Order and procedures for granting certificates of establishments meeting food safety conditions for food production and trading establishments under the authority of the Ministry of Health

1. Legal grounds
– Law on food safety and hygiene 2010;
– Decree 15/2018/ND-CP dated February 2, 2018 detailing the implementation of a number of articles of the law on food safety;
– Decree 155/2018/ND-CP dated November 12, 2018 amending and supplementing a number of regulations related to business investment conditions under the state management of the Ministry of Health;
– Circular 43/2018/TT-BCT dated November 15, 2018 regulating food safety management under the responsibility of the Ministry of Industry and Trade;
– Circular 13/2020/TT-BCT dated June 18, 2020 amending, supplementing and abolishing a number of regulations on business investment conditions in the field of state management of the Ministry of Industry and Trade;
– Decision No. 135/QD-BYT dated November 15, 2019 on amending and supplementing new administrative procedures promulgated in the field of food safety and nutrition under the management function of the Ministry of Health economic.

2. Cases in which a Certificate of establishments meeting food safety conditions must be applied for food production and trading establishments under the Ministry of Health’s jurisdiction.
According to Article 11, 12 of Decree 15/2018/ND-CP, all food production and trading establishments must have a Certificate of eligibility for food safety when operating, except for the following cases: :
– Small initial production;
– Producing and trading in food without a fixed location;
– Small processing;
– Retail food business;
– Trading in prepackaged foods;
– Producing and trading in tools and materials for food packaging and storage;
– Restaurant in the hotel;
– The collective kitchen does not have a registered food business;
– Trading in street food.
– The establishment has been granted one of the Certificates: Good Manufacturing Practice (GMP), Hazard Analysis System and Critical Control Point (HACCP), ISO 22000 Food Safety Management System, Standard International Food Standard (IFS), Global Standard for Food Safety (BRC), Food Safety System Certification (FSSC 22000) or its equivalent.
Although these establishments do not need to be issued a Certificate to operate, they still have to comply with the requirements of the corresponding food safety assurance conditions.

3. Conditions for granting the Certificate of eligibility for food safety
Food production and trading establishments must have a Certificate of eligibility for food safety when operating, except for the case specified in Clause 1, Article 12 of Decree 15/2018/ND-CP (an establishment that does not meet food safety requirements). subject to a certificate of eligibility for food safety):
– Having sufficient conditions to ensure food safety suitable to each type of food production and trading as prescribed in Chapter IV of the Law on Food Safety and Hygiene;
– Having registered the food business lines in the Business Registration Certificate.
Particularly for establishments producing health foods, they must comply with the requirements specified in Article 28 of Decree 15/2018/ND-CP.

4. Profile
4.1. Number of records: 01 set
4.2. Profile composition
– An application for a Certificate (Form 01, Appendix I of Decree 155/2018/ND-CP);
– A copy of the manufacturer’s business registration certificate or business registration certificate with lines suitable for food (with the establishment’s certification);
– An explanation of the facilities, equipment and tools to ensure food hygiene and safety conditions;
– A health certificate of the establishment’s owner and the person directly producing and trading food, issued by a medical facility at the district level or higher;
– List of food producers who have been trained in food safety knowledge, certified by the establishment’s owner.

5. Order and procedures
Step 1: Make a dossier and submit it through the online public service system or by post or at the application-receiving agency.
Step 2:
– In case there is a request to amend or supplement the dossier, the receiving agency shall notify in writing the establishment within 05 working days from the date of receipt of the complete dossier;
– In case more than 30 days after receiving the notice, the establishment fails to supplement or complete the dossier as required, the dossier of the establishment is no longer valid. Organizations and individuals must submit a new application to be granted a Certificate if there is a need;
– In case there is no request to amend or supplement the dossier, the dossier-receiving agency is responsible for establishing an appraisal team or authorizing the appraisal and making a minutes of appraisal according to Form No. 02, Appendix I attached to this Decree. 155/2018/ND-CP within 15 working days from the date of receipt of complete dossiers. In case of authorizing the appraisal to a lower-level competent agency, a written authorization is required;
– The appraisal team established by the agency competent to issue the Certificate or the agency authorized to appraise and issue the decision to establish has from 3 to 5 people. Including at least 02 members working on food safety (can invite experts in the field of food production of the establishment to join the establishment appraisal team);
– In case the appraisal results are satisfactory, within 05 working days from the date of getting the appraisal results, the agency receiving the application for Certificate shall be issued according to Form No. 03, Appendix I issued with this Decree. Decree 155/2018/ND-CP;
– In case the appraisal results at the establishment are unsatisfactory and can be remedied, the appraisal team must clearly write the contents, requirements and remedial time in the appraisal minutes with a time limit of not exceeding 30 days. .
After the establishment’s report on remedial results, within 5 working days, the appraisal team evaluates the remedial results and writes the conclusions in the appraisal minutes. In case the remedial results are satisfactory, a Certificate will be issued. In case the remedial results are unsatisfactory, the application-receiving agency shall notify the unsatisfactory appraisal results in writing to the establishment and to the local management agency;
In case the appraisal results are unsatisfactory, the application-receiving agency shall notify in writing the supervisory local management agency and request the establishment not to operate until the Certificate is issued.
In case the name of the enterprise is changed or the owner of the establishment is changed, the address is changed but the location and process of food production and food service business is not changed, and the certificate must be valid, the establishment shall send the notify the change of information on the Certificate and attach a copy of the legal document showing such change to the application-receiving agency that has issued the Certificate through the online public service system or by post or at the receiving office.

6. Agency implementing administrative procedures: Department of Food Safety

Above is the advice of Khoa Tin Law on: “Sequence and procedures for granting certificates of establishments meeting food safety conditions for food production and trading establishments under the authority of the Ministry of Health.”
In case customers have unclear issues or need to discuss further, please call us immediately at 0983.533.005 for a free consultation.

Best regards./.