Circular 11/2014/tt-Byt: Regulations Manager Fast Food Tests

Original Language Title: Thông tư 11/2014/TT-BYT: Quy định quản lý bộ xét nghiệm nhanh thực phẩm

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The CIRCULAR regulates the management of fast food tests _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ pursuant to the law on food safety, June 17, 2010;
Pursuant to Decree No. 38/2012/ND-CP dated 25 April 2012 of the Government detailing the implementation of a number of articles of the law on food safety;
Pursuant to Decree No. 63/2012/ND-CP on August 31, 2012 of the Government functions, tasks, powers and organizational structure of the Ministry of health;
At the suggestion of the Director of food safety;
The Minister of Health issued a circular regulating the management of fast food tests.
Chapter I GENERAL PROVISIONS article 1. Scope of regulations this circular assay, registering circulation, advertising, labeling and use the fast food tests.
Article 2. The object that applies to this circular apply to producers, trading, import, distribute chemicals, laboratory equipment (hereinafter enterprise) suggest that circulation of the register tests fast food in Vietnam.
Article 3. Explanation of terms In this circular, the terms below are interpreted as follows: 1. The fast food tests including tools, chemicals or the environment is prepared, the sync is eligible to test one or more indicators for food safety plan , shorten the time for results compared to standard testing methods.
2. Register the circulation process is done the prescribed procedure to verify its scientific, practical, the accuracy of the tests quickly and the legality of the proposed registration records to allow circulation by the grant of the certificate of registration.
3. assay is the experimental process to demonstrate the characteristics of the rapid tests on real food.
Article 4. Registration fees floated the quick tests of food business must file charges and fees when registering circulating the fast food tests as specified in circular No. 149/2013/TT-BTC dated 29 October 2013 of the Minister of finance salary rules, submission, management and use of fees management fees, food hygiene safety.
Chapter II the ASSAY TESTS FAST FOOD article 5. Assay requirements 1. The set of fast food tests before registered in circulation on the market to Vietnam through Vietnam, except at the assay the fast food tests prescribed in paragraph 2 of this Article.
2. The case of the fast-food testing kit has been the international organization, the WHO, the FAO, JECFA, AOAC, ISO acknowledges or countries have recognized protocol, acknowledge each other with Vietnam has allowed circulation not assay.
Article 6. The basis to conduct the assay test facilities meet all the conditions specified in article 7 of this circular shall be engaged to conduct technical assay rapid test kits for food due to the proposed business.
Article 7. Conditions for conducting base base conducted assay the assay must meet the following conditions: 1. Functional testing food safety and hygiene;
2. Have a recognized test standards according to ISO/IEC 17025 standard, the field was recognized there for food tests the norms need assay; or the specified test is the basis for testing food served in State management as specified in circular No. 01/2013/TTLT-BYT-BCT-BNNPTNT October 1, 2013 of Health Minister-Minister of industry and Trade-Minister of agriculture and rural development regulation conditions procedure sequence, specify the base testing food served in State management, the specified areas have food tests for indicators need assay.
Article 8. Procedure to conduct the assay 1. Every year, food safety Bureau announced the list of the test facility has sufficient capacity to appraise the quality of the food faster tests for businesses choosing to assay.
2. send business documents suggest considering results assay on food safety Bureau accompanied the results of assay testing basis 3rd by enterprises in the list of test facilities that are food safety Bureau announced annually as prescribed in paragraph 1 of this article.
3. after receiving enough profile as defined in article 11 of this circular, the Department responsible for food safety established the Council of professional appraisal reviews the rapid tests foods to advise Director food safety review and sign the certificate of registration.
4. enterprises should bear the entire cost of the assay according to the provisions of the law.
Chapter III REGISTRATION of CIRCULATING the FAST FOOD article 9 TESTS. Subscribe to circulate the fast food tests all the fast food tests originating domestic production and foreign production imported to Vietnam (not including temporary re-export import goods) shall be the Ministry of Health issued a certificate of registration issued prior to circulating in Vietnam to test evaluation norms of hygiene and food safety.
Model registration certificates in circulation the fast food tests prescribed in annex 1 attached to this circular.
Article 10. Registration forms circulating the fast food testing 1. Subscribe to circulate the fast food testing business proposal submission prescribed in clause 1 of article 11 of this circular.
2. Register the circulation changes, additional sets of fast food examination a) rapid test kits for food have been certificated registered circulation, within the circulation registration certificate is valid, if changed, adding one of the registered content must be approved in writing by the authority to grant registration;
b) When changing, adding one of the following content, the submission of business proposals according to the provisions in paragraph 2 of article 11 of this circular; the registration authorities shall consider the registration certificate kept in circulation were:-to change the time limit for use, the conditions of preservation;
-Change the (additional) labeling content;
-Change the application scope;
-Change detection limits;
-Change the (additional) instructions for use;
-Change the information about exact speed (or error);
-Change the (additional) packing.
c) When changing, adding one of the following registered content, then the procedure is performed as register circulation:-change the (additional) test criteria;
-Change the active principle;
-Change the nature of tests;
-Change the name of the fast tests;
-Change the suggested business register.
Business proposal submission prescribed in clause 1 of article 11 of this circular; registration authorities revoked the registration certificates in circulation was issued.
3. Renewal of registration of circulating the fast food tests during the 12 months before the circulation registration certificates expire, if businesses want to continue registering circulating in Vietnam, the renewed proposal submission prescribed in paragraph 3 article 11 of this circular.
After the time limit on, businesses have not yet completed the renewal procedure is filing registration proposal floated under the provisions of paragraph 1 of article 11 of this circular.
Sample of renewal of the certificate of registration issued the fast food tests prescribed in Appendix 2 attached to this circular.
Article 11. Records suggest the circulation registration fast food testing 1. Records suggest the circulation registration quick tests of food businesses are responsible for submission of 1 proposal registration record (the records must have a category attached document) for food safety Bureau, records include: a) petition the register floated the fast food tests according to the form prescribed in Appendix 3 attached to this circular;
b) certified copies of business registration certificate;
c) The study materials, testing related to the fast food tests; case documents in a foreign language must be accompanied by a Vietnamese translation (of business);
d) instructions for use the quick tests of food; the case of the manual in a foreign language must be accompanied by a Vietnamese translation (of business);
DD) assay results report the quick tests of food testing basis 3rd by enterprises in the list of test facilities that are food safety Bureau announced annually;
the label of the form e) 01 fast food tests include the label directly on the smallest packaging unit and indirectly on the package label (stamped by the enterprise);
g) a copy of the license issued in the country of production, export by the competent State agencies of the country (for quick test kit registration food import origin) and must be legalized by the Consulate in English or Vietnamese; the case of a licence issued in another country must be accompanied by a Vietnamese translation notarized;
h) 2 sets of sample fast food.
2. The records suggest change, additional registered content circulating for the fast food tests When there's change, addition of content specified in item 2 article 10 of this circular, enterprises are responsible for filing 1 record (the records must have a category attached document) for registration authorities profile, including: a) petition to change subscription content circulating the fast food tests according to the form prescribed in annex 4 attached herewith;
b) a copy of the certificate of registration (including the certificate was issued and the first renewal, if any);
c) documents pertaining to the suggested content changes and supplements; case documents in a foreign language must be accompanied by a Vietnamese translation (of business);
d) 2 sets of sample fast food.
3. Profile registration renewal proposals floated the quick tests of food businesses are responsible for filing 1 record registration renewal proposals floated (profile must have the document list attached) for registration agency, records include: a) petition to renew the certificate of registration issued according to the form prescribed in annex 5 attached This circular;
b) a copy of the certificate of registration (including the certificate was issued and the first renewal);

c) 1 set of sample fast food;
d) have written confirmation of stability and of at least 1 test facility used the tests as fast food ".
Article 12. The authority and procedures for review of certificate of registration issued for the fast-food testing 1. The Ministry of health authorize the Bureau of food safety assessment implementation profile, the registration certificate issued for the fast food tests.
2. Review procedures certificate of registration circulation: a) receiving registration documents;
b) establishing expert appraisal Board reviews the fast food: tests-review reviews and draw conclusions on the basis of science, practical, advice to the Director of food safety in the review, the review of fast food tests;
-Proposed resolution form the register floated for the fast food tests.
c) on the basis of the conclusions and recommendations of the Board, Director of food safety will decide to:-allow circulation: registration certificates in circulation, or change the certificate (for case changes, supplements) for each set of tests fast food;
-Request additional information and documents before allowing the circulation: notice for business in writing, stating the need for additional requirements;
-Do not allow registration circulation: notice for business writing, which stated the reason for not allowing subscription circulation.
d) time limit for reply results for business:-for registered records released the fast food tests: no more than 20 working days from the date of receiving documents;
-For registration documents circulation changes, additional sets of tests are fast food: not more than 10 working days from the date of receiving documents;
-Registration for the extension of the fast-food test: not more than 10 working days from the date of receiving documents.
3. The time limit for registration certificates in circulation quick tests a food Ministry) certificate of registration issued sets of fast food test has a time limit of 5 years from the date of signing.
b) registration certificates in circulation was renewed several times, the renewal takes effect for 5 years from the date of signing.
c) for the fast-food test has been issued a certificate of registration issued pursuant to decision No. 18/2007/QD-BYT on 27 February 2007 the Minister of health on issuing regulations quick tests on food safety and hygiene, insufficient the time limit of 5 years , after the time limit on, business must do the registration renewal procedures released under the regulations.
Chapter IV business, advertising, LABELING and USE the QUICK TESTS FOOD PRODUCTS article 13. The business fast food testing 1. Businesses are only allowed to the business of testing food faster after it has been issued a certificate of registration issued; Quick Test Kit business food according to the model and achieve the criteria.
2. enterprises are liable for any harm caused by the quick test his food not properly registered criteria.
Article 14. The ad tests fast food 1. Businesses are only allowed to conduct the advertising tests fast food after it has been issued a certificate of registration.
2. the advertising of fast food tests must comply with the provisions of the law on advertising.
Article 15. The label fast food testing 1. Quick Test Kit product label food products must comply with the provisions of the current law on tangle.
2. In addition, the content must appear on the label: a) the registration number in circulation;
b) Note on safety when circulation, use the quick tests for food.
Article 16. Use the quick tests of food in food safety testing according to the scope of application, the fast-food tests can be used in the following cases: 1. test support for inspection, food safety inspectors. The results obtained from testing using rapid tests are initial results, only brings the refinement, the orientation for the next assertion tests in the laboratory. Do not use results obtained from testing using rapid tests as the basis for food-handling violations;
2. test safety control service in the process of manufacturing, processing, food business;
3. test help consumers in food selection process.
Article 17. Suspension and revocation of registration certificates in circulation the fast food testing 1. The fast-food tests will support registration of the decision to suspend the circulation in the business case made one of the following behaviors: a) change, additional content as specified in point b and point c of item 2 article 10 of this circular but not yet agreed by the governing body;
b) information, advertisements about the fast food does not test the correct registered contents;
c) The fast food circulation tests on the market is not in the right form or not achieve the characteristics such as signed.
2. the registration authorities issued the decision to suspend the circulation fast food tests and reported on the website of the Bureau of food safety.
3. Upon receipt of the decision to suspend the circulation, corporate responsibility: a) urgently implement measures to revoke the food fast tests are circulating on the market; in the agent; or sold to customers;
b) file recovery;
c) reports results of recovery management agency;
d) made the remedy and report results to fix on the governing body.
4. enterprises must bear all costs of product recall when the fast food tests.
5. After the business has remedied the violation in Paragraph 1 of this article, the registration authorities consider the decision to allow the continued circulation of the fast food tests.
6. In the case of enterprises continue to perform the Act in Paragraph 1 of this article, the Agency may consider revoking registration certificates in circulation.
Chapter V PROVISIONS Enacted 18. Effective enforcement of this circular in force from 1 June 2014;
Circular No. 13/2009/TT-BYT on 12 May 2010 the Minister of health guide managing the fast-food tests and circular No. 28/2011/TT-BYT on June 24, 2011 of the Minister of health about the amendments and supplements to some articles of the circular No. 13/2009/TT-BYT on 12th May 2010 Guide and manage the quick tests the food out effect from the date of this circular effect.
Article 19. Implementation of food safety Bureau has responsibility for the Organization, the implementation of this circular.
In the process, if there are difficulties and obstacles, the agencies, organizations, individuals in need of timely reflection on food safety Bureau to consider, resolve.