THE MINISTRY OF SOCIALIST REPUBLIC OF VIETNAM

HEALTH Independence– Freedom – Happiness

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.
 

  FOR THE MINISTER OF HEALTH

Nguyen Thanh Long