Thông tư 19/2012/TT-BYT hướng dẫn việc công bố hợp quy và công bố phù hợp quy định an toàn thực phẩm do Bộ Y tế ban hành

CIRCULAR

GUIDING THE REGULATION CONFORMITY ANNOUNCEMENT AND ANNOUNCEMENT ON CONFORMITY WITH REGULATION ON FOOD SAFETY

Pursuant to the Law on Technical regulations and standards, of June 29, 2006 and the Government's Decree No.127/2007/ND-CP, of August 01, 2007, detailing the implementation of a number of articles of the Law on Technical regulations and standards;

Pursuant to the Law on quality of product, goods, of November 21, 2007 and the Government's Decree No.132/2008/ND-CP, of December 31, 2008 detailing the implementation of a number of articles of the Law on quality of product, goods;

Pursuant to the Law of Food safety, of June 17, 2010 and the Government's Decree No.38/2012/ND-CP, of April 25, 2012 detailing the implementation of a number of articles of the Law of Food safety;

Pursuant to the Government’s Decree No.63/2012/ND-CP, of August 31, 2012, defining the functions, tasks, powers and organizational structure of the Ministry of Health;

At the proposal of Director of the Food Safety Bureau;

the Ministry of Health promulgates Circular guiding the regulation conformity announcement and announcement on conformity with regulation on food safety.

Chapter I

GENERAL PROVISIONS

Article 1. Scope of regulation

This Circular stipulates order, dossier of regulation conformity announcement and announcement on conformity with regulation on food safety (hereinafter referred to as the product announcement) with respect to processed and/or packed food, food additives, food processing enhancers, packing materials, instruments in direct contact with food (hereinafter referred to as products); duties of agencies receiving registration of regulation conformity announcement and announcement on conformity with regulation on food safety (hereinafter referred to as agencies receiving registration) and organizations, individuals conducting product announcement (hereinafter referred to as organizations, individuals); inspection after announcing product.

Article 2. Interpretation of terms

In this Circular, some below terms shall be construed as follows:

1. Announcement on conformity with regulation on food safety: Means when organizations, individuals self-announce that their products are conformable with regulation on food safety for products not yet had corresponding technical regulations.

2. Principal quality norms: Means level or quantity of substances determining nutritious value and typical nature of products in order to identify, classify and distinguish with foods of same kind.

3. The detail table of product: Means the technical requirement of a product (which has common name of product, label, principal quality standards, chemical-physical standard, micro-organism) built by organizations, individuals and had announced in conformity with the corresponding National technical regulation (QCKT) or in conformity with regulations on food safety of Vietnam (in case the product not yet had QCKT) or in conformity with regulation of the international food standard Committee (Codex) in case Vietnam not yet had regulation.

4. The appointed testing laboratory: Means testing laboratory appointed by competent agencies in Vietnam.

5. The recognized independent testing laboratory: Means a testing laboratory which has recognized by an recognizing organization and independent with organization, or individual producing products.

6. The accepted testing laboratory: Means testing laboratory of organization or individual that producing product which has recognized by a recognizing organization and testing laboratory which is appointed by overseas competent agencies.

Article 3. Content of assessment on conformity of announced product compared to the corresponding technical regulation and assessment on conformity of announced product compared to regulation on food safety

1. Assessment on conformity of announced product compared to the corresponding technical regulation (hereinafter referred to as regulation conformity assessment) with respect to products have had technical regulations: Content of regulation conformity assessment applying for each type of specific product is specified in the corresponding technical regulation.

2. Assessment on conformity of announced product compared to regulation on food safety (hereinafter referred to as assessment on conformity with regulation on food safety) with respect to products not yet had technical regulation: Content of assessment on conformity with regulation on food safety is applied for each type of product based on criteria on food safety as prescribed by law on food safety. In case Vietnam not yet had regulation, regulations of Codex shall be applied.

Chapter II

ORDER, DOSSIER OF PRODUCT ANNOUNCEMENT

Article 4. Order, dossier of regulation conformity announcement

1. Order of regulation conformity announcement:

a) Step 1: The regulation conformity assessment

Organizations, individuals implement the regulation conformity assessment by one of two methods as follows: To self-assess regulation conformity based on content of regulation conformity assessment specified in clause 1 Article 3 of this Circular and test product in the appointed testing laboratory or recognized independent testing laboratory or accepted testing laboratory; through an organization certifying the regulation conformity appointed by the Ministry of Health.

b) Step 2: Registration of the regulation conformity announcement

Organizations, individuals announcing product shall make and submit dossier of announcement as prescribed in clause 2 this Article to agencies receiving registration specified in Article 7 of this Circular.

2. Dossier of regulation conformity announcement:

a) Papers, documents specified in Article 5 and Article 7 of the Government's Decree No.38/2012/ND-CP, of April 25, 2012 detailing the implementation of a number of articles of the Law of Food safety (hereinafter referred to as the Decree No.38/2012/ND-CP);

b) For results of testing product, stipulated as follows: The results of testing product within 12 months (originals or notarized copies enclosed originals for comparison or consular legalized copies), include criteria at the request of the corresponding technical regulations, of the appointed testing laboratory or recognized independent testing laboratory or accepted testing laboratory.

Article 5. Order, dossier of announcement on conformity with regulation on food safety

1. Order of announcement on conformity with regulation on food safety:

a) Step 1: Assessment on conformity with regulation on food safety

Organizations, individuals test products in appointed testing laboratory or recognized independent testing laboratory or accepted testing laboratory; assess conformity with regulation on food safety on based on results of testing and content specified in clause 2 Article 3 of this Circular.

b) Step 2: Registration of announcement on conformity with regulation on food safety

Organizations, individuals announcing product shall make and submit dossier of announcement as prescribed in clause 2 this Article to agencies receiving registration specified in Article 7 of this Circular.

2. Dossier of announcement on conformity with regulation on food safety:

a) Papers, documents specified in Article 6 and Article 7 of the Decree No.38/2012/ND-CP.

b) For results of testing product, stipulated as follows: The results of testing product within 12 months (originals or notarized copies enclosed originals for comparison or consular-legalized copies), include key quality norms, safe norms, of the appointed testing laboratory or recognized independent testing laboratory or accepted testing laboratory.

c) The results of testing utility effectiveness of product for functional food with new utility, being processed from new substances or under new technology, which circulated in market of Vietnam for the first time and not yet proved for safety and effectiveness of product;

Article 6. Announcement for import products (except for functional food) only aiming to used internally in production facilities, supermarkets, hotels at four stars or higher rank

1. Dossier of product announcement includes:

a) The product declaration:

- For food raw materials, packing materials, instruments in direct contact with import food just aiming to service for internal production of enterprises: The declaration specified in Form No.2 promulgated together with this Circular.

- For imported food additives, food processing enhancers just aiming to service internal production of enterprises: The declaration specified in Form No.3 promulgated together with this Circular.

- For imported food just aiming to trade in supermarkets, hotels at four stars or higher rank: The declaration specified in Form No.4 promulgated together with this Circular.

b) Certificate of Business registration (copy with stamp of organization, or individual);

c) The results of testing product within 12 months of producers or the details on product information of producers; or results of testing product of the appointed testing laboratory or recognized independent testing laboratory or accepted testing laboratory.

2. Organizations, individuals announcing products shall make and submit dossier of announcement as prescribed in clause 1 this Article to agencies receiving registration specified in Article 7 of this Circular.

Article 7. Authority to receive dossier of registration and to grant receipt of regulation conformity announcement and conformation on announcement on conformity with regulation on food safety

1. The Ministry of Health assigns the Food Safety Bureau to receive dossier of registration; grant receipt of regulation conformity announcement (hereinafter referred to as receipt), confirmation on announcement on conformity with regulation on food safety (hereinafter referred to as confirmation) for: Functional foods, food additives, food processing enhancers, imported products being processed, packaged foods, packing materials, instruments in direct contact with foods; the confirmation in writing for imported products (except for functional foods) just aiming to use internally in production facilities, supermarkets, hotels at four stars or higher rank.

2. The Department of Health assigns the Sub-departments of food safety and hygiene to receive dossiers of registration, grant receipts, confirmations for: Products being produced domestic are foods processed, packaged (except for functional foods), packing materials, instruments in direct contact with foods of organizations, individuals producing and trading such products and placed in their localities.

3. Products produced domestic with the export purpose are registered the product announcement at the Food Safety Bureau or the Sub-departments of food safety and hygiene where organizations, individuals placed head offices in localities as requested by importing countries.

4. Products with same quality of same an organization, individual who takes responsibility for product, but being produced in 02 (two) provinces, cities or more may be registered the product announcement at the Food Safety Bureau or at the Sub-department of food safety and hygiene where organizations, individuals placed head office in localities.

5. Agencies receiving registration specified in clauses 1, 2 this Article shall receive, grant receipt and confirmation as prescribed in clauses 3, 4, 5 Article 4 of the Decree No.38/2012/ND-CP.

Within 02 (two) months after receiving written notification on reason of refusal for grant of a receipt and a confirmation of agencies receiving registration, if organization, individual announcing product fail to supplement, complete dossier as requested, the agencies receiving registration shall cancel such announcement dossier.

6. Agencies receiving registration shall grant and mange number of receipts and confirmations.

a) For receipts and confirmations being granted by the Food Safety Bureau, being regulated to record corresponding notation as follows: (ordinal number)/(issuance year)/ATTP-TNCB and (ordinal number)/(issuance year)/ATTP-XNCB.

b) For receipts and confirmations being granted by the Sub-departments of food safety and hygiene of provinces, cities, being regulated to record corresponding notation as follows: (ordinal number)/(issuance year)/YT-abbreviated name of province, city-TNCB and (ordinal number)/(issuance year)/YT-abbreviated name of province-XNCB.

Convention on abbreviation of name of provinces, cities in receipts and confirmations is specified in Form No.5 promulgated together with this Circular.

Article 8. Announcement for food additives, food processing enhancers

1. For food additives, food processing enhancers in the list being permitted to use promulgated by the Ministry of Health Organizations, individuals implement the product announcement as prescribed in article 4, Article 5, Article 6 and Article 7 of this Circular.

2. For food additives, food processing enhancers not in the list being permitted to use of Vietnam; products containing food additives, food processing enhancers not in the list being permitted to use of Vietnam but in the list as prescribed by Codex or being permitted to use in producing countries, the Food Safety Bureau shall consider to allow the product announcement.

Article 9. Regrant of receipts and confirmations

1. Regrant of receipts and confirmations is implemented at the competent state agencies which having granted receipts or confirmations at the first time for such products and complies with Article 8 of the Decree No.38/2012/ND-CP.

2. In case organizations, individuals requesting for re-grant of product but fail to implement properly, fully the regime of periodical testing, agencies receiving registration shall held an inspection at the production, business facilities. Based on result of handling violation and remedial action, agencies receiving registration shall decide to re-grant or must re-announce.

Chapter III

DUTIES OF AGENCIES RECEIVING REGISTRATION AND ORGANIZATIONS, INDIVIDUALS ANNOUNCING PRODUCTS

Article 10. Duties of agencies receiving registration

Agencies receiving registration have rights and duties as follows:

1. To receive dossier of regulation conformity announcement or of announcement on conformity with regulation on food safety of organizations, individuals.

2. To grant and re-grant receipts and confirmations in proper time limit as prescribed in clauses 3, 4, and 5 Article 4 of the Decree No.38/2012/ND-CP.

3. Within 07 (seven) working days, after granting receipt or confirmation, agencies receiving registration shall notify in publicity about products having been granted receipts or confirmations on their websites.

4. To affix with an integrity seal between the pages on the detailed product information and affix with seal on label of products in order to confirm contents labeled compulsorily as prescribed by law. This stamp affixing has no value to confirm about industrial ownership. Agency receiving registration shall return for organization, or individual announcing product one set of dossier of product and store dossier as prescribed.

5. To hold management and use of charges and fees from grant of receipts, and confirmations as guided by the Ministry of Finance.

Article 11. Duties of organizations, individuals announcing products

Organizations, individuals announcing products have rights and duties as follows:

1. To announce products and re-announce products at agencies receiving registration specified in Article 7 of this Circular; pay charges and fees fully as prescribed by law.

2. Self-supervise quality, food safety of their products. To implement the regime on periodical examination and testing as prescribed and tale all responsibilities for conformity of the announced products.

3. To announce name of products clearly, presenting properly nature (structural components, functions, processing technology). If name of product is not clear its nature, it must be written together with name of product group and detailed the compulsory labeling contents.

4. To submit official label after one (01) month, since being granted receipt or confirmation, in case having just submitted the drafting design of labeling content upon announcement.

5. When detecting products breaching provisions of law on quality and food safety of product, labeling, advertisement, dishonest announcement, organizations, individuals shall:

a) Timely notify to competent state management agencies and agencies receiving registration about conformity of product;

b) To conduct measures to remedy non-conformity;

c) When necessary or having request of competent state management agencies, they must temporarily stop production or bringing products out off factory, and conduct withdrawing non-conformable products circulating in the market;

d) To notify to competent state management agencies and agencies receiving registration about result of remedying non-conformity before continuing to bring products into production and trading.

6. To keep dossier of product announcement in time limit as basis of examination, inspection or in order to prove conformity of their products with contents having announced, committed in dossier.

7. In case changing contents in the detailed product information relating to form of label, packing specification, quality norms, non-compulsory labeling contents, address of head office of organizations, individuals or production place, name of organizations, individuals (in case of changing Certificate of Business registration), organizations, individuals may submit a official dispatch to request for supplement enclosed with confirmation on contents changed, supplemented of organizations, individuals taking responsibility for product in order to continue use of number of receipts or confirmations which have been granted or re-granted.

Chapter IV

EXAMINATION AFTER ANNOUNCEMENT

Article 12. Examination after announcement

Agencies receiving registration and Sub-departments of food safety and hygiene where production-business facilities have placed in localities have authority to examine implementation of law on food safety, the regime of periodical testing for the announced products.

Article 13. Taking samples for periodical testing

1. The periodical testing regime is implemented as follows:

a) 01 (one) time/year for products of facilities having one of certificates on advanced quality control system: GMP, HACCP, ISO 22000 or equivalent one.

b) 02 (two) times/year for products of facilities not yet granted above-mentioned certificates.

2. The taking samples for periodical testing is performed by organizations, individuals or organizations, individuals proactively invite competent agencies for implementation.

3. Criteria for periodical testing are principal quality norms announced in the detailed product information or on label of products circulating; some chemical and physical norms, micro-organism norms announced in the detailed product information or as prescribed by law.

4. Result of testing of teams inspecting, examining irregularly, periodically, results of state examination on imported food safety may be used by organizations, individuals as result of periodical testing if meeting requirements specified in clause 3 this Article.

Chapter V

PROVISIONS OF IMPLEMENTATION

Article 14. Transitional provisions

The product quality standard certificates having granted under the Decision No.42/2005/QD-BYT, of December 08, 2005 of the Ministry of Health on regulation on statement of food product specifications are still value until the effective duration stated in such certificates are expired.

Article 15. Effect

1. This Circular takes effect on December 25, 2012.

2. The Decision No.42/2005/QD-BYT of the Ministry of Health, of December 15, 2005 promulgating regulation on statement of food product specifications is invalid since this Circular takes effect.

Article 16. Organizing implementation

1. The Ministry of Health assigns the Food Safety Bureau to implement, examine implementation of this Circular in nationwide.

Each six months, the Food Safety Bureau shall report to the Minister of Health on task of granting receipts and confirmations.

2. The Departments of Health assigns the Sub-department of food safety and hygiene to implement, examine implementation of this Circular in their management localities.

Each month, the Sub-department of food safety and hygiene shall report to Departments of Health and the Food Safety Bureau on task of granting receipts and confirmations.

Form No. 1

DECLARATION OF IMPORT FOOD CONTACT MATERIALS JUST AIMING TO SERVICE FOR INTERNAL PRODUCTION OF ENTERPRISES

Form No. 2

DECLARATION OF IMPORTED FOOD ADDITIVES AND FOOD PROCESSING AIDS JUST AIMING TO SERVICE FOR INTERNAL PRODUCTION OF ENTERPRISES

Form No. 3

DECLARATION OF IMPORTED PRODUCTS JUST AIMING TO BUSINESS IN AT LEAST 4-STAR SUPERMARKETS AND HOTELS

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