Circular No. 13/2010/TT-BYT guiding the management of rapid food testing kits

CIRCULAR

Guidelines for Managing Rapid Food Testing Kits

Based on the Food Safety Ordinance dated July 26, 2003;

Based on Decree No. 163/2004/NĐ-CP dated September 7, 2004 of the Government detailing the implementation of certain provisions of the Food Safety Ordinance;

Based on Decree No. 188/2007/NĐ-CP dated December 27, 2007 of the Government stipulating the functions, tasks, powers, and organizational structure of the Ministry of Health;

The Ministry of Health provides guidelines for managing rapid food testing kits as follows:

This technical regulation sets out technical requirements, testing methods, sampling procedures; management requirements; responsibilities of organizations and individuals producing, trading, and importing cigarettes.

Article 1. Scope of Regulation

Article 1. This Circular specifies the procedures for evaluating, registering for circulation, advertising, labeling, and using rapid food testing kits.

Article 2. All rapid food testing kits produced domestically and imported from abroad into Vietnam (excluding temporarily imported goods for re-export) must be granted a certificate of registration and a registration number by the Ministry of Health before being circulated in Vietnam to test food safety indicators.

Article 2. Applicability

This Circular applies to enterprises producing, trading, importing, and distributing chemicals and testing equipment (hereinafter referred to as enterprises) that request to register for circulation of rapid food testing kits in Vietnam.

Article 3. Explanation of Terms

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

1. Rapid food testing kit includes pre-prepared tools, chemicals, or culture media sufficient to conduct tests for one or more specific food safety indicators, reducing the time required for results compared to standard testing methods.

2. Registration for Circulation is the process of implementing procedures as prescribed to assess the scientific validity, practicality, accuracy of the rapid testing kit, and the legality of the registration application file to permit circulation through issuing a registration certificate and registration number.

3. Testing Article 5. Requirements for examination

1. All rapid food testing kits must undergo examination in Vietnam before being registered for circulation on the Vietnamese market, except for those specified in Clause 2 of this Article.

Enterprises must pay fees and charges when registering for circulation of rapid food testing kits according to the regulations of the Minister of Finance.

II. EVALUATION OF RAPID FOOD TESTING KITS

Testing institutions meeting the conditions stipulated in Article 7 of this Circular may participate in conducting technical examinations of rapid food testing kits proposed by enterprises.

Clause 1. All rapid food testing kits must undergo evaluation in Vietnam before being registered for circulation on the Vietnamese market, except those specified in Clause 2 of this Article.

Clause 2. In cases where rapid food testing kits have been recognized by international organizations such as WHO, FAO, JECFA or countries with mutual recognition agreements with Vietnam, they may be allowed to circulate without further evaluation.

Article 6. Authorities Conducting Evaluations

All technical units meeting the conditions stipulated in Article 7 of this Circular may participate in conducting technical evaluations of rapid food testing kits proposed by enterprises.

Article 7. Conditions for Authorities Conducting Evaluations

Authorities conducting evaluations must meet the following conditions:

1. Having the function of food safety testing;

Clause 2. Possess a laboratory certified to comply with ISO/IEC 17025 standards in the field of food testing for the indicators to be evaluated.

Clause 3. Have adequate equipment and specialized staff to meet the requirements of the evaluation work.

Article 8. Procedures for conducting testing

Clause 1. The Ministry of Health (Food Safety Administration) annually publishes a list of technical units with the capability to evaluate the quality of rapid food testing kits for enterprises to choose for evaluation purposes.

Clause 2. Enterprises must bear all costs of evaluation in accordance with the law.

Clause 3. Enterprises submit a written request for review of evaluation results to the Ministry of Health (Food Safety Administration) along with the evaluation results from three (03) technical units chosen by the enterprise from the annual list published by the Ministry of Health as stipulated in Clause 1 of this Article.

Clause 4. After receiving complete files as prescribed in Article 10 of this Circular, the Food Safety Administration is responsible for establishing a specialized review board to assess the rapid food testing kit and advise the Director of the Food Safety Administration to consider and sign the registration certificate for circulation.

III. REGISTRATION FOR CIRCULATION OF RAPID FOOD TESTING KITS

Article 9. Forms of Registration for Circulation

1. Registration for circulation: enterprises submit application files in accordance with Clause 1 and Clause 2 of Article 10 of this Circular.

2. Registration for change and supplement:

a) For rapid food testing kits that have been granted registration certificates and such certificates are still valid, if there is a change or supplement to any registered content, it must be approved by the issuing authority.

b) When changing or supplementing any of the following contents, enterprises shall submit application files in accordance with Clause 1 and Clause 3 of Article 10 of this Circular; the issuing authority will consider retaining the original registration number and issue a new registration certificate:

- Change of the enterprise requesting registration;

- Changing the shelf life, storage conditions;

- Changing (adding) labeling information;

- Changing the name of the food rapid test kit;

- Changing the scope of application;

- Changing the detection limit;

- Changing (adding) usage instructions;

- Changing (adding) accuracy (or error) information;

- Change (supplement) of the structure of rapid food testing kits, packaging specifications.

c) When changing or supplementing any of the following registered contents, the procedure will be carried out as a new registration for circulation; enterprises shall submit application files in accordance with Clause 1 and Clause 2 of Article 10 of this Circular; the issuing authority will revoke the previously issued certificate and registration number and proceed with the new registration process for the certificate and registration number:

- Changing (adding) testing criteria;

- Changing the operating principle;

- Change in testing characteristics.

Article 10. Application Files for Registration for Circulation and Registration for Change and Supplement

1. Enterprises are responsible for submitting two sets of application files for registration for circulation (hereinafter referred to as "application file") to the issuing authority. Legal documents in the application file must be originals or certified copies, foreign language documents must be accompanied by certified translations into Vietnamese. The application file must include a list of documents.

2. Application files for registration for circulation of rapid food testing kits include:

a) Application form for registration for circulation of rapid food testing kits (Annex 1 promulgated together with this Circular);

b) Business registration certificate;

c) Research and testing documents related to rapid food testing kits;

d) User guide accompanying the rapid food testing kits;

đ) Reports on examination results from examination agencies;

e) Product labels of rapid food testing kits including direct labels on the smallest unit of packaging and indirect labels on outer packaging;

g) Certificate of trademark protection and certificate of intellectual property rights protection, manufacturer's power of attorney (if any);

h) Permit for circulation in the country of production or export issued by the competent authority of the home country (for imported rapid food testing kits);

i) Three (3) samples of rapid food testing kits proposed for registration for circulation.

3. Application files for changes and supplements to already registered contents for rapid food testing kits include:

a) Application form for changes to registration contents of rapid food testing kits (Annex 2 promulgated together with this Circular).

b) Documents related to the changes and supplements to the registered contents.

c) Three (3) samples of rapid food testing kits proposed for registration for circulation.

Article 11. Competence and Procedures for Issuing Certificates and Registration Numbers for Rapid Food Testing Kits

1. The Ministry of Health delegates the Food Safety Agency to review application files, issue certificates, and registration numbers for rapid food testing kits.

2. The Food Safety Agency is responsible for:

a) Receiving registration files;

b) Establishing a specialized expert committee to evaluate food rapid test kits:

- Evaluating and concluding on scientific basis and practicality, advising the Ministry of Health (Food Safety Agency) on the evaluation of rapid food testing kits;

- Proposing solutions for registering the circulation of food rapid test kits.

c) Based on the conclusions and recommendations of the Council, the Director of the Food Safety Agency will decide:

- To allow circulation: issue a registration certificate for circulation (Annex 3 promulgated together with this Circular), or issue a new certificate (in cases of change or supplement) for each rapid food testing kit;

- Requesting additional information and documents before permitting circulation: notifying the enterprise in writing, specifying the required additional information;

- Not permitting registration for circulation: notifying the enterprise in writing, stating the reasons for not permitting registration for circulation.

d) Time limit for responding to enterprises:

- Within thirty working days from the date of issuance of the receipt for the result of the application for registration for circulation;

- Within fifteen working days from the date of issuance of the receipt for the result of the application for change or supplement to the registration for circulation.

3. The registration certificate for circulation of rapid food testing kits has a validity period of five years from the date of signature. When the registration certificate for circulation expires, enterprises wishing to re-register for continued circulation in Vietnam must submit application files within three months before the expiration of the registration certificate for circulation. If an enterprise does not submit application files within six months after the expiration of the registration certificate for circulation, they must submit new application files when re-registering.

IV. BUSINESS, ADVERTISING, LABELING AND USE OF RAPID FOOD TESTING KITS

Article 12. Business of Food Rapid Test Kits

1. A business entity shall only be permitted to engage in the business of food rapid test kits after obtaining a registration certificate for circulation.

2. A business entity shall only be permitted to engage in the business of food rapid test kits according to the models and criteria registered.

3. A business entity shall be responsible for any harm caused by its food rapid test kits not meeting the registered criteria.

Article 13. Advertising of Food Rapid Test Kits

1. Enterprises are only permitted to advertise food rapid test kits after obtaining certificates of registration.

2. Advertisements for food rapid test kits must comply with the laws on advertising.

Article 14. Labeling of Food Rapid Test Kits

1. The product labels of food rapid test kits must comply with current laws on labeling of goods circulating domestically and goods for export and import.

2. In addition, the following mandatory information must be included on the label:

a) Registration number for circulation;

b) Safety precautions for circulation and use of food rapid test kits.

Article 15. Use of Food Rapid Test Kits in Food Safety Testing

Depending on the scope of application, food rapid test kits may be used in the following cases:

1. Supporting testing and inspection work for food safety. Results obtained from testing using food rapid test kits are preliminary results, serving only as a screening and guiding tool for subsequent confirmatory tests in laboratories. Such results shall not be used as a basis for handling violations;

2. Monitoring food safety during production, processing, and trading of food products;

3. Testing to assist consumers in selecting food.

Article 16. Suspension of Circulation

1. Food rapid test kits will be suspended from circulation by the registration authority's decision in case the business entity violates any of the following circumstances:

a) Modifying or supplementing contents as stipulated in Article 9 of this Circular without the management agency's consent;

b) Advertising information about food rapid test kits does not conform to the registered content;

c) Food rapid test kits circulating in the market do not match the samples or do not meet the characteristics as registered.

2. The registration authority shall issue a decision to suspend the circulation of food rapid test kits and announce it nationwide.

3. Upon receipt of the suspension decision, the enterprise shall be responsible for:

a) Promptly implement measures to recall food rapid test kits circulating in the market; at distributors; sold to customers;

b) Preparing a recall report;

c) Report the results of the recall to the management agency.

4. In cases of serious quality violations, the state management agency may consider revoking the registration for circulation.

5. The business entity shall bear all costs associated with recalling food rapid test kits.

V. IMPLEMENTATION PROVISIONS

Article 17. This Circular takes effect from July 1, 2010;

Decision No. 18/2007/QĐ-BYT dated February 27, 2007 of the Minister of Health on the management of rapid hygiene and safety food testing shall cease to be effective from the date this Circular takes effect.

Article 18. The Director of the Ministry of Health’s Office, the Director of the Department of Food Safety, the Director of the Ministry of Health’s Inspectorate, relevant units under the Ministry of Health, Directors of Health Departments of provinces and centrally-run cities, Health Services of sectors, and related agencies shall be responsible for implementing this Circular.