43 - 2018 - TT-BCT - Form Vệ sinh an toan-EN
43 - 2018 - TT-BCT - Form Vệ sinh an toan-EN
43 - 2018 - TT-BCT - Form Vệ sinh an toan-EN
CIRCULAR
Pursuant to the Government’s Decree No. 98/2017/ND-CP dated August 18, 2017, defining the
functions, tasks, powers and organizational structure of the Ministry of Industry and Trade;
Pursuant to the Government’s Decree No. 77/2016/ND-CP dated July 01, 2016 on amendments
to regulations on investment and trading conditions in international trade in goods, chemicals,
industrial explosives, fertilizers, gas business and food business under the state management of
the Ministry of Industry and Trade;
Pursuant to the Government’s Decree No. 107/2016/ND-CP dated July 01, 2016 on eligibility
requirements to be satisfied to provide conformity assessment services;
Pursuant to the Government’s Decree No. 08/2018/ND-CP dated January 15, 2018 on
amendments to Decrees on investment and business requirements under the authority of the
Ministry of Industry and Trade;
Pursuant to the Government's Decree No. 15/2018/ND-CP dated February 02, 2018 on
elaboration of the Law on Food Safety;
The Minister of Industry and Trade promulgates a Circular stipulating food safety management
by the Ministry of Industry and Trade.
Chapter I
GENERAL PROVISIONS
Article 1. Scope
3. Appointment of food testing laboratories serving the state management of foods, and reference
testing laboratories.
This Circular applies to Vietnamese authorities, Vietnamese and foreign organizations and
individuals that manufacture, sell or import foods in Vietnam; regulatory authorities;
organizations and individuals whose operations involve food safety in Vietnam under the state
management of food safety by the Ministry of Industry and Trade.
For the purpose of this Circular, the terms below are construed as follows:
1. “general food business establishment” means an establishment that trades in various types of
foods which are under the management of at least 02 regulatory ministries (excluding wholesale
markets and centers for auction of agricultural products).
2. “establishment owner” means the legal representative of a food establishment (as specified in
the Investment Certificate or the Enterprise Registration Certificate) or the person hired and
assigned to directly manage manufacturing and trading operations of a food establishment.
3. “food testing laboratory serving the state management” means an organization which has the
legal status and is appointed by the Ministry of Industry and Trade to perform test(s) and
evaluate the conformity of foods, food additives, food processing aids, micronutrients, food
containers, and primary packages of foods with relevant technical regulations and standards.
5. “state authority responsible for inspection of food safety of imported foods" means an
authority or unit which meets relevant technical and capacity requirements to consider, evaluate
and certify the conformity of food products with relevant regulations, or technical regulations or
standards on foods safety as assigned or appointed by the Ministry of Industry and Trade.
6. “product recall” means the adoption of various measures for removing disqualified foods
from the lines of food production, import, export and distribution on the market.
7. “chain of food trading establishments” means a group of food trading establishments which
are under the ownership of an owner and located in 02 or more provinces or central-affiliated
cities.
Chapter II
a) The application form made according to the Form No. 01a provided in the Appendix enclosed
herewith;
b) The description of facilities, equipment and devices meeting food safety requirements made
according to the Form No. 02a (for food manufacturers), Form No. 02b (for food sellers) or both
the Form No. 02a and the Form No. 02b (for an establishment both manufacturing and selling
foods) provided in the Appendix enclosed herewith;
c) The certificate of good health or the written certification of health, granted by the health
facility of district level or higher, of the establishment owner and persons directly engaging in
the production or trading of foods (the copy certified by the food establishment);
d) The certificate of completion of training course in food safety or the certificate of qualification
in food safety of the establishment owner and persons directly engaging in the production or
trading of foods (the copy certified by the food establishment).
2. Application for re-issuance of the certificate of food safety because of loss or damage:
The application form made according to the Form No. 01b provided in the Appendix enclosed
herewith.
3. Application for re-issuance of the certificate of food safety because there are changes in
production and/or business location, production process, food products or when the certificate of
food safety expires:
a) The application form made according to the Form No. 01b provided in the Appendix enclosed
herewith;
b) The documents specified in Point b, Point c and Point d Clause 1 of this Article.
4. Application for re-issuance of the certificate of food safety because there is a change of the
food establishment’s name but the establishment owner, address, location, the production process
and food products are kept unchanged:
a) The application form made according to the Form No. 01b provided in the Appendix enclosed
herewith;
b) The certificate of food safety (the copy certified by the food establishment).
5. Application for re-issuance of the certificate of food safety because there is a change of the
establishment owner but the establishment’s name, address, location, production process and
food products are kept unchanged:
a) The application form made according to the Form No. 01b provided in the Appendix enclosed
herewith;
b) The certificate of food safety (the copy certified by the food establishment);
c) The certificate of good health of the establishment owner issued by the health facility of
district level or higher (the copy certified by the food establishment);
d) The certificate of completion of the training course in food safety or the certificate of
qualification in food safety of the establishment owner (the copy certified by the food
establishment).
Regulatory authorities prescribed in Article 6 hereof shall receive and check the validity of
applications, carry out site inspections and issue the certificate of food safety to qualified food
establishments. Procedures for issuance of the certificate of food safety are as follows:
Within 05 business days from the receipt of the application for issuance of the certificate of food
safety, the regulatory authority shall check and verify the validity of the received application. If
the received application is invalid, the regulatory authority shall request the food establishment
(the applicant) in writing to complete it. If the applicant fails to supplement the application
within 30 days from the day on which the written request is made, the application will be
invalidated.
b) Establishing an inspectorate:
Within 10 business days from the day on which the received application is checked and certified
satisfactory, the regulatory authority shall organize a site inspection. If an inferior authority is
authorized to carry out the site inspection, a written authorization is required. After completing
the site inspection, the authorized authority must submit the inspection record to the authorizing
authority to consider issuing the certificate of food safety.
The inspectorate responsible for carrying out the site inspection shall be established under the
decision of the regulatory authority competent to issue the certificate of food safety or its
authorized authority. An inspectorate is comprised of 03 – 05 members at least 02 of whom are
specialized in foods or food safety (have academic qualifications in foods or food safety) or in
food safety management (independent specialists who have appropriate professional
qualifications may be hired to carry out the site inspection). Head of the inspectorate shall be
responsible for the site inspection results.
Examine and verify the legality of the application for the certificate of food safety submitted to
the regulatory authority by comparing the application documents with their originals kept by the
applicant; inspect and evaluate the satisfaction of food safety requirements by the applicant.
The inspection result which is “Passed”, “Partially passed” or “Failed” must be specified in the
inspection record which is made according to the Form No. 03a if the applicant is a food
manufacturer or the Form No. 03b if the applicant is a food seller or a combined form of the
Form No. 03a and the Form No. 03b if the applicant is an establishment manufacturing and
trading foods;
The certificate of food safety is issued to a general food business establishment when at least a
group of food products is given "Passed” result. Groups of food products given “Passed” result
shall be specified in the certificate of food safety issued to this establishment;
If "Failed” or “Partially passed” result is given, explanation shall be provided in the inspection
record. If the “Partially passed” result is given, rectification must be completed within 60 days.
After the rectification has been done at the request of the inspectorate, the applicant shall send a
report made according to the Form No. 04 enclosed herewith and inspection fees to the
regulatory authority so as to carry out the site inspection again in accordance with regulations
laid down in Point c of this Clause. The re-inspection must be completed within a maximum
period of 10 business days from the day on which the report on rectification results is submitted.
If the applicant fails to submit the report on rectification within the period of 60 days, the
submitted application for the certificate of food safety and the inspection record which includes
“Partially passed” result shall be invalidated;
If the re-inspection result is “Failed” or the report on rectification is not sent by the prescribed
rectification deadline, the regulatory authority shall request local regulatory authorities in writing
to supervise the applicant and request the applicant not to operate until it obtains the certificate of
food safety;
The site inspection record is made in 02 copies of the same validity 01 of which is kept by the
inspectorate and the other is provided for the applicant.
Within 03 business days from the receipt of the valid application, based on retained documents,
the regulatory authority that has issued the certificate of food safety to the applicant shall
consider re-issuing the certificate of food safety. If an application is refused, a written notice in
which reasons for refusal are specified shall be given to the applicant.
3. Re-issuance of the certificate of food safety because there are changes in production and/or
business location, production process, food products or when the certificate of food safety
expires:
Procedures for re-issuing the certificate of food safety in this case shall be carried out in
accordance with regulations in Clause 1 of this Article.
4. Re-issuance of the certificate of food safety because there is a change of the food
establishment’s name but the establishment owner, the establishment’s address, location, the
production process and food products are kept unchanged:
Within 03 business days from the receipt of the valid application, based on retained documents,
the regulatory authority that has issued the certificate of food safety to the applicant shall
consider re-issuing the certificate of food safety. If the application is refused, a written notice in
which reasons for refusal are specified must be given.
5. Re-issuance of the certificate of food safety because there is a change of the establishment
owner but the food establishment’s name, address, location, production process and food
products are kept unchanged:
Within 03 business days from the receipt of the valid application, based on retained documents,
the regulatory authority that has issued the certificate of food safety to the applicant shall
consider re-issuing the certificate of food safety. If the application is refused, a written notice in
which reasons for refusal are specified must be given.
7. The site inspection of establishments that manufacturing and sell food products as prescribed
in Clause 8 and Clause 10 Article 36 of the Government’s Decree No. 15/2018/ND-CP dated
February 02, 2018 shall be carried out in accordance with relevant regulations on business lines
and sectors.
Article 6. Power to issue the certificate of food safety
1. The Ministry of Industry and Trade shall have the power to issue the certificate of food safety
to:
c) An establishment that both manufacturers and sells food products at the same location and has
an appropriate designed capacity as prescribed in Point a of this Clause.
d) Food trading establishments that are prescribed in Point b of this Clause and manufacture
foods with a designed capacity smaller than the one prescribed in Point a of this Clause.
dd) Establishments that manufacture and sell various types of food products as prescribed in
Clause 8 and Clause 10 Article 36 of the Government’s Decree No. 15/2018/ND-CP dated
February 02, 2018, and have a production capacity under the management of the Ministry of
Industry and Trade as prescribed in Point a of this Clause.
2. Provincial Departments of Industry and Trade shall directly issue the certificate of food safety
or request the Provincial People’s Committees to appoint or assign local competent authorities to
issue the certificate of food safety to:
a) Food manufacturers whose designed capacity is less than the ones prescribed in Point a Clause
1 of this Article;
b) Food wholesalers and retailers (including general food wholesalers and retailers) which
operate within the territory of 01 province or central-affiliated city; chains of mini-supermarkets
and chains of convenience stores whose area is equivalent to that of a mini-supermarket as
regulated by applicable laws;
c) An establishment that both manufacturers and sells food products at the same location and has
an appropriate designed capacity as prescribed in Point a of this Clause;
d) Establishments that manufacture and sell various types of food products as prescribed in
Clause 8 and Clause 10 Article 36 of the Government’s Decree No. 15/2018/ND-CP dated
February 02, 2018, and have a production capacity under the management of the Ministry of
Industry and Trade as prescribed in Point a of this Clause.
a) The regulatory authority shall issue 01 certificate of food safety to the food manufacturing and
trading establishment prescribed in Point c Clause 1 or Point c Clause 2 of this Article;
b) The Ministry of Industry and Trade shall issue 01 certificate of food safety to the food trading
establishment prescribed in Point b Clause 1 of this Article. The local competent authority shall
issue 01 certificate of food safety to the chain of mini-supermarkets or the chain of convenience
stores whose area is equivalent to that of a mini-supermarket as regulated by applicable lawsoft
as prescribed in Point b Clause 2 of this Article;
c) The food wholesale establishment that is prescribed in Point b Clause 1 of this Article and
carries out retail operations, and the food trading establishment prescribed in Point d Clause 1 of
this Article are entitled to decide regulatory authorities that shall process their applications for
the certificate of food safety.
1. A certificate of food safety shall be valid up to 03 years. At least 06 months before the
certificate of food safety expires, the certificate holder must submit the application for re-
issuance of the certificate of food safety in accordance with regulations in Clause 1 Article 4
hereof if the certificate holder plans to continue food production and business operations.
2. The valid period of the certificate of food safety re-issued as regulated in Clause 2, Clause 4 or
Clause 5 Article 4 hereof must correspond to the valid period of the old one.
3. The certificate of food safety re-issued as regulated in Clause 3 Article 4 hereof shall be valid
for 03 years from the date of re-issue.
1. Regulatory authorities that have the power to issue the certificate of food safety prescribed in
Article 6 hereof and other competent authorities shall conduct inspections after the issuance of
the certificate of food safety.
2. A regulatory authority is entitled to conduct inspection of the food establishment whose
certificate of food safety is issued by its inferior authority.
3. The inspection after the issuance of the certificate of food safety shall be conducted once a
year.
a) Documents included in the application for the certificate of food safety are forged;
a) The regulatory authority that issues the certificate of food safety shall have the power to
revoke the issued certificate of food safety;
b) A regulatory authority is entitled to revoke certificates of food safety issued by its inferior
authorities.
Chapter III
Article 10. State authorities responsible for inspection of food safety of imported foods
The Ministry of Industry and Trade shall consider appointing or assigning providers of
conformity assessment services that operate in the territory of Vietnam and are certified to meet
all capacity requirements to provide certification or inspection services in accordance with the
Government’s Decree No. 107/2016/ND-CP dated July 01, 2016 to act as state authorities
responsible for inspection of food safety of imported goods under the management of the
Ministry of Industry and Trade.
Article 11. Requirements to be satisfied by food testing laboratories serving the state
management
Food testing laboratories serving the state management must satisfy relevant requirements in
accordance with Clause 1 Article 25 of the Government’s Decree No. 77/2016/ND-CP dated July
01, 2016.
Article 12. Application and procedures for appointment of food testing laboratories serving
the state management
Application documentation and procedures for appointment of food testing laboratories serving
the state management shall comply with the Joint Circular No. 20/2013/TTLT-BYT-BCT-
BNNPTNT dated August 01, 2013 by the Minister of Health, the Minister of Industry and Trade,
and the Minister of Agriculture and Rural Development.
Reference testing laboratories must be state-owned testing laboratories and satisfy all
requirements specified in Clause 2 Article 25 of the Government’s Decree No. 77/2016/ND-CP
dated July 01, 2016.
Article 14. Application and procedures for appointment of reference testing laboratories
Application documentation and procedures for appointment of reference testing laboratories shall
comply with regulations laid down in Chapter III of the Circular No. 40/2013/TT-BCT dated
December 31, 2013 by the Minister of Industry and Trade.
Chapter IV
b) Regulatory authorities that have the power to impose penalties for administrative violations
shall have the right to enforce recall of food products in accordance with the Government's
Decree No. 115/2018/ND-CP dated September 04, 2018.
1. Within 24 hours after the discovery or receipt of feedback about safety issues of food products
and it is concluded that the food products have to be recalled, the product owner shall:
a) Notify the recall by telephone, email or other appropriate forms, and then give written
notification to all members of the production and distribution system (including factories,
distributors, agencies and stores) in order to request them to suspend the production and
distribution of products as well as carry out the recall of products;
b) Give written notification to provincial mass media agencies and other relevant authorities and
organizations as regulated in the Law on protection of consumer rights; If the recall involves
more than one province, central-level mass media agencies must be notified in writing in order to
publish the recall-related information to consumers;
d) The written notification of the recall must include the following information: Name and
address of the product owner and of the manufacturer, product’s name, packaging specifications,
batch number, date of manufacture, expiration date, quantity, reasons for recall, list of locations
receiving recalled products, and recall duration.
2. Within a maximum period of 03 days from the completion of the recall, the product owner
must submit a report on the recall of products, which is made according to the Form No. 06a
provided in the Appendix enclosed herewith, and must specify measures for disposal of recalled
products, to food safety authorities.
1. Within 24 hours after it is concluded that the food products are subject to the mandatory recall,
the authority that has the power to issue a recall decision as regulated in Clause 2 Article 18
hereof shall issue a recall decision made according to the Form No. 06b provided in the
Appendix enclosed herewith.
2. Upon the receipt of the recall decision, the product owner must carry out the procedures
specified in Clause 1 Article 19 hereof.
3. Within 03 days from the completion of the recall, the product owner must submit a report on
the recall of products, which is made according to the Form No. 06a provided in the Appendix
enclosed herewith, and must specify measures for disposal of recalled products, to food safety
authorities.
4. After issuing a recall decision, authorities competent to impose penalties for administrative
violations against regulations on food safety must supervise the recall of products and notify
food safety authorities and relevant authorities for cooperation.
1. In case a product owner fails to carry out the recall or conducts the recall inconsistently with
the mandatory recall decision issued by a competent authority or in another case of emergency as
regulated in Point d Clause 5 Article 55 of the Law on food safety, the competent authority shall
issue a decision to enforce and organize the recall. A decision on enforced recall of food
products must specify the name of the authority or organization responsible for that enforcement,
the name of the authority or organization supervising or witnessing the enforced recall of
products, the time limit for completion of the enforced recall, and measures for disposal of
recalled products.
2. Upon the completion of the recall and disposal of recalled products, the authority carrying out
the recall and disposal of recalled products shall give a written notification requesting the
product owner to pay expenses arising during the recall.
3. The product owner shall pay expenses for recall and disposal of recalled products (if any)
within 15 days from the receipt of a written notification from the authority responsible for such
recall.
a) Correction of label error: The product label is unconformable with the label description
provided in the self-declaration documents or the application for registration of the product
declaration;
b) Repurposing: Disqualified foods to be recalled may threaten the consumer health, are not
conformable with foods purposes but may be used to serve other purposes;
C) Re-exporting: Imported food products have quality or safety indicators unconformable with
the self-declaration documents of the application for registration of the product declaration or
may threaten the consumer health;
d) Destruction: Food products have quality or safety indicators unconformable with the self-
declaration documents of the application for registration of the product declaration, threaten the
consumer health, and cannot be repurposed or re-exported as regulated in Point b or Point c
Clause 1 of this Article and in other necessary cases as prescribed in Article 18 hereof.
2. If food products are recalled in accordance with provisions in Article 16 hereof, the product
owner shall himself/herself select an appropriate measure for disposing of recalled products in
accordance with regulations in Clause 1 hereof.
3. If food products are recalled in accordance with provisions in Article 17 hereof, within 03
business days from the receipt of the report on the recall of disqualified products, the competent
authority issuing the recall decision must give a written approval for the measure for disposing of
recalled products proposed by the product owner. If the competent authority disagrees with the
measure for disposing of recalled products proposed by the product owner, it must give a written
response indicating reasons thereof and another measure for disposing of recalled products to the
product owner.
Article 20. Reports on disposing of recalled products
1. The product owner must complete the disposal of food products recalled according to a
mandatory recall decision issued by a competent authority within 03 months from the receipt of
the competent authority's written approval for the measure for disposing of recalled products
proposed by the product owner.
a) Voluntary recall: Upon the completion of the correction of label error, the product owner must
give a written notification which specifies the product’s name and quantity, and the sample of the
product with correct label, to the food safety authority. After sending a written notification to the
food safety authority as regulated, the product owner may continue distributing food products;
b) Mandatory recall: Upon the completion of the correction of label error, the product owner
must give a written notification, which specifies the product’s name and quantity, and the sample
of the food product with correct label, to the authority issuing the recall decision. Within 03
business days from the receipt of the notification from the product owner, the authority issuing
the recall decision shall give a written approval for the distribution of food products; in case of
disapproval, reasons for disapproval must be given in writing. Upon the receipt of the written
approval for the distribution of food products whose label has been corrected as regulated from
the authority issuing the recall decision, the product owner must notify the food safety authority
in writing of such approval. The product owner shall continue distributing food products after
obtaining an approval from the authority issuing the recall decision.
3. Repurposing:
Within 05 working days from the completion of the repurposing of recalled food products, the
product owner must submit a report on the repurposing, which indicates the name and quantity of
the product to be repurposed, repurposing duration, new purposes, and must be accompanied by
the contract and invoices proving transactions between the product owner and the product buyer,
to the food safety authority or the authority issuing the recall decision. The buyer may only use
purchased food products for the purposes defined in the contract signed with the product owner
after reporting the food safety authority.
4. Re-exporting:
Within 05 business days from the completion of the re-exporting of products, the product owner
must submit a written report on the re-exporting, which must indicate the name and quantity of
the product to be re-exported, the country of origin, re-exporting time, and be accompanied by
re-exporting documents, to the food safety authority and the authority issuing the recall decision.
5. Destruction:
Within 05 business days from the completion of the destruction of recalled food products, the
product owner must submit a written report on the destruction, which must indicate the name and
quantity of the product to be destroyed, time and location of destruction, and be accompanied
with the destruction record certified by the authority in charge of organizing the destruction, to
the food safety authority or to the authority issuing the recall decision.
Chapter V
IMPLEMENTATION
The certificates of food safety and the Ministry of Industry and Trade’s decisions on appointment
of state authorities responsible for inspection of food safety of imported foods, food testing
laboratories serving the state management, and reference testing laboratories issued or made
before the effective date of this Circular are still valid until the expiration date of such
certificates or decisions.
2. The Circular No. 58/2014/TT-BCT dated December 22, 2014 by the Minister of Industry and
Trade; Chapter II, Chapter IV and Chapter V of the Circular No. 40/2013/TT-BCT dated
December 31, 2013 by the Minister of Industry and Trade; and the Circular No. 28/2013/TT-
BCT dated November 06, 2013 by the Minister of Industry and Trade are abrogated.
Play the leading role and coordinate with relevant departments, and Provincial Departments of
Industry and Trade in instructing the implementation of this Circular;
Receive and check the validity of applications, carry out site inspections, and request the head of
the Ministry of Industry and Trade to consider issuing the certificates of food safety to the
establishments that manufacturing and selling foods at the same location as prescribed in Point a,
Point c and Point dd Clause 1 Article 6 hereof;
Receive and check the validity of applications, appraise received applications, and request the
Minister of Industry and Trade to make decisions on designation or appointment of state
authorities responsible for inspection of food safety of imported foods, food testing laboratories
serving the state management, and reference testing laboratories in its managed sectors.
a) Based on actual conditions of each province, receive and check the validity of applications,
carry out site inspections, and consider issuing the certificates of food safety or request the
Provincial People's Committee to assign or appoint local competent authorities to receive and
check the validity of applications, carry out site inspections, and consider issuing the certificates
of food safety to food manufacturers and sellers prescribed in Clause 2 Article 6 hereof;
b) Submit annual reports to the Ministry of Industry and Trade on the issuance of the certificate
of food safety to food manufacturers and sellers prescribed in Clause 2 Article 6 hereof; the list
of food establishments which are under the state management of the Ministry of Industry and
Trade and exempt from the certificate of food safety as regulated in Article 12 of the
Government's Decree No. 15/2018/ND-CP dated February 02, 2018; reports on recall of
disqualified foods and disposing of recalled products according to mandatory recall decisions
made by local competent authorities.
4. Difficulties that arise during the implementation of this Circular should be reported to the
Ministry of Industry and Trade for consideration./.
MINISTER
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