory sample shall be at least 01 kg in weight

5.2.3. Sampling of cashew nuts for mycotoxin analysis (Aflatoxin B1, B2, G1, G2)

5.2.3.1. Step 1: Preparing for sampling

5.2.3.2. Step 2: Positioning sample units

According to the approved sampling plan, the sample collector shall position sample units as follows:

a) Determine shipments for sampling: The sample collector shall request the business facility to provide information necessary for identifying shipment origin and size, select bags for sample units.

b) Sample units:

b1) Every cashew nut pack that are lighter than the laboratory sample shall be considered as sample unit.

b1) Where the weight of a cashew nut pack is greater than that of the laboratory sample, the sample unit shall be taken from 03 deterrent positions of the pack.

5.2.3.3. Step 3. Collecting sample units, initial samples, bulk samples and laboratory samples.

a) Prior to sampling, the sample collector shall fill the sample identification tag and stick it to PE plastic bag, and wear their sterile disposable gloves.

b) The quantity of sampled packs is determined according to the shipment size as presented in the table below:

c) For initial samples: In case the weight of cashew nut pack is greater than that of required laboratory sample, the sample collector shall put such cashew nuts into a clean plane, then, mix and level such cashew nuts, select initial samples at 03 different positions thereafter.

d) Bulk samples shall be made up by mixing initial samples. The bulk sample shall be at least 03 kg in weight.

dd) The laboratory sample shall be made up by taking 02 opposite portions from 04 equal portions of the bulk sample divided by diagonal method.

5.2.4. Sampling of chicken and pork for microbiological and hormone residue analysis

5.2.4.1. Step 1: Preparing for sampling

5.2.4.2. Step 2: Positioning sample units

According to the approved sampling plan, the sample collector shall position sample units as follows:

a) Determine shipments for sampling: The sample collector shall request the business facility to provide information necessary for identifying shipment origin and size, select shipments for sample units.

b) Positioning sample units

5.2.4.3. Step 3. Collecting sample units, initial samples, bulk samples and laboratory samples.

a) Prior to sampling, the sample collector shall fill the sample identification tag and stick it to PE plastic bag, and wear their sterile disposable gloves.

b) The samples shall be taken as follows:

c) In case the whole chicken is packed, the pack of chicken shall be taken as sample.

d) The weight laboratory samples shall be as follows:

5.2.5. Sampling of fresh/ frozen fisheries for microbiological and antibiotics residue analysis

5.2.5.1. Step 1: Preparing for sampling

5.2.5.2. Step 2: Collecting sample units

According to the approved sampling plan, the sample collector shall position sample units as follows:

a) Determine shipments for sampling: The sample collector shall request the business facility to provide information necessary for identifying shipment origin and size, select shipment for sample units.

b) Each individual shall be considered a sample unit. The quantity of sample units is presented as follows:

5.2.5.3. Step 3. Collecting sample units, initial samples, bulk samples and laboratory samples.

a) Prior to sampling, the sample collector shall fill the sample identification tag and stick it to PE plastic bag, and wear their sterile disposable gloves, wash their hands with 70-degree alcohol. Note: Each sterile disposable gloves and sampling device shall be used once.

c) For fresh fishes: The sample collector shall catch each fish individual with racket, put aside for approximately 0.5 -1 minute before put it into a PE plastic bag; keep doing this until the laboratory sample is taken as required. Each PE plastic bag contain one or more sample units (01 or more individuals) that are considered as initial samples, bulk samples and laboratory samples as well.

d) For fresh/frozen fisheries: Initial samples shall be taken from trays as follows:

Each sample is considered as an initial sample, bulk sample and laboratory sample and is directly put into a PE plastic bag.

5.3. Sample labeling and seal

5.3.1. Put laboratory samples into PE plastic bags (except where the fishery sample is already in PE plastic bag)

5.3.2. Fasten/tape/staple PE plastic bag mouth.

5.3.3. Fill the sample identification tag (form 1) and sealing tag (form 2).

5.3.4. Stick a sealing tag to the PE plastic bag mouth

(note: the sealing tag shall not cover the sample identification tag).

5.3.5. Cover sealing tags with duct tape to ensure that the sealing tag will be torn with the tape.

5.3.6. Put all samples in sample containers to ensure the sample characteristics remained unchanged.

5.3.7. Clean sampling areas after sampling.

5.4. Sample storage

5.4.1. For samples required to be kept frozen or chilled (meat, fisheries and fresh vegetables): Put blocks of ice into the bottom and surroundings of sample containers having ice packs and carefully put samples into thereafter to keep samples from damage during the transport.

Cover samples with an ice layer before capping.

Note: Do not put samples in direct contact with blocks of ice.

5.4.2. For samples required to be stored in normal conditions (rice, cashew nuts): Put packed and sealed samples into sample containers.

5.4.3. Seal the sample container with tape; stick a sample identification tag to the sample container (where necessary or if such sample is transported to a laboratory).

5.4.4. Store samples for microbiological analysis under current technical regulations and standards by the Ministry of Health and Ministry of Agriculture and rural Development.

5.5. Sampling records

Every sample collector shall complete sampling records using the form No.3.

5.6. Transport of samples to laboratories

Samples shall be promptly transported to laboratories and shall be stored in proper conditions during the transport to ensure the samples are saved from damage that may affect the analysis results.

5.7. Sample transfer

Both sample transferors and recipients shall examine sample conditions, characteristics, information and analysis requirements prior to undertaking of samples and signature of sample records at the laboratory.

FORM 1: SAMPLE INDENTICATION TAG

FORM 2: SEALING TAG
(Fan stamped by supervisory authorities)

FORM 3: SAMPLING RECORD

SAMPLING RECORD

No. /BB-…

Name of business facility whose sample is taken (hereinafter referred to as “business facility”):

.........................................................................................................................................

Location of sampling:

..........................................................................................................................................

Sample collector (full name, title, organization):

..........................................................................................................................................

.........................................................................................................................................

Representative(s) of business facility
(Full name, title, organization)

.........................................................................................................................................

.........................................................................................................................................

This record is made in 02 copies having equal effect and kept by both parties.

FORM 4. SAMPLE TRANSFER RECORD

SAMPLE TRANSFER RECORD

No. /BB-…

This record is made as of........................ [date] at......................by Representatives of the supervising authority:

.........................................................................................................................................

..........................................................................................................................................

And
Representative of the laboratory:

....................................................................................................................................

..........................................................................................................................................

Note:

..........................................................................................................................................

..........................................................................................................................................

Enclosed documents:

...........................................................................................................................................

..........................................................................................................................................