Chapter IV
FOOD BUSINESS
Article 10. Amendments to some Articles and Clauses of the Government’s Decree No. 77/2016/ND-CP dated July 01, 2016 on amendments to some regulations on business conditions in international trade in goods, chemicals, industrial explosives, fertilizers, gas business and food business under the state management of Ministry of Industry and Trade and Government’s Decree No. 08/2018/ND-CP dated January 15, 2018 on amendments to certain Decrees related to business conditions under state management of the Ministry of Industry and Trade
1. Article 24 of the Decree No. 77/2016/ND-CP is amended as follows:
“Article 24. General requirements to be satisfied by food production and trading establishments
1. Food production and trading establishments that are required to have certificates of food safety must:
satisfy food safety conditions in conformity with each type of food production or business as prescribed in Sections 2, 3, 4, 5, 6, 7 Chapter VI of this Decree.
2. Food production and trading establishments that are not required to have Certificates of food safety must:
a) satisfy food safety conditions in conformity with each type of food production or business as prescribed by the Law on Food Safety;
b) The entities specified in Points a, b, c, d, dd, e, g, h and i Clause 1 of Article 12 of the Government’s Decree No. 15/2018/ND-CP dated February 02, 2018 on elaboration of some Articles of the Law on Food Safety must:
send their commitments to competent authorities appointed by provincial People’s Committees to manage food safety within provinces.
c) The entity specified in Point k Clause 1 of Article 12 of the Government’s Decree No. 15/2018/ND-CP dated February 02, 2018 on elaboration of some Articles of the Law on Food Safety must:
send a copy of the Certificate (confirmed by the food production and trading establishments) according to Point k Clause 1 Article 12 of the Decree No. 15/2018/ND-CP to competent authorities appointed by provincial People’s Committees to manage food safety within provinces.”
2. Some Points and Clauses of Article 26 of the Decree No. 77/2016/ND-CP are amended as follows:
a) Point c Clause 2 of Article 26 is amended as follows:
“c) The following areas shall be designed to be situated separately: raw materials storage, finished products storage; preliminary processing, processing and packaging areas; restrooms; protective clothing change rooms and relevant auxiliary areas. Raw materials, finished foods, packing materials and waste must be separately placed. Regarding the production establishments, products preserved in the finished product storage must be separately arranged by batches and signs reading formation about product name, batches, date of production and production shifts must be put up.”
b) Point dd Clause 2 of Article 26 is amended as follows:
“dd) The waste collection and treatment area must be outside the food manufacturing area and have sufficient waste and garbage containers. Such containers must be tightly covered and regularly cleaned.”
c) Point c, d and dd Clause 3 of Article 26 are amended as follows:
“c) Walls and ceilings must be flat, impervious to water, not be cracked and adhered by dirty substances, and facilitate cleaning;
d) Floors must be flat, smooth, non-slip and well-drained without pooled or standing water;
dd) Front door and windows must not be penetrated by pests or domestic animals.”
d) Clause 9 of Article 26 is amended as follows:
“9. Restrooms, protective-clothing change rooms
a) Restrooms must be constructed far away from the food production area; the restroom door is not opened towards the food production area; it is required to ensure that the air flow from the restrooms is not directed towards the food production area; a sign that reads “Rửa tay sau khi đi vệ sinh” (“Wash your hands after using the restroom” must be put up at a noticeable place in the restroom;
b) The air ventilation of the restroom must not be directed towards the food production area;
c) A room should be in place to change the protective clothing before.”
dd) Clauses 11, 12 and 13 are added Article 26 as follows:
“11. The food production, processing, packaging, transport, preservation and trading should be kept clean.
12. There must be places for preserving samples and keeping dossiers of preserved samples. Establishments shall comply with regulations on sample preservation and destruction applicable to each type of sample.
13. There must be a separate space for keeping substandard products pending disposal.”
3. Clause 1 Article 27 of the Decree No. 77/2016/ND-CP amended by Clause 1 Article 17 of the Decree No. 08/2018/ND-CP is amended as follows:
“1. Equipment and implements in direct contact with foods must be manufactured in such a manner as to satisfy production technology requirements; ensure safety and avoid food contamination.”
4. Some Points and Clauses of Article 27 of the Decree No. 77/2016/ND-CP are amended as follows:
a) Point a Clause 2 of Article 27 is amended as follows:
“a) provide sufficient equipment for washing and sterilization prior to food production.”
b) Point b Clause 3 of Article 27 is amended as follows:
“b) Equipment and implements must be made of materials that are non-toxic, do not allow migration of toxic substances and cause strange smell or food changes.”
5. Clauses 1 and 2 Article 28 of the Decree No. 77/2016/ND-CP are amended as follows:
“1. Persons who directly participate in the food production must be trained in food safety and their participation in training courses must be confirmed by the owner of the production establishment
2. Persons who directly participate in the food production must satisfy health conditions; do not contract cholera, dysentery, typhoid, hepatitis A, bacterial skin infection, tuberculosis and acute diarrhoea.”
6. Clauses 4 and 5 Article 29 of the Decree No. 77/2016/ND-CP are amended as follows:
“4. Raw materials and food products must be packed and preserved at 10 cm, 30 cm and 50 cm or more from the floor, the wall and the ceiling respectively; they must be stacked in the warehouse at the stacking height recommended by the food producer.
5. There should be equipment for adjusting temperature, humidity, air ventilation and elements affecting the food safety; appropriate specialized equipment for monitoring and controlling mode of preservation of each type of foods/ materials at the request of producers.”
7. Clauses 7 and 8 Article 30 of the Decree No. 77/2016/ND-CP are amended as follows:
“7. Floors must be flat, smooth, non-slip and well-drained without pooled or standing water.
8. Walls and ceilings must be flat and impervious to water, not be cracked and adhered by dirty substances, and facilitate cleaning.”
8. Clause 1 Article 31 of the Decree No. 77/2016/ND-CP is amended as follows:
“1. Equipment serving the food trading and storage must be conformable with requirements applied to each type of foods and those of the food producer.”
9. Clause 1 Article 32 of the Decree No. 77/2016/ND-CP is amended as follows:
“1. Persons directly selling foods must satisfy the conditions set forth in Clauses 1 and 2 Article 28 of this Decree”.
10. Clause 1 Article 33 of the Decree No. 77/2016/ND-CP is amended as follows:
“1. The food safety condition applied upon food preservation is specified in Clause 4 Article 29 of this Decree.”
11. Point a Clause 8 Article 34 of the Decree No. 77/2016/ND-CP is amended as follows:
“a) Raw milk warehouses:
Milk purchasing stations must have chilling system, equipment, implements and chemicals to test the quality of raw milk, and must keep samples of purchased milk; raw milk tanks must have a heat-resistant layer and inner layer made of migration-resistant materials and be maintained at a temperature of 4°C-6°C; the raw milk storage period, from the start of milking to the processing, must not exceed 48 hours; the tanks should be cleaned to ensure food safety before use.”
12. Clause 10 is added to Article 35 of the Decree No. 77/2016/ND-CP as follows:
“10. Regulations laid down in Article 27 of the Decree No. 77/2016/ND-CP shall be complied with.”
13. Some Points and Clauses of Article 36 of the Decree No. 77/2016/ND-CP are amended as follows:
a) Point d Clause 3 of Article 36 is amended as follows:
“d) The area where fermentation tanks are located:
- In case yeast is produced in the production area, the workshop where the yeast propagation is carried out must be sterile and equipped with a disinfection system, and the equipment therein shall be placed under constant control to ensure yeast quality;
- In case the yeast is produced outside the production area, equipment should be in place to ensure yeast safety and avoid bacterial contamination during the process of yeast delivery and receipt.”
b) Point a Clause 7 of Article 36 is amended as follows:
“a) Solid wastes:
Brewing grains shall be cleanly collected once every 48 hours to avoid cross-contamination during the production process;”
14. Clause 8 Article 37 of the Decree No. 77/2016/ND-CP is amended as follows:
“8. Filling equipment must be covered to prevent harmful elements during the operation thereof and a procedure must be in place to clean and disinfect such equipment.”
15. Clause 6 Article 38 of the Decree No. 77/2016/ND-CP is amended as follows:
“6. Solid wastes:
Waste oil, after pressing and extraction, must be collected into a separate area with an area appropriate to the design capacity of the production line and cleaned every 48 hours for avoidance of cross-contamination during the production process.”
16. Point b Clause 9 Article 38 of the Decree No. 77/2016/ND-CP is amended as follows:
“b) Filtration of vegetable oil
The filling process must be observed by equipment or human to ensure quantity, quality and food safety.”
17. Clause 4 Article 39 of the Decree No. 77/2016/ND-CP is amended as follows:
“4. Filling equipment must be covered to prevent harmful elements during the operation thereof and a procedure must be in place to clean and disinfect such equipment.”
Article 11. Repeal of some Articles and Clauses of the Government’s Decree No. 77/2016/ND-CP dated July 01, 2016 on amendments to some regulations on business conditions in international trade in goods, chemicals, industrial explosives, fertilizers, gas business and food business under the state management of Ministry of Industry and Trade
1. Points a and b Clause 1, Point d Clause 2, Point a Clause 5, Point a Clause 6, Clause 7 and Point a Clause 8 of Article 26 are repealed.
2. Point b Clause 2, Point c Clause 3 and Point a Clause 4 of Article 27 are repealed.
3. Clause 3 of Article 28 is repealed.
4. Clauses 1 and 2 of Article 30 are repealed.
5. Clause 2 of Article 32 is repealed.
6. Point dd Clause 5, Point c Clause 8, Points b and d Clause 9, Clauses 10 and 11 of Article 34 are repealed.
7. Clauses 2, 3, 5 and 8 of Article 35 are repealed.
8. Point b Clause 3, Point dd Clause 5, Points a and b Clause 8, Points a and b Claus 9 of Article 36 are repealed.
9. Points a and b Clause 4, Clause 5, Clause 7 and Clause 10 of Article 37 are repealed.
10. Points b and dd Clause 4, Point c Clause 7, Point a Clause 8, Point c Clauses 9 and 11 of Article 38 are repealed.
11. Clauses 3, 5 and 7 of Article 39 are repealed.
Article 12. Article 24a is added after Article 24 of the Decree No. 77/2016/ND-CP as follows:
“Article 24a. Application for issuance of the certificate of food safety
1. An application for issuance of a new certificate includes:
a) An application form, which is made using the Form No.01a in the Appendix enclosed with this Decree;
b) A copy of the Enterprise registration certificate or Investment certificate or Business registration certificate;
c) A description of infrastructure, equipment and implements meeting food safety requirements, which is made using the Form No. 02a (if the applicant is a food producer) or Form No. 02b (if the applicant is a food seller) or both Forms (if the applicant is a food production and trading establishment) in the Appendix I enclosed with this Decree;
d) A list of physically fit persons, which is certified by the applicant’s owner or certificates of fitness of the applicant’s owner and persons directly participating in the food production and trading, which are issued by the health facility at district level or higher;
dd) Certificates of training in food safety of persons who directly participate in the food production and trading, which are confirmed by the applicant’s owner.
2. Application for re-issuance of the certificate
a) In case of applying for re-issuance of the certificate due to loss or damage, the application includes:
An application form, which is made using the Form No.01b in the Appendix enclosed with this Decree.
b) In case of applying for re-issuance of the certificate due to change of the production and/or business location; change or addition of the production procedure or merchandise; or expiry of the certificate, the application includes:
- An application form, which is made using the Form No.01b in the Appendix enclosed with this Decree;
- The documents specified in Clause 1 Article 12 of this Decree.
c) In case of applying for re-issuance of the certificate due to change of the name of the applicant without change of its owner, address, location, production procedure and merchandise, the application includes:
- An application form, which is made using the Form No. 01b in the Appendix I enclosed with this Decree;
- A copy of the issued certificate of food safety (which is confirmed by the applicant’s owner);
- Documentary evidence for change of the applicant’s name.
d) In case of applying for re-issuance of the certificate due to change of the applicant’s owner without change of its name, address, location, production procedure and merchandise, the application includes:
- An application form, which is made using the Form No. 01b in the Appendix I enclosed with this Decree;
- A copy of the issued certificate of food safety (which is confirmed by the applicant’s owner);
- A copy of the list of physically fit persons, which is certified by the applicant’s owner or copies of certificates of fitness of the applicant’s owner and persons directly participating in the food production and trading, which are issued by a health facility at district level or higher (which is confirmed by the applicant’s owner).”
3. The applicant for issuance of the certificate of food safety shall submit the application to the competent authority, whether in person, by post or online.”
Article 13. Article 24b is added after Article 24a of the Decree No. 77/2016/ND-CP as follows:
“Article 24b. Procedures for issuance of the certificate of food safety
The competent authority shall receive and inspect the legitimacy of the application, carry out a site inspection and issue the certificate of food safety. Procedures for issuance of the certificate of food safety:
1. In case of issuance of a new certificate of food safety
a) Receive and inspect the legitimacy of the application
Within 05 working days from the receipt of the application, the competent authority shall inspect its legitimacy; if it is not satisfactory, the competent authority must request the applicant in writing to supplement it. If the application fails to supplement or insufficiently supplement the application within 30 working days from the date on which a written request is made, the application will be invalidated.
b) Establish an inspectorate
Within 15 working days from the date on which the received application is inspected and certified satisfactory, the competent authority shall organize a site inspection. If an inferior authority is authorized to carry out the site inspection, a written authorization is required. After the inspection is done, the inferior authority must send an inspection record to the superior authority to form the basis for issuing the certificate of food safety.
The inspectorate shall be established by the issuing authority or the authority authorized to carry out the site inspection. An inspectorate is comprised of 03 – 05 members, at least 02 of whom are specialized in foods or food safety (obtain academic qualifications in foods or food safety) or in food safety management. The inspectorate is entitled to invite independent experts who acquire appropriate professional qualifications. The chief of the inspectorate shall take responsibility for results of site inspection.
c) Carry out the site inspection
- Inspect the consistency of the documents included in the application for issuance of the certificate of food safety submitted to the competent authority with their originals kept by the applicant;
- Assess the satisfaction of food safety conditions by the applicant.
d) Give the site inspection result
- The inspection result which is “Passed”, “Partially passed” or “Failed” must be specified in the inspection record 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 both Forms if the applicant is a food manufacturing and trading establishment.
The certificate of food safety is issued to a general food trading 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, reasons shall be included in the inspection record. If the “Partially passed” result is given, rectification must be completed within 60 days from the date on which the inspection record is obtained. After the rectification has been done at the request of the inspectorate, the applicant shall submit a rectification report made according to the Form No. 04 in the Appendix I enclosed with this Decree and pay inspection fees to the competent 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 carried out within 10 working days from the date on which the rectification report is received. If the applicant fails to submit the rectification report, 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 rectification report is not sent by the prescribed rectification deadline, the competent authority shall request local the local authority in writing to supervise and request the applicant not to operate until it obtains the certificate of food safety.
- The site inspection record shall be made into 02 equally authentic copies, among which one is kept by the inspectorate and the other is kept by the applicant.
dd) Issue the certificate of food safety
Within 05 working days from the date on which the “Passed” result is given, the competent authority shall issue the certificate of food safety made according to the Form No. 05a (if the applicant is a food producer) or Form No. 05b (if the applicant is a food seller) or Form No. 5c (if the applicant is a food production and trading establishment) in the Appendix I enclosed with this Decree.
2. In case of applying for re-issuance of the certificate due to loss or damage
Within 03 working days from the receipt of the satisfactory application, based on retained documents, the competent authority that issued the certificate of food safety to the applicant shall consider re-issuing the certificate of food safety. In case of rejection of the application form, explanation shall be provided in writing.
3. In case of applying for re-issuance of the certificate due to change of the production and/or business location; change or addition of the production procedure or merchandise and expiry of the certificate.
Procedures for issuance of the certificate of food safety are specified in Clause 1 of this Article.
4. In case of change of the applicant’s name without change of its owner, address, location, production procedure and merchandise.
Within 03 working days from the receipt of the satisfactory application, based on retained documents, the competent authority that issued the certificate of food safety to the applicant shall consider re-issuing the certificate of food safety. In case of rejection of the application form, explanation shall be provided in writing.
5. In case of change of the applicant’s owner without change of its name, address, location, production procedure and merchandise.
Within 03 working days from the receipt of the satisfactory application, based on retained documents, the competent authority that issued the certificate of food safety to the applicant shall consider re-issuing the certificate of food safety. In case of rejection of the application form, explanation shall be provided in writing.
6. If there has been an increase in the number of food trading establishments of a chain of food trading establishments, adjustment to the certificate of food safety shall be made in accordance with Clause 1 of this Article. If there has been a decrease in the number of food trading establishments of a chain of food trading establishments, adjustment to the certificate of food safety shall be made in accordance with Clause 4 of this Article.
7. The site inspection of establishments that manufacture and sell food products 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 regulations on respective business lines and sectors.”
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