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THE MINISTRY OF
HEALTH
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SOCIALIST
REPUBLIC OF VIETNAM
Independence - Freedom - Happiness
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No. 52/2015/TT-BYT
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Hanoi, December
21, 2015
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CIRCULAR
REGULATIONS
ON STATE INSPECTION OF IMPORTED FOOD SAFETY, AND APPLICATIONS AND PROCEDURES
FOR GRANT OF CERTIFICATE OF EXPORT TO EXPORTED FOODS UNDER THE ADMINISTRATION
OF THE MINISTRY OF HEALTH
Pursuant to the Law on Food Safety dated June
17, 2010;
Pursuant to the Law on Food Safety dated June
17, 2010;
Pursuant to Decree No. 38/2012/ND-CP detailing
the implementation a number of articles of the Law on Food Safety date April
25, 2012 of the Government;
Pursuant to Decree No. 63/2012/ND-CP on functions,
power, responsibilities and organizational structure of the the Ministry of
Health dated August 31, 2012 of the Government;
Pursuant to the Decision No. 10/2010/QD-TTg on
Certificate of free sale of imports and imports dated February 10, 2010 of the
Prime Minister;
At the request of the Director of Department of
Food Safety
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Chapter I
GENERAL PROVISIONS
Article 1. Scope
This Circular regulates:
1. Inspection of imported food
under the administration of the the Ministry of Health prescribed in:
Annex No.01 of the Joint Circular No. 13/2014/TTLT-BYT-BNNPTNT-BCT
guiding the assignment and cooperation in State management of food safety dated
April 09, 2014 of inter-ministries including the Ministry of Health, Ministry
of Agriculture And Rural Development (hereinafter referred to as the Joint
Circular No. 13/2014/TTLT-BYT-BNNPTNT-BCT);
b) Clause 3, Article 14 of the Decree No.
38/2012/ND-CP detailing the implementation a number of articles of the Law on
Food Safety date April 25, 2012 of the Government;
2. The application and
procedure for grant/withdrawal of a certificate of free sale for an exported
food under the administration of the Ministry of Health
3. The application and
procedure for grant/withdrawal of a certificate of health and certificate of
export for an exported food under the administration of the Ministry of Health
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Article 2. Interpretation of
terms
For the purpose of this Circular, the terms below
shall be construed as follows:
1. A food owner means a
trader who is responsible for food quality presented in declarations
(hereinafter referred to as the trader) or any entity that is authorized
to import or export food by the aforesaid trader.
2. Articles means a group
of foods that bears the same name, label and package and such packages are
manufactured by the same manufacturer
3. Shipment means all
articles of an imported/exported shipment (that has the same reference number
of bill of lading). A shipment may contain more than one food products.
Chapter II
STATE INSPECTION OF
IMPORTED FOOD
Article 3. State inspecting
authorities for food safety
The State Inspecting authority of food safety
(hereinafter referred to as the inspecting authority) is an authority or agency
that is qualified for the food testing and inspection and appointed by the the
Ministry of Health.
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1. Declarations of conformity
or declarations of compliance with food safety regulations.
2. Regulations, national
technical regulations of Vietnam and international on food safety, quality and
labeling.
Article 5. Methods of
inspection
1. Standard inspection is the
inspection of the application and representative sample by which food labels,
packages and special preservation (if any) are organoleptically examined.
If any organoleptic indicator of packages or
special preservation (if any) of inspected foods is suspected, the inspecting
authority shall determine the group and testing indicators for the
inspected article based on its ingredients, the history of the product
quality, the history of owner’s importation, the origin of such product and its
quality control system.
2. Strict inspection applies
to the following cases:
a) Where the article fails to pass the previous
inspection, such product shall undergo a documentary inspection and shall be
sampled for testing of indicators presented in its declarations;
b) Where the Ministry of Health or overseas
competent authority or the manufacturer issues warnings against the article,
such product shall undergo a standard inspection and testing for warned indicators,
or where the results of warned indicator inspection is required to be issued by
inspecting agencies that is recognized by the State competent authority of
the exporting country.
3. A reduced inspection means
documentary inspection only.
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Article 6. Application of
inspection
1. The standard inspection
applies to all articles of an imported shipment, except for cases regulated in
clause 2 and clause 3 of this Article.
2. A reduced inspection is
granted to articles regulated in point a, b or c of this clause as follows:
a) Any article that is certified as satisfactory
for food safety requirements by competent authorities of the signatories of the
international agreement on mutual recognition of food safety inspection and
quality to which Vietnam is a signatory; a article that is certified as
conformable with Vietnam’s regulations by the competent authorities of the
exporting country;
b) Articles that meet the import requirements in 03
consecutive standard inspections conducted on different days within 12 months
(if any)
c) Articles having undergone a reduced inspection
in 12 months that satisfy requirements of periodic inspections under
regulations in clause 1, Article 13 of the Circular No. 19/2012/TT-BYT
guiding the declaration of conformity and declaration of compliance with food
safety regulations dated November 09, 2012 of the Minister of Health,;
d) Reduced inspection shall only apply when it is
granted by the Department of Food Safety -Ministry of Health on the basis of
fulfillment of requirements in point a, b and c, clause 2 of this Article.
The trader who wishes to be granted a reduced
inspection shall submit an application for reduced inspection of imported food
according to the Annex 1A enclosed with this Circular. Within 05 working days
from the date of receipt of the application, the Department of Food Safety
–Ministry of Health shall send a written notice of whether granting reduced
inspection to the applicant using the form in Annex 1B enclosed with this
Circular.
3. The strict inspection
applies to imported articles regulated in the following cases:
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b) Any article of which the Ministry of Health or
overseas competent authorities or its manufacturer gives warning signs.
4. Switchover from strict
inspection to standard inspection:
a) Where an article passes 02 consecutive strict inspections,
its next import shall be eligible for standard inspection as regulated in
clause 1 of this Article;
b) Where the Department of Food Safety – Ministry
of Health releases a document about cancelation of strict inspection of the
article of which the Ministry of Health or overseas competent authorities or
its manufacturer gives warnings.
Article 7. Applications for
inspection
1. An application for imported
food inspection using the form in the Annex 02 of this Circular.
2. A certified true copy of the
declaration of conformity or declaration of compliance to food safety
regulations, or a copy of such declaration that is sealed by the trader
enclosed with the original.
3. A decision on grant of
reduced inspection (if any) issued by the Department of Food Safety –Ministry
of Health.
4. The Power of Attorney of
the trader granted to entities that are authorized to import or export food (if
any).
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6. Certified true copies of
the bills of lading and invoices signed and sealed by the trader.
Article 8. Procedures for
inspection
1. The trader shall submit an
application for inspection at the inspecting authority or via the portal of
National Single Window System before or at the time his/her article reaches the
checkpoint.
2. Within 01 working day from
the date of receipt of the application, the inspecting authority shall examine
the application;
a) In case of a complete and valid application
under Article 7 of this Circular, the shipment shall be inspected as regulated
in clause 3 or clause 4 of this Article;
b) In case of an incomplete application under
Article 7 of this Circular, the inspecting authority shall return such
application enclosed with a notice of missing or unconformable documents to the
applicant.
3. Inspection of a shipment or
article that is eligible for the reduced inspection:
Within 02 working days from the date of receipt of the application, the
inspecting authority shall send the applicant a notice of whether such shipment
satisfies the import requirements using the form in the Annex 03 of this
Circular.
4. The strict inspection and
standard inspection of shipments or articles shall comply with the following
procedures:
a) Within 02 working days from the date of receipt
of the application, the inspecting authority shall take samples from the
shipment that reaches the checkpoint at the the time its trader applies for
inspection.
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b) With regard to articles under strict inspection
and those under standard inspection, within 06 working days and 08 working
days, respectively, the inspecting authority shall:
- The inspection shall comply
with the technical regulations of Vietnam or international on food safety,
quality and food labeling and shall be conducted according to the declaration
of conformity or the declaration of compliance with food safety regulations;
- The inspecting authority
shall issue of notice of whether such shipment satisfies the import
requirements using the form in the Annex 03 of this Circular.
5. With regard to any shipment
that fails to satisfies the import requirements, the inspecting authority shall
propose action against such shipment on the notice of unsatisfactory shipment
according to clause 3, Article 55 of the law on food safety, and send such notice
to the trader, and transfer all files of such shipment to the Department of
Food Safety - Ministry of Health, thereafter.
6. With 05 working days from
the date of receipt of the notice of unsatisfactory shipment, the trader may
request the inspecting authority to reconsider the inspection results and
remedies to his/her unsatisfactory shipment or to re-inspect such shipment.
7. With 05 working days from
the date of receipt of the proposed remedies against the unsatisfactory
shipment and the files of such shipment from the inspecting authority, the
Department of Food Safety –Ministry of Health shall make a decision on the
remedies to unsatisfactory shipment.
Article 9. Report on results of
remedies to unsatisfactory shipments
1. After the action against the
unsatisfactory shipment is taken, the trader submits one of the following
documents to the inspecting authority:
a)A certificate of re-export (for those serving the
purpose of re-export)
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c) A contract of repurposing signed between the
trader and purchaser or the transfer agreement enclosed with invoices or
certificates of transfer. The purchaser or transferee of the unsatisfactory
shipment must not use such shipment as food, except for those regulated in
clause 2 of this Article;
d) A report on the remedial measures and location
where defective products and incorrect labels are remedied.
2. If the trader wishes to
import articles whose defects have been remedied to Vietnam, the trader shall
apply for inspection under regulations in Article 8 of this circular.
If the shipment still fails to satisfy the import
requirements, such shipment shall not be eligible for the second remedy and
shall be subject to one of the remedies regulated in point d, c, and d of
clause 3 of d 55 of the law on food safety.
Chapter III
APPLICATIONS AND
PROCEDURES FOR GRANT AND WITHDRAWAL OF CERTIFICATE OF FREE SALE, CERTIFICATE OF
EXPORTATION
Article 10. Exported articles
eligible for Certificate of Free Sale, Certificate of Exportation
1. A Certificate of Free Sale
(CFS) is granted to exported articles metioned in the Annex 01 of the Joint
Circular No. 13/2014/TTLT-BYT-BNNPTNT-BCT.
2. The Certificate of
Exportation (CE) or Certificate of declaration of compliance with food safety regulations,
if required by the importing country.
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An application for CFS/CE of an article includes:
1. An application for CFS/CE
using the form in Annex 04 of this Circular.
2. A certified true copy of
the certificate of declaration of conformity or the certificate of declaration
of compliance with food safety regulations.
Article 12. Powers and
procedures for grant of CFS/CE
1. Food traders and businesses
(hereinafter referred to as food entities) shall submit an application for
CFS/CE to the Department of Food Safety –Ministry of Health directly or by
post.
2. After receipt of the
application for CFS/CE, the document processing team shall examine such
application, put it into the reception book and an grant the applicant with a
note of application receipt using the form in the Annex 05 of this Circular.
3. Within 05 working days from
the day stated on the note of application receipt, the State competent
authority in the clause 1 of this Article shall grant such entity with CFS/CH
using the forms in Annex 06 and 07 enclosed with this Circular or using forms
required by the importing country. In the case of rejection, the State
competent authority shall send the applicant an explanation on which reasons
for rejection shall be specified.
4. CFS/CE has its effective
date of 02 years and its effective date shall not exceed the effective date of
the Certificate of Declaration of Conformity or the Certificate of declaration
of compliance with food safety regulations.
Article 13. Cases of withdrawal of CFS/CE
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2. CFS/CE is granted to an
article that is unconformable with applicable technical standard or
regulations.
3. The certificate of
declaration of conformity or the certificate of declaration of compliance with
food safety regulations of the article is revoked.
4. CFS/CE is granted
ultra-vires.
Article 14. Procedures for withdrawal of CFS/CE
1. The State authority
competent to grant CFS/CE shall issue a written notice of CFS/CE withdrawal and
send it to the food entity that is granted CFS/CE.
2. Within 05 working days from
the date of receipt of such notice of the State competent authority, the food
entity that is granted CFS/CE shall return such certificate to the State
competent authority.
3. In case of non-return of
CFS/CE, the State authority competent to grant CFS/CE shall publicize an
announcement that such CFS/CE mentioned in clause 1 of this Article is no
longer valid and submit it to the customs authority.
Chapter IV
APPLICATIONS AND
PROCEDURES FOR GRANT AND WITHDRAWAL OF HEALTH CERTIFICATE OF EXPORTED FOOD
PRODUCTS
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The Health certificate (HC) is granted to a food
entity for food, food additives, food substances; instruments and materials for
wrapping and storing food in case that such entity applies for.
Article 16. Applications for
HC
An application for HC of 01 exported shipment
includes:
1. The application for HC
using the form in Annex 08 of this Circular.
2. The original or certified
true copy of inspection results of every article of the exported
shipment, comprising indicators required in respective technical regulations ( for
those whose technical regulations are available) or key quality norms , safety
norms under provisions (for those whose technical regulation are not
available), name of product, the lot number, date of production and expiry date
that are recognized by the appointed inspecting authority or the
accredited independent inspecting authority or recognized inspecting
authority.
3. Samples of product labels
(duplicates certified by the food entity).
4. Duplicates of the Certificate
of Business Registration, Certificates of Fulfillment of Food Safety Conditions
(except for food entities regulated in clause 1, Article 12 of the Decree No.
38/2012/ND-CP detailing the implementation of a number articles of the Law on
food safety dated April 25, 2012 of the Government) or the Certificate of
declaration of conformity or the certificate of declaration of compliance with
food safety regulations, signed and sealed by the food entity.
Article 17. Power and
procedures for grant of HC
1. Food entities that wish to
be granted a HC shall submit an application for CFS/CE to the Department of
Food Safety – Ministry of Health directly or by post.
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3. Within 05 working days from
the day stated on the note of application receipt, the State competent
authority in the clause 1 of this Article shall consider granting such entity
with a HC using the forms in Annex 09 and 10 enclosed with this Circular In the
case of rejection, the State competent authority shall send the applicant an
explanation on which reasons for rejection shall be specified.
Article 18. Cases of withdrawal of HC
1. Applicants falsify
documents in the application for HC.
2. HC is granted to an
exported shipment whose products are unconformable with applicable technical
standard or regulations (if any).
3. The Certificate of
Declaration of Conformity or the Certificate of declaration of compliance with
food safety regulations of the article is revoked (if any).
4. HC is granted ultra-vires.
Article 19. Procedures for withdrawal of HC
1. The State authority
competent to grant HC shall issue a written notice of HC withdrawal and send it
to food entities that are granted HC.
2. Within 05 working days from
the date of receipt of such notice of the State competent authority, the food
entity that is granted HC shall return such certificate to the State competent
authority.
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Chapter V
RIGHTS AND
RESPONSIBILITIES OF AUTHORITIES, ORGANIZATIONS AND INDIVIDUALS
Article 20. Rights and
responsibilities of traders
The trader shall have rights and responsibilities
as follows:
1. Request to be granted
reduced inspection of imported products regulated in point a/b/c, clause 2,
article 6 of this Circular.
2. Request the inspecting
authority to reconsider the inspection results or request the Department of
Food Safety –Ministry of Health to have an appointed testing authority
re-inspect the articles within 5 working days from the day receiving the notice
of unsatisfactory shipments.
a) Request the inspecting authority that carries
out the first inspection to claim expenses if its result is different from that
of the re-inspection;
b) Pay all costs of the re-inspection if its result
is consistent with that of the first inspection;
3. Propose, in writing, one of
the remedies to his/her unsatisfactory shipment or product that stated in the
notice in Annex 03 of this Circular.
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5. Follow penalties for
unsatisfactory shipment or articles imposed by the State competent authorities;
Article 21. Rights and
responsibilities of inspecting authorities
1. Have access to the store
and food transport container to inspect and take samples. Samples shall be
taken in accordance with the Circular No. 14/2011/TT-BYT guiding food sampling for
inspection of food quality and hygiene dated April 01, 2011 of the Minister of
Health.
2. Exercise food inspection in
accordance with regulations in this Circular.
3. Collect inspection fees and
charges under regulations of laws.
4. Store samples in a duration
regulated in testing method standards or similar documents. At the end of the
regulated duration of sample storage, the inspecting authority shall require
the trader to get his/her samples back or shall make a record of sample
clearance.
5. Ensure the profession,
accuracy, honesty and objectivity during the inspection of imported shipment.
6. Be subject to the
direction, guidance and inspection by the Department of Food Safety - Ministry
of Health in the respective field under the administration of the Ministry of
Health.
7. Receive and deal with the
trader’s complaints. Take responsibilities for mistakes occurring during the
inspection. If the customs authority’s mistakes cause any damage to the trader,
the inspecting authority must pay for the whole testing and inspection fees and
and compensate for such damage under the regulations of laws.
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9. Submit a monthly report to
the Department of Food Safety –Ministry of Health using the form in the Annex
11 of this Circular after 10 working days from the reported month ended.
10. Suspend the inspecting
authority from inspection of food safety under the administration of the
Ministry of Health if this inspection authority fails to submit its monthly
report in 03 consecutive months.
Article 22. Rights and
responsibilities of the Department of Food Safety –Ministry of Health
1. Publish warnings and the
effect of such warnings of the Ministry of Health or overseas competent
authorities or food manufacturers on the portal of the Department of Food
Safety.
2. Consider granting the
trader with the permission for taking responsibility for quality of articles
presented in the declarations that are eligible for reduced inspection in the
regulated time
3. Decide and instruct the
implementation of remedial measures against imported shipments that fail to
satisfy food safety requirements.
4. Deal with complaints of
traders and inspecting authorities, and propose actions against violations to
the competent authority
5. The Department of Food
Safety shall submit an annual report on State inspection of imported food and a
proposal for management strategies in each period.
Chapter VI
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Article 23. Entry into force
1. This Circular comes into
effect from February 23, 2016.
2. In case any legal normative
documents referred to this Circular is amended or replaced, the new one shall
prevail.
3. The Decision No.
23/2007/QD-BYT on State inspection of imported food safety shall be null and
void from the day on which this Circular takes effect.
4. Any issues or concerns
arising during the implementation of this Circular shall be promptly reported
to the Department of Health - Ministry of Health.
ON BEHALF OF THE
MINISTER
DEPUTY MINISTER
Nguyen Thanh Long
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