Is the certificate of food safety and hygiene mandatory to a bakery?

My name is Do Thi L. (23 years old) currently living and working in Da Nang city. I'm a bread maker so I want to open a bakery for manufacturing and selling bread and desserts. So, do I need to obtain the certificate of food safety and hygiene? What conditions I have to meet for being exempted from the certificate of food safety? Sincerely thank you!

FDVN’s opinions:

Thank you for concerning FDVN legal services. Base on your consulting requirements, after studying the legal documents, FDVN Law Firm offers the following advice:

I. Exemption from certificate of food safety:

Pursuant to Clause 1 Article 11 of the Decree No. 15/2018/ND-CP on elaboration of some articles of the Law Of Food Safety (Decree No. 15/2018/ND-CP): “Every food manufacturer and seller must obtain the certificate of food safety, except for those specified in Clause 1 Article 12 of this Decree”.  According to Clause 1 Article 12, the following entities are not required to obtain the certificate of food safety:

“1. The following entities are not required to obtain the certificate of food safety:

a) Micro food manufacturers;

b) Mobile food manufacturers and sellers;

c) Micro food processors;

d) Micro food sellers;

dd) Sellers of prepackaged foods;

e) Manufacturers and sellers of instruments and materials for wrapping and storing food;

g) Restaurants within hotels;

h) Industrial kitchens not registered as a food business;

i) Street food vendors;

k) Any food business that has one of the following certificates: GMP, HACCP, ISO 22000, IFS, BRC, FSSC 22000, or an equivalent certificate.”

Thus, if you are a micro bread seller, you don’t need to obtain the certificate of food safety and hygiene. Otherwise, you have to apply for this certificate.

II. Procedures to be granted food safety, hygiene certificate for the pastry production facility:

1. Conditions for food producers and traders:

According to Clause 1 Article 19 of Law on food safety in 2010, food producers and traders must meet the following conditions:

“a) Having suitable venues with appropriate areas and safety distance from toxic and contaminating sources and other harmful factors;

b) Having sufficient technically qualified water for food production and trading:

c) Having adequate appropriate equipment to process materials and process, package, preserve and transport different types of food: having adequate washing and sterilization equipment and tools, disinfecting fluid, and equipment for preventing and controlling insects and harmful animals;

d) Having a waste treatment system which operates regularly under the law on environmental protection:

dd) Maintaining food safety assurance conditions and keeping records of source and origin of food materials and other documents on the entire food production and trading process;

e) Complying with regulations on health, knowledge and practices of persons directly engaged in food production and trading.”

2. The application consists of:

(Pursuant to Clause 1 Article 4 of Circular No. 43/2018/TT-BCT on the food safety management by the Ministry of industry and trade)

“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).”

3. Procedures for the issuance of the certificate of food safety:

According to Clause 1 Article 5 of Circular No. 43/2018/TT-BCT, procedures for issuance of the certificate of food safety are as follows:

“a) Receiving and check 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.

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.

c) 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.

d) 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 established 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, an 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.

dd) 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 herewith.”

Above is FDVN Law Firm's opinion based on studying the relevant legal provisions. We hope that this opinion will be useful for you.

Legal advisor Dinh Thi Thong - FDVN Law Firm

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