PROCEDURES FOR OBTAINING CERTIFICATES OF FOOD SAFETY AND HYGIENE ELIGIBILITY FOR CIDER PRODUCTION FA

Legal situation: I would like to ask the lawyer, I am currently planning to open a large-scale cider production facility. Do I need a Certificate of Food Safety and Hygiene Eligibility to carry out this manufacturing activity? If it is required, what procedures should I follow to apply for the Certificate?

FDVN’s Opinion:

Thank you for submitting your question to FDVN Law Firm ("FDVN"). In response to your consultation request, after researching relevant legal regulations, FDVN would like to present our opinion as follows:

1. Legal regulations on cases requiring a Certificate of Eligibility for Food Safety

- A Certificate of Eligibility for Food Safety is a permit issued by a competent state authority to food production, business, and catering establishments that meet all legal requirements for food safety.

- A food production facility is an establishment that engages in one or more of the following activities: cultivation, livestock farming, harvesting, fishing, extraction, preliminary processing, processing, packaging, and storage to produce food.

- A food business establishment is one that performs one or more of the following activities: marketing, storage services, transportation services, or trading in food.

According to the provisions of Article 34 of the Food Safety Law of 2010 and Articles 11 and 12 of Decree No. 15/2018/ND-CP elaboration of some articles of the law of food safety, food production and business establishments must have a Certificate of Food Safety Conditions when operating, except in cases where the micro food manufacturers; mobile food manufacturers and sellers; micro food processors; micro food sellers; sellers of prepackaged foods; manufacturers and sellers of instruments and materials for wrapping and storing food; restaurants within hotels; industrial kitchens not registered as a food business; street food vendors; any food business that has one of the following certificates:  Good Manufacturing Practices (GMP), Hazard Analysis and Critical Control Points (HACCP), ISO 22000 Food Safety Management System, International Food Standard (IFS), Global Food Safety Standard (BRC), Food Safety System Certification (FSSC 22000) or an equivalent certificate.

In comparison to your case, since you are opening a large-scale liquor production facility and it does not fall under the exemptions for not needing a Certificate of Food Safety Conditions, you will need to carry out the procedures to obtain this certificate.

According to Number 2, Section II, Appendix IV of Decree No. 15/2018/ND-CP guiding the 2010 Food Safety Law, fruit-based liqueurs that you plan to produce fall under the jurisdiction of the Ministry of Industry and Trade.

2. The procedure for obtaining a Certificate of Food Safety Conditions includes the following steps

- Application for issuance of the certificate of food safety: (According to Article 4 of Circular No. 43/2018/TT-BCT stipulating food safety management by the Ministry of Industry and Trade).

+ The application for obtaining a Certificate of Food Safety Conditions should use Form No. 01a provided in Circular No. 43/2018/TT-BCT  tipulating food safety management by the Ministry of Industry and Trade.

+ 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 of Circular No. 43/2018/TT-BCT.

+ 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).

+ The certificate of completion of a 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). 

- The procedure for obtaining a Certificate of Food Safety Conditions, (According to Article 5 of Circular No. 43/2018/TT-BCT tipulating food safety management by the Ministry of Industry and Trade).

+ Step 1: Submit the application to the Ministry of Industry and Trade or the Department of Industry and Trade, depending on the liquor production capacity of the facility:

• For liquor production capacity of 3 liters or more per year, submit the application to the Ministry of Industry and Trade.
• For liquor production capacity of less than 3 liters per year, submit the application to the Department of Industry and Trade.

+ Step 2: Process the application

• The competent authority responsible for receiving and checking the validity of the application: 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.
• 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.
• Carrying out the site inspection: 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. 
• Giving the site inspection result: 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 provided in the Appendix enclosed of Circular No. 43/2018/TT-BCT. 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 in the Appendix enclosed of Circular No. 43/2018/TT-BCT and inspection fees to the regulatory authority so as to carry out the site inspection again in accordance with regulations laid down.

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.

+ Step 3: Issuing the certificate of food safety: Within 05 business days from the date on which the “Passed” result is given, the regulatory authority shall issue the certificate of food safety made according to the Form No. 05a (for a food manufacturer), the Form No. 05b (for a food seller), or the Form No. 05c (for an establishing manufacturing and trading foods) provided in the Appendix enclosed of Circular No. 43/2018/TT-BCT tipulating food safety management by the Ministry of Industry and Trade.

The above is the legal advice of FDVN related to your consultation request based on research of legal regulations. We hope FDVN's advice will be helpful to you.