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THE MINISTRY
OF HEALTH
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SOCIALIST
REPUBLIC OF VIETNAM
Independence– Freedom – Happiness
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No. 19/2012/TT-BYT
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Hanoi,
November 09, 2012
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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.
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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.
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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
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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.
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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.
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- 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.
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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
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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.
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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;
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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:
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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
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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
VICE MINISTER
Nguyen Thanh Long
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Form No. 1
DECLARATION OF
IMPORT FOOD CONTACT MATERIALS JUST AIMING TO SERVICE FOR INTERNAL PRODUCTION OF
ENTERPRISES
No.
Description
Components
Manufacturer
and country
Quality and
safety norms
Expiry date
Packaging
specifications
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(1)
(2)
(3)
(4)
(5)
(6)
(7)
(8)
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.............,
[Location].....,[Date]………………….
Representative
(Signature
and seal)
Form No. 2
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No.
Description
Components
Quality and
safety norms
Manufacturer
and country
Expiry date
Packaging
specifications
To be used
for
(1)
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(3)
(4)
(5)
(6)
(7)
(8)
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............., [Location].....,
[Date]………………….
Representative
(Signature and
seal)
Form No. 3
DECLARATION OF
IMPORTED PRODUCTS JUST AIMING TO BUSINESS IN AT LEAST 4-STAR SUPERMARKETS AND
HOTELS
No.
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Components
Quality and
safety norms
Manufacturer
and country
Expiry date
Packaging
specifications
(1)
(2)
(3)
(4)
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(6)
(7)
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.............[Location].....,[Date]………………….
Representative
(Signature
and seal)